Cardiac valve repair system and methods of use

• US 9,629,716 B2
• Filed: 02/24/2014
• Issued: 04/25/2017
• Est. Priority Date: 07/19/2010
• Status: Active Grant

• Current Assignee: Bmeye B.V. (Edwards Lifesciences Corporation)
• Original Assignee: Bmeye B.V. (Edwards Lifesciences Corporation)
• Inventors: Seguin, Jacques
• Primary Examiner(s): Sharma, Yashita
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US14/188,442
• Publication Number:
  US 20140172070A1
• Time in Patent Office: 1,156 Days
• CPC Class Codes: A61F 2/24 Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: A61F 2250/0098 : radio-opaque, e.g. radio-opaque markers

Abstract

Methods and apparatus are provided for repairing or replacing a defective cardiac valve including an anchor having a double helix configured to engage the cardiac valve leaflets of a diseased or defective cardiac valve, and a replacement valve body disposed in an expandable stent configured to be disposed within the anchor so that the anchor limits expansion of the expandable stent. The expandable stent of the replacement valve body may be self-expanding or mechanically expanded, e.g., using a balloon catheter or catheter-based mandrel and the valve body may be formed of animal tissue or a synthetic fabric.

Claims

1. A method of repairing a cardiac valve comprising:

inserting a first turn of a helical anchor through an opening defined by valve leaflets of the cardiac valve, such that the first turn is at a first side of the cardiac valve;

deploying a second turn of the helical anchor that is adjacent to the first turn at a second side of the cardiac valve, such that the helical anchor engages opposite sides of the cardiac valve and the valve leaflets without contacting any portion of existing valve annulus, and wherein at least part of the cardiac valve extends between the first and second turns and into an inner circumference of the helical anchor;

deploying an expandable stent including a replacement valve within the inner circumference of the helical anchor, the helical anchor limiting expansion of the expandable stent.

2. The method of claim 1, further comprising transitioning the helical anchor between a delivery state and an expanded, deployed state when the helical anchor engages the opposites sides of the cardiac valve.

3. The method of claim 1, further comprising rotating the helical anchor into engagement with the one or more leaflets of the cardiac valve when the helical anchor engages the opposite sides of the cardiac valve.

4. The method of claim 1, wherein the expandable stent comprises a self-expanding stent or a mechanically expanding stent that is expandable using a balloon or expanding mandrel.

5. The method of claim 1, wherein the replacement valve comprises a valve body formed from animal tissue or a synthetic fabric.

6. The method of claim 5, wherein the valve body is formed from porcine, equine or bovine pericardial tissue.

7. The method of claim 1, wherein the expandable stent is pre-attached to the helical anchor.

8. The method of claim 1, wherein when the expandable stent is deployed within the helical anchor, the expandable stent urges the helical anchor into engagement with the one or more leaflets of the cardiac valve.

9. The method of claim 8, wherein the expandable stent urges the turns of the helical anchor towards one another to enhance a grip on the cardiac valve.

10. The method of claim 1, wherein when the expandable stent is deployed within the helical anchor, upper and lower ends of the expandable stent respectively extend radially beyond the first and second turns of the helical anchor.

11. The method of claim 1, wherein a portion of the helical anchor that passes through the opening defined by the valve leaflets of the cardiac valve is positioned at a first commissural region between the valve leaflets.

12. The method of claim 11, where an outer edge of the first commissural region extends radially beyond the portion of the helical anchor that passes through the opening after the expandable stent is deployed.

13. The method of claim 11, wherein an outer edge of a second commissural region extends radially beyond a portion of the helical anchor opposite the portion that passes through the opening.

14. The method of claim 1, wherein an inner diameter of the helical anchor is smaller than a greatest width of the opening of the cardiac valve.

15. The method of claim 1, wherein deploying the second turn of the helical anchor comprises rotating a delivery catheter to release the second turn of the helical anchor from the delivery catheter.

16. The method of claim 1, further comprising reshaping the helical anchor after the second turn of the helical anchor is deployed and prior to deploying the expandable stent.

17. The method of claim 1, wherein when the helical anchor engages the opposite sides of the cardiac valve, the first and second turns sandwich at least part of the cardiac valve therebetween.

18. The method of claim 1, wherein when the expandable stent is deployed, the expandable stent engages both the first and second turns of the helical anchor.

19. The method of claim 1, wherein the cardiac valve is a mitral valve.

20. A method of repairing a cardiac valve comprising:

inserting a first turn of a helical anchor through an opening defined by valve leaflets of the cardiac valve, such that the first turn is at a first side of the cardiac valve;

deploying a second turn of the helical anchor at a second side of the cardiac valve, such that the helical anchor engages opposite sides of the cardiac valve;

deploying an expandable stent including a replacement valve within the helical anchor, the helical anchor limiting expansion of the expandable stent,

wherein when the expandable stent is deployed within the helical anchor, upper and lower ends of the expandable stent respectively extend radially beyond the first and second turns of the helical anchor.

21. A method of repairing a cardiac valve comprising:

inserting a first turn of a helical anchor through an opening defined by valve leaflets of the cardiac valve, such that the first turn is at a first side of the cardiac valve;

deploying a second turn of the helical anchor at a second side of the cardiac valve, such that the helical anchor engages opposite sides of the cardiac valve;

deploying an expandable stent including a replacement valve within the helical anchor, the helical anchor limiting expansion of the expandable stent,

wherein an inner diameter of the helical anchor is smaller than a greatest width of the opening of the cardiac valve.