Retaining mechanisms for prosthetic valves

• US 10,568,736 B2
• Filed: 10/11/2017
• Issued: 02/25/2020
• Est. Priority Date: 03/05/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Meiri, Oded, Levi, Tamir S., Witzman, Ofir
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/730,092
• Publication Number:
  US 20180028309A1
• Time in Patent Office: 867 Days
• 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 17/12013 for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/0488 Instruments for applying suture clamps, clips or locks
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular

Abstract

Methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve. In one embodiment, for instance, a support member is positioned to at least partially surround the native leaflets of a valve. A locking member is used to couple both ends of the support member, forming a support band. An expandable prosthetic heart valve is delivered into the native heart valve and expanded while the expandable prosthetic valve is at least partially within the support band, thereby causing one or more of the native leaflets of the native heart valve to be frictionally secured between the support band and the expanded prosthetic heart valve.

Claims

1. An assembly comprising:

a prosthetic heart valve comprising an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve structure positioned within the frame; and

a support member separate from the prosthetic heart valve configured to be positioned annularly around the native mitral valve leaflets within the left ventricle of a patient'"'"'s heart;

wherein the support member comprises a first end portion, a second end portion, and a longitudinally extending linking portion between the first end portion and the second end portion, wherein the first end portion comprises a locking member configured to mate with the second end portion to form an annular band; and

wherein the support member is deployable around the native mitral valve leaflets, the prosthetic heart valve is deployable within the native mitral valve leaflets such that the native mitral valve leaflets are positioned between and engaged by the annular band and the prosthetic heart valve.

2. The assembly of claim 1, wherein the locking member and the second end portion of the support member are configured to have a complementary mating configuration.

3. The assembly of claim 1, wherein the locking member comprises a receiving area and the second end portion of the support member is configured to be received within the receiving area.

4. The assembly of claim 3, wherein the support member comprises a securing member configured to allow the second end portion of the support member to move into the receiving area but restricts the second end portion from moving back out of the receiving area.

5. The assembly of claim 4, wherein the securing member comprises biased spring tabs.

6. The assembly of claim 1, wherein the second end portion of the support member comprises a nose cone having a tapered end.

7. The assembly of claim 1, wherein the linking portion of the support member comprises a braided member.

8. The assembly of claim 7, wherein the linking portion of the support member further comprises a sheath generally surrounding the braided member.

9. The assembly of claim 8, wherein the sheath comprises polyester.

10. The assembly of claim 1 further comprising:

a delivery catheter having a distal end; and

a guidewire configured to extend distally through the delivery catheter and beyond the distal end of the delivery catheter such that the guidewire can form at least a partial loop around the patient'"'"'s native mitral valve leaflets;

wherein the support member is configured to be advanced over the guidewire.

11. The assembly of claim 10, wherein the guidewire has a precurved portion that is biased to return to a predetermined curved configuration when it is advanced beyond the distal end of the delivery catheter, the predetermined curved configuration configured to curve around the native mitral valves to form at least a partial loop around the mitral valves.

12. The assembly of claim 10, further comprising a precurved catheter configured to extend through a lumen of the delivery catheter, the precurved catheter comprising a precurved distal end portion that is biased to return to a predetermined curved configuration when it is advanced out of an opening in the delivery catheter, the precurved catheter comprising a lumen configured to receive the guidewire such that the guidewire can be advanced through the precurved catheter and the delivery catheter.

13. The assembly of claim 10, further comprising a snare configured to capture a distal end portion of the guidewire.

14. The assembly of claim 13, wherein the snare is further configured to pull the distal end portion of the guidewire back through the delivery catheter.

15. The assembly of claim 10, further comprising an elongated pusher member configured to push the support member over the guidewire.

16. The assembly of claim 10, wherein the delivery catheter is configured to be advanced through the patient'"'"'s aortic arch toward the heart.

17. The assembly of claim 10,

wherein the assembly further comprises a valve delivery catheter configured to deliver the prosthetic heart valve into the patient'"'"'s heart with the prosthetic heart valve in the radially collapsed configuration on a distal end portion of the valve delivery catheter and deploy the prosthetic heart valve to the radially expanded configuration within the native mitral valve.

18. The assembly of claim 10, wherein the delivery catheter is configured to be inserted transapically into the left ventricle.

19. An assembly comprising:

a first delivery catheter having a distal end;

a guidewire configured to extend distally through the delivery catheter and beyond the distal end of the delivery catheter such that the guidewire can form at least a partial loop around the native mitral valve leaflets;

a support member comprising a first end portion, a second end portion, and a longitudinally extending linking portion between the first end portion and the second end portion, wherein the support member is configured to be advanced over the guidewire and around the native mitral valve leaflets, wherein the first end portion comprises a locking member configured to mate with the second end portion to form an annular band encircling the native mitral valve leaflets;

a prosthetic heart valve comprising an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve structure positioned within the frame, wherein the support member is separate from the prosthetic valve; and

a second delivery catheter configured to deliver the prosthetic heart valve into the patient'"'"'s heart with the prosthetic heart valve in the radially collapsed configuration on a distal end portion of the second delivery catheter and deploy the prosthetic heart valve to the radially expanded configuration within the native mitral valve such that the native mitral valve leaflets are positioned between and engaged by the annular band and the prosthetic heart valve.

20. An assembly comprising:

a prosthetic heart valve comprising an annular frame that is radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, and a valve structure positioned within the frame; and

a support member separate from the prosthetic heart valve configured to be positioned annularly around the native mitral valve leaflets within the left ventricle of a patient'"'"'s heart;

wherein the support member comprises a first end portion and a second end portion comprising a socket, wherein the first end portion comprises a tapered portion configured to extend into the socket to form an annular band configured to engage the native mitral valve leaflets and support the prosthetic heart valve when the prosthetic heart valve is deployed within the native mitral valve leaflets.

21. The assembly of claim 20, wherein the support member comprises an inner member and an outer fabric cover that surrounds the inner member.

22. The assembly of claim 21, wherein the inner member comprises a braided member.