Vascular sealing device with high surface area sealing plug

• US 7,621,937 B2
• Filed: 12/03/2003
• Issued: 11/24/2009
• Est. Priority Date: 12/03/2003
• Status: Expired due to Term

• Current Assignee: Terumo Puerto Rico, L.L.C. (Terumo Corporation)
• Original Assignee: St Jude Medical Puerto Rico LLC (Abbott Laboratories)
• Inventors: Roop, John Avi, Belhe, Kedar R., Pipenhagen, Catherine A.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/726,966
• Publication Number:
  US 20050125031A1
• Time in Patent Office: 2,183 Days
• Field of Search: 606/232, 606/213, 606/72, 606/95, 606/215, 606/151, 606/76, 424/423
• US Class Current: 606/232
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00663 the implement being a suture
• CPC Class Codes: A61B 2017/00668 the implement being a tack or a staple

Abstract

An internal tissue puncture closure method and apparatus. The method and apparatus provide a folded sealing plug that provides more surface area than conventional plugs to more fully cover and seal an external situs of an internal tissue puncture. The folded sealing plug may have a weave pattern that tends to cause the sealing plug to corkscrew into the internal tissue puncture as it is compressed toward an anchor placed inside of the tissue puncture.

Claims

1. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture, comprising:

a carrier tube;

a filament;

an anchor configured to be inserted through the tissue puncture, the anchor being attached to the filament at a first end of the closure device;

a sealing plug positioned in the carrier tube, the sealing plug comprising;

a first plurality of holes including one hole in the sealing plug, the first plurality of holes forming a first weave pattern in a first portion of the sealing plug, wherein a first portion of the filament extends from a first side of the anchor and passes through the first plurality of holes;

a second plurality of holes including another hole in the sealing plug, the second plurality of holes forming a second weave pattern in a second portion of the sealing plug, wherein a second portion of the filament extends from a second side of the anchor and passes through the second plurality of holes;

wherein the filament passes through the one hole in the sealing plug to a hole in the anchor and back through the another hole in the sealing plug;

wherein the one hole in the sealing plug is the last hole in the sealing plug that the filament passes through before entering the hole in the anchor and the another hole in the sealing plug is the first hole in the sealing plug that the filament passes through after exiting the hole in the anchor; and

wherein the filament passes through at least four holes in the sealing plug.

2. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the sealing plug is folded at least twice.

3. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 2 wherein the sealing plug is shaped at least approximately like an S.

4. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the sealing plug is folded.

5. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 4 wherein the sealing plug is folded between the one hole in the sealing plug and the another hole in the sealing plug.

6. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the first weave pattern and the second weave pattern each comprise a five-hole zigzag arrangement.

7. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the sealing plug and filament each comprise biologically resorbable materials.

8. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the sealing plug is folded between the first weave pattern and the second weave pattern.

9. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the scaling plug shape comprises an X-shape in cross-section.

10. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 9, further comprising a plurality of holes including the one hole in the sealing plug and the another hole in the sealing plug, the plurality of holes forming a staggered weave pattern in the sealing plug.

11. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 9 wherein the filament alternately passes through generally perpendicular walls of the sealing plug.

12. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 11 wherein the plurality of holes includes a first set of equally longitudinally spaced hole pairs in one of the perpendicular walls and a second set of equally longitudinally spaced hole pairs in another one of the perpendicular walls, the second set of hole pairs being staggered from the first set of hole pairs longitudinally.

13. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture according to claim 1 wherein the sealing plug shape comprises two components, and wherein the one hole in the sealing plug is in one of the two components and the another hole in the sealing plug is in the other one of the two components.

14. A tissue puncture sealing device, comprising:

an internal component configured to be positioned against an internal wall of a bodily lumen, the internal component comprising a stiff member;

an external component configured to be positioned external to the lumen, the external component being folded so that one portion of the external component is in contact with another portion of the external component, the external component comprising a sponge material;

wherein the external component is operatively connected to the internal component by a filament configured to compress and hold the internal and external components together to prevent fluid from passing through a puncture in the bodily lumen;

wherein the filament passes through one hole in the external component to a hole in the internal component and back through another hole in the external component, the external component being folded between the one hole in the external component and the another hole in the external component;

wherein the filament only passes once through each one of the one hole and the another hole; and

wherein the tissue puncture sealing device is in an undeployed configuration.

15. A tissue puncture sealing device according to claim 14 wherein the internal component is a stiff anchor and the external component is a collagen sponge.

16. A tissue puncture sealing device according to claim 15 wherein the collagen sponge is folded twice longitudinally.

17. A tissue puncture sealing device according to claim 16 wherein the collagen sponge is substantially S-shaped.

18. A tissue puncture sealing device according to claim 14 wherein the external component comprises a plurality of holes including the one hole in the external component and the another hole in the external component, wherein the plurality of holes form a weave pattern, and wherein the filament weaves through a first portion of the weave pattern, through the internal component, and back Through a second portion of the weave pattern.

19. A tissue puncture sealing device according to claim 18 wherein the external component is folded between the first portion of the weave pattern and the second portion of the weave pattern.

20. A tissue puncture sealing device according to claim 18 wherein the external component is folded latitudinally.

21. A tissue puncture sealing device according to claim 14 wherein the external component comprises two legs folded along a centerline such that the two legs are substantially aligned.

22. A tissue puncture sealing device according to claim 14, wherein the external component includes a first external component and a second external component, the second external component being folded and in contact with the first external component.

23. A tissue puncture sealing device according to claim 22 wherein the first and second external components are each folded into generally U-shapes.

