Executive Guide

MEDICAL

Advances in Medical
Technology Design

Sponsored by:

Back to TOC

Contents

Staff
Editorial
Publisher, Russell E. Pratt
Associate Publisher, Al Schmidt
Editorial Director, David Greenfield
Managing Editor, Jennifer Roy Campbell

Art/Production/Marketing

Rapid Prototypes Speed Diabetes Equipment to Market

Biorep uses an Eden250 to develop fast parts to test ideas and sell
concepts to management.

Biomedical Textiles in Implantable Medical Devices

Because material selection intersects the physical, chemical and
biological sciences, a multi-disciplinary team of engineers from each
of these areas should be involved when evaluating device design and
manufacturing options.

Robotic Surgical System Overcomes Manual Limitations

Comprising numerous technologies, from 3-D visualization to high-quality
motors, the da Vinci surgical system is widely considered a breakthrough
platform for performing complex, minimally invasive surgery.

13 Bal Seal to Launch First Contact System with Integrated

Isolation Seals

Lead Art Director, Marco Aguilera

Associate Art Director, Hector Torres
Production Director, Jeff Tade
Production Manager, Brian Wu
Senior Production Artists:
Jeff Polman, Derric Treece
Production Artists:
William Baughman, Ricardo Esparza,
Lucia Corona
Production Coordinator, Adrienne Davis
Director of Circulation, Sandra Martin
Circulation Manager, Carlotta Valle-Martinez
Marketing Manager, Melanie Perreault
Project Manager, Colleen Heckman

Design News
33 Hayden Ave.,
Lexington, MA 02421
Tel: 781-869-7967 Fax: 781-862-4853
e-mail: colleen.heckman@cancom.com

Company announces plans to launch the worlds first integrated seal

and electrical contact system for active implantable devices.

14 Low Power Piezo Motion

Reduced-voltage piezo motor breakthrough creates options
for medical devices.

18 Anatomy of a Life Saver

Inventor Larry Miller overcame technical issues, patent problems
and institutional resistance in the course of creating a successful
medical product.

20 Noise Reduction in Home Health Care Product Design

While not necessarily a barrier to FDA approval, noise created by home
health care devices is nonetheless an important design consideration that
should not be overlooked in the design and manufacturing process.

22 New Elastomers Target PVC in Medical Applications

Exposure to phthalate plasticizers raises concerns.
2

Sponsored by:

Back to TOC

Rapid Prototypes
Speed Diabetes
Equipment
to Market
Biorep uses an Eden250 to develop fast parts
to test ideas and sell concepts to management.
By Doug Smock, Contributing Editor, Materials and Assembly

Sponsored by:

When we outsourced 3-D printed

models, they were often more expensive
than the cost to machine them in-house,
and it wasnt much faster, says Echeverri.
We knew we could really accelerate our
design productivity if we had the ability
to print a part overnight, in our office.
Seventeen metal and plastic parts for
the pinch manifold were prototyped
on the Eden250, a smaller, entry-level
machine. Eight polyacetal parts are used
to pinch the tubing, shutting off the flow
of fluids. There are also two parts made
of Ultem, a polyetherimide engineering
plastic developed by Sabic Innovative
Plastics. The two metals used in the
manifold are stainless steel and anodized
aluminum.
Fluids only come into contact with
the tubing, which is disposable. The
prototypes were used to sell the concept
to management. Bioreps manifold, which
is now for sale, uses a series of cams and
a motor to control fluids in multiple
channels. Functional prototypes were
machined, and at that time parts were
designed for manufacturability (draft
angles, gate locations and so on).
Another technology developed jointly
between DRI and Biorep is a silicone
membrane petri dish. A standard plastic

dish allows oxygen in from the top.

Scientists at DRI wanted to test a dish in
which oxygen could reach from the top
and the bottom.
Silicone is permeable to oxygen,
so we decided to try to create a silicone
membrane petri dish, says Echeverri.
DRI scientists developed a proprietary
silicone blend that enhances oxygen
permeability we call the design the
Oxygen Sandwich because it envelops
the cells in oxygen from above and below.
Echeverris team (which includes
eight design engineers and 11 seats of
SolidWorks) prototyped parts on the
Eden250. The final design of the
membrane is just 300 microns thick
strong enough to be handled in a lab
without getting damaged and taut enough
to prevent sagging. We did a lot of
prototyping with different configurations
to arrive at that conclusion, says
Echeverri.
It took just six months to go from
concept to field testing. Six months is
an incredibly short time to get a medical
device into testing, he says. O
This illustration shows several parts for a
pinch manifold made from stainless steel and
aluminum that were rst prototyped on an
Eden250.

Source: Biorep

medical device manufacturer in

Florida is getting to market faster
with better designs by using a
3-D printing system to make prototypes.
The Eden250 3-D printing system
from Objet Geometries was used
extensively by Biorep Technologies
in Miami in the development of a
patent-pending pinch manifold. Pinch
valves are used in medical labs to keep
fluids, such as blood, in silicone tubing
from coming into contact with any
equipment components.
There are many pinch valves out
there, but none that are noncontact where
you can select multiple tubes, says Felipe
Echeverri, engineering director of Biorep
Technologies. Since it didnt exist in the
market, we had to design and build it.
Biorep, which was founded in 1995
as a pro bono engineering partner to the
Diabetes Research Institute (DRI) in
Miami, relied on its own machine shop
to make prototypes. The workload grew,
and included development of equipment
used to isolate islet cells from the pancreas.
This enabled advanced-stage diabetics
to receive transplants, allowing them to
live insulin-free. Biorep then began to
outsource models to service bureaus to
cope with a mushrooming workload.

