METHODS, SYSTEMS AND DEVICES FOR CARDIAC VALVE REPAIR

• US 20110060407A1
• Filed: 09/15/2010
• Published: 03/10/2011
• Est. Priority Date: 02/07/2005
• Status: Abandoned Application

• Current Assignee: Chris Bender, Eric A. Goldfarb, Steven A. Tyler, Ted Ketai, Troy L. Thornton
• Original Assignee: Chris Bender, Eric A. Goldfarb, Steven A. Tyler, Ted Ketai, Troy L. Thornton
• Inventors: Tyler, Steven A., Ketai, Ted, Bender, Chris, Thornton, Troy L., Goldfarb, Eric A.
• Application Number:
  US12/883,095
• Publication Number:
  US 20110060407A1
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/295 combined with cutting implements
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00783 Valvuloplasty
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00876 magnetic
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 : H-fasteners
• CPC Class Codes: A61B 2017/0427 : having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0435 : the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0441 : the shaft being a rigid coil or spiral
• CPC Class Codes: A61B 2017/0445 : cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0454 : the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0464 : for soft tissue
• CPC Class Codes: A61B 2017/048 : for reducing heart wall tension, e.g. sutures with a pad on each extremity
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/0647 : having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/12018 : Elastic band ligators
• CPC Class Codes: A61B 2017/22044 : with a pointed tip
• CPC Class Codes: A61F 2/2412 : with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2445 : Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2454 : Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/2457 : Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 : Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2463 : Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2/2487 : Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/249 : Device completely embedded in the heart wall
• CPC Class Codes: A61F 2002/30079 : magnetic
• CPC Class Codes: A61F 2210/009 : magnetic
• CPC Class Codes: A61F 2220/0016 : with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas

Abstract

Disclosed are methods, systems, and devices for the endovascular repair of cardiac valves, particularly the atrioventricular valves which inhibit back flow of blood from a heart ventricle during contraction. The procedures described herein can be performed with interventional tools, guides and supporting catheters and other equipment introduced to the heart chambers from the patient'"'"'s arterial or venous vasculature remote from the heart. The interventional tools and other equipment may be introduced percutaneously or may be introduced via a surgical cut down, and then advanced from the remote access site through the vasculature until they reach the heart.

Claims

1. A chordal replacement device comprising:

a proximal anchor comprising a flexible patch and a leaflet attachment device, wherein the flexible patch is affixed to an upper surface of a portion of a flailing leaflet with the leaflet attachment device;

a distal anchor extending and affixed to a distal attachment site in a ventricle; and

a flexible tether coupled to and tensioned between the proximal and distal anchors.

2. The device of claim 1, wherein the leaflet attachment device comprises a pair of expandable elements interconnected by a central attachment rod.

3. The device of claim 2, wherein the pair of expandable elements sandwich the flexible patch and the leaflet.

4. The device of claim 1, wherein the leaflet attachment device comprises an expandable element.

5. The device of claim 1, wherein the expandable element is self-deploying.

6. The device of claim 5, wherein the expandable element comprises a star-shaped barb, a mesh web, or a mesh ball.

7. The device of claim 1, wherein the proximal anchor further comprises a mesh stent deployable within an atrium.

8. The device of claim 7, wherein the mesh stent is coupled to a flexible rod that extends through a valve commissure into the ventricle.

9. The device of claim 8, wherein a distal end of the flexible rod couples to the distal anchor and provides consistent tension on the tether during a heart cycle.

10. The device of claim 8, wherein the flexible rod has a deflectable, spring-formed shape.

11. The device of claim 8, wherein the flexible rod is jointed.

12. The device of claim 1, wherein the distal anchor and tensioned flexible tether apply a downward force on the flailing leaflet.

13. The device of claim 1, wherein the distal anchor comprises a weight, barb, adhesive, screw, or fluid-filled element.

14. The device of claim 1, wherein the distal attachment site comprises a portion of the ventricle wall, ventricular septum or papillary muscle.

