Retaining mechanisms for prosthetic valves

• US 9,370,420 B2
• Filed: 03/11/2013
• Issued: 06/21/2016
• 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:
  US13/794,311
• Publication Number:
  US 20130253640A1
• Time in Patent Office: 1,198 Days
• US Class Current: 1/1
• 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

Disclosed herein are representative embodiments of 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. A delivery system for encircling native leaflets of a heart valve to deliver a support band that at least partially surrounds the native leaflets, the system comprising:

a delivery catheter with a lumen of a first diameter;

a precurved catheter with a lumen and an outer diameter that is smaller than the first diameter, the precurved catheter being receivable in the lumen of the delivery catheter and biased to return to a predetermined curved configuration when it is advanced out of an opening in the delivery catheter;

a precurved guidewire receivable in the lumen of the precurved catheter, the precurved guidewire being biased to return to a predetermined curved configuration when it is advanced out of the precurved catheter; and

a support band that has an elongate support member, the elongate support member having a lumen for receiving the guidewire.

2. The delivery system of claim 1, wherein the precurved catheter has a first bending section at its distal end and a second bending section proximal to the first bending section, and

when the first and second bending sections are advanced out of the delivery catheter, the first bending section is in a plane that is generally perpendicular to a longitudinal axis of the delivery catheter and the second bending section is in a plane that is at an angle of less than 90 degrees relative to the longitudinal axis of the delivery catheter.

3. The delivery system of claim 1, when the precurved guidewire is advanced out of the precurved catheter, the precurved guidewire forms a generally circular shape that is in the same general plane as the first bending section of the precurved catheter.

4. The delivery system of claim 1, wherein the support band further comprises a locking member, the locking member being coupled to a proximal end of the support member and having a receiving area for receiving the distal end of the support member.

5. The delivery system of claim 4, wherein the locking member further comprises a securing member to secure the distal end of the support member in the receiving area.

6. The delivery system of claim 5, wherein the securing member comprises a tab member that is biased to at least partially extend into the receiving area and engage the distal end of the support member.

7. The delivery system of claim 6, wherein the distal end of the support member comprises a nose cone with a grooved section, the grooved section being configured to mate with the tab member when the nose cone is received in the receiving area of the locking member.

8. The delivery system of claim 1, wherein the precurved guidewire is configured to form a loop around the native leaflets when it is advanced out of the precurved catheter.

9. The delivery system of claim 1, further comprising:

an elongated pusher member having a distal end portion;

wherein the support band is coupled to the distal end portion of the pusher member;

and further wherein the pusher member is configured to push the support band over the precurved guidewire.

10. A delivery system for encircling native leaflets of a heart valve to deliver a support band that at least partially surrounds the native leaflets, the system comprising:

a delivery catheter with a lumen of a first diameter;

a precurved catheter with a lumen and an outer diameter that is smaller than the first diameter, the precurved catheter being receivable in the lumen of the delivery catheter and biased to return to a predetermined curved configuration when it is advanced out of an opening in the delivery catheter;

a precurved guidewire receivable in the lumen of the precurved catheter, the precurved guidewire being biased to return to a predetermined curved configuration when it is advanced out of the precurved catheter; and

a snare configured to be advanced through the delivery catheter, the snare further configured to capture a distal end portion of the precurved guidewire and pull the distal end portion of the precurved guidewire back through the delivery catheter such that a section of the precurved guidewire forms a loop extending around the native leaflets.

11. The delivery system of claim 10, wherein the delivery catheter comprises another lumen and the snare is configured to pull the distal end portion of the precurved guidewire through the another lumen.

12. The delivery system of claim 10, wherein the precurved guidewire is sized such that the distal end portion and a proximal end portion of the guidewire can extend beyond a proximal end of the delivery catheter outside the body after the distal end portion of the guidewire is pulled back through the delivery catheter.

