HEART VALVE DOCKING DEVICES AND IMPLANTING METHODS

• US 20160228247A1
• Filed: 02/10/2016
• Published: 08/11/2016
• Est. Priority Date: 02/11/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Altman, Hernan, Maimon, David
• Granted Patent: US 10,039,637 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/006 modular

Abstract

A device is in various embodiments configured to repair a native heart valve or to secure a prosthetic heart valve within a native valve of the heart of a patient. Embodiments of the device include at least an upper coil and a lower coil, where the device is configured to assume an axially expanded state where the entire upper coil is positioned on a first side of the lower coil relative to the central axis, and an axially compressed state where at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite to the first side relative to the central axis.

Claims

1. A device for implanting at a native heart valve of a heart of a patient, the device comprising an upper coil and a lower coil, and a central axis extending through the upper coil and the lower coil;

wherein the device is configured to assume an axially expanded state wherein the entire upper coil is positioned on a first side of the lower coil relative to the central axis; and

wherein the device is configured to assume an axially compressed state wherein at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite to the first side relative to the central axis.

2. The device of claim 1, wherein the device comprises a first set of one or more coils comprising the upper coil and a second set of one or more coils comprising the lower coil, wherein the first set of coils has a first inner diameter, and the second set of coils has a second inner diameter different from the first inner diameter.

3. The device of claim 2, wherein the first set of coils comprises at least two coils and the second set of coils comprises at least two coils.

4. The device of claim 2, wherein at least one of the coils of the first set of coils is positioned relative to the central axis between two coils of the second set of coils when the device is in the compressed state.

5. The device of claim 2, wherein the first set of coils are configured to be positioned on a ventricular side of a native mitral valve, and the second set of coils are configured to be positioned on an atrial side of the native mitral valve.

6. The device of claim 1, wherein the upper and lower coils each comprises a shape-memory material.

7. The device of claim 1, wherein the upper and lower coils each comprises Nitinol.

8. The device of claim 1, wherein the upper coil is positioned radially inward relative to the lower coil when the device is in the compressed state.

9. The device of claim 8, wherein the upper coil is configured to exert a radially outwardly directed force against the lower coil when the device is in the compressed state.

10. The device of claim 1, wherein an axial tension is applied to the device when the device is in the axially expanded state.

11. A method of implanting a device comprising an upper coil and a lower coil at a native valve of a heart of a patient, the method comprising:

positioning the lower coil on a ventricular side of the native valve;

positioning the upper coil on an atrial side of the native valve, such that the entire upper coil is positioned on a first side of the lower coil relative to a central axis of the device; and

adjusting the device to a position where at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite to the first side relative to the central axis.

12. The method of claim 11, further comprising implanting a prosthetic heart valve in the device.

13. The method of claim 12, wherein implanting the prosthetic heart valve comprises positioning the prosthetic heart valve in the device when the prosthetic heart valve is in a radially compressed state, and radially expanding the prosthetic heart valve such that a radial pressure is applied between the prosthetic heart valve and the device to anchor the prosthetic heart valve in the device.

14. The method of claim 11, wherein the device comprises a first set of coils comprising the upper coil and a second set of coils comprising the lower coil, and wherein after adjusting the device, the upper coil is configured to be positioned between two coils of the second set of coils relative to the central axis.

15. The method of claim 11, wherein the upper and lower coil of the device are configured to radially compress leaflets of the native valve.

16. The method of claim 11, wherein implanting the device comprises advancing a distal end of a delivery catheter into the heart, and deploying the device from the delivery catheter such that the upper coil is deployed on the atrial side of the native valve and the lower coil is deployed on the ventricular side of the native valve.

17. The method of claim 16, wherein implanting the device further comprises maintaining an axial tension on the device when the device is being deployed from the delivery catheter, such that the device is at least partially axially expanded, and releasing tension on the device to allow the device to compress axially.

18. A system for securing a prosthetic heart valve at a native heart valve of a heart of a patient, the system comprising:

a helical docking device comprising an upper coil and a lower coil, and a central axis extending through the upper coil and the lower coil; and

a prosthetic heart valve configured to be held in the docking device;

wherein the docking device is configured to assume an axially expanded state wherein the entire upper coil is positioned on a first side of the lower coil relative to the central axis; and

wherein the docking device is configured to assume an axially compressed state wherein at least a portion of the upper coil is positioned on a second side of at least a portion of the lower coil opposite to the first side relative to the central axis.

19. The system of claim 18, further comprising a delivery catheter, wherein the delivery catheter is configured to deploy the docking device at the native heart valve.