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The Universal Prosthesis - Report February - November 2005

Feasibility of Written by:


Boudewijn Wisse

the Universal Below-knee Prosthesis


Mentors:
Johan Molenbroek
a Hands-Off PTB/TCB-Hybrid Prosthesis Marc Tassoul
Just Herder
with a Low-Expertise Fitting Method.
Delft University of Technology
Faculty of Industrial Design Engineering
The Netherlands
Preface

This report is about a quest to improve pros- In practice, this project is about the design
thesis for lower-limb amputees and is a result of a universal transtibial prosthesis. Imagine
of my graduation project. a comfortable, adaptable and adjustable leg
prosthesis, suitable for people with different
Although estimations vary wildly, it is cer- residual limb shapes and sizes! It could reach
tain that there are millions of limbless people at least some of the millions limbless, who
in the world. In 2002 I went to Sri Lanka to now cannot receive the health care and prod-
see if my expertise (product design) could uct they need. I hope my graduation project
help at least some of them. All my tries, trials will prove the universal prosthesis is feasible,
and adventures led to my graduation, of so production can be started and amputees
which this first report is lying in front of you. can be reached and benefit from this work.
I hope you will find the report informative
and inspiring. This report came into being from February
to May 2005, at the faculty of Industrial
It all started with a contest by Johan Design Engineering, at the Delft University
Molenbroek and Henk Kooistra, who asked of Technology in the Netherlands. I would
several groups of industrial design engineers like to thank Just Herder, Marc Tassoul and
to think about the land mine-victims in Sri Johan Molenbroek for their kind assistance
Lanka. I entered the “Design for All” com- and Wouter van Dorsser for his never ending
petition and was able to continue with an support. Every day I work on this project , I
internship in Sri Lanka. Now, two years and think about all the knowledge the people in
much thinking later, I started this graduation Sri Lanka taught me. Thanks again.
project.

II
The Universal Prosthesis
Summary Boudewijn Martin Wisse
TU Delft, 2005

The universal transtibial prosthesis is a below- volume-matching fit provides good control
over the prosthesis to the user.
Markets for the Universal Prosthesis include
knee prosthesis that can be fitted to the temporal, spare prostheses, and definite pros-

Approach
amputees residual limb by an inexperienced theses, especially for elder and still growing
person. Due to the lack of (time of) prosthetist The socket-pylon frame forms an exoskeletal children. When fully developed and opti-
in many countries, amputees world-wide can design, with good stiffness and strength. The mized, the Universal Prosthesis can be used
profit from better health care because of the pylon is connected to the foot by a connec- for amputees worldwide in all circumstances.
Universal Prosthesis. Nowadays, still one mil- tive component with a pivot point. In this Because of variations in residual limb shape,
lion people are in need of an artificial limb. way, dynamic alignment or alignment adjust- length and health, the Universal Prosthesis

Users
ments stay possible after the fabrication of is suitable for about 70% of the transtibial
the socket, though limited in respect to state- amputees in the target groups.
of-the-art modular endoskeletal designs.
The Universal Prosthesis primarily consists Suspension

Prostheses
is achieved by supracondy-
of a socket-pylon frame, a connective compo-
nent to the foot and a “liner” that will func-
lar brims. In cases where this suspension
is insufficient, a suspension sleeve can be
Price of the Universal Prosthesis can vary
tion as the inner and outer layer of the socket, widely and is dependent on the amount of
added.
and an injector. pieces produced a year. Market exploitation
in developed countries becomes commercially
The fitting procedure results in a prosthesis

Usage
During the fitting procedure the frame
that can be used daily, in the same way as
feasible at a price for the distribution kit that
transfers half the weight of the body of the is lower than 700 USD. Worldwide market
currently available designs. exploitation of the Universal Prosthesis
amputee to the residual limb’s pressure-toler-
ant areas. Then, a total contact fit is achieved becomes commercially feasible at prices of

Stragegy
by filling the inner and outer layer of the the 100-200 USD, dependent on the situation
socket with rigid Poly-Urethane foam. The of the users and the support of NGOs and
injector, that provides the foam, is basically Apart from the injector, which is part of the aid-funds. To reach these prices, development
a high-pressure aerosol spray with a special distribution kit containing all components, and organisation of the Universal Prosthesis
no tools are needed that can not be found from this report to European distribution

Criteria
nozzle.
in local hardware stores to fit the prosthe- and from that to worldwide distribution both
Because the frame loads the pressure toler- sis (basically, a saw and a screwdriver). The
Universal Prosthesis is independent of local
have to stay under 1,000,000 USD.
ant areas (in particular the patellar tendon)
and the injector pressurizes the inner space infrastructure which enables a broad and
of the socket during fabrication, the socket easy distribution.
is a patellar-tendon-bearing / total-contact-
bearing hybrid. (PTB-TCS-hybrid). This way, Page: III
maximal comfort is achieved. The precise,
Field studies have to prove the effectiveness
of the Universal Prosthesis and will provide
feedback for further improvements. These
field studies are the next big step towards
implementation. However, literature shows
that one prefabricated socket can already be
successfully used for 50% of the transtibial
amputees. Outcome is expected to indicate
that the Universal Prosthesis is suitable for
70-80% of the transtibial amputees.

Concluding, the development and implemen-


tation of the Universal Prosthesis is feasible.

IV
The Universal Prosthesis
Table of Contents Boudewijn Martin Wisse
TU Delft, 2005

1 Introduction___________________ 1 3.2 The Prosthetist and other 4.3 Components_ _________________ 33


Team Members in a 4.3.1 Basic Components: Socket________ 33

Approach
2 Project Background and Prosthetic Clinic_____________ 21 4.3.2 Basic Components: Pylon ________ 36
Approach_ _____________________ 2 3.3 Producer of Prostheses_______ 22 4.3.3 Basic Components: Foot/Ankle
System ________________________ 37
2.1 Time Line of Project and Design 3.3.1 Dutch Industry_ ________________ 22
4.3.4 Basic Components: Suspension ___ 40
Philosophy_ ___________________ 2 3.3.2 Worldwide Industry_____________ 22
4.3.5 Additional Components__________ 43

Users
2.2 The Need for More 3.3.3. Component and fitting prices_____ 23
4.3.6 Materials & Tools_ ______________ 44
Prosthetists___________________ 3 4.4 Biomechanics of
4 Transtibial Prostheses________ 24
2.3 Recommendation: The Universal Transtibial Prostheses________ 45

Prostheses
Prosthesis_____________________ 4 4.1 Types According to the Patients
Rehabilitation Stage__________ 25 4.5 Financial Issues &
2.4 Design Objective_______________ 5 Distribution_ _________________ 49
4.1.1 Removable Rigid Dressing - RRD__ 26
2.5 Project Approach______________ 5 4.1.2 Immediate Post Operative 4.5.1 To the Patient___________________ 49
Prosthesis - IPOP_ ______________ 27 4.5.2 To the Practitioner______________ 50

Usage
3 Actors and Users______________ 6 4.1.3 Removable Protective Socket - RPS 28 4.5.3 To the Producer_________________ 50
4.1.4 Temporary Prosthesis_ __________ 29 4.5.4 To Governmental Institutions_____ 50
3.1 The Patient____________________ 7
4.1.5 Definite Prosthesis______________ 30 4.6 Repair and Life-time_____________ 50
3.1.1 Anatomy of the Lower Limb_______ 7

Stragegy
3.1.2 Transtibial Amputations_ _________ 8 4.2 Structural Designs ___________ 31
3.1.3 Residual Limbs_ _________________ 9 4.2.1 Exoskeletal Structure____________ 31
3.1.4 Patients Posture and Principles 4.2.2 Endoskeletal Structure___________ 32
for Alignment___________________ 13

Criteria
3.1.5 Basic Biomechanics of Gait _______ 16
3.1.6 Gait Deviations_ ________________ 19
3.1.7 Special User Groups; children and
patients with a reduced activity level
20

Page: 
5 Life with a prosthesis - the 6 Ethics, Marketing and Design 7 Design criteria and requirements
amputee’s perspective_______ 51 Vision_________________________ 60 71

5.1 Preprosthetic care____________ 52 6.1 Ethics________________________ 60 7.1 Ten Design Criteria __________ 71
6.1.1 A World-wide Smart-tech product 60 7.2 Requirements for cycle 0:
5.2 Selecting the aid _____________ 53
6.1.2 Social-political consequences 60 6.1.3 The preparatory design
5.3 Alignment and rehabilitation 54 A product for the world__________ 61
trajectory____________________ 72
5.4 Daily routine: donning, 6.1.4 Production_____________________ 62
7.3 Criteria for cycle 1:
doffing and gait_ _____________ 55 6.2 Conclusions from the Sri
Market exploitation in
5.5 Statistics on functional Lankan test designs___________ 62
developed countries___________ 73
outcome and use______________ 58 6.3 Marketing ___________________ 63
7.4 Criteria for cycle 2:
5.6 Aftercare and concerns_______ 58 6.4 Substitute products and World market exploitation___ 75
competitive fitting methods___ 65
7.5 Additional goals______________ 76
6.4.1 Fabrication and fitting methods___ 65
6.4.2 Substitute products______________ 66
8 Discussion and conclusion
6.5 Vision of the fitting procedure
of part 1_ ____________________ 77
and usage_____________________ 67
6.5.1 Cycle 1 – for developed countries 67
9 Synthesis -
6.5.2 Cycle 2 – for developing countries 69
from idea to prosthesis_ ______ 79

VI
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

10 Ideas__________________________ 80 11.2 The soft socket _ _____________ 98 13 Recommandation_____________ 120


10.1 Idea generation_______________ 80 11.2.1 Fitting liner_ ___________________ 98 13.1 Fundamental research in

Approach
11.2.2 The Filler Material_ _____________ 99 prosthetics.__________________ 120
10.2 Idea discussion________________ 81
11.2.3 Adding pressure_______________ 101
10.3 Idea selection and integration 89 13.2 Improving the Universal
11.3 The connector_______________ 101 Prosthesis___________________ 121
10.4 Evaluation of the integrated
11.4 Resulting fitting procedure__ 104 13.3 Project continuation_ _______ 122
design and conclusion_________ 90

Users
11.5 Daily usage & Suspension_____ 105
11 Concept_______________________ 92 11.6 Production and price_________ 106 14 Conclusion___________________ 124
11.6.1 Production costs per part_______ 106 14.1 Strengths____________________ 124
11.1 The hard socket_ _____________ 92

Prostheses
11.6.2 Development costs_ ____________ 107
11.1.1 Selection of loadable and avoidable 14.2 Project progression__________ 125
area’s based on anatomy_________ 92 11.6.3 Marketing and Distribution costs 107
11.6.4 Conclusion____________________ 108
14.3 Final word___________________ 125
11.1.2 Determining the rough frame
shape._________________________ 93
R References___________________ 126

Usage
11.1.3 Optimizing the frame shape in 12 Evaluation___________________ 109
regards to the anatomy.__________ 94
12.1 Scoring criteria in comparison
11.1.4 Back to 3D_____________________ 95 F Figures & Tables List________ 127
with other prosthetic systems.___
11.1.5 Material choice_________________ 96

Stragegy
109
11.1.6 Mechanical properties___________ 97
12.2 Evaluation the concept against
the requirements.____________ 115

12.3 Model and Fit of the Frame__117

Criteria
12.4 Project evaluation___________ 119
12.5 Conclusions

Page: VII
The Universal Prosthesis
1 Introduction Boudewijn Martin Wisse
TU Delft, 2005

During previous projects [Wisse et al. 2002, The patient as well as the practitioner have II Synthesis
2003] it became clear that making, fitting and to use and feel comfortable with the univer- In this part the development of a proof-of-

Approach
aligning prostheses for patients can be a time sal prosthesis and are therefore the focus of principle concept of a universal socket is
consuming activity. A universal prosthetic the design process. In chapter 3 you will find described. Chapter 9 describes the followed
design for daily use could improve prosthetic a description of the actors and their relation- process to reach this result.
health care, but is not yet available. Chapter 2 ships.
explains the source of this problem.
The design of the universal prosthesis will It all starts with the right ideas. Altough a

Users
strong vision and general idea about how the
This is the first report of a project aiming to be based on existing knowledge, especially prosthesis should look like and function was
design such a prostheses. It exists of three from current designs. Chapter 4 discusses generated in Part I, a new set of ideas is for-
parts: current prostheses, existing types and their mulated to be sure that no good alternatives
fabrication.

Prostheses
I Analysis were overlooked (chapter 10).
II Synthesis
III Feasibility evaluation
The prosthetist needs to fit and align the This ideas need to be integrated into a new
prosthesis, but the patient needs to wear it fitting method and the components of which
daily. Chapter 5 discusses the daily use of the universal prosthesis is constructed. The
I Analysis current designs.

Usage
parts are optimized to ensure one integral
In the first part of this report, the analysis These analysis, combined with the strategic system in chapter 11.
and preconditions for this project can be
principles from chapter 6, result in chapter
found. It concludes with the possibilities and
7 in the requirements as will be used for the III Feasibility Study

Strategy
the design requirements for a universal pros-
thesis. This part will provide the information
design of the universal transtibial prosthe-
ses.
The concept has to be evaluated (chapter 12).
needed for the next phases in this research Will an universal prosthetic system become
project. Those with some background in
prosthetics and who are primary interested Finally, in chapter 8, the conclusion states
reality in the future? Chapter 13 gives some
recommendations and an overview about

Criteria
in the design requirements of the universal what needs to be done in the next phases of
what still needs to be done. Chapter 14 con-
prosthesis are referred to chapter 6 and 7. the project.
cludes with the answer to this question and
gives a notion about what the future might
bring.


2 Project Background and Approach

This chapter will describe how the need 2.1 Time Line of Project and Mainly because of our force analyses and
for a universal prosthesis was recognised.
It explains the underlying problem and the Design Philosophy international approach, we won the contest
and were able to continue our work in an
process that uncovered this problem. internship in Sri Lanka. During the intern-
While the project now focuses on a tech- ship, we worked at the Colombo Friends in
Those who understand the need for a uni- nologically advanced product, it started out
focusing on low cost, easy producible and
Need Society (CFINS), a non-governmental
versal prosthesis and are merely interested in organization (NGO). The CFINS provides pros-
the design analysis can skip to section 2.4. repairable prosthesis for use in developing thetic services all over Sri Lanka and uses
countries (see TABLE 2-1 and Appendix C for mainly the Jaipur Foot technology [Wisse et
an overview). al. 2003, p13]. Here we were able to build
and test some of our ideas from the contest.
In April 2002, Johan Molenbroek and Henk This resulted in a new design philosophy and
Kooistra started a “Design-for-All” contest in new designs, which we were able to present
which several groups designed a prosthesis at a World Congress of Alternative Medicine
for Sri Lanka. Of course, I was part of a team [Wisse et al. 2003]. Our results can be read in
that participated in this contest and the result the report: “The Alternative Prosthesis, final
was the report: “Prostheses for Sri-Lanka, report internship Sri Lanka 2002” [Wisse et
prostheses for tibial amputees focused on the al. 2003] (See appendix B for a summary of
3rd world “[Wisse et al. 2002] (See appendix the internship).
A for a summary of the design for all project).

(pre-) Sri Lanka This project


Time span Till December 2002 December 2004 till August 2005
Problem per- Number of produced prosthesis too Number of professionals too low
ceived low
Goal Prosthesis easy to manufacture from Universal prosthesis from plastics
basic materials
Target group Third world amputees Patients worldwide
Costs Extremely low costs Cost reducing through time

 Table 2-1: Project targets before and after the Sri Lanka internship [Adjusted from Wisse et al. 2003,
Chapter 5] (For a complete timeline see appendix C).
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

At the start of the internship, the design However, during the internship, we found 2.2 The Need for More
ideas were based on three basic forms, out that instead of producing prosthesis from
namely our redesign of the prosthesis by Inne aluminium, the advantages of using plastics Prosthetists

Approach
ten Have, the design by Michelle Kriesels and were needed. Plastics offer a lot of design
conventional prostheses. The prosthesis by freedom for a decent final product price (only The “Design-for-All” contest’s goal was
Inne consists of a long strap of metal, which at higher quantities, so the product needs to improving help for land-mine victims in Sri
can be folded to form a patellar bearing pros- be distributed to al least several countries). Lanka. However, because land mines are used
thesis [Wisse et al. 2002 for more informa- This design freedom is not only needed to in specific zones only, and Sri Lanka doesn’t

Users
tion]. We initially improved it by adding some provide a comfortable and stiff prosthesis, suffer from sliding landmasses, civilian cau-
parts. Michelle Kriesels also participated in but moreover to assist the user in fitting and salities are few. Still, the amount of amputees
the “Design-for-All” contest and her design alignment. With plastics, primary functions, is Worldwide an problem.
was based on (re)using bicycle parts to man- alignment functions and an adjustable shape
Worldwide

Prostheses
ufacture the prosthesis [Kriesels et al. 2002]. can be integrated in one product. Costs are there are about 15 million
Of modern conventional prosthesis, the mod- less an issue, as we see that US-Aid and other amputees (also see appendix F). With 39 per-
ular build-up (See section 4.2) and the patel- foundations have a “magical” 100$ border, cent of them living in the Asia’s, this area
lar tendon bearing principle (See section which they are ready to pay for in case of deserves special attention. In some coun-
4.3.1), were adopted to our designs. humanitarian distribution of a prosthesis tries land mines are a problem, though most

Usage
[Wisse et al. 2003]. common causes are accidents, diabetics,
cancer, infections and congenital deformities.
For a flowchart of the socket designs till now,
see Appendix D. Health care for the amputees is in many

Stragegy
cases insufficient. The production capacity is
low and there is a lack of experts (prosthetist)
to fit the prostheses. “It has been estimated
that it would require training up to 100,000
new prosthetists if conventional production

Criteria
methods are to meet the worldwide need”
[Michael 1994]. This results in a lack in
health care and aftercare. Although different
groups are thinking about (and working on)
this problem and developing alternatives, no
alternatives are available yet.

In general a better use of the prosthetists‘ 2.3 Recommendation: The For developing countries, the philosophy for
time will result in better overall care, more the universal prosthesis design could be as
patients helped, better aftercare and more Universal Prosthesis follows:
attention to difficult amputations and special
patients (such as children). As concluded in section 2.2, there is a need “A new concept for a everyday prostheses
for more prosthetists. could improve the situation of amputees.
Evidence shows possibilities for an adjust-
There is a worldwide need for the Given a certain amount of amputees and able, easy-to-fit but comfortable socket. The
prosthetist’s valuable time. the amount of care they need, the lack of more the patient can do himself, the fewer
prosthetists can be solved in three ways: prosthetists are needed, thus reducing the
1 Increasing the amount of prosthetists. lack of prosthetists. The higher quantities
needed for the newly reached amputees
2 Lowering the level of experience (knowl-
enable mass production. Costs are reduced.
edge) needed to be a prosthetist.
Distribution will speed up, because the need
3 Reducing the time asked per patient of the for the patient to travel to distribution points
prosthetists, which implies: is cancelled. This prosthesis can be produced
- Reducing the need for replacement. in developing countries, but has market
- Reducing the time per adjustment potential all over the world. It is especially
better suitable for children [Red: because it
The design and manufacturing of the pros- is adjustable and children and their residual
thesis is a time-consuming event for the limb keep growing].
prosthetist. Research trails and prototypes Ideally, the end users are capable of adjust-
strongly suggest that the prosthetist’s work ing the prostheses themselves. The product’s
can be more time-efficient with an alternative use should be self-explaining (e.g. by clues
design for transtibial prostheses, the univer- integrated in the product on how to use it).”
sal prosthesis. [Adapted from Wisse et al. 2003].

N ot only transtibial amputees will benefit


in such a way. The freed production capac-
ity can then be used to produce above knee
prostheses or orthoses.


The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

2.4 Design Objective the comfort of the prosthesis’s fit is the most 2.5 Project Approach
important functional outcome factor, this
It is clear that an easy-to-use, comfort- concept will focus on the development of the This project will consist of three phases,

Approach
able, adjustable and durable prosthesis for socket. that are parallel with the three parts of this
daily use could result in better health care report:
for amputees all over. However, the design Concluding, the aim of this project is to
- Analysis
requirements for a daily usable (definite) uni- design a concept of a universal prosthesis.
This concept will be used to assess if the pro- - Concept design
versal prosthesis are quite high. Much devel-

Users
duction of universal prostheses is feasible. - Feasibility assessment
opment is needed before the definite univer-
sal prosthesis is a reality.
In which the major tasks are:
Development of the universal prosthesis in - Analysing the possible markets and target

Prostheses
groups for a universal prosthesis.
stages (each with increasing design criteria)
(this phase)
is a solution. As becomes clear later in the
report, one possible stage is the universal - Formulating a set of requirements.
(this phase)
prosthesis for use as a temporal prosthesis.
Another possibility is developingthe prosthe- - Designing one or more concepts for (the

Usage
socket of) a universal prosthesis.
sis to be an avanced tool for prosthetists in
(second phase)
developed countries.
- Testing the best concept, preferably by testing
To determine which stages or scenarios are a physical model /mock-up of the socket.

Stragegy
(third phase)
beneficial to the project, this project starts
- Assessing the feasibility of universal prosthe-
with finding out what the possibilities are for ses in general and the concept in particular.
a universal prosthesis (solution -> problem) (third phase)
instead of finding the universal prosthesis as
the answer to a specific problem (problem ->

Criteria
solution).

The first step is to evaluate if the universal


prosthesis is a feasible product at all. Such a
feasibility study is most easily conducted at
the hand of a “proof-of-principle” design. As
suggested by the name, such a design proofs 
the concept of a universal prosthesis. Because
3 Actors and Users

An analysis of the properties and behav- The prosthesis is only part of the total care
iour of the actors is necessary to determine after an amputation and therefore in litera-
the better part of the design requirements. ture a team approach in rehabilitation of the
The user is the most important actor. In the patient is often mentioned [Seymour 2002,
case of prosthetics, the amount of actors is Chapter 3]. The team approach will be shortly
huge (see figure 3-1). The focus on the project discussed in 3.2.
will be on those actors who deal with the
prosthesis most intensively: the patient, the
prosthetist and the producer.
Amputee Revalidation TEAM
Traditionally, prosthetic designs were mainly
based on medical properties of the patient, Family Physician Nurse
especially the anatomy (of the residual limb)
and biomechanics. Only recently more atten- Support network Therapist Dietician
tion has been given to the production (the
modular design as discussed in section 4.2, is Occupation Social Worker
only developed in 1970 by the U.S. Veterans
Administration). Now, high tech (such as
Designer
microprocessor control of joints) solutions
are sought. [Seymour 2002, p7]. However,
till 2002, innovations for the patient or the
prosthetist, were sparse.

In this chapter the three most important Prosthesis


actors will be introduced: The patient (3.1),
the prosthetist (3.2) and the producer of com- Public Prosthetist
ponents (3.3). This chapter focusses on their
properties. Their actions will be discussed Suppliers Counsellor
Governament
later. Everyday use of the prosthesis by the
patient will be discussed in chapter 5. Most Insurances Eduction Component
use by the prosthetist will be discussed in Producer
chapter 4, together with the fabrication,
 alignment and fit of the prosthesis.
Figure 3-1: The prosthesis and its total context.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

3.1 The Patient 3.1.1 Anatomy of the


Lower Limb
Prosthetic design, selection and use starts Femur Illium

Approach
with a person who needs an artificial leg. Knowledge of the anatomy of Muscles

Some are born without limb (congenital defi- the lower limb is the basic: it Patella

ciency), others are amputated by trauma or provides insight in which func- Tendons
(Patella T)
disease. In case of the latter, the choice of tions are lost by the amputa-
amputation-level (3.1.2) is the most important Ischium
tion and is a major inspira-

Users
Tibia
for the eventual type of prosthesis and the tion in how to reintroduce
functional outcome of use. Transtibial ampu- them by means of a prosthesis. Fibula
tations are in about 70 percent of the cases Figure 3-2 shows the most men-
Femur
the best solution, resulting in a below-knee tioned bones and tissues. Calf

Prostheses
Muscle
stump -or better – a transtibial residual limb
(3.1.3). Scar

Of course, the primary purpose of a pros-


thesis is to improve the performance of func-

Usage
Patella
tional activities and mobility, including ambu-
lation. Some basic biomechanics of gait and Tubercle
of posture should be known (3.1.4 to 3.1.6).

Stragegy
Special user groups, children and patients
Gatroc-
Tibia
with a reduced activity level, have their own nemius Fibula
design requirements. They are introduced in
Peroneus
section 3.1.7 Tibialis tertius

Criteria
anterior
Tibials
Soleus posterior
Tarsal bones

Metatarsal bones
Figure 3-2: Bones of the lower limb (most right), mus-
cles (middle) and anatomy of the residual Phalanges
limb (below) [Adapted from IMT-Baghdad
and Wisse et al. 2002]. 
3.1.2 Transtibial Amputations most proximal to the transtibial are the knee-
disarticulation and the Syme amputation.
The term trans is used when an amputation The Syme amputation is an ankle disarticula-
extends across the axis of a long bone. When tion in which the heel pad is kept for good
two bones are involved, such as the tibia weight bearing. See figure 3-4. Transfemoral
and fibula, the primary bone is identified. (above-the-knee or thigh) amputations will
Transtibial is the proper term for a below- be mentioned as well, because biomechanics
the-knee amputation. Amputations between and solutions for transfemoral prostheses are
bones or through a joint are referred to as often comparable to transtibial amputations.
disarticulations. Requirements: The universal prosthesis
should fit most transtibial amputations, which
Levels implies a residual tibia length of at least 80
mm to 50% of the original length.
There are different levels of transtibial ampu-
tations (different types), namely short, stand-
ard and long (figure 3-4). During amputation
in a standard procedure, bone is cut shorter
than skin and muscle, so that the skin and
muscles can be folded over and the wound
can be closed well (figure 3-3).

S tandard transtibial amputation occurs


when between 20 and 50% of the total tibial
length is preserved. An elective amputation
in the middle third of the tibia, regardless of
measured length provides a well-padded and
biomechanical sufficient lever arm. An ampu-
tation shorter than 80 mm is not advised
because of the resulting small-moment arm,
ill-fitting of the prosthesis and the fact that
it makes knee extensions difficult. Long Figure 3-3: Amputation procedure [Seymour Figure 3-4: Different levels of transtibial amputa-
transtibial amputations result in poor blood 2002]. tion [Seymour 2002].
 supply in the distal leg. The two amputations
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Prevalence Because transtibial is the most common 3.1.3 Residual Limbs


Amputation is a common medical treatment level of amputation, the worldwide amount
of transtibial amputees is quite high. Where possible, the physicians will try to

Approach
all around the world. In most developed coun-
Unfortunately, reliable figures on the amount save the original limb of the patient. However,
tries the amputee point prevalence (amount of
of limbless (without a prosthesis) patients when tissue-saving techniques are no longer
amputees in one thousand residents) is about
aren’t available. However, our research in holding out, the practitioners will decide to
1.55 permillage and leg amputees make up
Sri Lanka shows that from the 40-160K amputate the patients leg. This results in a
about 1.33 permillage of the population (see
amputees (assume 80k) there, only about 10k residual limb, also called residua or stump.

Users
Appendix F for sources).
were provided a prosthesis. At least a million During the operation, the fibula is cut 20 mm
shorter than the tibia, so the calf muscle has
However, worldwide prevalence is much
limbless worldwide is very realistic assump-
tion. enough space to form a good stump. Compare
higher, about 2.44 permillage. figures 3-2 and 3-4.

Prostheses
Project: The universal prosthesis can be
In all zones, transtibial amputees form about used to provide European and US amputees
Residual limbs differ from patient to patient,
53% of the total amputees and about 65% of with an addition to their healthcare program.
not only in dimension, but also in skin condi-
all leg amputees. Calculations with these fig- However, to reach full potential, the project
tion, flexibility and strength. [Seymour 2002,
ures result in table 3-1. should aim to reach 1 million limbless world-
p38]. All these properties can change over

Usage
wide.
time.
Yearly figures from the UK show that the
percentage of lower limb amputations stay
constant in the next few years. Data from the

Stragegy
National Health Service shows that transtibial
amputations account for about 50% of all
6000 yearly amputations and congenital
deficiencies [UK NHS, 2005]. More figures of
prevalence can be found in Appendix F.

Criteria
Zone Population Transtibial
Amputees
Europe 450 M 370 K
U.S. 250 M 210 K
Worldwide 6,1 G 9,7 M

Table 3-1: Amount of amputees worldwide.
Development Measurement and Shape Requirements: The universal prosthesis
should fit all three basic residual limb shapes.
During the first 4 weeks, the residual limb Measurements of the residual limb can Residual limb lengths of 80 to 250 mm
will significantly change in shape and prop- be taken in many ways. In practice, only should be fitted comfortably. Circumferences
erties, mainly due to tissue-healing. Then, up basic measurements are taken, because in around the patellar tendon should be varied
to 6 months after the operation, the limb will most cases a plaster cast from the residual from 250 to 350 mm.
shrink to its final size. limb itself is used to shape interfaces of the
limb with prosthetic devices (see chapter 4).
Other changes in size may occur after Measurements are important to keep track
first 6 months. Some patients experience of the changes in the stump over time, espe-
changes during use (every day). Also, limbs cially during the first 6 months.
will change due to training and body-weight
increase or decrease. Common measurements are:
- Length from the tibial tubercle (or from the
Finally, skin conditions such as tissue middle of the patellar tendon) to the end of
damage, scar-forming, onset of callous spots the bone.
and oedema can change the shape of the - Length from the tibial tubercle (or from the
skin. middle of the patellar tendon) to the end of
the soft tissue.
Project: The universal properties of the pros-
thesis can be especially useful direct after - Circumferential measurements from 0 mm
the operation (during the first 6 months). (at the tibial tubercle or at the middle of the
patellar tendon) and than at every 40 mm
If the prosthesis can (also) be fine-tuned by
(downwards).
the patient, it can be used to adjust for small
daily shape-changes during day-to-day use These circumferential measurements are
(after 6 months). These adjustments should be also an indication for the shape of the resid-
very easy to do (few user actions). Slow, long ual limb (figure 3-5). In appendix G statistics
term changes (taking weeks/months) (e.g. are presented that show the measurements of
patient increases in weight) may be adjusted residual limbs in Sri Lanka. These measure-
for using a tool. ments give an indication of in which range
the prosthesis should be adjustable. A range
of 80-250 mm covers most of the amputa- Figure 3-5: Residual limb shapes: conical (a),
tions. cylindrical (b) and bulbous (c).
[Seymour 2002]
10
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Skin and Tissue Conditions Skin areas where these complications or Requirements: In situations were pressure
or friction on certain areas will cause pain
After the healing of the residual limb, most conditions occur, are often very sensitive to
pressure or friction. These areas should not or further complications, the universal pros-

Approach
patients are left with a scar. Also skin con- thesis must be able to avoid loading these
ditions may vary. Patient may have several be loaded (to much) by the prosthesis.
areas. The universal prosthesis should allow
area’s and combination of the conditions
mentionel in table 3-2: There are more factors that indicate possible or stimulate blood flow in the residual limb.
The socket has to make total contact with the
problems. A low temperature may indicate
residual limb to avoid oedema and invagina-
Other skin complications that can occur are: arterial insufficiency, abnormal warmth may

Users
tion.
abrasions (areas of skin breakdown), blisters indicate infection.
(mostly caused by friction), contact dermatitis
(inflammation), distal oedema (swelling) and Impaired sensitivity can lead to skin damage Preconditions: The patient has a reasonable
due to the lack of feedback to the patient. On

Prostheses
skin ulcerations. amount of loadable areas. The patient has a
the other hand, the patient may report phan- reasonable healthy residual limb. T
tom pain in stead of pain with a evident phys-
ical cause.

code condition explanation If the physician suspects blood flow problems,

Usage
t) tenderness over sensitivity, blood flow tests of the remaining extremity
NL: overgevoeligheid may indicate general health of blood flow.
a) adherence NL: aankleving Patients with blood flow problems cannot be
ignored, because most elderly amputations

Stragegy
i) invagina- to fold in so that an
tion outer becomes an are the result of reduced blood flow in the
inner surface, extremities (often due to diabetics).
NL: kloofvorming
“By the year 2005, the five countries with
c) callus a thickening of or a the highest incedence of diabetes will be

Criteria
hard thickened area India, China, the United States, Pakistan and
on skin, NL: eelt
Indonesia.” [ACA 2001, p79]
d) discolora- reduction of health
tion skincolor, NL: verk-
leuring
(nh) nonheal- NL: niet helend
ing
11
Table 3-2: Skin conditions.
Areas of Weight Bearing and Areas of Requirements: The universal prosthesis
should offer areas of pressure and areas of
Relief
relief according to the anatomy of the resid-
The tissue in the residual limb is more or less ual limb. In any case, load should be trans-
suitable for transferring load in certain areas. ferred to the patellar tendon.
The loadable areas can be seen in figure 3-6 . Preconditions: The patellar tendon, tissue
medial and lateral to the tibial crest, and
Areas of weight bearing include: tissue on the posterior is loadable.
- Patellar tendon
- Flare of the medial tibial condyle and the
anteriomedial aspect of the tibial shaft
- Anteriolateral aspect (pretibial group) of the
residual limb
- Midshaft of the fibula
- Gentle end-bearing if tolerated

Areas of relief include:


- Anterior and lateral edges of the lateral tibial
condyle
- Head and distal end of the fibula
- Crest and tubercle of the tibia
- Anterior distal end of the tibia

In general, relief areas include bony promi-


nences, areas of poor blood supply, or areas
that are near prominent nerves such as the
common peroneal nerve.