Back to TOC

Biomedical Textiles
in Implantable
Medical Devices
Because material selection intersects the physical, chemical and biological sciences,
a multi-disciplinary team of engineers from each of these areas should be involved
when evaluating device design and manufacturing options.
By Stephanie Lietz, development engineer, Secant Medical LLC

Sponsored by:

Source: Secant Medical LLC

lthough medical device

There are benefits to working
engineers have been
with well-known, established
utilizing textile structures
biomaterials such as polyester
for decades, their complexity
(polyethylene terephthalate) and
is increasing as biomaterial and
polypropylene. Since these materials
fabric-forming options become
have been used for decades, there
more abundant. Some well-known
is a wealth of information available
to engineers to better understand
examples include woven and knit
the mechanical and biological
polyester tubes that are used to
performance indicators to guide
bypass aneurysms in the aorta, and
them in designing the functionality
polypropylene warp knit meshes to
of a new device. Established
repair most hernia types.
Nitinol circular weft knit mesh that can be used for
materials can also offer device
These versatile fabric structures
containment (orthopaedics), ltration (cardiovascular),
manufacturers a smoother and faster
have captured the attention of
and radial support (delivery system).
regulatory approval path due to
device engineers and enabled them
to achieve unique results unattainable
properties. The exponential combination their historical use in implants.
The use of biomaterials that degrade
through the use of more rigid structures.
of these materials and the textile forming
As a result, device engineers are starting
processes results in components with or absorb within the body is increasing
to realize the importance of defining
highly customizable material character- in popularity as they are becoming more
the form and function of the end
istics, performance properties and drug readily available to device manufacturers.
device by initially making an informed
delivery substrates. All of these options Common bioabsorbable polymers
decision of the biomaterials that affect
allow device engineers to develop ultra- include but are not limited to PGA
the component structure design and the
sophisticated implantable devices across a (polyglycolides), PLLA (polylactides) and
development process.
range of medical therapy areas including their copolymers. These materials are
orthopedics, cardiology, tissue engineer- broken down inside the body by different
Known Biocompatible Materials
ing and neurology. Biomaterial selection processes of which the most common are
Biomedical textile structures consist is a critical factor in engineering a device hydrolysis and enzymatic degradation.
of an array of biocompatible materials, to function as required for the remainder Bioabsorbable biomaterials have been
including polymers and metals ranging of the patients life or the intended exis- used in applications associated with nonpermanent or hybrid biologic/synthetic
in dimensions, mechanical and physical tence of the device.

Back to TOC
repairs. New textiles constructed from
absorbable and bio-active polymers; for
example, are ideal in tissue engineering
and orthobiologic applications requiring
short-term tissue support while the body
repairs itself, followed by long-term
biologic integration.
In other medical therapy uses,
the enhanced mechanical properties,
abrasion resistance, chemical inertness,
temperature resistance and durability
are important design criteria for the
functionality of the device. These
therapies may require using advanced
polymers such as polyetheretherketone
(PEEK) and ultra-high molecular weight
polyethylene (UHMWPE). As these
materials prove their effectiveness, they
continue to attract attention among
biomedical textile innovators in using
these fiber forms to design new textile
structures.
Textile structures can also incorporate
or be made entirely of metals for several
added benefits. Nitinol is a common
metal utilized in the medical device
industry for its super elastic properties.
Utilizing nitinol within a braided
structure provides device engineers
the benefit of incorporating both the
properties of braids and nitinol to allow
a shape transformation to occur. The
braid can easily be compacted down to
fit into a small cannula, and once placed
into position, transform to the desired
shape. Device engineers can also design

Source: Secant Medical LLC

Nitinol braided tube used for blood ltration/

distal protection.

PET and gold braided tube to be used as

a component in an electrically active
cardiovascular or neurovascular device.

Sponsored by:

Design Considerations for Biomaterials Selection

The material selection process involved in device design using biomaterials requires
multiple steps:
Identication of an application-appropriate material, or combination of materials,
for the textile structure.
Laboratory and clinical analysis to ensure that biocompatibility, tissue response and
other long-term durability parameters are within specication.
Development of detailed specications and controls related to material composition.
Follow-on supply chain management to ensure quality, availability of materials and
execution of appropriate supply agreements.
The forming process that will be used to manufacture the textile structure must be
factored in. Each fabric-forming technology weaving, braiding, knitting and nonwoven has its own set of advantages, limitations and varying levels of compatibility
with the different biomaterials available. In this area, device manufacturers must
rely on the expertise of biomedical textile producers to determine the orientation of
the biomaterials in an engineered structure to balance the physical and mechanical
performance of both the fabric geometry and the biomaterial itself.

in all varieties of stainless steel, cobalt

chromium alloys, and titanium based
on their mechanical properties and
historical use within certain parts of the
body. There are also other metals that
can be utilized for their radio opacity
properties that allow them to be seen
under a fluoroscope to provide for easy
placement during implantation.

New Material Possibilities

As biomaterial developers introduce
new product grades and enhancements,
additional material combinations will be
available to fit increasingly detailed design
parameters. Combinations of resorbable
and non-resorbable materials are being
used to control device properties over
time. Some textile components can now
be engineered from materials designed to
degrade at varying rates over varying time
periods; by synchronizing the modulation
of fabric absorption with tissue healing,
this multi-phased structural degradation
promotes a more biologic repair.
With biomedical textiles, off the
shelf solutions dont work very well.
Every device application is unique
and specialized. Identifying the most
appropriate biomaterial and biomaterial
supplier is essential for maximizing the
performance of the device function.
Likewise, the wide variety of therapeutic

areas and the mechanical and

physiologic characteristics desired for
the finished device must be used to
guide decisions about textile material
composition.
Because material selection intersects
the physical, chemical, and biological
sciences, a multi-disciplinary team
of engineers from each of these areas
should be involved when evaluating
the options, whether on the side of the
device manufacturer or the biomedical
textile manufacturer (or a combination
of both). Collaboration between the
device engineers and their textile
engineering counterparts early in the
development process is the most effective
way of identifying and securing material
selection options.
Selection of appropriate biomaterials
for use within devices benefits device
manufacturers in leveraging these
materials for their submission to the FDA
with less risk of delays in getting their
devices to market. The combination
of established and emerging substrates,
along with a carefully structured material
selection process, offers an effective path
toward enhancing the performance of a
finished device.
For more information, go to
http://secantmedical.com/
5

