Cardiac valve annulus reduction system

• US 7,655,040 B2
• Filed: 11/12/2004
• Issued: 02/02/2010
• Est. Priority Date: 11/12/2003
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Barone, David D., Douk, Nareak, Rafiee, Nasser, Fogg, Douglas A., Bloom, Eliot, Huynh, Rany
• Primary Examiner(s): Erezo; Darwin P
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US10/531,819
• Publication Number:
  US 20070051377A1
• Time in Patent Office: 1,908 Days
• Field of Search: 623/2.11, 623 236- 237, 623/2.41, 623 111- 112, 606215-217, 606/219, 606/151
• US Class Current: 623/2.11
• 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 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2017/06052 Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2002/30545 for adjusting a diameter
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A catheter-based, annulus reduction device and system for cardiac valve repair and method of using the same. The system is usable for treating mitral valve regurgitation and comprises a catheter, a reduction ring carried within the catheter, the reduction ring including a plurality of exit ports formed in a side wall of the reduction ring and filament received in the reduction ring. The filament includes a plurality of radially extendible barbs corresponding to the sidewall openings. The reduction ring carrying the filament is deployed adjacent a mitral valve annulus and the filament is translated relative to the reduction ring to deploy the barbs through the exit ports and into the annulus and to further translate the reduction ring with deployed barbs to reshape the annulus.

Claims

1. A device for treating mitral valve regurgitation, comprising:

a tubular member being sufficiently flexible to be transformable between a relatively straight delivery configuration and a deployed ring shape approximating the size and shape of a mitral valve annulus, the tubular member having a through lumen and a plurality of sidewall openings generally disposed around a perimeter of the deployed ring shape; and

a barb assembly comprising a filament extending through the lumen and a plurality of self-extendible barbs coupled to the filament and corresponding to the sidewall openings, the barb assembly being slidable within the lumen to align the barbs with the corresponding sidewall openings to permit self-extension of the barbs there through;

wherein the tubular member has a plurality of protruding anchors generally disposed around a perimeter of the deployed ring shape.

2. The device of claim 1 wherein the filament is a hollow tube.

3. The device of claim 2 wherein the barbs are formed integrally from the hollow tube.

4. The device of claim 2 wherein the hollow tube has a plurality of notches to increase axial flexibility of the barb assembly.

5. The device of claim 1 wherein the tubular member has a plurality of notches to increase axial flexibility thereof.

6. The device of claim 1 wherein the tubular member has a temporary barb disposed at a distal end thereof.

7. The device of claim 1 further comprising a lock mechanism disposed upon the filament for locking the device in the deployed ring shape.

8. The device of claim 7 wherein the lock mechanism comprises:

a lock disposed at a proximal end of the filament and having a lumen there through, and

at least one key member disposed at a distal end of the filament and having a key body and a deflectable tab disposed on the key body, the deflectable tab being normally angled away from the filament and being elastically deflectable towards the filament to allow the at least one key member to pass through lock lumen in only one direction.

9. The device of claim 1 further comprising:

a cord ring disposed at a distal end of the filament; and

a reshaping cord having first and second ends and being threaded through the cord ring.

10. The device of claim 1 further comprising:

a stop attached to the tubular member and extending into the lumen, the stop being sized and shaped to prevent movement of the barb in one direction.

11. The device of claim 1 wherein the barbs comprise at least one material from the group consisting of nitinol, cobalt-based alloy, stainless steel, or combinations thereof.

12. A system for treating mitral valve regurgitation, the system comprising:

a device for treating mitral valve regurgitation in accordance with claim 1;

a delivery catheter; and

a locking mechanism disposed upon the filament for locking the device in a reduction configuration.

13. The system of claim 12 wherein the locking mechanism comprises a plurality of locking members securely attached to a distal portion of the filament and a lock attached to a proximal portion of the filament.

14. The system of claim 12 further comprising:

a wireform having a pre-shaped annular portion for placement adjacent a valve annulus, the wireform comprising a guide for delivering the delivery catheter to the valve annulus.

15. The system of claim 14 wherein the pre-shaped annular portion of the wireform comprises a shape memory material.

16. The system of claim 15 wherein the shape memory material comprises nitinol.

17. The system of claim 16 wherein the wireform further comprises a stabilizer portion extending distally from the pre-shaped annular portion.

18. The system of claim 17 wherein the stabilizer portion has a length sufficient to traverse a heart chamber and to contact a chamber wall opposite a heart valve.

19. The system of claim 17 wherein the wireform includes a soft distal tip.

20. The system of claim 17 wherein the stabilizer portion includes a plurality of radiopaque markers.

21. The system of claim 14 further comprising a wireform delivery catheter.

22. The system of claim 21 wherein the wireform delivery catheter comprises a restraining section for restraining the pre-shaped annular portion of the wireform when the wireform is disposed within the wireform delivery catheter.

23. The system of claim 22 wherein the restraining section of the wireform delivery catheter comprises a braided material embedded in a portion of a wall of the wireform delivery catheter.

24. The system of claim 1 wherein the barbs are composed of a material chosen from a group consisting of nitinol, cobalt-based alloy, stainless steel, or combinations thereof.