Tensioning device, system, and method for treating mitral valve regurgitation

• US 7,316,706 B2
• Filed: 06/14/2004
• Issued: 01/08/2008
• Est. Priority Date: 06/20/2003
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Huynh, Rany, Horrigan, John, Douk, Nareak, Rafiee, Nasser, Bloom, Eliot
• Primary Examiner(s): Woo; Julian W.
• Application Number:
  US10/867,394
• Publication Number:
  US 20040260317A1
• Time in Patent Office: 1,303 Days
• Field of Search: 606/232, 606/72, 606/74, 606/103, 606228-230, 606/172, 241/15.R, 241/29.W, 241/36.R, 241/15.A, 241/32.R, 607126-128, 607/132, 604/164.05
• US Class Current: 606/232
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints

Abstract

A system for treating mitral valve regurgitation comprises a tensioning device slidably received within a delivery catheter. The tensioning device includes a tether linking proximal an anchoring member and a distal anchoring member. At least one of the anchoring members includes an elastic portion that flexes in response to a heartbeat when the tensioning device is positioned across a chamber of a heart. The tether includes at least one locking member initially positioned between the anchoring members. A method for treating mitral valve regurgitation comprises piercing a first wall of a chamber of a heart, engaging a distal anchoring member with a second wall of the heart chamber, engaging a proximal anchoring member with the first wall, and pulling a locking member affixed to a tether linking the anchoring members from an initial position between the two anchoring members to a locked position proximal the proximal anchoring member.

Claims

1. A system for treating mitral valve regurgitation comprising:

a tensioning device comprising a tether, a distal anchoring member positioned adjacent to a distal end of the tether and a proximal anchoring member positioned adjacent to a proximal end of the tether, wherein at least one of the anchoring members includes an elastic portion that flexes in response to a heart beat when the tensioning device is positioned across a chamber of a heat; and

a delivery catheter, wherein the tensioning device is slidably received within a lumen of the delivery catheter, wherein the delivery catheter comprises a guiding sheath, a piercing tube slidably received within a lumen of the guiding sheath, a holding tube slidably received within a lumen of the piercing tube, a push cylinder slidably received within a lumen of the holding tube and a stop collar attached to an outside surface of a distal portion of the piercing tube, and wherein a portion of the stop collar is self-expanding when the stop collar is positioned outside the lumen of the guiding sheath.

2. A system for treating mitral valve regurgitation, comprising:

a delivery catheter; and

a tensioning device received in the delivery catheter, the tensioning device including a tether, a distal anchoring member positioned adjacent to a distal end of the tether, a proximal anchoring member positioned adjacent to a proximal end of the tether, and at least one locking member affixed to the tether;

wherein when the locking member is pulled from an initial position between the anchors to a locked position proximal the proximal anchoring member, the length of the tether is adjusted to change the proximity of the anchoring members one to the other,

wherein the delivery catheter comprises a guiding sheath, a piercing tube slidably received within a lumen of the guiding sheath, a holding tube slidably received within a lumen of the piercing tube, a push cylinder slidably received within a lumen of the holding tube and a stop collar attached to an outside surface of a distal portion of the piercing tube, and wherein a portion of the stop collar is self-expanding when the stop collar is positioned outside the lumen of the guiding sheath.

3. The system of claim 2 wherein the tether includes a release loop adjacent to a proximal end of the tether.

4. The system of claim 2 wherein the locking member comprises a generally cylindrical member having a flexible tab flaring out from the cylindrical member.

5. The system of claim 2 wherein the locking member comprises a generally cylindrical member having an end shaped to form an angle with the longitudinal axis of the cylindrical member that is less than 90 degrees.

6. The system of claim 2 wherein at least one of the anchoring members includes an elastic portion that flexes in response to a heart beat when the tensioning device is positioned across a chamber of a heart.

7. The system of claim 6 wherein the elastic portion of the at least one anchoring member comprises a material selected from a group consisting of a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, a thermoset plastic, stainless steel, a biocompatible shape-memory material, a biocompatible superelastic material, and a combination thereof.

8. The system of claim 6 wherein the elastic portion comprises a plurality of flexible arm segments.

9. The system of claim 8 wherein the flexible arm segments are in a radially compressed, folded configuration while the anchoring member is within a lumen of the delivery catheter and wherein the flexible arm segments self-expand when the anchoring member is released from the delivery catheter.

10. The system of claim 8 wherein the flexible arm segments of at least one of the anchoring members self-expand.

11. The system of claim 2 wherein the tether comprises a material selected from a group consisting of stainless steel, titanium, a nickel-titanium alloy, a nickel-cobalt alloy, a cobalt alloy, tantalum, polypropylene, polyethylene, polyurethane, polytetrafluoroethylene (PTFE), polyester (Dacron®

), nylon, a flexible and strong biocompatible material, and a combination thereof.

12. The system of claim 2 wherein at least a portion of the tensioning device includes a therapeutic agent selected from a group consisting of an antithrombotic, an anticoagulant, and a combination thereof.

13. The system of claim 2 wherein the tensioning device includes at least one sealing member.