Clip applier and methods of use

• US 7,867,249 B2
• Filed: 08/08/2003
• Issued: 01/11/2011
• Est. Priority Date: 01/30/2003
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories)
• Inventors: Palermo, Thomas J, Belef, William M, Ginn, Richard S, Pantages, Anthony, Carley, Michael T, Jabba, Ronald J
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): Nguyen; Tuan V
• Application Number:
  US10/638,115
• Publication Number:
  US 20040153123A1
• Time in Patent Office: 2,713 Days
• Field of Search: 606/139, 606/213, 606/151, 606/153, 606/140, 606/141, 606/142, 606/143, 606/144, 606/145, 606/146, 606/147, 606/148, 606/215, 606/216, 606/220, 606/221
• 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 locator assembly having a distal end region and 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 an unexpanded state and an expanded state for engaging said wall of said body lumen or said body tissue adjacent to said opening;

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

a cover member configured to retain said closure element, said cover member having a distal end region and a proximal end region, said distal end region of said cover member including one or more longitudinal extensions extending distally and substantially radially inwardly with respect to said proximal end region and being configured to expand radially;

an energy storing member associated with said carrier assembly and said locator control system, said energy storing member configured to cause a proximal end of said pusher member to move distally from a proximal end of said carrier member and to move a portion of said proximal end region of the locator control system proximally to disengage the distal end region of the locator assembly from engaging said wall of said body lumen or said body tissue.

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 6, 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.

8. The apparatus of claim 7, 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.

9. 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 and a pusher member for distally deploying said closure element, said carrier member, said pusher member, and said cover member being slidably coupled.

10. The apparatus of claim 9, 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.

11. The apparatus of claim 10, 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.

12. The apparatus of claim 11, 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.

13. The apparatus of claim 12, 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.

14. The apparatus of claim 9, 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.

15. The apparatus of claim 14, 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.

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

a locator assembly having a distal end region and 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 an unexpanded state and an expanded state for engaging said wall of said body lumen or said body tissue adjacent to said opening;

a carrier assembly coupled with and receiving at least a portion of said locator assembly, said carrier assembly comprising a carrier member configured for retaining said closure element in a substantially tubular configuration within said carrier assembly, and a pusher member adapted to deploy said closure element;

a cover member configured to retain said closure element, said cover member having a distal end region and a proximal end region, said distal end region of said cover member including one or more longitudinal extensions extending distally and substantially radially inwardly with respect to said proximal end region and being configured to expand radially;

means associated with said locator assembly and carrier assembly for causing a proximal end of said pusher member to move distally from a proximal end of said carrier member and to move a proximal portion of the locator assembly to disengage said distal end region of said locator assembly from said wall of said body lumen or body tissue.

17. The apparatus of claim 16, 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.

18. The apparatus of claim 17, 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.

19. The apparatus of claim 16, wherein said carrier assembly comprises a carrier member for receiving and supporting said closure element in said substantially tubular configuration and a pusher member for distally deploying said closure element, said carrier member, said pusher member, and said cover member being slidably coupled.

20. The apparatus of claim 19, 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.

21. The apparatus of claim 20, 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.

22. The apparatus of claim 21, 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.

23. The apparatus of claim 22, 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.

24. The apparatus of claim 19, 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.

25. The apparatus of claim 24, 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.

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

a locator assembly 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 and a proximal end region;

a carrier assembly coupled with said locator assembly, said carrier assembly comprising a carrier member for retaining said closure element in a substantially tubular configuration within said carrier assembly, and a pusher member adapted to deploy said closure element, said distal end region of said carrier member having 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, said distal end region of said pusher member including 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;

a cover member for retaining said closure element, said carrier member, said pusher member, and said cover member being slidably coupled, said carrier member, said pusher member, and said cover member being provided as a plurality of nested, telescoping members with a common longitudinal axis, said cover member having a distal end region and a proximal end region, said distal end region of said cover member including one or more longitudinal extensions extending distally and substantially radially inwardly with respect to said proximal end region and being configured to expand radially;

an energy storing member associated with said carrier assembly, said energy storing member configured to cause a proximal end of said pusher member to move distally from a proximal end of said carrier member and to move a portion of the proximal end region of the locator assembly proximally to disengage the distal end region of the locator assembly from engaging said wall of said body lumen or said body tissue;

wherein a portion of said locator assembly is substantially axially aligned with, and at least partially slidably disposable within, said lumen of said carrier 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.