15. The device of claim 14, wherein the distal anchor fine-tunes the tension of the tether after the distal anchor is affixed to the distal attachment site.

16. The device of claim 15, wherein the distal anchor comprises a coil screw and wherein rotation of the coil screw fine-tunes the tension on the tether.

17. The device of claim 15, wherein the distal anchor comprises a balloon and wherein infusion of fluid into the balloon increases tension on the tether.

18. The device of claim 1, wherein the flexible tether has a length that can be adjusted to a desired tension to apply a downward force on the flailing leaflet.

19. The device of claim 1, wherein the flexible tether comprises one or more loops of a flexible material.

20. The device of claim 19, wherein the one or more loops are drawn together at a distal end region with an enclosed element.

21. The device of claim 20, wherein the enclosed element couples the one or more loops to the distal anchor.

22. The device of claim 21, wherein the one or more loops are coupled to the proximal and distal anchors such that the one or more loops self-equalize and evenly distribute tension on the flailing leaflets and on distal attachment site.

30. The device of claim 1, wherein the tether has a length that can be adjusted to a desired tension to hold the leaflet down.

23. A chordal replacement device comprising:

a proximal anchor comprising a flexible crimp clip having one or more barbs that embed into and affix to a portion of a flailing leaflet;

a distal anchor extending and affixed to a distal attachment site in a ventricle; and

a flexible tether coupled to and tensioned between the proximal and distal anchors.

24. The device of claim 23, wherein the distal anchor and flexible tether hold down the flailing leaflet.

25. The device of claim 23, wherein the distal anchor comprises a weight, barb, adhesive, screw, or fluid-filled element.

26. The device of claim 23, wherein the distal attachment site comprises a portion of the ventricle wall, ventricular septum or papillary muscle.

27. The device of claim 26, wherein the distal anchor fine-tunes the tension of the tether after the distal anchor is affixed to the distal attachment site.

28. The device of claim 27, wherein the distal anchor comprises a coil screw and wherein rotation of the coil screw fine-tunes the tension on the tether.

29. The device of claim 27, wherein the distal anchor comprises a balloon and wherein infusion of fluid into the balloon increases tension on the tether.

31. A method for repairing a cardiac valve comprising:

accessing a patient'"'"'s vasculature remote from the heart;

advancing an interventional tool through an access sheath to a location near the cardiac valve, the interventional tool comprising a distal flange;

affixing a chordal replacement device to a portion of a flailing leaflet, the chordal replacement device comprising;

a flexible patch;

one or more leaflet attachment devices;

a distal anchor; and

a flexible tether coupled to and tensioned between the flexible patch and the distal anchor;

coupling the distal anchor to a distal attachment site in a ventricle; and

applying a downward force on the flailing leaflet with the tether and distal anchor so as to prevent flail of the leaflet into the atrium.

32. The method of claim 31, wherein affixing a chordal replacement device further comprises positioning the flexible patch on an upper surface of a flailing leaflet, piercing the patch and the leaflet with the one or more leaflet attachment devices, and sandwiching the leaflet and the patch between a pair of expandable elements.

33. The method of claim 32, wherein the pair of expandable elements are self-deploying.

34. The method of claim 31, wherein the distal anchor comprises a weight, barb, adhesive, coil screw or fluid-filled element.

35. The method of claim 31, wherein the distal attachment site comprises a portion of the ventricle wall, ventricular septum or papillary muscle.

36. The method of claim 31, further comprising observing flow through the cardiac valve to determine if leaflet flail, valve prolapse or valve regurgitation are inhibited.

37. The method of claim 31, further comprising adjusting tension of the tether coupled to and tensioned between the flexible patch and the distal anchor.

38. The method of claim 37, wherein the distal anchor comprises a coil screw and wherein adjusting the tension of the tether comprises rotating the coil screw.

39. The method of claim 37, wherein the distal anchor comprises a balloon and wherein adjusting the tension of the tether comprises infusing fluid into the balloon.

40. The method of claim 31, further comprising sensing contact between the distal anchor and the distal attachment site.