Heart valve docking devices and implanting methods

• US 10,039,637 B2
• Filed: 02/10/2016
• Issued: 08/07/2018
• Est. Priority Date: 02/11/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Maimon, David, Altman, Hernan
• Primary Examiner(s): TYSON, MELANIE RUANO
• Application Number:
  US15/040,772
• Publication Number:
  US 20160228247A1
• Time in Patent Office: 909 Days
• Field of Search: 606151, 623 21, 623 211
• 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 system for securing a prosthetic heart valve at a native heart valve of a heart of a patient, the system comprising:

a docking device comprising a first set of one or more coils and a second set of one or more coils, and a central axis extending through the first set of one or more coils and the second set of one or more coils; 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 first set of one or more coils is positioned on a first side of the second set of one or more coils relative to the central axis; and

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

2. The system of claim 1, further comprising a delivery catheter, wherein the delivery catheter is configured to deploy the docking device at the native heart valve.

3. The system of claim 1, wherein the first set of one or more coils has a first inner diameter, and the second set of one or more coils has a second inner diameter different from the first inner diameter.

4. The system of claim 1, wherein the first set of one or more coils comprises at least two coils and the second set of one or more coils comprises at least two coils.

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

6. The system of claim 1, wherein the first set of one or more coils is configured to be positioned on a ventricular side of a native mitral valve, and the second set of one or more coils is configured to be positioned on an atrial side of the native mitral valve.

7. The system of claim 1, wherein the first set of one or more coils and the second set of one or more coils each comprises a shape-memory material.

8. The system of claim 1, wherein the first set of one or more coils is positioned radially inward relative to the second set of one or more coils when the docking device is in the compressed state.

9. The system of claim 8, wherein the first set of one or more coils is configured to exert a radially outwardly directed force against the second set of one or more coils when the device is in the compressed state.

10. The system of claim 1, wherein, when in the axially expanded state, the entire first set of one or more coils and the entire second set of one or more coils have a positive pitch relative to each other, and when in the axially compressed state, at least a portion of the first set of one or more coils has a negative pitch relative to the second set of one or more coils.

11. A method of using the system of claim 1 to treat a native valve of a heart of a patient, the method comprising:

positioning the first set of one or more coils on a first side of the native valve;

positioning the second set of one or more coils on a second side of the native valve, such that the entire first set of one or more coils is positioned on a first side of the second set of one or more coils relative to a central axis of the device; and

transitioning the docking device to a position where the first coil of the first set of one or more coils is positioned on a second side of at least a portion of the second set of one or more coils opposite to the first side relative to the central axis.

12. The method of claim 11, further comprising implanting the 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 after transitioning the device, the first 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 first set of one or more coils and the second set of one or more coils of the device are configured to radially compress leaflets of the native valve.

16. The method of claim 11, wherein positioning the first set of one or more coils comprises advancing a distal end of a delivery catheter into the heart, and deploying the first set of one or more coils from the delivery catheter on the atrial side of the native valve, and wherein positioning the second set of one or more coils comprises deploying the second set of one or more coils on the ventricular side of the native valve.

17. The method of claim 16, wherein positioning the first set of one or more coils further comprises maintaining an axial tension on the docking device when the docking device is being deployed from the delivery catheter, such that the docking device is at least partially axially expanded, and wherein transitioning the docking device comprises releasing tension on the docking device to allow the device to compress axially.