Figure 3-6: Pressure tolerant and sensitive areas. Most left: A scematic of sensitive (light red)
and tolerant (dark red) areas [Seymour 2002]. 4 Right: anterior, lateral, anterior
and medial view of a positive (cast), with pressure sensitive (red) and tolerant areas
(blue).
12
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

R ange of Motion 3.1.4 Patients Posture and Principles Static alignment is the alignment of the
The knee joint should allow enough move- for Alignment socket and foot. The physician uses a plumb
line from the centre of the posterior wall of

Approach
ment to properly use the prosthesis (range
of motion or ROM). Additionally, the patient Posture is the alignment of the body seg- the socket to a location about 10 mm lat-
needs at least the strength to move the pros- ments in space. To maintain upright posture eral to the centre of the heel. This alignment
thesis. Before fitting a prosthesis, the knee is (to stand), the body must counteract the maintains a fairly normal base of support
normally tested for: effects of gravity or other forces acting on and loads the more-pressure-tolerant areas
it. This involves muscles, ligaments, capsules on the medial residual limb rather than the

Users
- Anterior and posterior drawer and other soft tissue, bone and the nervous fibular head region. In the sagittal plane, a
- Medial and lateral (valgus and varus) stability system. plumb line should fall from the centre of the
- Crepitus (a peculiar crackling, crinkly, or grat- lateral wall of the socket to just anterior to
ing feeling or sound under the skin or in the In the case of an amputee wearing a pros- the front edge of the heel (figure 3-8).

Prostheses
joints) thesis that weighs less than the original limb,
- Recurvatum (hyper extension of the knee) the centre of gravity will shift proximally and
Preconditions: The range of motion of the away from the prosthesis. The amputee may
patient allows walking with conventional lean the trunk towards the uninvolved side to
prosthesis. compensate. For the best stability the line of

Usage
gravity should pass through the base of the
support (see figure 3-7).
Requirements: The prosthesis should not be

Stragegy
too light (<0.5 kg). Distal weight has more
inpact on the energy consumption and expe-
rienced comfort.
center of
gravity Prosthetic alignment is the position of a

Criteria
prosthetic socket in relation to foot and
knee. Alignment is performed in two phases,
a bench or static alignment based on estab-
lished guidelines and a dynamic alignment
based on the patient’s gait patterns to fine- Figure 3-8: Static alignment for a transtibial pros-
tune the device to achieve an optimal gait thesis.
Figure 3-7: Base of support. The size of the base A) In the frontal plane,
of support varies with a change in pattern.
B) In the sagittal plane. 13
foot position. [Seymour 2002] [Seymour 2002]
Static alignment of the transtibial socket Subjects seem to find a PTB socket omst Gravitational Force
usually includes 5 to 10 degrees of flexion of comfortable with a PTB-bar at 4 mm depth of Body-Weight
the socket. A residual limb in a socket with [kim 2003]. Furhtermore, according to Besser
vertical walls would easily slide up and down. [1992] 45% of the total body weight can be
Also, flexion allows greater exposure of the carried by the Patellar Tendon.
patellar tendon for weight bearing (figure 3-9
and figure 3-10).
Requirements: Alignment of the prosthesis
should allow more load to the medial resid-
ual limb rather than the fibular head region.
Alignment allows 5 to 10 degrees of flexion of
the knee (and the socket).The patellar tendon
should be loaded most.

A well dynamic aligned prosthesis will not


rotate while standing, due to the equilib-
rium between the ground forces and the
forces from the residual limb on the prosthe-
sis. However, during gait the forces are not
along the same line and the fit of the socket
becomes crucial to resist the rotation during
gait.

Figure 3-9: Inclination of the bulge of the PTB Figure 3-10: Forces on the patellar tendon
(see section 4.2) socket. The bulge increase because of the need to
provides more surface for weight compensate moments due to distance
bearing than the wall of the socket. a and b and because the inclination of
Note the relatively longer horizontal the force factor on the patellar tendon
component of the vector. [Seymour [Wisse et al .2002]
14 2002]
14
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Also, the line of gravity of the prosthetic


limb should run near or through the (knee)
joint, because otherwise the body must com-

Approach
pensate the resulting moments with muscle
activity. This is mostly achieved by linear
alignment. Figures 3-11 to 3-14 show linear
alignment (in contrast to angular alignment)
problems and their resulting forces.

Users
Requirements. Rotational alignment of the
prosthesis should result in a minimum of
rotational forces while standing, while pro-

Prostheses
viding enough rotational support during gait.
The line of gravity of the prosthetic limb
should run through the knee joint. This might
imply the need for linear alignment.

Usage
Figure 3-11: Alignment of the transtibial pros-
thesis in the sagittal plane, placing

Stragegy
the foot medial to the socket. This
placement tends to cause a rota-
tion of the socket that then places Figure 3-13: Alignment in the frontal plane.
pressure on the proximal medial Left: normal. Right: Foot placed to
and distal lateral residual limb. far backward, causing pressure on

Criteria
[Seymour 2002] the distal anterior part and proxi-
Figure 3-12: Alignment in the sagittal plane mal posterior part of the limb.
placing the foot lateral to the Figure 3-14: Alignment in the frontal plane.
socket, resulting in pressure on Left: normal. Right: Foot placed to
the fibular head and distal medial far forward. If the force though the
residual limb. [Seymour 2002] spocket fell posterior to the ground
reaction force vector, the prosthesis
15
would tend to rotate.
3.1.5 Basic Biomechanics of Gait Gait or ambulation can be defined as the
translation of the body from one point to
Terms another by way of bipedal motion (NL: gang,
pas, loop). In both walking and running there
For an explanation of the terms used to is a rhythmic displacement of body parts that
describe the type of motion, rotary motions maintains the person in constant forward
(such as flexion/extension, abduction/adduc- progression.
tion, etc), the planes in the body (frontal or
coronal, horizontal or transverse and sagittal) Normal gait is not easily defined. Therefore, Figure 3-16: Distance variables of giat. a) left step
and biomechanical concepts (such as axes literature sometimes speaks of accept-
of joint motion, instant axis of rotation, kin- length, b) left stride length, c) right
able gait. From a mechanical perspective, it
ematic chain, degrees of freedom), etc, I refer stride length, d) right step length, e)
would seem logical to take energy efficiency width of base support f) Right toe-out,
to standard reference books and figure 3-15. and force transmission as main criteria, but g) left toe-out [Seymour 2002]
in practise a naturally looking gait is most
important. Overall the amputee should
exhibit even step length, step timing and arm
swing. Walking speed is less important (also
see section 5.5).
Requirements: The prosthesis should allow
acceptable gait.

Period Phase Description


Stance Initial contact When the foot hits the ground
Loading Until the opposite foot leaves the ground
Midstance Until the body is over and just ahead of the support
Terminal stance To toe-off
Preswing Just after heel-off to toe-off
Swing Initial swing Until maximum knee flexion occurs
Midswing Until the tibia is vertical
Terminal swing Until initial contact
16 Figure 3-15: Planes of the body. [Seymour 2002] Table 3-3. Phases in gait. [Seymour 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Gait can be described from both a kinematic


and kinetic standpoint.

Approach
Kinematics
Kinematics is the classification and compari-
son of motions. In gait, the feet are moved in

Users
different phases (table 3-3).

In figure 3-16 the different distance vari-


ables, occurring during the gait phases, can

Prostheses
be seen.

To provide adequate weight acceptance, initial


contact
loading
response
mid-
stance
terminal
stance
prewsing initial
swing
mid-
swing
terminal
swing
single-limb support and limb advancement,
% of gait 0-2 0-10 10-30 30-50 50-60 60-73 73-87 87-100
the hip, knee, ankle and subtalar joints need cylce

Usage
to flex and rotate. Their range of motion rocker Heel Ankle Ankle Forefoot
(excursions) accompanying the phases of gait phase rocker rocker rocker rocker
can be found in table 3-4. knee extension; flexion; flexion to extension extension gravity gravity gravity
moment valgus valgus extension to flexion extend- linear flexing;
Apart from joint mobility other factors can ing; distract- decelera-

Stragegy
accelra- ing tion
affect normal gait. Among these are age, tion
strength, cardiovascular status, habit, cloth- knee 0 0-15 15-5 5-0 0-30 to 60 to 30 0
ing, psychological status (including fear of angle flexion flexion flexion flexion flexion flexion
falling) and factors that affect the location of ankle plantar- plantar- plantar- dorsiflex- dorsiflex- gravity gravity gravity

Criteria
the centre of gravity (COG) of the total body. moment flexion; flexion; flexion ion ion plantar- plantar- plantar-
valgus valgus todiorsi- flexing flexing flexing
Preconditions: The joint excursions during flexion
normal gait are the minimum required range ankle neutral 0-15 15 0-5 0-20 10 neutral neutral
angle plantar- planter- dorsiflex- planter- plantar-
of motion that is also needed for proper gait
flexion flexion to ion flexion flexion
with the prosthesis. 10 dorsi-
flexion

Table 3-4: Phases of the gait cycle of the right leg. [Adjusted from Seymour 2002] 17
Kinetics knee passively extends with relaxation of the
knee flexors.
Kinetics is the branch of mechanics that
Requirements: The prosthesis should allow
is concerned with the forces that cause
motions. The primary external forces acting enough stability with a lateral feet placement
on the body in normal gait are gravity and which resembles normal gait.
the ground reaction force. Muscles function Requirements: The energy-cost of use of the
to counteract these forces and to accomplish universal prosthesis should be comparable to
the forward progression of the body. current prostheses. The ankle-foot complex
should decrease the vertical excursion of the
During gait the COG moves side-to-side. centre of gravity. The prosthesis should be
Placing the feet further apart, thus creating light.
a wider base of support increases stability, Requirements: During swing, the toes may
but results in an increase in the side-to-side not hit the ground.
excursion of the COG and thus an increase in
energy cost.

The ankle/foot complex plays a very impor-


tant role in limiting the vertical excursion of
the COG. A greater excursion will increase
the energy required for gait.

At initial contact (see table 3-3), the critical


event for normal gait is that the heel should
contact the floor first. Once the foot hits the
ground, loading response occurs. In this
phase knee flexion and plantarflexion occur
for shock absorption. Hereafter, stability is
of utmost importance. Especially during ter-
minal stance, the gastrocsoleus contracts to
stabilize the advancing tibial and to raise the
heel (heel-off phase). During swing the mus-
cles of the anterior compartment prevent the Figure 3-17: Gait deviations to accommodate a long limb. A) Hip hiking, B) Lateral trunk lean, C)
18 toes to drag on the ground. In midswing, the Circumduction, D) Vaulting, E) Excessive hip and knee flexion. [Seymour 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

3.1.6 Gait Deviations With impaired sensory control in transtibial Requirements: The length of the universal
prosthesis should be adjustable. The pros-
amputees, the ability to know when the feet
Gait deviations are often the result of a ill- are in contact with the floor and to know thesis must provide enough and direct sen-

Approach
fitted or poorly aligned prosthesis. Other where the joints are in space is lost. A person sory information to the residual limb. The
common and often related causes include: with an amputation must rely on the sensory prosthesis should be easily trusted (win the
muscle weakness, deformity (of bone or soft input from the residual limb, a factor that patients confidence), especially during gait.
tissue), impaired control including sensory may affect the individual’s confidence in gait. Pain, especially from to much stress or strain
loss, pain, fear or anxiety. As a result, the walking speed (cadence) of in the tissues of the residual limb, should be

Users
individuals with amputations is lower than avoided.
Weakness of the residual limb with poor normal.
muscle tone can result in rotation of the soft
tissue and of the prosthesis itself over the Fear and anxiety are particular pertinent

Prostheses
underlying bone. It can also increase pres- contributors to gait deviations among those
sure. with amputations. Vaulting may occur if
there is a fear of stubbing the toe of the pros-
A common deformity is a leg length differ- thesis during swing. If there is a lack of con-
ence. Either the leg consisting of a residual fidence in the prosthesis, the individual may

Usage
limb and prosthesis or the other side is to try to get off the limb quickly, resulting in an
long. This can be caused by the prosthesis uneven step length.
itself (pylon to long), or by insufficient flexion
in the knee (or in the hip). Whatever the cause, Pain can develop from the stress and strain

Stragegy
it is more difficult to clear the ground during of the device on the tissues of the body and
swing. An individual has several options to can cause major gait deviations. The natu-
accommodate the long limb (Figure 3-17). An ral response to pain is to try to move away
additional option to accommodate is a wide from it, to take the weight or pressure off the
walking base, but walking this way is very painful area. For example, an individual with

Criteria
energy inefficient. pain of the distal residual limb may bend the
trunk laterally to get more weight of the area.
[Seymour 2002, p109-13]

19
3.1.7 Special User Groups; children Children Patients with a Reduced Activity
and patients with a reduced Children need a new prosthesis every six Level
activity level months. The universal prosthesis could Inactive, often elder patients are sometimes
improve their comfort, because changes in bound to their beds. If their prognosis is not
There are several special patient groups, that stump size are more often adjusted for. While bright, the practitioners might decide not
can benefit from a universal prosthesis. the load during stance is lower (lower body to make a prosthesis (due to costs). These
Project: These special user groups are being weight) their life-style if often very active people could benefit from the universal pros-
reviewed to see later on if the specific require- (many loading cycles). Children are very thesis. The load during stance is standard,
ments they have for the prosthesis can give demanding and impatient users, the prosthe- but the load cycles and total usage time are
the Universal Prosthesis an edge over current sis should be even more easy to use than in much less.
existing systems for these groups the case of adult patients. The standard range
of sizes the universal prosthesis would be
usable for might not be sufficient. A smaller
With these patients, the donning and doff-
ing should be very easy. Also, extra attention
version may be needed. to the blood flow in the residual limb should
be given.
Requirements: Design requirements may
vary for these special target groups.

20 20
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

3.2 The Prosthetist and The Prosthetist Pre-Prescription Examination

other Team Members in In this project, the prosthetist receives spe-

Approach
cial attention, because he or she is the team
a Prosthetic Clinic member who is most in contact with prosthe-
Prescription

ses. In general, the prosthetist’s function is to


design, fabricate and fit prostheses.
Team Approach Pre-Fitting Intervention

Considering Knowledge

Users
the amputation as an accom- and Education: To select, fit or
plished fact, a whole team of experts is train an individual in the use of a prosthe- Prosthetic Fabrication
needed to provide optimal rehabilitation of a sis, a practitioner must posses a basic under-
patient. The team should include the physi- standing of biomechanical principles, normal

Prostheses
cian, prosthetist, orthotist, physical and occu- alignment, movement and forces acting on Initial Check-out / Examination
pational therapist, vocational rehabilitation the body or body segment. In addition, an
counsellor, social worker, psychologist, rec- understanding of normal gait and common
reation therapist, dietician, nurse, the patient gait deviations is important. Prosthetics is a Prosthetic Training
and the patient’s family or support network. profession that combines specialized clinical

Usage
The key to any team is communication. The and technical skills.
patient should be regarded as the team leader Final Check-out or Examination
and have clear expectations of the rehabilita- Professionals are educated in these subjects
tion process. and may be certified as either an orthotist, a

Stragegy
prosthetist, or both. Return to Existing Employment
Procedures of a Prosthetic Clinic or
Prosthetist may own their own business as
The procedures of a prosthetic clinic are out- a sole proprietor or work as an employee in a Vocational Training
lined in figure 3-18. The better the prosthesis hospital, rehabilitation centre, research facil-

Criteria
ity, or private business. or
assists several of these procedures, the more
successful it will be. On the Job Training

Placement

Figure 3-18: Procedures of a prostetic clinic 21


[Adapted from Seymour 2002]
3.3 Producer of Prostheses import/export centre [IEEE 1998].
In the Western European market (1996), big
players are France (17%), Germany (32%), Italy
In contrast with e.g. shoe manufacturers, 3.3.2 Worldwide Industry (10%) and The UK (11%). The Netherlands
who sell a complete product direct to the only make up for 4,7% of the market. In the
end-user, the manufacturers of prostheses In 1996, the World market for medical European market, the orthopedic and pros-
sell system components and materials to the devices was estimated at US$ 94340 Million, thetic product category is a bit bigger: 18.5%
prosthetist, who fabricates the final product of which 15.5% is within the orthopedic and [IEE 1998]
for the patient. prosthetic product sector (= 14717 Million)
[IEE 1998] Total import to Western European countries
Big producers of prosthetic components of other artificial body parts than artificial
include Össur, Otto-bock and Endolite. A Over 90% of the world market for medi- teeth (dentistry) and orthopedic implants was
(more) complete list of producers can be cal devices and supplies consists of the worth about 600 million US$.
found in appendix I. regions USA (42%), Europe (28%), Japan and
Australia.
3.3.1 Dutch Industry
Sells of prosthetic devices in 2001 2002 2003
Industry figures show a healthy grow in the Netherlands
Dutch medical equipment industry (Table 3- (Million Euros) 57 85 80
5). Also, specific figures about the revenues
show a healthy industry (Table 3-5). Table 3-6: Market for prostheitc devices in the Netherlands [CBS 2005].

Industry statistics about the production of The sales of the industry 2000 2002 2003 2004
medical equipment and instruments, ortho- National 100 106 110 112
pedic devices, prosthesis and precision
Foreign 100 102 103 104
instruments. Dutch product price industry
index figures can be found in table 3-6 [CBS Total 100 103 105 106
2005]. The use of resources and
half-fabricates From National 100 103 105 108
The Dutch industry is a relatively big importer Foreign (import) 100 97 93 94
of medical devices: 2015 million US$ in 1996.
Total 100 99 97 99
The Netherlands only imported 30% from the
EU, but this is most likely due to the status Table 3-5: Grow indexes of the sales in the medical equipment industry in the Netherlands [CBS
22
of the Netherlands as a leading European 2005].
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

3.3.3. Component and fitting prices They calculated the following costs (in With an more realistic man/machine hour
Euros): pice of 100 Euros this would lead to the fol-
lowing costs:

Approach
COSTS FACTOR ICEX PTB
The costs for fitting a prosthesis to a user Prosthesists salary 27 39 COSTS FACTOR ICEX PTB
can vary wide and is dependent of many fac- Technicians salary 7 49 Prosthesists salary 125 175
tors such as: Transportation of the 44 88 Technicians salary 42 300

Users
- currency rates, patient Transportation of the 44 88
- place / country, Component costs 1100 300 patient
- hour costs /salary TOTAL 1180 476 Component costs 1100 300
- machnines and tools needed TOTAL 1311 863
However, it has to be noted that they calcu-

Prostheses
- facility needed
- etc, etc lated with an hour price for the technicians And the price-difference is much less.
and the prosthetists of 22 Euros. It is clear
that this calculation is without machine costs,
facilitation costs, etc etc.
To give some indication, the numbers from

Usage
the study by D. Datta et al [2004] are used. The needed times where as follows (min-
They compared the cost, tima and functional utes):
outcome implications for changing from

Stragegy
TIME NEEDED ICEX PTB
PTB to ICEX sockets. These commonly used
socket systems are described in chapter 4. Prosthesists 75 105
Technicians 25 180
TOTAL 100 285

Criteria
23
4 Transtibial Prostheses

The prosthesis is a device with perhaps the Components come into existence in the fac-
most important function in the total care tory and are assembled into a prosthesis
after an amputation. It restores some of the by the prosthetists. Because of wear and
lost functions of the amputated limb. To do changes in the patients situation, the pros-
so, it will (1) suspend the limb (weight bear- thesis sometimes need to be repaired (4.6).
ing), (2) give the patient stability (balance),
(3) allow an acceptable gait (ambulation), (4)
prevent further deformations of the body
and (5) provide some sociopsychological
support (cosmetics) for the patient. The
choice of prosthetic design is therefore very
dependent on the patient’s rehabilitation
stage and prognosis (section 4.1).

Almost all current prostheses are build-


up from pre-fabricated components and a
custom-made socket (4.2). The fabrication
supplies, in orthopaedics often called mate-
rials, and the components are bought from
prosthetic device manufacturers and assem-
bled by the prosthetist. Generally, compo-
nents (4.3) offered by different manufactur-
ers don’t differ much, because their shape,
function and properties are dictated by
biomechanics(4.4) and the anatomy of their
users. Components and professional care
are not cheap, but social services enable
most Western patients to acquire the right
prosthesis (4.5).

24 24
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.1 Types According to the -


-
Immediate Postoperative Prosthesis (IPOP)
Early Postoperative Prosthesis (EPOP)
The prosthesis that is used for gait training
is in almost all literature referred to as the
Patients Rehabilitation - Immediate postoperative prosthetic fittings temporary prosthesis. Terms which also refer

Approach
Stage -
(IPPF)
Custom Removable IPOP
to temporary prostheses are:
- Universal Prosthesis
There are three types of prostheses (interim, - Weight Bearing Rigid Dressing (WRD)
- Prefabricated Prosthesis (PFP)
temporary and definite) each appropriate - Removable Rigid Dressing (RRD)
- Preparatory Prosthesis
- Post Surgical Prosthesis (PSP)

Users
for different stages after amputation. These
stages can be determined by the health of - Removable Protective Socket (RPS) The prosthesis that the patient will use finally
the wound and the dressing that the wound - Protective Prosthesis is called the definite or permanent prosthesis.
needs to heal. A clear definition is difficult. - Early Fitting Prosthetic Socket

Prostheses
In practise, the period in which a certain - Early Ambulatory Prosthesis
prosthetic type can be used overlaps several
- Early Rehabilitation Prosthesis
rehabilitation stages. Table 4-1 gives an over-
- Adjustable Postoperative Protective and
view.
Preparatory System (APOPPS) – FLO-Tech.

In - Initial Prosthesis

Usage
this section descriptions of these pros-
thesic types are given. While many terms
are employed, the designs that are used in Start use after sur- Used till (after surgery) Prosthesis type / Compression
the early stages following amputation (in this
Direct 1 months (wounds heal) Soft and semi-rigid dressings

Stragegy
report referred to as interim prostheses) are
very similar in function. 0 to 1 weeks 1 months (incision heals) Rigid dressing interim, partial
load possible
Other terms used for Interim Prosthesis
5 to 21 days 3 months (incision and sutures Rigid dressing interim, complete
include (common abbreviations are added in
healed) loading possible
brackets):

Criteria
10 to 21 days 6 months (residual shape almost Removable Protective interim,
stable) compression needed during use
1 to 3 months 6 months (residual shape stabilizes) Temporary, compression during
night
3 to 6 months Prosthesis wears out Definitive

Table 4-1: An overview of clinical patient stage and applicable prosthesis type. In practise, the choice is
less time dependent, but is determined by the healing rate and activity level of the amputee. 25
4.1.1 Removable Rigid Dressing - Advantages: Very early load on the residual
limb, while wound inspection is still possible.
There are no commercial packages that offer
RRD a complete solution including a rigid dressing
It offers protection and access. Pre-ambula- and ambulation components.
The removable rigid dressing is a form of a tory training is possible (limited load), An
early start with patient education can be
dressing (also see section 5.1 for prepros-
made.
thetic care), which can be used very soon after
the operation. The problem with rigid dress- Disadvantage: Time consuming to make and
ings is that the wounds cannot be inspected fit and highly skilled personnel needed.
and attended to. A removable setup solves
this problem. The Removable Rigid Dressing
with integrated components for amublation is
called an custom removable IPOP. In contrast
with a conventional IPOP, it can be applied
before the patients’ incisions are closed (and
the sutures healed). Full load on the risidual
limb is not possible till the wound is closed
fully. Removable rigid dressings are always
made by the prosthetist. The procedure
includes making a rigid dressing, cutting it
open along specific lines and applying Velcro
bands (See figure 4-1). The materials needed
are standard and easily available.

Figure 4-1: Fabrication of a RRD and Custom Removable IPOP. Left: 3 spandex socks, pads and an
attachment plate, 3 velcro straps and attachment base plates. Middle: fiberglass cast with
cut lines and base plate attachment points and the result. Inset: anterior and posterior sec-
26 tions of the cast with gel pads. Right: Ambulation is possible, with weightbearing limited to
10-20 kg. [Walsh 2003]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.1.2 Immediate Post Operative Disadvantage: High skilled personnel needed. These inflatable IPOPs are far less time
Prosthesis - IPOP Wound inspection is difficult. consuming to apply to the patient and are
used in many Dutch revalidation hospitals.
Some companies sell universal IPOPs based

Approach
An IPOP (see figure 4-2) is a combination on air compression. These prostheses exist of
However, the residual limb must be healed
of a rigid dressing, a pylon and a foot. It was fully, the inflatable IPOP cannot be used
developed in the late 60s. An IPOP is used a universal outer socket and insertable air- too long and the weight distribution cannot
while the residual limb still changes shape cells. An example can be seen in figure 4-3. be controlled. Therefore the inflatable IPOP
fast, but the incision of the operation is cannot be applied to all patients.

Users
healed and the sutures removed.

In the first place, an IPOP can provide the


psychological and physiologic benefits attrib-

Prostheses
uted to walking soon after the amputation.
The early use of an IPOP is attributed many
other advantages to the patient (although
not by all researchers), but (because fabri-
cation is time consuming and not easy), the

Usage
IPOP is little used. IPOPs are made by the
prosthetists in the hospital. While the orig-
inal design is based on a plaster cast (rigid
dressing), a fibreglass cast can also be used

Stragegy
to reduce weight.
Advantages: Control and shaping of the
residual limb, protection of the surgical site,
improving healing time, maintenance of resid-

Criteria
ual and sound limb and upper body strength,
reduction of contracture development, main-
tenance of cardiovascular status, early return
to balance and ambulation, social and emo-
tional support, shorter hospital stay, shorter
overall recovery time, quicker identifications Figure 4-2: A complete IPOP (without pylon). Figure 4-3: The universal IPOP (Aircast Air-limb)
of the patients functional levels [Seymour [Source: Seattle Rehab Research, US is inflatable to accomodate differ-
2002, p128]. Veteran Affairs] ent stump sizes. [source: ACA 2001, 27
4.1.3 Removable Protective Flo-tech also provides pre-fabricated protec-
Socket - RPS tive sockets (APPOP-system). Their system
exists of a flexible outer socket which allows
If a (rigid) dressing is no longer needed, gentle reduction of the socket’s overall cir-
but the residual limb still needs to be cumference. The mid-thigh design prevents
formed through compression, a com- knee flexion contractures. The Velcro bands
pression device (see section 5.1) can be help to shape the residual limb (see figure 4-
used in conjuncture with a removable 4).
protective socket. This socket is used
for patients with very easily damaged The Flow-Tech UFOS (Universal Frame Outer
residual limbs. Weight bearing toler- Socket ), also fits over the VCSPS (Variable
ance is gradually build, to enable the Circumference Supra Patellar Preparatory
patient to wear a firm definite prosthe- Socket), together forming a complete pre-
sis later [Seymour 2002, p138]. Over this paratory system to fit 80% of the transtibial
custom-fitted device a Universal Frame amputations. [Source: flow-tech brochures]
Outer Socket (UFOS) can be put to enable Disadvantage: Many sizes needed, expensive.
weight bearing (See figure 4-4).
Advantages: The residual limb is well
protected to additional trauma. The pres-
Figure 4-4: The Flow-tech Adjustable Postoperative sure and weight bearing tolerance of the
Protective and Preparatory System (APPOPS) provides a residual limb is gradually improved. The
prefabricated prosthetic system offering protection, con- socket and the Universal Frame Outer
trolled shaping of the residuum and early rehabilitation. Socket can be easily adjusted to accom-
The TOR (top left) is a prefabricated socket (available in modate each patient. Easy access for
22 sizes) that fits over elastic wrapping and bandages. hygiene.
The socket prevents knee contraction and provides pro-
tection for the residual limb. When fitted with a UFOS Disadvantage: Sockets custom made,
(universal frame outer socket, middle) it functions as an expensive.
interim prosthesis (top right). Full load and knee flexion
becomes possible with the VCSPS (bottom). Fitted with a
UFOS the VCSPS (available in 34 sizes) can be used as a
temporary prosthesis. [Source: Flow-tech Brochures]

28
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.1.4 Temporary Prosthesis The preparatory socket is normally created Some systems are said to be usable as
by using a plaster mould of the residual limb interim and temporary prosthesis, such as
The temporary prosthesis is a socket, pylon as a template ( just as with definite prostheses, the Maramed components (figure 4-5).

Approach
and foot system which is used when the compare figure 4-8). The other components,
patient wounds are fully healed, while the such as the pylon and the foot, are stand-
residual limb still changes its shape fast and ard available. In most cases, a SACH foot is
the socket needs to be replaced several times used (see section 4.3.3). The connective com-
as the volume of the residual limb stabilizes. ponents, such as the interface between the

Users
The temporary prosthesis came into exist- socket and the pylon, can be easily rotated.
ence in the 1970s, together with the develop- The alignment of the prosthesis is deter-
ment of the endoskeletal design (See section mined by the angle between the socket, pylon
4.2), which made the use of adjustable align- and foot.

Prostheses
ment components possible. It provides the
same functions as a definite prosthesis, but Most companies offer a wide range of
the alignment can be adjusted more easily by temporary components, because after the
the prosthetist to improve the patient’s gait. dynamic gait training the temporary parts
The patient can use the temporary prosthesis will be replaced by definite components (of

Usage
at home. However, in most cases the tempo- the same company). Also, many definite com-
rary prosthesis is not yet fitted with an opti- ponents can be adjusted quick enough to be
mal foot and additions such as a rotator or suitable for a temporary prosthesis, such as
shock-absorber (see section 4.3.5). Also, aes- the connective devices from Endolite (see

Stragegy
thetically the prosthesis is not finished yet figure 4-4 and section 4.3.5).
(e.g. no cosmetic cover) and the temporary
prosthesis could be heavier than a definite.
Advantages: Better control over the align-

Criteria
ment for the prosthetists, the socket needs to
be fabricated several times. Figure 4-6: Components of Maramed orho-
Disadvantage: The system might be heavier, pedic Systems. Left: X-tender
system can be used as a temporary
not all components can be fitted, the prosthe-
prosthesis(middle). At the right a
sis lacks cosmetics. Figure 4-5: Connective part between socket and retainer is shown, in which a custum-
pylon, which can be used in tempo- made socket can be attached. [Source:
rary and definite prostheses. [Source: Maramed website]
Endolite brochure] 29
4.1.5 Definite Prosthesis Normally, a plaster cast is made from the
residual limb, of which in turn a positive cast
The definite prosthesis is the prosthesis that is formed. This cast is then adjusted (see sec-
the patient will use in daily life. In most cases, tion 4.3.1) and the final socket is then fabri-
it highly resembles the temporary prosthesis, cated by either vacuum thermoforming or
now finished with a cosmetic cover or pros- applying epoxy resins (plastic lamination).
thetic skin (see section 4.3.5). The definite (See figure 4-8).
socket is difficult to adjust. When the residual
limb changes in shape or pressure sensitivity,
a new socket is needed.
Advantages: Firm fit and therefore the
best gait and control over the prosthesis.
Cosmetics are pleasing.
Disadvantage: Difficult to adjust.

The definite prosthesis is always fabricated


by the prosthetists. However, there is a wide
range of available materials and production
methods. The choice of these have a great
impact on weight (composites are very light),
adjustability (thermoforming plastics can still
be somewhat adjusted after fabrication by
applying local heat) and comfort. An interest-
ing commercial material is ICEX from Össur
which consists of carbon fibre enhanced
sheets that harden when mixed with water Figure 4-8: Standard fabrication starts with
(see figure 4-7). The ICEX is one of the few taking a negative mold. Then plas-
systems which can be fabricated directly onto ter is poured into the negative mold
the residual limb. to create a positive mold. At last,
the positive mold is shaped by the
prosthetist to emphasis the shape.
The final socket is made by laminat-
30 Figure 4-7: The ICEX toolbox and component box. ing or thermoforming it around the
[Source: Ossur website] positive. [Seymour 2002, p179]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.2 Structural Designs 4.2.1 Exoskeletal Structure

There are two solutions for the structural An exoskeletal structure has a hard outer

Approach
build-up of a prosthesis: the exoskeletal cover made of plastic laminate (figure 4-9).
design, which is around for a long time and Socket and pylon are integrated into one
the endoskeletal or modular design, invented product. Sometimes, the foot is a standard
in 1970 (compare Appendix E). Nowadays, component, such as in the case of the Jaipur
the endoskeletal design is by far the most prosthesis (see figure 4-10), but it can also be

Users
common. integrated (figure 4-9).

