1. 2010 NOTES ® Summit Working Group Report Device Groups/ Targeted Technology Assessment BASIC TOOLS July 8-10, 2010 Chicago, IL

2. Basic Tools Participants Industry-7 Industry-7 FDA-1 FDA-1 Engineer-1 Engineer-1 Physicians- 9 Physicians- 9 GI2 GI2 Surgeon7 Surgeon7 Total-18 Total-18

3. Basic Tools Needs Addressed Basic tools needs- lessons from current NOTES experience Basic tools needs- lessons from current NOTES experience Categories of basic tools Categories of basic tools Characteristics of ‘ideal’ tools’ Characteristics of ‘ideal’ tools’ Limitations of current basic tools Limitations of current basic tools Design challenges- materials, physics, … Design challenges- materials, physics, … Lessons from breakthrough lap tools Lessons from breakthrough lap tools Operator issues- Training, ‘Creative use’ Operator issues- Training, ‘Creative use’

4. Basic Tools Basic tools – What do we need? Clips- Tissue Occlusion/ Hemostasis Clips- Tissue Occlusion/ Hemostasis Cutting- Tissue division Cutting- Tissue division Dissection- Tissue manipulation Dissection- Tissue manipulation Retraction Retraction Suturing/Staplers- overlap closure devices Suturing/Staplers- overlap closure devices Advanced tools- miniature flexible US, RFA Advanced tools- miniature flexible US, RFA Access tools Access tools Tool enhancers/ overtubes Tool enhancers/ overtubes

5. Basic Tools Classifications Use Use Shaft type: Flexible or Rigid Shaft type: Flexible or Rigid Working length Working length End effector: Rotation, Articulation End effector: Rotation, Articulation Energy sources- need to become flexible Energy sources- need to become flexible Load/ force transfer Load/ force transfer Interface with platforms: Magnets, etc. Interface with platforms: Magnets, etc.

6. Basic Tools Design challenges for all tools Uncouple visualization from action Uncouple visualization from action Working length: Need variability Working length: Need variability End effector length: Longer working tips End effector length: Longer working tips End effector control: Articulation/rotation, key- independent steerability End effector control: Articulation/rotation, key- independent steerability Robustness of end effector function Robustness of end effector function Precision of tip, effector control Precision of tip, effector control Load/ force transfer; Eliminate whipping/ wind Load/ force transfer; Eliminate whipping/ wind Variable stabilization- shapelock like ability Variable stabilization- shapelock like ability

7. Basic Tools Design challenges Loss of tactile feedback/ haptics Loss of tactile feedback/ haptics Materials: Materials: Strength Strength Torque/ force transfer Torque/ force transfer E.g.: Scissors, Dissectors, Graspers E.g.: Scissors, Dissectors, Graspers Durability Durability Radioopacity Radioopacity Overall: Basic tool needs are in the flexible universe- need more robust tools Overall: Basic tool needs are in the flexible universe- need more robust tools

8. Basic Tools Lesson from current usage Analysis of global experience: Majority of NOTES procedures are hybrid, predominantly rigid Analysis of global experience: Majority of NOTES procedures are hybrid, predominantly rigid Underlying reason for hybrid access: Underlying reason for hybrid access: Reliance on laparoscopic clip technology Reliance on laparoscopic clip technology Lack of robust flexible clip technology Lack of robust flexible clip technology

9. Basic Tools Clip challenges Clip characteristics Clip characteristics Size options (need for range of sizes) Size options (need for range of sizes) Occlusive v. non-occlusive (hemostasis) Occlusive v. non-occlusive (hemostasis) Tissue purchase Tissue purchase Absorbable v. non-absorbable Absorbable v. non-absorbable

10. Basic Tools Clip design challenges Clip applicator Clip applicator Manipulation of clip location Manipulation of clip location Repositionable Repositionable Articulation Articulation Control/ precision of application Control/ precision of application Ease of use Ease of use Multifire Multifire

11. Basic Tools Tissue cutting Scissors Scissors Cold knife Cold knife Energy sources Energy sources Cautery Cautery Needle knife, etc. Needle knife, etc. Ultrasonic devices Ultrasonic devices Laser Laser Contact and non-contact Contact and non-contact

12. Basic Tools Alternate tissue cutting technologies Delivery through a flexible working shaft Delivery through a flexible working shaft Use of currently available energy generators Use of currently available energy generators Precision- Precision- Control of tip Control of tip Control of depth of cut Control of depth of cut Ease of use Ease of use Use of existing generators Use of existing generators

13. Basic Tools Tissue cutting design challenges Scissors Scissors Single action v. double action Single action v. double action Energy capable Energy capable Articulation/ rotation Articulation/ rotation Working length Working length Tip length Tip length Strength Strength