Back to TOC

Robotic Surgical
System Overcomes
Manual Limitations
Comprising numerous technologies, from 3-D visualization to high-quality
motors, the da Vinci surgical system is widely considered a breakthrough
platform for performing complex, minimally invasive surgery.
By Scott Hamilton, sales and applications engineer, Maxon Precision Motors,
and Trisha McDonell, National Instruments

aparoscopy is a surgical
approach in which long-shafted
instruments are inserted through
small incisions to access targeted
anatomy. Compared with traditional
open procedures, laparoscopy has
revolutionized surgical treatment by
shortening recovery time with less pain
and fewer adhesions, resulting in better
post-operative quality of life. However,
manual laparoscopy has several limitations,
including lack of depth perception,
poor camera control, limited degrees
of freedom for the instrument tips, and
inverted hand-instrument movements.
These limitations lead to unnatural and
painful surgical postures that result in
surgeon fatigue.
Robotic-assisted laparoscopy, such as
the da Vinci system, allows the surgeon
to sit at a stereo console and remotely
control endoscopic instruments via
a patient-side robot. The da Vinci
system consists of three components:
the surgeon console, a patient-side
cart that holds the instruments, and
the image processing equipment. The
systems 3-D visualization provides
depth perception, and the wrist-like
articulations of the miniaturized
6

instruments improve surgeons dexterity

and range-of-motion. The system also
improves control by reducing hand
tremor and providing motion scaling.
The ergonomic instrument-hand-eye
alignment and intuitive instrument
movement can also reduce surgeon
training time in comparison to using
manual laparoscopy.
The da Vinci system is based on
foundational robotic surgery technology
developed at SRI (formerly known as
Stanford Research Institute). Intuitive
Surgical later formed relationships
with IBM, Massachusetts Institute of
Technology, and Heartport Inc. to
further develop the system. The FDA has
cleared the da Vinci for a range of general,
thoracic, urological, gynecological, head
and neck, and cardiac procedures in both
adults and children.

da Vinci Explained
The da Vinci system requires up to five
small (<1 cm) incisions for insertion of the
two surgical manipulators and a camera.
The da Vinci patient-side cart holds the
instruments docked to the patient as surgical
assistants stand over the patient. Meanwhile,
the surgeon can operate the system while
seated across the room at the console,
where the look and feel of the open surgery
is replicated. The surgeon performs movements using masters (which help translate
surgery motions). The surgeons fingers
grasp the master controls below the display
with wrists naturally positioned relative to
his or her eyes. The surgeons movements
are then translated into precise, real-time
robotic movements inside the patient.
The robotic masters are controlled
by the surgeon through wrist, hand and
finger movements, just as with a typical

Sponsored by:

open surgery. A full range of optional

EndoWrist Instruments are also provided
for the system. These instruments are
designed with seven degrees of motion
that exceed the dexterity of the human
wrist. Each instrument has a specific
surgical mission such as clamping, suturing
and tissue manipulation.
The patient-side cart houses the two
robotic arms and one endoscope arm,
which duplicate the surgeons movements.
The laparoscopic arms pivot at the
operating port, eliminating the use of
the patients body wall for leverage, thus
minimizing tissue and nerve damage.
Supporting surgical team members install
the correct instruments, prepare the
port in the patient, and supervise the
laparoscopic arms and tools being used.

while an assistant surgeon moves the end

effectors into position. The motors exhibit
low hysteresis at the instrument tips.
Among the more than 30 motors used
by Intuitives engineers in the da Vinci
system, are the RE 25 motor, some with
and some without encoder feedback;
RE 13 mm motors equipped with GP
13 series gearheads and 13 mm magnetic
encoders; and RE 35 series motors with
third-party encoders.
Maxon motors are key to each da Vinci
system critical performance characteristic
tests, including friction, backlash and
compliance profiles, as well as a range of
sensor feedback monitoring, says Mike
Prindiville, manager, manufacturing
engineering for Intuitive Surgical.

Software-Based Training

Source: Intuitive Surgical

Actuation Design

Although the prevalence of robotic-assisted,

The da Vinci surgical system incorporates minimally invasive surgery has increased
high-end motion control technologies so tremendously, training opportunities remain
that every motion provides the smooth, relatively limited. Because comprehensive
accurate movements reminiscent of a skilled practice and experience is necessary in order
surgeon even at slow, calculated speeds. to develop proficiency with a sophisticated
Each da Vinci S HD System contains more tool such as the da Vinci system, the develthan 30 motors manufactured by Maxon opment of training aids for robotic surgery
Precision Motors. These motors are located is critical in helping meet the demand for
at the heart of each manipulator.
this technique.
The Maxon motors provide the inputs
At the Nebraska Biomechanics Core
and outputs to the da Vinci System.
Facility in the HPER Biomechanics
Through a series of feedback controls, the
Lab. at the University of Nebraska at
motors and encoders receive inputs from
Omaha, a group of Ph.D. students work
the surgeon, are translated in
with the Robotic Surgical
real-time through the console
Lab at the universitys medical
center to develop a computer
electronics, and provide output
signals to the motors in the
training program for robotic
manipulators. In turn, the
surgery where new surgeons
manipulators exert forces back
can learn how to use this
through the console electronics This endoscope
advanced technology.
instrument is used
Two training platforms have
to the surgeons hands.
with the da Vinci
Maxon motors are designed robotic surgical
been developed with National
with rare earth magnets in
Instruments LabVIEW
system.
their stators and incorporate
graphical programming
an ironless rotor design that eliminates
software. The first is designed for
magnetic cogging, even at slow
monitoring and recording a surgeons
operating speeds.
performance during a training program
The surgeons side cart employs motors and ensuring that the surgery is performed
referred to as masters to distinguish their
using the correct movements. This
dual role. The slave side, or manipulator
training platform also incorporates visual
motors, require the same precision, but
real-time feedback to show trainees how
also need to be able to be backdriven
much force they apply on the training task

Sponsored by:

Source: Intuitive Surgical

Back to TOC

The top image shows EndoWrist actuators

manipulating sutures. The bottom image
shows console masters handled by a surgeon
to direct EndoWrist actuators.

or animate tissue. This visual feedback

helps trainees reduce tissue damage
inflicted during the procedure.
LabVIEW was also used to create
a working environment for robotic
surgery training in virtual reality. This
second training platform offers flexibility
to conduct research by collecting data
and adjusting training tasks in the virtual
simulator via Ethernet. Virtual robotic
surgical training allows multiple surgeons to
train simultaneously using software instead
of actual medical equipment. This process
provides problem-based training protocols
for new surgeons to learn robotic surgery.
All of the data communications on
the da Vinci robotic surgical system is
acquired via TCP/IP using NIs USB6009 data acquisition board to connect
to the electromyography system and
electrogoniometers. These connections
acquire physiological measurements, such
as muscle activations and joint angles, from
the surgeons. Using this data, researchers
and medical personnel can objectively
evaluate surgical proficiency before and
after the robotic surgical training protocol.
For more information:
Intuitive Surgical: www.intuitivesurgical.com
Maxon Motors: www.maxonmotorusa.com
National Instruments: www.ni.com
7

