Literature Thesis About Problems in Colonos

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TU Delft BioMechanical Engineering
Advancing the Colonoscope - A.J. Loeve
Literature Thesis
BME MR1009
Advancing the Colonoscope

An analysis on insertion problems and pain in conventional colonoscopy and a patent study on alternative colonoscopic devices.
By:
A.J. Loeve BSc
Student number: Master number: Department: E-mail: Address:
WB1048589 MR1009 Section BioMechanical Engineering Faculty Mechanical Engineering Delft University of Technology A.J.Loeve@student.TUDelft.nl Langesteeg 7 3371 BZ Hardinxveld-Giessendam The Netherlands
Preface
This thesis handles a literature study, in vitro demonstrations and thought experiments on the insertion problems occurring in colonoscopy, patent research on possible solutions and the design of an experimental set-up to test colonoscopic devices on animal colons. All drawings without reference have been drawn by the author, who therefore claims all rights on these drawings. When referring to the author in this thesis, signatory is meant unless stated otherwise. Readers with special interest in insertion techniques in colonoscopy, found in medical literature, are being referred to Chapter 2. In Chapter 3 a technical analysis is given about the causes of insertion problems and pain during conventional colonoscopy. Those who would like to read more about the state of the art in colonoscopic devices are being referred to Chapter 4. The description of the literature assignment belonging to this thesis can be found in Appendix A. I owe special thanks to my tutor Dr. Ir. Paul Breedveld for his guidance during my study, Dr. Paul Fockens and Dr. Jeanin van Hooft of the Amsterdam Medical Centre for their enthusiastic help and discussions on clinical matters and Dr. Gert-Jan Kleinrensink of the Erasmus Medical Centre who made it possible for me to perform an anatomical study on human cadavers and accompanied me very enthusiastically. I would also like to thank everyone who, even in the smallest things, helped me to get to these results, either by providing concrete matters or by giving support, discussions or motivation. Delft, June 2005 Arjo Loeve
Abstract
Since 1970 inspection of the human colon to screen for abnormalities of diseases is being done with a colonoscope. This device consists of a flexible tube with a controllable tip that is inserted via the anus into the colon. The device contains a camera, light source and working channels. Using this instrument is hard to learn and stays difficult even after a lot of experience. It also causes pain to the patient because the colon and its attachments are often stretched during insertion. There are some alternatives to this conventional method but these all have their limitations, making the conventional colonoscope still indispensable. The insertion problems that occur in colonoscopy with the conventional colonoscopes have been analysed by the author and four main problem areas have been identified: The S-shaped sigmoid colon; fixed at both ends The U-shaped splenic flexure; suspended in the curve and fixed at one end The flattened-U-shaped transverse colon; suspended on both ends The U-shaped hepatic flexure; suspended in the curve and fixed at one end
Combining the medical perspective, the technical analysis and in vitro demonstrations, it became clear that the sigmoid colon is the most important area. If the colonoscope can be easily advanced through the sigmoid colon and recurrent looping can be prevented, the rest of the trajectory will be easier to advance through and in most cases will cause less insertion problems unless some anatomical abnormalities are present. Insertion problems and deformation mechanisms of the colon in the main problem areas have been described. During insertion of a colonoscope four deformation types occur: Ligament stretching Transversal stretching of the colon Longitudinal stretching of the colon Peritoneum stretching
Longitudinal stretching occurs the most during the formation of bends in the colon. More research should be performed to find quantitative relations between force distributions, stretching and pain. But it is clear that each stretching type occurs during conventional colonoscopy and could thus cause pain. Four directions to solutions to the causes of insertion problems and pain have been proposed by the author and are combined and listed below: Minimizing the necessity to inflate or make inflation better controllable. Making the scope follow the shape the colon easier. Making the colon provide better guidance to the scope. Preventing the scope from excessive pushing against the colonic wall.
To find out whether there already are devices that comply with the four directions to solutions, stated by the author, a patent study on alternative colonoscopic devices has been done. For this, al interesting new devices have been categorized into two main areas: shape-memory mechanisms and self-propelling mechanisms. Many promising devices have been found but a complete alternative to nowadays colonoscopy has not yet been found.
Table of contents
Preface.....................................................................................................................................3 Abstract ...................................................................................................................................7 1 2 Introduction ....................................................................................................................11 Medical perspective on current problems ...................................................................15
2.1 2.2 Insertion ....................................................................................................................... 15 Pain............................................................................................................................... 20 Introduction ................................................................................................................. 21 Simplified representation ........................................................................................... 21
3.2.1 3.2.2 Colonoscope.................................................................................................................... 21 Colon ............................................................................................................................... 22 Sigmoid colon .................................................................................................................. 25 Splenic flexure ................................................................................................................. 32 Transverse colon ............................................................................................................. 33 Hepatic flexure................................................................................................................. 34 Problems caused by abnormal anatomies ...................................................................... 34 Conclusion ....................................................................................................................... 38
Technical perspective on current problems ................................................................21

3.1 3.2
3.3
Main insertion problems in normal anatomy............................................................ 24

3.3.1 3.3.2 3.3.3 3.3.4 3.3.5 3.3.6
3.4 3.5
Pain............................................................................................................................... 39 Discussion ................................................................................................................... 43 Shape-memory mechanisms ..................................................................................... 47

4.1.1 4.1.2 Passive shape guidance.................................................................................................. 47 Active shape control ........................................................................................................ 50 Clamp/slide locomotion ................................................................................................... 51 Peristaltic locomotion....................................................................................................... 56 Rolling locomotion ........................................................................................................... 57
State of the art in invasive colonoscopy......................................................................45

4.1
4.2
Self-propelling mechanisms ...................................................................................... 51

4.2.1 4.2.2 4.2.3
Conclusions....................................................................................................................61
References ............................................................................................................................63 Appendix A: Assignment literature thesis .........................................................................67 Appendix B: Design of an experimental set-up .................................................................69
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Introduction
Since the beginning of the 19th century, many attempts have been made to inspect the hollow organs of mans body. During that century, and particularly the next, many inventions and improvements were made. This eventually led to the development of safe high quality instruments that make it possible to visualise most of the gastro intestinal tract (see Figure 1.1 for an anatomical scheme of the gastro intestinal tract). For the diagnostics and therapeutics in the colon, a push enteroscope for the colon, the colonoscope, is the most used instrument. Only for large therapeutic interventions, emergencies and some delicate operations, more invasive methods like laparascopic surgery or even open surgery are being applied. The colonoscope actually came forth from the esophagoscopes (used to look into the esophagus). A timeline of the development from stiff esophagoscopes to the current high-tech electronic video colonoscopes is given in the form of an illustrated timeline in Figure 1.3 (A3 size inlay). [Classen et al.,2002, Ch.1, Ch.14 ]
Fig. 1.1: Anatomy of the human gastrointestinal tract. (Adopted from [www.merck.com, 2005], edited by the author)
Fig. 1.2: Human Anatomical positon and medical terms for directions. (Adopted from [van der Helm, 2003])
Nowadays, colonoscopes are used to examine the rectum, colon and ileum in order to screen for diseases and abnormalities and to treat them. For this examination, the patients colon has to be clean. Therefore, the patient has to drink several litres of laxative in the preceding 24 hours, receive a gut washing, or a combination of both. To make the patient more comfortable and cooperative, a light sedation can be used. This makes the patient a little drowsy but still able to react. The tendency to use sedation differs between cultures, hospitals and even between different endoscopists. [Classen et al.,2002, Ch.6]
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In order to visualise the entire colon, the flexible colonoscope is slowly pushed into the colon. Because of the compliant nature of both the colon and the colonoscope, there are many problems in inserting the scope. It is nearly impossible to insert the scope without creating large bends and stretching the colon. This makes it difficult and sometimes impossible to reach the cecum and to visualise the entire colon. Furthermore it also causes pain to the patient. Although there are also many problems to be solved in the therapeutic area, this thesis will focus on the problems related to the insertion of the colonoscope while keeping Fig. 1.4: Physician performing a colonoscopy. The patient is in mind that it must be possible to equip lying in the standard left lateral position. the colonoscope with therapeutic tools like (Adopted from [www.hopkins-gi.nts.jhu.edu, 2005]) tools to take biopsies (tissue samples) or remove polyps. Another drawback of the current colonoscopes is the length of the learning curve. A physician has to perform several hundreds of colonoscopies in simulators and under the supervision of a trained endoscopist before he is skilled enough to be allowed to work alone. That makes the colonoscope a very expensive instrument in its training costs. These costs could be lessened if there was an easier way to perform a colonoscopy. [Classen
et al.,2002, Ch.9]
There are some alternatives to colonoscopy with a colonoscope. The oldest one is the barium enema method in which the patient drinks a contrast fluid before an X-ray picture is taken. The main disadvantage of this technique is that when some abnormality shows up, there is no possibility to take a biopsy, which is necessary to make a distinction between benign and malignant abnormalities. It is also impossible to remove polyps during the examination. Furthermore, not all abnormalities or diseases can be seen on X-ray since it does not provide photographic images of the colonic wall, it only visualises the anatomy of the colon. Virtual colonoscopy, using 3D MRI, gives better images than a barium enema, without using the harmful X-rays. However it further has the same disadvantages as the barium enema. The recent development of wireless capsule endoscopy gives hope to a painless, comfortable way of examining the entire gastro-intestinal tract. However, this capsule has been designed for the jejunum and not for the colon. Furthermore it is transported by the digestive system and only looks in one direction. It is not possible to manoeuvre the capsule to visualise the entire colon, including spots behind folds. This enlarges the risk of missing important things. Another problem again is the lack of possibilities to perform therapeutic actions or taking biopsies. This also goes for sonde enteroscopy. [Classen et al.,2002, Ch. 4] The preceding discussion clearly indicates that something must be designed, having all the diagnostic and therapeutic possibilities of the colonoscope, but without its shortcomings. The goals of this study are to [1] find the fundamental causes of insertion problems and pain during conventional colonoscopy (Chapters 2 and 3) and to [2] find out whether there already are new devices that provide an alternative for conventional colonoscopes (patent study in Chapter 4). In this thesis, medical terms for human organs will be used in combination with medical terms for positions in or on the body. These terms are illustrated in Figures 1.1 and 1.2 to make these terms understandable for those who are not yet familiar with these terms. An anatomical scheme of the colon in more detail is given in Chapter 2, in Figure 2.1. In order to save space, colonoscope will be abbreviated to scope.
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Page of A3 inlay Fig. 1.3
13
Page of A3 inlay Fig. 1.3
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Medical perspective on current problems