The structure consists of soft foam con-


toured to match the other limb with a hard

Prostheses
laminated shell.
Advantages: High strength, better suited
for occupations that require great durability,
such as farming or construction work. Better

Usage
resistant against dirt. Sometimes also better
heat resistant.
Disadvantages: Alignment and replacement
are difficult. Difficult to fabricate. Flexion,

Stragegy
shock-absorption and rotation is absent in
the rigid prosthesis.
Vision: An integration of the socket and the
pylon, while allowing for adjustability, could
result in a highly durable and resistant pros-

Criteria
thesis.
Figure 4-10: The Jaipur prosthesis, here
drying from paint finish, consists
of a exoskeletal structure with
Figure 4-9: The exoskeletal prosthesis (depicting a separate manufactured foot.
socket, plastic exterior and foot) is
[Source: FINS- Sri Lanka]
one, integrated product. [Seymour
31
2002]
4.2.2 Endoskeletal Structure Advantages: Being adjustable, being light-
weight, this setup is cost efficient when com-
In an endoskeletal design, a pylon is used to ponents need to be replaced, the (mass-pro-
transfer forces from the residual limb to the duced) components are of relatively low costs.
floor. The endoskeletal or modular prosthesis The total system is highly customizable to the
is build from components. The basic compo- patient’s needs.
nents of an endoskeletal prosthesis (figure 4- Disadvantages: Not so strong, components
11) are the socket (4.3.1), the pylon (4.3.2) and may be expensive, custom-made socket
the terminal device (4.3.3) (almost always needed.
referred to as the foot). Every prostetic design
needs suspension (4.3.4) to stay put when the Vision: The universal prosthesis will be really
leg is lifted. Sometimes additional compo- successful when the socket and the pylon
nents (4.3.5) are included such as a rotator, can be used together with a wide range of
shock-absorbers, a sock or (gel-) liner, a cover (already available) feet.
or a prosthetic skin.
A combination of socket and pylon, while
maintaining the endoskeletal principles is
called a monolithic socket and pylon combi-
nation and may be attached to commercially
available prosthetic feet. One thermoplastic
design is the Endoflex [Valenti, 1991]. See
figure 4-12 for an example without cosmetic
cover. It is suitable for a majority of amputees
and its advantages include increased flex-
ibility, absorption of stress and shear and
reduced cost.
Vision: An integration of the socket and the
pylon, while allowing for adjustability, could Figure 4-12: The 4C Air Lite Monolithic (above 2
result in a highly durable and resistant pros- pictures show manufacturing steps.
Figure 4-11: The endoskeletal prosthesis always thesis. A carbon-fibre sock is one of the
contains a pylon. Very seldom the important materials) and the Endoflex
other parts are integrated. Normally, (lower pictures) are two of the few
the socket and foot are modular com- designs in which the pylon and socket
32 are integrated. [4C Air-Lite Tech
ponents. [Seymour 2002]
Manual, Valenti 1991]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.3 Components Project: The definite socket is in practically


every case custom made and therefore the
Traditionally, the socket is constructed as
hard as possible, because this rigid type of
Components for the endoskeletal prosthesis most challenging part for a complete univer- sockets transfer the forces well to the pylon

Approach
sal prosthesis. Therefore this project must and gives control to the patient. However,
are widely available. This section offers an
focus on the socket and its effects on the since the invention of the liner, a new devel-
overview.
patient and the prosthetist. opment is the hard outer, soft inner socket
Vision: The universal prosthesis will be really (semi-rigid sockets). These sockets consist
4.3.1 Basic Components: Socket successful when the interface with the body of a shell and a liner that are both formed

Users
is as comfortable as current sockets. to the residual limb. The outer sockets func-
The socket is the connection between the tion is protection of the residual limb and
residual limb and the prosthesis. It must not the transfer of forces. The outer socket sur-
only protect the residual limb but also trans- Rigidity rounds the liner, made of a flexible material

Prostheses
mit the forces associated with standing and
ambulation.
There are different types of hardness for the (in most cases Pelite, a poly-ethylene foam).
socket. Again, there is a multitude of terms in This socket helps with the better distribu-
tion of forces. The difference between a soft
Sockets are generally created by using a
use and definitions are unclear:
socket and a conventional liner [see section
plaster mould of the residual limb as a tem- - liner
4.3.5] is that the liner is a hollow, stretch-

Usage
plate. Some prosthetic manufacturing facili- - soft socket or softsocket able, standard tube, while the soft socket is
ties use computer-assisted technology to - semi-rigid socket fabricated to the shape of the residual limb
“map” the residual limb and then manufacture - Flexible socket of the patient. Soft sockets are more often
a socket directly from that data (CAD-CAM - Hard outer, soft inner socket system used for transfemoral amputees than for

Stragegy
fabrication). - Hard socket transtibial amputees. Also, for transfemoral
amputees there is a system that integrates
There are primarily two socket designs hard elements (ISNY concept, figure 4-13 and
used for transtibial amputations, the patellar 4-14) with flexible (polyurethane) parts into
tendon bearing (PTB) and the total surface one socket. However, this socket type is only

Criteria
bearing (TSB). Since the late 50’s, the PTB recently developed at Össur [2002] and infor-
socket has been the design of choice for most mation about development of a transtibial
traumatic transtibial amputees [VHI 2002]. type is limited [COTA 2002].
Project: Recent developments in softsockets
for transfemoral amputees, seem to suggest
that a flexible socket could be well adapted to
Figure 4-13: ISNY Components [Source: Website
Otto-Bock] transtibial prosthetics. 33
Rectification Patellar Tendon Bearing (PTB)
There are two principles for force distribu- Socket
tions between the residual limb and the pros- The PTB socket is the best known rectified
thetic socket. The first, “Rectified” takes in socket design. The PTB socket offers areas
account which areas and tissues are less sen- of pressure and areas of relief in accordance
sitive to pressure and the socket puts more with figure 3-6 from section 3.1.3. As can be
pressure there. The second, “Unrectified” does seen, important pressure bearing areas are
not take the difference in tissue in account the patellar tendon, the medial tibial flare
and the socket is fabricated such that it dis- (next to the tibial crest) and the posterior of
tributes the forces of the residual limb best the residual limb. The socket makes contact
distributed as possible (in most cases except with the residual limb even in areas where no
the distal end). Interesting, there is little liter- pressure is transferred, including the distal
ature that compares these two types of pres- end, to avoid pockets of oedema.
sure distribution. However, recent studies do
suggest that unrectified sockets perform just Requirements: The universal socket should
as well as rectified sockets. Rectified sock- make contact with all areas of the residual
ets tend to be evaluated better in less active limb, to avoid pockets of oedema.
situations, while unrectified sockets are more
comfortable during heavy use. [Weeks 2003]

O n the other hand, prosthetists at LIVIT


(Den Haag) suggested that unrectified sockets
tend to rotate around the residual limb and
thus offer problems when subjected to tor-
sion. Also, they mentioned that rectification
(while years ago being quite exaggerated) is
Figure 4-14: Flexible ischial-containment practically not so strongly emphasized any-
socket for transfemoral amputees
more in the socket fabrication.
(this one from Otto-Bock, inset
from Hanger) consist of a flexible
inside and a frame. Other names
include Total Flexible Brim, the
ISNY and SFS (Scandinavian
34 Flexible Socket)[Seymour 2002].
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Total Surface Bearing (TSB) Socket Plug Fit Socket Hydrostatic Socket
The TSB socket design is an unrectified The plug fit prosthesis, mostly used for trans- The Hydrostatic socket is a socket that is

Approach
design, that was developed in the mid 1980’s. femoral amputations, was very popular from unrectified, but in stead of determining its
It provides complete contact of the prosthetic WWI to mid 1950’s, but is seldom used today. shape from the shape of the unloaded resid-
socket to the residual limb with no built-in The socket shape is a simple cone (figure 4- ual limb, it is formed around the (hydrostatic)
pockets for relief of bones and other sensi- 15). Transtibially, this socket design provided loaded limb. This socket type is very com-
tive tissue. By allowing total surface contact, weight bearing at the patellar tendon and fortable while standing, because pressure

Users
all tissue of the residual limb is in contact was used in conjunction with a thigh lacer for distribution is optimal [SOURCE]. However,
with the prosthetic socket, thus reducing the suspension (see section 4.3.4). Additionally by when soft tissue is hydrostatically loaded, it
loading on the medial tibial flare and patel- tightening the thigh lacer additional weight becomes more round shap round shaped.
lar tendon. When using this type of design it bearing was transferred to the thigh. The This may cause friction and instability when

Prostheses
is usually necessary to use a roll-on type of distal end of the the prosthesis is subject to rotation or torque.
liner made of silicone, mineral gel or similar prosthesis is usu-
material. The thickness of these liners is usu- ally left open with
ally three, six or nine millimetres. This design no distal wieght
is fast becoming the socket design of choice bearing. [VHI

Usage
for traumatic amputees. [VHI 2002] 2002]
Requirements: The socket can either transfer
pressure equally or rectified, as long as the
total area over which the pressure is distrib-

Stragegy
uted is optimized.

Criteria
Figure 4-15: Plug fit socket. The first prosthetic
socket without weight-bearing at the
distal end by Verduin 1696 [Wetz
35
2000]
The before mentioned ICEX socket (figure 4-7, 4.3.2 Basic Components: Pylon Also, there are low cost systems with mul-
figure 4-16) is produced on the residual limb. tiple pylons, however these seem to be only
It is cast under pressure with a pressure-cast- The pylon is a tube or shell that attaches the used in Argentina (about 2000 produced in
ing device. Due to this production method, it socket to the terminal device. The main func- 1989, see figure 4-18).
is a hydrostatic socket design. All pressure is tion of the pylon, is to transfer force from the
distributed equally, but areas still be relieved socket to the ground. Pylons have progressed New types of pylons are slightly flexible
and
from pressure by applying pressure pads. from simple static shells to dynamic devices take-over some of the functions of the ankle
that allow axial rotation and absorb, store (figure 4-19).
and release energy.
Pylons can be orderd in standard sizes
Because of the high forces involved, most or sawn into the needed length by the
pylons are made from titanium. For geriatric prosthetist.
purposes (less use and low weight) some-
times aluminium is needed. Plastic pylons
are used in designs meant for the third world,
such as the ICRC-limb (figure 4-17) (polypro-
pylene) and monolithic prostheses (see figure
4-12). In these cases, an addition exoskeletal
can be applied after alignment, to enhance
the durability of the prosthesis.

Figure 4-18: (left) Trimodular Pylon as used in


the sauer-bruck trimodular physi-
ological prosthesis [Angarami 1989]
Figure 4-16: Icex finished socket (left). Pressure Figure 4-19: (right) Springlite Advantage DP flex-
pads are added to compensate for Figure 4-17: The ICRC-limb makes use of a poly- ible pylon and dynamic response foot
weight intolerant areas (cutt-through propylene pylon.. Its cross-section is by Hanger Orthopedic Group. [Source:
36 right) [Source: Ossur Icex brochures.] H-shaped. website]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.3.3 Basic Components: Foot/Ankle Because of the biomechanical and anatomi- The SACH foot designs allow compression
System cal parallel, designers often speak of the of the foam heel at heel-strike to simulate
foot-ankle system. Prosthetic feet are broadly planter-flexion. A wooden internal keel pro-

Approach
The foot is the typical form of the terminal classified as energy-storing feet and non– vides stability in mid-stance and allows for
device, but it may take other forms for water energy-storing feet. a relatively easy rollover in late stance. [VHI
or sports activities, or for use as an interim- 2002]
prosthesis. The main function of the foot is
Non-Energy-Storing Feet SAFE foot: Solid Ankle Flexible Endoskeleton
to aid in gait and provide aesthetics.

Users
Rocker “foot”: The rocker is the most simple – This in 1980s developed foot is more flex-
Better defined the functions of the prosthetic terminal device. It does not try to resemble a ible than the SACH foot. This design had an
foot are (1) to provide a stable weight-bearing normal foot, but is a stump end, which allows elastic keel, which enabled a smoother and
surface, (2) to absorb shock, (3) to replace lost a very nice ambulation. This terminal device easier rollover, which is more preferable than

Prostheses
muscle function, (4) to replicate the anatomic is most useful in interim prostheses. the rigid keel of the SACH foot. Some disad-
joint, and (5) to restore cosmetic appearance. vantages include limited push-off, increased
SACH foot: Solid Ankle Cushion Heel – cost and added weight. [VHI 2002].
The ankle function usually is incorporated Developed in the 1950s, the SACH foot is the
into the terminal device. Separate ankle simplest foot. It mimics ankle plantar flexion,

Usage
joints can be beneficial in heavy-duty indus- which allows for a smooth gait. There are no
trial work or in sports such as mountain moving parts, which makes this design very
climbing, swimming, and rowing. However, durable and ideal for children and for individ-
the additional weight requires uals whose ambulation is limited to walking

Stragegy
more energy expenditure and (sedentary patients).
more limb strength to control
the additional motion.

Criteria
Figure 4-20: Left: Principle of Rocker foot or sole. Figure 4-22: SAFE II foot. (Original manufacturer
[Adapted from: www.customfootware. is Campbell Childs Inc, now bought by
com] Right: Low cost prosthesis with 4C (Foresee Orthopeadic Products)).
Figure 4-21: SACH foot (Adapted from Seymour 37
cane pylon and rocker foot 2002]
Single-Axis foot: Predating the 1860s, single Multiple-Axis foot: The multiaxial foot adds Simple Energy Storing
axis feet contain an ankle joint that adds pas-
sive plantar flexion and dorsiflexion, which
inversion-eversion and transverse rotation
capabilities to the function of the single-axis
STEN foot: The STored ENergy foot is a
simple energy storing foot that has a keel that
increase stability during stance phase. Single- foot and is often recommended to accommo- compresses in the loading response to mid-
Axis feet pre-date the American Civil War and date uneven terrain. Its weight and mainte- stance of gait, thereby storing energy. The
still are used today on a limited basis. The nance requirements are similar to that of the energy is released in the terminal stance to
main advantage is that the foot will allow for single-axis foot and is a good choice for the the preswing phase of gait. [Seymour 2002]
a quick foot-flat, which increases knee stabil- individual with a minimal-to-moderate activ-
ity in an above-knee prosthetic wearer or in ity level. [VHI 2002]
a below-knee prosthetic wearer who uses a
thigh corset with knee joints in early stance.
This feature is important in the individual
who has knee instability. Disadvantages
include weight, maintenance, abrupt dorsi-
flexion stop, noise and cost. [VHI 2002]

Figure 4-25: STEN foot. [Source: Kinsley


38 Figure 4-23: Single-axis foot. [Seymour 2002] Figure 4-24: Multiple axis foot. [Seymour 2002] Manufacturing Co brochure]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Dynamic Response:
Dynamic Response (formerly known as

Approach
advanced Energy Storing) feet have a plastic
spring keel that provide a dynamic respon-
siveness during stance. There are numerous
dynamic response feet available, such as the
Carbon Copy, Seattle, Flex-foot, Springlite,etc

Users
(figure 4-26, 4-27). The more aggressive
ambulator can use these designs, including
runners and those participating in recrea-
tional or competitive sports who can load the

Prostheses
forefoot for these activities. Disadvantages
include increased fabrication time and Figure 4-26: (Above) Though from the outside
increased cost for some designs. [VHI 2002] not visible, energy storing feet differ
from the inside [Impulse foot, OHIO
Hybrid Design feet (figure 4-28) are avail-
Willow Wood] Various energy-stor-
ing feet. Earch foot is composed of a

Usage
able that combine multiaxial ankle mecha- compressible heel and a flexible keel
nism with dynamic response, such as the spring.
College Park foot/ankle and the Phoenix foot. A) Seattle foot, B) Dynamic foot,
These designs can be used for recreational C) STEN foot, D) SAFE foot,

Stragegy
and competitive sports, as well as for uneven E) Carbon Copy II foot.
terrain. Disadvantages would include mainte- [Hafner et al. 2002]
nance and cost. [VHI 2002]

Criteria
Figure 4-28: Two hybrids: The Seattle Cadence
Figure 4-27: Advanced energy-storing prostheses: HP [Source: Seattle website] and the
A) Modular III, B) Reflex VSP, MICA Genisis II+. [Source: MICA web-
C) Advanced DP, D) Pathfinder. site]
[Hafner et al. 2002] 39
4.3.4 Basic Components: Suspension 1) Supracondylar Cuff – A supracondylar Anatomical Suspension
Prostheses can be attached to the residual
cuff, affixed to a socket, allows the prosthesis
to hang from the top of the knee (Anatomical
Anatomical suspension designs (figure 29)
are the second most desirable option for
limb by a variety of belts, wedges, straps, suc- suspension). In Dutch often referred to as the suspension of the prosthesis. Suspension is
tion, or a combination of the above. Designs KBM design. achieved by careful contouring of the socket
include differential pressure suspension sys-
walls over and proximal to the femoral epi-
tems, anatomical suspension systems, strap 2) Joint and thigh corset – This suspension condyles to lock the condyles in place. This
suspension, thigh corset with mechanical method bears much of the patient’s weight on method of suspension is known as supra-
hinges, Silesian Belt and pelvic joint with belt. the thigh. (corset suspension) condylar (SC, In Dutch often referred to as
Most important transtibial suspension meth- 3) Waist belt suspension – In this design,
the Kondyl Bettung Munster, KBM) and can
be very effective in suspending the prosthe-
ods: much of the weight of the prosthesis is dis- sis and in providing enhanced mediolateral
tributed around the waist (corset suspension). stability in individuals with a shorter residual
limb.
4) Sleeve suspension – An elastic or neo-
prene sleeve is pulled over both the prosthe- A variant to this design allows for moulding
sis and a large area of skin, thereby suspend- of the socket anteriorly above the patella for
ing the prosthesis by partial suction (suction added suspension and to control hyperexten-
suspension). sion in the shorter residual limb. This design
is known as supracondylar/suprapatellar
5) Gel liner with shuttle-lock – One of the (SC/SP), sometimes referred to as the Patellar
more advanced designs, this pin, incorporated Tendon Suspension (PTS). [VHI, 2002]
at the end of the liner, fits into a shuttle-lock-
ing mechanism fabricated into the bottom Advantages: Are increased medial-lateral sta-
of the socket. (suction suspension). The liner bility with the SC and increased anterior-pos-
is equipted with a pin or plunger threaded terior stability with the SP feature.
into the distal end. This pin can lock into the Disadvantages: include localized pressure
socket. to remove the prostesis, a button on over condyles and restriction of full flexion.
Figure 4-29: (right) Anatomical Suspension. The the locking mechanism is depressed.
supracondylar suspension is in this
case removable due to the brim.
(right, middle) The supracondylar
suprapattelar system is fixed.
40 [Seymour 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Straps Corsets Suction Suspension


When it is not feasible to use differential The thigh corset (figure 4-31) with mechani- Suction suspension uses an atmospheric

Approach
pressure or anatomical modes of suspen- cal hinges was the design of choice up until pressure (vacuum) or suction to maintain
sion, a strap (figure 4-30) can be used to sus- the early 1960’s. [VHI, 2002] Also, a corset the prosthesis onto the residuum. Suction
pend the prosthesis. A popular strap, called a can be worn around the waist. suspension is broken down into 2 categories:
PTB or supracondylar cuff, is attached to the standard suction and silicon suspension suc-
medial and lateral walls of the prosthesis at Nowadays, there are to much disadvantages tion. A standard suction is simply a form-fit-

Users
their posterior-proximal juncture and is then in comparison to the other suspension meth- ting rigid or semi-rigid socket into which the
angled proximally over the patella. The lower ods to use corsets for definite prostheses, residual limb is fitted. The silicon suction
border of the cuff touches the superior border but they are still used in conjuncture with a uses a silicon-based sock, liner or sleeve (also
of the patella to achieve suspension. In addi- interim or temporary prosthesis. see section 4.3.5) that slips onto the residual

Prostheses
tion to the cuff, a waist belt with extension limb, which is then inserted into the socket.
Advantages: In using the thigh lacer with
assist can be attached to the proximal border The silicon helps to form an airtight seal that
joints include the reduction of weight bearing
of the cuff to increase suspension and to stabilizes the prosthesis. [VHI 2002]
on the residual limb and can greatly increase
assist the individual in extending
the medial-lateral stability. Advantages: These designs tend to provide
the prosthesis. [VHI, 2002]
the amputee with enhanced function, great-

Usage
Disadvantages: Include pistoning, added
Advantages: This design can est range of motion, added sense of security,
weight and bulk, difficul-
accommodate changes in greater control of prosthesis and no piston
ties in donning and exces-
volume and is relatively simple action when fitted properly. Of all suspension
sive wear and tear on
to adjust. modes, suction designs tend to be the most
clothing.

Stragegy
desirable because of the enhanced retention
Disadvantages: Include slight
of the prosthesis to the residual limb created
pistoning and belt irritation.
by the vacuum.

Criteria
Figure 4-31: The thigh corset can be used in
conjuncture with a waist belt and an
elastic strap. [Seymour 2002]. The
Figure 4-30: The PTB cuff or supracondylar cuff. suspension sleeve has a similar work- 41
[Seymour 2002] ing principle (left) [Otto Bock].
S everal suction suspension designs are used 3 ) Variants to these methods include the 5) The simplest design of achieving suc-
[VHI, 2002]: “hypobaric” design, which has a valve dis- tion suspension could be to use a rubber-
tally in the socket to expel air and a silicone ized sleeve over the outer socket surface and
1) One design incorporates an overall snug fit rubber band (gasket) moulded into standard onto the mid-thigh, thus preventing air from
with a valve placed distally into the prosthetic textile stump liners at the proximal socket. entering into the socket. This design allows
socket. The skin is in direct contact with the This gasket is positioned slightly distal to for stump socks and/or soft insert to be used.
socket interface. In order to use this type of the socket edge, which creates a seal and
suspension, the residual limb has to be stable maintains vacuum or suction. This silicone
with no fluctuations in volume and generally band is moulded into prosthetic sheaths and
free of scars that could prevent vacuum from stump socks of varying plies to accommodate
being achieved volume changes. Sometimes, to enhance the
seal, a skin lotion is used for a wet fit.
2) Another system includes the use of elas-
tomer sleeves made of silicone, urethane or 4) Another design allows a mineral gel sleeve
mineral gel. (Figure 4-32) These sleeves are to be rolled onto the residual limb, with a
rolled onto the residual and have a distal fabric backing and no distal pin. (Figure 4-
pin attachment (plunger) that anchors dis- 33) Once the sleeve has been placed onto the
tally into the socket locking the prosthesis. residua, the residua is placed into the socket,
in place. These systems allow where a distal valve expels the air. With all
for moderate volume changes by the air expelled, a second sleeve is placed over
placing socks of varying plies the inner mineral gel sleeve and outer socket,
on the outside of the sleeve to sealing any air from entering the socket, thus
achieve a snug fit. Also, applica- creating a suction or vacuum. This design
tion for residual limbs that may can accommodate some volume changes by
have some scarring or grafts is use of a thicker sleeve.
possible.

Figure 4-32: Pin/Shuttle suspension. [Seymour Figure 4-33: Mineral gel sleeve suction suspen-
42 sion. [www.customprosthetics.com].
2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.3.5 Additional Components Rotators and Shock-Absorbing Couplers, Locks, Valves and Grace
Systems Plates
Liners and Socks The All basic components are connected by spe-

Approach
Torque Absorber (figure 4-35) allows
Liners (figure 4-34) fit inside prosthetic the leg to rotate with reference to the socket cific components. These connective compon-
sockets and are used to cushion and protect during stance phase, automatically returning vents (figure 4-36) often exist of a “male”and
fragile limbs and to accommodate volume the leg to the normal position during swing a “female”part, that can be attached in a
changes. They can be used to suspend pros- phase. The torque absorber is excellent in range of angles. These angles determine the

Users
theses by rolling them onto a residual limb activities where rotation is important: golfing, alignment. The connective component that is
to provide suction suspension or they can dancing, bowling, base-ball, standing and integrated with the socket is called the grace
have wedges built into them to provide supra- working at a bench for considerable periods plate.
condylar suspension. They can be made of of time. Generally, the shorter the residual
In case of suction suspension, valves need to

Prostheses
silicone, urethane, and mineral gel, rubbers limb, the greater the loss of natural torsional
and expanded polyethylene foam. The thick- capabilities. A torsion absorber would restore be added. Locks are needed for above-knee
ness of liners is usually three, six or nine mil- the loss of torsion. prostheses.
limetres and this thickness is referred to as a
ply. [VHI 2002] Shock absorbing pylons allow for telescoping

Usage
of the pylon to absorb shock to the residual
- Stockinet (tubular open ended cotton of nylon
limb that occurs in jumping and running
material)
activities, as well as aggressive walking.
- Sleeves

Stragegy
- Compressors
- Shrinkers (Elastic Wraps or compression sock)
- Socks (not only for the feet!, wool of cotton)
- Liners
- Gel sheath

Criteria
Figure 4-36: Some examples of connective com-
Figure 4-34: Double/Single Socket Gel Liner Figure 4-35: Demountable Torque absorber and ponents [adapted from www.atlas- 43
[Silipos]. its effects. [adapted from endolite] ti.com]
Covers and Prosthetic Skins 4.3.6 Materials & Tools
Most endoskeletal setups are finished with Plastics, supplies, tools, alignment systems,
a cosmetic cover. This cover usually exists of
they are the resource for the prosthetist
a foam inner part and is finished with a very
(figure 4-38).
flexible “sock”. In very expensive prostheses,
the outer sock can resemble the remain-
ing limb, including hairs, veins, etc. then the
cover is called a prosthetic skin. Some manu-
factures speak of skin coatings. (figure 4-37)

Figure 4-38: Examples of supplies (above): Rivits,


Polyester Resin-Laminae, box of
stockinettes, pneumatic cast cutter,
Figure 4-37: Prosthetic skins can have a high
carbon tape [Fillauer Supplies bro-
life-like appearance [left, dorset and
chure]. Static alignment is done on an
orthopeadic]. Uflate sleeve skin covers
alignment table [otto bock[. Supplies
44 shrinks to fit the prosthesis when
enable prosthetists to make custom
treated with a heat-gun.
liners [otto bock].
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.4 Biomechanics of Kinematics Range of motion: The prosthetic device


Transtibial Prostheses Orientation of axes of motion: For the total should allow normal range of motion in
any plane, which for a transtibial prosthesis

Approach
limb to move in its normal path of motion
involves primarily the rotation of the knee
Now the structure of prostheses and the (figure 4-39), the axes of the human joint and
and ankle in the sagittal plane.
used components are discussed, a applica- the prosthetic orientation must be aligned
similarly. The choice of the type and location
tion of biomechanics on the residual-limb-
prosthesis system is useful. From this analy- of the axes will affect the movement and sta- However, because of the closed kinematic
chain (the foot stands on the ground), adja-

Users
ses important criteria and insight why the bility of the prosthetic limb. [Seymour 2002,
p78]. For example, a dynamic ankle joint can cent joints are likely to be effected. For
endoskeletal structure is so popular can example, when a prosthetic foot is locked in
be derived. Again kinematics and kinetics improve ambulation on rough terrain, but
reduces the stability of the prosthetic limb. plantarflexion it will result in an abnormal
are considered (compare sections 3.1.5 and knee angle (FIG 4-40). [Seymour 2002, p79].

Prostheses
3.1.6). Both have implications for the selec- Requirements: The universal prosthesis This is an important observation, because for
tion, fit, use and design of prosthetic devices. should be normally aligned similar to the example an abnormal knee angle could result
Generally, kinematic considerations provide axis of motion of the knee. Enhanced flex- from a problem in the foot/ankle system.
insight into the alignment of the prosthe- ibility and additional joints (such as a flexible
sis, while kinetic considerations will provide pylon) could be applied, but stability is more Requirements: The universal prosthetic

Usage
insight in the design requirements. important. system should include hints when it is aligned
well.

Stragegy
Figure 4-39: Pathway of the instant axis of rota-

Criteria
tion for the knee joint. [Seymour
2002]
Figure 4-40: Limited dorsiflexion at the ankle. If
the ankle can not dorsiflex normally,
either A) the individual will weight
bear on the toe or B) the knee must
hyperextend to get the foot flat on the
45
ground. [Seymour 2002]
Degrees of freedom: If the prosthesis has tions for the size and location of suspensions
should take in account the relationship of
a different number of degrees of freedom as
force area, stress toleration and deformation.
the normal joint, the function of the joint will
[Seymour 2002, p80]. Deformation of the
be affected. For example, some prosthetic feet,
tissue also occurs while the residual stump
such as SACH feet, allow plantar- and dorsi-
is loaded. Therefore, the shape during load
flexion, but do not allow pronation/supination.
can be different from the unloaded shape.
This will affect the interface of the foot with
Especially in hydrostatic socket, semi-rigid
the ground. Adaptation to uneven terrain is
and softsocket designs this can be a problem.
diminished and forces may be transferred to
Under evenly distributed pressure, the soft
the residual limb. [Seymour 2002, p79]
tissues tend form a cylinder or cone. If this
happens, the system will find it difficult to
Kinetics transfer torque (cylinder in cylinder). A solu-
tion is using a somewhat triangular socket.
Stress: Stress or pressure considerations
lead to a preference of a large surface to bear Requirements: the socket design should con-
forces. A typical application of this principle sider rotational forces, while the residual limb
Stress
is the use of a total surface-bearing (TSB) is loaded.
Equal stess Increased stess Relief (pressure) Relief
socket [See section 4.3.1]. High pressure on (pressure) equilized
the tissue of the residual limb could occlude throughout throughout
the vessels, creating ischemia (oxygen short-
age) and tissue damage. Also, nerves are
pressure sensitive, resulting in pain or nerve
damage. [Seymour 2002, p80]

Deformation: Tissues of the residual limb


A B C D
as well as materials used in prosthetics, Decreased stress
Build up Build up
vary in their stiffness (their ability to resist
deformation). In the residual limb, the stiffer
Figure 4-41: Stress on the residual limb from the prosthesis. A) The hypothetical situation in which the
bone bears the brunt of the load, but is also
residual limb is of uniform firmness and the socket matches the circular shape of the limb. B)
more pain-sensitive to pressure. These con- A residual limb of nonuniform firmness and a socket that matches the circular shape of the
siderations lead to designs such as the patel- limb. This would result in increased stress on the firm areas of the residual limb. C) The same
lar tendon bearing (PTB) socket [See section residual limb with a socket designed to equalize the pressures over the firm and soft areas.
46 4.3.1] as shown in figure 4-41. All considera- D) The same socket design used to accommodate pressure-sensitive areas and pressure-toler-
ant areas. [Adapted from Seymour 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Elasticity: Tissue should not be loaded Area and Problem Effect


beyond the yield point, which would result - foot rotation
in permanent deformity. The same principle too hard

Approach
- execssive knee flexion
applies to materials used in the prosthetic heel cushion
- foot-slap
design. The material characteristics such too soft
- absent or insufficient knee flexion
as yield strength and ductility affect their
usage in the fabrication of prosthetic devices. posterior - early knee flexion (drop-off)
Displacement of the keel
[Seymour 2002, p82] anterior - delayed knee flexion

Users
- excessive knee flexion
The materials used in the components of the dorsiflexion
- early knee flexion (drop-off)
prosthesis may cause or solve gait deviations. Excessive flexion of the pros-
- absent or insufficient knee flexion
They will affect deformation and the energy thetic foot

Prostheses
plantarflexion - delayed knee flexion
deformed of returned, wit a result impact on
gait. In transtibial conventional prosthesis, - circumduction
this principle is mostly used in shock-absorb- medial - excessive lateral thrust of prosthesis
ing feet (compare table 4-2, first row). The - absent or insufficient knee flexion
Excessive placement of the anterior
socket and pylon are generally designed as

Usage
- delayed knee flexion
foot in relation to the socket
stiff as possible. - excessive knee flexion
posterior
- early knee flexion (drop-off)
posterior - delayed knee flexion

Stragegy
Excessive tilt of the socket - early knee flexion (drop-off)
anterior
- excessive knee flexion
- foot rotation
too loosely
Socket fits - pistoning

Criteria
too tightly - reduced knee flexion/exention

Table 4-2: Gait deviations due to materials and the alignment [Seymour 2002]. Note that many align-
ment choices can have the same effect. If the effect is unwanted, all can be adjusted, but
47
some will cause other problems (because one alignment choice will have multiple effects).
Strain: Some materials exhibit a differ- Bending forces: The patellar tendon bear- Viscoelasticity: Viscoelastic materials,
ent stress/strain curve for increasing and ing prosthesis is in principle a three-point such as the connective tissues of the body,
decreasing stress, called hysteresis. Materials system, resulting in bigger forces than one exhibit some of the characteristics of both
which can dissipate a lot of energy, such as would expect purely from the patients weight elasticity and viscosity. Viscous substances
vulcanised rubber, can be used to absorb (see figure 4-42). have the ability to resist loads that produce
energy. These materials will be selected for shear. Viscoelastic materials may be used in
either their return energy or absorption of prosthetics to reduce shear and pressure, as
energy. Important here is that one material can be seen in liners (often containing ure-
would not work for all individuals, because thane) (see section 4.3.5). Viscoelastic mate-
the load or stress placed on the material rials demonstrate the characteristic of creep,
would be different from, for example a light the increase in strain with time under a con-
individual and a heavy individual. A case in stant load. Constant loading, subjects joints,
point would be the firmer heel of a SACH (see surrounding structures and the prosthesis
section 4.3.3) prosthetic foot for a heavier itself to the effects of creep. Deformation of
individual. [Seymour 2002, p83] the residual limb or of the prosthesis will be
the result. [Seymour 2002, p88]
Tension, compression and torsion forces
play an important part in the design of the
pylon.

Shear forces: The application of a shear or


tangential force can cause shear stress and
strain on weight-bearing surfaces, for exam-
ple, in a poorly fitted prosthetic device. Soft
tissue in general should not be loaded with
shear force. [Seymour 2002, p84]

Figure 4-42: Bending forces on the residual limb


48 while standing. [Wisse et al. 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

4.5 Financial Issues & 4.5.1 To the Patient In developing countries, the patient will
have to pay for the prosthesis themselves, or
Distribution Most prostheses are reimbursed by in assur- their “social insurance” will be provided by

Approach
ances, but reimbursement rates may vary humanitarian aid organisations, such as US-
Of course, the prosthesis and its components widely. Usually an insurance company will Aid. Normally, a transtibial prosthesis can be
are not fabricated freely. For every prosthetic pay for a new prosthesis every 3-5 years or provided between $60 and $100. $100 seems
design that becomes a success, benefits to the sooner in cases of ill-fitting caused, for exam- to be the “magic border” for the amount most
patient (such as improved comfort), the prac- ple, by weight gain or loss. NGO’s are willing to pay for prosthetic help.

Users
titioner (such as reduced fabrication time), the These costs include components, materials,
producer (higher revenues or bigger market The cost of a prosthesis varies widely depend- labour, office visits and adjustments in the
share) and to governmental institutions such ing on the degree of disability, activity needs first weeks. However, long-term aftercare is
as assurances (a clear solution with a good of the wearer, and the types of components generally unavailable until the time a patient

Prostheses
prognosis for a fair price) should be out- and materials used. The cost of a transtibial really needs a new prosthesis.
weighing the costs. prosthesis ranges from $4,000 to $16,000
Project: The universal could cut back total
[Seymour 2002, p49], including components,
All transtibial components are part of a com- materials, labour, office visits and adjust-
cost, because of the reduced need of office
visits and adjustments.
plex value chain (figure 4-43). ments (in the first 90 days).