13. A delivery system for encircling native leaflets of a heart valve to deliver a support band that at least partially surrounds the native leaflets, the system comprising:

a delivery catheter having a distal end;

a precurved guidewire configured to extend distally through the delivery catheter in a first direction beyond the distal end of the delivery catheter, around the native leaflets, and proximally back though the delivery catheter in a second direction so as to form a loop around the native leaflets;

an elongated pusher member having a distal end portion; and

a support band coupled to the distal end portion of the pusher member;

wherein the pusher member is configured to push the support band over the precurved guidewire such that the support band extends around the native leaflets.

14. The delivery system of claim 13, wherein the support band comprises opposite end portions that are configured to connect to each other and form a loop around the native leaflets.

15. The delivery system of claim 13, 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 precurved guidewire such that the guidewire can be advanced through the precurved catheter and the delivery catheter.

16. The delivery system of claim 13, further comprising:

a prosthetic heart valve delivery catheter having a distal end portion; and

a radially expandable prosthetic heart valve adapted to be coupled to the distal end portion of the prosthetic heart valve delivery catheter in a radially compressed configuration, the prosthetic heart valve having an outer surface;

wherein the delivery catheter is configured to deliver the prosthetic heart valve to a position within the native leaflets and wherein the prosthetic heart is expandable for compressing the native leaflets between the support band and the outer surface of the prosthetic heart valve.

17. A method comprising:

providing the delivery system of claim 13;

advancing the delivery catheter into the body of a patient;

advancing the precurved guidewire distally through the delivery catheter in the first direction such that a distal end portion of the guidewire extends beyond the distal end of the delivery catheter;

further advancing the precurved guidewire such that the guidewire curves around the native leaflets of the heart valve; and

moving the distal end portion of the precurved guidewire proximally back through the delivery catheter in the second direction.

18. The method of claim 17, further comprising withdrawing the distal end portion of the precurved guidewire from a proximal end of the delivery catheter such that the distal end portion and a proximal end portion of the guidewire are outside the patient'"'"'s body.

19. The method of claim 17, further comprising:

advancing the support band over the precurved guidewire such that the support band extends around the native leaflets of the heart valve; and

connecting opposite ends of the support band to each other so as to form a loop around the native leaflets of the heart valve.

20. The method of claim 19, further comprising:

delivering a prosthetic heart valve to a position between the native leaflets; and

expanding the prosthetic heart valve such that the native leaflets are in contact with an outside surface of the prosthetic heart valve and inside surface of the support band.

21. A delivery system for encircling native leaflets of a heart valve to deliver a support band that at least partially surrounds the native leaflets, the system comprising:

a delivery catheter having a distal end;

a precurved guidewire configured to extend distally through the delivery catheter in a first direction beyond the distal end of the delivery catheter, around the native leaflets, and proximally back though the delivery catheter in a second direction so as to form a loop around the native leaflets; and

a snare configured to be advanced through the delivery catheter, the snare further configured to capture a distal end portion of the precurved guidewire and pull the distal end portion of the precurved guidewire back through the delivery catheter in the second direction to form the loop extending around the native leaflets.

22. A method comprising:

providing a delivery system for encircling native leaflets of a heart valve, the system comprising;

a delivery catheter having a distal end;

a precurved guidewire configured to extend distally through the delivery catheter in a first direction beyond the distal end of the delivery catheter, around the native leaflets, and proximally back though the delivery catheter in a second direction so as to form a loop around the native leaflets;

advancing the delivery catheter into the body of a patient;

advancing the precurved guidewire distally through the delivery catheter in the first direction such that a distal end portion of the guidewire extends beyond the distal end of the delivery catheter;

further advancing the precurved guidewire such that the guidewire curves around the native leaflets of the heart valve; and

moving the distal end portion of the precurved guidewire proximally back through the delivery catheter in the second direction, wherein moving the distal end portion of the precurved guidewire proximally back through the delivery catheter further comprises advancing a snare distally through the delivery catheter, capturing the distal end portion of the guidewire with the snare, and pulling the snare and the distal end portion of the guidewire proximally back though the delivery catheter.