Anchoring and tethering system

• US 20070265658A1
• Filed: 05/12/2006
• Published: 11/15/2007
• Est. Priority Date: 05/12/2006
• Status: Abandoned Application

• Current Assignee: AGA Medical Corporation (Abbott Laboratories Incorporated)
• Original Assignee: AGA Medical Corporation (Abbott Laboratories Incorporated)
• Inventors: Anderson, Kent, Nelson, Dale, Gu, Xiaoping
• Application Number:
  US11/433,302
• Publication Number:
  US 20070265658A1
• Time in Patent Office: Days
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/048 for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A method and apparatus for providing safe and efficient transcatheter correction of the shape of heart chambers, valves, or other body members. The apparatus generally performs this correction by securing a tether to body surfaces. The attachment device includes an anchor comprising a wire braid and at least one clamp affixed to and constraining a portion of the wire braid, the clamp having threading for temporarily coupling the anchor to a delivery member and an internal lumen through which the tether can pass. The device also includes a locking member cooperating with the lumen to lock the tether to the clamp at a preselected position along the length of the tether.

Claims

1. An apparatus for securing a tether to a body surface comprising:

an anchor comprising a wire braid and at least one clamp affixed to and constraining a portion of the wire braid, the clamp having threading for temporarily coupling the anchor to a delivery member and an internal lumen through which said tether can pass; and

a locking member cooperating with said lumen to lock the tether to the clamp at a preselected position along the length of the tether.

2. The apparatus for securing a tether to a body surface of claim 1 wherein a portion of the anchor is made from a shape memory or super-elastic alloy.

3. The apparatus for securing a tether to a body surface of claim 2 wherein the body surface is part of a human heart.

4. The apparatus for securing a tether to a body surface of claim 3 wherein the anchor includes a first expanded diameter portion on one side of the body surface, a second expanded diameter portion found on the opposing side of the body surface, and a narrow waist portion that passes through the body surface and joins the expanded diameter portions.

5. The apparatus for securing a tether to a body surface of claim 4 wherein the tether is a flexible braided cable.

6. The apparatus for securing a tether to a body surface of claim 1 wherein the anchor is made from a bioabsorbable material.

7. The apparatus for securing a tether to a body surface of claim 1 wherein the locking member comprises at least one barb member projecting from a wall of said lumen of said clamp to lock the tether to the clamp.

8. The apparatus for securing a tether to a body surface of claim 1 wherein the locking member comprises a wedge member that cooperates with said lumen of said clamp to lock the tether to said clamp.

9. The apparatus for securing a tether to a body surface of claim 1 wherein the tether contains a hollow lumen.

10. The apparatus for securing a tether to a body surface of claim 9 wherein the locking member comprises an expansion member coaxially located within the hollow lumen of the tether capable of expanding the outer diameter of the tether to lock the tether to the clamp so that the tether cannot move relative to the clamp at least in one direction.

11. A method of securing a tether to a body surface having a hole comprising the steps of:

a. providing an anchor comprising a wire braid and at least one clamp affixed to and constraining a portion of the wire braid, said clamp having a lumen and a threaded section;

b. providing a delivery member having a lumen and threads that cooperate with the threaded section of said clamp to temporarily attach said anchor to said delivery member;

c. threading the tether through said lumen of said clamp and said lumen of said delivery member;

d. using the delivery member to advance the anchor to a hole in the body surface and attach the anchor to the body surface at the location of said hole in said body surface;

e. inserting a locking member into said lumen of said clamp to lock said tether to said clamp.

12. A method of securing a tether between first and second body surfaces of a patient comprising the steps of:

a. determining the desired anchoring site in a first body surface for a proximal anchor and in a second body surface for a distal anchor, said proximal anchor comprising a wire braid and at least one clamp coupled to and constraining a portion of said wire braid, said clamp having a lumen;

b. advancing the distal end of a catheter from outside the body to a proximal anchoring site in the first body surface for the proximal anchor and, if there is no hole through the first body surface at the proximal anchoring site, advancing a puncturing tool through the catheter and puncturing a hole through the first body surface at the proximal anchoring site;

c. advancing the catheter through the hole at the proximal anchoring site to a distal anchoring site in a second body surface for said distal anchor and if there is no hole through the second body surface at the distal anchor site for the distal anchor, advancing the puncturing tool through the catheter to the distal anchoring site, puncturing a hole through the wall at the distal anchoring site, and then withdrawing the puncturing tool from the catheter;

d. providing a tether having a distal end and a proximal end and attaching the distal end of said tether to the distal anchor;

e. passing the distal anchor through the catheter to the distal anchor site and attaching the distal anchor to the distal anchor site while retaining the proximal end of the tether outside the body;

f. retracting the distal end of the catheter back to the proximal anchor site;

g. threading the proximal end of the tether through the lumen of the clamp of the proximal anchor;

h. advancing said proximal anchor along the tether through the catheter and deploying it in the hole at the proximal anchor site;

i. applying tension to the tether to draw the proximal and distal anchors and the body surfaces to which they are attached closer to each other while monitoring the effect of such tension on the patient;

j. coupling the tether to the proximal anchor at the proper position along the length of the tether so that proper tension is supplied using a securement member that cooperates with said lumen of said clamp or said proximal anchor; and

k. trimming the excess length of the tether and withdrawing the excess length of the tether and the catheter from the body.