Methods and apparatus for gastric reduction

• US 20040122456A1
• Filed: 07/01/2003
• Published: 06/24/2004
• Est. Priority Date: 12/11/2002
• Status: Abandoned Application

• Current Assignee: USGI Medical, Inc.
• Original Assignee: USGI Medical, Inc.
• Inventors: Chen, Eugene, Ewers, Richard C., Saadat, Vahid C.
• Application Number:
  US10/612,170
• Publication Number:
  US 20040122456A1
• Time in Patent Office: Days
• US Class Current: 606/157
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0443 the shaft being resilient and having a coiled or helical shape in the released state
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61F 5/0086 using clamps, folding means or the like

Abstract

Apparatus for use with a gastric reduction system for narrowing a cross-sectional area of a patient'"'"'s gastro-intestinal lumen. The apparatus comprises an anchor that is adapted to be reconfigured from a reduced delivery profile within a delivery catheter to an expanded deployed profile once the anchor is released from the delivery catheter.

Claims

1. An anchor for use with a gastric reduction system for narrowing a cross-sectional area of a gastro-intestinal lumen, the anchor comprising:

a sleeve including proximal and distal bushings;

wherein the sleeve is adapted to be reconfigured from a reduced delivery profile to an expanded deployed profile.

2. The anchor of claim 1, further comprising a suture coupled to the distal bushing and extending through the interior of the sleeve.

3. The anchor of claim 2, wherein the suture extends through an aperture in the proximal bushing.

4. The anchor of claim 3, wherein the sleeve is configured so that application of tension on the suture approximates the distal bushing to the proximal bushing.

5. The anchor of claim 3, wherein the sleeve is configured so that application of tension on the suture transitions the sleeve from the reduced delivery profile to the expanded deployed profile.

6. The anchor of claim 1, wherein the sleeve is braided.

7. The anchor of claim 1, wherein the sleeve is formed of individual monofilament elements.

8. The anchor of claim 7, wherein the monofilament elements are made of polyester, nylon, TEFLON, polypropylene or combinations of these materials.

9. The anchor of claim 1, wherein the sleeve comprises a shape memory material.

10. The anchor of claim 1, further comprising a filament attached to the proximal bushing to facilitate removal of the anchor.

11. The anchor of claim 1, further comprising an internal lock for retaining the sleeve in the expanded deployed profile.

12. The anchor of claim 1, wherein the internal lock comprises a ferrule and mating barb.

13. The anchor of claim 1, further comprising a coating of bioactive agent applied to an outer surface of the sleeve.

14. The anchor of claim 13, wherein the bioactive agent is selected to either promote or hinder tissue ingrowth.

15. The anchor of claim 1, wherein the sleeve comprises a plurality of longitudinal struts.

16. An anchor for use with a gastric reduction system, the anchor comprising:

a shank having proximal and distal ends; and

a reconfigurable member disposed on the distal end of the shank, the reconfigurable member having a reduced delivery profile and an expanded deployed profile.

17. The anchor of claim 16, wherein the proximal end of the shank defines an eyelet.

18. The anchor of claim 16, wherein the reconfigurable member comprises a plurality of struts affixed to the distal end of the shank, the plurality of struts having a reduced delivery profile wherein the plurality of struts are substantially parallel to the shank and an expanded deployed profile wherein the plurality of struts extend at angles away from the shank.

19. The anchor of claim 18, further comprising a membrane affixed to the plurality of struts.

20. The anchor of claim 18, wherein the shank is arranged so that tension applied to the shank urges the reconfigurable member to the expanded deployed profile.

21. The anchor of claim 16, wherein the reconfigurable member comprises a shape memory material.

22. The anchor of claim 16, wherein the reconfigurable member transitions from an elongate member in the reduced delivery profile to a corkscrew in the expanded deployed profile.

23. The anchor of claim 16, wherein the reconfigurable member transitions from an elongate member in the reduced delivery profile to a ball in the expanded deployed profile.

24. The anchor of claim 16, wherein the reconfigurable member transitions from an elongate member in the reduced delivery profile to a disk in the expanded deployed profile.

