Clip applier and methods of use

• US 20040153123A1
• Filed: 08/08/2003
• Published: 08/05/2004
• Est. Priority Date: 01/30/2003
• Status: Active Grant

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Belef, William M., Ginn, Richard S., Pantages, Anthony, Carley, Michael T., Palermo, Thomas J., Jabba, Ronald J.
• Granted Patent: US 7,867,249 B2
• Time in Patent Office: Days
• US Class Current: 606/213
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen

Abstract

An apparatus for delivering a closure element into an opening formed in a blood vessel or other body lumen and methods for manufacturing and using same. The apparatus is configured to retain the closure element such that the closure element is disposed substantially within the apparatus. The apparatus also can engage, and position the closure element substantially adjacent to, the blood vessel wall adjacent to the opening. During deployment of the closure element, the apparatus expands the closure element beyond a natural cross-section of the closure element such that the closure element, when deployed, is configured to engage a significant amount of the blood vessel wall and/or tissue. Engaging the blood vessel wall and/or tissue, the closure element is further configured to return to the natural cross-section, thereby drawing the engaged blood vessel wall and/or tissue substantially closed and/or sealed, such that hemostasis within the opening is enhanced.

Claims

1. An apparatus for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

a backing member having a distal end region configured to extend into said opening and to selectably engage said wall of said body lumen or said body tissue adjacent to said opening;

a carrier assembly coupled with said backing member, said carrier assembly comprising a carrier member retaining said closure element in a substantially tubular configuration within said carrier assembly, and a pusher member adapted to deploy said closure element; and

an energy storing member associated with said carrier assembly, said energy storing member adapted to cause relative motion between said carrier member and said pusher member;

wherein said closure element is configured to engage at least a portion of said wall of said body lumen or said body tissue whereby said opening is drawn substantially closed.

2. The apparatus of claim 1, wherein said energy storing member comprises a spring.

3. The apparatus of claim 2, wherein said spring is disposed substantially between said carrier member and said pusher member.

4. The apparatus of claim 3, wherein said spring is substantially disposed in a cavity located on one of said carrier member or said pusher member.

5. The apparatus of claim 3, further comprising a catch member adapted to selectably maintain said carrier member in proximity to said pusher member against a spring force imparted by said spring.

6. The apparatus of claim 5, further comprising a trigger selectably engageable with said catch member, said trigger adapted to cause said catch member to release said spring.

7. The apparatus of claim 3, wherein said backing member comprises a locator assembly that is selectably controllable between an unexpanded state and an expanded state for engaging said wall of said body lumen or said body tissue.

8. The apparatus of claim 7, wherein said distal end region of said locator assembly includes an expansion element configured to expand substantially transversely with respect to a longitudinal axis of the locator assembly.

9. The apparatus of claim 8, wherein said expansion element comprises a plurality of substantially flexible members each having a substantially fixed end region fixedly coupled with said distal end region of said locator assembly, an intermediate region, and a movable end region movable coupled with said distal end region of said locator assembly such that said intermediate regions are configured to expand transversely outwardly when said movable end regions are axially moved toward said substantially fixed end regions.

10. The apparatus of claim 9, wherein said locator assembly further includes a locator control system coupled to a proximal end region of said locator assembly, said locator control system being configured to selectively control said distal end region of said locator assembly between said expanded state and said unexpanded state.

11. The apparatus of claim 3, wherein said carrier assembly comprises a carrier member for receiving and supporting said closure element in said substantially tubular configuration, a pusher member for distally deploying said closure element, and a cover member for retaining said closure element, said carrier member, said pusher member, and said cover member being slidably coupled.

17. The apparatus of claim 11, wherein said carrier assembly further includes a support member being slidably coupled with said carrier member, said pusher member, and said cover member and being configured to provide radial support for said distal end region of said cover member.

18. The apparatus of claim 17, wherein said carrier member, said pusher member, said cover member, and said support member are provided as a plurality of nested, telescoping members with a common longitudinal axis.

12. The apparatus of claim , wherein said carrier member, said pusher member, and said cover member are provided as a plurality of nested, telescoping members with a common longitudinal axis.

13. The apparatus of claim 12, wherein said carrier member defines a lumen, said distal end region of said locator assembly being substantially axially aligned with, and at least partially slidably disposable within, said lumen of said carrier member.

14. The apparatus of claim 13, wherein said distal end region of said carrier member has a cross-section that increases distally for expanding said closure element to a cross-section that is greater than a natural cross-section of said closure element.

15. The apparatus of claim 14, wherein said distal end region of said pusher member includes one or more longitudinal extensions extending distally and being configured to expand radially as said distal end region of said pusher member moves distally and engages said distally-increasing cross-section of said distal end region of said carrier member.

16. The apparatus of claim 14, wherein said distal end region of said cover member includes one or more longitudinal extensions extending distally and being configured to expand radially.

19. An apparatus for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

a backing member having a distal end region configured to extend into said opening and to selectably engage said wall of said body lumen or said body tissue adjacent to said opening;

a carrier assembly coupled with said backing member, said carrier assembly comprising a carrier member retaining said closure element in a substantially tubular configuration within said carrier assembly, and a pusher member adapted to deploy said closure element; and

means associated with said carrier assembly for causing relative motion between said carrier member and said pusher member;

wherein said closure element is configured to engage at least a portion of said wall of said body lumen or said body tissue whereby said opening is drawn substantially closed.

