Heart valve treatment device and method

• US 10,682,231 B2
• Filed: 06/17/2019
• Issued: 06/16/2020
• Est. Priority Date: 09/29/2014
• Status: Active Grant

• Current Assignee: The Provost, Fellows, Foundation Scholars & The Other Members Of Board Of The College Of The Holy & Undivided Trinity Of Queen Elizabeth
• Original Assignee: The Provost, Fellows, Foundation Scholars, and other members of Board, of the College of the Holy and Undivided Trinity of Queen Elizabeth near Dublin
• Inventors: Quinn, Martin
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/443,792
• Publication Number:
  US 20190298514A1
• Time in Patent Office: 365 Days
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/044 with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2451 Inserts in the coronary sinus for correcting the valve shape
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/9517 handle assemblies therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/001 for adjusting a diameter
• CPC Class Codes: A61F 2250/006 modular

Abstract

A heart valve therapeutic device (1) has an elongate anchor (7) wherein the anchor has a stiffness to hold its shape and location to support the valve element. The anchor may have a stylet or a shaped or stiff collar (70) arranged to provide a desired shape to the anchor (7) and it may be lockable. A prosthetic valve element (15) has leaflets (17) and is supported on the anchor by coupler (16, 50) at a desired location. There is an actuator for changing relative axial position of the proximal and distal couplers (16, 50) on the anchor. The anchor stiffness may be sufficient to provide sufficient support to resist axial forces from the ventricle in use without necessarily having a fixing element engaging heart tissue. The prosthetic leaflets (240) may extend proximally and radially outwardly, so that there is excellent co-apting of the native leaflets (NL) against the prosthetic leaflets (240).

Claims

1. A heart valve therapeutic device configured to be implanted in a patient having a heart and a native heart valve, the heart valve therapeutic device comprising:

a prosthetic valve comprising a plurality of prosthetic leaflets configured to allow blood to flow through the prosthetic valve; and

a support comprising an elongate anchor having a proximal region and a distal region, the support coupled at the distal region to the prosthetic valve and configured to extend from the distal region out of the heart into a blood vessel coupled to the heart, the support configured to suspend and maintain the prosthetic valve across the native heart valve without anchoring to either an atrial wall or a ventricular wall of the heart.

2. The heart valve therapeutic device of claim 1, wherein the support is lockable.

3. The heart valve therapeutic device of claim 1, wherein the support comprises at least one of a stylet, a shaped collar, a stiff collar, or a catheter configured to provide a shape for implantation.

4. The heart valve therapeutic device of claim 1, wherein the support comprises a deflectable and lockable catheter to suspend and maintain the prosthetic valve across the native heart valve.

5. The heart valve therapeutic device of claim 1, wherein the prosthetic valve comprises an outer skirt configured to reduce regurgitation between native leaflets of the native heart valve and the prosthetic valve.

6. The heart valve therapeutic device of claim 1, wherein the support is configured to suspend and maintain the prosthetic valve across a tricuspid valve of the heart.

7. The heart valve therapeutic device of claim 1, wherein the prosthetic leaflets comprise at least one of bovine, porcine, or equine pericardium, or intact porcine aortic valves.

8. The heart valve therapeutic device of claim 1, wherein the prosthetic leaflets are arranged around and attached to a ring at a proximal end of the prosthetic valve.

9. The heart valve therapeutic device of claim 8, wherein the support is coupled to the ring by a plurality of radially extending spokes.

10. The heart valve therapeutic device of claim 8, wherein the ring is flexible and transitionable between a compressed delivery state and an expanded deployed state.

11. The heart valve therapeutic device of claim 1, wherein the prosthetic valve comprises a cover coupled to a frame, and wherein the prosthetic valve has a shape to allow native valve leaflets of the native heart valve to co-apt against the cover.

12. The heart valve therapeutic device of claim 11, wherein the frame comprises Nitinol and the cover comprises a biocompatible material.

13. The heart valve therapeutic device of claim 11, wherein the frame is transitionable between a compressed delivery state and an expanded deployed state.

14. The heart valve therapeutic device of claim 1, wherein the support is coupled to the prosthetic valve by a plurality of radial arms extending therefrom.

15. The heart valve therapeutic device of claim 1, wherein the prosthetic valve is configured to allow washout of blood to prevent thrombosis.

16. A method of repairing a native heart valve of a heart, the method comprising:

introducing a prosthetic valve across the native heart valve, the prosthetic valve comprising a plurality of prosthetic leaflets configured to allow blood to flow through the prosthetic valve; and

anchoring the prosthetic valve using an elongate anchor coupled to the prosthetic valve such that the prosthetic valve is suspended and maintained across the native heart valve without anchoring to either an atrial wall or a ventricular wall of the heart.

17. The method of claim 16, wherein introducing the prosthetic valve across the native heart valve comprises percutaneously introducing the prosthetic valve in a delivery catheter via a blood vessel coupled to the heart and moving the prosthetic valve until the prosthetic valve is positioned across the native heart valve.

18. The method of claim 16, wherein introducing the prosthetic valve comprises delivering the prosthetic valve in a compressed state and transitioning the prosthetic valve to an expanded deployed state.

19. The method of claim 16, further comprising locking the elongate anchor in place to suspend and maintain the prosthetic valve across the native heart valve.

20. The method of claim 16, wherein anchoring the prosthetic valve comprises suspending and maintaining the prosthetic valve across a native tricuspid valve.

21. The method of claim 16, wherein introducing the prosthetic valve further comprises actuating one or more actuators to control positioning of the prosthetic valve.