4 Design of Capsule
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Bidirectional Propulsion of Devices Along the Gastrointestinal Tract Using Electrostimulation Maurice Paul Burke University College London Department of Medical Physics and Bioengineering Thesis submitted for the degree of Doctor of Philosophy (Ph.D) 1 I Maurice Paul Burke confirm that the work presented in this thesis is my own. Where information has been derived from other sources, I confirm that this has been indicated in the thesis. 2 Abstract This thesis describes a method for propelling devices such as video capsule endoscopes in either direction along the small intestines using electrostimulation-induced muscular contractions. When swallowed, passive diagnostic ‘one-shot’ devices rely on sporadic peristaltic movement, possibly missing vital ‘areas of interest’. This bidirectional propulsion method provides active control for that all-important ‘second look’. Design considerations, within the dimensional constraints, required a device shape that would achieve maximum propulsion from safely induced useful contractions produced by the electrodes and encapsulated miniature electrostimulator. Construction materials would have to produce minimal friction against the mucosal surface while having the physical properties to facilitate construction and electrode attachment. Design investigations included coefficient of friction measurements of different construction materials and the evaluation of different capsule and electrode dimensions over a range of stimulation parameters, to obtain optimal propulsion. A swallowable 11 mm diameter device was propelled at 121 mm/min with stimulation parameters of 12.5 Hz, 20 ms, at 20 V in an anaesthetised pig. A modified passive video capsule endoscope was propelled at 120 mm/min with stimulation parameters of 12.5 Hz, 20 ms, at 10 V in an unanaesthetised human volunteer. A radio-controlled capsule incorporating an electrostimulator, voltage converter and 3 V power supply was propelled at 60 mm/min with stimulation parameters of 12.5 Hz, 20 ms, and 30 V in an anaesthetised pig. 3 Other possible uses of electrostimulation were investigated including propulsion of anally administered large intestine devices and introduction of the intestinal mucosal surface into a biopsy chamber. Results are presented. The ultimate aim of the project was to provide bidirectional propulsion for wireless remote controlled devices along the gastrointestinal tract utilising contractile force produced by electrostimulation of the intestinal wall. The controllability of this system could provide clinicians with a real time view of the entire small intestines without surgical enteroscopy. 4 Acknowledgements I would like to thank my supervisors: Dr. Timothy Mills for his support and guidance throughout the project; Dr. Alexander Mosse for his guidance and insight; Professor Jeremy Hebden for his support, guidance and encouragement especially during the latter stages of the project. I would also like to thank Professor Paul Swain and Dr. Annette Fritcher-Raverns for their guidance and insight, providing a clinician’s point of view to the project, and also for their clinical expertise, without which testing of the equipment would not have been possible. I would like to give special thanks to Professor Gary Royle, Dr. Nick Everdell and Dr. Julian Henty for their continued guidance, support, discussions and invaluable transfer of knowledge. I would like to thank the staff of the Medical Physics Technical Workshop, especially Mr. Billy Raven, Mr. Denzil Booth and Mr. Stuart Morrison for their tuition, guidance and expertise. I would also like to thank my friends and colleagues in the Department of Medical Physics and Bioengineering who provided a convivial atmosphere within which to work. Funding for the project was provided by Given Imaging who I would like to thank along with the Department of Medical Physics and Bioengineering for giving me the opportunity to carry out this research. I would like to thank my family and friends for all their support and encouragement throughout the project. I would especially like to thank my 5 parents, Brigid and Paul Burke for their continued love, support, encouragement and understanding, without which this would not have been possible. 6 Table of Contents Abstract .................................................................................................................. 3 1. Introduction ............................................................................................... 13 1.1 Guide to the Thesis ................................................................................ 15 2. Medical Science Background .................................................................... 18 2.1 Introduction ........................................................................................... 18 2.2 Anatomy of the Gastrointestinal Tract .................................................. 18 2.2.1 Physiology of the Gastrointestinal Tract ........................................ 22 2.3 Pathologies of the Gastrointestinal Tract .............................................. 23 2.4 Methods of Observing the Gastrointestinal Tract ................................. 34 2.4.1 Contrast Enema .............................................................................. 34 2.4.2 Endoscopy ...................................................................................... 35 2.5 Current Methods and Techniques of Observing the Gastrointestinal Tract ............................................................................................................... 36 2.5.1 Radiological Examination of the Colon Procedures ...................... 37 2.5.2 Virtual Colonoscopy ...................................................................... 43 2.5.3 Endoscopy (Push Enteroscopy) ..................................................... 48 2.5.4 Video Capsule Endoscopy ............................................................. 50 2.5.5 Evaluation of Current Methods of Observing the Gastrointestinal Tract ........................................................................................................ 56 3. Electrostimulation Considerations ............................................................ 75 3.1 Introduction ........................................................................................... 75 3.2 Electrophysiology of the Gastrointestinal Tract .................................... 75 3.2.1 Cell Membranes ............................................................................. 75 3.2.2 Muscle Contraction ........................................................................ 78 3.2.3 Smooth Muscle Contraction ........................................................... 81 3.3 Functional Electrical Stimulation .......................................................... 82 3.3.1 Electrostimulation of Smooth Muscle ............................................ 86 3.4 Electrical Safety .................................................................................... 91 3.4.1 Introduction .................................................................................... 91 3.4.2 Safety Regulations and Precedents ................................................ 92 3.4.3 Effects and Potential Hazards of Electrical Stimulation ................ 92 3.4.4 The Effects that Charge has on Electrodes During Stimulation .... 94 3.4.5 The Effects of Electrical Stimulation ............................................. 96 3.4.6 In Vivo Electrical Stimulator .......................................................... 97 3.5 A Model for Electrode Impedance ...................................................... 101 7 3.6 Aims of the Project .............................................................................. 111 4. Design, Construction and Testing of a Wire Driven Electrostimulation Induced Propulsion Device ................................................................................ 114 4.1 Objectives and Strategies .................................................................... 114 4.2 Introduction ......................................................................................... 117 4.3 Design Considerations ......................................................................... 118 4.3.1 Selection of Materials for Device Body ....................................... 118 4.3.2 Equipment Used to Determine Coefficients of Friction .............. 119 4.3.3 Measurement of the Coefficients of Friction ............................... 120 4.3.4 Capsule Design ............................................................................ 122 4.4 Initial Designs and Construction ......................................................... 127 4.4.1 Initial Animal Tests ...................................................................... 129 4.4.2 Design and Construction of a Bidirectional Device ..................... 131 4.4.3 Initial Bidirectional Capsule In Vivo Experiment ........................ 134 4.4.4 Design and Construction of Devices of Different Diameter ........ 135 4.4.5 The One Minute Tests .................................................................. 140 4.4.6 Capsule Construction from Animal to Man ................................. 151 4.5 Human Subject Experiments ............................................................... 154 4.5.1 Modifications to the Capsule ....................................................... 155 4.5.2 The First Human Subject Experiment .......................................... 156 4.5.3 The Second Human