Innovation Forum I: Engineers in Reproductive Surgery (Didactic) PROGRAM CHAIR Alan H. DeCherney, MD Peter Basser, MD George Patounakis, MD Sponsored by AAGL Advancing Minimally Invasive Gynecology Worldwide
Professional Education Information Target Audience This educational activity is developed to meet the needs of residents, fellows and new minimally invasive specialists in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 1.50 AMA PRA Category 1 Credit(s). Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.
Table of Contents Course Description... 1 Disclosure... 2 Innovation in Surgery A. DeCherney... 3 Imaging Techniques: How Are They Developed and Applied? R. Basser... UNA Engineers and Development of Equipment for Reproductive Surgery G. Patounakis... 7 Cultural and Linguistics Competency... 11
Innovation Forum I: Engineers in Reproductive Surgery (Didactic) Alan H. DeCherney, Chair Faculty: Peter Basser, George Patounakis The advancement of minimally invasive surgery depends on the skill of the surgeon and availability of proper instrumentation. Collaboration between engineers and physicians is imperative in new product design and development, ultimately benefiting the patient with the least invasive approach. This session will illustrate how new instruments and technology are developed and how engineers are involved in the process: from idea, to design, to execution. Modern medicine and surgery have taken on tremendous complexity because of the initiative of engineers. We are now able to measure individual genes and perform surgery utilizing a robot. These are dramatic changes, all of which would be impossible without engineers; yet, engineers are often misunderstood. Our goal is to help you understand what engineers do and how they carry out their profession; this will allow you to better understand the technology that you use, and guide you in developing new technologies. Learning Objectives: At the conclusion of this course, the clinician will be able to: 1) Discuss how engineers collaborate with the medical community to design surgical instrumentation; 2) analyze the steps involved in bringing a surgical innovation from concept to commercial use in the operating room; and 3) develop new ideas for surgical instrumentation. Course Outline 10:00 Welcome, Introductions and Course Overview A.H. DeCherney 10:05 Innovation in Surgery A.H. DeCherney 10:30 Imaging Techniques: How Are They Developed and Applied? R. Basser 10:55 Engineers and Development of Equipment for Reproductive Surgery G. Patounakis 11:20 Question & Answers Faculty 11:30 Adjourn 1
PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Kimberly A. Kho* Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* M. Jonathan Solnik* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Ceana H. Nezhat Consultant: Ethicon Endo-Surgery, Lumenis, Karl Storz Other: Medical Advisor: Plasma Surgical Other: Scientific Advisory Board: SurgiQuest Arnold P. Advincula Consultant: Blue Endo, CooperSurgical, Covidien, Intuitive Surgical, SurgiQuest Other: Royalties: CooperSurgical Linda D. Bradley* Victor Gomel* Keith B. Isaacson* Grace M. Janik Grants/Research Support: Hologic Consultant: Karl Storz C.Y. Liu* Javier F. Magrina* Andrew I. Sokol* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the best available evidence from medical literature (in alphabetical order by last name). Peter J. Basser* Alan H. DeCherney* George Patounakis* Asterisk (*) denotes no financial relationships to disclose.
INNOVATION IN SURGERY Disclosure I have no financial relationships to disclose. { alan decherney m.d. PRAE/NICHD/NIH 3
Ideal paradigm of hypothesis-driven basic research. Hypothesis-driven research, based on many years study of the basic physiology of embryo development Hypothesis developed and tested in animal models, including small rodent (mouse) and large animal (bovine and pig) Tested in human embryos donated to research Tested in small scale single site clinical IVF study Tested in larger multi-site clinical study Assess clinical and cost effectiveness Harper J, Magli MC, Lundin K, Barratt CLR, and Brison D. When and how should new technology be introduced into the IVF laboratory? Hum. Reprod. (2012) 27(2): 303 313 Evidence based surgery 4
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Kluger J. Time. Ideas, Assessing the Creative Spark What Americans think about creativity. May 20, 2013 Praise without end the go ahead zeal of whoever it was invented the wheel; But never a word for the poor soul s sake that thought ahead and invented the brake. The Poet Laureate of the United States, Howard Nemerov, read a poem with these last lines at a joint session of Congress on the 200 th anniversary of the convening of our nation s first Congress. Kluger J. Time. Ideas, Assessing the Creative Spark What Americans think about creativity. May 20, 2013 6
