Plunger apparatus and methods for delivering a closure device

• US 8,007,512 B2
• Filed: 10/08/2003
• Issued: 08/30/2011
• Est. Priority Date: 02/21/2002
• Status: Expired due to Fees

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Ginn, Richard S., Pantages, Anthony
• Primary Examiner(s): Ho; (Jackie) Tan-Uyen T
• Assistant Examiner(s): Dornbusch; Dianne
• Application Number:
  US10/682,459
• Publication Number:
  US 20040073255A1
• Time in Patent Office: 2,883 Days
• Field of Search: 606/139, 606/142, 606/143, 606/151, 606/153, 606/157, 606/158, 606/213, 606/215, 606/219, 128/898
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple
• CPC Class Codes: A61B 2017/00672 Locating means therefor, e.g. bleed back lumen
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body

Abstract

An apparatus for delivering a clip includes an introducer sheath including an outer surface extending between its proximal and distal ends, and a hub on the proximal end that includes spacer elements spaced away from the outer surface. An annular clip includes a plurality of tines extending from its distal end and its proximal end is held away from the outer surface of the sheath by the spacer elements. A handle assembly is attached to the hub that includes an actuator member slidable between the spacer elements and the outer surface of the sheath. The actuator member includes radial protrusions for coupling with the clip, whereby distal movement of the actuator member advances the clip towards the distal end of the sheath. Optionally, a skin overlies the outer surface of the sheath and the clip that is separable from the outer surface as the clip is advanced.

Claims

1. A method for delivering a closure element to seal an opening through tissue, the method comprising:

inserting a distal end of an elongate member into an opening through tissue, the elongate member having a distal end, a proximal end, a lumen extending from the distal end to the proximal end, and a skin overlying at least a portion of the outer surface of the elongate member between the distal end and the proximal end and at least partially overlying a carrier assembly slidably disposed on the elongate member and carrying the closure element;

deploying one or more medical devices through the lumen of the elongate member;

following removal of the one or more medical devices from within the lumen, locating a portion of a separate actuator assembly in fluid communication with the lumen of the elongate member and advancing the carrier assembly distally along the elongate member from the proximal end towards the distal end of the elongate member with the actuator assembly, thereby advancing the closure element towards the distal end of the elongate member and causing the skin to separate from the outer surface of the elongate member;

engaging tissue adjacent the distal end of the elongate member with a plurality of tissue engaging elements on the closure element; and

withdrawing the elongate member from the opening, thereby leaving the closure element to close the opening.

2. The method of claim 1, wherein the skin comprises a weakened region extending towards the distal end of the elongate member, the weakened region tearing as the carrier assembly is advanced towards the distal end of the elongate member.

3. The method of claim 1, wherein a portion of the skin is folded over itself to define a flap, the flap extending generally axially along the outer surface of the elongate member and overlying an adjacent region of the skin, and wherein the flap is released from the adjacent region as the carrier assembly is advanced towards the distal end of the elongate member, thereby allowing the skin to separate from the outer surface.

4. The method of claim 1, wherein the skin expands to a cross-section that is larger than a cross-section of the elongate member as the carrier assembly is advanced towards the distal end.

5. The method of claim 1, wherein the skin comprises a skin outer surface that is substantially slippery.

6. The method of claim 1, wherein the opening through tissue extends through one or more layers of fascia, and wherein the skin facilitates advancing the closure element through the one or more layers of fascia.

7. The method of claim 1, wherein the opening through tissue communicates with a blood vessel, and wherein leaving the closure element to close the opening comprises leaving the closure element to substantially seal the opening from blood flow therethrough with the closure element.

8. The method of claim 1, wherein the actuator assembly comprises an actuator member, the method further comprising inserting a distal end of the actuator member into the elongate member to cooperate with the carrier assembly and advancing the actuator member in a distal direction to advance the carrier assembly along the elongate member.

9. The method of claim 8, further comprising manipulating the actuator member to deploy the closure element and engage the tissue adjacent the distal end of the elongate member.

10. The method of claim 1, wherein engaging tissue adjacent the distal end of the elongate member with tissue engaging elements on the closure element comprises deploying the closure element from the carrier assembly and elongate member, the closure element comprising a generally annularly-shaped body comprising proximal and distal ends and a plurality of tissue engaging portions extending from the distal end, the closure element being configured to move from a first expanded configuration when on the carrier assembly to a second contracted configuration when deployed, thereby drawing tissue around the opening together.

11. A method for delivering a closure element to seal an opening through tissue, the method comprising:

inserting a distal end of the elongate member into an opening through tissue along a guidewire, the elongate member having a distal end, a proximal end, a lumen extending from the proximal end to the distal end, and a skin overlying at least a portion of the outer surface of the elongate member between the distal end and proximal end and at least partially overlying a carrier assembly;

deploying one or more medical devices through the lumen of the elongate member;

following removal of the one or more medical devices from within the lumen, selectively connecting a separate actuator assembly to the elongate member and locating a portion of the separate actuator assembly in fluid communication with the lumen of the elongate member and inserting a distal end of an obturator through the lumen of the elongate member and through a portion of the actuator assembly and through the opening through tissue;

advancing the carrier assembly distally along the elongate member from the proximal end towards the distal end of the elongate member with the actuator assembly, thereby advancing the closure element towards the distal end of the elongate member and causing the skin to separate from the outer surface of the elongate member;

engaging tissue adjacent the distal end of the elongate member with a plurality of tissue engaging elements on the closure element; and

withdrawing the elongate member from the opening, thereby leaving the closure element to close the opening.

