Methods for delivering prosthetic valves to native heart valves

• US 10,500,047 B2
• Filed: 04/15/2016
• Issued: 12/10/2019
• Est. Priority Date: 07/23/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Olson, Christopher J., Rabito, Glen Thomas, Armer, Dustin P., Ma, Minh T., Marr, Devin H., Huang, Cheng-Tung, Okabe, Hiroshi, Stewart, Kevin M., Curtis, Alison S., Corso, Jr., Philip P.
• Primary Examiner(s): Templeton, Christopher L
• Application Number:
  US15/130,402
• Publication Number:
  US 20160228240A1
• Time in Patent Office: 1,334 Days
• 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 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2250/006 modular

Abstract

Representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve are disclosed. In one embodiment, for instance, a support structure and an expandable prosthetic valve are delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior) via a delivery system. The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable, prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

Claims

1. A method, comprising:

advancing a self-expandable support structure and a self-expandable prosthetic heart valve into a patient'"'"'s heart using a delivery apparatus and a transapical delivery approach, wherein the support structure and the prosthetic heart valve are in a radially compressed state;

positioning the support structure on or adjacent a surface of an outflow side of the patient'"'"'s native aortic valve using the delivery apparatus;

radially expanding the support structure from the compressed state to a fully expanded state, the support structure having a support-structure interior;

positioning the prosthetic heart valve radially within the support-structure interior and within the patient'"'"'s native aortic valve using the delivery apparatus;

radially expanding the prosthetic heart valve from the compressed state to an expanded state while the prosthetic heart valve is in the support-structure interior and while the support structure is in the fully expanded state; and

releasing the support structure from the delivery apparatus after the prosthetic heart valve is radially expanded.

2. The method of claim 1, wherein the support structure comprises first and second end portions, and the first and second end portions of the support structure are in the fully expanded state in the act of radially expanding the support structure, and wherein the act of radially expanding the support structure occurs before the act of radially expanding the prosthetic heart valve.

3. The method of claim 1, wherein the support structure comprises a plurality of U-shaped portions that are connected together at apices of the U-shaped portions.

4. The method of claim 3, wherein the support structure includes a plurality of retaining arms extending from the apices of the U-shaped portions.

5. The method of claim 4, wherein the delivery apparatus comprises a plurality of flexible arms that are releasably coupled to the retaining arms of the support structure.

6. The method of claim 4, wherein the retaining arms comprise attachment apertures.

7. The method of claim 3, wherein the delivery apparatus comprises a plurality of flexible arms that are releasably coupled to the support structure during the acts of advancing the support structure and the prosthetic heart valve, positioning the support structure and the prosthetic heart valve, and radially expanding the support structure, and the flexible arms are released from the support structure after the prosthetic heart valve is radially expanded.

8. The method of claim 1, wherein the support structure and the prosthetic heart valve are axially spaced relative to each other along the delivery apparatus in the act of advancing the support structure and the prosthetic heart valve.

9. The method of claim 1, further comprising inserting a tube into a left ventricle of the patient'"'"'s heart, and the act of advancing the support structure and the prosthetic heart valve comprises inserting the support structure and the prosthetic heart valve through the tube using the delivery apparatus.

10. The method of claim 1, wherein the act of radially expanding the prosthetic heart valve causes one or more native leaflets of the native aortic valve to be frictionally secured between the support structure and the prosthetic heart valve.

11. A method, comprising:

advancing an expandable support structure and an expandable prosthetic heart valve into a patient'"'"'s heart using a single delivery apparatus, wherein the support structure and the prosthetic heart valve are in a radially compressed state;

positioning the support structure on or adjacent a surface of an outflow side of a native heart valve of the patient using the delivery apparatus;

radially expanding the support structure from the compressed state to a fully expanded state, the support structure having a support-structure interior, wherein the support structure is self-expandable;

positioning the prosthetic heart valve radially within the support-structure interior and within the patient'"'"'s native heart valve using the delivery apparatus; and

radially expanding the prosthetic heart valve from the compressed state to an expanded state while the prosthetic heart valve is in the support-structure interior and while the support structure is in the fully expanded state, wherein the prosthetic heart valve is self-expandable, and wherein the act of radially expanding the prosthetic heart valve causes one or more native leaflets of the native heart valve to be captured between the support structure and the prosthetic heart valve.

12. The method of claim 11, wherein the support structure comprises first and second end portions, and the first and second end portions of the support structure are in the fully expanded state in the act of radially expanding the support structure, and wherein the act of radially expanding the prosthetic heart valve occurs after the act of radially expanding the support structure.

13. The method of claim 11, wherein the support structure comprises a plurality of U-shaped portions that are connected together at apices of the U-shaped portions.

14. The method of claim 11, wherein the patient'"'"'s native heart valve is a native aortic valve, and the support structure and the prosthetic heart valve are advanced into the patient'"'"'s heart transapically.

15. The method of claim 11, wherein the patient'"'"'s native heart valve is a native aortic valve, and the support structure and the prosthetic heart valve are advanced into the patient'"'"'s heart transfemorally.

16. A method, comprising:

advancing a delivery apparatus into a patient'"'"'s heart, wherein an expandable support structure and an expandable prosthetic heart valve are mounted at spaced-apart locations along a distal end portion of the delivery apparatus in a radially compressed state, wherein the support structure and the prosthetic heart valve are self-expandable and are advanced together in the same direction toward the patient'"'"'s heart on the delivery apparatus;

positioning the support structure at or adjacent a native heart valve of the patient using the delivery apparatus;

radially expanding the support structure from the compressed state to a fully expanded state, wherein the support structure remains coupled to the delivery apparatus after the support structure is expanded;

positioning the prosthetic heart valve radially within the support structure and within the patient'"'"'s native heart valve using the delivery apparatus;

radially expanding the prosthetic heart valve from the compressed state to an expanded state while the prosthetic heart valve is radially within the support structure and while the support structure is in the fully expanded state; and

releasing the support structure from the delivery apparatus after the prosthetic heart valve is radially expanded.

17. The method of claim 16, wherein the support structure comprises a first end portion and a second end portion, and the first end portion and the second end portion of the support structure are in the fully expanded state in the act of radially expanding the support structure and before the act of radially expanding the prosthetic heart valve.

18. The method of claim 16, wherein the delivery apparatus comprises a first sheath and a second sheath,

wherein the first sheath is configured to retain the support structure in the radially compressed state when the support structure is disposed radially within the first sheath, and the support structure is disposed radially within the first sheath in the act of advancing the delivery apparatus and in the act of positioning the support structure, and

wherein the second sheath is configured to retain the prosthetic heart valve in the radially compressed state when the prosthetic heart valve is disposed radially within the second sheath, and the prosthetic heart valve is disposed within the second sheath in the act of advancing the delivery apparatus, in the act of positioning the support structure, and in the act of radially expanding the support structure.

19. The method of claim 18, wherein the act of radially expanding the support structure includes relative axial movement between the first sheath and the support structure to expose the support structure from the first sheath, and the act of radially expanding the prosthetic heart valve includes relative axial movement between the second sheath and the prosthetic heart valve to expose the prosthetic heart valve from the second sheath.

20. The method of claim 16, wherein one or more native leaflets of the patient'"'"'s native heart valve are captured between the support structure and the prosthetic heart valve when the support structure is in the fully expanded state and the prosthetic heart valve is in the expanded state.