AFE5807 and AFE5808

High-Performing Analog
Front Ends for Ultrasound

Texas Instruments brings velocity

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SPI Logic

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16 Phases
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16 x 8
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1X CLK

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The two new devices complete TIs

power management solutions allowing

AFE58xx analog front end family for

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of embedded processors, analog and

Ultrasound system block diagram

Integrated HV Pulser

149 mW/Ch, 65 MSPS and a

OR
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AC/DC Supply
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Common Interfaces
IDE/ATA

Backlight
Touchscreen

LEGEND
Product Availability and Design Disclaimer - The system block diagram depicted above and the devices recommended are designed in this
manner as a reference. Please contact your local TI sales office or distributor for system design specifics and product availability.

www.ti.com/ultrasound

Processor
Interface
RF/IF
Amplifier

Logic
Power
ADC/DAC
Clocks
Other

Tools, availability and packaging

The AFE5807 and AFE5808 are
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Find out more about TIs ultrasound

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Click here to view more videos in our Medical Media Gallery.

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The AFE58xx family includes the
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join a full portfolio of embedded
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Key Features

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122

101

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@ 40 MSPS
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0.85

1.23

5.5

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8*10

8*10

N/A

N/A

Back to TOC

Bal Seal to Launch First

Contact System with
Integrated Isolation Seals
Company announces plans to launch the worlds rst integrated
seal and electrical contact system for active implantable devices.
Courtesy of Bal Seal Engineering Inc.

al Seal Engineering Inc. has

confirmed it has set a date of
Oct. 13, 2010 for the official
rollout of its SYGNUS Implantable
Contact System, which combines
electrical contacts and isolation seals in
a standardized, platform-ready stack
configuration to provide a turnkey
connecting solution for implantable
devices used in cardiac rhythm
management, neuromodulation and
neuro-sensing therapies.
According to Bal Seal, the new
SYGNUS system pairs the companys
Bal Conn electrical contact
technology with pre-tested silicone
seals, resulting in an all-inclusive
package engineered to help large and
small device OEMs improve speed

Active
Implantable
unit courtesy
of CCC
Medical
Devices

to market and eliminate the need for

procurement and testing of individual
components.
Bal Seal says the number of
contacts and seals in the SYGNUS
system will be configurable to
meet unique application and
industry requirements, such as the
IS-4 standard for cardiac health
management devices. The Cantedcoil spring contact design will offer

Company URL Sponsored by Company name

multi-point conductivity and low

insertion force, and will compensate
for surface irregularity. The systems
silicone seals will provide dielectric
isolation, and the combined stack will
offer resistance to potential fatigue
caused by multiple lead insertion
cycles. Contacts in the stack will be
force and resistance tested, and sealing
components will be packaged to
critical clean standards.
13

Back to TOC

Low Power Piezo Motion

Reduced-voltage piezo motor breakthrough creates options for medical devices.
By Al Presher, Contributing Editor, Automation and Controls

applications, says Ralph Weber,

product manager for New Scale. Even
though their previous systems and ASIC
could run on a 3.3-V input, Weber
says that the boost circuits to produce
the higher input voltage required by all
piezoelectric motors can scare designers.
This is a breakthrough because
using multi-layer ceramic technology,
the system doesnt need 40 volts to
operate, he says. There is no aspect
of the system which is high voltage
anymore, and our approach also enables
the drive chip and control circuitry to
be reduced to very small sizes.

Piezoelectric micro motors are small

enough for use in portable, handheld
and implantable medical devices.
The technology allows engineers
to add motion where traditional
electromagnetic motors would be
impractical due to size and power
limitations. Applications include
positioning devices that can be adjusted
after being implanted and robotic
surgical tools. Special non-magnetic
versions can also be designed to operate
near MRI equipment without affecting
image quality or motor performance.
Piezoelectric materials produce a

Source: New Scale Technologies

ramatic reductions in voltage

and power requirements are
making tiny piezo motors and
drive systems an interesting option for
portable, low-power medical devices.
By eliminating the need for the high
voltage normally associated with piezo
systems, a new piezo motor design
from New Scale Technologies enables
miniature motion systems that operate
on a single 3-V battery without using
voltage boost circuits.
Normally piezo technology
requires input of 40 volts or more,
which is a concern especially in medical

With New Scales M3 linear MicroMechatronics Module design platform, a board-mounted SQUIGGLE RV micro motor is placed on a printed
circuit board with a position sensor, drive ASIC and microprocessor. This base design can be customized for each OEMs mechanical
conguration and electrical interface (i.e. SPI, I2C).

14

Sponsored by:

stress or strain when electrically excited,

yielding a few micrometers of motion
with very low force. Piezoelectric
motor designs harness ultrasonic
vibrations of these actuators with a
mechanical coupling to produce many
millimeters of travel and high force,
while retaining the benefit of submicrometer resolution.
Weber says the smallest
commercially available piezo motor is
New Scales SQUIGGLE micro motor,
a linear motor measuring less than 2.8
x 2.8 x 6 mm. Using a patented design,
four piezoelectric plates are bonded to
the sides of a rectangular tube which
is threaded on the inside. A two-phase
drive voltage applied to the plates causes
the nut to vibrate in an orbital motion
at its resonant (ultrasonic) frequency.
Friction engages the threaded screw
and drives it forward. Reversing the
phase reverses the screw direction. The
micro motor produces a smooth linear
motion with no gears. Weighing only
0.16 gm, it can produce up to 50 gm of
force, a variable speed of up to several
millimeters per second and a position
resolution of 0.5 micrometer.
Like most piezo motors, Weber
says the first SQUIGGLE motors
employed hard PZT ceramic plates to
minimize dielectric losses and associated
temperature rise. Unfortunately this
material requires an applied voltage of
around 40V, requiring boost circuits
in battery-powered applications.
A breakthrough in PZT ceramic
production has reduced this voltage
requirement to 2.8V, making these
tiny piezo motors even more appealing
to designers of portable and handheld
medical devices.
To achieve this breakthrough, New
Scale collaborated with TDK-EPC
on an advanced multi-layer piezo
ceramic plate. The patent-pending
plate is a co-fired assembly consisting
of many thin layers of hard piezo
ceramic, and each layer is less than 15
micrometers thick.
The new plate design has enabled

