Clip applier and methods of use

• US 8,926,656 B2
• Filed: 01/10/2011
• Issued: 01/06/2015
• 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, Carley, Michael T, Jabba, Ronald J, Pantages, Anthony, Ginn, Richard S
• Primary Examiner(s): NGUYEN, TUAN VAN
• Application Number:
  US12/987,792
• Publication Number:
  US 20110166584A1
• Time in Patent Office: 1,457 Days
• Field of Search: 606/213, 606/219, 606/220, 606/139, 606/140, 606/141, 606/142, 606/151, 606/153, 606/154, 606/155, 606/157, 606/158, 606/148
• 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. A method for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

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

positioning a distal end region of a carrier assembly through said elongate tubular member adjacent to the opening, said distal end region of said carrier assembly being configured to retain said closure element in a substantially tubular configuration and 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 the wall of the body lumen or the body tissue, 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, wherein said energy storing member is substantially disposed in a cavity located on one of said carrier member or said pusher member and said energy storing member increases in length greater than a length of said cavity upon being released.

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

3. The method of claim 1, wherein said elongate tubular member is an introducer sheath.

4. The method of claim 1, wherein at least a portion of said elongate tubular member expands radially during said positioning step.

5. The method of claim 1, wherein no portion of said elongate tubular member substantially expands radially during said positioning step.

6. The method of claim 1, wherein at least a portion of said elongate tubular member splits during said positioning step.

7. The method of claim 1 wherein at least a portion of said elongate tubular member splits as a result of said positioning step.

8. The method of claim 1, further comprising retaining said closure element in said carrier assembly in a substantially tubular configuration.

9. The method of claim 8, 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.

10. The method of claim 8, wherein said closure element maintains a substantially uniform cross-section during said deploying step.

11. The method of claim 8, wherein said closure element transitions to a natural, planar configuration during said deploying step.

12. The method of claim 1, wherein said carrier assembly is slidably coupled with said backing member.

13. The method of claim 12, wherein said backing member comprises a locator assembly having a distal end region adapted to extend into the opening and to selectably engage the wall of the body lumen or the body tissue adjacent to the opening.

14. The method of claim 13, wherein said distal end region of said locator assembly is selectably controllable between an unexpanded state and an expanded state for engaging the wall of the body lumen or the body tissue.

15. A method for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

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

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

activating means associated with said carrier assembly for causing a proximal end of a pusher member to move distally from a proximal end of said carrier member and to move a portion of said backing member to disengage said backing member from the wall of the body lumen or the body tissue and for causing said closure element to engage at least a portion of the wall of the body lumen or the body tissue whereby said opening is drawn substantially closed.

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

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

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

releasing a spring to deploy a pusher member to deploy said closure element from said carrier assembly such that said closure element engages at least a portion of the wall of the body lumen or the body tissue whereby the opening is drawn substantially closed, said carrier member being selectably maintained in proximity to said pusher member against a spring force imparted by said spring by a catch member, wherein said spring is substantially disposed in a cavity located on one of said carrier member or said pusher member and said spring increases in length greater than a length of said cavity upon being released.

17. A method for delivering a closure element to an opening formed in a wall of a body lumen or body tissue, comprising:

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

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

releasing a spring to deploy said closure element from said carrier assembly such that said closure element engages at least a portion of the wall of the body lumen or the body tissue, wherein said carrier assembly comprises a carrier member retaining said closure element in a substantially tubular configuration within said carrier assembly, a pusher member adapted to deploy closure element, a catch member adapted to selectably maintain said carrier member in proximity to said pusher member against a spring force imparted by said spring, a trigger selectably engageable with said catch member and adapted to cause said catch member to release said spring, and said spring is disposed substantially between said carrier member and said pusher member.

18. The apparatus of claim 17, wherein said spring is substantially disposed in a cavity located on one of said carrier member or said pusher member.