Sheath apparatus and methods for delivering a closure device

• US 6,749,621 B2
• Filed: 02/21/2002
• Issued: 06/15/2004
• Est. Priority Date: 02/21/2002
• Status: Expired due to Term

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Jabba, Ronald J., Ginn, Richard S., Pantages, Anthony
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US10/081,725
• Publication Number:
  US 20030158578A1
• Time in Patent Office: 845 Days
• Field of Search: 606/213
• 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. A clip is carried on the outer surface, e.g., on a carrier assembly that is slidable along the outer surface from the proximal end towards the distal end. A skin overlies the outer surface of the sheath and the carrier assembly that is separable from the outer surface as the carrier assembly is advanced from the proximal end towards the distal end of the sheath. During use, the distal end of the sheath is inserted into an opening through tissue, e.g., into a puncture communicating with a blood vessel. The carrier assembly is advanced towards the distal end of the sheath, causing the skin to separate from the outer surface of the elongate member, and the clip is deployed from the carrier to seal the opening.

Claims

1. An apparatus for delivering a closure element into an opening through tissue, comprising:

an elongate member comprising proximal and distal ends defining a longitudinal axis therebetween, and an outer surface extending between the proximal and distal ends;

a carrier assembly slidable on the elongate member from the proximal end towards the distal end;

a closure element carried by the carrier assembly, the closure element being deployable from the carrier assembly; and

a skin overlying at least a portion of the outer surface of the elongate member and the carrier assembly, the skin being separable from the outer surface of the elongate member as the carrier assembly is advanced from the proximal end towards the distal end of the elongate member.

2. The apparatus of claim 1, wherein the skin comprises a weakened region extending axially along the skin, the weakened region configured to tear as the carrier assembly is advanced from the proximal end towards the distal end of the elongate member.

3. The apparatus of claim 2, wherein the weakened region comprises at least one of a thin region and a perforated region of the skin.

4. The apparatus of claim 1, wherein the skin comprises a flap extending axially along the outer surface of the elongate member and overlying an adjacent region of the skin, the flap being bonded to the adjacent region such that the flap may be separated from the adjacent region as the carrier assembly is advanced towards the distal end of the elongate member.

5. The apparatus of claim 4, wherein the skin comprises a tubular member extending around the outer surface of the elongate member, and wherein the flap comprises a region of the tubular member that is folded over itself to secure the tubular member to the outer surface of the elongate member.

6. The apparatus of claim 5, wherein the tubular member comprises a periphery that is larger than a periphery of the elongate member when the skin is separated from the outer surface.

7. The apparatus of claim 1, wherein the skin comprises an outer surface that is substantially slippery for facilitating advancement of the elongate member through layers of tissue.

8. The apparatus of claim 1, wherein the carrier assembly passes between the skin and the outer surface as it is advanced towards the distal end of the elongate member.

9. The apparatus of claim 1, wherein the skin comprises an elastic material.

10. The apparatus of claim 1, wherein the skin comprises fibers embedded therein.

11. The apparatus of claim 1, wherein the skin is bonded to the outer surface of the elongate member by an adhesive, the adhesive having sufficient adhesive strength such that the skin may be peeled away from the outer surface as the carrier assembly is advanced towards the distal end of the elongate member.

12. The apparatus of claim 1, further comprising an actuator comprising a housing that is connectable to the proximal end of the elongate member, and one or more elongate actuator elements that are movable axially relative to the housing, the one or more actuator elements being configured to couple distal movement of the carrier assembly to distal movement of the one or more actuator elements.

13. The apparatus of claim 12, wherein the carrier assembly comprises a carrier member carrying the closure element and a pusher member movable distally with respect to the carrier member, and wherein the actuator comprises a control member, and the one or more actuator elements comprise cooperating detents for coupling distal movement of the carrier assembly to the one or more actuator elements as the control member is directed distally, the cooperating detents releasing the carrier member upon attaining a first distal position, thereby permitting further distal movement of the pusher member to deploy the closure element from the carrier member.

14. The apparatus of claim 12, further comprising:

a locator member connectable to at least one of the elongate member and the actuator, the locator member having a distal portion extendable distally beyond the distal end of the elongate member; and

one or more positioning elements on the distal portion of the locator member, the positioning elements being expandable between a collapsed configuration and a transversely expanded configuration.

15. The apparatus of claim 14, further comprising a locking mechanism on the locator member for releasably retaining the positioning elements in the expanded configuration.

16. The apparatus of claim 14, wherein the elongate member comprises a sheath, and the locator member comprises an obturator insertable into a lumen of the sheath.

17. The apparatus of claim 1, wherein the closure element comprises a clip including a plurality of tissue engaging elements oriented distally along the outer surface of the carrier member.

18. The apparatus of claim 1, wherein the carrier assembly comprises a carrier member carrying the closure element and a pusher member movable distally with respect to the carrier member, the carrier member comprising one or more ramped portions, each portion defining a ramped distal surface, and wherein the closure element comprises a plurality of tines extending distally, the tines being disposed proximal to the one or more ramped portions.

