Vascular hole closure device

• US 8,968,361 B2
• Filed: 11/07/2011
• Issued: 03/03/2015
• Est. Priority Date: 02/15/2008
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, James F. Jr., Leedle, John D., Tarmin, James S., Anidharan, Thanu
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US13/290,941
• Publication Number:
  US 20120046673A1
• Time in Patent Office: 1,212 Days
• Field of Search: 606151-154, 606/157, 606/213, 606/215, 606/216, 606218-221
• 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 2017/00004 (bio)absorbable, (bio)resorbable, resorptive for implantable prostheses A61F2210/0004
• 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 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening

Abstract

A device for closing an aperture in a vessel wall comprising a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture and a first spherical retainer positionable external of the vessel. The covering member has a dimension to prevent egress of fluid through the aperture.

Claims

1. A method of closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall, the method comprising:

inserting a covering member inside the vessel and subsequently moving the covering member in a first direction to position the covering member against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture;

inserting a first spherical retainer external of the vessel, the first spherical retainer having a first configuration during initial placement external of the vessel; and

advancing the first spherical retainer toward the covering member in a second different direction for placement external of the vessel to retain the covering member, the first spherical retainer maintaining the first configuration when fully placed and initially left external of the vessel and advanced by proximal movement of a flexible member fixedly attached to the first spherical retainer.

2. The method of claim 1, wherein the flexible member is a suture and the step of advancing the first spherical retainer comprises the step of moving the suture, by pulling an opposing end of the suture.

3. The method of claim 2, further comprising the step of inserting a second spherical retainer external of the vessel.

4. The method of claim 3, further comprising the step of advancing the second spherical retainer in the second direction toward the covering member.

5. The method of claim 4, wherein the second spherical retainer is advanced by suture movement.

6. The method of claim 5, wherein the first and second spherical retainers are placed in substantially side by side relationship such that a proximal surface of the first and second spherical retainers is not in contact with a distal surface of the other spherical retainer and the first and second spherical retainers are left in the body to resorb over a period of time.

7. A method of closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall, the method comprising:

providing a closure device having a covering member, a first retainer and a second retainer, each of the retainers having a proximal surface and a distal surface;

inserting the covering member inside the vessel against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture;

after inserting the covering member, subsequently advancing the first retainer toward the covering member for placement proximal of the covering member and external of the vessel; and

after advancing the first retainer, subsequently advancing the second retainer toward the covering member for placement proximal of the covering member and external of the vessel, the first and second retainers being positioned in side by side relationship such that the proximal surface of the first and second retainers is not in contact with the distal surface of the other retainer.

8. The method of claim 7, wherein the step of advancing the first retainer toward the covering member comprises the step of pulling a first suture proximally, the first retainer fixedly attached to the first suture.

9. The method of claim 8, wherein the first suture is coupled to the covering member and the first suture positions the covering member against an internal wall of the vessel.

10. The method of claim 8, wherein the covering member has first and second openings to receive the first suture such that proximal movement of the first suture moves the first suture within the first and second openings.

11. The method of claim 8, wherein the step of advancing the second retainer toward the covering member comprises the step of pulling a second suture proximally, the second retainer fixedly attached to the second suture.

12. The method of claim 11, wherein the second suture is coupled to the covering member and the second suture positions the covering member against an internal wall of the vessel.

13. The method of claim 11, wherein the steps of advancing the first and second retainers places the first and second retainers in position in side by side relationship external of the vessel.

14. The method of claim 7, wherein the step of advancing the second retainer toward the covering member comprises the step of pulling a second suture proximally, the second retainer fixedly attached to the second suture.

15. The method of claim 7, wherein delivery of the covering member enables the covering member to pivot from a longitudinal delivery position to a transverse position within the vessel.

16. The method of claim 7, wherein the first and second retainers are held in a stacked relationship for delivery and are in a non-stacked relationship when in a placement position external of the vessel.

17. The method of claim 7, wherein the second retainer is within a delivery tube when the first retainer is initially advanced from the tube.

18. The method of claim 7, further comprising the step of leaving the closure device in the body to resorb over a period of time.

19. The method of claim 7, further comprising the step of inserting a delivery instrument into the vessel.

20. The method of claim 7, wherein the covering member is moved into contact with an internal wall of the vessel prior to the step of advancing the first retainer.

21. A method of closing an aperture in a vessel wall, the aperture having an external opening in an external region of the vessel wall and an internal opening in an internal region of the vessel wall, the method comprising:

providing a closure device having a covering member, a retainer and a suture fixedly attached at a first end to the retainer;

inserting the covering member inside the vessel and subsequently moving the covering member in a first direction to position the covering member against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture;

inserting the first retainer external of the vessel; and

advancing the first retainer toward the covering member in a second different direction for placement external of the vessel to retain the covering member, the first retainer advanced by pulling a second end of the suture whereby the retainer remains fixedly attached to the suture at the same location as it is advanced toward the covering member.

22. The method of claim 21, wherein the suture is looped through the covering member and moves the covering member against the internal wall of the vessel.

23. The method of claim 21, wherein the covering member is moved into contact with an internal wall of the vessel prior to the step of advancing the first retainer.