20. The apparatus of claim 19, wherein said backing member comprises a locator assembly that is selectably controllable between an unexpanded state and an expanded state for engaging said wall of said body lumen or said body tissue.

21. The apparatus of claim 20, wherein said distal end region of said locator assembly includes an expansion element configured to expand substantially transversely with respect to a longitudinal axis of the locator assembly.

22. The apparatus of claim 21, wherein said expansion element comprises a plurality of substantially flexible members each having a substantially fixed end region fixedly coupled with said distal end region of said locator assembly, an intermediate region, and a movable end region movable coupled with said distal end region of said locator assembly such that said intermediate regions are configured to expand transversely outwardly when said movable end regions are axially moved toward said substantially fixed end regions.

23. The apparatus of claim 22, wherein said locator assembly further includes a locator control system coupled to a proximal end region of said locator assembly, said locator control system being configured to selectively control said distal end region of said locator assembly between said expanded state and said unexpanded state.

24. The apparatus of claim 19, wherein said carrier assembly comprises a carrier member for receiving and supporting said closure element in said substantially tubular configuration, a pusher member for distally deploying said closure element, and a cover member for retaining said closure element, said carrier member, said pusher member, and said cover member being slidably coupled.

25. The apparatus of claim 24, wherein said carrier member, said pusher member, and said cover member are provided as a plurality of nested, telescoping members with a common longitudinal axis.

26. The apparatus of claim 25, wherein said carrier member defines a lumen, said distal end region of said locator assembly being substantially axially aligned with, and at least partially slidably disposable within, said lumen of said carrier member.

27. The apparatus of claim 26, wherein said distal end region of said carrier member has a cross-section that increases distally for expanding said closure element to a cross-section that is greater than a natural cross-section of said closure element.

28. The apparatus of claim 27, wherein said distal end region of said pusher member includes one or more longitudinal extensions extending distally and being configured to expand radially as said distal end region of said pusher member moves distally and engages said distally-increasing cross-section of said distal end region of said carrier member.

29. The apparatus of claim 27, wherein said distal end region of said cover member includes one or more longitudinal extensions extending distally and being configured to expand radially.

30. The apparatus of claim 24, wherein said carrier assembly further includes a support member being slidably coupled with said carrier member, said pusher member, and said cover member and being configured to provide radial support for said distal end region of said cover member.

31. The apparatus of claim 30, wherein said carrier member, said pusher member, said cover member, and said support member are provided as a plurality of nested, telescoping members with a common longitudinal axis.

32. A method for closing an opening formed in a wall of a body lumen or body tissue, comprising:

extending a backing member through an elongate tubular member into said opening such that said backing member engages said wall of said body lumen or said body tissue adjacent to said opening;

positioning a distal end region of a carrier assembly through said elongate tubular member adjacent to said opening, said distal end region of said carrier assembly being configured to retain a closure element substantially within said carrier assembly; and

releasing an energy storing member to deploy said closure element from said carrier assembly such that said closure element engages at least a portion of said wall of said body lumen or said body tissue whereby said opening is drawn substantially closed.

33. The method of claim 32, wherein said energy storing member comprises a spring.

34. The method of claim 33, wherein said carrier assembly comprises a carrier member retaining said closure element in a substantially tubular configuration within said carrier assembly, and a pusher member adapted to deploy closure element, and said spring is disposed substantially between said carrier member and said pusher member.

35. The apparatus of claim 34, wherein said spring is substantially disposed in a cavity located on one of said carrier member or said pusher member.

36. The apparatus of claim 34, further comprising a catch member adapted to selectably maintain said carrier member in proximity to said pusher member against a spring force imparted by said spring.

37. The apparatus of claim 36, further comprising a trigger selectably engageable with said catch member, said trigger adapted to cause said catch member to release said spring.

38. The method of claim 32, wherein said elongate tubular member is an introducer sheath.

39. The method of claim 32, wherein at least a portion of said elongate tubular member expands radially during said positioning step.

40. The method of claim 32, wherein no portion of said elongate tubular member substantially expands radially during said positioning step.

41. The method of claim 32, wherein at least a portion of said elongate tubular member splits during said positioning step.

42. The method of claim 32 Wherein at least a portion of said elongate tubular member splits as a result of said positioning step.

43. The method of claim 32, wherein said closure element is retained in said carrier assembly in a substantially tubular configuration.

44. The method of claim 43, wherein said closure element substantially uniformly expands to a cross-section that is greater than a natural cross-section of said closure element during said deploying step.

45. The method of claim 43, wherein said closure element maintains a substantially uniform cross-section during said deploying step.

46. The method of claim 43, wherein said closure element transitions to a natural, planar configuration during said deploying step.

47. The method of claim 32, wherein said carrier assembly is slidably coupled with said backing member.

48. The method of claim 47, wherein said backing member comprises a locator assembly having a distal end region adapted to extend into said opening and to selectably engage the wall of the body lumen or the body tissue adjacent to said opening.

49. The method of claim 48, wherein said distal end region of said locator assembly is selectably controllable between an unexpanded state and an expanded state for engaging said wall of said body lumen or said body tissue.