Vascular hole closure device

• US 9,463,005 B2
• Filed: 11/10/2012
• Issued: 10/11/2016
• 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, DeFonzo, Stephan A.
• Primary Examiner(s): Dornbusch, Dianne
• Application Number:
  US13/673,995
• Publication Number:
  US 20130066364A1
• Time in Patent Office: 1,431 Days
• Field of Search: 606151-154, 606/157, 606/213, 606/215, 606/216, 606218-221
• US Class Current: 1/1
• 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 dimension to prevent egress of fluid through the aperture, the covering member having a first opening and a second opening spaced from the first opening;

a proximal first retainer positionable external of the vessel and engageable with tissue to retain the distal covering member;

a second retainer movable toward the covering member, the second retainer being movable independently of the first retainer;

a flexible connecting member operatively connecting the covering member and the first retainer for placement of the closure device to close the aperture in the vessel wall, the first retainer fixedly secured to the flexible connecting member, the flexible connecting member advancing the first retainer toward the covering member, the first opening of the covering member configured to frictionally engage the flexible connecting member to restrict movement of the flexible connecting member until a predetermined force is applied which enables the flexible connecting member to move through the first opening, and the second opening having a larger diameter than the first opening for unrestricted movement of the flexible connecting member, wherein movement of the flexible connecting member in a proximal direction away from the covering member advances the first retainer toward the covering member in a distal direction as the flexible connecting member is moved through the first opening; and

a second flexible connecting member, the second retainer attached to the second flexible connecting member and pulling of the second flexible connecting member advances the second retainer toward the covering member, the covering member having a third opening configured to restrict movement of the second flexible connecting member, and the second flexible connecting member is advanceable through the third opening until a predetermined force is applied and is not advanceable through the third opening if the predetermined force is not applied.

2. The device of claim 1, wherein the flexible connecting member comprises a first suture.

3. The device of claim 2, wherein the first retainer is spherical in configuration.

4. The device of claim 1, wherein the second retainer is spherical in configuration.

5. The device of claim 1, wherein the covering member is composed of a polymeric material.

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

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 flexible connecting member has a first portion, a second free end portion, and an intermediate portion positioned between the first portion and the second portion, the first retainer is secured to the first portion and the intermediate portion loops through the covering member.

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 distal covering member 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 spaced from the first opening;

a proximal first retainer positionable external of the vessel and engageable with tissue to retain the distal covering member;

a flexible connecting member operatively connecting the covering member and the first retainer for placement of the closure device to close the aperture in the vessel wall, the first retainer fixedly secured to the flexible connecting member, the flexible connecting member advancing the first retainer toward the covering member, the first opening of the covering member configured to frictionally engage the flexible connecting member to restrict movement of the flexible connecting member until a predetermined force is applied which enables the flexible connecting member to move through the first opening, and the second opening having a larger diameter than the first opening for unrestricted movement of the flexible connecting member, wherein movement of the flexible connecting member in a proximal direction away from the covering member advances the first retainer toward the covering member in a distal direction as the flexible connecting member is moved through the first opening, the flexible connecting member composed of a first suture;

a second suture and a second retainer attached to the second suture, the second suture advancing the second retainer toward the covering member; and

the first and second retainers are positioned in a substantially side by side non-stacked relationship in a placement position and are positioned in a stacked relationship one above the other in a delivery position.

10. The device of claim 9, wherein the covering member has a third opening configured to restrict movement of the second suture, and the second suture is advanceable through the third opening until a predetermined force is applied and is not advanceable through the third opening if the predetermined force is not applied.

11. The device of claim 10, further comprising a fourth opening in the covering member for unrestricted movement of the second suture.

12. The device of claim 9, wherein the first and second retainers and the first and second sutures are composed of a resorbable material.

13. The device of claim 9, wherein the covering member has a third opening having a first diameter smaller than a second diameter of a fourth opening to frictionally engage the second suture to restrict movement of the second suture.

14. 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 dimension to prevent egress of fluid through the aperture, the covering member having a first opening and a second opening spaced from the first opening;

a proximal first retainer positionable external of the vessel and engageable with tissue to retain the distal covering member;

a flexible connecting member operatively connecting the covering member and the first retainer for placement of the closure device to close the aperture in the vessel wall, the first retainer fixedly secured to the flexible connecting member, the flexible connecting member advancing the first retainer toward the covering member, the first opening of the covering member configured to frictionally engage the flexible connecting member to restrict movement of the flexible connecting member until a predetermined force is applied which enables the flexible connecting member to move through the first opening, and the second opening having a larger diameter than the first opening for unrestricted movement of the flexible connecting member, wherein movement of the flexible connecting member in a proximal direction away from the covering member advances the first retainer toward the covering member in a distal direction as the flexible connecting member is moved through the first opening, the flexible connecting member composed of a first suture;

a second suture and a second retainer attached to the second suture, the second suture advancing the second retainer toward the covering member; and

wherein in a placement position the first and second retainers are in a substantially side by side non-stacked relationship and in a transverse orientation with respect to the covering member.