Nowadays colonsocopy is a very difficult to learn routine because of the difficulty of controlling the flexible push colonoscope through the very flexible and sometimes also mobile colon. Many problems are easily pointed at, like the compliant nature of both the colon and the colonoscope, buckling of the colonoscope and the formation of stretched bends in the colon, but what is the real cause of these problems? And what could be done to make this routine easier? Colonoscopy can also be painful for the patient. What causes this pain and how can it be prevented? In Chapter 2, the problems in colonoscopy will be analysed from a medical perspective based on existing literature, focusing on advancing through the colon. In Chapter 3, the author will translate the medical difficulties into generalized technical problems to give better insight in the difficulties and the ways they can be solved. The problems in nowadays colonoscopy will be split into two main areas: -
Fig. 2.1: Anatomical scheme of the colon.
The insertion of a long, flexible scope into the flexible and elastic colon. The causes of pain during the insertion of a colonoscope.
2.1
Insertion
Because of the flexibility and length of a colonoscope tube and the compliant nature of the colon and its attachments, it is impossible to push a colonoscope through the colon without encountering various difficulties. A short overview of insertion techniques and difficulties, found in medical literature, will be given in this section. Figure 2.1 gives an anatomical scheme of the colon and its attachments. Anus and Rectum To ensure that the anus can be entered safely, it should first be examined with a digit finger. This is to feel whether there are any obstructions or abnormalities in the anus, but also to pre-stretch the anus and to facilitate the insertion of the scope. Next, after checking the proper function of the scope, the scope tip should be lubricated and gently inserted into the anus. Before advancing into the rectum (Figure 2.2) and colon, the tip should be properly orientated to make suction of fluids possible. [Classen et al.,2002, Ch.12; Waye et al.,2003, Ch.29]
Fig. 2.2: Scope in anus and rectum.
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Sigmoid Colon The sigmoid colon has a length of 40-70 cm when stretched and 30-35 cm when crumpled. During insertion, the anatomy of the colon and the surrounding organs pressing on the colon, force the scope to move from the back of the pelvis (rectum), anteriorly into the abdominal cavity (sigmoid colon, Figure 2.3) and then posteriorly into the fixed descending colon. In atypical situations the descending colon can be fully mobile and can move to the middle of the abdomen instead of lying in the left lateral part of the abdomen. This can result in complex combinations of clockwise and counter clockwise looping (Figure 2.4) of the colon, which makes it difficult to advance further through the colon.
Fig. 2.3: Scope in sigmoid colon.
In general, in order to prevent overstretching, angling and looping of the sigmoid colon, it is wise to often pull back after hooking the tip around a fold or acute bend in the colon to straighten the sigmoid colon and make it crumple on the shaft like one can shove a sleeve up ones arm. While moving through the sigmoid colon, six main situations can occur. Table 2.1 gives an overview of the six main situations, the underlying causes, the problems or benefits they might give and instructions to handle Fig. 2.4: Definitions of clockwise and counter-clockwise looping. those situations. After tackling the sigmoid colon, passing the sigmoid-descending junction and entering the descending colon, it is important to continue frequently twisting and pulling back to keep the sigmoid colon straight and prevent it from recurrent looping. This also counts when using the -loop manoeuvre in which a loop with the shape of the Greek letter is intentionally formed (Figure 2.5). Not straightening enough causes difficulties later on and can make it necessary to pull back to a length of 40-50 cm in order to straighten again and retry tackling the splenic flexure, transverse colon or hepatic flexure. It is important to keep in mind that things are not always going as expected. When a clockwise loop has formed (like in Figure 2.5), it can only be straightened with clockwise twist. Using counter clockwise twist only worsens the situation. Sometimes counter clockwise loops form (see reversed -loop in Table 2.1) and an inattentive colonoscopist will get stuck when not keeping in mind the possibility of atypical loops having formed. [Classen et al.,2002, Ch.12; Waye et al.,2003, Ch.29]
Fig. 2.5a: Intentionally creating an -loop with the -loop Fig. 2.5b: Straightening a clockwise -loop. (Adopted from [Waye et al.,2003]) manoeuvre. (Adopted from [Waye et al.,2003])
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Table 2.1: Loop types in the sigmoid colon (Drawings adopted from [Waye et al., 2003]). Favourable loop types Straight(ened) How to obtain - Successful insertion without exerting high forces, with frequent pulling back and straightening, no abnormal anatomy. - By straightening other loops before entering descending colon. - Very long sigmoid colon and no other problems. Why beneficial Provides relatively easy continuation. How to continue - Continue frequent pulling back and deflation, which may allow direct passage to the descending colon. - When straightened, mostly the descending colon is already entered.
Flat loop, no acute bend
Makes insertion easy - Advancement to descending because of the favourable colon should be easy by gently shape of the loop. pushing. Straighten the loop after reaching the descending colon.
-loop (clockwise, 90% of s)
- Intentional by using loop manoeuvre (See Fig. 2.4) - Beneficial anatomy and luck
Provides easy insertion with little pain, no hairpin bend in sigmoiddescending junction.
- Straighten loop when being halfway descending colon by applying clockwise torque and drawing back. - Keep using some clockwise torque to prevent recurrent looping of sigmoid when advancing through the rest of the colon. (See Fig. 2.5)
Difficult loop types Flat loop, with acute bend
Cause - Too much force exerted - Not pulling back often enough - Very long sigmoid colon
Why difficult
How to continue
Acute bends are hard to - Hook into descending colon. passage, reduce effective - Pull back and on maximum transmission of push straightened scope; forces and cause high - Straighten the tip, push and use friction in the steering clockwise twist. cables. This causes looping and steering problems in the proximal parts of the colon and thus an increase of pain. Produces an acute clockwise hairpin bend in the sigmoid-descending junction, causing problems like flat looping with acute bend. Harder to overcome than flat loops: - To straighten, advance up to the sigmoid-descending junction. - Twist clockwise and withdraw to straighten the loop. - Keep twisting and find the lumen. When feeling too much resistance, try counter clockwise twist or convert to -loop when being halfway the N-loop. Same as -loop, but - Same as -loop, but using counter counter clockwise. clockwise torque. Because the endoscopist - It is important that the endoscopist cannot see that it is not a keeps in mind the possibility of regular -loop, the wrong reversed -loops when trying to direction of twist is often straighten a loop. If the situation applied when trying to worsens why applying clockwise straighten the loop. This torque, use counter clockwise worsens the configuration torque. and can increase pain.
N-loop
- Long sigmoid colon - Too little straightening actions - Trying to straighten an -loop without having reached the sigmoiddescending junction.
Reversed -loop (counterclockwise, 10% of s)
- Persistent descending mesocolon - Fully mobile descending mesocolon
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Descending Colon When using sufficient straightening of the sigmoid and the sigmoiddescending junction, the descending colon (Figure 2.6) can be rapidly advanced up. While in the descending colon, clockwise twist is needed to avoid recurrent looping of the sigmoid colon. If clockwise twist does not work this can be in indication of atypical mobility of the colon and/or a reversed -loop. In that case, counter clockwise twist should then be used instead. After reaching the splenic flexure and straightening, the scope will have an inserted length of 40-50 cm. [Classen et al.,2002, Ch.12;
Fig. 2.6: Scope in descending colon.
Waye et al.,2003, Ch.29]
Splenic Flexure In order to pass the splenic flexure (Figure 2.7) it is important not to use excessive push force and to prevent the tip from flexing too much and create a so-called walking stick handle. Otherwise the scope will push the splenic flexure away instead of sliding through it (Figure 2.8). Deflation to shorten the splenic flexure makes it easier to pass. If regular tricks of twisting, pulling back and using abdominal hand pressure do not work, the scope should Fig. 2.7: Scope in splenic flexure. be drawn back from the splenic flexure and the manoeuvre should be retried. Changing the patients position to right lateral to let the transverse colon drop down and straighten the splenic flexure can also help (Figure 2.10).
[Classen et al.,2002, Ch.12; Waye et al.,2003, Ch.29]
Fig. 2.8: Walking stick configuration. (Adopted from [Waye et al.,2003])
Transverse Colon N-loops (N-shaped loops, see Table 2.1) in the sigmoid colon cause friction in the steering cables and a reduction of transmission of effective, inward push pressure to the tip. Problems in the transverse colon (Fig. 2.9) are often caused by loops in the sigmoid colon or by a mobile splenic flexure (Figure 2.12). To reach the hepatic flexure the transverse colon should be straightened first, either by hooking the tip around a bend and pulling back or by using counter clockwise twist Fig. 2.9: Scope in to lift and shorten the transverse colon. transverse colon. If the hepatic flexure is in close reach but all efforts to reach it fail, abdominal hand pressure can be applied to suppress loops and shorten the colon. If the scope feels looped and cannot be straightened by the basic methods, there are three possible Fig. 2.10: Moving patient from left lateral to right lateral drops and splenic causes as described in Table 2.2, together the transverse colon from [Waye et flexure into an easier configuration. (Adopted al.,2003]) with instructions for continuation. [Classen et
al.,2002, Ch.12; Waye et al.,2003, Ch.29]]
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Hepatic Flexure When the hepatic flexure has been reached (Figure 2.11), the scope tip should be hooked around a bend and the scope should be pulled back in order to Fig. 2.11: Scope in straighten the descending colon. scope. After that, the tip should be straightened to advance through the hepatic flexure. Fig. 2.12: Mobile splenic flexure. (Adopted from [Waye et al.,2003]) Normally, it is also possible to set the scope tip in the correct steering direction, insufflate, use hand pressure, withdraw and aspirate. The scope tip will progress forward while drawing back. If this does not work either, changing the patients position could be tried and loops should be considered. [Classen et
al.,2002, Ch.12; Waye et al.,2003, Ch.29]
Ascending Colon To advance down the ascending colon (Figure 2.13), the colon should be deflated to make the scope tip slide into the ascending colon. Only for the last few centimetres, gentle pushing should be used. Using excessive push pressure only causes recurrent looping in the more distal parts of the colon. [Classen et al.,2002, Ch.12; Waye et al.,2003, Ch.29]
Fig. 2.13: Scope in ascending colon.
Ileum When advanced down the ascending colon, the last goal is to enter the ileal valve (Figure 2.14). Methods to do so, like the appendix trick, direct entry, retrovision and entry with biopsy forceps, are described in literature and are no part of this study. When the ileum is reached, the flexible colonoscope has successfully been inserted through the entire colon. [Classen et al.,2002, Ch.12; Waye et al.,2003, Ch.29]
Fig. 2.14: Scope in cecum at ileal valve.
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Table 2.2: Possible problems when scope seems looped in transverse colon (Drawings adopted from [Waye et al.,2003]). CW = Clockwise, CCW = Counter Clockwise. Loop Type Reversed splenic flexure loop Causes - Mobile colon - Lax pherococolic ligament thus mobile splenic flexure (Fig. 2.12) Problems Instructions
Lifting manoeuvres in the - Withdraw to distal transverse transverse colon are only colon, use CCW torque to possible if the splenic flexure straighten and retry. is fixed by its suspending - Aggression and force only ligament. If this suspending worsens the looping in this ligament is lax, it can be case. pulled back +/- 10 cm.
-looping of transverse colon
- Hypermobile colon Difficult to regain normal - Very long colon anatomy after looping due to - Post-surgical adhesions size and mobility. It is well possible to reach the cecum with a -loop but entering the ileum is difficult because of the high friction in the steering cables. Failing to keep the sigmoid colon from looping due to excessive pushing or twisting to the wrong side. Reduces effective transmission of push forces and causes high friction in the steering cables when advanced up to the transverse colon.
- Withdraw and use suction to deflate colon - Re-insert and use CW / CCW twist. - Use abdominal compression to lift the transverse colon and prevent looping.
Recurrent sigmoid colon looping
- Withdraw to secum - Slowly reinsert with CW twist and sigmoid abdominal compression
2.2
Pain
During colonoscopy, the colon and its attachments are stretched in a variety of ways. This can cause pain to the patient. Though when some abnormalities are present, the colon can be over sensitive and the pain levels will increase. The main common pain causes according to literature and expert endoscopists are listed below: In order to keep the lumen open, air is blown into the colon. Inflating too much causes an unpleasant wind pain (the same kind of pain that is felt when an accumulation of gas is present in the colon). When inserting the colonoscope, some looping is inevitable. Thereby the colon will be stretched as well as peritoneum and the ligaments that suspend the colon. During excessive looping the patient experiences unpleasant wind pain. When removing loops or straightening the colon, the scope tip is hooked around a bend where after the scope is pulled back. This causes high pull forces on the ligaments.
In order to make the patients drowsy and cooperating while easing the experience, they are often given a light sedation. Though it is important to keep them able to respond since the endoscopist does not always feel when he is exerting too much force and too high forces can cause perforation of the colonic wall. [Classen et al.,2002, Ch.6 and Ch.12]
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3
3.1
Technical perspective on current problems

Introduction
Since medical literature does not give a proper analysis of the fundamental causes of insertion problems and pain during colonoscopy, in this chapter, the insertion problems as treated from an applicated medical point of view in Chapter 2, will be analysed by the author from a technical perspective. The goal is to find the fundamental causes behind the insertion problems and pain that occur during colonoscopy. This analysis will be a purely qualitative one and will therefore not mention exact sizes or distributions of forces, since this would take an entire study on its own. All anatomical and medical facts are either derived from Chapter 2 and from discussions with endoscopists unless stated otherwise. The exact anatomy of the colon and its surrounding organs differs greatly between various persons. The exact anatomy depends on the sex of the person, whether there have been any previous operations, the presence of anatomical abnormalities like lax ligaments, or abnormalities caused by diseases like cancer etc. In this chapter, generalized configurations of flexible tubes with different shapes, fixations and flexible suspensions will be derived from human anatomy to create a simplified representation of the colon (Section 3.2) and will be used to gain better insight into deforming mechanisms (Section 3.3) and pain (Section 3.4).
3.2
Simplified representation
In order to gain insight into the causes behind the insertion problems and pain, a simplified representation of the colon and the colonoscope will be derived in this section. In the remaining part of this chapter this simplified representation of the colon will be called a colonic model.
3.2.1 Colonoscope
The bending stiffness of a scope is an important factor in insertion problems and pain. Figure 3.1 shows a compliant, flexible and elastic tube with three theoretical options for the bending stiffness of the colonoscope: 1 2 3 A scope with infinite stiffness; A scope with zero stiffness; A scope with average stiffness like the well-developed, modern colonoscopes.
It is obvious that only the third option makes it possible to push the scope through the compliant, flexible and elastic tube. A scope with infinite stiffness cannot bend. A zero stiffness scope will not transfer push forces and will therefore buckle in a large number of folds. Hence, only a scope with average stiffness will be useful. Therefore, from now on the problem will be discussed using a scope with average stiffness like the well-developed, modern colonoscopes, optimised to being pushed through a flexible, curved, elastic tube like the colon.
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Fig. 3.1: The importance of the correct stiffness of the scope when pushing through a curved, flexible, elastic tube. 1) Scope with infinite stiffness. 2) Scope with zero stiffness. 3) Scope with average stiffness.
3.2.2 Colonic model

In order to make a model of the colon that is realistic enough to be representative but also simple enough to stay understandable, some simplifications have to be made. Since anatomical variations between human subjects are always present, an average anatomy of the colon will be assumed to model the colon. In order to make a realistic model of the colon it was necessary to have a proper image of the anatomy of the colon. Thanks to the kind help of Dr. Kleinrensink of the Erasmus Medical Centre in Rotterdam it was possible to perform a cadaver study on four human cadavers, three females and one male. The results of this cadaver study fitted well with the literature: It turned out that the rectum cannot move since it is fixed in the pelvic bone. The ascending colon and the descending colon are both firmly attached to the abdominal wall and can hardly move. The sigmoid colon however is only fixated at its ends and can move freely over its entire length. The suspending ligaments, present at both the hepatic and the splenic flexure, turned out to be double folds of peritoneum and were only slightly stretchable. The transversal colon hangs in the peritoneum, which is large enough to allow the transversal colon to move and even to be forced into a loop. Figure 3.2 shows the colon, modelled as a flexible, elastic tube. The tube walls are straight and not wrinkled like in a real colon since the wrinkles have little influence on the basic behaviour of a bending tube. Movement and deformation of the colon and the colonic wall are mainly limited by three factors: The stiffness of the colonic wall The abdominal wall and the organs surrounding the colon, such as the small bowel The suspending ligaments of the colon
The small bowel can be simplified as a viscous and elastic mass lying in the abdomen and thereby delimiting the movements and deformations of the colon in all directions and over the entire length of the colon. Therefore the small bowel will be simplified by supposing that it only enlarges the stiffness of the colonic wall. The pressure in the abdomen is only slightly different from atmospheric pressure. Furthermore, the movements and deformations of the colon will be assumed to stay inside the limits of the abdominal wall. Therefore the abdominal wall will be left out of the model. Since friction in the colon is extremely low, it will be neglected. The hepatic and splenic flexures are suspended on ligaments. These ligaments can bend freely but are barely stretchable and can only constrain pull forces. However, the surrounding organs prevent the flexures from moving too far upwards. Therefore these ligaments are modelled as cable suspensions. Because the ascending colon and the
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descending colon have a tight ligament attachment over the entire length and are thus almost completely constrained in their motion, these attachments are simplified as fixations. In this chapter the colon is simplified to a 2D configuration. When necessary the configuration is allowed to move in the third dimension because otherwise, not all loop types could be treated. In real colonoscopies, the position of the patient can be altered to make the colon drop into an easier configuration [Classen et al.,2002, Ch.12; Waye et al.,2003, Ch.29; Marieb, 2004]. In the colonic model, the patient is taken to be lying on his back or slightly angled to rule out the effects of gravity and have the colon in the configuration as illustrated by Figure 3.2.
Fig. 3.2: Colon surrounded by colonic model
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The rectum lies fixated in the pelvic bone and is therefore modelled as a fixated part of the sigmoid colon. The sigmoid colon lies in a free S-shape between the rectum and the descending colon. The transverse colon hangs on the splenic and the hepatic flexures, which are suspend on ligaments. It can move and stretch but is constrained by the ligaments of both flexures. The connections between the transverse colon and the both flexures are as elastic as the colonic wall (since it is just a part of the colonic wall) and are therefore modelled as springs. Similar to the splenic flexure, the hepatic flexure is suspended by a cable suspension and fixed at one and by the ascending colon that is fixated like the descending colon. The cecum hangs freely on the fixed ascending colon and is therefore fixed at only one end. The colon is often is often inflated or deflated to make the scope advancement easier. This technique is left out of the discussion in Section 3.3 since these methods are only used when the regular techniques fail and the effects of these methods depend on many variables. The inflation of the colon is picked up again when treating the mechanical causes of pain during colonoscopy in Section 3.4.
3.3
Main insertion problems in normal anatomy