Usage
Project: In the value chain, the universal In Western countries the assurances will
prosthetic system can be regarded as a spe- reimburse the more cheaper prostheses
cific component. ($4000). The fight for reimbursement of

Stragegy
more expensive components can be difficult
and the improvement in functionality for the
patient should be very clear.

Criteria
Party Raw Materials Components Distributor
Resources producer producer
Product Carbon, Oil Sheets Feet System
example
Company Shell GE Otto-Bock Otto-Bock LIVIT Jan
example Plastics Klaas

Figure 4-43: A Simple model of the value chain of prostheses. Value is increased from left to right. Note
that some companies have multiple roles. 49
4.5.2 To the Practitioner the patient and how they will develop in time. 4.6 Repair and Life-time
Then they select the most price efficient solu-
The most valuable resource to the prosthetist tion over a longer period. Just as shoes, a prosthesis has a limited life-
is time. He needs this time not only to fit and Project: Even a more expensive universal time. A study done in the United Kingdom
fabricate the prosthesis, but also for meetings prosthesis could in many cases be selected found that on average, a new prosthesis was
with other members of the team and to adjust by the social insurances, because it will still needed every two years.
prosthesis for patients in their rehabilitation. function when the residual limb changes
Project: The universal prosthesis could allow shape. Costs of maintenance and adjustments In some cases, the prosthesis can be repaired.
the prosthetist to cut back costs (time) or to are decreased, especially when the patient In the same UK study, one major repair was
improve his service to the patients. can adjust (some aspects of) the prosthesis needed every 5 years and two minor repairs
himself. were needed per year.
Requirements. The Universal Prosthesis has
4.5.3 To the Producer a lifetime comparable with normal shoes, 1 a
Because of the high requirements to the
2 years.
components (light, durability, etc), they
can be quite expensive. The customer (the
prosthetist) will suggest them to the insur-
ance company or the patient as long as the
benefit to the end user is clear (and that
depends highly on the patients level of activ-
ity).
Project: The producer could improve his
market share, while maintaining his profit-
revenue ratio, especially in the niche for
products between temporary and definite
prosthesis.

4.5.4 To Governmental Institutions


Insurances primarily look for solutions, not
for the final price of the product. That is ,
50
they assess what the functional needs are of
The Universal Prosthesis
5 Life with a prosthesis - the amputee’s perspective Boudewijn Martin Wisse
TU Delft, 2005

For a succesful design, insight into the expe- Phase Discription See Section
riences of the recently amputated is needed.
From a patient’s perspective, the news that

Approach
a leg or arm needs to be amputated can be The accident In a case of trauma the patient has to deal with the
or the disease accident. Treatment is acute.
shocking and comes with a lot of emotions
In case of disease, such as diabetics (vascular), the
and questions. In this chapter an overview patient has time to prepare for the amputation. He
of actions that a (new) amputee has to take consults a practisioner and makes the decision
is given. (or hearing the annoucement that he needs) to be

Users
amputed.
Recommended reading: For additional Hospitalization During the period of surgery to provide the patient
information, the First Step guide from the with a clean and useable residual limb.
Amputee Coalition of America is very useful.

Prostheses
Preprosthetic care Shrinking of the residual limb with compressive wrap- section 5.1
[ACA 2001] and rehabilitation pings. Physiotherapy to prevent contractures. Fit of a
temporal prosthesis as a training to use and life with a
The patient will experience a sequence of prosthesis. The residual limb reaches final shape.
happenings as mentioned in table 5.1. Definite prosthesis The choice and fit of the prosthesis is based on the section 5.2
assessed functionality and the amputees life-style.

Usage
All these situations will require sociopsy- Dynamic alignment Further rehabilitation and adjusting the alignment of section 5.3
chological adjustment of the patient and a the prosthesis.
lot of effort to learn how to use the prosthe- Learning (daily Learning to maintain, don, dof and use the prosthesis. section 5.4
sis. However, life is not care-free. Some major

Stragegy
routine).
concerns of users of prostheses are summa-
Rebuilding life Rebuiling his or hers life after a long period of rehabili- section 5.5
rized in section 5.6. tation. Best results with the help of a rehabilitation and
aftercare team .

Criteria
51
5.1 Preprosthetic care thermoplastics. It protects the wound from
traumatic impact, shapes the residual limb
During the first weeks after an amputation,
and adjusts to volume changes in the residual the psychological effect is the most severe.
After the surgery (the incision is healed and limb (see also chapter 4.1.2). The patient will become conscious of the con-
the sutures removed), a patient will need a sequences of his amputation and the changes
compression device to contain residual limb that will become evident in his life. To
oedema and to accomodate the shaping of the emphasize the fact that the patient can stay
residual limb. Learning the patient to apply highly independent with the use of a pros-
the compression device themselves is an thesis, an interim prosthesis is very useful.
important part of early rehabilitation. Most Also rehabilitation will start very soon.
patients will need to wear a compression Pysiotherapy will prefend contractures and
device during the night indefinitely because muscles need to be used to stay in shape. The
of oedema fluctuations. In the preprosthetic sooner a patient is out of hospitalization, the
phase, compression devices should be worn cheaper his treatment becomes.
24 hours a day and reapplied about every 4
hours. Several types of compression devices
are possible such as:
- Elastic wraps (Bandages): Elastic wraps are
strips of elastic fabric, which are wrapped
around the residual limb. 50% of the patients
will be able to wrap the elastic bandages
themselves, but this is a difficult practice.
Wraps are readily available and inexpensive,
they promote a tapered shape to the residual
limb (see figure 5-1).
- Shrinkers: Shrinkers are preformed elastic Figure 5-1: Figure-8 wrap for the transtibial
“socks”. Shrinkers are easier to use, but are amputation: [Seymour 2002]
also more expensive. Because of the difficulty A. First wrap max extend from proxi-
of applying wraps around the hip, shrinkers mal medial to distal lateral.
are very often used for transfemoral ampu- B. Second wrap may extend from
tations. Shrinkers can only be used after proximal lateral to distal medial.
sutures are removed. C. Thrid wrap may overlie first wrap.
D. Bandage is looslely wrapped
- Removable protective socket: This socket is approximately 60 milimeter to the
often used with elastic wraps or shrinkers. knee.
52 The socket is a custom-fitted device made of E. Completed wrap.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

5.2 Selecting the aid Success criteria in clinical decision Considerations for prosthetic type

Having seen the huge amount of available


making Once these basic requirements are met, a
When

Approach
the amputation is a fact, the first prosthesis can be provided to the patient.
prostheses, it is clear that the choice of pros- Stability, ease of movement, energy efficiency,
thesis is vital to the successrate of prosthetic decision to make is to fit the patient with a
prosthesis at all, or if his functioning will be and the appearance of a natural gait are
use. However, the patient is not aquintanced key elements to achieve with prosthetic use.
with all the available brands and systems. He better by providing other solutions (such as
a wheelchair). This is an important decision Considerations that influence the choice of
will partly have to trust the prosthetist with

Users
made by the prosthetic team in close col- type of prosthesis are:
his selection of the type of prosthesis. But,
because of differnt finances (the approval of laboration with the patient and has to take - What is the amputation level?
reimbursement of more expensive prosthe- many factors on account, including available - What is the expected function of the prosthe-
ses by social insurances can take months) finances. Most important functional require- sis?

Prostheses
patients will have to make some decisions ments of the patient to fit a prosthesis are - What is the cognitive function of the patient?
themselves. The first decision for the patient sufficient trunk control, good upper body - What is the patient’s vocation (desk job vs.
is to buy a temporal prosthesis or a definite. strength, static and dynamic balance and manual labour)?
(Temporal can cost more, but can also save adequate posture. Once these basic require- - What are the patient’s avocational interests
money, because adjustments are easier). The ments are met, then (e.g., hobbies)?

Usage
second most imporant choice is which type of - What is the cosmetic importance of the pros-
socket and in the third place comes the com- thesis?
ponents, most important being the foot. Most - What are the patient’s financial resources (e.g.,
patients will start with a decent but relatively medical insurance, worker’s compensation)?

Stragegy
simple temporal prosthesis. Later, especially
when the patient’s prosthesis is not perform-
ing to expectations, he will look for other
solutions himself.

Criteria
53
Factors in outcome of prosthetic use 5.3 Alignment and Adjustment of the dynamic alignment and
If the chosen prosthesis is provided, the rehabilitation
the patient learning how to ambulate is a
cyclic process and can take months. For the
patient has, from a functional perspective, a
patient, who’s energy is already used to heal
proper prosthesis. However, there are more Now the type of prosthesis is chosen, a tem- the wounds of the trauma and the amputa-
criteria for a successful outcome of prosthetic porary prosthesis can be provided to begin
use: tion, the rehabilitation is very tiring. That
gait training and to determine the right fit constricts the available time per day the
- motivation individual and alignment. patient can practise. Also, the forming resid-
- team approach ual limb is still sensitive and needs to get
- comfortable to wear Static alignment (see 3.1.4) is done on fore- used to the high pressures of prosthetic gait
- easy to don (put on) and doff (take off) hand and is primary dependent on the (again constricting practise time). And the
patient’s atonomy and posture. shape of the residual limb is not optimal yet.
- lightweight and durable
For example, oedema could make the residual
-
-
cosmetically pleasing
low maintenance requirements
Dynamic alignment needs to be done in gait. limb more round, therefore rotational resist-
However, the patient needs to learn how to ance is reduced, while the alignment and fit
- function mechanically satisfactory walk properly with the prosthesis (e.g. with are right in principle. It is the experience of
enough confidence). His muscles need to
As will become evident in section 5.4, in be trained to accommodate for the higher
the prosthetist to determine where the prob-
lem lies (in the prosthesis or in the patient)
many cases, the factors don’t add up, and the energy requirements of ambulation with a and what can be done about it.
prosthesis is not used properly or not used at prosthesis.
all.

54
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

5.4 Daily routine: donning, Daily care for the residual limb and Donning and doffing
doffing and gait
the prosthesis It is important that the residual limb and the
The

Approach
wet environment in the sockets com- interfaces are clean, before the prosthesis is
After the hospitalization and rehabilitation bined with socks, inserts, and shrinkers may donned, because hairs and other small par-
period, the patient will go home. His level of cause fungi and bacteria. Proper, daily care ticles can cause pressure concentration and
functional ability, will determine the things is needed. If there are problems, it might be become a source of skin problems.
he can do with his prosthesis and thus his necessary to temporarily pause using the
Prosthetic

Users
“daily routine”. Most actions however, will be prosthesis. Daily healthcare, such as washing socks are often worn over the
comparable for the majority of patients. In and drying of the residual limb, the socket residual limb, because they add cushioning,
a way, it is very comparable with wearing and socks or liners, will prevent most trou- reduce friction and replace lost volume in the
shoes: bles. Shrinkers and socks should be changed socket due to shrinking of the residual limb.

Prostheses
more frequently during the day in humid, hot As the residual limb size changes socks can
weather. If needed, a 2-liter bottle may be be added and removed. Prosthetic socks are
inserted to restore the shape. available in various thicknesses often called
- Daily care for the residual limb ply.
- Daily care for the prosthesis
The inside of the socket should be cleansed
Wearing

Usage
- Donning: inner sockets, liners and socks, then the fewest number of socks to
weekly, washed with warm water and mild
outer sockets (and components) achieve the desired ply will help reduce
soap and dried thoroughly [Seymour 2002,
- Wearing the prosthesis during activities p141]. It needs to be inspected daily for cracks bunching and wrinkling of the socks.
(ambulation, work, sitting, etc)
or rough areas.
Liners

Stragegy
- Changing the prosthesis? in most cases are rolled onto the
- Doffing: removing the prosthesis residual limb, just like a condom is. This
- Applying a compression device (see section method prevents pre-stretching of skin by
5.1). Amputees don’t need to shave their residual donning and ensures a tight fit between the
limb. Shaving can cause ingrown hairs, and liner and the residual limb. Applying a liner

Criteria
often leads to infected hair follicles. can sometimes be difficult. The liner needs to
have the right orientation and the application
of the liner requires some force.

Requirements: The socket should be wash-


able.

55
Sockets are donned in different matters, Changing the prosthesis for special Exercise is the key
often dependent on the suspension system
(see section 4.3). In some cases, the amputee
activities The prosthesis is (has to become) part of
wears only the hard socket and the prosthe- Some special activities, such as shower- everyday life. All successful use of prosthe-
ing and all kind of sportsactivities (biking, ses starts with the amputee. As Jon Holmes
sis can be shoved right on the residual limb. states it [ACA 2001, p84]: “The most impor-
In most cases however, users use a donning skiing, swimming), require specialized
prostheses, specifically made for that tant part of the prosthesis is the motor’’. And
sock. A donning sock is a stockinette, without the motor is the amputee. Good functionality
a end (a long tube). It is protruded through purpose. An example is the shower-limb
(figure 5-2). In these cases, the requirements and control over the prosthesis is obtained by
a hole at the distal end of the prosthesis. By daily exercise. Keeping the muscles and joints
pulling that sock, the residual limb is pulled for the prosthetic design differ.
in shape and keeping confidence by practic-
in the prosthesis. In case of an amputee using
a liner with a pin/shuttle lock, or a liner with And for some activities the prosthesis is not ing and using the prosthesis. Use it or lose it!
suction suspension, the donning sock often needed at all. Many amputees, especially kids,
can not be used (of course, there are systems like to move in-house without their prosthe-
in which the patient can pull the end of the sis (instead using a wheelchair or nothing).
donning sock through the valve). Also, the
donning of (hard) sockets can be a problem
with patients with a very bulbous residual
limb shape.

Shoes are often changeable. Of course, most


persons wearing a prosthesis, also wear
shoes, so that the artificial and the unaf-
fected limb are harmonically clad.

Figure 5-2: LEFT: The endolite Aqualimb with


anto-slip tread patterm on the sole
for extra grip on wet surfaces. [www.
endolite.com].
RIGHT: The rampro activankle swim-
56 ming prosthesis [www.rampro.net].
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Ambulation during everday life 1. The normal person walks 83 m/min and
expends 0.063 kcal/min/kg and 0.000764
Many prosthetist use the thumb rule that
A very important factor in functional out- kcal/m/kg. using a unilateral transtibial prosthesis
takes about 50% more energy than normal.

Approach
come and use of the prosthesis is the amount 2. The average transtibial amputee walks 43%
of energy it takes to use it. slower, and expends five% less kcal/min and Especially for elderly, this can be very signifi-
89% more kcal/m than the normal person. cant.
People with amputations tend to walk slower, 3. Normal and disabled persons naturally
Another difficulty can be a limited range
to bring the power needed to walk to normal attempt to walk at a speed which is most effi-
cient in terms of Ee /kcal/min. of motion in the joints. This can prevent

Users
levels. Since the disabled person, like the
normal subject, tends to choose his most effi- 4. Disabled persons decrease their speed of the amputee from climbing and descending
cient speed of ambulation, it seems appro- walking, so that their Ee /kcal/min decreases stairs, sidewalks, etc. Also, it can slow down
priate to let the subject pick his own speed, toward the normal range. the amputee when turning.

Prostheses
instead of imposing an unnatural speed of 5. The more disabled a person, the more deter-
minants of gait are lost; therefore, the more Ee
walking for the researcher’s convenience.
/unit distance is used in ambulating and the
Standing and sitting
[Seymour 2002, p.166]. Some general proper- Requirement: The prosthesis must enable
less efficient is the gait.
ties of ambulation with a prosthesis can be the patient to stand up fully (else it takes a lot
drawn from the averaging of the results of of energy to stand) and to sit (allow enough

Usage
studies in which the subjects did choose their movement and avoid painful brims).
own speed. However, the results given should
be taken as approximations and generaliza-
tions: [Fisher 1978]

Stragegy
Criteria
57
5.5 Statistics on functional Young 5.6 Aftercare and concerns
outcome and use Younger people are much more forgiv-
Amputation results in social losses due to
ing to the design. A study of 88 children of
amputation involve loss of function, loss of
Practically, how often and intensive the pros- transtibial amputation in the Netherlands
sensation and loss of body image [Seymour
thesis is used, is dependent on a lot of factors, found high use rates. 90% of them attended a
regular school. This increased use is a result 2002, p63]. Successful adaptation to the disa-
most important being age. bility results in change of behaviour, such as:
of various factors. These include early fitting,
decrease in pain and home and work modifi- - Increased confidence
Elderly cations. [Seymour 2002] - Taken charge of life rather than allowing
Functional outcome of elderly is partly pre- -
external factors to control one’s life.
Return to work or hobbies,
dictable by age at amputation, one-leg balance
on the unaffected limb and cognitive impair- Project: Comfort of fit and use are the most - Focus on new activities and skills
ment [Schoppen, 2001]. One study found that important criteria of the prosthesis - Renewal of friendships
of 50+ US amputates only 44% wore their - Increased feelings of independence
prostheses every day [Seymour 2002, p71]. A
Canadian study [Bilodeau et al, 2000] shows
different statistics: over 70% of amputees 60
years or older used their prosthesis every day.
It concludes: “A multiple regression analysis
showed that satisfaction, not possessing a
wheelchair and cognitive integrity explained
46% of the variance in prosthesis use”. It is
safe to conclude that the comfort level of the
prosthesis and its easy of use is a major factor
determining functional outcome.

58
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

The patient himself is responsible for finding


the right support in his neighbourhood, but
the rehabilitation team will help him on his

Approach
way. However, life after an amputation is chal-
lenging. The amount of concerns of patients
show this [Seymour 2002, p70]:
- Health-care access and expense

Users
- Financial concerns
- Coordination of social services benefits
- Disability rights and advocacy
- Lack of knowledge of new prosthetic compo-

Prostheses
nents
- Fit of the prosthetic socket
- Functioning of the prosthesis
- Adaptation to life with the prosthesis
- Lack of available information on new tech-

Usage
nologies
- Accessibility to Commercial Services

Stragegy
Criteria
59
6 Ethics, Marketing and Design Vision

6.1 Ethics big group of customers. Future requirements: The Universal prosthe-
sis should consist of few parts. The price of
To determine the design target, apart from However, low-cost products generally are the product (in higher production volumes)
quite stigmatizing. Even people in need want should fall in time. The Universal prosthesis
function and practical requirements, a dis-
the best. High-end “Western” products are should have a high-tech or modern look.
cussion of ethical implications is needed. It
better accepted. The universal prosthesis
provides insight in the social requirements of
could acquire a good reputation by beginning
the product.
as a high-end product for developed areas.
6.1.2 Social-political consequences
The Universal Prosthesis is a healthcare
Later, it can become cheaper and available
everywhere. In the controlled environment
An important factor to predict the social-
product. Its benefits for the user are clear. political consequences of a product is to look
of orthopaedic clinics, the design can be per-
It is evident that there are also benefits for to the influence of the production and use of
fected and later translated to a design that is
the society. How to optimize these bene- the product to the distribution of wealth in
better suitable for the “stand alone” distribu-
fits? By assessing the positive and negative the society. Will the product contribute to an
tion in developing areas.
impact of the product and building on the egalitarian or an in-egalitarian society?
strengths. The following sections discuss
these strengths, especially in the Universal
How can this evolution from high to low-
The Universal Prosthesis is a product that
cost product already be incorporated into
Prosthesis’s final form, as a worldwide avail- helps the users to better fulfil their daily
the design now? The key is the use of smart-
able product. tasks, needs and functioning. This makes
tech and developing a smart-product. A smart
them more interdependent of their envi-
product is a product, which development is
6.1.1 A World-wide Smart-tech ronment. There social integration is eased,
dependent on high input levels of knowledge.
improving their social, educational and voca-
product Often, also high-end production facilities and
tional chances.
technologies are needed. However, the need
The Universal Prosthesis is a product that for resources and parts in the final product is
low. Smart products generally consist of high- The differences between the transtibial
improves the live of the limbless that it is amputees and other people become smaller,
provided to. It is clear that a wide distribution end materials. While being expensive at the
start-up, the price of a smart product reduces also there economical differences. We can
of prostheses is wanted. In developed coun- say that a prosthesis is a product that advo-
tries, the amputees are generally provided when the investments are turned over, the
product can be produced in higher volumes cates an egalitatian society by its function.
good healthcare. The wealth is available to
improve these person’s welfare and Quality of (mass-production) and the price of the used
Life. However, in developing countries, there materials and technologies drop as well.
is still a high unattended need for healthcare.
A low-cost universal prosthesis can reach a
60
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Politically, there is a need for high knowl- 6.1.3 A product for the world The second limiting factor is economics.
edge and production technologies to produce There must be enough interest to produce and
the prosthesis. High investments are needed In the long term, the Universal Prosthesis distribute the Universal Prosthesis worldwide.

Approach
at the start-up of the implementation process. will become available to a wide public. It is Even while in this cases humanitarian NGO’s
The resources for these investments need to favourable to integrate this development in and funds, and social insurance play an enor-
be collected by a small group of people, who the current design. mous role, costs will always be an issue.
gain power by their possibilities. To accommo-
date such power/money concentrations, an in- As seen in chapter two, the distribution and Demand for the Universal Prosthesis is

Users
egalitarian society is needed. The differences use of the Universal Prosthesis is the limiting highly dependent on its comfort level during
between the rich and the poor become bigger. factor in the feasibility. Economics comes in use.
However, the improvement in social function- the second place.
ing of the owners of a Universal Prosthesis To combine price, adjustability (to reach new

Prostheses
has a more powerful egalitarian impact on Important for its distribution is the easy of markets) and a high comfort level in one
society. Especially, when the investments are use. The product must be understandable for product, a lot of knowledge is needed. Again,
returned and the prosthesis becomes avail- a wide range of people, from different cul- the smart-tech approach seems to be appro-
able to the masses for a low price. tures and languages. priate.

Usage
We can conclude that on the long run, the Requirements: use-cues should be multi-lan-
Universal Prosthesis will advocate an egalitar- guage
ian society. General healthcare will improve.
The effect of the product will be most notice- Another distribution factor is the

Stragegy
able in developing countries. (in)dependency of the product on the local
infrastructure of resources. For example, it
can be assumed that water and electricity are
available everywhere but helium-gas is not.
The same story goes for dependency on the

Criteria
local infrastructure of knowledge. For exam-
ple, electrical-engineers are not available eve-
rywhere.

61
6.1.4 Production It is well possible (and probably smart) too 6.2 Conclusions from the Sri
include many locally made parts in the kit,
To ensure better distribution the Universal such as manuals or components. That gives Lankan test designs
Prosthesis is adjustable. But more is needed. the local production facility the possibility to
give the product a local character. People and Apart from identifying the lack of
While designed as a total concept, the the local society will feel more involved with prosthetists as the mean problem in devel-
Universal Prosthesis will still have a modu- the product. oping countries, additional lessons where
lar setup. Especially the foot, because of the learned from the design made there and the
need for different sizes, left-and-right models In the world of tomorrow, environmental tests conducted.
and varying requirements will have to be considerations can’t be ignored. In the case
produced separately. It could be possible to of smart products, when the applied produc- Trials of amputees walking in open-frame
use existing designs for the feet (produced by tion methods are reasonable, the product can sockets (see appendix D for some designs)
now operating companies), but the feet could have a low impact on the environment. Smart indicate that open-frame sockets can be
also be locally produced, in accordance with products are produced in mass and often effi- used to stand in. During ambulation the test-
the local culture and needs. ciency of resources is needed. Also, they exist models in Sri Lanka buckled within a few
of fewer parts. steps.
On the other hand, the socket needs high
input of skills and knowledge. It is better to
produce it centrally.

A good option to combine these different


production places is to offer the product as
an assembly kit. The socket is build centrally
and imported. Locally, (in the country of WATCH THE VIDEO
distribution) feet and other component are
added to complete the kit. Final assembly can ON THE CD
be done by the user or the local specialist.
This strategy is very similar to current dis-
tribution strategies, where components and
assembly kits are sold to the prosthetists.
Figure 6-1: A movie, in which an amputee
walks several steps in a frame
62 socket. [Wisse et al. 2002]
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

These results indicate that open-frame sock- This is an important find. If an open-frame 6.3 Marketing
ets can be used to stand in and might be socket can be used to stand in during the fit-
developed further, so that even ambulation is ting procedure, the prosthesis can be fitted In chapter four we have seen that current

Approach
possible. while the residual limb is under load. A total prosthetic design vary widely in quality (com-
contact socket can than be formed in respect fort level) and price. The market in developing
The open-frame design was never reported to the loaded limb. The resulting unique fit- countries is completely different than that in
as being comfortable. One problem was the ting procedure will result in: western markets. This results in different cri-
connection between the back and front part teria, a different maximum price and a differ-

Users
- higher pressures on the interface between the
of the open-frame (usually a leather belt). The limb and the open-frame on pressure-tolerant ent value the users will give to the universal
system had to be very precisely dimensioned area’s (see section 3.1.3) prosthesis.
and stiff connected; otherwise the amputee - less tissue deformation during load (prosthe-
would slip downwards into the prosthesis Because the current state of prosthetics in

Prostheses
sis will be formed to the situation when the
(pistoning). highest pressures find place). This results in developing countries has to be improved (and
more comfort during stance and probably to a the amputees won’t accept else!), compromis-
To achieve a comfortable fit (a level of com- higher overall comfort. ing comfort is not an option.
fort comparable to current sockets) as many
areas as possible must assist in weight-bear- These intermediate finds strongly suggest
Given the high requirements on comfort

Usage
ing and control (up to their maximum pres- that the universal prosthesis should exist of
level, it is challenging to offer the universal
sure tolerance). a hard open-frame part and an easily deform-
prosthesis for a low price (for a better fit,
able soft part.
more or better adjustable parts are needed).
This leads to a multi-step approach to the

Stragegy
world market. Because each step requires a
new design (optimization), the phases in this
approach are referred to as cycles:

Criteria
63
- Cycle 0 - The preparatory design trajectory:
In this phase, the feasibility of the universal
Each cycle will have a different target group. - Cycles 2: - Standard group”,
“Kids” and “Inactive”. The final design has to
prosthesis is shown by developing a proof-of- Most users of the universal prosthesis will be combine all the positive sides of the universal
principle design (this graduation project) and part of these groups: prosthesis. If feasible, multiple versions will
testing it with users (continuation). - Cycle 0 – “Standard group”: improve the comfort for the target groups.
Healthy man and women with a unilateral The “UP Kids” can be smaller and the “UP
transtibial amputation. The age group for Senior” can be lighter than the “UP Standard
- Cycle 1- Market exploitation in developed
which the universal prosthesis is designed, edition”.
countries:
A high quality (medium-high costs) design is will be around 20-60, because (anatomical
made. In this phase, the design is tested on a and statistical) data is used from this age-
broader scale, while production quantities can group (see appendix G).
stay low. It will be used by many experienced
prosthetists, whose feedback is invaluable. - Cycle 1 – “Inactive amputees”:
such as bed-bound people, because the lim-
- Cycle 2 – World market exploitation: ited use of the prosthesis leads to low struc-
A high quality, low coast design is made. tural/mechanical demands. In this case, the
The product can be low in costs because universal prosthesis can be designed lighter
the product is produced in large quantities (and more easily adjustable if deformation
(>10,000 a year). This high volume production forces are needed). The quickly fitted prosthe-
is supported by a well organized distribution sis results in more elders that are fitted.
around the world (compare 6.1.4).
- Cycle 1 – “Kids”:
The lower body weights leads to low struc-
tural/mechanical demands. Also, because of
the growth of the younger, more frequently
new prostheses have to be fitted. The univer-
sal prosthesis can lead to a higher replace-
ment rate. The design can be smaller, or
issued in multiple sizes.

64
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

6.4 Substitute products to alleviate the same problem as the universal


prosthesis does, namely, the lack of experts
Water-cast: wrap residual limb in plaster of Paris,
put limb in pressure-tank, add pressure while
and competitive fitting and the difficulty of making new prosthetic hardening, make a positive with plaster of

Approach
(sockets). They compare as follows: Paris, laminate with fibre and resin.
methods Icex: Fit liner with silicone pads to protect bones,
prepare Icecast component, calibrate, wrap
Most direct competitive products for the Basic procedures: limb, shove on residual limb, harden (plaster
universal prosthesis are mentioned in chap- Standard: make a negative of the residual limb of Paris or directly laminated), finish.
with plaster of Paris, make a positive with Universal prosthesis: For an impression see sec-

Users
ter 4, during the discussion of the different
plaster of Paris, rectify for pressure distribu- tion 6.5.
prosthetic types. However, the most distinc-
tion, laminate with fibre and resin.
tive property, the fabrication method, is only
discussed very briefly in section 4.1.5.
Sand-cast: put residual limb in plastic bag, Put A scan of the advantages of the systems can
the limb in a container, fill the container with be found in table 6-1. Concluding from it, if

Prostheses
sand, suck air out of container (negative shape
For the acceptance in developing countries, forms), fill the negative with sand and evacu-
the universal prosthesis can keep its promise,
it will be a good alternative (also see evalua-
the prosthesis has to be more wanted than ate air (positive sand form), rectify, vacuum
two important substitute products, the wheel- tion chapters).
form or laminate socket.
chair and the cane.

Usage
6.4.1 Fabrication and fitting methods
In section 4.1.5 the standard fabrication

Stragegy
method is shown (figure 4-9) and the ICEX-
system is introduced, which is an example of Product Rectification? Expertise level Tools needed
a pressure-cast method (see 4.3.1). Its fabrica- needed?
tion manual can be found in appendix N. The Standard Yes (PTB) High often vacuum forming
sand-cast-method is developed for use in the

Criteria
Sand-cast Yes (PTB) Medium-High Pressure device + air-tight container
third world as another pressure-cast method
Water-cast No Low Pressure device + water-tight fitting-tank
(fabrication details in appendix O). Finally,
the water-cast-method, currently in develop- Icex No (but pads) Medium-High Icecast compact component
ment at orthopaedic centre “de Hoogstraat” Uni. Pros Yes (PTB) Low None other than for do-it-yourself (saw,
in Utrecht and the University of Strathclyde, screwdriver, etc)
is developed with the same target group in
Table 6-1: Several fitting methods and their properties.
mind. These last three, all pressure casts, aim 65
6.4.2 Substitute products
The wheelchair and the cane are widely
spread and used in developing countries.
They compare as presented in table 6-2.

The universal prosthesis can alleviate the


problem with the quality of currently pro-
duced prosthetics in developing countries.
It will stay more expensive than a cane, and
100 USD will stay a high amount for a large
part of the world population. The wheelchair
has to be available, especially for people
with other amputations or disorders than a
transtibial amputation.