Engineers and Development of Equipment for Reproductive Surgery Disclosures I have no financial relationships to disclose. George Patounakis, M.D., Ph.D. Program in Reproductive and Adult Endocrinology National Institutes of Health Learning Objectives Identify the different phases of the engineering design process Apply the engineering design process to the development of new surgical equipment Number of Articles Laparoscopy & Engineering Articles per Year 70 60 50 40 30 20 10 0 1975 1980 1985 1990 1995 2000 2005 2010 Year Minimally Invasive Surgery & Engineering Articles Per Year Number of Articles 100 90 80 70 60 50 40 30 20 10 0 1985 1990 1995 2000 2005 2010 Year Engineering Definition: the application of science and mathematics by which the properties of matter and the sources of energy in nature are made useful to people Source: www.merriam-webster.com 7
Engineering Design Process Redesign Define Problem Think of Ideas Biomedical Engineering Electrical & Computer Engineering Present Results Select Best Solution Medicine Mechanical Engineering Test Prototype Prototype Chemical Engineering Biomedical Engineering Example Surgeon s Role Define Problem Redesign Think of Ideas Present Results Select Best Solution Test Prototype Prototype Defining the Problem Environment Example: Sterilization Maximal Physical Dimensions Example: Port size Human Interface Cost Safety Minimally Invasive Surgery Design Specification Example Minimize movement across abdominal wall Decreases incision size needed Decreases trauma to abdominal wall 8
Solution: Remote Center of Motion US Patent # 5,402,801 by Russell Taylor in 1995 Testing the Prototype Proof of concept Does not require human subjects May not expose real-life problems In vivo testing Surgeon essential Potentially dangerous Early laparoscopy by Fervers in 1933 Haptic Haptic Feedback in Robotics Definition: relating to or based on the sense of touch Source: www.merriam-webster.com Haptic Displays Device that provides tactile information Example: PHANToM Arm Do We Need Haptics in Robotics? Lacking haptics: Increases learning curve Increases surgical errors Especially knot tying van der Meijden 2009 http://www.sciencephoto.com/ 9
Robotic Knot Tying UCLA Robotic Haptic System Tension in Newtons (mean ± standard deviation) TiCron 2-0 Prolene 5-0 Prolene 6-0 Prolene 7-0 Hand tied 2.4 ± 0.58 1.41 ± 0.14 0.71 ± 0.06 0.36 ± 0.04 Robot w/o haptic feedback 5.16 ± 2.46 1.54 ± 0.67 0.78 ± 0.48 0.29 ± 0.14 Robot w/ haptic feedback 2.99 ± 0.83 1.61 ± 0.27 0.99 ± 0.11 0.58 ± 0.13 p-value <0.001 0.546 0.053 <0.001 Bethea et al. 2004 King et al. 2009 Will Haptics Make a Difference in Robotics? Early in engineering design Prototypes need more validation In vivo testing Cost Safety Conclusions Innovation in minimally invasive reproductive surgery requires a multi disciplinary team approach Surgeons and engineers need to work together to develop the next generation of minimally invasive surgical equipment Culmer et al. 2012 References Bethea, BT, Okamura, AM, Kitagawa, M, Fitton, TP, Cattaneo, SM, Gott, VL, Baumgartner, WA, Yuh, DD, Application of haptic feedback to robotic surgery, Journal of Laparoendoscopic and Advanced Surgical Techniques-Part A, 2004, Vol 14 (3), pp. 191-195. Culmer, P, Barrie, J, Hewson, R, Levesley, M, Mon- Williams, M, Jayne, D, Neville, A, Reviewing the technological challenges associated with the development of a laparoscopic palpation device, International Journal of Medical Robotics and Computer Assisted Surgery, 2012, Vol 8 (2), pp. 146-159. References King, C-H, Culjat, MO, Franco, ML, Lewis, CE, Dutson, EP, Grundfest, WS, Bisley, JW, Tactile feedback induces reduced grasping force in robot-assisted surgery, IEEE Transactions on Haptics, 2009, Vol 2 (2), pp. 103-110. Van Der Meijden, OAJ, Schijven, MP, The value of haptic feedback in conventional and robot-assisted minimal invasive surgery and virtual reality training: A current review, Surgical Endoscopy and Other Interventional Techniques, 2009, Vol 23 (6), pp. 1180-1190. 10
CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as the AAGL, to assist in enhancing the cultural and linguistic competency of California s physicians (researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP). US Population Language Spoken at Home California Language Spoken at Home English Spanish Spanish Indo-Euro Asian Other English Indo-Euro Asian Other 19.7% of the US Population speaks a language other than English at home In California, this number is 42.5% California Business & Professions Code 2190.1(c)(3) requires a review and explanation of the laws identified above so as to fulfill AAGL s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the program, the importance of the services, and the resources available to the recipient, including the mix of oral and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm. Executive Order 13166, Improving Access to Services for Persons with Limited English Proficiency, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies, including those which provide federal financial assistance, to examine the services they provide, identify any need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access. Dymally-Alatorre Bilingual Services Act (California Government Code 7290 et seq.) requires every California state agency which either provides information to, or has contact with, the public to provide bilingual interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population. If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills. A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538. ~ 11