20102010 NOTESNOTES®®SummitSummitDevice Working GroupDevice Working Group

Advanced PlatformAdvanced Platform

Needs AssessmentNeeds Assessment

While NOTES procedures are able to be While NOTES procedures are able to be done with rigid devices and hybrid with done with rigid devices and hybrid with laparoscopic assistance, NOTES will not laparoscopic assistance, NOTES will not fully move forward without the fully move forward without the development of a functional platform.development of a functional platform.

Until the development of new platforms, Until the development of new platforms, the major medical centers will function as the major medical centers will function as the platform with current use the platform with current use technologiestechnologies

Key Features of a PlatformKey Features of a Platform

Provide traction/counter-traction with Provide traction/counter-traction with triangulationtriangulation

Appropriate maneuverability in Appropriate maneuverability in operative fieldoperative field

Stable, mountableStable, mountable Deal with reverse handednessDeal with reverse handedness ScalableScalable Length variable from pelvis to diaphragmLength variable from pelvis to diaphragm

Key Features of a PlatformKey Features of a Platform

Create/support 6 degrees of motionCreate/support 6 degrees of motion Ergonomic, easy to use, comfortableErgonomic, easy to use, comfortable Reasonable size (18-20 mm OD max TG)Reasonable size (18-20 mm OD max TG) Reusable, ease of reprocessingReusable, ease of reprocessing Can exchange end-effectors easilyCan exchange end-effectors easily Platforms designed for parallelism may Platforms designed for parallelism may

be good for intralumenal use, while those be good for intralumenal use, while those providing triangulation likely needed for providing triangulation likely needed for translumenal indications.translumenal indications.

ChallengesChallenges Price point, risk vs. benefit analysisPrice point, risk vs. benefit analysis Systems designed for site of entry (TG, TV, Systems designed for site of entry (TG, TV,

TC, etc) or procedure (diagnostic vs. TC, etc) or procedure (diagnostic vs. therapeutic) or type of procedure: therapeutic) or type of procedure: intralumenal, translumenal, SILS – can one intralumenal, translumenal, SILS – can one system “fit all”system “fit all”

NOTES as an evolving process – perhaps NOTES as an evolving process – perhaps some of a procedure can be NOTES (organ some of a procedure can be NOTES (organ removal, retraction, visualization)removal, retraction, visualization)

Industry needing to know for which Industry needing to know for which procedure the platform is neededprocedure the platform is needed

ChallengesChallenges

We await the catalyst in a NOTES platform We await the catalyst in a NOTES platform – for lap surgery it was video-system – for lap surgery it was video-system integration allowing for team dynamicintegration allowing for team dynamic

Knowing where the system is – role of Knowing where the system is – role of augmented reality imagingaugmented reality imaging

Anchoring the platform and making it Anchoring the platform and making it stablestable

Training and credentialingTraining and credentialing

Solutions/FutureSolutions/Future Enhance the endoscope – sophisticated Enhance the endoscope – sophisticated

over tubes and operative endoscopesover tubes and operative endoscopes Deconstruct the endoscope – separate Deconstruct the endoscope – separate

eyes and armseyes and arms Platformless platform – “port-free surgery”Platformless platform – “port-free surgery” Multiport natural orifice accessMultiport natural orifice access MicrobotsMicrobots NanobotsNanobots Near term use of current technology, 3 to Near term use of current technology, 3 to

5 yrs for new platform availability5 yrs for new platform availability

NOTES PlatformsNOTES Platforms

Laparoscopic adaptation Laparoscopic adaptation

Enhanced endoscopesEnhanced endoscopes

Manual robotManual robot

Computer assisted robotsComputer assisted robots

Deconstructed platformsDeconstructed platforms

2050 platform2050 platform

Laparoscopic AdaptationLaparoscopic Adaptation

NeedNeed: enhance current use devices for NOTES : enhance current use devices for NOTES specific application (port and instrument specific application (port and instrument development)development)

BenefitsBenefits: enhanced operator capability: enhanced operator capabilityRiskRisk: functionality: functionalityOperatorsOperators: Gen Surg, Colorectal Surg, Gyn, Urol: Gen Surg, Colorectal Surg, Gyn, UrolTimelineTimeline: now: nowObstaclesObstacles: training, learning curve, reluctance : training, learning curve, reluctance

to “drink the Koolaide”to “drink the Koolaide”ApplicationsApplications: for anything that can be reached: for anything that can be reached

Enhanced EndoscopesEnhanced EndoscopesNeed: enhance current use devices for NOTES specific application (working over tube and mountable accessories, “superscopes” )Benefits: enhanced operator capabilityRisks: Functionality, reprocessabilityOperators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, UrolTimeline: nowObstacles: training, learning curve, reluctance to “drink the Koolaide”Applications: intralumenal, translumenal, SILS

Manual Robot Manual Robot (i.e.. Olympus, BSC, Ethicon, Storz, (i.e.. Olympus, BSC, Ethicon, Storz,

Transenterix)Transenterix)Need: Rigid platforms and current flexible endoscopes are limited and will delay advancesBenefits: enhanced operator capability, more procedural capability, avoid cross handedness, separates hands and eyesRisks: Functionality, ergonomics Operators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol, other surgeonsTimeline: 3 to 5 yearsObstacles: training, learning curve, reluctance to “drink the Koolaide”, engineering limitationsApplications: intralumenal, translumenal, SILS

Computer Assisted RobotComputer Assisted Robot(Endovia, Singapore, Intuitive)(Endovia, Singapore, Intuitive)

Need: Rigid platforms and current flexible endoscopes are limited and will delay advancesBenefits: enhanced operator capability, more procedural capability, avoid cross handedness, separates hands and eyesRisks: Functionality, ergonomics, may continue endoscope modelOperators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol, other surgeonsTimeline: 3 to 5 yearsObstacles: training, learning curve, reluctance to “drink the Koolaide”, engineering/programmingApplications: intralumenal, translumenal, SILS

Deconstructed PlatformsDeconstructed Platforms(EES/Storz/UTSW, U Nebraska)(EES/Storz/UTSW, U Nebraska)

Need: Disassociate link of eyes and hands microbots

Benefits: remote control, ?enhanced accessRisks: Functionality, limited operating fieldOperators: GI Endoscopists, Gen Surg, Colorectal Surg, Gyn, Urol, other surgeonsTimeline: 3 to 5 yearsObstacles: training, learning curve, reluctance to “drink the Koolaide”, engineering, tetheredApplications: intralumenal, translumenal, SILS

2050 Platforms2050 PlatformsNanotechnology

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