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Development of Medical Equipment to Make Colonoscopy Procedures Safer For Development of Medical Equipment to make Colonoscopy Procedures Safer for Physicians: Control Head Holder and Splatter Shield A thesis presented to the faculty of the Russ College of Engineering and Technology of Ohio University In partial fulfillment of the requirements for the degree Master of Science Rajesh Ravindra Shanbhag December 2014 © 2014 Rajesh Ravindra Shanbhag. All Rights Reserved. 2 This thesis titled Development of Medical Equipment to make Colonoscopy Procedures Safer for Physicians: Control Head Holder and Splatter Shield by RAJESH RAVINDRA SHANBHAG has been approved for the Department of Mechanical Engineering and the Russ College of Engineering and Technology by JungHun Choi Assistant Professor of Mechanical Engineering Dennis Irwin Dean, Russ College of Engineering and Technology 3 ABSTRACT SHANBHAG, RAJESH RAVINDRA, M.S., December 2014, Mechanical Engineering Development of Medical Equipment to make Colonoscopy Procedures Safer for Physicians: Control Head Holder and Splatter Shield Director ofThesis: JungHun Choi The physicians performing colonoscopy are at risk due to the occupational overuse injuries and exposure to infectious splatters from the patient’s anus. The objective of this thesis is to develop medical equipment to make the colonoscopy procedure safer and more comfortable for performing physicians. To understand the problem well, the colonoscopy procedure was directly observed. Additionally, physicians were questioned to better comprehend safety issues associated with the procedure. Subsequently, two devices were developed in an attempt to make the procedure safer for the physicians[1]. The Control Head Holder (CHH) holds the control head of the colonoscopy equipment, which provides the physician with less fatigue during the procedure. A splatter shield was also developed to mitigate the physician’s exposure to bodily fluids. The splatter shield provides added advantage of a holder for the insertion tube of the colonoscope which grants the physician the extra freedom to perform activities that may require two hands. A proof of concept prototype of the CHH and the shield with the Tube Holder (TH) was fabricated as per the requirements. The shield was then subjected to drop test and drop ball test to validate the desired deliverables. The force required to initiate slipping from the TH was determined using a force sensor. The CHH was checked for fatigue reduction with medical students through surface 4 Electromyography (sEMG). The equipment was also evaluated by a group of students and experts who performed the procedure on the Active Colonoscopy Training Model (ACTM) simulator while monitoring space preservation, ease of use, clarity, degree of freedom and overall rating. The results of this research suggest that the implementation of the CHH is a positive value addition for the comfort of physicians performing colonoscopy. However, further research is necessary to enhance the capability of the developed equipment for serving physicians better. 5 ACKNOWLEDGMENTS Above all, I give complete gratitude and appreciation to my advisor, Dr. JungHun Choi for his interest, patience and motivation he extended throughout the duration of my Masters degree. Without Dr. Choi’s support, I would not have been able to complete my Masters degree in such a timely manner. I thank Dr. David Drozek for allowing me to gain experience by letting me shadow multiple colonoscopy procedures at Doctor’s Hospital, Nelsonville, Ohio. I also would like to acknowledge him for his time and valuable inputs for the development of my equipment and giving me the necessary information to have a complete understanding of a basic colonoscopy. I would also like to thank Dr. Crystal Mills for providing ideas and guidance for my research. I would like to thank Dr. Brain Clark for letting me use his OMNI TMS laboratory for my experimentation and advising me throughout my research. I would also like to thank Dr. Niladri Kumar Mahato for guiding me throughout the medical trials and his knowledge in statistical data analysis played a major part in my thesis. If it was not for his guidance in writing the analysis section, I would have struggled greatly, and for that I am grateful. I also would like to thank Dr. Kremer for guiding me and helping me understand the deliverables through the validation of developed prototype. I would also take this opportunity to thank Mr. Thomas Joseph Boyle for his time and help in fabricating the prototype. It was his knowledge and assistance which made me successfully build the proof of concept prototype. 6 Lastly, I must recognize all the support and encouragement given by the administrative staff and faculty members of Mechanical Engineering Department, Ohio University. 7 TABLE OF CONTENTS Abstract ............................................................................................................................... 3 Acknowledgments............................................................................................................... 5 List of Tables ...................................................................................................................... 9 List of Figures ................................................................................................................... 10 Chapter 1: Introduction ..................................................................................................... 12 1.1 Literature Review.................................................................................................. 13 1.1.1 Colonoscopy Overview ................................................................................. 13 Chapter 2: Endoscopist Risks Involved in Colonoscopy .................................................. 16 2.1 Forces Involved in Colonoscopy .......................................................................... 17 2.2 Risks Involved in Colonoscopy ............................................................................ 19 2.3 Equipment Which Aid Physicians ........................................................................ 21 2.4 Surface Electromyography and Muscle Fatigue ................................................... 24 2.5 Thesis Objectives .................................................................................................. 25 Chapter 3: Development of the Equipment ...................................................................... 27 3.1 Requirements for the Developed Proof of Concept Prototype ............................. 27 3.2 Development of the Proof of Concept Prototype .................................................. 34 3.3 Failure Mode Effect and Analysis ........................................................................ 46 Chapter 4: Methods of Study. ........................................................................................... 55 4.1 Testing of the CHH ............................................................................................... 55 4.1.1 Test of Fatigue Through Surface Electromyography.................................... 55 4.2 Testing of the Splatter Shield. ............................................................................... 58 4.2.1 Drop Test ...................................................................................................... 58 4.2.2 Drop Ball Test ............................................................................................... 60 4.3 Testing of the TH .................................................................................................. 62 4.3.1 Compliance of a Colonoscope Insertion Tube .............................................. 62 4.3.2 Force Test of the TH ..................................................................................... 66 4.4 Equipment Evaluation Through Survey................................................................ 67 Chapter 5: Results and Discussions. ................................................................................. 70 5.1 Validation of the CHH .......................................................................................... 70 5.1.1 Test for Fatigue Reduction Using Surface Electromyography ..................... 71 5.2 Validation of Splatter Shield ................................................................................. 89 5.2.1 Drop Test ...................................................................................................... 89 5.2.2 Drop Ball Test ............................................................................................... 90 5.3 Validation of the TH ............................................................................................. 91 5.3.1 Force Test of the TH ..................................................................................... 92 5.4 Equipment Evaluation Through Survey................................................................ 94 8 Chapter 6: Conclusions ..................................................................................................... 99 6.1 Evaluation of Thesis Objectives ........................................................................... 99 Chapter 7: Future Work .................................................................................................. 103 Bibliography ................................................................................................................... 106 Appendix A – Bill of Materials of the Developed Equipment ....................................... 110 Appendix B - Survey
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