Sponsored by:

the introduction of a new, reducedvoltage SQUIGGLE RV micro motor,

which operates directly from a battery
at less than 2.8V without boost circuits.
Weber says this milestone is significant
because it is the first piezoelectric motor
to match the voltage requirements of
traditional electromagnetic voice coil,
dc and stepper motors. It removes
the perception of risk associated with
higher-voltage boost circuits and
interconnections, and also enables
radically smaller drive electronics by
eliminating the need for boost circuits
in the drive ASIC, as well as external
inductors, capacitors and diodes.
Additional power-saving technology
designed into the new drive ASIC for
the SQUIGGLE RV produces the
ultrasonic voltage signals that drive the
motor. The NSD-2101 drive IC was
developed in conjunction with New
Scales partner, austriamicrosystems.
It incorporates patent-pending smart
drive technology that monitors motor
performance and adjusts the ultrasonic
drive frequency to lock on to the
mechanical resonant frequency of the motor.
Because of the motors self-locking
design, no power is needed to hold the
motor position. A practical application
is for periodic adjustment of an
implanted device because the motor can
be powered on to make the adjustment
and then switched off entirely, drawing
no battery power until the next
adjustment is needed.
The voltage reduction and the
corresponding shrinking of the drive
electronics enable a new class of
integrated micro motion modules.
The M3 (Micro-Mechatronic
Module) design platform combines
a SQUIGGLE RV motor, a position
sensor, the drive ASIC and a
microprocessor in a miniature, closedloop motion assembly.
A TRACKER position sensor
provides closed-loop feedback with
resolution of 0.5 micrometers and
repeatability of 2 micrometers. The
onboard microprocessor provides PID

Source: New Scale Technologies

Back to TOC

Shown above is a breakdown of New Scales

M3 linear MicroMechatronics Module design
platform (shown in photo at left). This base
design can be customized for each OEMs
mechanical conguration and input interface.

control in the module. Input to the

module can be configured for I2C,
SPI or USART, and simple, serial
communications from a PC or master
microprocessor can command this
miniature advanced motion control
system.
The mechanical assembly and
housing are customized to OEM
specifications. The reference design
contains all components and control
electronics in a compact 12- x 30- x
8-mm package, with an actuator arm
that travels up to 6 mm to push an
external load.
Another reference design incorporates
these advanced M3 platform controls
into a miniature lens module, creating
precise autofocus capabilities in a package
only slightly larger than the lens holder
for board-mounted camera systems.
Using this platform, modules can be
developed for nearly any configuration
or application. They can also be sealed
for use in high-moisture applications or
implantable devices. O
For more information, go to
http://www.newscaletech.com/
15

Innovate faster in medical

With its full range of analog and
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www.ti.com/medical

leading product traceability

TI ICs, system block diagrams,

application notes, tools and more
s

Click on a medical application to view its fully interactive system block diagram.

Consumer medical

Medical imaging

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www.ti.com/consumermedical.
Core Portable Medical System
(Processor, Memory, Display, Keypad, Power,
Battery Management)

HV
MUX

Zigbee

T/R
Switches

Bluetooth

Precision
Reference
Instrumentation
trumentat
A
AMP

Low Power Wireless

LCD
Controller

Transmit
Beamformer

Time Gain
Control

REF

Analog Front End

Back End Processing

Passive RF

Ultrasound Processing and UI

Flash/EEProm

Transducer

Buffer
Buffe
AMP
ADC

USB
Controller

Controller

Transient
Protection

Signal Chain
Power

Wired Data
Transmission

Temp
Sense

Core and
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Power

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Preprocessing
Spectral
Doppler
Processing

Clock

AFE Power

Keypad

LED
Driver

Controller
and
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Beamformer
Control Unit
and
Receiver
Beamformer

DAC

Front End Processing

Wireless Data
Transmission or
Sensor Access

Bio Sensors
MSP430

Card Slot
For system
Calibration

Current Limit Switch

Lithium
Battery
Protection

Fuel
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Plug
~
AC Line

AC
Adaptor

Lithium Battery
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Battery
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Fuel
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B
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MMC/SDIO
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LEGEND

(optional)

Processor
Interface
RF/IF
Amplifier

Product Availability and Design Disclaimer - The system block diagram depicted above and the devices recommended are designed in this manner
as a reference. Please contact your local TI sales office or distributor for system design specifics and product availability.

Logic
Power
ADC/DAC
Clocks
Other

Common Interfaces
Product Availability and Design Disclaimer - The system block diagram depicted above and the devices recommended are designed
in this manner as a reference. Please contact your local TI sales office or distributor for system design specifics and product availability.

Portable Medical Meters system block diagram

Portable ultrasound system block diagram

Diagnostic, patient monitoring

Medical instruments

and therapy

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www.ti.com/medicalinstruments.
Biopsy Tool
Control Head

Backlight

Lens, Imager and

Optional Biopsy Tool

Touch Screen Control

Low Pass
(DC)
Filter

ADC
Display
Driver

System Connection Cable

Wireless:
Zigbee
Bluetooth

Need is dependent on length of scope tube and whether

AFE is in the imagining end or processing end of the scope.
Analog Video
deo Out

ADC

Summer
(resistive)

Clock

Wired:
USB
RS232

CCD/CMOS
Sensor
Lens

Pace Detection
Temp Sense
Lead Off Detection

Core
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Low Noise Power

Green
Mode
Control

Battery
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DDR
Power

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Line
Drivers

Imager
Power

Low Noise
Power Rails

REF

Clock

LED
Drivers

System Power

Logic

Core and
I/O Power

Light
Source

Memory
Power
LEGEND

Product Availability and Design Disclaimer - The system block diagram depicted above and the devices recommended are designed in this manner
as a reference. Please contact your local TI sales office or distributor for system design specifics and product availability.

www.ti.com/medical

Interfaces to Display

Video
Processing
Engine

HDMI
DVI

RS232
RS485
Ethernet

Level Shift

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Plug

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FLASH/
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Signal
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FLASH
EPROM

Mux

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SDRAM

Input
Buffer

Endoscope
Electronics Head

LCD

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Endoscopes system block diagram