Product Comfort Availability / support Price


Prosthesis The prosthesis can be very comfortable, but the user has to A comfortable prosthesis is difficult to make. Because of this, ± 100
have a decent residual limb (health and length). Social accepta- properly functioning prostheses are not wide-spread. On the USD
tion is high. other hand, a robust prosthesis can be used in many situations
(city, farmland, etc)
Wheelchair The comfort level of the wheelchair is high, especially for Wheelchairs are easy to manufacture from blue-prints. ± 100
people with difficult amputation levels. Wheelchairs are wide-spread, but use is limited because the USD
user needs flat roads and other adaptations of the environ-
ment. These adaptations are part of normal life in developed
countries, but not so in developing countries.
Cane The comfort level is low during ambulation. The user needs an With a cane most places are accessible. Also, canes are easily ± 10
arm while walking. However, the cane can easily be put away. produced and distributed USD
Social acceptance is low, but some make use of this (beggars).
Universal High-comfort fit made possible without expertise for a select Better distribution ?
Prosthesis group (of medium-active, healthy, transtibial amputees). USD
66
Table 6-2: Several walking and mobility aids and their properties
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

6.5 Vision of the fitting 6.5.1 Cycle 1 – for developed easily visible from the outside of the pack-
age. On the box is basic information about
countries the range in stump shape, circumference and
procedure and usage

Approach
length for which the kit is suitable.
The results in Sri Lanka (section 6.2), com- Design and production
bined with the market possibilities from sec- - After the feasibility of the concept is proven, Distribution:
tion 6.3 and the project and vision remarks the product has to be developed into a final - The kits cost about 500 USD.
found all over chapter 3 and 4, lead to one design. This development can be conducted - The kits are being advertised as an
at universities or at one of the big compa-

Users
vision about how the prosthesis and its fitting (cost)effective, customizable, base from which
nies, such as Otto-Bock or Ossur, that can a prosthetist can (time)efficiently fit a prosthe-
procedure should be. This vision is hereafter finance it. A new team, combining industrial
presented for both cycle 1 and 2 and follows sis.
design engineers, technical engineers and
the life-cycle of the product (design and pro- - The kits are being sold via existing reselling
prosthetists optimizes the design. The exist-

Prostheses
duction, distribution, fitting procedure, use companies, from two centralized points, one
ing requirements list (chapter 7) defines the
in the United States and one in Europe.
by patient, disposition). design target.
- The kit is bought in conjuncture with a serv-
- With a small number prostheses clinical
ice contract. This service contract will help
tests are conducted to answer questions as:
the prosthetists with information and will sell
“can the universal prosthesis find its way in
additional parts when needed. The service

Usage
current (orthopaedic) practise?” and “what is
contract will provide the producer of the uni-
long-term functional outcome?”.
versal prosthesis with addition feedback on
- Now, after evaluation and redesign, produc- usage and functioning.
tion can be started. The first batch will exist
of 10,000 pieces. The assembly of the pros-

Stragegy
thetic parts is mostly left to the prosthetists. Use – fit and alignment procedure:
They buy assembly kits, so that they have - The kits are easy to lift, they don’t weigh more
greater influence on the final shape of the that 5 kilograms. The can be easily stored due
fitted prosthesis. The kits don’t contain to their form.
feet, which are easily available through the - The prosthetist opens the kit, when basic

Criteria
common distribution channels. information on the residual limb is known,
- The kit contains: a manual for the prosthetist, before the patient arrives, so he has time to
a manual for the user, the parts needed for prepare the parts he will need. The socket
the prosthesis, additional parts that can can be connected to a fitting pylon/foot if the
improve the fit for non-standard residual prosthetist doesn’t know yet which type of
limbs (such as gel pads), a brochure that foot he will use for his client. If he knows, he
explains the long term project objective. can immediately connect the selected foot.
The main part of the prosthesis, the socket, is 67
- When the patient arrives, the basic setup - SITTING: The prosthesis now can be doffed. Use- daily use by the client:
is ready. The patient has to sit and to stand The fitting sock and gel stickers can be dis- - PREPERATIONS: The socket has to be clean,
during the fitting procedure, so a frame or a posed of. A thin liner or sock (as thick as the especially on the inside. The user can, depend-
walking aid and a chair are needed. The order fitting sock) can be worn during the use of ent on the type of foot that was provided with
of the parts in the box support the procedure the prosthesis. the prosthesis, don socks and shoes over the
the prosthetist has to follow. - AMBULATION: The client walks. The pros- prosthesis.
- SITTING: To protect the residual limb of the thesis now behaves as a PTB-prosthesis. - DONNING: The user dons a liner or sock. The
client, a sock is donned. The still (de)formable To improve pressure distribution (more prosthesis is donned over the liner or sock. If
socket is being donned over it. The prosthetist TCB-behaviour), a thick, but viscous liner is needed, a suspension belt or sleeve is attached.
adjusts the total limb length by adjusting the donned. The user himself can choose the most
- AMBULATION: The client now can do his
length of the pylon. The socket is provided comfortable combination.
normal, daily activities. In the beginning, the
in its biggest shape, the prosthetist can by - The fitting procedure is finished. The fitted patient has to get used to the prosthesis. He
deforming it, globally adjust the form to the pylon and foot are definitely attached to the has to gradually increase the daily period of
shape of the residual limb. If needed, gel pads socket. The client can take the result home, use.
or gel stickers are attached on the sock over together with the manual. Not-used parts,
wounds or extra-sensitive areas. - DONNING: The prosthesis is donned. It can be
which might be used later for repairs or when
stored everywhere. Socks need to be washed.
- STANDING: The patient can stand now. The a new prosthesis is fitted, can be given to the
hard part of the socket provides weight bear- client or send back to the factory. - MAINTENANCE: For reparations and main-
ing. The pylon is aligned in such a way, that tenance, the client visits the prosthetist. The
the line of gravity is normal on the axis of prosthesis is checked every half a year.
rotation of the knee. The feet of the patient Disposition
have a natural distance and angle.
- The prosthesis is returned to the prosthetist,
- STANDING: The soft part of the socket now who will provide a new one.
exactly forms itself around the loaded residual
limb. The prosthetist can aid this formation. - The prosthetist detaches the foot.
When the soft part has the right shape, the - The prosthetist sends the prosthesis back to
prosthetist starts the hardening phase. The the factory. The factory will check the pros-
soft socket now quickly settles, the complete thesis on wear and will evaluate the way it
hardening doesn’t take longer than 10 min- was used.
utes. Meanwhile, the patient is standing in the
prosthesis (with about half its body weight
supported by the prosthesis).

68
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

6.5.2 Cycle 2 – for developing and a liner. The final product (after fitting pro- - SITTING: To protect the residual limb of the
cedure) is shown on the outside of the box. On client, a sock is donned. The still (de)formable
countries the box is shown for which residual limb sizes socket is being donned over it. The helper

Approach
the prosthesis is suitable and the size and side adjusts the total limb length by adjusting the
If the use of the prosthesis is successful in of the foot that is in the box. length of the pylon. The length can be easily
the developed countries, the transition to the determined by comparing the resulting knee
use for the developing countries can be made. heights. The socket is provided in its big-
Distribution: gest shape, the helper can, by deforming it,
- The kits cost about 100 USD.
globally adjust the form to the shape of the

Users
- The kits are being advertised as a good, com- residual limb. If needed, gel pads or gel stick-
plete and easily fitted prosthesis.. ers are attached on the sock over wounds or
Design and production - The kits are being sold in every country from extra-sensitive areas.
- After the success on the markets in the centralized spots. - STANDING: The patient can stand now. The

Prostheses
developed countries, the product has to - Additional parts are easily available through hard part of the socket provides weight bear-
be improved further. The producers of the the centralized selling points. ing. The pylon is aligned in such a way, that
prosthesis, in combination with subsidy and the line of gravity is normal on the axis of
grants, finance the new development. The new rotation of the knee. The feet of the patient
team, again with multi-disciplinary now also Use – fit and alignment procedure: have a natural distance and angle.
combines members from all around the world. - The kits are easy to lift; they don’t weigh more
- STANDING: The soft part of the socket

Usage
that 5 kilograms. The can be easily stored due
- With a small amount of prototypes new clini- to their form. now exactly forms itself around the loaded
cal tests are conducted. Now, the ability of residual limb. The helper can aid this forma-
the prosthesis to function in area’s such as - The user is able to fit the prosthesis himself, tion. When the soft part has the right shape,
farmland and the ease of fitting need to be but aid is useful. The helper and the user the helper starts the hardening phase. The

Stragegy
assessed. together open the kit. soft socket now quickly settles, the complete
- After redesign and optimization, mass produc- - The order of the parts in the box supports the hardening doesn’t take longer than 10 min-
tion can be started. At least 10,000 pros- procedure the users have to follow. The socket, utes. Meanwhile, the user is standing in the
theses a year are fabricated. The prosthesis the pylon and the foot are connected by them. prosthesis (with about half its body weight
will be as much as possible pre-assembled The user has to sit and to stand during the supported by the prosthesis).

Criteria
in the factory. The result will be distributed fitting procedure, so a frame or a table and a
in assembly kits, which consist of the socket chair are needed. For the functioning of the
parts, pylon and a foot. prosthesis, a right alignment of the feet is
required. The user can easily see this on the
- The kit contains: the parts needed for fabri- fit-sheet, which is placed on the ground and
cation, a manual for the one who will help has an image of to feet printed on it.
during the fitting procedure (hereafter called
helper), a manual for the user, a fit-sheet with
feet positions printed on it and gel-stickers 69
- SITTING: The prosthesis now can be doffed. Use - daily use by the client: Disposition
The fitting sock and gel stickers can be dis- - PREPERATIONS: The socket has to be clean, - The prosthesis can be send or brought back to
posed of. A thin liner or sock (as thick as the especially on the inside. The user can, depend- the factory, who will issue a new kit against a
fitting sock) can be worn during the use of ent on the type of foot that was provided with slightly reduced price.
the prosthesis. the prosthesis, don socks and shoes over the
prosthesis.
- AMBULATION: The amputee walks. The
prosthesis now behaves as a PTB-prosthe- - DONNING: The user dons a liner or sock. The
sis. To improve pressure distribution (more prosthesis is donned over the liner or sock. If
TCB-behaviour), a thick, but viscous liner is needed, a suspension belt or sleeve is attached.
donned. The user himself can choose the most - AMBULATION: The client now can do his
comfortable combination. normal, daily activities. In the beginning, the
- The fitting procedure is finished. The user patient has to get used to the prosthesis. He
take the result home, together with the has to gradually increase the daily period of
manual and unused parts, which might be use.
used later for small repairs. - DONNING: The prosthesis is donned. It can be
stored everywhere. Socks need to be washed.
- MAINTENANCE: Small reparations and
adjustments can be done by the user himself.
For bigger defects, a new prosthesis has to
be fitted. The manual will advice the user to
replace the prosthesis every year.

70
The Universal Prosthesis
7 Design criteria and requirements Boudewijn Martin Wisse
TU Delft, 2005

In chapter 3 it became clear that transtibial The list of requirements also isn’t complete. 1. Universal
The prosthesis can be fitted to a big group of
amputation is the most prevalent level of The complete set of requirements relates to transtibial amputees.
amputation. Therefore, the universal prosthe- the complete service that de producer and the

Approach
2. Comfortable
ses should be usable by this group. But what prosthetist offer to the client (of which the The prosthesis is comfortable during use by
are other requirements? Ten criteria, which prosthesis is a part). That would be a long list. the amputee.
are constantly used while evaluating ideas, Here is chosen for a shorter, better usable list, 3. Easily fitted
and the total concept can be found in section that suits the purpose of this project, namely The prosthesis can be fitted easily to the
7.1. to conduct a feasibility study. Areas which amputee by low educated.

Users
won’t be the bottleneck for the feasibility of 4. Controllable
The requirements (Dutch: eisen) are depend- the project are not worked out. The prosthesis provides the control and feed-
ent on the cycle (see section 6.3) in which the back during use.
development of the prosthesis is. However,

Prostheses
5. Usable
requirements for a later cycle, are always 7.1 Ten Design Criteria The prosthesis can be easily used (espe-
goals (Dutch: wensen) for the preceding cycle. cially donning, doffing and cleaning) by the
That’s why the requirements can be found per Design criteria follow from what the design amputee.
cycle (section 7.2 to 7.4). Additional goals can needs to be successful. The design can 6. Safe
be found in section 7.5. comply with the criteria in a higher or lower The prosthesis is safe in respect to health of

Usage
level (score better or worse). In order of the user and of the planet.
importance the 10 criteria are: 7 Affordable
The price of the prosthesis is low.
A good list of requirements only consists of 8 Cosmetics

Stragegy
requirements for the design and doesn’t con- The cosmetics of the prosthesis are pleasing.
tain solution on how to meet these require- The amputee blends easily into the society.
ments. In the list of requirements hereafter, 9 Quickly fitted
this principle is not used. This project is a The fitting procedure takes little time.
continuation from the internship in Sri Lanka 10 Distributable

Criteria
and the results of that work determine the The distribution is easy and the prosthesis
global design and project form. is complete or well compatible with other
systems. The (fitting of the) prosthesis is inde-
pendent on locale infrastructure.

71
7.2 Requirements for cycle The socket:
- The interface with the residual limb can not
- The socket makes total contact with the
residual limb. Every area of the residual limb,
0: The preparatory be poisonous or irritate the skin (for P99). inclusive the distal end, has to make contact
with the socket (so no “holes”) (4.3.1)
- The socket is suitable for more than 70% of
design trajectory the transtibial amputees (2.3). - The pressure-distribution is optimized to
the PTB or the TCB-model or a hybrid/combi-
Corresponding sections are given between
- The socket is suitable for residual limbs with
lengths of 80 to 250 mm (3.1.2, 3.1.3).
nation of those. (4.3.1)
brackets (). - The socket is not uncomfortable (2.3), the
- The socket is suitable for residual limbs with
comfort level is comparable with existing
circumferences of 250 to 350 mm (at patellar
prostheses. (4.3.1)
Total distribution kit /prosthesis: tendon height) (3.1.3).
- The socket does not hurt.
- The prosthesis can be donned seated. - The socket is suitable for residual limb
shapes that are conical and cylindrical (3.1.3) - The socket does not obstruct normal
- The prosthesis can be doffed seated. movement.
- The prosthesis has roughly the same shape as - During the fitting procedure:
- The socket can not have obtruding or
the natural leg. - The socket is formed while the residual
sharp parts as well on the inside as on the
- The fitting procedure takes little time. limb is loaded (while the user stands in it):
outside.
- The prosthesis is suitable for at least 70% of - The socket provides weight-bearing at
the transtibial amputees (2.3). beginning of the procedure. The unhardened
socket is enough flexible and deformable, so
- The prosthesis improves the functional activi-
that the prosthetist can shape it in the shape
ties and mobility of the user in a similar way
of the residual limb.
as existing prostheses. Inclusive ambulation
and body posture. - The socket loads the pressure-tolerant
areas of the residual limb.
- The prosthesis provides an acceptable gait
(3.1.5). - The socket has to harden so that the
total area can add up to the transfer of loads
- Ambulation is possible without the toes
between the socket and the residual limb.
touching or skimming the ground.
The prosthetist has to be able to decide the
- The prosthesis provides enough stability moment of the hardening. The hardening
(during ambulation that resembles normal won’t take longer than ten minutes.
gait).
- During daily use:
- The prosthesis provides enough perception
- The sensitive areas of the residual limb
and control.
will not be overloaded. Most of the loading is
on the load tolerant areas (3.1.3 – 3.1.5).

72
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Pylon:
- The pylon can be adjusted in length. The total
Foot:
- A “rocker foot” suffices.
7.3 Criteria for cycle 1:
height of the prosthesis is the same as that of Market exploitation in

Approach
the opposing leg.
Additional parts: developed countries
- The pylon can transfer the forces that act - SUSPENSION: The comfort level has to be
upon it during stance (maximal 700 N) to the minimally equal to the comfort level of the Corresponding sections are given between brack-
ground without plastic deformation. The total currently used “knee-cuff” solution. ets ().
elastic bending may not be more than 6 mm
- CONNECTIVE COMPONENTS: The connec-
at a length of 240 mm and the total elastic

Users
rotation may not be more than 10 degrees,
tion between the socket and the pylon can be Total distribution kit /prosthesis:
rotated. The connection between the pylon - The product is optimized for production quan-
when the pylon is loaded with a torque of 60
and the socket can be rotated. tities over 10,000 pieces. (4.1)
Nm at a length of 240 mm.
- The pylon can be aligned: - The prosthesis complies with the current

Prostheses
West-European and American industry stand-
- The pylon can be aligned is such a way,
ards. (3.3)
that the medial side transfers more load than
the fibular head region (3.1.4). - The final price of the distribution kit is maxi-
mal 700 USD. Using the universal prosthesis
- The alignment is done with 5 to 10
will (in general) reduce the costs of the total
degrees flexed knees (3.1.4).

Usage
rehabilitation trajectory. (4.5.1-4.5.5)
- The complete prosthesis can be aligned
- The prosthetist assembles the socket, the
in such a way, that the rotation-forces on the
pylon and the foot within 2 minutes, so that it
residual limb while standing are minimal (no
is ready to be fitted.
more than current prostheses) (4.4).

Stragegy
- The final prosthesis will weight between
- The pylon can be aligned in such a way
2.2 and 3.5 kilograms (3.1.4, 3.1.5) with the
that the line of gravity of the body will be
centre of gravity of the prostheses as proxi-
normal to the rotational axis of the knee
mal as possible.
during stance.
- The prosthesis will stay functioning properly
at normal use (average usage of the target

Criteria
group) al least one year. (4.6)
- The prosthesis doesn’t attract attention when
worn under a pair of trousers, socks and
shoes (4.1).
- The donning and doffing of the prosthesis
does not take longer than one minute (5.4).
73
- The prosthesis aids the prosthetist in finding Additional parts: Packaging and manuals:
the right alignment (use-cues). The prosthetist - SUSPENSION: The included suspension will - The manual for the prosthetist contains a (tex-
has to experience the fitting and alignment keep the prosthesis connected to the residual tual) description of the preferred procedures.
procedure as more natural and intuitive than limb during swing-phase. - The manual for the user contains information
the procedures of current prostheses (2.3-4.4).
- CONNECTIVE COMPONENTS: The included about donning and doffing, the maintenance
- The prosthesis is suitable for daily use (2.3). connective components provide connection and cleaning of the prosthesis, how the user
- The energy expenditure of normal use of the with popular feet designs. The connection to can recognize problems and what actions to
prosthesis is comparable with that of current the feet stays adjustable (translation and rota- take.
prostheses (maximal 30% more) (3.1.5). tion), even when the prosthesis is hardened. - OPTIONAL FOR CYCLE 1: A brochure that
(4.2) explains the long term project objective.
The socket: - FITTING SOCK: The supplied fitting sock can - On the outside of the distribution box (pack-
- The total production cost of the socket is be donned sitting. The fitting sock protects aging) is printed for what range of residual
maximal 500 USD. (the skin of) the residual limb during the fit- limb sizes and shapes the prostheses is suit-
ting procedure. able. The socket is visible from the outside of
- The socket must be easy to clean (5.4).
- PRESSURE-RELIEVING-PARTS (GEL PADS): the packaging.
These included parts will diminish the pres- - The total package is easily displaceable by a
Pylon: sure on extra sensitive areas of maximal 600 single person. It is not bigger than 0,12 M3)
- The total production cost of the pylon is maxi- mm2. and it has sides shorter than 800 mm. The
mal 100 USD. - FITTING PYLON – OPTIONAL FOR CYCLE 1: package is not heavier than 5 kg.
- The pylon can be fitted with a shock-absorp- The fitting pylon is an extra pylon part that - The order in which the parts come out of the
tion component or rotator. can be attached to make up for the lacking package supports the fitting procedure.
foot during the fitting procedure.
Foot:
- REMARK: In this distribution kit, no foot is
supplied. Standard feet designs can be con-
nected to the universal prosthesis.

74
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Marketing:
- The distribution kit is being advertised as an
7.4 Criteria for cycle Foot:
- The total production cost of the foot is maxi-
(cost)efficient, customizable, base from which 2: World market mal 30 USD.

Approach
a prosthetist can (time)efficiently fit a prosthe- - The foot has a natural appearance.
sis. exploitation
- The foot is available in left and right.
- The kit is bought in together with a service Corresponding sections are given between brack- - The foot is available in several sizes.
contract. ets ().
- The foot can be fitted with sandals.

Users
Total distribution kit /prosthesis:
- The final selling price of the distribution kit is Additional parts:
maximal 200 USD. - CONNECTIVE COMPONENTS: The included

Prostheses
connective components provide connection
- The total prosthesis will keep functioning sat- to the included foot. The connection to the
isfactory for two years when normally used. foot stays adjustable (translation and rotation),
- The assembly has to be finished as far as pos- even when the prosthesis is hardened.
sible in the factory. Pylon and socket are one - FITTING SOCK: Included.
part.
- SOCKS FOR DAILY USE: Included in 2 thick-

Usage
- The prosthesis can be worn without shoes nesses. The wearing of these socks increases
(without attracting negative attention). the pressure in the socket.
- The prosthesis can be fitted by non-experts. - LINER FOR DAILY USE: Included. Wearing of
the liner results in a more evenly distributed

Stragegy
The socket: pressure in the socket.
- The total production cost of the socket is - PRESSURE-RELIEVING-PARTS (GEL PADS):
maximal 80 USD. Included.
- FEET-SHEET AND OTHER ASSISTIVE
Pylon: DEVICES: Simple products that can improve

Criteria
- The total production cost of the pylon is maxi- the ease of aligning (the residual limb in) the
mal 30 USD. prosthesis.

75
Packaging and manuals:
- The manuals are internationally interchange-
7.5 Additional goals Foot:
- The included foot is suitable for multiple
able. It uses mainly figures / drawings. If possible, the following goals can add value to weights, multiple foot sizes and for left and
the solution: right use (adjustable foot).
- On the package (distribution kit) the final
product and the included foot-size and foot-
side are printed. Additional parts:
Total prosthesis: - SOCK: The sock is transparent. The sock is as
Marketing - The prosthesis is adjustable after the fitting thin as possible. The fitting sock and the sock
- The kits are being advertised as a good, com- procedure. for daily use are the same.
plete and easily fitted prosthesis. - The prosthesis is as light as possible. - SUSPENSION: The suspension is as easy and
- The prosthesis fits into the locale culture. comfortable as current suction suspensions.
(Part of the) production is conducted locally.
Local, social involvement is stimulated Marketing:
- The prosthesis exists of as few as possible - In an early stage, a big organization (pro-
parts (2.3). ducer), such as Otto-Bock or Ossur is involved.
- The prosthesis is accepted by the total reha-
bilitation team (3.2)

Socket:
- The socket is transparent (makes evaluation
of the interface between the socket and the
residual limb easier)
- The socket is adjustable during use (adjust-
ments take place several times a year).
- The socket is adjustable during use (adjust-
ments take place multiple times a day).

Pylon:
- The pylon is adjustable during use (adjust-
ments take place several times a year)
- The pylon is an integral part of the socket and
forms an exoskeletal design (4.2).
76
The Universal Prosthesis
8 Discussion and conclusion of part 1 Boudewijn Martin Wisse
TU Delft, 2005

The analysis indicates that the design an Focus on fitting procedure A high comfort level can be reached
implementation of the universal prosthesis is
possible, although with some constraints.
Still unclear in the design objective (see sec- A high comfort level of the socket can be

Approach
tion 2.4) is if the adjustability of the design reached best if pressure tolerant areas are
refers only to the fitting procedure or also loaded more than pressure intolerant areas
A broad range of market options. to periodically or even daily adjustments. (PTB-principle, section 3.1.3). The bony prom-
However, it became clear that comfort and inences (figure 3-6) and the distal end are
In chapter 2 the benefit for users all around control acre the main determines for func- the areas of relief and the patellar tendon is
the world, amputees and prosthetists,

Users
tional outcome (see section 5.5) and these very pressure tolerant. The limited variation
becomes clear. The fact that designing a requirements are met by a socket with a stiff in these areas (except in distal end height)
prosthesis takes time is recognised and the fit and an appropriate pressure distribution indicated that a standard socket shape is pos-
project is split into phases. These phases are (see section 3.1). Current solutions for daily sible (appendix F, elaborated on in chapter 11
design cycles and are “a preparatory design

Prostheses
adjustable sockets are few and only improve and appendix R).
trajectory”, “market exploitation in developed comfort significantly for a very select group
countries” and “world market exploitation” of users. Adjustability of the socket during J. Foort (appendix X) even concludes that
(see section 6.3). use therefore is not a requirement for the the use of prefabricated Below-knee sock-
Universal Prosthesis to be successful. ets “taught us that five sizes for each side
The unique selling point of the Universal

Usage
of the body were sufficient to fit all the new
Prosthesis is that it is quickly fitted by low- The pylon has to stay adjustable. To allow for amputees managed in this way and that one
educated experts. For the amputee, this dynamic alignment of the pylon/foot after size alone met 50% of the needs”. However,
means better access to prosthetics and more socket production is an important factor to the use of prefabricated sockets in current
often replaced prostheses. On the other hand, improve gait and will make the Universal prosthetic practise is not mainstream. The

Stragegy
because the shape of the socket has to be Prosthesis easier accepted by current day adjustability of the universal prosthesis could
formable, the strength and stiffness of the prosthetists (see section 3.1.4). improve the trust prosthetists have in the fit
Universal Prosthesis could be limited. These of the prefabricated (universal) socket and
facts combined indicate that the Universal increase it use.
Prosthesis is especially suitable for two spe-

Criteria
cific target groups, namely children and elder
(see section 3.1.7 & 6.3). It also is useful as
a temporal prosthesis (3-6 months after
amputation) or a spare one (see section 2.4,
4.1.4). When, by smart design, stiffness and
strength become less a problem, the Universal
Prosthesis can be used for daily activities. 77
A vision of the socket design
User tests in Sri Lanka show that weight-
bearing in a frame is possible, but total con-
tact is necessary for comfort. This leads to a
socket system that consists of a hard, weight-
bearing frame and a flexible total contact
part. The form and properties of these are
determined in part 2 of this report: “synthe-
sis”.

78
The Universal Prosthesis
9 Synthesis - from idea to prosthesis Boudewijn Martin Wisse
TU Delft, 2005

Having determined the project target and The result exits of rigid and flexible parts. The In part 3 (chapter 12, 13 and 14) of this
design requirements, the materialization of form of the rigid parts needs to be refined. A report, the universal prosthesis will be
the design can begin. study of the anatomy of the residual limb and evaluated.

Synthesis
the (expected) biomechanical behaviour is
The base for the new design is the design the basis for their shapes (section 11.1). The
made in Sri Lanka. However, because of (fabrication of the) flexible parts is another
changes in the design philosophy (from important design step (section 11.2). The con-
cheap production to easy fitting procedure) nector, connects these parts with the foot

Ideas
and the preferred production method (from (section 11.3). When the shape of the frame
low-budget to mass-production) a review of is determined, the prosthesis is ready to be
the (sub)problems is needed (section 10.1) optimized for daily use (11.4), the fitting pro-
and solutions need to be re-evaluated (sec- cedure (11.5) and production (11.6).

Concept
tion 10.2). The real synthesis can now take
place; the chosen ideas are integrated into a
final concept (section 10.3).

Evaluation
Recomm.
Conclusion
79
10 Ideas

In Sri Lanka it became clear that weight 10.1 Idea generation Conflicts in the criteria
bearing can be achieved by making an open-
frame based socket (see section 6.2). However, From the criteria and design requirements,
Two specific equilibriums need to be found
in opposing criteria which are:
made from aluminium and basic production sub-problems follow:
methods, the open frame socket was not Variable vs. stiff
1 Universal (1) How can one socket vary in Stiffness is an important aspect of safety and
comfortable enough to be used for ambula- length, circumference or shape (the socket control, while variability or adjustability is
tion (for a prolonged period of time). Another has to be hollow)? (2) How can one pylon/ an important aspect of the universality. How
problem was that the design was not stiff and total prosthesis vary in those properties (the can the prosthesis be made stiff enough,
strong enough, which resulted in buckling pylon can be solid)? (5) How to align a load- while still being variable? We know that the
(during ambulation). able frame or pylon? prosthesis will incorporate an open-frame
2 Comfortable (6) How can one prosthe- socket design. Therefore this question can be
A better fit and pressure distribution as sis make total contact with different shaped restated as: (3) “How to make a frame (that
well as higher stiffness and strength can be residual limbs? (7) How to improve weight can transfer loads) deformable?” and (4) “How
achieved by new form-giving and new mate- bearing properties and pressure distribution to attach a deformable part to a rigid skeletal
rial choice. in the socket? frame?”.
3 Easily fitted (8) How can the fitting procedure Comfort vs. control
made easier? More control can be achieved by a tighter
4 Controllable (together with 6) How fit, which means higher pressures. However,
can a tight fit be assured by a wide range of control is more important during ambula-
residual limb shapes? tion/stance than during sitting or swing, so
the problem is: (9) “How can a tight fit be
5 Usable (11) How can a prosthesis be
accented during load and a comfortable fit
donned and doffed? (12) Even when the
during rest?”.
patient has a bulbous residual limb shape?
6 Safe (13, 14, 15, 16) How can stiffness and
strength be guarantied?
Another way to improve comfort is to reduce
pressure-peaks by vertical dampening. The
7 Affordable (Optimization) problem is: (10) “How to improve vertical
8 Social (Optimization) dampening while keeping control (and direct
9 Quickly fitted (Optimization) sensory feedback) during use?
10 Distributed (17) How can integration with
existing parts (connective components and The problems are explored in appendix Q.
the suspension system) be made easy? The presented solutions were obtained by
looking at existing solutions, looking into
80 other products with similar problems and by
creative thinking.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

10.2 Idea discussion 1 able belts are chosen as part of the final solu-
tion, the user has to be able to determine
Subproblems and ideas (solutions) can than The “flower principle” is a very interesting
the length of the belt quite precise. (see 6.2).

Synthesis
The “harmonica” option can also be used in
be evaluated by rating them against the 10 to use for an adjustable socket. It promotes a
a tapered socket shape, so it can accommo-
criteria. However, selected solutions have to pylon at the distal end of the socket and the
date for variable stump sizes and lengths.
be integrated into one prosthesis. Also, we “opening of the flower” is the normal response
know that the socket will exist of hard and of shell parts when loaded from the inside
soft parts and that the hard parts will func- (when you try to stand in it. The flower prin-

Ideas
tion as an open-frame socket (see 6.3). It is ciple can be used, but the normal response
therefore important to select idea’s that inte- should be counteracted, for example, by a belt
grate well into each other and that contribute all around the socket.
to an integrated fitting procedure.
The “multi-link” option is also very interest-

Concept
Hereafter follows a short discussion and ing. Theoretically, the more parts an open-
some considerations of the subproblems and frame socket consists of, the better the fit is
the solutions that can be found in appendix that can be achieved. J. Foort formulated the

Evaluation
Q. potential usefulness of the multi-link option
in 1977 and proposed that “Shapeable matri-
Each number correspondences with the ces can be used to construct biomechanical
number and the figures in the Appendix. structures directly”.

Recomm.
However, elements of which these shapeable
matrices should consist of are not satisfac-
tory developed until now. Cousins proposes
that “hybrid modular-matrix systems may

Conclusion
develop as stepping stones to either matrix
or modular structures” [J Foort, 1986]. The
Universal Prosthesis, with its hard open-
frame and connective soft-frame parts does
in a way resemble a modular-matrix system.
Belts as seen in the “ellipse with belts” option
are suitable to transfer tensile forces between
frame parts over a variable length. If adjust- 81
2 The “saw it” option for the pylon is w
“ raps” can be used, especially in combina- 6 Total contact is of utmost importance
basic and can be integrated well into designs tion with Velcro (NL: klittenband). “Dip and for the comfort and function of the socket.
that can only be fitted once (can only be made coat” is another option that is only usable in
shorter after the fitting procedure). For addi- the factory. ”Following the contour” of the (unloaded)
tional adjustments during use, a combination residual limb, in literature sometimes
with the “telescope” or “screw it” options can ”plait/weave” is an option that can lead to referred to as surface matching, is currently
be chosen. advanced designs with varying stiffness the most used method for determining the
(or other properties” in direction and place. stump shape. However, due to the compres-
3 Building the prosthesis from parts However, the production method for woven sive forces, deformation of the soft tissue is
that are deformable of displaceable when components is not easy, especially when the to be expected. Deformation of the soft tissue
separated, but are that are rigid when con- textile has to be integrated into hard frame is used in the first (3 to 6) months after the
nected, is a good option. It compares well to a parts. Another limit is that it is not easy to amputation to promote a stiffer residual limb,
modular “Lego” kind of build-up. predetermine the shape of the end-product. with a taper shape (see section 5.1). Also,
deformation of the residual limb will not
”One-way-deformation can be unsafe for the 5 A “standard solution” (multi-axis) pivot stop blood flow up to a internal (skin) pres-
patient and result in a locked-in residual limb. at the distal end of the pylon seems a natural sure of 35 kPA (Sangeorzan et al. 1989). For
On the other hand, it might be a useful tool and satisfying solution, especially when mul- posterior soft tissues in the residual limb (the
during the fitting procedure. In this case, the tiple distal ends can be inserted (see subprob- calf muscle) this implies that load pressures
“one-way-deformation” has to be reversible or lem 17). However, the proximal bending point of up to 70 kPa are allowed (Sangeorzan et
to be reset. will differ from location, according to the al. 1989). Deformation of the limb will then
length of the residual limb of the amputee. be up to 5.4 ± 1.1 mm, dependent on the
4 “Gluing parts together” is a good For this “pivot” point the “angle by deforma- amount of soft tissue, it stiffness and other
option in case it can be done during the pro- tion” or “bend” solutions seem to be more factors (Sangeorzan et al. 1989).
duction of the prosthetic components. Glue is appropriate. These deformations must hen
difficult to use during the fitting procedure: be easy for the prosthetist to apply, while the
it can get quite messy and results may vary. pylon still has to provide weight bearing after
These difficulties can partly be removed by the bending. This is a typical example of the
using a bag around the glue and the parts variable-stiff conflict which makes the design
that need connecting. However, in this last of the universal prosthesis such a challenge.
case it is difficult to add a reaction agent or
to start the reaction otherwise.