From Section 2.1 and discussions with experts, it seems that when no anatomical abnormalities are present, the key to a successful colonoscopy is to keep the sigmoid colon straight after reaching the descending colon. However, to gain such a situation, the sigmoid colon must first be passed and straightened, which can be quite a difficult job. Figure 3.3 shows the colon, its suspending ligaments and the main problem areas (MPAs) that can be identified according to the medical perspective, given in Section 2.1, when no anatomical abnormalities are present. Four MPAs can be identified: 1 2 3 4 The S-shaped sigmoid colon. The U-shaped splenic flexure. The flat-U-shaped transverse colon. The U-shaped hepatic flexure.
Each of these MPAs has its own Fig. 3.3: Colon and suspending ligaments. MPAs are main characteristics in shape, fixations and problem areas in colonoscopy. flexible suspensions. The distance from each MPA to the anus, the start of the trajectory, also has a major influence on the difficulty of advancing through that MPA. In Sections 3.3.1 to 3.3.4, the insertion problems in the four MPAs of Figure 3.3 will be discussed using corresponding parts of the colonic model of Figure 3.2 and the assumptions that where stated in Section 3.2. It is not the intention of the author to present the exact force distributions and wall deformations of the colon during advancement of a scope but to give more insight in the global deformation mechanisms and to find the reasons why these deformations occur. In Section 3.3.5 some insertion problems will be discussed that occur when anatomical abnormalities are present, followed by a conclusion on insertion problems in Section 3.3.6.
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3.3.1 Sigmoid colon

When a colonoscope is pushed into the S-shape of the sigmoid, push force will be exerted on the wall of the tube, causing the tube to stretch and/or to bend. The amount of stretching and bending of the tube wall depends on the combination of: The stiffness of the tube. The force exerted on the tube.
In this section, the loop types of Table 2.1 will be discussed and the deformation mechanisms thereof will be analysed. Flat loop without acute bend Figure 3.4 illustrates what happens when the scope is pushed trough the first curve of an S-shaped, elastic, flexible tube. At first it is supposed that the tube wall will stay smooth during moving and deformation. Therefore, when the scope tip hits the tube wall, the tip will not stick into the tube wall but will slide along it. When the scope enters the first bend and comes in contact with the tube wall, the tube wall will be pushed away by the normal forces that are exerted on it by the scope. Figure 3.4-A1 shows a qualitative estimation of the push force distribution (qpush-1) on the tube wall. There can only be normal forces exerted by the scope on the tube wall since there is no friction between the scope and the tube. The exact force distributions are not known but can be determined by using finite element models. However, making finite element models of the force distributions will cost much time and effort and goes beyond the goal of this thesis. Figure 3.4-B1 shows an elementary part of the tube wall with the push forces acting normal on the wall and the very small deformation stresses (e) that act along the curve of the bend. Figure 3.4-C1 shows the resultants of these forces. Fpush-1 is the resultant of the push forces on the tube wall. Fe is the resultant force of the deformation stresses, the component of this force that acts in the opposite direction of the push force is the force that provides guidance for the scope and makes the scope bend to follow the shape of the tube. In this first stadium of advancement through the first bend, the bend does not provide much resistance yet, since the deformation stresses in the tube wall are still small. Therefore, the tube wall will mainly be pushed away and the bend will be enlarged. To enlarge the bend, additive tube length is needed. This length is taken from the second bend, thereby making the second bend smaller. During the second stage of advancement (Figure 3.4-A2), the total push force on the tube wall will be enlarged. Due to its properties, the scope will tend to act as a bended spring and will always try to be straight. Therefore, the larger part of the scope is to be bended, the more force is needed. Furthermore, the smaller bending radius is to be obtained, the more force is needed to bend the scope. Hence, when the scope is advanced further through the first bend, each elementary part of the scope in the bend will push against the tube wall and the total force acting on the tube wall will increase. There is a moment when no more length can be taken from the second bend to enlarge the first bend without stretching the tube. The tube has a certain resistance to deformation and when this resistance is large enough to prevent the second bend from bending further, and thereby giving up length in favour of the first bend, the tube has to stretch to make further enlargement of the first bend possible. In Figure 3.4-B2 it can be seen that the deformation stresses in the tube wall have grown due to the stretching of the tube wall. In this stage, enlargement of the bend is caused mainly by stretching of the tube wall. This is also illustrated by Figure 3.4-C2, where it is shown that the deformation forces are being enlarged and begin to cancel out the resultant push force.
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Fig. 3.4: Three stages of scope advancement through the first bend of an S-shaped, flexible, elastic tube (1: Bend enlargement, mainly caused by shifting of tube. 2: Bend enlargement, mainly caused by stretching the tube. 3: Equilibrium.). (A) Representation of the configuration of the tube with the scope in it. The distributed forces (qpush-1) are the normal forces that are exerted by the scope shaft on the tube wall. There are only normal forces since friction in the tube is zero; (B) Detailed view of an elementary part of the tube wall, the normal force (qpush-1) on the tube wall and the deformation stresses (e) that act in the tangential direction of the tube wall; (C) Resultant forces of the distributed forces in B. Fpush-1 is the resultant push force against the tube wall, Fe is the resultant force of the deformation stresses. Dark grey, double arrows indicate the direction of bend deformation.
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In the third stage (Figure 3.4-A3) the scope has past the first bend. The push forces that act on the tube wall in the first bend are now in equilibrium with the resisting forces that are caused by the deformation stresses in the tube wall (Figures 3.4-B3 and -C3) and bend the scope. Therefore the bend will not enlarge when advancing further since the length of scope that has to be bend by the first bend, and therefore also the force needed to bend the scope, is constant now. Furthermore, if the scope behaves like an ideal spring, the energy that is released by the part of the scope that straightens after passing the first bend will be transferred to the part that just enters the bend. Therefore, the scope can be advanced without having to apply more force at the scope shaft. However in practice, the scope will have some hysteresis that will cause energy loss. Therefore it will be necessary to keep applying push force at the scope shaft. Once the first bend has been passed, the second bend is entered. In the previous paragraphs it was assumed that the scope tip slides along the smooth tube wall without prodding into it. In reality however, this constantly happens since the colonic wall is very compliant. In Figure 3.5- A1 an enlargement of the situation at the scope tip shows that when the scope tip pushes against the tube wall and is pushed forward, there will always be a part of the normal forces that is exerted by the tip of the scope. In Figure 3.4 it was already shown that when normal forces are exerted on the tube wall a reaction force is acting in the opposite direction. Furthermore, when the scope is pushed through a bend and is deforming it, the distal part of the scope will always be pressed into the tube wall a little. Hence a reaction force will be acting against the scope tip. Since a push force is exerted at the proximal part of the scope, there will be a force pushing at each end of the scope shaft. Therefore the scope will buckle and an additive normal force is added to the push forces already present in the first bend. During further advancement of the scope through the second bend (Figure 3.5-A2) the total push force on the second bend will increase. The normal forces exerted by the tip of the scope on the tube wall will vary but this variation will depend on factors like the structure of the wall, the shape of the wall, the amount of irregularities of the wall and the bending radius of the controllable part of the tip. When assuming that the tip is always correctly controlled and will thus always push into the tube wall equally far, the normal forces exerted by the tip of the scope will be constant during advancement through the entire second bend. Therefore, the push forces on the first bend, caused by the buckling effect, will be constant. When the scope tip has past through the second bend (Figure 3.5-A3) the backwardly directed reaction force on the scope tip will disappear since the tip does not push against the wall anymore. Due to the disappearance of this backwardly directed reaction force, the buckling effect cancels and the first bend will recover from the stretching that was added due to the backwardly directed reaction force. The resulting configuration when both bends have been passed resembles the flat loop without acute bend in Table 2.1. Had the S-shape not been fixated at its end points, it would have translated when pushed against instead of deforming and guiding the scope. Therefore, it is clear that there must be constraining reaction forces acting in the fixation points. In Figure 3.5-B the tube is cut loose from its attachment points. The attachment points are set aside and the reaction forces are drawn at the correct places and in the correct directions. This shows that when the scope is pushed through the sigmoid colon, there are pull forces acting on the fixating ligaments. The effect of buckling due to the backwardly directed push force has been explained above. Furthermore, it does not change the basic deforming mechanisms of the bend where the most distal part of the scope is in. Therefore for the remaining part of Section 3.3.1 it will be assumed again that the scope tip will not be pushed into the tube wall and therefore.
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Fig. 3.5: Three stages of scope advancement through the second bend of an S-shaped, flexible, elastic tube. (A1) Scope tip enters second bend and deforms the tube wall, thereby exerting normal forces on the tube wall, not only with the side of the shaft but also with the tip. The enlargement shows the distribution of the push force on the tube wall by the distal end of the scope (qpush-2). Note that there will be a reaction force acting perpendicular to the tip and thereby pushing backwards on the scope. This will result on an accumulation of the push forces on the first bend (qpush-1). (A2) Scope tip keeps deforming the tube wall while sliding through the bend. The normal forces on the tube wall (qpush) will be enlarged and the bend will be stretched further. (A3) The scope has past the second bend, equilibrium. Note that the backwardly directed reaction force on the tip has disappeared now since the bend is already formed and the tip lies free in the tube. Due to the absence of the backwardly directed reaction force, the forces on the first bend have decreased again and the first bend partly recovers from stretching. (B) The tube cut loose from its attachment points to illustrate that there are constraining forces acting on the fixating ligaments of the colon.
Flat loop with acute bend As shown in Figure 3.6 the resistance to deformation of the S-shaped tube is much smaller (and amplifies the effects as seen in Figure 3.4.) when the tube is less stiff or very lax. Since the first bend will be stretched much further because it is less stiff now, the scope will have to push the first bend further away before the tube will give enough resistance to make the scope slide through the first bend. The tube length needed to move away the first bend is taken from the second bend. Since the length of the second bend has been reduced a sharp or acute bend will form in the second bend. And because the tube is already
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stretched to its limits in the first part, it will become very difficult to advance through the second bend. When the scope tip is bent too sharply, which is necessary to fit into an acute bend, the push forces in the second bend are all directed onto a very small area, causing the tip to advance no further. Here the so-called walking stick configuration occurs (Figure 2.8). This resulting configuration of the sigmoid colon resembles the flat loop with acute bend in Table 2.1.
Fig. 3.6: Normal forces on the tube wall (small arrows) in three stages of advancement through the second bend of a lax S-shaped tube, resulting in a flat loop with a sharp bend.
When the situation of Figure 3.6 occurs there is no way to advance further by increasing the push force. Any attempt to do so will enlarge the first bend or perforate the tube in the second bend because the second bend is now too acute to push through. So the solution lays in decreasing the bending radius of the second bend. Therefore the length of the first bend should be reduced to give some length to the second bend. This can be done by hooking into the end of the second bend and pulling back (Figure 3.7). In this way, the configuration of the tube changes into a straight line and a force, carefully applied at the end of the scope, will result in a forward movement of the tip due to the stiffness of the scope causing the forces to be transmitted by the scope again.
Fig. 3.7: Straightening a lax S-shaped tube by hooking the scope tip into the tube wall and pulling back to make further advancement possible
N-loop The configurations treated in this chapter up to now, were all two-dimensional configurations. Since the human body and the real world are three-dimensional and since the colon is not constrained in the third dimension, also three-dimensional configurations exist. One of these configurations is the N-loop (see Table 2.1). This N-shaped loop occurs when the S-shaped tube is lax and moves not only in the plane of the S-shape but also out of that plane.
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This creates the possibility to form a three-dimensional loop by moving the first bend over the second bend as is illustrated in Figure 3.8. It depends on the exact configuration of the surroundings, the attachment points of the colon and the direction of the forces whether a two-dimensional or a three-dimensional loop will form. N-loops can also occur when trying to straighten an -loop without having reached the distal end of the S-shape. This will be explained later in this section, when treating recurrent looping.
Fig. 3.8: Normal forces on the tube wall (small arrows) in three stages of advancement through a lax S-shaped tube, resulting in an N-loop.
As can be seen in Figure 3.8, when an N-loop occurs, there is also a reduced radius of curvature of the second bend, making it too sharp to push the scope further. In order to advance further, the second bend has to be straightened or at least its radius must be enlarged. There are two ways to do this. The first method is illustrated in Figure 3.9. This method is also described in Table 2.1 from a medical perspective: When using clockwise twist in combination with pulling back, the distal bend of the scope is lifted, pulled back and straightened. This is caused by the torsion stiffness of the scope, making it possible to transfer applied torque from the shaft to the tip of the scope and thereby lift the distal end of the scope. Since the scope is much stiffer than the tube, the sharp bend is lifted and straightened while straightening the scope. It depends on the configuration of the loop whether one should use clockwise or counter-clockwise twist. To resolve a normal clockwise loop, clockwise twist should be used and vice versa (for difference between clockwise and counter-clockwise looping see clockwise and counter-clockwise -loop figures in Table 2.1 and Figure 2.4).
Fig. 3.9: Straightening an N-loop by applying clockwise twist (TCW) and pulling back.
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-Loop Another method to make further advancement possible after the forming of an N-loop depends on successfully transforming the N-loop into a so-called -loop. An -loop is an shaped loop which provides a relatively easy advancement through the S-shaped tube because of its big radius of curvature. Figure 3.10 illustrates how an N-loop can be transformed into the beneficial -loop configuration. The scope must be pulled back to half way the first bend. Then twist should be applied in the correct direction (clockwise twist in the case of Figure 3.10) to transform the N-loop into an -loop and prevent it from turning back. An -loop can also form due to the correct application of the -loop manoeuvre as illustrated in Figure 2.5a. After the creation of an -loop it is very easy to advance through the tube due to the large radii of curvature of both the first and the second bend.
Fig. 3.10: Straightening the sharp bend in an N-loop by transforming it into an -loop, using clockwise twist (TCW).
Recurrent looping If the tube does not end after the S-shaped curve, it is of great importance to straighten the loops in the S-shape so that forces applied to the shaft of the scope are correctly transferred to the tip. Otherwise, recurrent looping can occur because of the scope pushing against the tube wall and buckling of the scope. Figure 3.11 gives an example of starting recurrent looping. When the upper bend is being tried to advance through, the scope can bend at any place where it is not correctly straightened or supported. Because the endoscopist normally cannot see this, it can cause large problems when it happens when
Fig. 3.11: Starting recurrent looping in a long flexible elastic tube with various bends. The Small arrows indicate the normal forces on the tube wall exerted by the scope.
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the endoscopist is not considering the possibility of this situation to occur. For example, one might be trying to resolve some expected looping in the splenic flexure while actually worsening the bends in the sigmoid colon by applying twist in the wrong direction or by keeping pushing while a bend is formed. When straightening an -loop, it is very important that the end of the sigmoid colon has been reached. When trying to straighten the -loop with the scope still in the S-shape of the sigmoid colon, the straightening manoeuvre will result in the creation of an N-loop, which only worsens the situation. The creation of an N-loop when straightening too early is caused by the scopes tendency to adopt a straight configuration. This is illustrated by Figure 3.12; When the scope tip has not yet passed the end of the S-shape, where it is constrained by the fixation of the colon, the scope will force the compliant piece of colon between the scope tip and the fixation in any direction the scope goes. Since the scope is twisted to resolve the -loop, the scope will be twisted into a U-shape. Because of the bending stiffness of the scope it will tend to adopt the shape of a U with a bending radius as large as possible until constrained by the tube or the tube fixations.
Fig. 3.12: Formation of an N-loop when trying to straighten an -loop with the tip of the scope not yet at the end of the S-shape. TCW is the applied clockwise torque, grey dashed arrows indicate the movement of the tube.
3.3.2 Splenic flexure