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RF/IF
Amplifier

Logic
Power
ADC/DAC
Clocks
Other

> Subscribe at
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Back to TOC

Anatomy of a Life Saver

Inventor Larry Miller overcame technical issues, patent problems and institutional
resistance in the course of creating a successful medical product
By Charles J. Murray, Senior Technical Editor, Electronics

o one knows how many lives

Larry Millers drill has saved.
Tens of thousands for sure.
Maybe hundreds of thousands.
But from the first day Miller conjured
up the vision for his medical product
while attending a standing-room-only
funeral in Texas seven years ago, the
path to success has never been easy.
By most accounts, it should have
been a slam-dunk. Miller, an emergency
room physician, had an eminently
logical idea: To restore fluids in patients
who have lost massive amounts of blood
during life-threatening emergencies, he
wanted to use the bodys bones. Bones,
it seems, transport blood to the heart
quickly, just as our veins and arteries
do. The difference is that bones dont
collapse when blood pressure plummets.
The vision was, There are
thousands of people who are dying
because we cant get into their veins,
Miller recalls. So I said, If we can
develop a needle and a mechanism to
get into their bones, it would save lives
and be a big hit.
In retrospect, Millers vision was
dead-on. Since he launched Vidacare
Corp. in 2001, the company has shipped
more than a half-million needle sets
and treated more than 350,000 patients
with its hand-operated bone drill.
Approximately half the ambulances in the
U.S. now employ the technology. In a
few years, the companys annual revenues
have climbed to more than $20 million.
Moreover, Vidacare has moved into a
new medical arena by launching a drill
that takes much of the pain out of bone
biopsies for cancer patients.
18

For engineers, though, the real story

of Millers success is one of persistence.
During the past seven years, Millers
product has become a monument to the
kind of staying power thats needed by
every would-be inventor. In the course
of achieving success, Miller tried nail
guns and drills, worked with thousands
of cadaver bones, tested more than 100
needle tip designs, struggled with patent
problems, hunted for funding and battled
institutional indifference, before finally
realizing some measure of success.
It was astronomically difficult
getting this accepted, says Scotty
Bolleter, a flight paramedic for San
Antonio AirLife and a nationally known
educator familiar with the technology.
Its always very, very difficult gaining
acceptance in the medical industry, and
this technology was no exception.

Tragic Inspiration
Millers journey began after a friend
and paramedic, Nick Davila, died in
an auto accident. At the scene of the
crash, ground paramedics tried desperately to start intravenous (IV) fluids,
sticking Davila unsuccessfully nearly 20
times before he fell into cardiac arrest.
Although paramedics say Davilas death
a few minutes later was not caused
by the lack of an IV, the emotional
trauma of the event planted the seeds
of an idea in Millers mind. He was
determined to find a more reliable way
of administering fluids.
It was a moment of truth for
Miller, largely because he understood
from previous experience the value of
using bones as a conduit for fluids. A

decade earlier, Miller tried to launch

a product called Osteoport that
administered cancer drugs through a
connection to the hip bone or tibia.
Although the company never took
off, the experience served as a lesson.
Thats when I first learned about
the capability of bone marrow to
transfer drugs and fluids, Miller says.
Indeed, his experience with
Osteoport gave Miller a unique
perspective, especially in light of his
30-plus years as an emergency room
physician. After years at Chicagos
Cook County Hospital he had seen
victims of virtually every imaginable
illness, accident and violent crime, and
had struggled countless times to stick
IVs into patients whose traumas had
caused their veins to collapse.
Thats where Millers idea came into
play. Although bones had rarely been
used to transport fluids, emergency
medical technicians and physicians
knew that they could do the job.
Coming out of the bone, you find
veins, running into bigger and bigger
veins, says flight paramedic Bolleter. Its
a dynamic flow. I can measure it with a
pressure transducer. I can hook up a bone
and show you the blood pressure inside it.
Within days of Davilas funeral,
Miller hooked up with biomechanical
engineers in the prototype lab at the
University of Texas Health Science
Center at San Antonio. There, he
began work on the sticky problem of
finding a mechanism to deliver fluids to
the center of a bone.
We got cadaver bones and started
trying different things, Miller recalls.

Sponsored by:

Back to TOC
We shot the bones with a nail gun. That
seemed to be a good idea until one of the
engineers shot himself in the finger.
Miller subsequently began working
with drills, but learned that when he
pulled the drills out of the bone, he
couldnt locate the hole for the IV. He
tried putting funnels into the bones, but
that didnt work either.
After more than a year of research,
a solution emerged. Growing up
in Ypsilanti, MI, as the son of an
automotive engineer, Miller had been
exposed to manufacturing technology.
Eventually, his memories from those
days kicked in. I woke up one night
and had the answer, he says. I
remembered my dad had a tiny, hollow,
oil-cooled drill. I figured we could use
that kind of drill and hook an IV to it.
The hollow drill worked because it
provided an avenue for fluid travel. Miller
could now keep the drill tip engaged in
the hole, while connecting the IV to it.
As the design evolved, Miller
applied for a patent. But here, obstacles
appeared. Earlier searches for so-called
intraosseous infusion products
(products that inject fluids into bone
marrow) had yielded nothing. But
after countless hours of research, patent
attorneys told Miller that there was
another such product that hadnt been
noticed previously because it spelled
intraosseous with a dash (intra-osseous)
and had therefore evaded earlier
computer searches.
When I saw that, I said, No one
will ever invest in us now, Miller
says. Worse, the patent was about to
expire for lack of payment because the
owner had given up on the idea.
Still, Miller wasnt ready to quit.
He tracked down the patents owner,
a retired pediatric emergency doctor
in Detroit, and traveled to Michigan
to visit him. I said, We dont have
money but I need your patent and
I can give you some shares in our
company. So the patent became ours.

Rening the Design

With the patent reinstated in his name,
Miller started looking for funding. But

Sponsored by:

potential investors were dubious.