24. An internal tissue puncture closure device, comprising:

an anchor for insertion through a tissue puncture;

a filament threaded through the anchor;

a flexible sealing plug aft ached to the anchor by the filament;

wherein the sealing plug comprises two cross members each of which includes a plurality of holes which extend therethrough;

wherein the filament extends through the plurality of holes in each of the two cross members;

wherein the filament alternately extends through the plurality of holes in the two cross members in a spiral pattern; and

wherein the tissue puncture sealing device is configured so that applying a tension force to the filament moves the anchor and the sealing plug together.

25. An internal tissue puncture closure device according to claim 24 wherein the two cross members are arranged in a generally X-shape.

26. An internal tissue puncture closure device according to claim 25 wherein each of two portions of the filament extending from the anchor in opposite directions traverse separate holes through the two cross members.

27. A tissue puncture sealing device, comprising:

a filament;

an anchor attached to the filament and configured to be inserted through a tissue wall puncture; and

a sealing plug disposed proximal of the anchor, the sealing plug including a first plurality of openings and a second plurality of openings;

wherein the filament passes through at least two openings from the first plurality of openings, through the anchor, and back through at least two openings from the second plurality of openings;

wherein the sealing plug is tri-folded into substantially an S-shape wherein each fold is aligned substantially parallel with a longitudinal axis of the sealing plug; and

wherein the filament weaves between the anchor and the first plurality of openings in a nonlinear pattern.

28. A tissue puncture sealing device according to claim 27 wherein the sealing plug is folded and the tissue puncture sealing device is in an undeployed configuration.

29. A tissue puncture sealing device according to claim 27 wherein the sealing plug has two legs that form an at least approximately symmetrical shape, and wherein the first plurality of openings are in one leg and the second plurality of openings are in another leg.

30. A tissue puncture closure device for partial insertion into and sealing of an internal tissue wall puncture, comprising:

an insertion sheath having first and second ends;

a carrier tube disposed inside the insertion sheath, the carrier tube having first and second ends;

an anchor disposed inside the insertion sheath at the first end thereof, the anchor being disposed outside of the carrier tube at the first end thereof, wherein a portion of the anchor is positioned radially adjacent to an outer diameter of the carrier tube;

a sealing plug disposed inside the carrier tube at the first end thereof;

wherein the sealing plug is folded at least once; and

wherein the tissue puncture closure device is in an undeployed configuration when the tissue puncture closure device is not inserted into a patient;

wherein the sealing plug is tri-folded into an S-shape, wherein each fold is aligned substantially parallel with a longitudinal axis of the sealing plug.

31. A tissue puncture closure device, comprising:

an anchor configured to be inserted through a tissue puncture;

a sealing plug that is compressible; and

a filament configured to couple the anchor and the sealing plug together, the sealing plug being configured to compress when a tension force is applied to the filament;

wherein the sealing plug is generally X-shaped in cross section;

wherein the sealing plug comprises two cross members which form the X-shaped cross section; and

wherein the filament alternately extends through holes in the two cross members in a spiral pattern.

32. A tissue puncture closure device, comprising:

a carrier tube;

an anchor configured to be inserted through a tissue puncture, the anchor comprising a stiff member;

a sealing plug that is compressible, the sealing plug comprising a sponge material; and

a filament configured to couple the anchor and the sealing plug together;

wherein the filament passes through one hole in the sealing plug, though a hole in the anchor, and back Through another hole in the sealing plug, wherein the filament only passes once through each one of the one hole and the another hole; and

wherein the sealing plug is positioned in the carrier tube in an undeployed configuration; and

wherein the one hole is in one leg portion of the sealing plug and the another hole is in another leg portion of the sealing plug.

33. The tissue puncture closure device of claim 32 wherein the sealing plug comprises a first plurality of holes including the one hole in the sealing plug and a second plurality of holes including the another hole in the sealing plug, and wherein the filament passes through the first plurality of holes, through the hole in the anchor, and back through the second plurality of holes.

34. The tissue puncture closure device of claim 32 wherein the sealing plug is folded.

35. The tissue puncture closure device of claim 32 wherein the sealing plug is folded between the one hole in the sealing plug and the another hole in the sealing plug.

36. The tissue puncture closure device of claim 32 wherein the one leg and the another leg form at least two portions that are symmetrical and are folded together, the sealing plug comprising a first plurality of holes in one of the at least two symmetrical portions and a second plurality of holes in another one of the at least two symmetrical portions, the first plurality of holes including the one hole and the second plurality of holes including the another hole, and wherein the filament extends through the first plurality of holes in the one symmetrical portion, through the hole in the anchor, and back through the second plurality of holes in the another symmetrical portion.

37. The tissue puncture closure device of claim 32 wherein the tissue puncture closure device is a vascular puncture closure device, wherein the anchor is configured to be inserted through an opening in a blood vessel and the sealing plug is configured to be positioned opposite the anchor outside of the blood vessel, and wherein the filament is configured to couple the anchor and the sealing plug together across the opening in the blood vessel.

38. A tissue puncture closure device, comprising:

an anchor configured to be inserted through a tissue puncture;

a sealing plug including a first component and a second component, the first component being separate from the second component; and

a filament configured to couple the anchor and the sealing plug together when the anchor and the sealing plug are deployed;

wherein the first component and the second component each have a general U-shape;

wherein the filament passes through one hole in the first component and one hole in the second component before passing through a hole in the anchor and wherein the filament passes through another hole in the first component and another hole in the second component after passing through the hole in the anchor.

39. The tissue puncture closure device of claim 38 wherein the first component and the second component are positioned in an interconnected relationship to each other.