As discussed in Section 3.2.2 the splenic flexure is modelled as a U-shape, suspended in its bend on a cable suspension, fixated at one end and connected to springs at the other end. Figure 3.13 gives an illustration of this U-shape and its attachments as well as the passage of the scope through it. When the preceding trajectory allows a proper transfer of forces that are applied to the shaft of the scope, it is not very difficult to advance the scope through this U-shape since its distal end (left end in the image) can adapt easily to the shape of the scope. One of the main points of attention is that the scope tip should not be bent too sharply when steering through the bend of the U-shape. If so, the walking stick configuration can occur (Figure 2.8) which will push the U-shape away and into a sharp bend, making further advancement impossible without pulling back. This U-shape becomes harder to advance through when there is some looping in the preceding trajectory since the push force will not be properly transferred to the scope tip and friction in the steering cables will make proper navigation harder. Figure 3.11 showed what happens when the preceding trajectory is not kept straight.
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Fig. 3.13: Scope pushed through a flexible elastic U-shaped tube. The small arrows indicate the normal forces exerted on the tube wall.
3.3.3 Transverse colon

The transverse colon is quite easy to advance through when no abnormalities are present and when the preceding trajectory is kept straight. The transverse colon can move almost only constrained by its attachments to the hepatic and splenic flexures (see Figure 3.14). Therefore it can easily adapt itself to the shape of the scope. After moving and/or stretching until enough tension has built up to guide the scope, the transverse colon provides a smooth guidance for further advancement of the scope. The scope can be advanced with the tip slightly bent.
Fig. 3.14: Scope pushed through a flexible, elastic tube, suspended on springs at it ends. The small arrows indicate the normal forces on the tube wall.
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3.3.4 Hepatic flexure

The hepatic flexure is modelled in almost the same way as the splenic flexure. The only difference is that the scope enters on the free hung side and exits at the constrained side. It is this difference that makes the hepatic flexure more difficult to advance through than the splenic flexure. Care should be taken when advancing through the hepatic flexure, since the proximal end (left in the image) is not able to adapt itself to the shape of the scope and the proximal end is not fixed and therefore does not directly force the scope to slide into the curve. Figure 3.15 shows what happens when pushing against the wall with a too sharply bent scope tip and pushing too early; The U-shape will be pushed into a sharp bend making it very hard to advance through it and some pull back motion must be made to retry to enter the bend since pushing further creates the risk of perforation and probably worsens the configuration. Pushing with a sharply bent tip when past the suspending ligament will give similar problems. Furthermore, since the hepatic flexure is further away from the anus than the splenic flexure there is a higher risk of recurrent looping and high friction in the steering cables. Especially when the endoscopist keeps pushing when the tip gets stuck in the hepatic flexure. It is not always necessary to resolve recurrent loops when already advanced up to the splenic flexure since there is only a small part of the colon left to examine after the splenic flexure. Therefore it can be better to continue while having loops in the preceding part of the scope and try to reach the cecum while coping with the deteriorated steering properties caused by loops or sharp bends. Sometimes it is sufficient to try to reach the ascending colon and then straighten the scope while hooking the scope tip into the wall of the ascending colon. The ascending colon itself normally does not give any difficulties since it normally is a fixed straight tube, just like the descending colon.
Fig. 3.15: Pushing the scope through a flexible elastic U-shaped tube while pushing against the tube wall too early. Fpush is the push force exerted on the scope shaft.
3.3.5 Problems caused by anatomical abnormalities

