2010 NOTES ® Summit Device Working Group Advanced Platform

Needs Assessment While NOTES procedures are able to be done with rigid devices and hybrid with laparoscopic assistance, NOTES will not fully move forward without the development of a functional platform. Until the development of new platforms, the major medical centers will function as the platform with current use technologies

Key Features of a Platform Provide traction/counter-traction with triangulation Provide traction/counter-traction with triangulation Appropriate maneuverability in operative field Appropriate maneuverability in operative field Stable, mountable Stable, mountable Deal with reverse handedness Deal with reverse handedness Scalable Scalable Length variable from pelvis to diaphragm Length variable from pelvis to diaphragm

Key Features of a Platform Create/support 6 degrees of motion Create/support 6 degrees of motion Ergonomic, easy to use, comfortable Ergonomic, easy to use, comfortable Reasonable size (18-20 mm OD max TG) Reasonable size (18-20 mm OD max TG) Reusable, ease of reprocessing Reusable, ease of reprocessing Can exchange end-effectors easily Can exchange end-effectors easily Platforms designed for parallelism may be good for intralumenal use, while those providing triangulation likely needed for translumenal indications. Platforms designed for parallelism may be good for intralumenal use, while those providing triangulation likely needed for translumenal indications.

Challenges Price point, risk vs. benefit analysis Price point, risk vs. benefit analysis Systems designed for site of entry (TG, TV, TC, etc) or procedure (diagnostic vs. therapeutic) or type of procedure: intralumenal, translumenal, SILS – can one system “fit all” Systems designed for site of entry (TG, TV, TC, etc) or procedure (diagnostic vs. therapeutic) or type of procedure: intralumenal, translumenal, SILS – can one system “fit all” NOTES as an evolving process – perhaps some of a procedure can be NOTES (organ removal, retraction, visualization) NOTES as an evolving process – perhaps some of a procedure can be NOTES (organ removal, retraction, visualization) Industry needing to know for which procedure the platform is needed Industry needing to know for which procedure the platform is needed

Challenges We await the catalyst in a NOTES platform – for lap surgery it was video-system integration allowing for team dynamic We await the catalyst in a NOTES platform – for lap surgery it was video-system integration allowing for team dynamic Knowing where the system is – role of augmented reality imaging Knowing where the system is – role of augmented reality imaging Anchoring the platform and making it stable Anchoring the platform and making it stable Training and credentialing Training and credentialing

Solutions/Future Enhance the endoscope – sophisticated over tubes and operative endoscopes Enhance the endoscope – sophisticated over tubes and operative endoscopes Deconstruct the endoscope – separate eyes and arms Deconstruct the endoscope – separate eyes and arms Platformless platform – “port-free surgery” Platformless platform – “port-free surgery” Multiport natural orifice access Multiport natural orifice access Microbots Microbots Nanobots Nanobots Near term use of current technology, 3 to 5 yrs for new platform availability Near term use of current technology, 3 to 5 yrs for new platform availability

NOTES Platforms Laparoscopic adaptation Laparoscopic adaptation Enhanced endoscopes Enhanced endoscopes Manual robot Manual robot Computer assisted robots Computer assisted robots Deconstructed platforms Deconstructed platforms 2050 platform 2050 platform

Laparoscopic Adaptation Need: enhance current use devices for NOTES specific application (port and instrument development) Benefits: enhanced operator capability Risk: functionality Operators: Gen Surg, Colorectal Surg, Gyn, Urol Timeline: now Obstacles: training, learning curve, reluctance to “drink the Koolaide” Applications: for anything that can be reached

Enhanced Endoscopes Need: enhance current use devices for NOTES specific application (working over tube and mountable accessories, “superscopes” ) Benefits: enhanced operator capability Risks: Functionality, reprocessability Operators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol Timeline: now Obstacles: training, learning curve, reluctance to “drink the Koolaide” Applications: intralumenal, translumenal, SILS

Manual Robot (i.e.. Olympus, BSC, Ethicon, Storz, Transenterix) Need: Rigid platforms and current flexible endoscopes are limited and will delay advances Benefits: enhanced operator capability, more procedural capability, avoid cross handedness, separates hands and eyes Risks: Functionality, ergonomics Operators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol, other surgeons Timeline: 3 to 5 years Obstacles: training, learning curve, reluctance to “drink the Koolaide”, engineering limitations Applications: intralumenal, translumenal, SILS

Computer Assisted Robot (Endovia, Singapore, Intuitive) Need: Rigid platforms and current flexible endoscopes are limited and will delay advances Benefits: enhanced operator capability, more procedural capability, avoid cross handedness, separates hands and eyes Risks: Functionality, ergonomics, may continue endoscope model Operators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol, other surgeons Timeline: 3 to 5 years Obstacles: training, learning curve, reluctance to “drink the Koolaide”, engineering/programming Applications: intralumenal, translumenal, SILS

Deconstructed Platforms (EES/Storz/UTSW, U Nebraska) Need: Disassociate link of eyes and hands microbots Benefits: remote control, ?enhanced access Risks: Functionality, limited operating field Operators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol, other surgeons Timeline: 3 to 5 years Obstacles: training, learning curve, reluctance to “drink the Koolaide”, engineering, tethered Applications: intralumenal, translumenal, SILS

2050 Platforms Nanotechnology Swallow the operating system Does the procedure and is then excreted from the body The true sign of intelligence is not knowledge, but imagination. - Albert Einstein