I took it around to investors and
told people I had this little device that
looked like a Dremel drill, Miller says.
I showed them the hollow needle and
demonstrated how you could hook
an IV to it. But it was too crude. The
investors looked at me and said, A
Dremel drill wont work for this.
Miller still wasnt giving up, though.
Deciding he needed a more refined
prototype, Miller traveled to a medical
design show in Anaheim, CA and
searched for engineering contract firms
that could build one for him. He found
five companies, mailed out requests for
bids, and waited.
One company in Colorado wanted
$80,000 and six months to complete
it, another wanted $40,000 and three
months, a third just wanted to do the
CAD drawings, he recalls. Finally,
a fourth one BC Tech in Santa
Cruz, California called and said they
wanted $14,000 and told me they could
do it in two weeks.
Miller chose BC Techs bid and, sure
enough, had a prototype in hand two
weeks later. With the refined prototype,
which was about the size of a glue
gun and powered by a 9-V battery, he
began to attract investors.
At that point, though, the real
engineering was just beginning. Miller,
now teaming with a design engineer
and a quality engineer, soon realized
his product needed more power to go
though bone more efficiently. Over
the course of the next year, Miller
and the engineering team tried more
than 100 different types of needle tips.
They learned that minor changes in
pitch as little as 3 degrees could
dramatically affect the torque, as well
as the time it took to reach the center
of a bone. They tried various hollow
tips, including twist drill tips and
paddle tips, along with different shapes,
angles and materials, including 316 and
304 stainless steels. Ultimately, they
settled on a uniquely shaped, hollow
304 stainless-steel tip manufactured
by K-Tube Corp., machined in the
U.S. then sent outside the country for

injection molding of two pieces of the

attached hub.
In concert with the needle design,
Vidacare engineers also developed the
drills electromechanical driver. The
company wont provide names of
vendors or the details of the design, but
Miller does say that engineers selected a
30,000-rpm off-the-shelf electric motor
and linked it to a planetary gearbox to
reduce the speed to about 1,200 rpm.
The speed reduction prevents it from
getting bogged down and stalling as it
bores through a patients bone.
We had to have a certain amount
of torque and a certain amount of speed
to make this drill work, says Bob
Titkemeyer, senior director of quality
assurance and regulator affairs for Vidacare.
The FDA, however, was not impressed
by any kind of motor-gearbox. They
told us it was dangerous to put a needle
into bone using a powered device, Miller
says. We had to do studies showing it
was actually safer using power.
After FDA approval in 2004,
there was still skepticism. Many in
the medical community insisted
that drilling would cause infection.
Immediately after FDA approval, we
conducted a study on our first 250
patients, and it worked like a charm,
Miller says. It had a 97 percent success
rate, saved lives, and had no infections
and no complications.

Growth Potential
In 2005, the medical world began to see
the wisdom in Millers device, which
by that time had been dubbed EZ-IO
Intraosseous Infusion System.
There were some early adopters
people who got it immediately,
Bolleter says. Since that time, some
of the most prominent physicians
and nurses in the country have rallied
behind it and written articles about it.
But it went slow at first.
In 2008, EZ-IO won The Wall Street
Journals Gold Technology Innovation
Award and during the first half of 2009,
revenues jumped 30 percent over the
previous year. Sales of the device also
recently topped the 500,000 mark.
19

Back to TOC

Noise Reduction in Home

Health Care Product Design
While not necessarily a barrier to FDA approval, noise created by home health
care devices is nonetheless an important design consideration that should
not be overlooked in the design and manufacturing process.
By Gladys Unger, Ph.D., noise and vibration control specialist, Acentech Inc.

20

This photo shows how a CPAP system ts on the user, as well as the proximity of the base unit
to the user, underscoring the need for quiet system operation.

wearing a mask to bed and the noise

the unit makes. Noise complaints can
simply take the form of too loud, but
they can also involve the quality of the
sound. When noise is present, hissing,
whining, clicking or tonal sounds are
readily apparent and disconcerting to
the listener, especially since the device
is typically placed on a bedside table in
an otherwise quiet environment.

CPAP noise is a combination of air

flow and motor noise. With another
sleep apnea device, known as BiPAP
units (Bilevel Positive Airway Pressure),
valve clicking can also be audible.
These noise sources can be minimized
and the quality of the overall sound
enhanced; however, these goals are best
accomplished by including noise as a
priority during the design process.

Sponsored by:

Source: American Sleep Apnea Assn.

edical devices are allowing

patients to live longer,
healthier lives, and remain
in their homes when theyre ill. But
noise from medical devices is one
complaint often cited by patients.
Noise, then, can be viewed as a
product defect, albeit not one that the
Food & Drug Administration (FDA)
would recognize.
Among the growing list of
home health care medical devices
increasingly coming to market, CPAP
(Continuous Positive Airway Pressure)
units a fairly simple device used
to treat sleep apnea are becoming
more and more common. Sleep apnea
is a condition in which the individual
fails to get enough oxygen while
asleep. The CPAP unit is profiled
in this article to illustrate how and
when medical product designers and
manufacturers should consider noise in
the design process. Devices to control
sleep apnea, such as the CPAP, use
a hose and mask to deliver pressure
to the respiratory tract, thereby
preventing oxygen deprivation.
As much as the snoring associated
with sleep apnea might annoy a spouse,
CPAP devices are also a source of
complaints. The two biggest objections
are the discomfort or claustrophobia of

Back to TOC
35

Targeting the Source

Source noise can have various exciting

mechanisms including electrical excitation
and mechanical components. DC brushless motors, reputed to be very quiet, can
create noise due to poor bearing tolerances and from non-uniformities in their
rotation created by the electrical excitation
waveform that drives the motor. The fan
itself must be selected so it operates near
its point of maximum static efficiency.
The fan impeller and shroud, unless carefully designed, can cause pulsations at the
rotation frequency and especially at the
blade passage rate. Blades themselves have
structural resonances that can be excited

Sponsored by:

25

20

15

10

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

Frequency (Hz)
All Sources
All Surfaces Except Bottom + Outlet Noise + Inlet Noise
All Surfaces Except Bottom + Outlet Noise

All Surfaces Except Bottom

All Sources Eliminated

Contributions of individual sources to the overall sound level produced by a CPAP unit.

