Vascular hole closure device

• US 10,390,808 B2
• Filed: 04/09/2016
• 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, DeFonzo, Stephan A.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US15/095,047
• Publication Number:
  US 20160220237A1
• Time in Patent Office: 1,235 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 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 2017/00004 (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 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/0404 Buttons
• 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 comprising a covering member having a longitudinal axis and positionable inside the vessel against the internal opening of the aperture and having a dimension to prevent egress of fluid through the aperture and having a first opening. A first retainer is positionable external of the vessel. A flexible connecting member operatively connects the covering member and the first retainer, wherein the first opening of the covering member is configured to restrict movement of the connecting 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 distal covering member positionable inside the vessel against the internal opening of the aperture, the covering member having a first opening, a second opening, a third opening and a fourth opening;

a proximal first retainer positionable external of the vessel;

a proximal second retainer positionable external of the vessel; and

a first flexible connecting member operatively connecting the first retainer to the covering member and a second flexible connecting member operatively connecting the second retainer to the covering member, the first flexible connecting member advancing the first retainer toward the covering member, the first opening of the covering member restricting movement of the first flexible connecting member and the second opening of the covering member providing for freer movement of the first flexible connecting member, the second flexible connecting member advancing the second retainer toward the covering member, the third opening of the covering member restricting movement of the second flexible connecting member and the fourth opening of the covering member providing for freer movement of the second flexible connecting member.

2. The device of claim 1, wherein the second flexible connecting member is movable independently of the first flexible connecting member.

3. The device of claim 1, wherein the first retainer and the second retainer are spherical in configuration.

4. The device of claim 1, wherein movement of the first flexible connecting member in a proximal direction away from the covering member advances the first retainer toward the covering member in a distal direction and movement of the second flexible connecting member in a proximal direction away from the covering member advances the second retainer toward the covering member in a distal direction.

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

6. The device of claim 1, wherein the first and second retainers are positioned in a substantially side by side non-stacked relationship in a placement position external of the vessel.

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

8. The device of claim 1, wherein the covering member has a first end portion, a second end portion and an intermediate section between the first and second end portions, the intermediate section having a thickness greater than a thickness of the first and second end portions.

9. The device of claim 8, wherein the first, second, third and fourth openings are in the intermediate section of the covering member.

10. The device of claim 1, wherein the covering member has a longitudinal axis and the first and second openings are on opposing sides of the longitudinal axis and the third and fourth openings are on opposing sides of the longitudinal axis.

11. The device of claim 10, wherein the first and fourth openings are on one side of the longitudinal axis and the second and third openings are on an opposing side of the longitudinal axis.

12. The device of claim 1, wherein the first retainer is fixedly secured to the first flexible connecting member and the second retainer is fixedly secured to the second flexible connecting member.

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 distal covering member positionable inside the vessel against the internal opening of the aperture, the covering member having an upper surface, a lower surface and a first opening extending through the upper surface and lower surface;

a proximal first retainer positionable external of the vessel; and

a first flexible connecting member operatively connecting the first retainer and the covering member, the first flexible connecting member having a first portion, a second portion and an intermediate portion between the first and second portions, a first portion of the first flexible connecting member secured to the first retainer by securement within the first retainer and terminating at the first retainer, the first opening of the covering member restricting movement of the first flexible connecting member, wherein the first opening retains the flexible connecting member in a fixed position along a length and a sufficient proximal force on the second portion moves the first flexible connecting member within the first opening and advances the first retainer toward the distal covering member, wherein when the sufficient proximal force is terminated, the flexible connecting member is restricted from movement by the first opening.

14. The device of claim 13, wherein the first flexible connecting member has a single loop as it extends through an intermediate section of the covering member.

15. The device of claim 13, wherein the covering member has a first end portion, a second end portion and an intermediate section between the first and second end portions, and the first opening is in the intermediate section.

16. The device of claim 13, wherein the covering member is pivotable from a first position to a second placement position when outside a distal opening of a delivery device.

17. The device of claim 13, wherein the covering member has a second opening configured for freer movement of the first flexible connecting member.

18. The system of claim 17, wherein a diameter of the first retainer exceeds a distance between the first and second openings.

19. 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 distal covering member positionable inside the vessel against the internal opening of the aperture, the covering member having a first opening;

a proximal first retainer positionable external of the vessel; and

a first flexible connecting member operatively connecting the first retainer and the covering member, the first flexible connecting member having a first portion, a second portion and an intermediate portion between the first and second portions, the first retainer secured to a first portion of the first flexible connecting member, the first opening of the covering member restricting movement of the first flexible connecting member, wherein the first opening retains the flexible connecting member in a fixed position along a length and a sufficient proximal force on the second portion moves the first flexible connecting member within the first opening and advances the first retainer toward the distal covering member, wherein when the sufficient proximal force is terminated, the flexible connecting member is restricted from movement by the first opening and further including a second retainer positionable external of the vessel, wherein the first retainer is advanceable from a first position within a delivery device to a second position outside a 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 outside the distal opening of the delivery device.

20. The device of claim 19, wherein the first and second retainers in a placement position are not positioned atop one another but are positioned side by side such that they are each positioned above a different region of the covering member.