82
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Also, pressure cast methods deform the Tissue deformation is therefore not only a Extra dampening can reduce shocks and
soft tissue, but the volume (is assumed to) design option, but a tissue reaction to load therefore decrease the amount of pressure
stays constant. This is called volume match- that has to be taken into account. Also, tissue peaks and promote comfort (also see section

Synthesis
ing. The “inflate/fill” option is therefore a cannot be deformed to much, especially when 4.3.5). On the other hand, the extra freedom
deisgn option that promotes volume-match- the amputee has a bony residual limb. of movement decreases the direct feedback
ing (and a TSB socket fit). The big difference and control over the prosthesis. In this light,
between this solution and current pressure 7 Smart designs can further improve vertical freedom of movement is less prob-
cast solutions is that the currently pressure the weight-bearing and pressure-distributing lematic than horizontal or rotational move-

Ideas
is applied by an apparatus that completely properties of the socket. ments (see subproblem 10).
envelops the socket. In the presented solu-
tion, the pressure is added to the socket itself. Most professional prosthetists agree that Increasing the pressure (perpendicular
The “suck/vacuum” solution is used in the in general, the distal end of the residual forces on the residual limb) increases the

Concept
otto bock Harmony system. In this system limb should not be loaded. The distal end control and can improve weight bearing.
(figure 10-1) every step is used to decrease pad (an idea that came into existence in Sri On the other hand, during swing-phase and
the pressure between the socket and a spe- Lanka) does exactly that, but in a very con- other cases in which there is no load on the
cial liner, thus improving the connection trollable manner. It contributes to the total prosthesis (e.g. sitting), constant elevated

Evaluation
between them. The fit is said to be com- weight bearing properties of the socket, if pressure on the residual limb should be
fortable and provides excellent control. the amputee has some pressure tolerance avoided to avoid tissue damage. Several idea’s
in that area. Because there is always some are shown in the appendix that increase the
pistoning of the residual limb in the socket pressure during load, but keep pressures low
(or the residual bones in the soft tissue), the without the load. All these solutions react on

Recomm.
distal end pad has to be designed in such a a displacement (that is caused by the loading
way that it will not exceed the tolerance level of the prosthesis). The “four bar mechanism”
during stance and ambulation. In the appen- is the most basic solution of which some
dix, a possible solution with springs, one other presented solutions are spin-offs. The

Conclusion
with elastic band and the commonly used gel “force redirected with pulleys”-option uses the
pad are shown. The distal end pads should vertical dampening displacement to increase
be inserted at different distances from the the posterior(-anterior) pressure. This way,
Pattelar tendon, because of variations in the control is only limited decreased. However,
residual limb lengths. these systems introduce moveable parts in
the prosthesis thus decreasing life-time, ease-
Figure 10-1: Otto-Bock Harmony system of-use and increasing costs.
83
8 The success of the universal prosthe- Simplifying the fitting and production of 9 The advantages of promoting a tight
sis is highly dependent on the east of the fit- the universal prosthesis can be achieved by fit during use have been mentioned while dis-
ting procedure. Several strategies can be fol- combining them into one procedure. In this cussing subproblems 6 and 7. Also rotation
lowed to keep the fitting method simple. respect the “immediate production method” (displacement) can be used to achieve this.
is similar of that of the ICEX (see section 4.3.1 The “strangle-fit” will tighten when rotational
First of all, use-cues can be added where use – hydrostatic socket). If this can be achieved, forces are applied. Two springs, one winded
is ambivalent. Examples are the length of the the universal prosthesis not only reduces clockwise and the other counter-clockwise,
total prosthesis and the socket-residual limb the need for skilled prosthetists, but also for will make sure that rotation in both direc-
angle. Use-cues are tips that are part of the technicians and machinery. tions will result in this behaviour. An advan-
design. For example, by accenting the patel- tage of this system is that a relatively small
lar tendon and the tibial crest on the out- Quick feedback of the user will also reduce rotation is needed to increase the pressure.
side of the socket, users immediately know the time the prosthetist needs per client. A difficulty is that spring hat to be deformed
what the front side of the socket is. The total Especially when feedback can be incorpo- to be used for amputees with variable stump
height of the prosthesis can be shown by tag- rated and reacted on immediately. When the circumferences.
ging the height which the prosthesis should patient is loading the residual limb during the
have when the user stands in it (mid-patellar- fitting procedure, it becomes directly clear
tendon is easily comparable with the opposite when the fit is not optimal and the prosthetist
leg). Another option is to attach a temporal and the amputee can take action by adding
part that needs to be level with the top-knee pressure pads, realigning the hard parts of
height of the opposite limb when the amputee the socket or realigning the residual limb. If
sits (figure 10-2). this direct feedback will reduce the visits of
the amputee to the prosthetist in practise,
Another way to improve the easiness of the clinical tests have to determine.
fitting procedure is to standardize it. The uni-
versal prosthesis will standardize it, because Another way to increase the feedback is to
it will incorporate a hands-off fitting proce- make as many parts as possible transparent.
dure for the socket. Further standardization If this is the case, the prosthetist can check if
can be achieved throughout the procedure by sensitive area’s are avoided, if all the tissue
copying the fitting techniques now commonly makes contact with the socket and how the
used. These are practical and using them will tissue reacts to the pressure.
improve the acceptation rate of the universal
prosthesis for the current prosthetists. Figure 10-2: Possibilities for adding use-cues
84 to ease the fitting procedure.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

A completely other solution is to change the One basic way to avoid this problem is to use
a flexible socket, that when donned is fas-
The wrapping solution is another idea that
(transversal) shape of the socket. The rounder is very suitable for the fitting procedure.
tened or tightened (“fix it with a rubber ring”,
the shape, the more volume it can contain With the wrapping method, a material can

Synthesis
“tightening”, ”zip” and “belt” idea’s). In the
with the same circumference, resulting in be applied around all sorts of residual limb
“bend /deform” idea, the socket is elastic but
lower pressures. On the other hand, the shapes. The same principle is used in the
the force needed for deformation is higher
round shape is not resistant to torque. The ICEX-system see section 4.3.1 – hydrostatic
than the forces during ambulation. This can
triangular shape results in higher pressures sockets), in which carbon fibre reinforced
only be achieved when and additional device
and is far better in transferring rotational wraps are used, that during the fitting proce-

Ideas
or tool is used for donning and doffing, which
forces from the socket to the residual limb. dure are impregnated and hardened.
doesn’t fit the design philosophy.
10 Vertical dampening can increase
The “roll on” idea is now commonly used in 12 Discussed with 11
comfort, but also means less control (also see
the donning and doffing of the liner. If it is

Concept
subproblem 7). Currently, most dampening
applied on the socket itself, this would result
systems are integrated into the foot. In gen-
in a very flexible socket and force transfer
eral, the more distal the dampening system
would be a problem. However, the roll on
is placed, the better the experienced control
principle can be very useful during the fitting

Evaluation
will be.
procedure, because it results in a very pre-
11 Donning and doffing the prosthesis
cise total contact fit. Even while a liner can’t
transfer loads, it will prevent oedema.
is an important factor in how user friendly
the prosthesis will be experienced. Also,

Recomm.
because the socket will be formed directly
on the residual limb, the doffing should get
extra attention. In most cases the residual
limb shape will be taper (see section 3.1.3)

Conclusion
and the socket can just be slipped of the limb
(“shove”-option). However, caution has to be
taken when handling bulbous shaped resid-
ual limbs. In these cases the directly on the
residual limb fabricated socket can get locked
in.

85
13 The pylon has to deal with the same The H-basic shape is also interesting. When 15 To achieve a light but stiff total con-
stiffness-deformable conflict. Does it have to two vertical pylons are connected by an addi- cept design, the flexible part of the design has
change shape? Well, extra leverage acting on tional surface, a transversal H-shape will be to contribute to the total stiffness. The fitting
the residual limb should be avoided, because formed (figure 10-4) procedure is an important factor in this.
that implies extra pressure. Normally, that is
solved by connecting the pylon to the socket This increases the stiffness of the total struc- The soft parts can add “tensile forces” to the
at the intersection with the line of gravity ture. In the same way, many connections with open socket frame. Imagine this principle as
(figure 10-3, compare section 3.1.4). a stiff socket can also enhance the stiffness elastic bands or springs between the hard
(“attach-surface-above” idea). This connec- frame parts. The tensile forces increase the
A nother option is to use multiple pylons tive surface can be integrated into one part pressure on the residual limb. As long as this
(see section 4.3.2). In function this last solu- by adding surfaces that can be rotated from pressure doesn’t exceed the threshold of the
tion resembles an exoskeletal prosthesis parallel (deformable status) to perpendicular residual limbs tissue tolerance, the total stiff-
(see section 4.2.1). The exoskeletal setup is (stiff status). ness of the system will improve.
in this regard very suitable for the universal
prosthesis. It provides a very stiff and strong 14 Discussed with 13 Problematic is the variance in residual limb
prosthesis, while it can easily adept to vari- circumferences. If the connective bands are
able residual limb lengths. stretched to accommodate for bigger resid-
ual limbs, the elastic bands will exert higher
Because the universal prosthesis incor- forces, which can result in higher pressures.
porates a hard open-frame, the pylon will Ideally, the tensile force, or even better, the
have properties of both the multi-pylon and extra pressure resulting from the tensile
exoskeletal solution. The basic shape used for forces, can be controlled. This implies that
the pylon will than be the round or triangu- the elastic bands can at least be adjusted
lar shape. in length. One fundamental problem is that
(elastic) bands will always try to find the
lowest force route, which results in straight
lines and can result in pressure peaks on the
tissue between the hard parts (figure 10-5).

Figure 10-5: Flexible bands


that connect parts
will result in pres-
Figure 10-3: Moments around the socket, as a Figure 10-4: H-profile. sure peaks.
86 result of diffrent pylon types.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

That last property of elastic bands is some- This solution allows for a high freedom of 17 The completeness of the UP is in
thing that “hardening” the connective flexible shapes that can be given to the socket and regard to its distribution options very impor-
parts can prevent. Of course, the flexible part is successfully used in the ICEX-system (com- tant.

Synthesis
than no longer generates tensile forces, but pare subproblem 11 and 8). The big disadvan-
the hardened part can transfer tensile (and tage of the ICEX system is that water has to In cycle 1 of the marketing (see section 6.3),
compressive) forces. The pressure on the be added as the reaction agent. This makes multiple or easily interchangeable pylon ends,
residual limb is now determined by the shape the fitting procedure a complicated and time- will make sure that the Universal Prosthesis
and circumference of the socket. For satis- critical happening. Because the universal can be used in conjuncture with existing feet.

Ideas
factory results with the “harden”-option, the prosthesis eventually has to be fitted by inex- For cycle 2, a foot has to be part of the distri-
shape has to be determined very precisely. perienced people, this solution is not optimal. bution kit.
Better are solutions that can use (UV)-light,
16 There are a few options for hardening heat or electricity as the reaction trigger or The suspension system (see section 4.3.4)

Concept
flexible parts. Two fundamental principles reaction agent. However, these agents bring is another integral part. Suction suspension
both can lead to a satisfying solution. along their own difficulties, sometimes in is regarded as the most comfortable option
regard to the fitting procedure, sometimes in nowadays. It does demand a highly accurate
First of all, the parts can be hard in normal regard to the safety of the amputee. fit of the socket.

Evaluation
circumstances and become deformable when
altered. The most commonly used materi- Other options, that require the addition (or Knee straps or suspension sleeves are some-
als in which this principle is used, are plas- removal) of parts or the use of specific tools what less comfortable during the donning
tics that can be heated, (de)formed and then or machinery (“deform it”-option), are less and doffing of the prosthesis, but provide
cooled again (“freeze it” idea). A current useable for the Universal Prosthesis. The excellent suspension.

Recomm.
application of these materials can be found additional parts or tools have to be included
in ski-shoes, violin supports. This are heated into the distributed package or kit, thereby
to approximately 60 degrees Celsius to fit the increasing its costs.
user’s body shape. This principle could be

Conclusion
applied to the hard open socket parts, if more
variance in these parts proves to increase the
comfort level of the fit.

Secondly, for the flexible parts, “chemical


reactions” can be used, that harden a mix of
(carbon) fibres and resin, exactly in the same Figure 10-6: Suspension sleeve
way currently PTB-sockets are produced. 87
Problems arise when the suspension is to
loose and the residual limb starts pistoning
in and out the prosthetic socket.

Supra-condylar and supra-patellar sock-


ets (section 4.3.4 – anatomical suspension)
enclose the hard parts of the residual limb
and the knee. This suspension “cups” are
stiffly connected to the socket. In current
condyle suspended sockets, such as the KMB,
the suspension parts are integrated into the
(high) socket.

88
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

10.3 Idea selection and For the fitting procedure of the hard frame, limb, because else the socket becomes shape
matched instead of the preferred volume
this results in figure 10-7.
integration matched (subproblem 6).

Synthesis
Having discussed all these possibilities,
In contrast to the open-frame principle, every To achieve this pressure casting, the outer
area of the residual limb should make contact
those who integrate well into a total design and inner layer of the socket with a material
with the socket, to prevent oedema (see sec-
have to be selected. that will become hard after filling and apply
tion 3.1.3). This can most easily be achieved
pressure. The outer layer of the socket can
by rolling a highly flexible and stretchable
In section 6.2 it became clear that the socket

Ideas
also exist of a roll-on component. To avoid
textile or material on the residual limb, as is
has to exist of both hard and soft parts and deformation on the outside, the outside layer
currently done with liners (subproblem 11). If
that it will at least contain an open-frame needs to be either very stiff or restricted. For
we can harden this flexible material (subprob-
socket that can provide weight bearing for the Universal prosthesis, this restriction can
lem 15,16) or fill the space behind it (subprob-
be achieved by simply wrapping the outside

Concept
the amputee. This open-frame socket can lem 15), the total contact surface can become
at least partly morph into a multi-pylon / with difficult to expand material or textile.
weight bearing and thereby increasing the
exoskeletal pylon (as discussed in subprob- comfort level of the socket. In this case,
lem 13/14). The pylon can end in a multi-pur- pressure has to be applied onto the mate- For the fitting procedure of the soft socket,

Evaluation
pose connection component (subproblem 17). rial that will become rigid and the residual this results in figure 10-8.
Alignment can be improved if this component
can be rotated (subproblem 5). To attach the
frame parts, (elastic) bands or belts can be
used (subproblem 1, compare subproblem

Recomm.
15/16) but it has to be possible to adjust them
precisely in length. More distal the length
of these bands has to vary more, because of
different residual limb shapes. Velcro can be
used to attach these bands. Velcro is com-

Conclusion
monly used in orthopaedic appliances and a
blood pressure meter (sphygmomanometer)
illustrates that the connection can cope with
medium-high pressures (200 mmHg = 26,6
kPa) of the connective area is big enough.
Figure 10-7: Steps for fitting the hard frame Figure 10-8: Steps for fitting the soft frame
89
The two fitting procedures have to be inte- 10.4 Evaluation of the
grated into one, resulting in figure 10-9.
integrated design and
conclusion

If we quickly evaluate the resulting proce-


dure and design, we see that the total has
high potential to achieve that:
- The fitting procedure is a hands-off method
which combines the best of the TCB and PTB
principles.
- The fitting procedure is suitable for a wide
range of residual limb shapes. The range is
primarily dependent on the shape of the open-
frame parts.
- The resulting prosthesis is not too heavy, not
bulky, comfortable and siff.

The distribution kit will contain at least 2 or


3 hard frame parts, several Velcro bands, a
special fabrication liner, an connective com-
ponent, a filler (material), a means to apply
pressure to the inside of the socket while
hardening, wraps. The only tool needed is a
saw, which is widely distributed and accessi-
ble.

Figure 10-9: Steps for fitting the combined


system
90
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Comparison Discussion
This intermediate design can be scored If the currently presented fitting procedure

Synthesis
against the commonly used PTB-procedure can be realised, the Universal Prosthesis
and the ICEX-system (table 10-1): is very comparable with the ICEX-system
in performance. This is not so surprising
because the ICEX-system is also a hands-off
fitting method (and also needs a compres-

Ideas
sive device). However, the ICEX-system is not
to suitable for inexperienced prosthetists,
because pressure-pads have to be applied by
Criterium Universal ICEX Standard Main argument / comments the prosthetists on pressure sensitive area’s
Pros. PTB and the wrapping of the residual limb (and

Concept
1 Universal ++ + + The UP combines the best of two worlds, pads) is difficult.
because it’s a PTB-TCB-hybrid.
2 Comfortable ++ + + (needs clinical test) The Universal prosthesis has some other
advantages. It is fitted with the amputee

Evaluation
3 Easily fitted ++ + - UP has many steps, but ICEX requires
standing and it uses the PTB-principle, thus
knowledge to apply pads, apply wrappings
and steps are time-critical using pressure tolerant area’s to a much
better extend. These two features will very
4 Controllable + + ++ PTB can be adjusted better after the fitting
probably lead to a more comfortable fit (espe-
procedure.
cially during stance). Clinical test will have to

Recomm.
5 Usable 0 0 0 The PTB might not need a cosmethic cover, prove this in practise.
because it is an exoskeletal design.
6 Safe + + ++ There are no problems expected, but PTB is
used for many years by now. PTB normally

Conclusion
produced with toxic resins.
7 Affordable 0 0 0 Dependent on the costs of personel and the
tools needed such as a compressor.
8 Cosmetic 0 + + (needs to be improved)
9 Quick fitted + + - PTB needs many steps.
10 Distribution + + - PTB needs specific tools

Table 10-1 Quick comparison between the Universal Prosthesis and two popular fitting systems.e 91
11 Concept

Having determined the global design and Having redesigned the parts, the resulting 11.1 The hard socket
fitting procedure, the final shape and the fitting procedure (section 11.4) needs to be
properties of each part have to be chosen. optimized. Incorporating a low-expertise fit-
The final design evolves over multiple cycles, ting procedure is the unique selling point of
11.1.1 Selection of loadable and
because each change in a part influences the universal prosthesis and therefore it has avoidable area’s based on
other parts. Hereafter the most important to be solid (no buyers means no product). The anatomy
design considerations for each part are dis- user-friendliness of the design is discussed
cussed, but not (necessarily) in chronological in section 11.5 (no satisfied users means The open-frame socket has to make contact
order.. no buyers). The high-tech design that is the with the pressure-tolerant areas of a variation
result has to be produced in such a way that, of residual limbs. The variance in circumfer-
The hard open-frame socket parts (section in time, the universal prosthesis becomes ences and lengths of these residual limbs
11.1) are the base of the design. They are affordable for a broad group of users around can be found in appendix G. As emphasized
the parts of which the most clear idea about the world (section 11.6). in section 3.1.3, these measurements where
how they should look exists, because they taken in Sri Lanka. Amputation procedures
evolved out of the designs made in Sri Lanka in developed countries are somewhat more
and it became clear what improvements were standardized, resulting in a lower standard
needed in the analysis. deviation. However, residual limb lengths in
developed countries will vary from 100-180
The best argument against an open-frame mm, quite comparable with the data gath-
socket design (that total contact is needed to ered in Sri Lanka. It is clear that the first
prevent tissue damage and oedema), is solved 100 mm from (mid) patellar tendon are the
by adding a soft socket (section 11.2). most important for the open-frame socket.
Luckily, the variance in circumference is also
The pylon (section 11.3) is the connection the smallest around that area. At 50 mm
between the socket and the foot (and indi- from mid patellar tendon the P5-95 spread
rectly to the ground). Especially the connec- is 230-340 mm). At 150 mm distance from
tive component at the distal end is important. mid patellar tendon, the circumference can
It is needs to connect the hard socket to the vary from 170-320 mm. That apart from the
foot while providing an air-tight seal for the fact that many amputees will have a shorter
soft socket. residual limb length (and no circumference at
all).

92
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

In appendix R, this data is combined with the 11.1.2 Determining the rough It is concluded that the interface surfaces
of the frame will have to be maximized to
anatomy of the residual limb (overlay 1 to 4). frame shape.
ensure a comfortable fit during the fitting
Overlay 5 shows the resulting spread in pres-

Synthesis
sure sensitive and tolerant areas. The bony Having selected the loadable areas, the
procedure.
prominences are the most important factor in
determining these areas. These were scaled
interface frame that will transfer the load to
the residual limb have to be materialized. The
The preferred area’s of load as presented in
in respect to the circumference variance (P5- overlay 7, lead to the frame parts as shown
bigger these parts are, the better the pres-
P50-P95). It has to be noted here that these in overlay 8, shown in blue. These parts will
sure distribution will be. The smaller these

Ideas
areas are estimations, because in reality form the interface to the residual limb and
parts are, the better they will be adaptable
the anatomy of everybody differs. It would still need to be connected by a stiff frame
to accommodate for the wide range of stump
be far better if the data would be obtained that is able to transfer the loads between the
sizes and shapes.
from (scans of) a large amount of residual interface parts and to the ground (overlay 9,
On overlay 7, an estimation of the maximal shown in red).

Concept
limb shapes and measured tissue properties.
However, that information is not available in
literature and time-consuming to generate.
load that can be carried by the soft tissue is
given. Every surface has a maximum pres-
The interface frame can be some what easier
The estimation here is reasonable and makes deformable to fit the varying residual limb
sure tolerance, an area (size) and an average

Evaluation
use of the same assumptions as prosthetists shapes. More distally, the variance is bigger
angle in respect to the gravitation load line of
do while fitting a prosthesis. and therefore the parts have to be better
the total body mass. From these, the maximal
deformable there. To maximize contact, mul-
upward force is calculated.
Interpreting the data from appendix R, over- tiple strips downwards are chosen where
lay 5, it becomes clear that there are quite Note that the Free Body Diagram shown
possible. Near the patellar tendon and on

Recomm.
some areas that overlap (mid patellar tendon the opposite side (posterior), the variance in
is not in equilibrium. The current forces
taken as a fixed point). The pressure sensi- residual limb shapes can be compensated by
will coerce the soft-tissue to deform and
tive area’s are shown in red and don’t domi- translation of the frame.
the residual limb to rotate and trans-
nate. The big blue and green area is loadable. late (if the socket is regarded as fixed in
This stiff frame can be translated because of

Conclusion
This results in overlay 6, where the loadable space). Also, resulting shear stresses are
and avoidable areas are selected. The chosen two vertical areas where no frame is present.
not taken in account. However, this behav-
areas are shown till approximately 130 mm This effectively splits the frame into two
iour cannot be predicted without more
from patellar tendon, after which they fade parts.
knowledge of the (properties and shape of
out, in conjuncture with the variable residual the) frame parts. It is assumed that the user
limb length. will compensate for pressure overload and
that the maximum upwards force will not
diminish significantly by the relocations. 93
Tensile forces (that need to be transferred 11.1.3 Optimizing the frame shape in Tensile parts (straight lines between them on
from the anterior from the anterior to the regards to the anatomy. the border) will not result in tissue damage.
posterior to prevent the parts to part and the
residual limb to slip downwards) are trans- Having determined the rough shape of the
ferred by belts of connective textile, shown in frame parts, these have to be (re)matched to
green in layout 9. the anatomy of the residual limb. In the second row, the cross-sections of the
rough frame design from layout 9 are shown.
Layout 10 summarizes the tough frame In overlay 11 this process is shown. In the These are used as a guide to determine the
design. The belts can be fastened by a tight- top row, slices from the “visible human optimised shape.
ening mechanism or by Velcro. The space in project” are given at steps of 10mm, from the
between the frame parts is filled with carbon patellar tendon, to 130mm distal. To stabilize the forces resulting from pres-
or glass fiber textile, which will help to sure on the inside of the frame, the support-
strengthen the connection between the parts These slices give a good impression of the ive areas and stiff frame parts need to be
after hardening of the soft socket (see section bone structure of the residual limb. As a divided as good as possible over the circum-
11.2). The stiff frame parts are lengthened so reminder: ference.
that they will function as a pylon. For small
- Bony prominences (with only skin over them)
amputees, these frame parts can be short- cannot be loaded. Having tree strips downwards this means
ened by sawing the distal end. A connective that midpoints of the strips have to be equal
- Muscle with bone “behind” it can be loaded
part (see section 11.3) is added to connect distance from each other (an isosceles trian-
well, but perpendicular.
the foot. gle).
- Large areas of muscle can be loaded well, but
deformation has to be restricted.

The general shape of the bones is shown in


black. Muscle that borders these lines can be In row 3 this has been pursued, without
loaded (perpendicular). The green lines indi- neglecting the tissue pressure tolerance. The
cate where the stiff frame can part. Variation V-shape of the anterior part is to protect the
in residual limb circumference can be com- tibial crest. The patellar tendon indent can be
pensated by moving the green lines together easily recognised in blue (at PT-height).
or away from each other.

94
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

To prevent the limb from slipping through 11.1.4 Back to 3D They were connected and a little smoothened.
the frame near the distal end, the anterior This was necessary because the slices from
strip and the medial strip get closer together the “visible human project (see layout 11)

Synthesis
near the end. This is in line with the higher proved not to be well centred.
distal forces during gait in anterior-poste- The optimized cross-sections from Appendix
rior direction to compensate the then acting R, layout 11, were stacked together in 3D, The result is as seen in figure 11-2 and
moments and the higher force to compensate resulting in figure 11-1. appendix R - layout 12,
for the moment caused by the load on the

Ideas
patellar tendon (see section 11.1.5).
for aligning the
cross-sections.

In row four, these strips are connected proxi-

Concept
mally to bridge over and protect the pressure
intolerant areas. Also, the stiffness of the stiff
frame parts is added to maximise the contact

Evaluation
area with the residual limb. Where necessary, supra condylar
direct contact with the hard borders of the brims
stiff frame is countered by overlapping the
some cross-sec-
soft frame with the interface frame.
tion placements

Recomm.
needed to be
adjusted. The
slices from the
In row five, the frame is optimised for the visible human
variance in residual limb circumferences. project where not

Conclusion
The more flexible blue parts that are not sup- aligned before
ported or attached to the stiff frame are given processing.
a curvature that is equal to that of P5. These basic shape of
parts also bend in more distally, to extra sup- the pylon.
port smaller residual limbs. Figure 11-2: Together with the resulting frame
Figure 11-1: 13 stacked layers that where parts. [Top] stiff frame, two views.
derived from the anatomy of the [Below] interface frame.
residual limb. Top view and isomet-
95
ric view.
Note that the tensile textile (see layout 10 11.1.5 Material choice Several, commonly available plastics are
and section 11.1.2) has been replaced by suitable; PP, PVC, PS, ABS, PMMA, POM, PPO.
extensions of the frame parts. These exten- To assess the mechanical properties of the PVC is toxic for the environment and will
sions are thinner and more flexible as the rest frame, first the material has to be specified. therefore not be used. POM and PPO have
of the stiff frame. They are connected to the softening temperatures which are quite high,
opposing frame by Velcro. This improvement Material of the interface frame 155°C and 130°C respectively. It would be
was made to ensure that: possible to use them, but there are other pos-
- the frame parts are on the proper height in For the interface frame (blue) a plastic will sibilities with lower softening temperatures
respect to each other be used. It should be possible to deform the (table 11-1).
- there will be some curvature of a straight line, interface frame to fit the varying residual
improving comfort. limbs, but it should also be able to transfer ABS was chosen from those four, as it is said
- assembly is quicker because there are less some forces. Solution to this contradictory is to have good chemical and mechanical prop-
parts. found in deforming the plastic by heating it, erties. Examples of applications are security
and then fix it into the desired position while helmets and profiles for skis and surfing
cooling down. This should be possible with boards.
normal heating equipment, so the soften-
The most distal end of the stiff frame strips ing temperature should not be higher than
has been punctured to enable the connection 150°C. But it also should not deform at a tem-
of the connective component on the desired perature lower than 50°C, as it might turn
height. soft during use in the sun on a hot day.

Technical drawings of the frames can be


found in appendix Z.

PP PS ABS PMMA
Bending strength (Nmm ) 2
40-115 80 55-80 140
Modulus of elasticity (N/mm ) 2
1250-2200 2600-3200 1800-2500 3250
Softening temperature (C) 90 100 90 115

96 Table 11-1: Four material options for the interface frame.


The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Material of the stiff frame 11.1.6 Mechanical properties or in the residual limb were assessed. In this
stage of the development these specific FEM-
For the stiff frame (red) Hylite, a composite The mechanical properties of the frame models are too time-consuming. Instead, a

Synthesis
material developed by Corus) will by used. quick indication of the stresses during stand-
can be assessed in several ways. The best
This is a sandwich material, existing of two ing on the two force conducting frame parts
way is to build the frame and to experiment.
aluminium layers with a plastic layer (poly- (red frame) and on the connective compo-
However, production of several parts of the
propylene) in between. It is a very lightweight nents (strips & Velcro) between these frames
frame is expensive.
and strong material. At a thickness of 1.2 is given. The applied loads were chosen as
With the material properties of Hylite and

Ideas
mm it has the same flexural stiffness as steel shown in appendix S - FBD.
at 0,74mm and aluminium at 1.06mm, while
ABS known and the frame design available
having a much lower mass.
as an 3D model, the behaviour of the parts Appendix S - FBD shows the main resultant
under load can be simulated (finite elements forces when standing with 50% of the body
When the aluminium layers are grinded or weight (100% of the load on the prosthesis)

Concept
methods).
machined, hinges can be formed as is shown supported by the patellar tendon. It again
in figure 11-3. It can also be formed in the
desired shape by deep drawing as shown in
Many studies to socket fit and socket illustrates (as in section 3.1.4) that the PTB-
deformities were conducted in literature. bearing principle increases the loads on the
figure 11-4. anterior distal end and the posterior mid of

Evaluation
These in-depth studies were demanding and
the shear and stress forces in the total socket the residual limb. For people with sensitive
Other options are: distal ends, this can be a problem. In that
- Carbon fibre reinforced resins case, a TCB-approach is more suitable (see
- Aluminium section 11.2).

Recomm.
-
-
Titanium
Glare
The 3D-application of thise forces and the
frame’s displacement behaviour can be found
in appendix S - FEM.

Conclusion
Figure 11-4: Deep drawed car part from Hylite.
Figure 11-3: Applying hinges to Hylite (source: (source: Corus) 97
Corus)
What we can conclude is that with the cur- 11.2 The soft socket Because the fitting liner will be the outside
rent thickness (2 mm) and shape, (Hylite and) of the prosthesis, it also makes contact with
aluminium has such a stiffness, that major The soft socket exists of a flexible closed tube the skin and the environment. Resulting in
deformations can be expected. Solutions can or “fitting liner”, that will become the inner the following requirements:
be found in applying ribs, thickening the and outer layers of the prosthesis, and the
- The material has to be able to lengthen more
structure or increasing the area of the frame filler that will harden in between these layers
than 215% in transverse direction.
parts. Also, the residual limb will constrict (also see 10.3).
- The material has to be non toxic / non-irritat-
the total amount of deformation. And, as ing.
can be seen in figure 11.2, the general shape - The material has to be smooth and repel dirt.
that follows the anatomy of the user will not
- The material has to resist impact.
change much, thus staying comfortable while
11.2.1 Fitting liner
deforming.

The socket/pylon in this shape is not suitable The fitting liner is rolled on to the residual
for prolonged ambulation. Because of its free-
limb and, after placing the frame parts, rolled One possible material is a combination
down over them again. It will function as the between PP and PU. PU (on the inside) will
dom to move, it will become subject to fatigue stretch easily (up to 500%) and will integrate
inner and outer layer of the prosthesis. These
and break. However, the addition of the soft with the PU-foam (see later this section). PP
fitting liner will envelop empty space and
socket will improve this. (on the outside) will be smooth and non-irri-
the frame parts. The resulting inner space or
chamber will be filled with a filler or foam. tating. If necessary, for example when the
amputee has work that is very demanding on
The material choice of the fitting liner deter- the prosthesis, the outer layer can be coated
mines most of its properties. In its relaxed (with for example epoxy resin) to increase
form it has the smallest circumference. impact resistance.
Because it has to fit around the connector
and the frame this minimal circumference is
about 200 mm. While rolled on to the knee
or even higher, it has to be stretched to at The fitting liner can be tube-shaped, but has
least the p95 maximal circumference (at 25 to have a padded distal end to overcome high
mm proximal from patellar tendon), which is distal-end pressures. This is common for
about 370 mm (see appendix F) and, when most liners.
taking a maximal thickness of 10 mm of the
socket in account is about 430 mm.
98
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

11.2.2 The Filler Material Resins Polyurethane can be used in the universal
The space within between the layers of the prosthesis if a mix can be found that meets
the following requirements.
Effects of filling

Synthesis
prosthesis can also be filled with resins.
Filling the space inside the prosthesis will
When combined with fibres, the result can be
very stiff and strong. In the case that resins
- It connects to the frame parts and the outer
layer of the prosthesis
contribute to the stiffness of the whole.
are used, a suction method as is commonly - It does not grind to powder (wears) under
However, to contribute significantly, the foam dynamic load
used while fabricating prostheses (resins
has to have stiffness in the same order as

Ideas
applied from above, air sucked out below, so - It divides itself well within the prosthesis.
that of the load bearing frame. Foam that will
that the resin will divide through the space) - It reacts slow enough, so that the pressure
have this type of stiffness is often very brittle
is preferred. In that case, the inner space of can be homogenous increased. But within 10
and in that case, the inside would deteriorate
the prosthesis is minimized and the increase minutes, so that the fitting procedure stays
with use. Filling the inside with foam can best comfortable
in weight will be minimal.

Concept
contribute to compressive forces (in between
the frame parts). However, weight-bearing
will result in the frames wanting to part and Polyurethane
thus in tensile forces.
Foams have some special properties that are The application examples, especially the

Evaluation
use in shoes, show that PU can meet these
A completely other advantage of filling the useful in prosthetics:
requirements. Its use in aerosol sprays, such
prosthesis is that it will contribute in weight - It has a very good mass-volume ratio as PUR, makes it plausible that it also can
bearing. The prosthesis will effectively - It can take make shapes be distributed in a spray. It can use water (a
become a total contact bearing socket (TCB). - It is available with a great variation of proper- component of air) as the reagent (in a spray

Recomm.
Without pressurizing the foam (0-5 kPa), ties, including mass, rigidity /stiffness, yield the reacting chemical components of poly-
this would already prevent oedema. However, strength, etc. urethane are prepared in a special way) and
with higher pressures ranging from 30-40 use the air in the chamber in the prosthe-
kPa (50% TCB-behaviour) to 60-80 kPa Polyurethane is one material that is easy sis as the filling gas. It is no problem when
to foam and is available for a broad range

Conclusion
(100% TCB-behaviour, comparable pressures the reaction increases the inner pressure,
as used in the hydro-cast and ICEX methods), of applications. Polyurethanes and derived because this is an effect that is wanted for
the socket will contribute more and more to plastics are used in PUR-foam, but also in weight-bearing anyways.
the weight-bearing properties of the total. dashboards of cars, for cushions in seats and
chairs, for shoes (soles) and in other flexible,
semi-rigid and rigid applications.

99
To optimize the properties of the universal In this example, the (massive) PU layer can
prosthesis, the choice of foam is very impor- be stretched up to 500% of its original length,
tant. Because the application is very specific, where no fibres are integrated and can not be
it is probably a better option to develop a stretched where the fibres are integrated. The
“new” foam in corporation with a producer of two layers can slide along each other. The
PU. foam will “glue” then together and a much
stiffer connection is obtained than when the
foam or PU directly connects the frames.
Fibre reinforcements
Even when instead of resin PU (foam) is
used, glass or carbon fibres can enhance the
stiffness of the prosthesis. Note that the bot-
tleneck is the connection between the fibres.
However when the connective material (foam)
would strain 25% when a certain force is
applied, the distance between the two attach-
ments of the material to the stiffer compo-
nents becomes critical in the stiffness of the
whole, as explained in figure 11-5.

This principle can be used by applying thin


extensions of carbon or glass fibres to the
weight bearing frame parts as shown in
figure 11-6.

