CARDIAC IMPLANT CONFIGURED TO RECEIVE A PERCUTANEOUS PROSTHETIC HEART VALVE IMPLANTATION

• US 20140031930A1
• Filed: 09/26/2013
• Published: 01/30/2014
• Est. Priority Date: 09/19/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Keidar, Yaron, Konno, Mark A.
• Granted Patent: US 9,636,219 B2
• Time in Patent Office: Days
• US Class Current: 623/2.37
• 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 2/2433 using balloon catheter
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

The invention is a cardiac implant, and associated methods therefore, configured to repair and/or replace a native heart valve, and having a support frame configured to be reshaped into an expanded/changed form in order to receive and/or support an expandable prosthetic heart valve therein. The implant may be configured to have a generally rigid and/or expansion-resistant configuration when initially implanted to replace/repair a native valve (or other prosthetic heart valve), but to assume a generally non-rigid and/or expanded/expandable form when subjected to an outward force such as that provided by a dilation balloon. The implant may be configured to have a generally D-shaped configuration when initially implanted, but to assume a generally circular form when subjected to an outward force such as that provided by a dilation balloon.

Claims

1. An annuloplasty ring comprising:

a plurality of rigid sections, wherein each rigid section comprises a first end and a second end, wherein in a first configuration of the annuloplasty ring the plurality of rigid sections are assembled in end-to-end form to create an annuloplasty ring support frame, wherein in the first configuration the annuloplasty ring defines an inner orifice having a first area;

a restraint configured to prevent movement of adjacent rigid sections with respect to each other, wherein the restraint is further configured to permit movement of the adjacent rigid sections with respect to each other and thereby permit transformation of the annuloplasty ring from the first configuration to a second configuration when the annuloplasty ring is subjected to a dilation force of at least 1 atm.

2. The annuloplasty ring of claim 1, wherein the restraint is configured to plastically deform when the annuloplasty ring is subjected to the dilation force of at least 1 atm.

3. The annuloplasty ring of claim 2, wherein the restraint comprises a suture, weld, solder, or adhesive configured to break when the annuloplasty ring is subjected to the dilation force of at least 1 atm.

4. The annuloplasty ring of claim 1, wherein the restraint comprises elastically deformable material.

5. The annuloplasty ring of claim 4, wherein the restraint comprises an elastic material passing around a perimeter of the annuloplasty ring support frame.

6. The annuloplasty ring of claim 4, wherein the restraint comprises a spring.

7. An annuloplasty ring having a non-circular shape in the form of a D-shape, kidney shape, or dog-bone shape, the annuloplasty ring comprising a rigid portion defining at least a portion of the non-circular shape, wherein the annuloplasty ring is configured to transform to a circular shape when subjected to a dilation force from a balloon catheter.

8. The annuloplasty ring of claim 7, wherein the annuloplasty ring comprises plastically deformable materials configured to maintain the annuloplasty ring in the non-circular shape.

9. The annuloplasty ring of claim 8, wherein the plastically deformable materials are configured to plastically deform and no longer maintain the annuloplasty ring in the non-circular shape when the annuloplasty ring is subjected to the dilation force.

10. The annuloplasty ring of claim 7, wherein the annuloplasty ring comprises a continuous loop, and the annuloplasty ring further comprises an elastically deformable materials configured to provide tension within the continuous loop.

11. The annuloplasty ring of claim 7, wherein the annuloplasty ring is configured to transform to a circular shape when subjected to a dilation force from a balloon catheter inflated to a pressure of at least 2 atm.

12. The annuloplasty ring of claim 7, wherein the annuloplasty ring is configured to transform to a circular shape when subjected to a dilation force from a balloon catheter inflated to a pressure of at least 1 atm.

13. An annuloplasty ring comprising an annuloplasty support frame, the support frame comprising a rigid curved segment having a first end and a second end, wherein in a first configuration the first end is positioned against and rigidly secured to the second end via a plastically-deformable connection to form a continuous loop, and in a second configuration the plastically deformable connection is plastically deformed and the first end is moved with respect to the second end, wherein the annuloplasty support frame is configured to transform from the first configuration to the second configuration when subjected to a significant radially expansive force in vivo of at least 2 atm.

14. The annuloplasty ring of claim 13, wherein the plastically-deformable connection is configured to break if the annuloplasty support frame is subjected to the radially expansive force of at least 2 atm.

15. The annuloplasty ring of claim 13, wherein the plastically-deformable connection comprises suture, adhesive, solder, or weld which is configured to break if the annuloplasty support frame is subjected to the radially expansive force of at least 2 atm.

16. The annuloplasty ring of claim 13, wherein the annuloplasty support frame in the first configuration is circular and has a first diameter, and the annuloplasty support frame in the second configuration is circular and has a second diameter, wherein the second diameter is larger than the first diameter.

17. The annuloplasty ring of claim 13, wherein the annuloplasty support frame in the first configuration is non-circular in shape in the form of a D-shape, kidney shape, or dog-bone shape, and the annuloplasty support frame in the second configuration is circular in shape.

18. The annuloplasty ring of claim 13, further comprising:

an elastic element passing around the annuloplasty support frame, wherein the elastic element in the second configuration provides a radially compressive force to the annuloplasty support frame.

19. The annuloplasty ring of claim 18, wherein the rigid curved section comprises an inner lumen, and the elastic element comprises an elastic cord positioned within the inner lumen.

20. The annuloplasty ring of claim 18, wherein the elastic element comprises a covering positioned around the rigid curved section.

21. The annuloplasty ring of claim 20, wherein the first configuration is non-circular, and the second configuration is circular.