Vascular hole closure device

• US 10,390,807 B2
• Filed: 04/04/2016
• Issued: 08/27/2019
• Est. Priority Date: 02/15/2008
• Status: Active Grant

• Current Assignee: REX Medical LP
• Original Assignee: REX Medical LP
• Inventors: McGuckin, Jr., James F., Leedle, John D., Tarmin, James S., Anidharan, Thanu
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US15/089,599
• Publication Number:
  US 20160213360A1
• Time in Patent Office: 1,240 Days
• 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 or resorptive
• 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 vascular device for closing an aperture in a wall of a vessel, the vascular device comprising:

an intravascular distal covering member positionable inside the vessel, the covering member having a length and a width, the covering member pivoting from a first position to a second placement position when outside a delivery device;

an extravascular first retainer positionable external of the vessel, the first retainer positioned proximal of the covering member during delivery and placement outside of the aperture; and

a first flexible member extending between the distal covering member and the first retainer, wherein applying a proximally directed force on a portion of the first flexible member advances the first retainer distally toward the covering member as the position of the first retainer remains fixed with respect to a first end and a second end of the first flexible member.

2. The device of claim 1, further comprising a second retainer positionable proximal of the covering member and external of the vessel, the second retainer movable distally toward the covering member.

3. The device of claim 2, further comprising a second flexible member extending between the distal covering member and the second retainer, wherein applying a proximally directed force on a portion of the second flexible member advances the second retainer distally toward the covering member, wherein the second retainer is advanceable independently of the first retainer and after the first retainer is advanced.

4. The device of claim 3, wherein the covering member, first flexible member, first retainer, second flexible member and second retainer are composed of a resorbable material.

5. The device of claim 2, wherein the first and second retainers in a placement position are positioned in a substantially side by side relationship.

6. The device of claim 1, wherein the covering member, first flexible member and first retainer are composed of a resorbable material.

7. The device of claim 1, wherein the length of the covering member is greater than the width of the covering member.

8. The device of claim 7, wherein the covering member has a first end region, a second end region and an intermediate region between the first and second end regions, and the intermediate region is thicker than the first and second end regions.

9. A vascular device for closing an aperture in a wall of a vessel, the aperture extending through the wall of the vessel from a first proximal end to a second distal end opposite the first end and communicating with an internal lumen of the vessel, the vascular device comprising:

an intravascular distal covering member, the covering member having a dimension to prevent blood flow through the aperture, the covering member positionable within the lumen of the vessel and against an internal side of the aperture, the covering member having a longitudinal axis, and a first end region at a first end of the longitudinal axis and a second end region at a second opposite end of the longitudinal axis;

an extravascular first retainer having a width and positionable external of the vessel in a placement position, the first retainer in the placement position being outside the aperture, the first retainer positioned proximal of the covering member during delivery and placement and movable distally toward the covering member;

a first flexible member extending from the distal covering member to the first retainer and attached to the first retainer to effect movement thereof, the first flexible member extending though the aperture, the width of the first retainer being greater than a width of the first flexible member;

an extravascular second retainer having a width and positionable external of the vessel in a placement position, the second retainer in the placement position being outside the aperture, the second retainer positioned proximal of the covering member during delivery and placement and movable distally toward the covering member; and

a second flexible member extending from the distal covering member to the second retainer and attached to the second retainer to effect movement thereof, the width of the second retainer being greater than a width of the second flexible member, the first and second flexible members extending though the aperture and being the only components of the vascular device extending through the aperture.

10. The device of claim 9, wherein the covering member and the first and second retainers are composed of a resorbable material.

11. The device of claim 10, wherein the first and second retainers in a placement position are not positioned atop one another but are positioned side by side such that the first retainer is closer to the first end region of the covering member and the second retainer is closer to the second end region of the covering member.

12. A vascular hole closure system for closing an aperture in a vessel comprising:

a delivery device having a distal opening at a distal end;

an intravascular distal covering member, the covering member moving from a first position to a second placement position when outside the distal opening of the delivery device;

an extravascular first retainer positionable external of the vessel, the first retainer positioned proximal of the covering member during delivery and placement, the first retainer contained within the delivery device during insertion of the delivery device into the vessel to deliver the covering member inside the vessel; and

an extravascular second retainer positionable external of the vessel, the second retainer positioned proximal of the covering member during delivery and placement, the second retainer contained within the delivery device during insertion of the delivery device into the vessel to deliver the covering member inside the vessel, wherein the first retainer is advanceable from a first position within the delivery device to a second position outside the distal opening of the delivery device and the second retainer is advanceable from a first position within the delivery device to a second position outside the distal opening of the delivery device subsequent to advancement of the first retainer to the second position outside the distal opening of the delivery device, the first and second retainers applying a retention force in the second position to maintain the covering member, and the first and second retainers are advanced by separate members attached thereto.

13. The device of claim 12, wherein the covering member and the first and second retainers are composed of a resorbable material.

14. The device of claim 12, wherein the first and second retainers in a placement position are positioned side by side such that the first retainer is closer to a first end region of the covering member and the second retainer is closer to the second opposite end region of the covering member, the first end region being adjacent a first end of a longitudinal axis of the covering member and the second end region being adjacent a second end of the longitudinal axis of the covering member.

15. The system of claim 14, wherein the covering member has a central region between the first and second end regions, and the central region is thicker than the first and second end regions.

16. The system of claim 12, wherein a length of the covering member is greater than a width of the covering member.

17. The system of claim 12, wherein the covering member pivots from a first position to a transverse position when delivered from the delivery device.

18. The system of claim 12, wherein a pusher contacts the covering member to advance the covering member from the delivery device.