Figure 11-6: A Polyurethane layer is partly rein-


forced with fibres. The Hylite is milled
Figure 11-5: Less space in between the frames is to better attach the reinforced PU.
better; it results in a stiffer prosthesis. The two Polyurethane layers can slide
100 along each other
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

11.2.3 Adding pressure Using the spray is the preferred solution in 11.3 The connector
situations where only a few prostheses are
When the chamber is filled with foam, pres- fitted. The spray is easily distributed and The connector has several important func-

Synthesis
sure has to be added before it has taken its relatively cheap. In situations where more tions in the design. It has to:
final form. This can be achieved in several prostheses are fitted, such as an orthopaedic - connect the weight-bearing frame parts.
ways: workshop, a compressor can be cheaper and
- connect the frame to the foot.
- Using the pressure from the aerosol spray, at more environment friendly.
- be adjustable in height.
the same time injecting the foam. Current

Ideas
sprays have a nozzle that will vaporize the - be airtight.
contained liquid. In this application, the - be stiff.
nozzle is not necessary and the needed pres-
sure can be directly added to the prosthesis.

Concept
- A mini hand pump or compressor
- A separate CO2, N or air spray or gas patron. Connection to the frame
The volume that needs to be filled when a
residual limb of length 100 mm and a maxi- Because the frame parts will be completely

Evaluation
mal socket height (430) is fitted is estimated surrounded by (foam) and the outer layers
to 1.5 litres. To apply a pressure of 0.8 bar they can contain holes. There are two basic
(80 kPA) to such a volume, the following gas
options to connect the frame parts to the
patrons can be used: 0.97 litres at 2 bar, 0.36
litres at 4 bar or 0.16 litres at 8 bar. connector. One is with screws and the other
is without.
- A compressor.

Recomm.
The use of screws is chosen for safety rea-
sons. A disadvantage of this system is that
it results in that the prosthesis can only be

Conclusion
Figure 11-8: Two ways to connect the frame lengthened or shortened in steps. This can be
parts. Because all mayor forces between the solved by adding an extra lengthening com-
frame and the connector work in vertical direc- ponent between the foot and the frame.
tion, fitting of the frame on just shape is sufficient
(left). However, to be sure the frame parts connect
well, also during ambulation, and the connec-
tion is airtight, screws can be added (right). Both
solutions are cheap, intuitive understandable and
Figure 11-7: The airman Panter is an example of position the posterior and anterior frame parts on 101
a hand-pump. the right height from each other.
Connection to the foot Airtight
The connection to the foot is a standard pyr- The connector has to seal the inner chamber
amid alignment core (see Appendix M) that of the prosthesis, while allowing the frame to
is commonly used. When screwed in tight, it protrude.
can be removed with a tool and replaced with
another alignment core when necessary. To
resist the torque that acts upon it as a result
from turning (the foot), it is better when it is
attached permanently (figure 11-10). In the
latter case, transition extensions to other
systems can be made available, possibly inte-
grated with the extension as shown in figure
11-9.

Figure 11-10: The connection to the foot is


achieved by either screwing a standard pyramid
alignment core into it (changeable) or by integrat-
ing the alignment core in the piece (improved
strength). The dome increases the range in which
the foot can be aligned.

Figure 11-11: (Up and Left) The airlock is


Figure 11-9: An extra component that can fine- achieved by an outer and an inner
tune the length enhances the adjust- seal. NOTE: The dome on the connec-
102
ability of the prosthesis. tor is drawn on the wrong side!
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

The airlock can be made from two seals. The Fill channel and valve
first seal is made from a compressible rubber
or plastic, and will be placed on top of the
Because it is the only place where the outer

Synthesis
layer is interrupted, it is also the perfect spot
connector and between the connector and from where to inject the foam and apply the
the frame parts. The second seal is placed pressure. To achieve this, a channel that con-
over on the outside of the connector and the nects the outside with the inside is drilled in
frame parts. This part is made from an elas- the corner of the component (figure 11-12).
tic and compressive material. Its elasticity is

Ideas
For safety, a Minivalve is added. These valves
used to generate the force that is needed to are mass-produced and very cheap (figure 11-
keep the whole airtight, even when apply- 13).
ing the maximum pressure (80 kPA) and the
compressibility to fill height differences and

Concept
filleted corners.

Note on alignment
In current endo-skeletal prostheses, not only

Evaluation
a distal alignment core, but also a proximal
alignment core is added. The universal pros-
thesis only uses one alignment core (dis-
tally). One would expect that this results in

Recomm.
reduced possibilities for alignment. However,
traditional endoskeletal systems did not
incorporate a proximal alignment core. The
placement of the connection to the pylon
was determined during the fitting proce-

Conclusion
dure. In practise, this went wrong so often
Figure 11-12: The fill channel and the valve in
the connector. To transfer the filler that an extra alignment core was added to
up to the proximal side of the pros- the system. In the universal prosthesis, the
thesis, flexible tubes (straws) and socket and pylon are integrated and the
splitters can be used. The entrance of alignment between them cannot go wrong!
the channel has to be distally or on The distal alignment core provides sufficient
the bottom of the connector, because adjustability.
else the air seals would be in the way. 103
The placement of the residual limb in the 11.4 Resulting fitting his body-weight on each leg) without sliding
down, while experiencing the most satisfac-
socket will determine the right alignment. tory fit. If the prosthesis seems too long or
This placement will only be problematic in procedure
too short, the connector can be re-adjusted.
(the few) cases where contractures are a prob-
lem. In those cases, the pylon can be short- The fitting procedure doesn’t change funda- If specific areas are painful, gel pads can be
added or the interface frame parts can be
ened (at 260 mm from patellar tendon) and a mentally (see section 10.3). With optimized adjusted by heating and deforming.
normal pylon can be attached with standard components it adds up to the figure in appen- 7) It is made sure that the supracondylar brims
screw connections as seen in appendix M). dix U and the following steps: press against the knee (see section 11.5).
8) The prosthesis is taken off the residual limb
SITTING (doffed) and the distally extending frame
1) The foot is connected to the connector. parts are sawn from the prosthesis. (TOOLS
NEEDED: SAW)
2) The user rolls the fitting liner that will
become the outer layer of the prosthesis, onto 9) The straws inside the prosthesis are cut on
his residual limb and up to his thigh or knee. to the right length (10-20 mm from the upper
border of the frame parts).
3) The needed length of the prosthesis is meas-
ured with the frame parts and the connector. 10) The prosthesis is donned again and the fitting
The height of the total has to end on top knee liner is rolled down, over the frame parts.
height. 11) The outer seal is pulled over the connec-
4) The frame parts are attached to the connec- tor and the fitting liner. The extending liner
tor. The connector is already distributed with parts are cut off (TOOLS NEEDED: KNIFE OR
the inner air seal and straws attached (see SCISSORS).
section 11.3), so the connection is immedi- 12) The prosthesis and the knee are wrapped
ately airtight. The needed screws are included (tight) with wrapping bandage.
in the distribution kit (TOOLS NEEDED: 13) The foam spray is attached to the connector.
SCREWDRIVER).
14) The foam is injected.
5) The frame parts are placed on the residual
15) The pressure is increased till a comfortable
limb.
level is found or the maximal pressure of 60-
80 kPa is reached.
16) Waiting 10 minutes.
STANDING 17) The wraps can now be taken away.
6) The frame parts are connected to each other
and the user can stand in the prosthesis. The
Velcro can be detached and reattached until
104 Figure 11-13: An example of a Minivalve (source: the user can stand in the prosthesis (50% of
www.minivalve.com)
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

WALKING 3) Supracondylar cuff suspension or suspension 2) The second, more expensive solution, provides
18) The user can now walk around. The align- sleeve. an easier to use and in cases where pistoning
ment of the foot can be adjusted when neces- A cuff or belt is attached to the finished is a problem, more comfortable suspension.

Synthesis
sary. prosthesis. A suspension sleeve can also be This option can be used for people who are
attached. sensitive, have less force, have problems with
pistoning or whose anatomy doesn’t allow for
11.5 Daily usage & Suspension The suspension types result in a different supracondylar suspension with the integrated
donning/doffing approach brims. Before the donning of the prosthesis,
The universal will basically be used in the the user has to roll on the liner with the pin

Ideas
1) In the standard (supracondylar) solution, the threaded in. The pin has to be positioned well,
same way as currently available prostheses residual limb slides, while pushing the brims because it has to lock in the shuttle.
(see section 4.3.4). Most important aspects slightly apart, into the prosthesis. When the
user has to little force to do so (for example 3) If the integrated brim solution fails, and
of use are donning/doffing, suspension and finances are limited, a very functional and
cleaning. elder), or when the condyles are too sensitive,
quite comfortable (except in some case where

Concept
a hole can be made in the prosthetic socket
after the fitting procedure. Through this hole, knee flexion (sitting) results in high forces in
the popliteal space [Seymour 2002]) solution
Suspension and donning/doffing a sock can be pulled, which assists in the
is the knee cuff.
donning of the prosthesis. The hole has to be
Suspension can be achieved in three ways: finished to protect the (rigid) foam that will
Suction

Evaluation
otherwise wear too fast. suspension might be integrated in
1) Standard supracondylar brim suspension. the system in the future.
The integrated brims on the interface socket
make contact with the knee at the broadest
part of the fibular head (see figure 11-14). The Cleaning & Cosmetics
variance in this distance from patellar tendon

Recomm.
is expected to be small, so the brims can be Whether or not the prosthesis is cleanable
fabricated on a predetermined length. is mostly dependent on the outer layer (see
2) Shuttle lock suspension. section 11.2). An extra outer layer could be
In this suspension type, a shuttle lock is applied that makes cleaning easier. This extra

Conclusion
added to the standard fitting liner and an layer could also function as a cosmetic transi-
extra liner is rolled on before the fitting pro- tion from the pylon to the foot (add an ankle
cedure with a pin or plunger threaded into the shape) and make the pylon more oval shaped.
distal end of the liner (compare figure 4-32).
The shuttle has to be unlocked before doffing,
so a button needs to be brought to the outside
of the socket. One possible solution is shown
Figure 11-14: Height of supracondylar suspen-
in figure 11-15 (next page).
sion.
105
11.6 Production and price 11.6.1 Production costs per part Weight-bearing frame

Warning: Keep in mind that the estimations The Hylite, used for both the higher and
Interface frame lower production volume, is relatively expen-
in this section are quite rough.
The interface frame exists of two parts, each sive, but easily processed.

The production price and production method in a left and right version. The frame parts
is dependent on the amount of produced can be made by cutting and deep drawing. Fabrication liner
When higher quantities are produced, the
parts (production volume). Estimations are
made for 1000 and for 10.000 pieces. For frame parts can be injection moulded. The basic version of the production liner for
the universal prosthesis (without pin/shut-
this relatively low amount of pieces produced
tle suspension) uses a simple tube on which
(per year) the production can be out-sourced.
a distal end pad is welded together by sonar
The estimated prices can be found in appen-
heating. The distal end pad is made of sili-
dix V.
cones.

Connector
For the lower quantities, the connector is
milled and drilled. For the higher quantities
a redesign might lead to a decent solution
that can be injection moulded (in high qual-
ity plastic, ceramic or aluminium). The inner
air seal has to be produced, other parts are
bought in.

Distribution Kit
In the kit, that protects the parts, extra com-
ponents can be found, such as manuals, gel
pads and a sock (also see section 10.4).

Figure 11-15: The shuttle for the pin/shuttle suspension can perforate the outer layer. The rings will
restore the system to an airtight state. The shuttle can be attached on most heights (with
106
varying circumference). During the fitting procedure the pin is locked in the shuttle.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

This results in a production cost price of 110 This would imply that a team consisting 11.6.3 Marketing and Distribution
(at 1000 pieces a year) to respectively 55 (at of about 17 full-time workers could launch costs
10,000 pieces a year. the universal prosthesis in one year. With a

Synthesis
FTE price (including accommodation, etc) of Marketing will make the universal pros-
47,000 Euro a year, the first cycle costs would thesis a well known alternative for the
11.6.2 Development costs add up to 800,000 Euro. If 1000 universal prosthetist. Sales and services are needed to
prostheses are sold for a period of 5 years,
It is clear that the costs of developing the this would be a 160 Euro increase of the cost
distribute the product.

Ideas
universal prosthesis will be primarily made of price of the product. For the next cycle (world
developing costs. The way to a market-ready market), another development round of the Marketing
product is long. Among others, to make the
prosthesis ready for the first market (cycle 1
same magnitude (800,000 Euro)is expected The marketing, especially for the first cycle,
to be needed, resulting in an increase of 14.5 has to be pro-active and direct. The buyers
section 6.3), time (FTE’s in brackets) should

Concept
Euro a piece (over 11,000 sold prostheses a of the universal prosthesis are well known
be invested in (also see chapter 13): year). (prosthetists, orthopaedic workshops, hos-
- (1) researching the pressure tolerance of the pitals, etc), so the campaign can be reason-
residual limb. This results in a R&D and production cost ably focussed. On the other hand, the end-

Evaluation
- (2) collecting data about residual limb vari- price of 370 and 70 Euros respectively. users or amputees need to be informed as
ances, including bone-shape and soft tissue
well, because they might opt for the universal
properties. The R&D prices can be lowered significantly prosthesis while choosing the prosthesis that
- (2) development and selection of the right by intensive collaboration with big orthopae- will be fitted. Also, they have to know the uni-
materials. dic producers (who have a lot of knowledge versal prosthesis is available for them in the

Recomm.
- (2) optimizing the design of the components in-house and who can divide the R&D-costs case they need a spare one.
and parts. over multiple products), and by attracting
- (4) clinical trials. grants and subsidies.
- (2) re-evaluate and improve business-setup

Conclusion
and distribution strategy.
- (1) project management.
- (3) project office support.

107
For the second cycle, the initial buyers are 11.6.4 Conclusion
even better known (local workshops and
hospitals) and distribution or collabora- Keeping in mind that the estimations in this
tion with expert NGO’s, such as the World section are quite rough, the expected costs
Health Organization and the Cambodia stay well within the requirements. For both
Trust Foundation has to be sought. A budget the prices (European/US and World market)
for both marketing campaigns has to be the R&D-costs are significant, but there are
reserved: possibilities to lower them by attracting
grants and by choosing the right business-
Cycle 1: 100,000 Euro, resulting in an increase of
partners. Delivering a quality product will
100 Euro and a total price of 470 Euro.
result in lower costs on the long term, so cut-
Cycle 2: 100,000 Euro, resulting in an increase
ting down on the input in research is not an
of 9 Euro and a total price of 79 Euro.
option.

Sales and Service For the world market product, collabora-


The service has to be good, because this is an tion with NGO’s such as the Red Cross, WHO,
Cambodia Trust Foundation, etc can further
important source for feedback. Feedback will
reduce design cycles and R&D-costs. Also, it lower the price. Costs of this product are
is the most important factor for a good cus- made up from service and sales for 40% and
tomer base. from marketing costs for 7%. Collaboration
with well organized NGO’s can reduce both
Cycle 1: 4 FTE at 50,000 Euro a year, resulting costs significantly and the costs price of the
in an increase of 50 Euro and a total price of
Universal Prosthesis could fall under 100
520 Euro.
USD.
Cycle 2: 6x4 FTE at a mean of 25,000 Euro a
year, resulting in an increase of 55 Euro and a
total price of 134 Euro.

108
The Universal Prosthesis
12 Evaluation Boudewijn Martin Wisse
TU Delft, 2005

The concept as presented in chapter 11 can 12.1 Scoring criteria in methods and designs to be compared:
be evaluated in several ways: 1) PTB-resins (standard PTB)
comparison with other 2) PTB-ICRC

Synthesis
1) Review it against the criteria (section 7.1).
2) Review it against the requirements and the prosthetic systems. 3) PTB-Jaipur
additional goals (section 7.2-7.5). 4) The Universal Below-knee Prosthesis
3) Review it in comparison with other prosthetic In section 10.4, Table 10-1, a rough com- 5) ICEX-IDC
systems for transtibial amputees. parison between the Universal Prosthesis, 6) ICEX-resins
the Ossur ICEX-system and a standard PTB-

Ideas
4) Have it reviewed by professionals (experi- 7) Hydro-cast/sand-cast
enced prosthetists). system was given.
5) Build a model and evaluate the design by This six can be weighted against the criteria,
inspections However, the ICEX-system can be used with of which some are further specified:
6) Build a working model (prototype) and try direct fabrication on the residual limb (the

Concept
that out in practise. IDC-Icelandic Direct Casting system) and
without direct fabrication (with plaster of
1) Universal
Paris as shown in appendix N).
2 ) Comfort

Evaluation
In section 12.1 evaluation method 1 and 3 Both systems use the Ice-cast Compact pres- A)Socket fit
are taken together and a discussion with the surizing device as shown in figure 4-7 and B) Prosthesis weight
requirements as a guide (method 2) is added appendix N. C) Materials used and their effects (such as
in 12.2. perspiration).
Also, the PTB is produced in two ways. The 3) Easy fit

Recomm.
In section 12.3 a model is presented that first is the vacuum technique with fibre rein- A) Easy fit Amount of steps needed to fit and
was build. This model can be used for assess- forced resins and the second is a polypro- produce a socket/prosthesis
ing the shape of the frame parts (evaluation pylene vacuum-forming technique. The latter B) Specific knowledge needed
method 5), but it is not able to provide weight- fabrication method is used often in develop- 4) Control

Conclusion
baring (evaluation method 6). In section 12.4, ing countries, as a part of the ICRC (red-cross) 5 Usable
a conclusion is given in which remarks of design, by the aluminium/wood hand pro-
A) Donning/doffing and suspension
experts are integrated (evaluation method 4). duced Jaipur-system is very commonly used
B) Cleaning
as well (see Wisse et al. 2002,2003 for more
information about these production meth-
ods). Water-cast/sand-cast prostheses are an
important development, not to be neglected.
This adds up to the following production 109
6 Safe
A) Design toughness
1) Universal The PTB-socket is, because all features are
B) Toxicity of the fitting materials and the The Universal prosthesis offers a TCB-PTY- hand made from direct measurements, suit-
able for all residual limb shapes, lengths and
interface for user and environment hybrid for amputees with a healthy residual
limb, within a specified range of residual limb seizes, al long as they result in enough weight-
7 Affordable bearing area’s (residual limb length is more
lengths, sizes and shapes. From data (appen-
A) Material/component price
dix G) this range is expected to be P10-P90. than 80 mm). In practise, not all amputees
B) Service For most of the amputees in this range it will fint the PTB-socket comfortable (because of
8) Cosmetics provide a comfortable fit, however problems pressure concentrations and fabrication mis-
9) Quick fit can be expected with amputees that: takes made by prosthetists). Probably around
90% of the fitted prosthesis will be experi-
10) Distribution - Have contractures (reduced knee movement) enced as comfortable.
because of the reduced alignment possibilities
of the prosthesis
- Have a bulbous residual limb shape.
The same reasoning goes for the TCB-socket,
These are all compared with the commonly - Have a deviating bone structure (for example
only with less influence of prosthetist-mis-
used PTB-resin system taken as a 100% refer- takes and a suitability of around 95% can be
as a result of bone fractures). assumed. The IDC-fabricated TCB-socket can
ence-index. The resulting table can be found
- Have too little weight-bearing tolerance on the not be fitted to bulbous residual limbs and
in appendix Y, and a discussion per criterion interface with the frame (but just enough to
below. will be confronted with roughly the same
allow total contact weight bearing).
problematic residual limbs as the Universal
Note that the final verdict about for example For the latter, a prosthesis could be fitted
Prosthesis.
affordability will be dependent on multiple without the user initially standing (with half
points in the table (7,9 and 10) and the situ- of his body weight supported) in it fully. All The PTB-Jaipur system is made from drawing
ation that is reviewed (the market cycles as these exceptions don’t add up to a group of and measurements and doesn’t have a distal
mentioned in section 6.3). more than 10% of all transtibial amputees, end pad. This results in higher pressures and
resulting in that the Universal Prosthesis is will the system is comfortable for a smaller
expected to be suitable for about 70-80% of group than standard (70-80%).
all transtibial amputees that will ever find a
comfortable socket.

Of course, this needs to be validated in prac-


tise (see chapter 13).

110
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

2 A) Socket fit 2 B) Weight Conclusively, the weight-scores (compen-


Socket comfort depends on the users expe- The weight of the socket is highly depend- sated for the distal-weight) will all be close
together.

Synthesis
rience and therefore can not really be pre- ent on the material used. This results in the
dicted. Also, it has to be mentioned here that following order from light to heavy: carbon-
most literature (studies) in which prosthetics resins, glass-resins, either the Universal
are functionally compared are with only a Prosthesis or the PP-ICRC-sockets and the
few subjects (n < 15) so significant data is most heavy being the Jaipur-socket. 2 C) Materials used and perspiration

Ideas
limited. However, standard PTB-sockets are
found to be satisfying in most cases (lets say The mass of the Universal Prosthesis frame All sockets envelop the complete residual
80%) and TCB-sockets even perform a bit is nearly nothing (<200 grams), but the limb. Also in all cases, the prosthesis will
better (85%). socket will be filled with foam, increasing the be worn with socks or liners. The Universal
weight. The foam itself is expected to weight Prosthesis might feel more hot, because of

Concept
The Universal Prosthesis will have a combi- up to 1 kg, but more heavy are the fibre-rein- the isolating property of foam, however, after
nation of both, resulting in 85-90% comfort. forcements as proposed in section 11.2. Still, a few days of wearing a prosthesis (even in
However, because of less optimal use of pres- the total prosthesis (without foot) is expected tropical countries) problems with perspira-
sure tolerant area’s and possibly a pressure to stay under 2 kg. tion usually disappear. The Jaipur might feel

Evaluation
differences during the TCB-fitting (pressuriz- more foreign, because of the cold metal feel
ing the inner chamber of the prosthesis) as In the endoskeletal prostheses, where the of the aluminium used.
a result of the frames being in the wat, this pylon is separate from the socket, the pylon
percentage will drop to about 75-80%. Other can be either heavy or expensive. This is
systems compare, except the Jaipur which

Recomm.
important because weight more distally is
performs a little worse due to the lack of experienced more cumbersome (and will take
the distal end pad and due to the fabrication more energy during ambulation) that weight
method. Again, 100% is taken as all amputees more proximal. The Jaipur and the Universal
that can find a comfortable design. Prosthesis are the only exoskeletal systems

Conclusion
in this comparison.

The Universal Prosthesis’s connector can be


optimized by either taking by either taking
redundant material away or examining the
possibility to use other materials, resulting
in about the same weight for all connectors
used in the compared prostheses. 111
3 A) Amounts of steps needed to fit 3 B) Specific knowledge needed 4) Stiffness
and produce the prosthesis Specific knowledge is needed for all the sys- All current socket systems can be assumed
The Universal Prosthesis ant the ICEX-IDC tems to be fitted. to be almost equally stiff, because the socket
are two systems in which the measurement/ designs are optimized that way. The resins
fitting and the fabrication method are inte- For the Universal Prosthesis, this is basic will be slightly stiffer that the ICRC and the
grated. Comparing appendix N and other knowledge, such as the preferred 5 degree Jaupir, but not very significantly. The stiffness
sources on www.ossur.com with section 11.4, flexion of the knee and the right foot posi- of the Universal Prosthesis is for the biggest
they both need about the same amount of tions, can be communicated easily with part dependent of the function of the foam.
steps to fabricate the sockets. manuals with figures or with easy-to-use The foam has not been developed yet, so the
measurement tools, such as the proposed fit- stiffness cannot be assessed. However, with
PTB-sockets have a separated fitting and ting-foot-board (see chapter 10). All other sys- the suggestion from section 11.3, a sufficient
stiffness seems to be feasible. The Universal
fabrication method, which does increase the tems require advanced knowledge of biome-
amount of steps needed. Because adjustments chanics and the residual limb anatomy. Even Prosthesis can always be made stiffer, by
are might manually, the socket often has to the pressure-cast/TCB-systems are produced coating it with fibre reinforced resins, but at
be adjusted after fabrication. Even more so after the prosthetist has applied pressure the cost of weight and size. Also, more straps
for the Jaipur socket, which is hand-made pads on the specific area’s of the residual can be added. Note that the strap at 100 mm
and adjusted many times, until a decent fit limb that need to be shielded from the pres- below patellar tendon as shown in appendix
has been achieved. sure. Additionally, the Universal Prosthesis R-12, cannot be found in the final design. It
and the IDC prosthesis do not require knowl- is expected to be unnecessary, until proven
edge about the fabrication technique used, in otherwise.
contrast with the other systems.
By mechanical principle, the exoskeletal
designs are more stiff than the endoskel-
etal designs. The Jaipur and the Universal
Prosthesis score well here, but overall stiff-
ness (control) is not expected to improve sig-
nificantly by this.

112
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

5 A) Donning, doffing and suspension 6 A) Toughness 6 B) Toxicity of the fitting

The donning/doffing-ease is dependent of The frame parts of the Universal Prosthesis materials and the interface for user

Synthesis
the suspension type. In the comparison table, can easily be bended in transverse directions. and environment
all possible suspension types of each system
is shown. Except for the designs made for
However, Appendix S shows that they will not
buckle. Performance will improve after the
Toxicity of the materials used is an impor-
tant factor during use and during the fit-
developing countries (ICRC, Jaipur), each can fitting procedure, because of the filling of the
ting method, both in respect to the user/
be fitted with all popular suspension systems. soft socket. Long term outcome (more than
prosthetist as to the environment.

Ideas
Beside this, no real differences for donning 2 years under dynamic loading) has to be
and doffing can be identified. assessed experimentally. All prostheses can
be assumed to be safe. Some problems with The used materials in all prosthetic compo-
ICRC prostheses have been observed when nents are generally non-toxic to humans.
5 B) Cleaning they where produced with recycled PP.
However, glass-fibres, epoxy and especially

Concept
All modular/endoskeletar systems can be
more difficult to clean, because of the attach- When the prostheses fail, their failure will polyester resins are difficult and dangerous
to work with.
ment points. However, most systems are probably be tearing of the material (espe-
cially so with the exoskeletal systems), so that
finished with a cosmetic cover, eliminating
The

Evaluation
the user will have time to notice and does not heating and forming of the PP is not
problems. The Universal Prosthesis does not
fall. dangerous, when performed well.
really provide a good protection for the tran-
sition between the connector and the foot.
Something that might prove easy to solve, Most methods (PTB,ICEX-resin, ICRC, hydro-
cast) use plaster of Paris to cast and fabricate

Recomm.
either by adding a cosmetic cover for the
complete prosthesis or the ankle piece only. positive and negative moulds of the residual
The Jaipur-system consists of many material limb to form the socket around. The impact
(finished with leather and paint) and is most of plaster of Paris on the environment is low.
difficult to clean.
The Universal Prosthesis uses foam which is

Conclusion
non-toxic. In addition, the prosthetist and the
user cannot come into contact with it.

113
The Universal Prosthesis doesn’t produce 7B) Service B asically, all systems can be fitted with a
much residual material and powder, except
for the aerosol spray with probably some
Except for the ICEX (system from Össur) and (foam) aesthetic cover. Only the Jaipur system,
though looks are acceptable because of the
the ICRC (from the International Committee
spare foam left in it. of the Red Cross, factories in Switzerland and paint and because it is the only affordable
Ethiopia) the presented systems are widely system with a life-like foot under it, scores
When discarded (end-of-life of the prosthe- available from a broad range of suppliers. worst. It has a make-shift look.
sis), the Universal Prosthesis is difficult to
recycle. After fitting, the socket has become This implies that the prosthetist should The Universal Prosthesis is thicker than the
a mix of glass fibre, foam PP, aluminium, ABS deliver service and guarantees about the average prosthesis, which might show, even
and PU. Also the resins-based prostheses fit and comfort level. Knowledge about and when the prosthesis is worn under a pair of
cannot be recycled. The Jaipur, made of basic experience with the fitting procedure is trousers. The frame does show that it has
material can be recycled best. The PP used in spread and varies in quality, but the amount been thought about, tough that won’t be vis-
the ICRC-design can be recycled as well. of prosthetists that are known with the sys- ible anymore after fabrication.
tems is huge.

The Universal Prosthesis and the ICEX-sys-


7 A) Material costs tems both have a centralized selling strategy, 9) Quick fit
better enabling feedback and future develop-
Material prices are taken from 11.6, 3.3.1 ments. Service in respect to material quality The time-consumption of the prosthetist
and Wisse et al, 2004. They are summarized (for example wear resistance) can be consid- and technicians is related to the amount of
in the comparison table. For the comparison, ered equal for all components, except for the steps taken to produce the socket (see point
the high (first-cycle) Universal Prosthesis Jaipur system, which is 100% dependent on 3). Times of standard PTB and ICEX-IDC
price is taken, in which a budget for research the local workshop. are known from literature (see section 3.3).
is taken in account. Estimations for other systems can be found in
the comparison table. It has to be emphasized
8) Cosmetics that all technicians and prosthetists have
Cosmetics is most important during daily to be educated, except in case the Universal
Prosthesis is used. This is also true for the
use (how does the finished product look), but
also before and during the fitting procedure Jaipur-socket. Its fit is highly dependent on
(trust of the user and the prosthetist in the the skill of the technician.
system might depend on it).

114
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

10) Distribution 12.2 Evaluation the concept The Flexible socket:


How well the system can be distributed is against the requirements. The frame parts can be adjusted by the

Synthesis
dependent of: prosthetist, either by plastic deformation of
- the tools needed The requirements and design goals as pre- the hard frame parts) or by heating the inter-
sented in chapter 7, are divided per cycle. face frame parts. The small distal ends of the
- the compatibility with currently used systems
During this project a concept was developed interface frame parts can easily be adjusted
- services (see point 7B)
(chapter 11) that should comply with cycle to provide extra weight-bearing, and no spe-
- life-time/visits needed per year

Ideas
0. All requirements for cycle 1 and 2 where cial knowledge is needed. However, changing
- and of course the dependency of the system the proximal end of the interface frame parts,
design goals, but not required as such. Also
on the infrastructure (such as water, electric- needs experience and insight, and is not rec-
ity, etc) and on the availability of prosthetists. the requirements where catagorized by pros-
thetic component or part. Hereafter follow ommended (nor necessary) for the un-expe-
From the list, the tools and service types are rienced. The flexibility is added to the design

Concept
remarks about the concept where necessary
and which are not discussed in section 12.1 to facilitate the acceptance of the system by
specified in the table.
or where the Universal Prosthesis is expected current prosthetists.
The life-time of all systems can be taken as to perform as well as a PTB-standard design.

Evaluation
1 to 5 years (dependent on the activity of the
user, with a mean of 2.5 years), which is com- The Posterior side of the soft-socket:
parable to the use of a pair of shoes.
The prosthesis can be donned seated, cer-
The current design for the Universal tainly when only reviewing the hard frame. It

Recomm.
Prosthesis might have a shorter life-time, but can be that the soft frame will be too long
a decent optimization and the right choice at the posterior side, because the fabrication
of foam will result in a lifetime in the same liner can stay in between the brims (figure 12-
order. 1). In that case, some of the fitted and hard-

Conclusion
ened prosthesis might need to be removed.
All systems are well compatible with com- Or an extra brim has to be developed that
monly used connection systems (such as the keeps the foam below while hardening and
pyramid connection core) except the ICEX- pressurizing. Figure 12-1: A high posterior socket as a result
IDC (standard distributed with Össur com- of the fitting of the soft socket. The
brims will keep the fitting liner high
ponents) and the Jaipur (though the used
(dotted lines).
woodblock can be adapted at will by the tech-
nician). 115
The Advanced fit sock: Cycle 1 Prices: This is a market share of 0.47%, which is a lot
The fit sock can be further developed, so Tough the maximal total price for the system considering:
that it is thickened at places where the even- is correct and the concept does complies with - The current prosthetists have been using the
tual pressure will have to be lower than the it (see section 11.6), the maximal production current system for over 20 years.
pressure used during the foaming of the soft costs of the parts is formulated completely - It will be difficult to reach all amputees in
socket, especially the distal end. This will wrong. For example, the socket mentions a Europe.
result in a bit more distance between the total production cost price of maximal 500 - In Lower-income countries such as Rumania
residual limb and the fabricated socket. After USD. This has to be either the price inclusive and Poland, the price of 700 Euro is high in
fabrication and without wearing the special R&D, or a percentage of the total production comparison to the hour-price of technicians
sock, the pressure in those area will be lower costs price. For example, the production cost and prosthetists.
than that used during the filling of the soft price of the socket should not be higher than
socket. This sock is comparable with the gel 80% of the production cost price of the total.
For cycle 2 the total market size adds up
2,300,000 pieces needed worldwide a year,
pads used during the fabrication of the ICEX-
with the same calculation:
socket.
Market share:
For Cycle 1 a price was calculated with 1000 This is a market share of 0.48%, which is a
The Mechanical properties of the lot considering:
pieces sold a year for 5 year, resulting in an
pylon: break-even price of 700 Euros. For Cycle 2 a - The current prosthetists have been using the
It has to be mentioned here, that analysis break-even price of 200 was calculated with
-
current system for over 20 years.
Worldwide a lot of initiatives exist to promote
of the mechanical properties of the pylon is 10,000+1000 sold a year for 5 years.
the education of prosthetists.
incomplete. A working model has to be build
and tested, to see if the pylon/socket combi- These amounts of products sold are huge for - It will be impossible to reach all amputees.
nation comes up to the requirements. the prosthetic market. For cycle 1 the market - The price of 200 Euro or even 100 Euros can
size be considered high. Development of cheap
The whole design of the pylon might have to 1.416.000 Amputees in Europe (see appendix F)
systems that work on known systems (PTB-PP
for example), with cheap components is being
be rotated (about 5 degrees) to take the opti- X 54% which have a transtibial amputation (see conducted and prices of other systems are
mal 5 degrees of knee flexion in account. This appendix F) expected to drop.
is not so in the concept, the frame shapes X 70% that can be fitted with the UPis (see 12.1-
have been derived from a stretched leg. 1) These market shares can only be reached
X 0.4 new prostheses needed a year for each within the 5 year periods when using exist-
amputee (see 12.1-10) ing distribution channels, such as that of well-
= 215.000 prostheses a year (total market size). known companies or in this field operating
116
NGO’s.
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

12.3 Model and Fit of the


Frame

Synthesis
Shape
If we evaluate the shape of the interface
frame, two things can be noticed. One, the

Ideas
model is slightly to big. This is an effect of
the slices used of the Visual Human project.
These were bigger than P95, probably
because of conversion mistakes (see appen-

Concept
dix R-10).

