Plunger apparatus and methods for delivering a closure device

• US 20030158577A1
• Filed: 02/21/2002
• Published: 08/21/2003
• Est. Priority Date: 02/21/2002
• Status: Active Grant

• Current Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Integrated Vascular Systems, Inc. (Abbott Laboratories Incorporated)
• Inventors: Ginn, Richard S., Pantages, Anthony
• Granted Patent: US 6,695,867 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 17/08 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. An apparatus for delivering a closure device, 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 hub on the proximal end of the elongate member, the hub comprising one or more spacers spaced away from the outer surface of the elongate member;

a closure element comprising a generally annular-shaped body comprising proximal and distal ends and a plurality of tissue engaging portions extending from the distal end, the proximal end being held away from the outer surface of the elongate member by the one or more spacers; and

an actuator assembly comprising an elongate actuator member slidable between the one or more spacers and the outer surface of the elongate member, the actuator member comprising one or more protrusions for engaging the closure element, whereby distal movement of the actuator member advances the closure element towards the distal end of the elongate member.

2. The apparatus of claim 1, wherein the hub comprises an annular hub defining a passage between the annular hub and the outer surface of the elongate member.

3. The apparatus of claim 2, wherein the annular hub is attached to the elongate member by one or more radial spokes.

4. The apparatus of claim 3, wherein the actuator member comprises a tubular member defining a “

C”

shaped cross-section for inserting the tubular member through the passage around the one or more radial spokes.

5. The apparatus of claim 1, wherein the actuator member comprises a tubular member comprising a distal end, and wherein the one or more protrusions comprises a plurality of tabs extending radially outwardly from the distal end of the tubular member.

6. The apparatus of claim 5, wherein the closure element comprises a plurality of pockets for receiving respective tabs on the tubular member therein.

7. The apparatus of claim 6, wherein the closure element comprises a plurality of alternating diagonal elements extending between the proximal and distal ends of the closure element, and wherein the distal end of the closure element comprises curved elements connecting adjacent diagonal elements, the curved elements defining the pockets.

8. The apparatus of claim 6, wherein the tissue engaging elements comprise tines extending distally from the distal end of the closure element, and wherein the closure element comprises offset elements on an inner surface of the curved elements on the distal end of the closure element for maintaining the tines away from the outer surface of the elongate member.

9. The apparatus of claim 1, wherein the actuator assembly is attachable to the hub.

10. The apparatus of claim 1, wherein the elongate member comprises a sheath comprising a lumen extending between proximal and distal ends thereof.

11. The apparatus of claim 1, further comprising a skin overlying at least a portion of the outer surface of the elongate member between the carrier assembly and the distal end of the elongate member, and at least partially overlying the closure element, the skin being separable from the outer surface as the closure element is advanced towards the distal end of the elongate member.

12. The apparatus of claim 11, 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.

13. The apparatus of claim 12, wherein the weakened region comprises at least one of a thin region and a perforated region of the skin.

14. The apparatus of claim 11, 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.

15. The apparatus of claim 14, 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.

16. The apparatus of claim 15, 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.

17. The apparatus of claim 11, wherein the closure element passes between the skin and the outer surface as it is advanced towards the distal end of the elongate member.

18. The apparatus of claim 17, wherein the protrusions have a height that is greater than a thickness of the closure element such that the protrusions extend radially outwardly from the outer surface of the elongate member a greater distance than the closure element.

19. The apparatus of claim 11, 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.

20. The apparatus of claim 1, wherein the closure element is carried on a distal end of the actuator member when the closure element is engaged by the one or more protrusions, and wherein the actuator assembly comprises an outer member slidable on the actuator member for deploying the closure element from the distal end of the actuator member.

21. A method for delivering a closure element to seal an opening through tissue, the closure element being carried on a proximal end of an elongate member such that a proximal end of the closure element is spaced apart from an outer surface of the elongate member, the method comprising:

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

inserting a distal end of an actuator member between the proximal end of the closure element and the outer surface of the elongate member until the distal end of the actuator member is coupled with the closure element;

advancing the actuator member distally, thereby advancing the closure element towards the distal end of the elongate member;

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

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

22. The method of claim 21, wherein the elongate member comprises a skin overlying at least a portion of the outer surface between the closure element and the distal end of the elongate member and at least partially overlying the closure element, and wherein the skin separates from the outer surface of the elongate member as the closure element is advanced towards the distal end.

23. The method of claim 22, 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.

24. The method of claim 22, 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.

25. The method of claim 22, 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.

26. The method of claim 22, 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.

27. The method of claim 22, wherein the skin comprises an outer surface that is substantially slippery for facilitating advancement of the elongate member into the opening through tissue.

28. The method of claim 22, 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.

29. The method of claim 21, 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.

30. The method of claim 29, wherein the elongate member comprises a lumen extending between the proximal and distal ends, and wherein the method further comprises inserting one or more instruments through the lumen into the blood vessel.

31. A method for delivering a closure element to seal an opening through tissue over an elongate member comprising a hub on its proximal end, the method comprising:

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

inserting a distal end of an actuator member between the hub and the elongate member, the distal end of the actuator member carrying a closure element;

advancing the actuator member distally, thereby advancing the closure element towards the distal end of the elongate member;

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

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

32. The method of claim 31, further comprising deploying the closure element from the distal end of the actuator member before withdrawing the elongate member.

33. The method of claim 32, wherein the closure element is deployed from the actuator element by advancing a pusher member relative to the actuator member to push the closure element off of the distal end of the actuator member.