There are several abnormalities that can make it more difficult or even impossible to perform a full colonoscopy. Diseases that affect the appearance of the colonic wall can make it more difficult for the endoscopist to use the scope view to determine where it is in the colon. These diseases can also make a colonoscopy more painful for the patient so that the endoscopist cannot use too much pushing force because this increases the pain. There are also abnormalities that change the anatomy of the colon. These abnormalities can be divided into obstructions in the lumen and anatomical variations. Obstructions in the lumen occur in the inside of the colon and can make it difficult to advance the scope due to a decrease of the diameter of the lumen but these obstructions do not change the global behaviour of the colon as a flexible elastic tube. Anatomical variations are abnormalities in the main anatomy of the colon. Table 3 gives an overview of the most occurring obstructions in the lumen and anatomical abnormalities in the colon. Anatomical variations highly defer
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from the average colonic anatomy. Therefore it can become more difficult for the endoscopist to know how to handle. A very long sigmoid colon however, actually can make it easier to advance through the sigmoid colon since there is more sigmoid length available to make bends with a large bending radius (see Section 3.3.1). The fully mobile descending colon, very long transverse colon and lax phericocolic ligament are the most occurring abnormalities that give additive insertion problems and will be treated next.
Table 3: Abnormalities: obstructions in the lumen and anatomical variations of the colon. [Classen et al.,2002, Ch.(12,4042); Waye et al.,2003, Ch.29; Marieb, 2004; www.emedicine.com, 2005] Obstructions in the lumen Colonic cancer Colonic Neoplasia Colonic polyps Diverticular Disease Mass lesions Anatomical variations Fully mobile descending colon Very long transverse colon Very long sigmoid colon Lax phericocolic ligament Megacolon Explanation Malignant growth or tumor caused by abnormal cell division in the colon. Can decrease the diameter of the lumen. Probably precancerous abnormal cell growth. Can decrease the diameter of the lumen. Slow-growing mushroom head shaped overgrowths of the mucosa. Can become malignant (<1%). Decreases the diameter of the lumen. Inflammation of diverticulae in the colon, causing decrease of the diameter of the lumen. Benign or malignant soft-tissue neoplasms or tumors. Can decrease the diameter of the lumen. Explanation Caused by missing ligaments of the descending colon Transverse colon of big length, often found in women. Sigmoid colon of big length, may allow the scope to push through without a hairpin bend. Very stretchable ligament of the splenic flexure. Extremely long colon.
Fully mobile descending colon When the ligaments that attach the descending colon to the abdominal wall are missing, the descending colon hangs free and is only slightly constrained by the peritoneum and by the surrounding organs. The sigmoid colon and the descending colon (normally straight and fully attached to the abdominal wall) now both lay free in the abdomen. When the scope is inserted it will push the free lying sigmoid colon inwards (upwards in the pictures) and thereby enlarge the first bend. The length of colon needed to enlarge the first bend is taken from the second bend, like described in Section 3.3.1. In a normal anatomy this borrowing of length is limited by the fixation of the end of the sigmoid colon. Since this fixation is lacking in the case of a fully mobile descending colon, this phenomenon will continue and length will be taken from the descending colon as well, until some constraint is met (see Fig. 3.16). The first constraint will be the suspension of the splenic flexure. Since the colon is much less stiff than the scope and the sigmoid and descending colon can move freely, the scope often will not be forced to bend until the splenic flexure has been reached. Therefore, the splenic flexure will mostly be approached from the medial side (left side in the picture) when the descending colon is mobile. To reach the splenic flexure, the colon should be kept as straight as possible by often pulling back and straightening the scope. This way the colon is crumpled on the shaft of the scope and thereby shortened. After reaching the splenic flexure there often is a sharp loop to pass. This type of loop is called a reversed splenic flexure loop, since the natural loop of the splenic flexure goes from left lateral to medial and not from medial to left lateral. Since a sharp bend is very difficult to advance through by pushing, it should first be transformed into a configuration that can be treated easier. The first picture in Table 2.2 shows how to derotate a reversed splenic flexure loop. The mechanism behind this manoeuvre resembles transformation of an N-loop into an -loop; By twisting the torsion stiff scope, the compliant colon is forced to follow and will rotate with the scope.
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Fig. 3.16: Advancing a scope through a mobile flexible elastic tube. The small arrows indicate the normal forces on the tube wall. The grey dashed arrows indicate the movement of the tube and its upper suspending ligament.
Very long transverse colon When the transverse colon is very long, like often in women, it becomes harder to advance through it because its U-shape can hang down as far as to the bottom of the abdomen. Since the transverse colon is longer now, while its attachment points are still the same distance apart from each other, the bend of the U-shape will naturally adopt a small bending radius when this bend is moved down (see Fig. 3.17 for an explanation with cables). In such cases it is not possible to push the scope gently through it since it will get stuck when it is in the sharply bent bottom of the U-shape. In order to make advancement possible the deep hanging tube should first be lifted by hooking the scope tip into it and using the splenic flexure as a lever. When the transverse colon has been lifted the scope can be advanced further through it. Figure 3.18 shows the colonic model of a very long transverse colon as well as the lifting manoeuvre to straighten the U-shape.
Fig. 3.17: (top) Short cable with large bending radius (rlarge) due to push force Fpush. (bottom) Long cable with small bending radius (rsmall) due to same push force Fpush.
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Fig. 3.18: Using the suspending ligament as a pivot point to lever the long horizontal hanging tube to straighten it. Small arrows indicate the normal forces on the tube wall..
Lax pherococolic ligament When the splenic flexure is mobile, it is often called a lax splenic flexure. Actually however, the flexure itself is not lax but its suspending ligament, the pherococolic ligament is. Since passing the U-shaped splenic flexure is done by slowly pushing or twisting the scope through it and not by pulling at it, having a lax pherococolic ligament often does not add any difficulty to advancing through the splenic flexure itself. However, a lax pherococolic ligament makes it hard, if not impossible, to use the splenic flexure as a lever to lift the transverse colon in order to straighten it. How difficult this is, depends on how lax the ligament is and on the length of the transverse colon. Sometimes the ligament can be stretched for an extra 10 cm. Figure 3.19 shows how the splenic flexure with the attached transverse colon should be modelled in case of a lax pherococolic ligament. The normal suspension of the small U-shaped tube is now replaced by a spring with low stiffness, creating an extra degree of motion in the configuration.
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It is obvious that when the splenic flexure is used as a pivot point for a levering action to lift the transverse colon, the pivot point is pulled down and the long horizontal tube will be lifted less or not at all. The first U-shaped bend and the long, flattened U-shaped bend now have a high freedom of motion. This makes it more difficult to advance through these bends. Only by using many straightening manoeuvres and twist, the scope can be advanced through the transverse colon when the splenic flexure is lax.
Fig. 3.19: Splenic flexure with lax pherococolic ligament and transverse colon, modelled as a flexible elastic tube suspended on springs. The right spring has a very low stiffness.
3.3.6 Conclusion
In the treatment in Sections 3.3.1 to 3.3.5 there are some common issues that seem to be causing the insertion problems in colonoscopy. The first issue is that to pass bends in a piece of colon these bends will always be deformed in some extend. This is caused by the fact that the colon is much more compliant then the scope. Thus the bend will be enlarged until the tension in the colonic wall is high enough to provide guidance for the scope to advance further or when the bend cannot be pushed away further due to its surroundings. Secondly, when an S-shaped piece of colon is attached between two fixation points it is difficult to prevent the occurrence of unfavourable loops. The main cause of thereof is that to advance through the first bend of the S-shape it must be moved and then stretched until it provides guidance for the scope to advance further. The length needed for this enlargement is taken from the second bend of the S-shape. Thereby the bending radius of the second bend will be reduced making the bend too acute to advance through it by pushing at the scope. In such cases it is always needed to perform some straightening manoeuvres, which can cost a lot of time and effort. Another problem, actually the underlying cause of the first two, is that the pushing forces applied to the end of the scope cannot be properly transmitted to the scope tip through the scope shaft when the scope is bended. The pushing forces will have to be guided by the colonic wall. This means that pushing forces are applied to the colonic wall, causing it to move or to deform, which is often unwanted. In conclusion, all difficulties seem to arise from the necessity to push against the end of the shaft of the colonoscope while the flexible colon is not stiff enough to force the scope to follow the curvature of the colon. The solution to the insertion problems will lie in solving one or more of the causes by: Making the scope follow the shape the colon easier. Making the colon provide better guidance to the scope. Preventing the scope from excessive pushing against the colonic wall.
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3.4
Pain
In Section 2.1.2 three mechanical causes of pain during colonoscopies were listed: In order to keep the lumen open, air is blown into the colon. Inflating too much causes an unpleasant wind pain (the same kind of pain that is felt when an accumulation of gas is present in the colon). When inserting the colonoscope, some looping is inevitable. Thereby the colon will be stretched as well as the peritoneum and the ligaments that suspend the colon. During excessive looping the patient experiences unpleasant wind pain. When removing loops or straightening the colon, the scope tip is hooked around a bend where after the scope is pulled back. This causes high pull forces on the ligaments.
The colon is flat and crumpled when empty. When food or faeces are transported through the colon or when an amount of gas builds up, its diameter increases and thus the circumference of the intersection increases. This natural stretching of the colonic wall can hurt quite a lot. To advance a scope through the colon, the colon has to be inflated to have a proper view and more freedom of movement. To inflate the colon, air or carbon dioxide is used. For the patient this feels the same as an accumulation of natural gas in the colon. Inflating the colon too much can cause a considerably unpleasant pain to the patient. Stretching of the colonic wall in the direction of its circumference is called transversal stretching. Excessive transversal stretching can be dangerous because when the colonic wall is stretched it also becomes thinner and tensioned, which increases the risk of perforation of the colonic wall. Longitudinal stretching is the stretching of the colon in the direction of its length. When inflating the colon it is also stretched in the longitudinal direction locally. This effect is comparable to inflating a balloon. Transversal and longitudinal stretching and the thereby occurring stresses (T and L respectively) by inflation are illustrated in Figure 3.20.
Fig. 3.20: Longitudinal and transversal stretching and stresses () resulting from inflation of the colon.
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From literature (see Chapter 2), attendance during colonoscopies and discussions with expert endoscopist it became clear that the sigmoid colon is the most difficult part of the colon to advance through with a conventional scope. It is also clear that looping of the sigmoid colon almost always occurs. It is not quite clear though, whether the sigmoid colon is stretched beyond its natural unfolded length when it is forced into a loop (Figure 3.21) or just unfolded. In each of the four studied cadavers (see Section 3.2.2) the, free hanging, sigmoid colon had a length of about 30 cm. This complies with the measurements on the sigmoid colon by Bhatnagar et al. in [Bhatnagar et al. 2004] where the sigmoid colon length in cadavers was measured to be 28 +/- 7.6 cm. Bhatnagar et al. measured the average unfolded sigmoid colon length in live subjects to be 44.4 cm in females and 48.6 cm in males. The two attachment points of the sigmoid colon, the rectum and the start of the descending colon, lie about 20 cm apart when measured in a straight line.
Fig. 3.21: Sigmoid length before (left) and after (right) unfolding and stretching by looped colonoscope.
To determine whether the sigmoid colon will be stretched beyond its natural unfolded length during looping, a hypothetical case will be discussed next. A sigmoid colon has a length of 50 cm and it is attached between the rectum and the descending colon, lying 20 cm apart. An inverse -loop is made in this sigmoid colon length between two attachment points lying 20 cm apart. The loop is made as large and as round as possible without stretching sigmoid colon beyond its natural unfolded length. The resulting loop will look like a circle lying on the straight line of 20 cm between the attachment points. The loop will have a circumference of 30 cm since there is only 30 cm left when 20 cm is used to span the distance between the two attachment points. The resulting configuration is shown in Figure 3.22. To find out whether the shape of the loop from Figure 3.22 can also be adopted by a colonoscope a conventional colonoscope Olympus CF Type 1301 has been forced into a loop as small as possible without damaging it by pulling at both ends of the scope shaft. The resulting loop has a circumference of about 30 cm (Figure 3.23). So in this ideal case the
Fig. 3.22: Sigmoid colon when not stretched and looped between its two attachment points.
Fig. 3.23: Colonoscope tube pulled into an -loop. The distance between two white markings is 10 cm. The diameter of the loop is about 10 cm.
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scope can adapt to the shape of the loop of Figure 3.22 without having to stretch the colonic wall beyond its natural unfolded length. Though to advance the scope when in this minimal bending radius is practically impossible. Since the colonic wall has to redirect the push forces to the longitudinal direction of the scope, the forces on the colonic wall will be very large when the scope is in a small loop. Also because of the scopes tendency to adopt a larger bending radius due to its stiffness. Since the colonic wall is very elastic it will be stretched further when push force is being applied to the scope. Therefore it is clear that when trying to advance the scope, the sigmoid colon will definitely be substantially stretched beyond its natural unfolded length before the scope will advance. Thus it is realistic to assume that longitudinal stretching will always occur when the sigmoid colon is forced into a loop or large bend. Especially since most sigmoid colons have an unfolded length that is less than 50 cm. Assuming that longitudinal stretching of the colon causes pain, there will always be some level of pain during conventional colonoscopy, depending on the sensitivity of the colon, on the properties of the colon and depending if the colon is just being unfolded or stretched even further. When the colon is moved or deformed, the peritoneum will also move. Since the peritoneum lies in large folds and is very loose it is not clear whether the peritoneum is being moved or is also being stretched during moving or deformation of the colon. Though it is known that during excessive stretching of the sigmoid colon the peritoneum can even torn. When the scope is being advanced through a bend, the force exerted on the wall by the scope stretches the bend. Had the bend not been constrained by its attachments it would just be pushed away by the scope. So the attachments have to give resistance to all the forces exerted on the piece of colon between to prevent it from displacing as a whole. Figure 3.5-B showed a force diagram of the sigmoid colon. There are reaction forces (Fr,#) in the fixating ligaments. So it is obvious that the fixating ligaments are being pulled at and are therefore stretched. Another example of ligament stretching is given in Figure 3.24a. It
Fig. 3.24: (a) Model of the lifting manoeuvre in the transverse colon, using the splenic flexure as a lever. Fpull is the pull force applied to the scope shaft. (b) Free body diagram of the model in (a), FResist is the resistive force of the transverse colon against lifting, Fup and Fdown are the upward directed and downward directed forces, exerted by the scope shaft on the colonic wall during the lifting manoeuvre.
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shows the situation where the transverse colon is being lifted while the splenic flexure is used as a lever. There is a pulling force Fpull applied to the scope shaft. In Figure 3.24b this configuration is split up in a free body diagram. The scope is removed and replaced by the forces it exerts on the tube wall. The tube is cut loose at its attachments and the reaction forces (FR#) are placed in the place of the fixation. At the place where the scope tip hooks into the colonic wall a pull force is placed and resistive forces (Fresist) are added to compensate for the resistance of the transverse colon against lifting. From Figure 3.24b it is obvious that during the lifting manoeuvre the suspending ligament will be pulled at and thus stretched. From the discussion above it becomes clear that there are four deformation types that occur during the insertion of a colonoscope and that these can be categorized like in Figure 3.25: ligament stretching, stretching of the colon in transversal and longitudinal directions and peritoneum stretching.
Fig. 3.25: Deformation types of the colon and its attachments during colonoscopy.
The colonic wall is insensible to touching. That is also the reason why for example removing polyps with wire loop resection can be done without anaesthesia. But it is known that the colon is sensitive to stretching. Very little is known about the colonic ligaments and their pain sensitivity. It is known that the ligaments on which the flexures are suspended are not really ligaments in the precise meaning of the word. Since they do not contain collagen it actually are peritoneal folds. It is known from literature and discussions with surgeons and endoscopists that the peritoneum is sensitive to stretching and touching. Therefore it is very likely that the suspending ligaments of the flexures are also sensitive to stretching. [Classen et
al.,2002, Ch.12; Marieb, 2004; Discussions with surgeons and endoscopists]
Peritoneum stretching can occur with every deformation of the colon. However, the peritoneum is also very loose. It has not yet been discovered whether stretching of the colon causes pain because of the sensitivity of the colonic wall itself or whether it causes pain due to the simultaneous stretching of the peritoneum. When the colon is only being slightly stretched out of its crumpled state there is no longitudinal stretching as long as the colon is not stretched further after it is unfolded. So when pain occurs during unfolding of the colon this can only be caused by stretching of the ligaments or the peritoneum or by over sensitivity of the colonic wall. It depends on the level of sensitivity of the colon and its suspending ligaments to each of the four deformation types stated above, which type of stretching causes the most pain. The pain level also depends on the amount of stretching (and thus on the force causing the stretching). Therefore, more research is needed on the exact causes of pain during colonoscopy. From the foregoing discussion it appears that to avoid the mechanical causes of pain there are three main problems that must be solved: Minimize the necessity to inflate or make inflation better controllable. Avoid looping and stretching of the colon. Avoid pulling on the ligaments.
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3.5
Discussion
The pain and insertion problems during colonoscopy all come forth from the combination of a compliant scope being inserted into an even floppier colon. During the insertion of a colonoscope four deformation types occur: Ligament stretching Transversal colon stretching Longitudinal colon stretching Peritoneum stretching
However, it is not yet known which occurs the most or causes the most pain, since there is no quantitative data about force distributions during colonoscope insertion available and a quantitative relation between the stretching types and pain is not available either. However, in conventional colonoscopy, using nowadays colonoscopes, excessive transversal colon stretching can be well avoided by using as little inflation as possible. Longitudinal colon stretching however is almost unavoidable, since advancing a push colonoscope through a curved flexible elastic tube will always cause some longitudinal stretching due to the push forces against the tube wall. Therefore, suspension stretching and peritoneum stretching are also unavoidable; since longitudinal colon stretching always causes pull forces in the ligaments and moving or stretching of the peritoneum as has been stated above. However, all stretching types can be limited by careful handling and by using the right manoeuvres in every situation. The main problem herein is that the endoscopist cannot see from the outside of the body what is happening inside and has mainly to handle on expertise and feeling. There are two methods to visualise the position and shape of the scope in the bowel: using ScopeGuide or fluoroscopy. However, these are not used very often since they are expensive, make the procedure preparations take more time and do not always provide much benefit. Though in some difficult situations with recurrent looping these techniques can help to make the procedure quick and easy. The first method makes use of an Olympus Video Endoscope with ScopeGuide technique. ScopeGuide is an Olympus product, which displays real time images of the position and 3D-shape of the scope, which uses magnetic fields, generated by small coils that are built inside the scope, which are picked up by an antenna. The data is than used by the computer to create a schematic 3D-image of the scope on a display. The second method makes use of fluoroscopy in combination with colonoscopy. This technique uses X-ray to obtain live 2D-images of the abdomen to visualize the colon and the scope in it. A disadvantage of this technique is that it only generates 2D-images and makes use of radioactive and thus harmful radiation. As a result fluoroscopy was soon abandoned as an assisting means to colonoscopy. [Classen et al.,2002, Ch.(4,12); Waye et al.,2003, Ch.29; Marieb, 2004;
www.olympus-europa.com/medical/, 2005]
Visualizing the configuration of the scope during a colonoscopy can help the endoscopist to perform the right actions at the right moments. However, it does not solve the problems of looping and stretching that where stated in Sections 3.3 and 3.4. Three solutions to avoid all types of stretching have been stated in Section 3.4. However, looping and stretching of the colon and pulling on the ligaments will also be avoided when the solutions of Section 3.3 are being followed. Therefore, solving insertion problems and preventing pain can be achieved by following the four directions to solutions, advised by the author, that are stated below: Minimizing the necessity to inflate or make inflation better controllable. Making the scope follow the shape the colon easier. Making the colon provide better guidance to the scope. Preventing the scope from excessive pushing against the colonic wall.
At the end of this discussion it is clear that there are reasons and possibilities enough to develop an instrument that will not excessively stretch the colonic wall and will not form large bends or loops, thereby making colonoscopies easier for the endoscopist and less uncomfortable for the patient.
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44
State of the art in invasive colonoscopy