14. Basic Tools Retraction Current options devices: ? Current options devices: ? Ideal characteristics: Ideal characteristics: Rotation Rotation Articulation Articulation Strength- load transfer/ torque Strength- load transfer/ torque Stability Stability Stiffener capability Stiffener capability Independence from instruments/ vision system Independence from instruments/ vision system Cost Cost

15. Basic Tools Suturing devices Deferred to ‘closure device’ group Deferred to ‘closure device’ group Ideal device characteristics: Ideal device characteristics: Absorbable v. non-absorbable suture Absorbable v. non-absorbable suture Variable needle size Variable needle size Precision of needle deployment Precision of needle deployment Articulation, Roticulation Articulation, Roticulation Force transfer/ load, strength Force transfer/ load, strength

16. Basic Tools Suturing devices Device profile Device profile User friendly platform User friendly platform Visualization system not tied to device Visualization system not tied to device Tissue manipulation precision Tissue manipulation precision Ease of use Ease of use Both device use reparation & deployment Both device use reparation & deployment Multiuse Multiuse

17. Basic Tools Stapling devices Deferred to closure device group Deferred to closure device group

18. Basic Tools Instrument integration Goal for interoperable / exchangeable instrument shafts, exchangeable, and/or multi-use effector tips Goal for interoperable / exchangeable instrument shafts, exchangeable, and/or multi-use effector tips Tool kits Tool kits Integration with evolving platforms Integration with evolving platforms

19. Basic Tools Access devices Perspective: Perspective: 1) Access has been on NOSCAR ‘white paper’ task list since inception 1) Access has been on NOSCAR ‘white paper’ task list since inception Laparoscopic standard: 0.3% injury rate Laparoscopic standard: 0.3% injury rate 2) Majority of procedures are performed with laparoscopic visualization of access, in part, by protocol as a ‘safety net’ backup, in part, to provide access for an acceptable clip system. IF clip issues resolved, ACCESS approaches may need to be readdressed 2) Majority of procedures are performed with laparoscopic visualization of access, in part, by protocol as a ‘safety net’ backup, in part, to provide access for an acceptable clip system. IF clip issues resolved, ACCESS approaches may need to be readdressed

20. Basic Tools Access issues Standard access options? Standard access options? PEG technique model PEG technique model Ultrasound guided –TV, TG, TC- pick best site Ultrasound guided –TV, TG, TC- pick best site Needleoscopy guided?-watch ALL access? Needleoscopy guided?-watch ALL access? Standard access devices?- access kit/PEG? Standard access devices?- access kit/PEG? Standard access steps- Standard access steps- Reproducible Reproducible Teachable Teachable

21. Basic Tools Basic tool enhancers Problem with flexible manipulation: “You cannot push rope…” Problem with flexible manipulation: “You cannot push rope…” Overtubes Overtubes Stability Stability Stiffeners Stiffeners Design options Design options Simple, low tech, preshaped Simple, low tech, preshaped Complex, high tech stiffeners Complex, high tech stiffeners

22. Basic Tools Operator issues Training/ User preparation burden related to device use- devices have different training requirements- but all have some… Training/ User preparation burden related to device use- devices have different training requirements- but all have some… Who is responsible for training? Who is responsible for training? Previous Vendor training model- changed business model- particularly for vendors Previous Vendor training model- changed business model- particularly for vendors Collaboration : FDA, vendors and professional societies Collaboration : FDA, vendors and professional societies Who pays for training? Who pays for training? Training models? Train to numbers, or objective based competence? Simulators? Training models? Train to numbers, or objective based competence? Simulators?

23. Basic Tools Operator issues Creative device use: What are the implications of equipment / device modification, creative solutions with off label use or modification of existing, approved instruments? What are the implications of equipment / device modification, creative solutions with off label use or modification of existing, approved instruments?

24. Basic Tools Development priorities Clip applier Clip applier Global tool design limitations related to control, precision, robustness, stability, load / force transfer Global tool design limitations related to control, precision, robustness, stability, load / force transfer Scissors Scissors Energy sources Energy sources Retraction Retraction Access Access

25. Basic Tools Timeline/ Future Anonymous vendor comment- basic tools Anonymous vendor comment- basic tools “so at five years, we have the same basic tool needs as when we started NOSCAR?” “so at five years, we have the same basic tool needs as when we started NOSCAR?” More robust basic tools will enable options for both flexible & laparoscopic NOTES- & potential procedure applications can expand More robust basic tools will enable options for both flexible & laparoscopic NOTES- & potential procedure applications can expand Timeline needs acceleration – make prototypes available for more common use Timeline needs acceleration – make prototypes available for more common use