25. The anchor of claim 16, wherein the reconfigurable member is fluid inflatable.

26. An anchor for use with a gastric reduction system, the anchor comprising:

a plurality of struts, each one of the plurality of struts having a proximal end and a distal end, at least one of the proximal end or the distal end of each one of the plurality of struts affixed to a fixation point; and

a suture coupled to the fixation point,

wherein the plurality of struts have a reduced delivery profile wherein the plurality of struts are substantially parallel to one another and an expanded deployed profile where the plurality of struts extend at angles away from one another.

27. The anchor of claim 26, wherein the fixation point comprises a distal bushing and distal end of each one of the plurality of struts is coupled to the distal bushing and the proximal end of each one of the plurality of struts is coupled to a proximal bushing.

28. The anchor of claim 27, wherein the plurality of struts is formed by creating a plurality of through-wall longitudinal slots in a hollow cylinder.

29. The anchor of claim 28, wherein, in the expanded deployed profile, the plurality of struts bow radially outward to form a disk-like configuration.

30. The anchor of claim 26, wherein the fixation point comprises one or more loops that couple the distal ends of opposing ones of the plurality of struts, the loops acting as torsion springs to bias the anchor to the expanded deployed profile.

31. The anchor of claim 30, wherein each strut further comprises one or more flexure points.

32. The anchor of claim 27, wherein the plurality of struts form a petaled disk-like configuration is the expanded deployed profile.

33. The anchor of claim 26, wherein the plurality of struts are self-expanding.

34. The anchor of claim 33, further comprising a membrane affixed to the plurality of struts.

35. The anchor of claim 26, wherein the fixation point has a sharpened tip to facilitate tissue penetration.

37. The anchor of claim 30, wherein the plurality of struts are disposed within a tube including a plurality of slots, each one of the plurality of slots dimensioned to permit a corresponding one of the plurality of struts to extend therethrough.

38. The anchor of claim 37, wherein, in the reduced delivery profile, the plurality of struts are substantially disposed within the tube.

39. The anchor of claim 27, wherein the distal ends of the plurality of struts are disposed within a tube including a plurality of slots, each one of the plurality of slots dimensioned to permit a corresponding one of the plurality of struts to extend therethrough.

40. The anchor of claim 39, wherein the slotted tube is dimensioned to receive an obturator, insertion of the obturator causing the plurality of struts to rotate from the expanded deployed profile to the reduced delivery profile.

41. The anchor of claim 26, wherein the fixation point comprises a proximal hub and proximal end of each one of the plurality of struts is coupled to the proximal hub.

42. The anchor of claim 41, wherein the distal ends of adjacent ones of the plurality of struts are coupled together to form petals.

43. The anchor of claim 41, wherein the distal end of each of the plurality of struts terminates in an atraumatic ball.

36. The anchor of claim 36, wherein the struts are configured to form a central opening dimensioned to permit passage of an obturator therethrough.

44. An anchor for use with a gastric reduction system, the anchor comprising:

a suture having proximal and distal ends; and

a reconfigurable member disposed on the distal end of the suture, the reconfigurable member having a delivery profile and a deployed profile.

45. The anchor of claim 44 wherein the reconfigurable member comprises a tube.

46. The anchor of claim 45 wherein the tube comprises a plurality of through-wall slots, the reconfigurable member further comprising a plurality of struts, each one of the plurality of struts having a proximal end and a distal end, each one of the plurality of slots dimensioned to permit a corresponding one of the plurality of struts to extend therethrough.

47. The anchor of claim 44 wherein the reconfigurable member comprises first and second struts having longitudinal axes, the longitudinal axes of the first and second struts transitioning between the delivery profile, wherein the longitudinal axes are aligned, and the deployed profile, wherein the longitudinal axes intersect.

48. The anchor of claim 47, further comprising a membrane affixed to the first and second struts.

49. The anchor of claim 44, wherein the reconfigurable member comprises a tubular member having a longitudinal axis, the longitudinal axis of the tubular member transitioning between the delivery profile, wherein the longitudinal axis is aligned with a longitudinal axis of a delivery needle, and the deployed profile, wherein the longitudinal axis intersects the longitudinal axis of the delivery needle.