Since it becomes more and more clear that the device that is currently being used for colonoscopy has many disadvantages, much research is being done on the design of new colonoscopic devices. Most activity on this topic is found in Europe, the USA and Japan. As discussed in Chapter 1, there are some non-invasive alternatives to colonoscopy. But these all have the lack of therapeutic possibilities as main common disadvantage. Invasive colonoscopic devices, equipped with working channels have more (therapeutic) possibilities. This prevents, for example, from having patients to return to the hospital when polyps have been found, because these can be removed during the same procedure. Many patents and publications can be found on invasive colonoscopic devices, ranging from supporting over-tubes to self-propelling colonoscopes and colon inspection micro robots. The author performed a patent study to search for devices that might provide a good alternative to the conventional colonoscope. Therefore, devices are looked for that (partly) comply with the four directions to solutions that where stated in Section 3.5. Even when designing a diagnostic colonoscopic device it is desirable to have some working channel extending to the exterior of the patient. This working channel can be used to suck or insert water or air from or into the colon, or to take biopsies. It also provides some safety in case the (self-propelling) device gets defect. In such a case the device can be pulled out by pulling at the working channel that than serves as a livewire. The presence of a flexible tube, hanging behind the device, also eliminates the necessity to equip a small device with autonomous power supply, light source and air or water tanks. Al sources can be supplied from the outside through cables or channels in the flexible tube. For all these reasons, this overview will confine to patents on mechanisms that are not wireless and are inserted through the anus. Even though there are some very promising and interesting developments in wireless intestine inspection devices. For those who are interested in wireless colonoscopic techniques the author refers to [Classen et al.,2002, Ch.(4); Byungkyu et al., 2005; Ouchi, 2003; Kim et al., 2003 ]. Wired internal colonoscopic devices, other than nowadays colonoscopes have been categorized by the author as shown in Figure 4.1. Each group of devices provides a solution to one or more of the problems stated in Chapters 2 and 3. The sets of shaded boxes under each group indicate which directions to solutions on pain or insertion problems this group covers. The group passive shape guidance has two of these sets because devices in this group are only inserted after advancing the scope trough the colon and after straightening torturous curves. So these devices only prevent for recurrent looping. The active shape control devices are not self-propelling but also do not push against the colonic wall. A more detailed description of shape-memory mechanisms will be given in Section 4.1. Selfpropelling mechanisms will be discussed in Section 4.2. In Figure 4.1 it appears like none of the groups minimizes the necessity to inflate. But in fact, it could be that some of the self-propelling mechanisms do. Though, it is not known what influence each device has on the necessity to inflate. In principle, some inflation is always needed to have a proper view and to have some space to manoeuvre or perform therapeutic actions in. Further more, none of these devices has been specially designed to minimize the necessity to inflate and neither has some automated inflation control.
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Fig. 4.1: Categorization of wired internal colonoscopic devices and the partial solutions each provides.
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4.1
Shape-memory mechanisms
Passive shape guidance mechanisms are mostly designed as overtubes either selectively stiffened or with a constant stiffness. The colonoscope has to be negotiated through one or more bends and when this has been done successfully, a stiffer overtube is slit over the scope shaft to keep it in the desired form. After that the scope is further advanced while supported by the overtube. One of the most basic types of overtubes is the type described in [Butler et al., 2004]. It is a colonic overtube, consisting of a ribbed tube, significantly stiffer than the scope, with a lumen for the scope. On its distal end there is a tubular sheet of film to provide a safe connection between the overtube and the scope and to prevent colonic tissue from getting stuck between the overtube and the scope. This overtube is to be inserted when the scope has been advanced through the sigmoid colon and the sigmoid colon has been straightened. After insertion the scope can move through the overtube and the overtube prevents from recurrent looping (Figure 4.2). This means that it is still necessary to first negotiate through the torturous curves of the sigmoid colon. So this does not prevent from the formation of loops as described in Chapters 2 and 3.
4.1.1 Passive shape guidance
Fig. 4.2: (a) colonic overtube put on scope; (b) colonic overtube in straightened sigmoid colon with scope advanced up to transverse colon. (Adopted from [Butler et al., 2004], modified by the author)
Already in 1989 the German Peter Bauerfeind claimed a much more advanced type of overtube as described in [Bauerfeind, 1989] and later with some new developments in [Bauerfeind and Bauerfeind, 1994]. The overtube (see Figure 4.3) described herein consists of an outer tube with an inner tube in it and an intermediate space between those. The overtube is inserted with the scope in it. In steps the scope is advanced around a bend and then the overtube is shoved over the scope until it is near the scope tip. Then the scope is advanced again and when needed, the overtube is being advanced too, and so on. This overtube has an advanced, and thus expensive, system to control the rigidity of the tube. The outer tube is flexible but cannot be expanded in radial direction; the inner tube is also flexible and can be deformed radial inwardly by introducing fluid in the intermediate space. Controlling the fluid in the intermediate space is done via the control box shown in Figure 4.3a. On the inner wall of the outer tube are curved parts with teeth that fit in the teeth of a toothed part on the inner tube outer wall. When the intermediate space is evacuated, the inner tube is pressed against the outer tube by its own elasticity and by the suction in the intermediate space. This causes the teeth of the inner tube and the outer tube to connect. The toothed parts cannot slide over each other so the curvature of the overtube is locked and thus the overtube is made stiff in the configuration it than has. Now the scope can be advanced without recurrent looping, supported by the overtube that shields the colonic wall. When another bend is passed, the overtube can be unlocked by introducing fluid in the intermediate space and the overtube can be advanced further over the scope. When the desired position is reached, the overtube can be locked again by evacuating the intermediate space and so on.
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Though this device seems to work well, its complexity makes it expensive and the colonoscope still has to be negotiated around each bend first. This can be facilitated by frequently advancing the overtube so that the scope is always supported and will not push against bends. However, this will slow down the intervention and will thus induce more costs.
Fig. 4.3: (a) Overtube with variable rigidity and controller; (b) Overtube and colonoscope in colon; (c) Section of the overtube; (Numbered parts: 14 Overtube; 16 Inner tube; 18 Outer tube; 20 Intermediate space; 82 Ring on inner tube; 86 Ring in outer tube; 88 Contact teeth of outer ring; 90 Teeth on inner ring; 92 Contact teeth on inner ring.) (Adopted from [Bauerfeind and Bauerfeind, 1994], modified by the author)
Another guiding overtube stiffening mechanism is described in [Saadat et al., 2004] and an improved version in [Ewers et al., 2005]. This device uses a trail of small nestable elements (see Figure 4.4b) placed in the overtube that rotate on each other like a pile of half sphere shaped
Fig. 4.4: (a) Stiffenable overtube for colonoscope; (b) Detail of nestable elements and tension wires. (Numbered parts: 1 Entrance of colonoscope; 2 Pistol grip for stiffening control; 3 Stiffenable overtube; 4 A-traumatic tip; 5 Nestable elements; 6 Tension wires) (Adopted from [Ewers et al., 2005], edited by the author)
cups. On these elements a tension wire is attached so that when the wires are pulled on, the small elements are pressed against each other and relative movement of the elements becomes blocked by the friction between the elements. Different shapes of nestable elements can be used and some are described in the patent. This device can be stiffened
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and loosened very quickly and easily with the pistol grip shown in Figure 4.4a. This device also has to be advanced after the scope has been advanced some distance. Because it can be stiffened and loosened quick and easy, it might facilitate scope insertion since the scope insertion and overtube advancement can be alternated quickly and thus small, easy insertion steps can be taken. But it is questionable whether the friction between the small nest-able elements is high enough to stiffen the overtube when it is inserted as far as up to the hepatic flexure. Guiding overtubes create a risk of colonic wall perforation since colonic tissue can become stuck between the overtube and the scope. Therefore most patents also include some kind of a-traumatic tip. Tartaglia et al. came up with a smart solution by putting a shape guiding mechanism inside the working channel of the scope [Tartaglia et al., 2005]. The shape guiding mechanism in this device is stiffened like in the one of [Ewers et al., 2005], with a tension wire. It also consists of nested elements. Depending on the chosen lumen in the colonoscope, a construction with one or two shape guiding mechanisms can be applied. Figure 4.5a-c shows an embodiment with two guiding mechanisms being inserted in a flexible tube and Figure 4.5d-f shows different views of a variant of nested elements and the tension wire.
Fig. 4.5: (a-c) Scope with double guiding mechanism to alternate quicker; (d-f) Diagonal section, side view and longitudinal section of a trail of nested elements with the guiding wire in it. (Numbered parts: 1 First guiding mechanism; 2 Second guiding mechanism; 3 Colonoscope; 4 Front of colonoscope tip; 5 Colon) (Adopted from [Tartaglia et al., 2005], modified by the author)
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4.1.2 Active shape control

Active shape control mechanisms are shape memory mechanisms in which the shape of the colonoscope is actively controlled while advancing through the colon. The entire shaft follows the path of the tip, without having to stiffen and loosen a guiding element. This results in a snakelike motion. The first active shape control mechanism was patented in 1977 by Seufert et al. [Seufert et al., 2005]. This very complex device contains a train of articulated segments with magnetic clutches controlling the angular displacement of each segment (Figure 4.6a). The device has a flexible controllable tip and the angle of the leading element is automatically repeated in the following elements when advancing into the colon or other body cavity. Activation of small electromagnets on the surface of each element lets it attract the next element and makes it rotate relative to the longitudinal axis when only attracting on one side (Figure 4.6b and 4.6c). There is a central lumen in the elements so that instruments can be inserted and wires or channels can be put into it. The design that is claimed in this patent is promising. But it questionable whether the small magnets will provide enough strength to keep the angles when the device is not supported along its length. Especially the elements in the proximal part will have to be very strong since when angling upwards at the beginning of the shaft, the entire distal part (measuring up to 1.50m) of the shaft has to be lifted by a very small electromagnet. Furthermore this device will be very expensive since it is filled up with numerous small elements and electromagnets, each separately controlled.
Fig. 4.6: (a) Partially cut through image of the distal end of a shape memory controlled instrument carrier for endoscopic procedures in unsupported cavities. (b) Detail of nested elements with electromagnets. (c) Train of nested elements and the correlation between the individual angles of the elements and the curvature of the train. (Numbered parts: 2 Nested element; 2A Concave top plane of nested element; 26a Electromagnet on concave plane of nested element; 26b Electromagnet on convex plane of nested element; 30 Lumen) (Adopted from [Seufert et al. 2005], modified by the author)
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Another shape-controlled mechanism was proposed by Belson et al. in [Belson et al., 2003] and improved in [Ohline et al., 2005]. This mechanism is controlled in almost the same way as the mechanism described in [Seufert et al., 2005]. It has a selectively controllable distal portion and a train of segments following the pathway of the tip (see Figure 4.7a), controlled by a motion controller. But in this device, an element is not angled with magnets but with two or more tension wires as shown in Figure 4.7b. The elements are vertebra type rings like illustrated in Figure 4.7c and have one or more lumens to provide working channels for instruments. A drawback of this invention is that each controlled element needs at least two tension wires. When the controlled segments are small enough to negotiate through sharp curves, the number of tension wires necessary becomes enormous. Therefore the proximal part of the instrument shaft should have a bigger diameter. This also provides a better base to lift the distal part and can thus be advantageous for the design.
Fig. 4.7: (a) Portion of a steerable segmented endoscope. The segments are numbered to give a proper distinction. (b) Vertebra type elements. (c) An example of a distal portion controlled by three tension wires and three methods to control the angulations of an element by using (2) two tension wires and a spring; (3) three tension wires or (4) four tension wires. (Adopted from [Belson et al.,2003; Ohline et al., 2005], modified by the author)
4.2
Self-propelling mechanisms
The first self-propelled endoscopic device was an early inchworm system, described in It is a flexible tube with two inflatable, radially expandable members on it (Figure 4.8). The distal expandable member pushes the tube forward when inflated. The proximal member is inflated to anchor the device before deflating the distal member and has a surface with higher gripping properties than the distal member. When the distal member is deflated, it also shifts back to the distal end of the tube. Just before inflating the distal member to take a step forward, the anchoring proximal member is deflated. When repeating this cycle, a stepwise progression is achieved. This stepwise progression is also illustrated in Figure 4.9.
4.2.1 Clamp/slide locomotion

[Choy, 1975].
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Fig. 4.7: (a) Inchworm mechanism before push-off. (b) After push-off, the inflated distal cuff is still in position and the rest of the device has advanced the length of the arrow. (Numbered parts: 1 Proximal- 2 Distal inflatable radial expandable cuff) (Adopted from [Choy, 1975], modified by the author)
In [Krasner and DiBenedetto, 1987] an improved inchworm system is described. This device, moving in an inchworm way, also has two inflatable, radial expandable members and is placed on the distal shaft of a conventional endoscope. The proximal member (cuff) can slide over the shaft of the instrument, towards or away from the distal cuff. The distal cuff is fixed on the shaft. By inflating one of the cuffs and expanding the section between the cuffs, the scope can be advanced step by step (Figure 4.10b illustrates this inchworm movement for another inchworm mechanism). This device is an improved version of the one proposed by Lyddy et al. in 1979 and improved in [Lyddy et al., 1987]. The main difference between these patents is that Lyddy et al. described the mechanism in more detail and Lyddy et al.s inchworm system does not have a protective sheet between the two cuffs (see Figure 4.9).
Fig. 4.9: Inchworm mechanisms for a self-propelling colonoscope by Krasner and DiBenedetto and by Lyddy. (Numbered parts: 1 Proximal cuff; 2 Median part; 3 Distal cuff) (Adobpted from [Krasner and DiBenedetto, 1987; Lyddy et al., 1987], modified by the author)
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A controllable, very complex inchworm robot with many sensors was proposed in This device uses a long trail of cuffs. Each cuff can be inflated, deflated and shifted selectively and between each two cuffs the device can be angled. This way the device can be manoeuvred through a tortuous tube in a fully controllable way. It is a complex, expensive system and it is not clear what benefits come with the enlarged amount of cuffs. A new device, eliminating the need of a conventional endoscope, is described in [Ortiz et al., 1995]. This device consists of a distal, a median and a proximal part with an inflatable cuff on the distal and proximal part (see Figure 4.10a). Between the distal and the median part a controllable coupler mechanism is placed. This is used to angle the distal part in two directions so that curves can be advanced through. In the median section a bellows is placed which can be shortened or elongated by either deflating or inflating it. The proximal cuff is attached to the bellows. In the starting position the distal cuff is inflated to secure the position of the tip in the lumen of the body cavity. When the bellows is shortened, by deflating it, the proximal cuff is pulled towards the distal end of the device. By inflating the proximal cuff it is secured against the wall in the lumen of the body cavity. If the distal cuff is deflated and the bellows is inflated next, the device is pushed forward into the cavity. To start a new step, the distal cuff is inflated and the proximal cuff is pulled to the distal end again. During the advancement of the device. Figure 4.10b illustrates this motion cycle.
[Grundfest et al., 1994].
Fig. 4.10: (a) Trans-sectional view of inchworm mechanism self-propelling endoscope. (b) Motion cycle. (c) Exploded view of the distal part. (Numbered parts: 1 Proximal cuff; 2 Median bellows; 3 Controllable angling mechanism; 4 Distal cuff; 5 Atraumatic tip; 6 Cone shaped reflector to look sideways; 7 Glass fibres and cables for CCD) (Adopted from [Ortiz et al., 1995], modified by the author)
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The distal tip of the instrument (Figure 4.10c) has an a-traumatic shape to slide easily through a body cavity, like a colon, without damaging it. In the distal tip, a CCD camera has been placed. It can be used to look forward. However, when building a cone shaped reflector in the tip, it can also be used to look sideways. The angulations of the distal tip are being controlled with shape memory alloy elements. More about shape memory alloys and the control of shape memory alloy mechanisms can be found in [MacGregor, 2003; Byungkyu et al. 2005]. A drawback of the inchworm devices with balloons is that they all stretch the colonic wall by inflating the balloons grasp in a shape-closed way. In Chapter 3 it was shown that transversal and longitudinal stretching of the colonic wall can cause pain to the patient. In [Dario et al., 1999] Dario et al. proposed an inchworm mechanism that uses suction to anchor itself instead of inflating cuffs. This is a force-closed attachment instead of a shape-closed attachment and secures the grip without stretching the colonic wall. The device (see Figure 4.11) has a proximal, median and a distal part. The proximal and distal parts both have a perforated surface for aspiration means. By selectively applying suction through these perforations, the colonic wall can be sucked against the proximal or distal part. The median part is a variable length element that has the same function as, for example, in [Krasner et al., 1987].
Fig. 4.11: Inchworm mechanism with suction clamping. (Numbered parts: 1 Proximal part with aspiration holes; 2 Median part with variable length, selectively controllable; 3 Distal part with aspiration holes) (Adopted from [Dario et al., 1999], modified by the author)
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Another device to push off against the colonic wall is proposed in [Meiri et al., 1980]. It is a sleeve that is placed on the colonoscope. The sleeve has an annular chamber with an elastic outer wall with small, hollow protrusions. When fluid under pressure is introduced in the chamber, the hollow protrusions extrude outwards and backwards and will push against the colonic wall, making the colonoscope advance forwardly. When the chamber is evacuated, the protrusions retract inwardly and forwardly, thus preparing for the next step. This device looks simple and might work when the protrusions extrude far enough. However, in this patent the protrusions seem too small to generate the desired motion (see Figure 4.12). While most inchworm mechanisms use inflatable cuffs, Ng et al. designed a device using small legs to clamp and push off against the Fig. 4.12: Colonoscope advancing device with The device is colonic wall (see Figure 4.13a). It is a device, extendable legs. legs are extendedplaced over a colonoscope. The by pressurized consisting of a train of segments with controllable fluid and push the device forward. joints in between them. On each segment, a (Adopted from [Meiri et al., 1980], modified by the author) number of (telescopic or inflatable) legs are placed which can be shoved out (Figure 4.13b) to push off against the colonic wall and create a forward motion of the device. The legs can be rotated to reverse the direction of motion as can be seen in Figure 4.13c. When moving forward, actuating the legs from most proximal leg to most distal leg in a sine wave pattern can create a continuous motion. Which is a big improvement compared to the stepwise motion of the inchworm mechanisms that were discussed before.
Fig. 4.13: (a) Endoscopic device using legs to push itself forward. (b) Cross sectional view of the front part and two elements. (c) Detail of an element and its legs. (Numbered parts: 1 Leg; 2 Controllable joint; 3 Lumen for cables and instruments; 4 Extendable leg; 5 Pressure supply for legs) (Adopted from [Meiri et al., 1980], modified by the author)
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In [Chiel et al., 2004] a device is proposed that has a large resemblance with the inchworm mechanisms discussed before. Though by combining more inflatable cuffs and by using another control method, a more continuous motion is created than can be achieved with the inchworm mechanisms with only two cuffs or two clamping elements. In this patent, three cuffs are used as an example (see Figure 4.14). With three cuffs the motion will still be stepwise but with longer strokes than when using the standard inchworm principle. Using even more than three cuffs will further enlarge the stroke length, smoothen the motion and improve the insertion speed.
Fig. 4.14: From top to bottom, the six steps of a motion cycle of a three-cuffs inchworm type clamp-slide mechanism. (Numbered parts: 1 Flexible tube containing channels for instruments, air, controls and pressurized fluid; 2 Most proximal cuff; 3 Middle cuff; 4 Most distal cuff; 5 Distal tip of the device; 6 Stroke length of a mechanism with one anchor cuff and one moving cuff; 7 Stroke length of three-cuffs device) (Adopted from [Chiel et al., 2004], modified by the author)
4.2.2 Peristaltic locomotion

