Vascular hole closure device

• US 9,943,300 B2
• Filed: 12/13/2014
• Issued: 04/17/2018
• 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:
  US14/569,670
• Publication Number:
  US 20150100082A1
• Time in Patent Office: 1,221 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, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied

Abstract

A device for 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 device includes a covering member positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture. First and second retainers are positionable external of the vessel and have a tip of a smaller transverse dimension and facing in a direction toward the covering member for advancement toward the covering member. A flexible connecting member operatively connects the covering member and the first retainer and moves the first retainer toward the covering member.

Claims

1. A device for 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 device comprising:

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

first and second retainers positionable external of the vessel and being movable independently, the first and second retainers being one of substantially cylindrical and substantially pill shaped;

a first flexible connecting member operatively connecting the first retainer to the covering member, the first flexible connecting member movable proximally to advance the first retainer toward the covering member and;

a second flexible connecting member operatively connecting the second retainer to the covering member, the second flexible connecting member movable proximally to advance the second retainer toward the covering member.

2. The device of claim 1, wherein the covering member has a first opening configured to restrict movement of the first connecting member and a second opening spaced from the first opening configured for unrestricted movement of the first connecting member.

3. The device of claim 1, wherein the covering member and first and second retainers are composed of a resorbable material.

4. The device of claim 1, wherein the first and second retainers are positioned in a stacked relationship in a delivery position.

5. The device of claim 1, wherein the covering member is pivotable between a more longitudinal orientation for delivery and a transverse position for placement.

6. The device of claim 1, wherein the first and second retainers are fixedly secured to the respective first and second connecting members and independently movable toward the covering member while maintaining their position with respect to the respective connecting member.

7. The device of claim 6, wherein the first and second flexible connecting members are sutures, and the first and second retainers and the first and second flexible connecting members are composed of a resorbable material.

8. The device of claim 1, wherein the first and second retainers in a placement position to retain the covering member are positioned in a substantially side by side relationship such that inner side surfaces of the first and second retainers are closer than outer side surfaces, the side surfaces extending between lower and upper surfaces of the first and second retainers.

9. A device for 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 device comprising:

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

first and second retainers positionable external of the vessel and proximal of the covering member, the first and second retainers each having a body of a first transverse dimension and having a substantially cylindrical configuration with a longitudinal axis transverse to the longitudinal axis of the covering member in a placement position; and

a first flexible connecting member operatively connecting the covering member and the first retainer and a second flexible connecting member operatively connecting the covering member and the second retainer, the first flexible connecting member movable to move the first retainer toward the covering member and the second flexible connecting member movable to move the second retainer toward the covering member, the first and second flexible connecting members being independently movable.

10. The device of claim 9, wherein the covering member has a first opening and a second opening spaced from the first opening, the first opening configured to restrict movement of the first connecting member and the second opening configured to restrict movement of the second connecting member.

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

12. The device of claim 9, wherein the first and second retainers in a placement position to retain the covering member are positioned in a substantially side by side relationship such that inner side surfaces of the first and second retainers are closer than outer side surfaces, the side surfaces extending between lower and upper surfaces of the first and second retainers.

13. A device for 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 device comprising:

a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture, the covering member having a dimension to prevent egress of fluid through the aperture, the covering member having a first opening and a second opening;

first and second retainers positionable external of the vessel and proximal of the covering member in a placement position, the first and second retainers each having a body having a substantially cylindrical configuration, the first and second retainers being independently movable toward the covering member; and

a first flexible connecting member operatively connecting the covering member and the first retainer, the first flexible connecting member being fixedly secured to the first retainer at one end wherein the first flexible connecting member is movable to move the first retainer toward the covering member as a second end of the first flexible connecting member is moved proximally, the first retainer remaining fixedly secured to the first flexible connecting member at the first end to maintain its position on the first flexible connecting member as it is moved toward the covering member, the second opening in the covering member configured to enable unrestricted movement of the first flexible connecting member through the second opening and the first opening in the covering member configured to restrict movement of the first flexible connecting member until a predetermined force is applied.

14. The device of claim 13, further comprising a second flexible connecting member operatively connecting the covering member and the second retainer, the second flexible connecting member being fixedly secured to the second retainer at one end wherein the second flexible connecting member is movable to move the second retainer toward the covering member as a second end of the second flexible connecting member is moved proximally, the second retainer remaining fixedly secured to the second flexible connecting member at the first end to maintain its position on the second flexible connecting member as it moved toward the covering member, and the first and second flexible connecting members being independently movable.

15. The device of claim 13, wherein the first and second openings are of different sizes to receive the first flexible connecting member and the covering member includes third and fourth openings of different sizes to receive the second flexible connecting member.

16. The device of claim 15, wherein the first and third openings frictionally engage the first and second flexible connecting members and the second and fourth openings are dimensioned for free unrestricted movement of the first and second flexible connecting members.

17. The device of claim 16, wherein the second opening has a larger cross-sectional dimension than the first opening and the fourth opening has a larger cross-sectional dimension than the third opening.

18. The device of claim 13, wherein the covering member, first and second flexible connecting members and first and second retainers are composed of resorbable material.