12. The method of claim 11, wherein engaging tissue adjacent the distal end of the elongate member with tissue engaging elements on the closure element comprises deploying the closure element from the carrier assembly and elongate member, the closure element comprising a generally annularly-shaped body comprising proximal and distal ends and a plurality of tissue engaging portions extending from the distal end, the closure element being configured to move from a first expanded configuration when on the carrier assembly to a second contracted configuration when deployed, thereby drawing tissue around the opening together.

13. The method of claim 11, wherein the obturator comprises an expandable distal portion coupled with an elongate portion extending proximally for manipulation by a user.

14. The method of claim 13, further comprising retracting the elongate portion of the obturator in a proximal direction to expand the expandable distal portion distal of the opening through tissue to stabilize or secure tissue surrounding the opening.

15. The method of claim 11, wherein the skin comprises a weakened region extending towards the distal end of the elongate member, the weakened region preferentially splitting as the carrier assembly is advanced towards the distal end of the elongate member.

16. The method of claim 15, wherein the weakened region comprises a thin-walled seam or a plurality of perforations to define a seam.

17. The method of claim 11, wherein the skin comprises embedded fibers to bias the skin to preferentially tear.

18. The method of claim 11, wherein the actuator assembly comprises an actuator member, the method further comprising inserting a distal end of the actuator member into the elongate member to cooperate with the carrier assembly and advancing the actuator member in a distal direction to advance the carrier assembly along the elongate member.

19. The method of claim 18, further comprising manipulating the actuator member to deploy the closure element and engage the tissue adjacent the distal end of the elongate member.

20. A method for delivering a closure element to seal an opening through tissue, the method comprising:

following positioning a guidewire through the opening through tissue, inserting a distal end of an elongate member into an opening through tissue along the guidewire, the opening communicating with a blood vessel, the elongate member having a distal end, a proximal end, a lumen extending between the proximal and distal ends, and a skin overlying at least a portion of the outer surface of the elongate member between the distal end and proximal end and at least partially overlying a carrier assembly;

inserting one or more instruments through the lumen into the blood vessel to perform a therapeutic or diagnostic procedure;

following removal of the one or more instruments, including the guidewire, selectively connecting a separate actuator assembly to the elongate member and locating a portion of the separate actuator assembly in fluid communication with the lumen of the elongate member and advancing the carrier assembly distally along the elongate member from the proximal end towards the distal end of the elongate member with the actuator assembly, thereby advancing the closure element towards the distal end of the elongate member and causing the skin to separate from the outer surface of the elongate member;

engaging tissue adjacent the distal end of the elongate member with a plurality of tissue engaging elements on the closure element; and

withdrawing the elongate member from the opening, thereby leaving the closure element to close the opening and to substantially seal the opening from blood flow therethrough with the closure element.

21. The method of claim 20, wherein engaging tissue adjacent the distal end of the elongate member with tissue engaging elements on the closure element comprises deploying the closure element from the carrier assembly and elongate member, the closure element comprising a generally annularly-shaped body and a plurality of tissue engaging portions extending from the generally annularly-shaped body, the closure element being configured to move from a first expanded configuration when on the carrier assembly to a second contracted configuration when deployed, thereby drawing tissue around the opening together.

22. The method of claim 20, wherein the skin comprises a preferential splitting region extending towards the distal end of the elongate member, the preferential splitting region splitting as the carrier assembly is advanced towards the distal end of the elongate member.

23. The method of claim 20, wherein the skin comprises a flap extending generally axially along the outer surface of the elongate member and overlying an adjacent region of the skin, and wherein the flap is released from the adjacent region as the carrier assembly is advanced towards the distal end of the elongate member, thereby allowing the skin to separate from the outer surface.

24. The method of claim 20, wherein the skin expands to a cross-section that is larger than a cross-section of the elongate member as the carrier assembly is advanced towards the distal end.

25. The method of claim 20, wherein the skin is bonded to the outer surface of the elongate member by an adhesive bond or a thermal bond, and wherein the bond has sufficient strength such that the skin is peeled away from the outer surface as the carrier assembly is advanced towards the distal end.

26. The method of claim 20, wherein the skin comprises a skin outer surface that is substantially slippery.

27. The method of claim 20, wherein leaving the closure element to substantially seal the opening from blood flow therethrough with the closure element.

28. The method of claim 20, further comprising inserting a distal end of an obturator disposed within the elongate member through the opening through tissue.

29. The method of claim 28, wherein the obturator comprises an expandable distal portion coupled with an elongate portion extending proximally for manipulation by a user.

30. The method of claim 29, further comprising retracting the elongate portion of the obturator in a proximal direction to expand the expandable distal portion distal of the opening through tissue to stabilize or secure tissue surrounding the opening.