Vascular hole closure device

• US 10,342,524 B2
• Filed: 04/17/2016
• Issued: 07/09/2019
• 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:
  US15/130,996
• Publication Number:
  US 20160228111A1
• Time in Patent Office: 1,178 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, resorptive for implantable prostheses A61F2210/0004
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00778 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 method for closing an aperture in a vessel wall of a vessel, 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 delivery device containing therein a distal covering member, a first retainer and a first flexible connecting member connecting the first retainer to the covering member;

inserting the delivery device so a distal opening of the delivery device is within a lumen of the vessel;

exposing the covering member from the delivery device for placement of the covering member within the lumen of the vessel and for placement against the internal opening of the aperture in the vessel wall to block flow through the aperture; and

applying a proximal force to the first flexible connecting member to advance the first retainer toward the covering member, wherein upon cessation of the proximal force the first flexible connecting member is automatically retained by the covering member to retain the first retainer in position, the first retainer remaining outside the vessel lumen during movement of the first flexible connecting member,

wherein the delivery device further contains therein a second retainer and a second flexible connecting member connecting the second retainer to the second flexible connecting member, and further including the step of applying a proximal force to the second flexible connecting member to advance the second retainer toward the covering member, wherein upon cessation of the proximal force, the second flexible connecting member is automatically retained by the covering member to retain the second retainer in position, the second retainer remaining outside the vessel lumen during movement of the second flexible connecting member, and the second retainer is fixedly secured to a first portion of the second flexible connecting member so the step of applying a proximal force to the second flexible connecting member to advance the second retainer includes pulling a second portion of the second flexible connecting member.

2. The method of claim 1, wherein upon cessation of the proximal force the first flexible connecting member is automatically retained by frictional engagement of the first flexible connecting member within a first opening in the covering member.

3. The method of claim 2, wherein the first flexible connecting member freely passes through a second opening in the covering member when the proximal force is applied to the first flexible connecting member.

4. The method of claim 3, wherein the first flexible connecting member has a length and upon cessation of the proximal force the first flexible connecting member can be frictionally engaged at continuous locations along its length.

5. The method of claim 4, wherein the second flexible connecting member has a length and upon cessation of the proximal force the second flexible connecting member can be frictionally engaged at continuous locations along its length.

6. The method of claim 5, wherein upon cessation of the proximal force the second flexible connecting member is automatically retained by frictional engagement of the second flexible connecting member within a third opening in the covering member.

7. The method of claim 6, wherein the second flexible connecting member freely passes through a fourth opening in the covering member when the proximal force is applied to the second flexible connecting member.

8. The method of claim 2, wherein the first retainer is fixedly secured to a first portion of the first flexible connecting member so the step of applying a proximal force to the first flexible connecting member to advance the first retainer includes pulling a second portion of the first flexible connecting member.

9. The method of claim 1, wherein the first and second retainers are placed outside the lumen of the vessel in a side by side non-stacked relationship.

10. A method for closing an aperture in a vessel wall of a vessel, 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 delivery device containing therein a distal covering member, a first retainer and a first flexible connecting member connecting the first retainer to the covering member;

inserting the delivery device so a distal opening of the delivery device is within a lumen of the vessel;

exposing the covering member from the delivery device for placement of the covering member within the lumen of the vessel and for placement against the internal opening of the aperture in the vessel wall to block flow through the aperture; and

applying a proximal force to the first flexible connecting member to advance the first retainer toward the covering member, wherein upon cessation of the proximal force the first flexible connecting member is automatically retained by the covering member to retain the first retainer in position, the first retainer remaining outside the vessel lumen during movement of the first flexible connecting member;

wherein upon cessation of the proximal force the first flexible connecting member is automatically retained by frictional engagement of the first flexible connecting member within a first opening in the covering member, and the first flexible connecting member has a length and upon cessation of the proximal force the first flexible connecting member can be frictionally engaged at continuous locations along its length;

wherein the delivery device further contains therein a second retainer and a second flexible connecting member connecting the second retainer to the second flexible connecting member, and further including the step of applying a proximal force to the second flexible connecting member to advance the second retainer toward the covering member, wherein upon cessation of the proximal force, the second flexible connecting member is automatically retained by the covering member to retain the second retainer in position, the second retainer remaining outside the vessel lumen during movement of the second flexible connecting member, and the second retainer is fixedly secured to a first portion of the second flexible connecting member so the step of applying a proximal force to the second flexible connecting member to advance the second retainer includes pulling a second portion of the second flexible connecting member.

11. A method for closing an aperture in a vessel wall of a vessel, 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 delivery device containing therein a distal covering member, a first retainer and a first flexible connecting member connecting the first retainer to the covering member;

inserting the delivery device so a distal opening of the delivery device is within a lumen of the vessel;

exposing the covering member from the delivery device for placement of the covering member within the lumen of the vessel and for placement against the internal opening of the aperture in the vessel wall to block flow through the aperture; and

applying a proximal force to the first flexible connecting member to advance the first retainer toward the covering member, wherein upon cessation of the proximal force the first flexible connecting member is automatically retained by the covering member to retain the first retainer in position, the first retainer remaining outside the vessel lumen during movement of the first flexible connecting member,

wherein the delivery device further contains therein a second retainer and a second flexible connecting member connecting the second retainer to the second flexible connecting member, and further comprising the step of applying a proximal force to the second flexible connecting member to advance the second retainer toward the covering member, wherein upon cessation of the proximal force, the second flexible connecting member is automatically retained by the covering member to retain the second retainer in position, the second retainer remaining outside the vessel lumen during movement of the second flexible connecting member, and the second flexible connecting member has a length and upon cessation of the proximal force the second flexible connecting member can be frictionally engaged at continuous locations along its length;

wherein the proximal force is applied to the first retainer prior to the proximal force being applied to the second retainer.