Devices, systems, and methods for supporting tissue and/or structures within a hollow body organ

• US 20060287661A1
• Filed: 03/01/2006
• Published: 12/21/2006
• Est. Priority Date: 11/28/2001
• Status: Abandoned Application

• Current Assignee: Aptus Endosystems Inc. (Medtronic Plc)
• Original Assignee: Aptus Endosystems Inc. (Medtronic Plc)
• Inventors: Bolduc, Lee, Houle, Philip R., Chiang, Andrew L., Laroya, Gilbert S.
• Application Number:
  US11/365,056
• Publication Number:
  US 20060287661A1
• Time in Patent Office: Days
• US Class Current: 606/153
• 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 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0441 the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/0646 for insertion into cartillege, e.g. meniscus
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2466 : Delivery devices therefor
• CPC Class Codes: A61F 2/2478 : Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2481 : Devices outside the heart wall, e.g. bags, strips or bands
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall

Abstract

Devices, systems and methods support tissue in a body organ for the purpose of restoring or maintaining native function of the organ. The devices, systems, and methods do not require invasive, open surgical approaches to be implemented, but, instead, lend themselves to catheter-based, intra-vascular and/or percutaneous techniques.

Claims

1. A system for supporting tissue within a hollow body organ comprising

a first implant sized and configured to penetrate a first region of tissue in the hollow body organ,

a second implant sized and configured to penetrate a second region of tissue in the hollow body organ spatially distinct from the first region, and

at least one tension element to apply tension on the first and second implants and thereby draw tissue inward, thereby defining a reduced interior volume within the hollow body organ.

2. A system according to claim 1

wherein the tension element folds tissue between the first and second implants.

3. A system according to claim 2

further including a patch element fastened to tissue and overlaying the fold between the first and second implants.

4. A system according to claim 1

wherein the first and second implants are part of an array of implants that penetrates spatially distinct regions of tissue in the hollow body organ, and

wherein the tension element applies tension on the array of implants and thereby draw tissue inward.

5. A system according to claim 1

wherein at least one of the implants comprises a helical fastener.

6. A system according to claim 1

wherein the tension element includes first and second tether elements joined, respectively, to the first and second implants, and

at least one clip element gathering the first and second tether elements together in a taut condition.

7. A method of supporting tissue in a hollow body organ comprising the step of using a system as defined in claim 1.

8. A method of supporting tissue in a heart chamber comprising the step of using a system as defined in claim 1.

9. A system for forming a tissue fold within a hollow body organ comprising

a first implant sized and configured to penetrate a first region of tissue in the hollow body organ,

a second implant sized and configured to penetrate a second region of tissue in the hollow body organ spatially distinct from the first region,

at least one tension element extending between the first and second implants to apply tension on the first and second implants and thereby create a tissue fold between the first and second implants.

10. A system according to claim 9

further including a patch element fastened to tissue and overlaying the tissue fold.

11. A system according to claim 9

wherein the first and second implants are part of an array of implants that penetrates spatially distinct regions of tissue in the hollow body organ, and

wherein the tension element extends among the array of implants to apply tension between adjacent implants and thereby create a pattern of tissue folds.

12. A system according to claim 11

further including a patch element fastened to tissue and overlaying the pattern of tissue folds.

13. A system according to claim 9

wherein at least one of the implants comprises

a helical fastener.

14. A system according to claim 9

wherein the tension element includes a tether element extending between the first and second implants in a taut condition.

15. A method of folding tissue in a hollow body organ comprising the step of using a system as defined in claim 9.

16. A method of folding tissue in a heart chamber comprising the step of using a system as defined in claim 9.

17. A method of folding tissue to close an atrial appendage comprising the step of using a system as defined in claim 9.

18. A method of folding tissue to close a perforation, hold, or defect comprising the step of using a system as defined in claim 9.

19. A system for supporting tissue in a hollow body organ comprising

a prosthesis sized and configured for placement within an interior of the hollow body organ to regulate a size and/or shape of the hollow body organ, and

at least one fastener securing the prosthesis to tissue in the hollow body organ.

20. A system according to claim 19

wherein the fastener comprises a helical fastener.

21. A system according to claim 19

wherein the prosthesis comprises an array of prosthetic patches.

22. A system according to claim 19

wherein the prosthesis includes a formed body.

23. A system according to claim 19

wherein the prosthesis includes an assembly of prosthesis sections.

24. A method of supporting tissue in a hollow body organ comprising the step of using a system as defined in claim 19.

25. A method of supporting tissue in a heart chamber comprising the step of using a system as defined in claim 19.

26. A system for supporting tissue around a hollow body organ comprising

a prosthesis sized and configured for placement on an exterior of the hollow body organ to regulate a size and/or shape of the hollow body organ, and

at least one fastener securing the prosthesis to tissue on the hollow body organ.

27. A system according to claim 26

wherein the fastener comprises a helical fastener.

28. A system according to claim 26

wherein the prosthesis comprises an array of prosthetic patches.

29. A system according to claim 26

wherein the prosthesis includes a formed body.

30. A system according to claim 26

wherein the prosthesis includes an assembly of prosthesis sections.

31. A method of supporting tissue around a hollow body organ comprising the step of using a system as defined in claim 26.

32. A method of supporting tissue around a heart chamber comprising the step of using a system as defined in claim 26.

33. A system for supporting tissue within a hollow body organ comprising

an elongated implant sized and configured to penetrate tissue and extend along a curvilinear path within or partially within a tissue wall to regulate a size and/or shape of the hollow body organ.

34. A system according to claim 33

wherein the elongated implant comprises a helical shape.

35. A method of supporting tissue in a hollow body organ comprising the step of using a system as defined in claim 33.

36. A method of supporting tissue in a heart chamber comprising the step of using a system as defined in claim 33.

37. A system for reducing volume within a hollow body organ comprising

a prosthesis sized and configured for placement within the hollow body organ, the prosthesis including an expandable segment to regulate a size and/or shape of the hollow body organ, and

at least one fastener securing the prosthesis to tissue in the hollow body organ.

38. A system according to claim 37 wherein the expandable segment is sized and configured to expand in response to receipt of fluid.

39. A method of reducing volume within a hollow body organ comprising the step of using a system as defined in claim 37.

40. A method of reducing volume within a heart chamber comprising the step of using a system as defined in claim 37.

41. A prosthesis for reducing volume within a hollow body organ comprising

a prosthesis body sized and configured for placement within the hollow body organ, the prosthesis body including an expandable segment to regulate a size and/or shape of the hollow body organ, the expandable segment being sized and configured to expand in response to receipt of fluid.

42. A method of reducing volume within a hollow body organ comprising the step of using a prosthesis as defined in claim 41.

43. A method of reducing volume within a heart chamber comprising the step of using a prosthesis as defined in claim 41.