19. The apparatus of claim 18, wherein the pusher member is configured for advancing the closure element over the one or more ramped portions when the carrier assembly is advanced to a distal position.

20. The apparatus of claim 18, wherein the carrier member is coupled to the proximal end of the elongate member by a tether, the tether having a predetermined length to prevent further distal movement of the carrier member once the carrier assembly has been advanced to the distal position.

21. An apparatus for delivering a closure device, comprising:

a sheath comprising a lumen extending between proximal and distal ends thereof;

a carrier assembly slidable along an outer surface of the sheath;

a closure element carried by the carrier assembly;

an actuator assembly comprising one or more actuator elements coupled to the carrier assembly for advancing the carrier assembly towards the distal end of the sheath; and

a skin overlying at least a portion of the outer surface between the carrier assembly and the distal end of the sheath, and at least partially overlying the carrier assembly, the skin being separable from the outer surface as the carrier assembly is advanced towards the distal end of the elongate member.

22. The apparatus of claim 21, wherein the skin comprises a weakened region extending axially along the skin, the weakened region configured to tear as the carrier assembly is advanced from the proximal end towards the distal end of the elongate member.

23. The apparatus of claim 22, wherein the weakened region comprises at least one of a thin region and a perforated region of the skin.

24. The apparatus of claim 21, wherein the skin comprises a flap extending axially along the outer surface of the elongate member and overlying an adjacent region of the skin, the flap being bonded to the adjacent region such that the flap may be separated from the adjacent region as the carrier assembly is advanced towards the distal end of the elongate member.

25. The apparatus of claim 24, wherein the skin comprises a tubular member extending around the outer surface of the elongate member, and wherein the flap comprises a region of the tubular member that is folded over itself to secure the tubular member to the outer surface of the elongate member.

26. The apparatus of claim 25, wherein the tubular member comprises a periphery that is larger than a periphery of the elongate member when the skin is separated from the outer surface.

27. The apparatus of claim 21, wherein the skin comprises an outer surface that is substantially slippery for facilitating advancement of the elongate member through layers of tissue.

28. The apparatus of claim 21, wherein the carrier assembly passes between the skin and the outer surface as it is advanced towards the distal end of the elongate member.

29. The apparatus of claim 21, wherein the skin is bonded to the outer surface of the elongate member by an adhesive, the adhesive having sufficient adhesive strength such that the skin may be peeled away from the outer surface as the carrier assembly is advanced towards the distal end of the elongate member.

30. The apparatus of claim 21, wherein the carrier assembly comprises a carrier member and a pusher member movable distally with respect to the carrier member, and wherein the closure element comprises a clip carried by the carrier member, the clip being deployable from the carrier member upon distal movement of the pusher member relative to the carrier member.

31. The apparatus of claim 21, wherein the skin comprises a plurality of weakened or perforated slots, the slots expanding as the carrier assembly is advanced under the skin to separate the skin from the outer surface.

32. A method for delivering a closure element to seal an opening through tissue, the closure element being carried by a carrier assembly slidable on an outer surface of an elongate member, the elongate member comprising a skin overlying at least a portion of the outer surface between the carrier assembly and a distal end of the elongate member and at least partially overlying the carrier assembly, the method comprising:

inserting the distal end of the elongate member into an opening through tissue;

advancing the carrier assembly towards the distal end of the elongate member, the carrier assembly causing the skin to separate from the outer surface of the elongate member as the carrier assembly is advanced towards the distal end; and

deploying the closure element from the carrier assembly within the opening.

33. The method of claim 32, further comprising withdrawing the elongate member from the opening.

34. The method of claim 32, 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.

35. The method of claim 32, 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.

36. The method of claim 32, 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.

37. The method of claim 32, wherein the skin is bonded to the outer surface of the elongate member by an adhesive, and wherein the adhesive has sufficient adhesive strength such that the skin is peeled away from the outer surface as the carrier assembly is advanced towards the distal end.

38. The method of claim 32, wherein the skin comprises an outer surface that is substantially slippery for facilitating advancement of the elongate member into the opening through tissue.

39. The method of claim 38, wherein the opening through tissue extends through one or more layers of fascia, and wherein the skin facilitates advancement of the carrier assembly through the one or more layers of fascia.

40. The method of claim 32, wherein the opening through tissue communicates with a blood vessel, and wherein the deploying step comprises substantially sealing the opening from blood flow therethrough with the closure element.

41. The method of claim 32, further comprising coupling the carrier assembly to a proximal end of the elongate member.

42. The method of claim 41, wherein the carrier assembly comprises a plunger, the closure element is carried on the distal end of the plunger, and wherein the coupling step comprises inserting the distal end of the plunger through a hub on the proximal end of the elongate member.

43. The method of claim 32, wherein the skin comprises a plurality of longitudinal slots, the slots opening as the carrier assembly is advanced, thereby expanding the skin.

44. The method of claim 43, wherein the longitudinal slots are staggered relative to one another such that the skin assumes a zigzag mesh configuration as it expands.