Cardiac valve repair system and methods of use

• US 8,657,872 B2
• Filed: 07/19/2010
• Issued: 02/25/2014
• Est. Priority Date: 07/19/2010
• Status: Active Grant

• Current Assignee: Bmeye B.V. (Edwards Lifesciences Corporation)
• Original Assignee: Jacques Seguin
• Inventors: Seguin, Jacques
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): PRESTON, REBECCA STRASZHEIM
• Application Number:
  US12/839,363
• Publication Number:
  US 20120016464A1
• Time in Patent Office: 1,317 Days
• Field of Search: None
• US Class Current: 623/2.38
• 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 replacement cardiac valve comprising:

a helical anchor configured to engage opposite sides of one or more leaflets of a defective cardiac valve, the helical anchor consisting of an upper turn and a lower turn and configured to be extruded through a delivery catheter;

an expandable stent configured to transition from a contracted delivery state to an expanded deployed state, the expandable stent having an upper flared portion with an upper flared end and a lower flared portion with a lower flared end, the upper and lower flared portions meeting at a waist; and

a replacement valve disposed within the expandable stent,

wherein the expandable stent is configured to be deployed within the helical anchor such that the waist captures the helical anchor, the upper and lower flared portions urge the upper and lower turns into engagement with the one or more leaflets, and the upper and lower flared ends extend radially beyond the helical anchor, the helical anchor limiting expansion of the expandable stent.

2. The replacement cardiac valve of claim 1, wherein the helical anchor is configured to transition between a delivery state enabling transcatheter delivery and an expanded, deployed state.

3. The replacement cardiac valve of claim 1, wherein the helical anchor assumes a circular shaped when in the expanded deployed state.

4. The replacement cardiac valve of claim 1, wherein expandable stent is self-expanding.

5. The replacement cardiac valve of claim 1, wherein expandable stent is configured to be mechanically expanded by a balloon or mandrel.

6. The replacement cardiac valve of claim 1, wherein the valve comprises a valve body comprising animal tissue.

7. The replacement cardiac valve of claim 6, wherein the animal tissue comprises porcine, equine or bovine pericardial tissue.

8. The replacement cardiac valve of claim 1, wherein the valve comprises a valve body comprising a synthetic fabric.

9. The replacement cardiac valve of claim 1, wherein the expandable stent comprises a slotted tube.

10. The replacement cardiac valve of claim 1, wherein expandable stent comprises a plurality of interconnected wires.

11. The replacement cardiac valve of claim 1, wherein the expandable stent is configured to urge the helical anchor into engagement with the one or more leaflets of the defective valve.

12. The replacement cardiac valve of claim 1, wherein the expandable stent is configured so that expansion of the expandable stent urges the helical anchor into engagement with the one or more leaflets of the defective valve.

13. The replacement cardiac valve of claim 1, wherein the replacement cardiac valve is configured to repair a defective mitral valve.

14. The replacement cardiac valve of claim 1, wherein the helical anchor is configured to be delivered with a first catheter and the expandable stent and valve are configured to be delivered with a second catheter.

15. The replacement cardiac valve of claim 1, wherein the replacement cardiac valve is configured to be delivered transvascularly.

16. The replacement cardiac valve of claim 1, wherein the replacement cardiac valve is configured to be delivered transapically.