Secondly, the interface frame performs well


in avoiding the pressure-sensitive areas and

Evaluation
loading the pressure tolerant areas. The
exception to this is the lateral place is the lat-
eral edge of the lateral tibial condyle (figure
12-2). This load is the result of the need to
connect the interface parts as defined in

Recomm.
section 11.1.3. This place should be avoided
better, possibly by increasing the distance
between the interface frame and the residual
limb.

Conclusion
Figure 12-2: Assessing the fit of the interface frame parts. 117
Flexibility of the weight-bearing
frame

The model that has been build demonstrates


that the first 200 mm from PT, the shape of
the frame parts contributes to the strength
and stiffness. Even when thermoformed, the
frame parts do have enough flexibility to
accommodate for a wide range of circumfer-
ences at patellar tendon height, while staying
in shape, so that the pressure-tolerant areas
are loaded, and the pressure-intolerant areas
are avoided.

However, the posterior weight-bearing


frame is too flexible from 200 mm below PT
and downwards. This can be solved, either
by adjusting the material used, or by adding
a rib. The anterior frame does perform well,
as a result of the shape that it has to follow
the tibial crest. Giving this shape to the two
extensions of the posterior frame is another
good option to improve weight-bearing per-
formance. Additionally, a second connec-
tor can be added, that can be used for long
amputees at PT-260 mm.

Figure 12.3 gives an impression of the


model.

Figure 12-3: Impression of the model build.


118
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

12.4 Project evaluation Independency The road to innovation


This back-to-base strategy was needed to Around 1950 the quadrilateral AK-socket

Synthesis
Building from base come up with a completely new system. In and the PTB-socket were developed (also
current day scientific research (also see sec- see appendix E). These socket designs were
Looking back, it becomes clear that at the tion 13.1) the focus is too much on FEM-anal- two of the few fundamental innovations in
beginning of the whole trajectory toward yses and modelling and functional outcome prosthetics after WWII. It can be said that
the Universal Prosthesis (the design-for-all analyses between PTB and TCB-sockets. This these and other important innovations are
subject, the internship in Sri Lanka and the

Ideas
also explains why this project was done by an the work of a small group of people, one of
graduation project), all knowledge has been industrial design engineer, and not by a team them being J. Foort. In appendix X, the story
gathered from base. of prosthetists. Prosthetists know too much of his experiences can be found. I found read-
to even think about making a low-expert ing them really intriguing, because the devel-
Producing aluminium frame sockets in Sri system. opment methods and processes he describes

Concept
Lanka, with anvil and hammer, was neces- highly resemble the methods and processes
sary to learn the properties of the materials Now the most innovative steps have been of this graduation project. A few quotes to
and of the human body. taken, and the system needs to be optimized, give an impression:
bringing a team together of prosthetists, engi-

Evaluation
Being in Sri Lanka was necessary to learn neers, market experts, etc is the only way to
what the wants and musts are of both ensure a practical and high-quality product.
prosthetists and users worldwide. In this
project, the target was not to develop a cheap
but inferior product for developing countries.

Recomm.
Instead, the aim was to develop an excellent
performing product for a good price that an
be used worldwide.

Keeping

Conclusion
the vision of the Universal
Prosthesis clear and keeping trust in the
intuitive notion that this vision is good, in
spite of negative advices of some individu-
als, was needed to keep going on until the
needed technological innovations were con-
ceived. Listening to other people is essential
but never without listening to your own intui- 119
tion.
13 Recommandation

In the evaluation it has become clear, that The lack of knowledge about pressure The lack of knowledge about shape
the concept presented in this report needs to tolerances and property variances
be further improved (better properties) and
further developed (made market ready). In Now, the amazing part of the story is that For the development of the Universal
section 13.1 recommendations for fundamen- fundamental knowledge about the anatomy Prosthesis, the data that was gathered in Sri
tal research that needs to be conducted can and properties of the human body (needed Lanka (appendix G) was of utmost impor-
be found. Section 13.2 offers specific sugges- to design an interface) in literature is either tance. It was assumed that the bone-structure
tions for improvements of the universal pros- extremely out-dated and lacking or not for everybody is the same and only propor-
thesis. public available. Ming Zhang concludes in tions (scale) differ. This assumption has to be
his overview of FEM-analyses [Zhang 1998], validated.
Section 13.3 discusses possibilities on how that mechanical properties of the soft tis-
sues are little known. A bigger question is This can be achieved by scanning the limbs
to continue the development of the universal
prosthesis. the tolerance to load of the tissue. Zheng of a range of people (N>100). Scans can be
in “state-of-the-art methods for geometric made with CT or MRI. Other (less preferred)
and biomechanical assessments of residual approaches are the study of corpses and
limbs: A review” states: “While FE analysis the study of 2D-X-ray images. These people
can estimate the stress distribution within don’t have to be amputees, though this would
13.1 Fundamental research in the residual limb and the socket interface, it
cannot tell us whether a stress distribution is
improve the data.

prosthetics. good or not. A good interface stress distribu- Better insight in the variance of the bony
tion should facilitate effective load transfers structure and the soft tissues of people leads
All interface design starts with knowledge during gait and should be well tolerated by to a better optimized interface frame fit, and
about human behaviour and the human body the residuum soft tissues. Such tissue toler- a better overview of the group for who the
and its properties. Prosthetists make prod- ance involves tissue damage criteria and Universal Prosthesis would provide a com-
ucts for people. The prosthesis replaces a tissue adaptation mechanism in response to fortable solution.
(lost) body part and restores a function that external loading. How residuum tissues react
is lost and is needed for the participation of and adapt to external loading deserve much
the user in society. Logical, it seems. further investigation.“ While FEM-analyses
are numerous, nobody actually knows what
pressure distribution they are looking for.

120
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

The PTB-TCB battle These two factors should be split and studied 13.2 Improving the Universal
This lack of knowledge about whether a pres- separately:
Prosthesis

Synthesis
sure distribution is good or not results in a - A study determining the functional outcome
battle between promoters of the PTB and differences between hands-off and hands-on
promoters of the TCB-system. Comparative systems. The frame
studies are being conducted but with a small
population in subject groups.
- A study determining the functional outcome
between rectified and unrectified systems When more data about the variance in
(such as the PTB and the TCB sockets). residual limb shapes and tissue structures

Ideas
and more data about the pressure tolerance
Worse, the studies that are conducted are
Before the development of the Universal of residual limb tissue is obtained, the frame
functional outcome studies in which both shapes can be optimized in respect to anat-
Prosthesis this could be achieved by:
sockets are fabricated for the same subject omy.
(in which a slight, but often insignificant - Comparing hands-on and hands-off produced

Concept
TCB’s.
preference for the TCB-sockets can be seen).
However, the PTB-socket is a hands-on socket - Comparing hands-on produced PTB’s with
FEM-analyses can be a valuable tool for the
hands-on produced TCB’s. optimization in mechanical properties. Ribs
design, which means that the experience
on the frame parts, especially the injection
and the knowledge of the prosthetist are the

Evaluation
moulded interface frame parts, can improve
determining factor. The prosthetist will make
their properties significantly. It might be nec-
“mistakes” which results in a negative outcome
bias for the PTB-socket . The TCB-socket on Now, because the Universal Prosthesis is a essary to add more connective belts between
hands-off produced PTB also it can also be the weight-bearing frame parts.
the other hand is a hands-off socket design.
compared with hands-off produced TCB’s.
There is less chance that the fit will not be
Other materials might prove more suitable

Recomm.
optimal after the fitting procedure. None of the mentioned comparisons have
been made in literature. for the frame. For example, Hylite could also
be used for the interface frame, while glare
or possibly normal aluminium could improve

Conclusion
the performance of the weight-bearing frame
parts.

121
Improvements would include: Cost reduction 13.3 Project continuation
- a better, more comfortable fit To make the Universal Prosthesis a real suc- There are basically three realistic options to
- a wider group that can be fitted with the cess in cycle 2, it have to overcome the high
Universal Prosthesis (bigger target group) competition during cycle 1 (section 6.3). A continue this project:
- a lighter prosthesis lower price would give the system the edge 1) Find an enthusiastic entrepreneur, that is
- a stiffer prosthesis (more control) over the ICEX-system it needs. Costs can be willing to start a company, bring together
reduced by smart use of subsidies and grants. several business-partners, such as a orthopae-
Also, this project might best be developed in dic workshop, a hospital, a knowledge insti-
The soft socket universities. In that case, initial investments tute (university) and try to start independent
production of the Universal Prosthesis. The
Absolute priority is the development and needed for R&D are lower, but the problem
success of this enterprise would be highly
testing of the foam that will fill the prosthe- might be that no companies are willing to dependent on the amount of subsidies and
sis. Without a proper foam, the complete con- take the risks that come with production, grants that can be attracted.
cept fails. The posterior side of the prosthesis because the design is not patented or pro- 2) Find a big player in the current market, such
might prove to be in the way for donning/ tected otherwise, as discussed in the next as Otto-Bock or Össur, and start in-house
doffing and sitting as shown in figure 12-1. section. development of the Universal Prosthesis as a
new addition to their assortment.
3) Try to encourage America/Canadian
Cosmetics research institutes, such as the US National
C osmetics after fabrication of the Universal Rehabilitation Information Center, to take up
the project and develop it further with help of
Prosthesis can and needs to be further
the world-wide prosthetic scientific research
improved. A prosthetic cover can be put community.
over the outside, but it can also be put inside
the prosthesis. In that case the fitting liner
is pulled over the frame and the cosmetic
socket. Another option is to integrate it in
the frame (as was the intention). Now, the
problematic shape difference between the
Universal Prosthesis and a natural leg occurs
near the connector, where the frame is too
triangular.

122
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

O ption two is preferred, because in this It might well be that the time just is not ripe
way quality and development speed of the for the Universal Prosthesis to appear on
Universal Prosthesis can be controlled. Also, the market. Tough the tendency (trend) of

Synthesis
when production is started, a company the branch towards standardized systems,
will benefit most by wide-spread use of the with customized results has been identified,
system and will actively promote it. Contact prosthetists still keep using their well known
has been sought with Össur to discuss this systems, such as the PTB-resin system.
possibility. However, to make commercial And why not, it does perform well, and the

Ideas
exploitation feasible on a broad scale, protec- needed knowledge to fabricate them has
tion of the intellectual property is a must. A been invested in (years of training by exactly
patent is a way to protect the knowledge. It those prosthetists). The negative attitude
has to be emphasized that the development towards the new systems by some (and the

Concept
of the Universal Prosthesis will cost consid- naïve positive attitude to new technologies by
erately and that the investments for this R&D others) can even be read between the lines
will have to return to the entrepreneur to in literature publications. It takes time for the
ensure future developments and continues prosthetists to realize that with the Universal

Evaluation
production. Prosthesis (and other low-expertise systems)
their knowledge doesn’t become obsolete,
but that it can be used better and with more
effect elsewhere.

Recomm.
Conclusion
123
14 Conclusion

“I urge you to do this – aim for universal solu- 14.1 Strengths QUICK:
tions “ J. Foort, Appendix X.
The Universal Prosthesis has some unique
The Universal Prosthesis can be fitted within
an hour. The efficient use of the prosthetist’s
features or Unique Selling Points (UPS). Its time, can lead to cost reduction and better
strongest point is that the Universal Below- overall healthcare in current orthopaedic
Is the development, production and distribu- Knee Prosthesis combines a customized, com- workshops. Patients for which a prosthesis is
tion of an Universal Below-Knee Prosthesis fortable fit with a low-expertise fitting proce- now regarded as too expensive or time-con-
feasible? dure. This strength fits in the market trend suming (for example bed-staying elder, with
toward standardized systems that provide a a bad prognosis), can be fitted more easily.
Yes it is. customized fit. Also, the amputee can be a prosthesis more
often, for example during the post-operative
But the road is long. COMFORT: period (1-6 months after amputation) or as a
spare one when the custom-made prosthesis
The Universal Prosthesis combines the is being repaired or being replaced.
Total Contact Bearing (TCB) and the Patellar
Tendon Bearing (PTB) weight-bearing prin-
ciples. During the fitting procedure, the LOW-EXPERTISE:
amount of pressure added during the filling
of the soft socket, will determine if the pros-
The Universal Prosthesis can be fitted by
relatively un-educated people. This unique
thesis will behave more like a TCB or more features addresses the lack of experienced
as a PTB socket. This flexible system ensures prosthetists worldwide. The educated
that a wide range of amputees can be fitted prosthetists can use their valuable time to
with a comfortable prosthesis. solve orthopaedic problems for people with
non-standard BK-amputations. In the long
run, more people can benefit from proper
prosthetic care.

124
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

14.2 Project progression Commercial feasibility 14.3 Final word


The here-presented concept if far from fin-
It is clear that a huge amount of research
History learns us that innovation in socket

Synthesis
and development work has to be done before
ished. A lot of fundamental questions have to the Universal Prosthesis can be a qualita- designs doesn’t occur often. However, innova-
be researched to improve the base of knowl- tive system, that has an edge over other cur- tions that occurred, such as the PTB-socket
edge on which this innovation is build. Apart rent prosthetic systems. And R&D-work is and the quadrilateral socket, did become
from that, the frame parts have to be opti- an expensive investment that needs to be mainstream. These innovations were not pat-
mized and the formation of the soft-frame, ented, were not commercialized, but were

Ideas
returned by the revenues of the product.
by filling the prosthesis with foam, has to be developed by a relatively small group of
developed from scratch. When the first series
of prostheses become available clinical/field
With 2 x 800.000 Euros R&D-investments, enthusiastic scientists and practitioners.
the Universal Prosthesis can be developed.
test have to make sure the procedure is Return of investment is possible when sell- Because the Universal Prosthesis is a prod-

Concept
indeed understandable and efficient when ing 1000 Universal Prostheses for 5 years at uct that will only be economically feasible
performed by non-experts. After that, bring- a price of 700 Euros and then selling 11,000 when produced in large quantities, for this
ing it to other markets, other cultures and pieces a year for 5 more years at a price of new innovation commercial exploitation
other environments brings along a complete 100-200 Euros. These market share of 0.47% might be the best option.

Evaluation
new set of challenges. will be difficult to reach. Strategies to do so
include: I know that the development of the Universal
Prosthesis is not finished. But I feel that the
- Cutting down on R&D-costs by attracting
here presented concept is a good step towards
grants and encouraging many parties to par-
the next generation of prostheses. Whether

Recomm.
ticipate.
the concept is freely developed or com-
- Get support from existing distribution net-
mercialized, I believe that within 10 years,
works, including NGO’s, producers of pros-
thetic components and governments. many people can benefit from the Universal
Prosthesis or similar innovations. And I hope
- Integrate the Universal Prosthesis into an

Conclusion
assortment of prosthetic systems, components
that some of the 1,000,000 people that cur-
and methods, so that the R&D costs can be rently are without proper prosthetic care, will
spread over a group of products. be able to walk once more.

125
R References

- Wisse BM, WD van Dorsser, F Soleymani, Prosthesis for Sri Lanka - UK NHS, 2005 (website): www.pasa.doh.gov.uk/prosthetics/
– Prosthesis for tibial amputees focused on the 3rd World, Delft, 2002 - Walsh TL, Custom Removable Immediate Postoperative Prostheses,
- Wisse BM, WD van Dorsser, The Alternative Prosthesis – final report Journal of Prosthetics and Orthotics 2003; Vol 15, Num 4, p158-161.
internship Sri Lanka 2002, Delft, 2003 - COTA, Centrum voor Orthopedie Techniek Amsterdam, De Softsocket,
- Seymour R, Prosthetics and Orthotics: lower limb and spinal, USA: 2002
Lippincott Williams & Wilkins, 2002 - Hafner BJ, JE Sanders, JM Czerniecki, J Fergason, Transtibial energy-
- IMT-Baghdad, Institute of medical technology department of rehabili- storage-and-return prosthetic devices: A review of energy concepts
tation, Baghdad, Iraq, Education for orthopedic technician, Part 1 and a proposed nomenclature, Journal of Rehabilitation Research and
– Symes and partial foot prostheses and below knee prostheses, year Development 2002; Vol 39, Num 1, p1-11.
unknown - Michael JW, JH Bowker, Prosthetics/Orthetics Research for the
- CBS, Centraal Bureau voor de statistiek, Statistisch Bulletin, 60e jaar- Twenty-first Century: Summary 1992 Conference Proceedings, Journal
gang no. 5 / 3 februari 2005 of Prosthetics and Orthotics 1994; Vol 6, Num 4, p100.
- CBS, Centraal Bureau voor de statistiek, Statline online database (web- - Sangeorzan BJ, Harrington RM, Wyss CR, Czerneicki JM, Matsen FA,
site): statline.cbs.nl, 2005 Circulary and Mechanical Response of Skin to Laoding, Journal of
- IEE, Medical Equipment Industry-potential for growth, edited by pro- Orthopaedic Research 1989, Vol 7, p425-431
fessor Alan Murray (Freeman Hospital), 1998 - Foort J, 1986, Innovation in prosthetics and orthotics, The Knud
- VHI, Veteran Health Institute, Traumatic Amputation And Prosthetics, Jansen Lecture, Copenhagen 1986
Independent Study Course, May 2002 - Kim WD, Lim D, Hong KS, An evaluation of the effectiveness of the
- Weeks DL, Preliminary Investigation Comparing Rectified and patellar tendon bar in the trans-tibial patellar-tendon-bearing
Unrectified Sockets for Transtibial Amputees, Journal of Prosthetics prosthesis socket, Prosthetics and Orthotics International 2003, Vol 27,
and Orthotics 2003; Vol 15, Num 4, p119 p23-35
- Fisher SV, G Gullickson Jr., Energy cost of ambulation in health and - Reswick JB, Rogers JE, Experience at Rancho Los Amigos hospital
disability: a literature review, Archives of Physical and Medical with devices and techniques to prevent pressure sores, Bedsore
Rehabilitation. 1978 Mar; 59: 124-133. Biomechanics, 1975
- Angarami GR, An Efficient Low Cost Prosthetic Structural System, - Convery P, Buis AWP, Socket/stump interface dynamic pressure
Journal of Prosthetics and Orthotics 1989; Vol 1, Num 2, p86. distributions recorded during the prosthetic stance phase of gait of
- Valenti TJ, Experience with Endoflex: A Monolithic Thermoplastic a trans-tibial amputee wearing a hydrocast socket, Prosthetics and
Prosthesis for Below-Knee Amputees, Journal of Prosthetics and Orthotics International, 1999, Vol 23, p107-112
Orthotics 1991, Vol 3, Num 1, p43. - Zhang M, Mak AFT, Roberts VC, Finite element of a residual lower-
- Schoppen T, Physical, Mental and Social predictors of functional out- limb in a prosthetic socket: a survey of the development in the first
come, Rijks Universiteit Groningen 2001 decade, Medical Engineering & Physics 1998, Vol 20, p360-373
- ACA, Amputee Coalition of America, FirstStep 2001, www.amputee-coali- - Datta D, Harris I, Heller B, Howitt J, Martin R, Gait, cost and time
tion.org/aca_first_step.html. implications for changing from PTB to ICEX sockets, Prosthetics and
Orthotics International 2004, Vol 28, p115-120.
126 - Kriesels M, Protheses voor Sri Lanka uit fietsonderdelen, 2002, please
contact the writers for more information
The Universal Prosthesis
F Figures & Tables List Boudewijn Martin Wisse
TU Delft, 2005

Tables and figures Figure 3-11: Alignment of the transtibial prosthesis in the sagittal plane,
placing the foot medial to the socket. This placement tends
Table 2-1: Project targets before and after the Sri Lanka internship
to cause a rotation of the socket that then places pressure
[Adjusted from Wisse et al. 2003, Chapter 5] (For a complete

Synthesis
on the proximal medial and distal lateral residual limb. 15
timeline see appendix C). 2
Figure 3-12: Alignment in the sagittal plane placing the foot lateral to the
Figure 3-1: The prosthesis and its total context. 6
socket, resulting in pressure on the fibular head and distal
Figure 3-2: Bones of the lower limb (most right), muscles (middle) and medial residual limb. [Seymour 2002] 15
anatomy of the residual limb (below) [Adapted from IMT-
Figure 3-13: Alignment in the frontal plane. Left: normal. Right: Foot
Baghdad and Wisse et al. 2002]. 7
placed to far backward, causing pressure on the distal ante-

Ideas
Figure 3-3: Amputation procedure [Seymour 2002]. 8 rior part and proximal posterior part of the limb. 15
Figure 3-4: Different levels of transtibial amputation [Seymour 2002]. 8 Figure 3-14: Alignment in the frontal plane. Left: normal. Right: Foot
Table 3-1: Amount of amputees worldwide. 9 placed to far forward. If the force though the spocket fell
Figure 3-5: Residual limb shapes: conical (a), cylindrical (b) and bulbous posterior to the ground reaction force vector, the prosthesis

Concept
(c). [Seymour 2002] 10 would tend to rotate. 15
Table 3-2: Skin conditions. 11 Figure 3-15: Planes of the body. [Seymour 2002] 16
Figure 3-6: Pressure tolerant and sensitive areas. Most left: A scematic Table 3-3. Phases in gait. [Seymour 2002] 16
of sensitive (light red) and tolerant (dark red) areas [Seymour Figure 3-16: Distance variables of giat. a) left step length, b) left stride

Evaluation
2002]. 4 Right: anterior, lateral, anterior and medial view of length, c) right stride length, d)right step length, e) width
a positive (cast), with pressure sensitive (red) and to 12 of base support f) Right toe-out, g) left toe-out [Seymour
Figure 3-7: Base of support. The size of the base of support varies with 2002] 16
a change in foot position. [Seymour 2002] 13 Table 3-4: Phases of the gait cycle of the right leg. [Adjusted from
Figure 3-8: Static alignment for a transtibial prosthesis. A) In the fron- Seymour 2002]

Recomm.
tal plane, B) In the sagittal plane. [Seymour 2002] 13 Figure 3-17: Gait deviations to accommodate a long limb. A) Hip hiking,
Figure 3-9: Inclination of the bulge of the PTB (see section 4.2) socket. B) Lateral trunk lean, C) Circumduction, D) Vaulting, E)
The bulge provides more surface for weight bearing than Excessive hip and knee flexion. [Seymour 2002] 18
the wall of the socket. Note the relatively longer horizontal Figure 3-18: Procedures of a prostetic clinic [Adapted from Seymour

Conclusion
component of the vector. [Seymour 2002] 14 2002] 21
Figure 3-10: Forces on the patellar tendon increase because of the Table 3-5: Grow indexes of the sales in the medical equipment indus-
need to compensate moments due to distance a and b and try in the Netherlands [CBS 2005]. 22
because the inclination of the force factor on the patellar Table 3-6: Market for prostheitc devices in the Netherlands [CBS
tendon [Wisse et al .2002] 14 2005]. 22

127
Table 4-1: An overview of clinical patient stage and applicable prosthe- Figure 4-10: The Jaipur prosthesis, here drying from paint finish,
sis type. In practise, the choice is less time dependent, but consists of a exoskeletal structure with a separate
is determined by the healing rate and activity level of the manufactured foot. [Source: FINS- Sri Lanka] 30
amputee. 24 Figure 4-11: The endoskeletal prosthesis always contains a pylon. Very
Figure 4-1: Fabrication of a RRD and Custom Removable IPOP. Left: 3 seldom the other parts are integrated. Normally, the socket
spandex socks, pads and an attachment plate, 3 velcro and foot are modular components. [Seymour 2002] 31
straps and attachment base plates. Middle: fiberglass cast Figure 4-12: The 4C Air Lite Monolithic (above 2 pictures show manu-
with cut lines and base plate attachment points and the facturing steps. A carbon-fibre sock is one of the important
result. Inset: ant 25 materials) and the Endoflex (lower pictures) are two of the
Figure 4-2: A complete IPOP (without pylon). [Source: Seattle Rehab few designs in which the pylon and socket are integrated.
Research, US Veteran Affairs] 26 [4C Air-Li 31
Figure 4-3: The universal IPOP (Aircast Air-limb) is inflatable to acco- Figure 4-13: ISNY Components [Source: Website Otto-Bock] 32
modate different stump sizes. [source: ACA 2001, Aircast Figure 4-14: Flexible ischial-containment socket for transfemoral
brochures] 26 amputees (this one from Otto-Bock, inset from Hanger) con-
Figure 4-4: The Flow-tech Adjustable Postoperative Protective and sist of a flexible inside and a frame. Other names include
Preparatory System (APPOPS) provides a prefabricated Total Flexible Brim, the ISNY and SFS (Scandinavian Flexible
prosthetic system offering protection, controlled shaping of Socket)[Seym 33
the residuum and early rehabilitation.... 27 Figure 4-15: Plug fit socket. The first prosthetic socket without weight-
Figure 4-5: Connective part between socket and pylon, which can be bearing at the distal end by Verduin 1696 [Wetz 2000] 34
used in temporary and definite prostheses. [Source: Endolite Figure 4-16: Icex finished socket (left). Pressure pads are added to com-
brochure] 28 pensate for weight intolerant areas (cutt-through right)
Figure 4-6: Components of Maramed orhopedic Systems. Left: X-tender [Source: Ossur Icex brochures.] 35
system can be used as a temporary prosthesis(middle). Figure 4-17: The ICRC-limb makes use of a polypropylene pylon.. Its
At the right a retainer is shown, in which a custum-made cross-section is H-shaped. 35
socket can be attached. [Source: Maramed website] 28
Figure 4-18: (left) Trimodular Pylon as used in the sauer-bruck trimodu-
Figure 4-7: The ICEX toolbox and component box. [Source: Ossur web- lar physiological prosthesis [Angarami 1989] 35
site] 29
Figure 4-19: (right) Springlite Advantage DP flexible pylon and dynamic
Figure 4-8: Standard fabrication starts with taking a negative mold. response foot by Hanger Orthopedic Group. [Source: web-
Then plaster is poured into the negative mold to create a site] 35
positive mold. At last, the positive mold is shaped by the
Figure 4-20: Left: Principle of Rocker foot or sole. [Adapted from: www.
prosthetist to emphasis the shape. The final socket is made
customfootware.com] Right: Low cost prosthesis with cane
by laminat 29
pylon and rocker foot 36
Figure 4-9: The exoskeletal prosthesis (depicting socket, plastic exterior
and foot) is one, integrated product. [Seymour 2002] 30
128
The Universal Prosthesis
Boudewijn Martin Wisse
TU Delft, 2005

Figure 4-21: SACH foot (Adapted from Seymour 2002] 36 Figure 4-37: Prosthetic skins can have a high life-like appearance [left,
Figure 4-22: SAFE II foot. (Original manufacturer is Campbell Childs Inc, dorset and orthopeadic]. Uflate sleeve skin covers shrinks to
now bought by 4C (Foresee Orthopeadic Products)). 36 fit the prosthesis when treated with a heat-gun. 43

Synthesis
Figure 4-23: Single-axis foot. [Seymour 2002] 37 Figure 4-38: Examples of supplies (above): Rivits, Polyester Resin-
Laminae, box of stockinettes, pneumatic cast cutter, carbon
Figure 4-24: Multiple axis foot. [Seymour 2002] 37
tape [Fillauer Supplies brochure]. Static alignment is done on
Figure 4-25: STEN foot. [Source: Kinsley Manufacturing Co brochure] 37 an alignment table [otto bock[. Supplies enable prosthetists
Figure 4-26: (Above) Though from the outside not visible, energy storing to ma 43
feet differ from the inside [Impulse foot, OHIO Willow Wood] Figure 4-39: Pathway of the instant axis of rotation for the knee joint.

Ideas
Various energy-storing feet. Earch foot is composed of a com- [Seymour 2002] 44
pressible heel and a flexible keel spring. A) Seattle foot, B)
Figure 4-40: Limited dorsiflexion at the ankle. If the ankle can not dor-
Dynamic foot,C) STEN foot, D) SAFE foot,E) Carbon Copy II
siflex normally, either A) the individual will weight bear on
foot.[Hafner et al. 2002] 38
the toe or B) the knee must hyperextend to get the foot flat

Concept
Figure 4-27: Advanced energy-storing prostheses: A) Modular III, B) Reflex on the ground. [Seymour 2002] 44
VSP, C) Advanced DP, D) Pathfinder.[Hafner et al. 2002] 38
Figure 4-41: Stress on the residual limb from the prosthesis. A) The
Figure 4-28: Two hybrids: The Seattle Cadence HP [Source: Seattle web- hypothetical situation in which the residual limb is of uni-
site] and the MICA Genisis II+. [Source: MICA website] 38 form firmness and the socket matches the circular shape of

Evaluation
Figure 4-29: (right) Anatomical Suspension. The supracondylar suspen- the limb. B) A residual limb of nonuniform firmness and a
sion is in this case removable due to the brim.(right, middle) socket that 45
The supracondylar suprapattelar system is fixed. [Seymour Table 4-2: Gait deviations due to materials and the alignment [Seymour
2002] 39 2002]. Note that many alignment choices can have the
Figure 4-30: The PTB cuff or supracondylar cuff. [Seymour 2002] 40 same effect. If the effect is unwanted, all can be adjusted,

Recomm.
Figure 4-31: The thigh corset can be used in conjuncture with a waist belt but some will cause other problems (because one alignment
and an elastic strap. [Seymour 2002]. The suspension sleeve choice will h 46
has a similar working principle (left) [Otto Bock]. 40 Figure 4-42: Bending forces on the residual limb while standing. [Wisse
Figure 4-32: Pin/Shuttle suspension. [Seymour 2002] 41 et al. 2002] 47
Figure 4-43: A Simple model of the value chain of prostheses. Value is

Conclusion
Figure 4-33: Mineral gel sleeve suction suspension. [www.customprosthet-
ics.com]. 41 increased from left to right. Note that some companies have
multiple roles. 48
Figure 4-34: Double/Single Socket Gel Liner [Silipos]. 42
Figure 4-35: Demountable Torque absorber and its effects. [adapted from
endolite] 42
Figure 4-36: Some examples of connective components [adapted from
www.atlas-ti.com] 42
129
Figure 5-1: Figure-8 wrap for the transtibial amputation: [Seymour Table 11-1: Four material options for the interface frame. 95
2002] A. First wrap max extend from proximal medial to Figure 11-3: Applying hinges to Hylite (source: Corus) 96
distal lateral. B. Second wrap may extend from proximal lat-
Figure 11-4: Deep drawed car part from Hylite. (source: Corus) 96
eral to distal medial. C. Thrid wrap may overlie first wrap. D.
Bandage is looslely wrapped approximately 60 milimeter to Figure 11-5: Less space in between the frames is better; it results in a
the knee. E. Completed wrap. 51 stiffer prosthesis. 99
Figure 5-2: LEFT: The endolite Aqualimb with anto-slip tread patterm on Figure 11-6: A Polyurethane layer is partly reinforced with fibres. The
the sole for extra grip on wet surfaces. [www.endolite.com]. Hylite is milled to better attach the reinforced PU. The two
RIGHT: The rampro activankle swimming prosthesis [www. Polyurethane layers can slide along each other 99
rampro.net]. 55 Figure 11-7: The airman Panter is an example of a hand-pump. 100
Figure 6-1: Snapshots of a movie, in which an amputee walks several Figure 11-8: Two ways to connect the frame. 100
steps in a frame socket. [Wisse et al. 2002] 61 Figure 11-9: An extra component that can fine-tune the length enhances
Table 6-1: Several fitting methods and their properties. 64 the adjustability of the prosthesis. 101
Table 6-2: Several walking and mobility aids and their properties 65 Figure 11-10: The connection to the foot is 101
Figure 10-1: Otto-Bock Harmony system 82 Figure 11-11: (Up and Right)The airlock is achieved by an outer and an
Figure 10-2: Possibilities for adding use-cues to ease the fitting proce- inner seal. 101
dure. 83 Figure 11-12: The fill channel and the valve in the connector. To transfer
Figure 10-3: Moments around the socket, as a result of diffrent pylon the filler up to the proximal side of the prosthesis, flexible
types. 85 tubes (straws) and splitters can be used. The entrance of
the channel has to be distally or on the bottom of the ... 102
Figure 10-4: H-profile. 85
Figure 11-13: An example of a Minivalve (source: www.minivalve.com)
Figure 10-5: Flexible bands that connect parts will result in pressure
102
peaks. 85
Figure 11-14: Height of supracondylar suspension. 104
Figure 10-6: Suspension sleeve 86
Figure 11-15: The shuttle for the pin/shuttle suspension can perforate the
Figure 10-7: Steps for fitting the hard frame 88
outer layer. The rings will restore the system to an airtight
Figure 10-8: Steps for fitting the soft frame 88 state. The shuttle can be attached on most heights (with
Figure 10-9: Steps for fitting the combined system 89 varying circumference). During the fitting .... 105
Table 10-1: Quick comparison between the Universal Prosthesis and two Figure 12-1: A high posterior socket as a result of the fitting of the soft
popular fitting systems.e 90 socket.
Figure 11-1: 13 stacked layers that where derived from the anatomy of the Figure 12-2: Assessing the fit of the interface frame parts.
residual limb. Top view and isometric view. 94 Figure 12-3: Impression of the model build.
Figure 11-2: Together with the resulting frame parts. [Top] stiff frame,
two views. [Below] interface frame. 94
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