by the interaction of air moving across

their surfaces.
The airborne and structure-borne
transmission paths must be considered
separately. In designing the airflow path,
a balance is needed between a circuitous
path that hinders sound from leaving the
unit, and a path of low resistance that
allows the fan to operate at a slow speed.
The flow ducts can be lined with FDAapproved sound-absorbing foam, but in
order to be effective, the foam will, by
necessity, occupy a substantial portion
of the interior volume. In some medical
devices, designers have set aside a small
piece of real estate on the device where an
inlet or outlet silencer can be incorporated,
should a reduction in noise through the
flow path be found to be beneficial once a
prototype is built and tested.
In comparison with the flow path,
the transmission of vibration through
the structure can be much more difficult
to control, particularly as the market
pushes medical devices to be smaller and
lighter. In a unit such as a CPAP device,
the motor and fan will have little mass,
making isolation at lower frequencies

(for example 60 Hz) difficult, due to

the required softness of the supporting
isolators. Lightweight structures often
lack stiff attachments points, which are
needed to design an effective isolator.
Structural ribbing at mounting locations
can be used to stiffen attachments points,
and new moldable foams can provide
a distributed spring which makes local
housing stiffness less important.
When noise reduction is examined
according to its various elements
noise source, transmission path and
radiating surface it becomes clear that
factoring these into the design process in
its early stages offers the best opportunity
to produce a quiet product. Acoustical
noise and vibration consultants can
assist designers and manufacturers with
noise reduction on a finished product;
however, after the design is complete
and the unit has gone into production,
the noise control options become much
more limited. O
For more information, go to
http://www.acentech.com/experience/
healthcare.html
21

Source: Acentech Inc.

Understanding the Cause

30

Lp( (dbA re20 uPa)

Good practices exist for designing both

quiet products and products with superior
sound quality. A simplified approach is
to picture noise as a combination of a
source mechanism, a transmission path
and one or more surfaces radiating sound.
A typical CPAP device contains a motor,
a fan, a flow path within the unit, a hose
and a mask fitted to the patients face.
The sources in this case are the motor and
the fan, both of which can create noise
and vibration. Two transmission paths
exist: an airborne path, in which noise is
created by pressure fluctuations in the air
itself, and a structure-borne path, whereby
vibration forces from the motor and/or
fan excite vibration at the mounting location. Vibrating surfaces can then radiate
noise like small loudspeakers. Radiating
surfaces are most likely the flat outer
panels that are good radiators of sound,
excited by the vibration traveling from the
mounting juncture.
For BiPAP units, impacts from the
valves follow a similar vibratory path
through the structure. The operation
of the valves can also produce airborne
noise directly. In both types of devices,
exhalation air near the mask can be
a source of continuous noise, while
an ill-fitting mask can cause short
duration noise bursts as the air pressure
momentarily lifts the mask from the
face, creating a small opening similar to
releasing air from the neck of a balloon.

Back to TOC

New Elastomers
Target PVC in
Medical Applications
Exposure to phthalate plasticizers raises concerns

everal new medical grades of

plastics are directly targeting
flexible PVC, which has been
criticized for potential health risks.
Companies introducing new
thermoplastic elastomers aimed at
medical vinyl applications, such as IV
bags, include DuPont, PolyOne and
Teknor Apex. The new materials
were introduced at Medical Design
& Manufacturing West, Anaheim
Convention Center, Anaheim, CA.
DuPont Hytrel thermoplastic
polyester elastomer is a versatile
engineering material with potentially
significant advantages in performance
and part costs over alternative flexible
materials, including plasticized PVC,
conventional rubbers and several other
TPEs (thermoplastic elastomers), says
John Gavenonis, global health care
manager DuPont Performance
Polymers. Potential uses for the DuPont
material include soft-touch/grip surfaces,
valves, seals, springs, shock absorbers,
tubing and noise management parts for
medical products and pharmaceutical
equipment.
PolyOnes NEU Specialty
Engineered Materials LLC subsidiary is
offering GLS Versaflex grades that are
said to feature excellent clarity, flexibility
and non-plasticized formulations
22

Medalist MD-500 Series

with exceptionally
products outperform traditional
low leachables and
PVC-alternative technologies
extractables for
by mirroring many of the
enhanced patient safety.
performance and handling
PolyOne is also offering
characteristics of flexible PVC
non-phthalate flexible
tubing compounds, while
Geon HC vinyl
providing distinct advantages
compounds.
in some key capabilities, says
We use a
Elliott Pritikin, new business
collaborative approach
development specialist.
to help customers
Medalist MD-500 Series
reduce the risk inherent
elastomers have been tested
in product design,
Medalist MD-500 Series
for compliance with ISO
material selection
products are said to
10993-5 cytotoxicity standards
and manufacturing
outperform traditional PVCand are free of animal-derived
start-up, which in turn alternative technologies
for applications such as
materials, phthalates, latex,
speeds time to market
medical tubing.
silicones and additives not
and ultimately, drives
directly required for medical
marketplace success,
applications. Standard formulations
says Larry Johnson, global healthcare
include five grades, with Shore A hardness
marketing director for PolyOne.
(15 sec) ranging from 53 to 86.
Teknor Apex says its new Medalist
Some suppliers consider the
MD-500 Series compounds exhibit
composition of their new elastomers
crystal clarity and mechanical properties
to be proprietary, and describe them as
comparable to those of PVC; provide
using a broad range of chemistries.
similar clamp resilience and resistance
The European Unions Scientific
to kinking and necking; have a PVCCommittee on Emerging and Newly
like feel; and are substantially more
Identified Health issued a report in 2008
flexible and significantly less dense. A
stating that some medical procedures may
typical compound in the series, Medalist
create significant exposure to DEHP-type
MD-575, exhibits 70 percent less heatplasticizer used in PVC compounds to
aged color shift than a gamma-stabilized
PVC compound of comparable hardness. make them more flexible.

Sponsored by:

Source: Teknor Apex

By Doug Smock, Contributing Editor, Materials and Fastening

Medical Applications Guides

Our Medical Applications Guide helps you get your medical equipment design to market faster with system block diagrams
for a broad range of medical electronics, component selection tables, device details and information about development
tools and evaluation modules. Download the one that best ts your needs at www.ti.com/medicalguides.
Medical Applications Guide
This is the full version including individual chapters for Consumer Medical, Diagnostic, Patient
Monitoring and Therapy, Medical Imaging and Medical Instruments, which can also be
downloaded individually.

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Features technical and product information for a variety of patient monitoring, diagnostic and
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Features system block diagrams, key device details and selection tables for a variety of medical
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Features technical and product information from a variety of clinical applications such as blood
analysis, endoscopes, robotics, prosthetics and confocal microscopy.

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