All clamp-slide locomotive devices and most of the shape memory mechanisms produce a intermittent motion with short strokes. When transporting a bolus of digested food, the colon creates a more or less continuous motion by using peristaltic contractions to push the bolus forward. This type of motion can also be used to advance a scope through the colon or any other body cavity with contractive tissue. In [Mosse et al., 2004] a device is proposed that uses the peristalsis of the colon to advance through the colon. Camera pills and resembling devices that use the natural peristalsis to travel through the intestines have already been produced and used. However, these devices are transported in the same way as a bolus of food and can therefore not be controlled. The device of Mosse et al. selectively induces peristaltic contractions in the colon and can thus be moved forwards or backwards at will. The device (see Figure 4.15) is dimensioned to fit in the colon and have contact with the colonic walls. On its shell electrodes are placed. One
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pair of electrodes is used to move the device backwards; the other pair is used for forward motion. When the electrodes activate the colonic wall it will contract at the position of the activated electrodes and thereby transport the device by induced peristalsis. On the tail of the device a flexible tube is attached to provide a lumen for cables, air and instruments. In case of a defect or an emergency, this tube can also be used to slowly pull out the device.
Fig. 4.15: Self-propelling lumen travelling device using induced peristalsis. (Numbered parts: 1 Contractile tissue; 2 Forward direction of motion; 3 Body of the device; 4 Electrodes for electro stimulation to create forward motion; 5 Electrodes for electro stimulation to create backward motion; 6 Flexible tube containing working channel for instruments, air channels and wires for electronics; 7 Nose of the device with exit hole for instruments and window for camera view) (Adopted from [Mosse et al., 2004], modified by the author)
Long et al. published a similar device in [Long et al., 2005] but this device only has electrodes for forward motion (see Figure 4.16). Apparently, retrieving the instrument has to be done by pulling on the tube that hangs behind the self-propelling device. This tube also contains the working channel for instruments and air. The motion of the device is controlled through controlling the electrical stimulation frequency and current amplitude. A major disadvantage of these devices is that there is no possibility to look backwards or to look behind folds. Furthermore, inducing peristalsis by eloctronic pulses appeared to induce mass contractions of the colon, making the device uncontrollable, and to cause painful cramps to the patient.
Fig. 4.16: Self-propelling lumen travelling device using colonic peristalsis induced by two electrodes. (Numbered parts: 1 Tip of the self-propelling device; 2 Electrode; 3 Electrode; 4 Tail of the selfpropelling device; 5 Flexible tube; 6 Air suction or aspiration channel; 7 Working channel for instruments; 8 Electric wires for electrodes) (Adopted from [Long et al., 2005], modified by the author)
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4.2.3 Rolling locomotion

Since the invention of the wheel, mankind has made al sorts of transportation means, propelled by or rolling on wheels. So since ancient times we are used to rolling locomotion. In the area of self-propelling colonoscopes there are also several designs using a rolling locomotion mechanism. Rolling locomotion gives a continuous motion if there is no slip and excessive stretching of the colonic wall will be prevented. Takada patented a self-propelling colonoscope using rolling, endless belts in 1996 [Takada, 1996]. He improved the design and patented it again in 2000 [Takada, 2000] and again together with a cleaning method for the device in 2001 [Takada, 2001].
Fig. 4.17: (a) Partially cross sectional view of belt driven self-propelled colonoscope. (b) Distal part of the flexible tube with endless belts. (c) Cross sectional view of the distal part of the flexible tube with endless belts. (Numbered parts: 1 Scope tip; 2 Bending section; 3 Flexible section; 4 Control housing; 5 Connecting tube; 6 Glass fibre light source; 7 Endless belt; 8 Guiding hook; 9 Guiding tube; 10 Guiding hole; 11 Video CCD; 12 Inside area of flexible section) (Adopted from [Takada, 2000], modified by the author)
The device is a colonoscope with endless belts running over the exterior of the flexible colonoscope tube to the control part in which the driving mechanism is enclosed (see Figure 4.17). The endless belts act like the tracks of a tank. At the distal end of the flexible tube is a controllable tip, like in conventional colonoscopes. The belts are in frictional contact with the colonic wall and by driving the belts the scope is advanced into the colon. To prevent the belts from becoming loose when the flexible part bends the belts are supported by guiding hooks. The belts should provide high frictional contact with the colonic wall to make this mechanism working. The colon does not have a constant diameter and has many irregularities. Therefore a positive point to this device is the very long contact area between the colonic wall and the belts extending over the full length of the scope tube. However, since it uses very thin belts, the contact area in circumference is quite small. Furthermore, tissue could get stuck between the belts and the guiding hooks or can be pulled with the belts into the guiding holes, resulting in dangerous damaging of the colonic wall, like perforations. In [Kim et al., 2003] a car-like micro robot for colonoscopy is treated. The device, shown in Figure 4.18, is wireless but could also be equipped with a flexible tube at its rear, providing
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safety and power, light and air supply from outside the patient. It has a body consisting of two parts pivoting in the connecting pivot between them. Around this pivot point are supporting units to provide an easy and safe advancement through the colon without the risk of tissue getting stuck between the distal and proximal body parts. Steering is controlled with shape memory alloy actuators and electro motors actuate the wheels of the device. On the nose of the device two passive steering wheels are placed to make the device follow the curves of the colon. In the centre of these wheels are sensors that measure the pressure exerted on the colonic wall and then control the active steering of the device. In the nose of the device a camera and light source are placed. When a stable positioning of the device is needed the supporting units can be pushed outwards by contracting the fixing linear actuators as is shown in Figure 4.18c. With some alterations, this device could also be equipped with a working channel for therapeutic actions. It is questionable though if the simple wheels will be able to propel this device through the colon since the colon is very slippery and irregularly shaped.
Fig. 4.18: Micro robot for colonoscopy; (a) advancing through a curve in a colon; (b) advancing through a stricture; (c) securing position by putting out the supporting units. (Numbered parts: 1 Passive steering wheels; 2 Supporting units; 3 Colonic wall; 4 Wheels of proximal part; 5 Active steering linear actuators; 6 Fixing linear actuators; Wheels of distal part; 8 Camera and light source) (Adopted from [Kim et al., 2003], modified by the author)
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One of the latest developments in rolling locomotive intestine inspection devices has been designed in the research group Man Machine Systems of the faculty Mechanical Engineering of the Delft University of Technology. It is described in [Breedveld et al., 2004] and was developed as an improvement of a rolling caterpillar device that used six tracks to propel (Figure 4.19). In [Flynn et al., 1998] it was shown that rotating devices often cause damage to the colonic wall. One of the causes is the gap between the parts. This creates the possibility for tissue to get stuck between the rotating parts. Furthermore, the propulsion is not optimal either since only a part of the circumference of the device is covered by the propelling Fig. 4.19: Rolling caterpillar device. (Adopted from [Breedveld et al., 2004]) tracks, leaving a big potential contact area unused. So a solution had to be found to increase the circumferential contact area and minimise the gaps between the tracks. The final design of Breedveld et al. exists of a donut constructed of three stents (a biomedical alloy gaze tube with spring-like characteristics having good frictional properties on the colonic wall), used to propel the device. The stents are driven by cables and mounted around a tube with light source, camera and working channel(s). The diameter of the propelling donut can be varied by pulling back or by elongating the driving cables since the spring characteristics of the stents will allow it to vary its diameter. This makes it possible to adapt the device to the diameter of the colon. Figure 4.20 shows the tip of this Rolling-Stent Endoscope. It is clear that the contact area has been maximised and the gaps have been minimised. Although this is a very promising design, one point of concern to the author is that the driving cables of the donut parts are not shielded and tissue might get stuck between them. This will have to be studied upon or solved before using the device in patients.
Fig. 4.20: (a) Side view of Rolling-Stent Endoscope. (b) Frontal view. (c) Cross section of driving mechanism. (Numbered parts: 1 Rolling-stent; 2 Driving wire; 3 Tip with camera, light and opening of working channel; 4 Steering wires) (Adopted from [Breedveld et al, 2004], modified by the author)
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Conclusions
At the end of this study, the main goals have been achieved. The first goal was to [1] find the fundamental causes of insertion problems and pain during conventional colonoscopy. These have been found through an analysis of the insertion problems and pain that occur in colonoscopy with the conventional colonoscopes from different perspectives. As a result, four main problem areas have been identified of which the S-shaped sigmoid colon causes the most difficulties. Insertion problems and deformation mechanisms of the colon in these areas have been described and four deformation types of the colon and the peritoneum it lies in have been found, knowing: Ligament stretching Transversal colon stretching Longitudinal colon stretching Peritoneum stretching
Each of these stretching types does occur during conventional colonoscopy. However, it is not yet known which occurs the most or causes the most pain, since there is no quantitative data about force distributions during colonoscope insertion available and a quantitative relation between the stretching types and pain is not available either. Directions to solutions to prevent the causes of insertion problems and to prevent the causes of pain have been stated by the author and are combined and listed below: Minimizing the necessity to inflate or make inflation better controllable. Making the scope follow the shape the colon easier. Making the colon provide better guidance to the scope. Preventing the scope from excessive pushing against the colonic wall.
To [2] find out whether there already are new devices that provide an alternative for conventional colonoscopes a patent study on alternative colonoscopic devices has been performed. For this, al interesting, new devices have been categorized into two main areas: shape-memory mechanisms and self-propelling mechanisms. Many promising devices have been found but a complete alternative to nowadays colonoscopy has not yet been found. Passive shape guiding mechanisms only prevent for recurrent looping. Active shape control devices are too complicated to be realised yet. Clamp-slide locomotion can be used if the stroke length can be made large enough. To use peristaltic locomotion, a good control of the colonic peristalsis must be obtained. Rolling locomotive devices should be improved to guarantee safety and make sure that slipping does not occur. The insertion problems and possible pain causes in colonoscopy have been identified and a complete alternative to conventional colonoscopy has not yet been found.
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References
Bauerfeind Peter and Bauerfeind Herbert, Tubular inserting device with variable rigidity, US Patent No.5,337,733, August 16, 1994, 11p. Bauerfeind Peter, Einfhrvorrichtung fr schlauchfrmige fiberoptische Instrumente, insbes. Kolonoskope, Patentchrift No.DE3935256 C1, October 23, 1989, 8 p. Belson Amir, DeWitt Frey Paul, Mcelhaney Christine Wei Hsien, et al., Steerable segmented endoscope and method of insertion, US Patent No.6,610,007 B2, August 26, 2003, 25 p. Bhatnagar B.N.S., Sharma C.L.N., Gupta S.N., et al., Study on the anatomical dimensions of the human sigmoid colon, Clinical Anatomy, 17, 2004, pp.236-243. Breedveld Paul, van der Kouwe Danille E., van Gork Maria A.J., Locomotion through the intestine by means of rolling stents, ASME Design Engineering Technical Conferences and Computers and Information in Engineering Conference, Paper DETC2004/MECH-57380, Salt Lake City, Utah, USA, September 28-October 2, 2004, 7p. Shah S.G., Brooker J.C., Williams C.B., et al., The variable stiffness colonoscope: assessment of efficacy by magnetic endoscope imaging., Gastrointestinal Endoscopy, 56(2), August 2005, pp.195-201. Butler John, Bonadio Frank, Gill Aoibheann, et al., Colonic overtube, US Patent No.6,793,621 B2, September 21, 2004, 39 p. Byungkyu Kim, Sunghak Lee, Jong Heong Park, et al., Design and fabrication of a locomotive Mechanism for capsule-type endoscopes using chape memory alloys (SMAs), IEEE/ASME Transactions on mechatronics, 10(1), February 2005, pp.77-86. Chiel Hillel J., Quin Roger D., Beer Randall D. and Mangan Elizabeth D., Peristaltically selfpropelled endoscopic device, US Patent No.6,764,441 B2, July 20, 2004, 28 p. Choy Daniel S.J., Self propelled conduit traversing device, US Patent No.3,895,637, July 22, 1975, 5 p. Classen M., Tytgat G.N.J. and Lightdale C.J., Gastroenterological Endoscopy, 2002, 799 p. Dario Paolo, Carrozza Maria Chiara, Pietrabissa Andrea, et al., Endoscopic robot, US Patent No.5,906,591, May 25, 1999, 8 p. Ewers Richard C., Saadat Vahid and Chen Eugene G., Shape lockable apparatus and method for advancing an instrument through unsupported anatomy, US Patent No.6,837,847 B2, January 4, 2005, 25 p. Flynn A.M., Udayakumar K.R., Barrett D.S. et al., Tomorrows surgery: micromotors and microrobots for minimally invasive procedures, Minimally Invasive Surgery & Allied Technologies, 7(4), 1998, pp. 343-352
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Grundfest Warren S., Burdick IV Jowel W. and Slatkin Andrew B., Robotic Endoscopy, US Patent No.5,337,732, August 16, 1994, 7 p. Helm van der, Reader Biomechatronics, 2003, 143 p. Kim et al., Micro-robot for colonoscope with motor locomotion and system for colonoscope using the same, US Patent No.6,648,814 B2, November 18, 2003, 18 p. Krasner Jerome L. and DiBenedetto John P., Medical apparatus having inflatable cuffs and a middle expandable section, US Patent No.4,676,228, June 30, 1987, 8 p. Long Gary L. and Wales Kenneth S., Self-propelled, intraluminal device with working channel and method of use, US Patent No.6,866,626 B2, March 15, 2005, 18 p. Lyddy James E., Jr., Penland William Z. and Sugarbaker Paul H., US Patent No.4,690,131, September 1, 1987, 11 p. MacGregor Roderick, Shape memory alloy actuators and control methods, US Patent No.6,574,958, June 10, 2003, 23 p. Marieb Elaine N., Human Anatomy & Physiology, 6th edition, 2004, 1242 p. Meiri Samuel, Kot Casey, Rogers Gerald B.H. and Epstein Max, Device and method for advancing an endoscope through a body passage, US Patent No.4,207,872, June 17, 1980, 5p. Mosse Charles Alexander, Mills Timothy and Swain Paul, Passage travelling device, US Patent No.6,709,388 B1, March 23, 2004, 6 p. Ohline Robert M., Tartaglia Joseph M., Belson Amir et al., Tendon-driven endoscope and methods of insertion, US Patent No.6,858,005 B2, February 22, 2005, 31 p. Ortiz Mark S. and Stubbs Jack B., Lumen traversing device, US Patent No.5,398,670, March 21, 1995, 18 p. Ouchi Teruo, Fully-swallowable endoscopic system, US Patent No.6,527,705 B1, March 4, 2003, 16 p. Pottecher T., Segura P. and Launoy A., Le syndrome du compartiment abdominal, Annales de chirurgie, 123(3), April 2001, pp.192-200. Rozov R., Pottecher T. and Laynoy A., Mesure de la pression intra abdominale par voie vsicale, Annales Franaises d anesthsie et de reanimation, 23(4), April 2004, pp.433-434. Saadat Vahid, Ewers Richard C. and Chen Eugene G., Shape lockable apparatus and method for advancing an instrument through unsupported anatomy, US Patent No.6,790,173 B2, September 14, 2004, 14 p. Seufert Wolf D. and Bessette France M., Device for carrying observation and/or manipulation instruments, US Patent No.4,054,128, October 18, 1977, 11 p. Takada Masazumi, Self-propelled colonoscope, US Patent No.5,562,601, October 8, 1996, 10p.
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Takada Masazumi, Self-propelled colonoscope, US Patent No.6,071,234, June 6, 2000, 9p. Takada Masazumi, Self-propelled colonoscope and cleaning process thereof, US Patent No.6,224,544 B1, May 1, 2001, 13p. Tartaglia Joseph M., Belson Amir and Ohline Robert Matthew, Endoscope with guiding apparatus, US Patent No.6,800,056 B2, October 5, 2004, 28 p. Waye Jerome D., Rex Douglas K. and Williams Christopher B., Colonoscopy: principles and practice, 1st edition, 2003, 700 p. www.olympus-europa.com/medical, 2005. www.emedicine.com, 2005. www.hopkins-gi.nts.jhu.edu, 2005. www.merck.com , 2005.
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Appendix A: Assignment literature thesis

Mr. A.J. Loeve BSc Langesteeg 7 3371 BZ Hardinxveld-Giessendam In the research group Man Machine Systems of the faculty Mechanical Engineering of the Delft University of Technology, one of the goals is to improve minimally invasive surgical and interventional techniques from a clinically driven approach. Several faculties of the DUT are participating in this research as well as several (academic) hospitals. One of the subjects this group is aiming at is the development of a better instrument to perform colonoscopies. This project is one of the continuations of the old MISIT project. The current instrument, used to perform colonoscopies, is a colonoscope. It is an instrument consisting of a long tube with a controllable tip, in which a camera, illumination, suction and biopsy channels are present. This instrument is inserted into the rectum and further into the colon, by pushing at the end of the flexible tube and controlling the tip by the means of steering wheels. Insertion of a colonoscope demands great expertise and always remains difficult because of the human anatomy. However pushing at the flexible tube, almost always causes unwanted looping of the colonoscope, stretching of the colon and thereby causing pain to the patient. Much research, all over the world, is being done to find a better way of performing colonoscopy, either by searching for another principle, like virtual colonoscopy whereby the body is not entered at all, or by designing a new and better instrument. A solution might be to provide the colonoscope with a self-propelling tip, so that excessive pushing at the flexible tube will no longer be necessary and the tube will not bend into loops. It is quite difficult to make such a self-propelling tip because of the flexible, wet and slippery nature of the inner colonic wall. The development of a new mucoadhesive (material that sticks to the mucosa of the inner colonic wall) might provide a part of the solution to design a self-propelling instrument. To provide a proper basis for the design of a new, self-propelling instrument, the following is asked: 1. 2. A proper analysis of the problems in colonoscopy, focussing on insertion problems and pain causes. An overview of existing alternatives to colonoscopy, new developments and self-propelling mechanisms, which offer good perspectives for colonoscopy in the future and the design of a new instrument.
For daily support, you can contact Dr. ir. P. Breedveld, Prof. Dr. J. Dankelman, and Prof. Dr. ir. P.A. Wieringa.
Dr. ir. P. Breedveld
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Appendix B: Design of an experimental set-up

In the research group Man Machine Systems of the faculty Mechanical Engineering of the Delft University of Technology much research is being done on the development of a new instrument for colonoscopy. This reaches from improved versions of the current colonoscopes to completely new concepts with self-propelling tips and friction manipulation. To demonstrate or test new concepts and to perform experiments, an experimental set-up is needed on short term. It should be a set-up in which a piece of pig colon can be attached in the human anatomical shape, but also in other shapes like a straight part, a single bend or an S-shaped bend. There should be enough freedom of movement for the colon, but it must also be able to constrain it like it is in human anatomy. When attached in the human anatomical shape the colon should be surrounded by something that resembles the environment in the abdomen (viscosity, pressure, organs) to make it behave as realistic as possible. Thus an average colon (length 1.5 m, sigmoid (free) length 47 cm and diameter 5.5-7 cm and 2.5-6 cm in rectal region) should fit and should be surrounded by a pressure of 0-6 mmHg [Pottecher, 2001; Classen et al.,2002, Ch.(12); Marieb, 2004; Rozov, 2004, Bhatnagar et al. 2004]. The housing of the set-up should have inner space dimensions resembling that of the human abdomen. From measurements on some students and the cadaver study described above, it is concluded that the human colonic anatomy should fit in a space of about 30x30x20cm. The experimental set-up should be designed in such a way that the experiment can be easily and good observed. It is also desirable that the set-up can be used as a demonstration means and thus it must be possible to visualise the experiment for a bigger audience by means of direct projection or by using cameras. Since the experimental set-up is needed on short term, it should be simple and easily producible. Table B gives an overview of the demands for the experimental set-up and suggested possibilities to fulfil these demands. There are already some training models for colonoscopy, ranging from very simple to highly advanced types. But the simple models are not realistic enough to test if a new apparatus is suitable for colonoscopy, since these are mainly built to train therapeutic manoeuvres and not to train insertion techniques. The advanced simulators are only suitable for one colonoscope, equipped with special electronics to use it in the simulator. So none of the existing models suits the current demands. Since short term availability and flexibility are the main criteria a new set-up has been designed with a maximal range of possibilities. It consists of a glass aquarium of 40x30x20cm. These sizes have been chosen to make it possible for the human colonic anatomy to fit and still have some space to place attachment devices for the colon in the aquarium. There are four holes with a closable tube (inner diameter 45 mm and outer diameter 50 mm since unstretched pig colon diameter is about 40 mm) in it, one on each side of the aquarium that can be used to attach an end of a colon to make an entrance or exit point. The colon can be attached to an entrance by putting it through, wrapping it inside-out around the closable entrance / exit tube and then securing it with a clamping device or rope. Ligament-like attachments of the splenic and hepatic flexures, the descending and ascending colon or any other type of attachment needed, can be created by using suture wire or clamps and attach these to suction pads with M4 ends that can be placed anywhere on the inner surface of the aquarium and that are part of the standard equipment of the setup. Performing tests on a straight piece of colon is just a matter of attaching the two ends of the colon on two opposing closable entrance / exit holes. By filling the aquarium with fluid the
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pressure and viscosity of the colons surroundings can be varied. There is a fifth, closable hole in one of the bottom corners to let the fluid out after use of the set-up. This new device will be called the Colarium from now on.
Table B: Demands and suggested fulfilments for an experimental set-up to test or demonstrate colonoscopic devices. Demands on: Available features Mobile set-up Colon or tube can be entered and exited from the outside. Colon or tube can be attached in sufficient diversity of forms. Anatomical realistic environment. Long lifetime Materials Clear transparent outside Water proof Easily workable Clear transparent contents Dimensions Anatomical realistic form of colon and deformations during colonoscopy must fit. Attachments of ends of colon or tube must correspond with size of colon and/or anus. Entrance must be possible for regular colonoscope and for new devices, not yet adapted to the narrow anal entrance. Colon length is about 1.5 m. Dimensions of human abdomen could be used. It should be possible to create a free hanging sigmoid part of 47 cm +/- 11 cm. Abdominal dimensions are about 30x30x20cm. Colon diameter is about 5.5-7 cm in diameter. Anal entrance is self-closing and can be stretched open up to several centimetres (2.5-6 cm). Pig colon diameter is 40 mm when not stretched, can stretch to 100 mm. Flexible, stretchable entrance which is removable to make it possible to insert mechanisms that are not yet small enough to insert through a normal anal entrance but do fit in the colon. Glass, acrylic sheet. (Though glass is more resistant to scratching and easier to clean) Glass, acrylic sheet. Glass, acrylic sheet. Transparent, clear jelly in transparent plastic cover as organs. Water or other clear low viscous fluid/gel as filling to create abdominal pressure and simulate viscous surroundings. Box-shaped outside, carrying handles, minimal size Enter and exit holes on which colon or tube can be securely, but easily attached. Possibility to create forms: Anatomical correct, straight, single bend, S-shape. Different enter and exit holes and resources to create ligament-like attachments on various places. Jelly objects to simulate organs, fluid for abdominal pressure (0-6 mmHg) outside the colon, realistic sizes and resources to have ligament-like attachments on anatomical realistic places. Strong, robust, low / no maintenance materials and attachments or cheap disposables. Suggested possibilities:
In the mean while, the Colarium has been built and has been used for several experiments. The Colarium seemed to work well and can easily be cleaned after usage. Figure B1 shows a photograph of the empty Colarium (a) and Colarium with a colon attached in it, placed in a measurement set-up to perform experiments (b). Figure B2 shows a detailed image of a test set-up used by Dimitra Dodou to test the grip that can be obtained in the colon by using a cylinder with a muco-adhesive layer.
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Fig. B1: (a) The Colarium, test set-up for in vitro experiments on colonic tissue. (b) The Colarium placed in a test set-up for measurements on friction between the colonic wall and a muco-adhesive that is developed by Dimitra Dodou. (Right photograph taken by Dimitra Dodou)
Fig. B2: Detailed drawing of the Colarium placed in a test set-up for measurements on friction between the colonic wall and a muco-adhesive that is developed by Dimitra Dodou. (By Dimitra Dodou)
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Literature Thesis About Problems in Colonos

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TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

Advancing the Colonoscope

A.J. Loeve BSc

Student number: Master number: Department: E-mail: Address:

TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

Technical perspective on current problems ................................................................21

Main insertion problems in normal anatomy............................................................ 24

State of the art in invasive colonoscopy......................................................................45

Self-propelling mechanisms ...................................................................................... 51

TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

Page of A3 inlay Fig. 1.3

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Page of A3 inlay Fig. 1.3

Advancing the Colonoscope - A.J. Loeve

Medical perspective on current problems

Fig. 2.1: Anatomical scheme of the colon.

Fig. 2.2: Scope in anus and rectum.

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Fig. 2.3: Scope in sigmoid colon.

Advancing the Colonoscope - A.J. Loeve

Flat loop, no acute bend

-loop (clockwise, 90% of s)

Difficult loop types Flat loop, with acute bend

Reversed -loop (counterclockwise, 10% of s)

- Persistent descending mesocolon - Fully mobile descending mesocolon

TU Delft BioMechanical Engineering

Waye et al.,2003, Ch.29]

Fig. 2.8: Walking stick configuration. (Adopted from [Waye et al.,2003])

Advancing the Colonoscope - A.J. Loeve

Fig. 2.13: Scope in ascending colon.

Fig. 2.14: Scope in cecum at ileal valve.

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-looping of transverse colon

Recurrent sigmoid colon looping

Advancing the Colonoscope - A.J. Loeve

Technical perspective on current problems

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3.2.2 Colonic model

Advancing the Colonoscope - A.J. Loeve

Fig. 3.2: Colon surrounded by colonic model

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Main insertion problems in normal anatomy

Advancing the Colonoscope - A.J. Loeve

3.3.1 Sigmoid colon

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Advancing the Colonoscope - A.J. Loeve

TU Delft BioMechanical Engineering

Advancing the Colonoscope - A.J. Loeve

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Advancing the Colonoscope - A.J. Loeve

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3.3.2 Splenic flexure

Advancing the Colonoscope - A.J. Loeve