Method for treating an aortic valve

• US 9,707,074 B2
• Filed: 05/05/2014
• Issued: 07/18/2017
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Pease, Matthew L., Walsh, Brandon G.
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US14/269,876
• Publication Number:
  US 20140243958A1
• Time in Patent Office: 1,170 Days
• Field of Search: None
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• 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
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A method for replacing a native heart valve with a prosthetic heart valve comprises moving a first portion of a prosthetic heart valve towards a second portion of the prosthetic heart valve along a plurality of guide wires, and lock the first portion to the second portion in a final, radially expanded configuration. The prosthetic heart valve is radially contractible and expandable, and in some embodiments, is self-expanding. Embodiments of the method are minimally invasive.

Claims

1. A method for replacing a heart valve in a patient in need thereof, the method comprising:

advancing a prosthetic heart valve in a radially contracted configuration from a distal end portion of a delivery tube into an annulus of a native aortic valve, the prosthetic heart valve comprising a first portion and a second portion, the first portion having a self-expanding, nickel-titanium alloy body and three bovine pericardium leaflets fastened to the body along three axially extending commissures;

allowing the first and second portions of the prosthetic heart valve to radially self-expand to an initial expanded configuration therein;

guiding the first portion of the prosthetic heart valve in the initial expanded configuration longitudinally along three guide wires towards the second portion of the prosthetic heart valve in the initial expanded configuration, wherein the body of the first portion comprises a tubular mesh and first coupling features,

the second portion is tubular and comprises second coupling features, the second coupling features complementary to the first coupling features,

each guide wire is threaded through a respective first coupling feature and a corresponding second coupling feature, and

each guide wire comprises a loop extending out from the distal end portion of the delivery tube; and

engaging each first coupling feature to the corresponding second coupling feature, wherein the first coupling features and the second coupling features comprise apertures and tabs, thereby locking the first portion of the prosthetic heart valve to the second portion of the prosthetic heart valve in a final expanded configuration.

2. A method for replacing a heart valve in a patient in need thereof, the method comprising:

advancing a prosthetic heart valve in a radially compressed configuration from a distal end portion of a delivery tube into an annulus of a native heart valve, the prosthetic heart valve comprising a first portion and a second portion;

radially expanding the first and second portions of the prosthetic heart valve in the annulus of the native heart valve to an initial expanded configuration;

guiding the first portion of the prosthetic heart valve in the initial expanded configuration longitudinally along a plurality of guide wires towards the second portion of the prosthetic heart valve in the initial expanded configuration, the first portion comprising first coupling features and the second portion comprising second coupling features complementary to the first coupling features; and

engaging each first coupling feature to a respective second coupling feature, thereby locking the first portion of the prosthetic heart valve to the second portion of the prosthetic heart valve in a final expanded configuration;

wherein the acts of guiding the first portion of the prosthetic heart valve in the initial expanded configuration longitudinally along the plurality of guide wires towards the second portion of the prosthetic heart valve in the initial expanded configuration and engaging each first coupling feature to a respective second coupling feature are performed after the acts of advancing the prosthetic valve into the annulus of the native heart valve and radially expanding the first and second portions of prosthetic heart valve.

3. The method of claim 2, wherein advancing the prosthetic heart valve into the annulus of a native heart valve comprises advancing the prosthetic heart valve into an annulus of a native aortic valve.

4. The method of claim 2, wherein the prosthetic heart valve comprises three bovine pericardium leaflets.

5. The method of claim 2, wherein the prosthetic heart valve comprises three bovine pericardium leaflets fastened along three axially extending commissures of the first portion of the prosthetic heart valve.

6. The method of claim 2, wherein radially expanding the first and second portions of the prosthetic heart valve comprises allowing the first and second portions of the prosthetic heart valve to radially self-expand.

7. The method of claim 2, wherein guiding the first portion comprises guiding the first portion along the plurality of guide wires, wherein each guide wire is threaded through a respective first coupling feature and a corresponding second coupling feature.

8. The method of claim 2, wherein guiding the first portion comprises guiding the first portion along the plurality of guide wires, wherein each guide wire comprises a loop extending from the distal end portion of the delivery tube.

9. The method of claim 2, wherein engaging each first coupling feature to the respective second coupling feature comprises engaging apertures and tabs.

10. The method of claim 2, wherein the first portion comprises a tubular mesh portion and guiding the first portion comprises guiding the tubular mesh portion.

11. The method of claim 10, wherein the second portion is tubular and guiding the tubular mesh portion comprises guiding the tubular mesh portion towards the tubular second portion.

12. The method of claim 2, wherein the second portion of the prosthetic heart valve is tubular and guiding the first portion of the prosthetic heart valve towards the second portion of the prosthetic heart valve comprises guiding the first portion towards the tubular second portion.

13. A method for replacing a heart valve in a patient in need thereof, the method comprising:

positioning a prosthetic heart valve in a radially contracted configuration in an annulus of a native heart valve, the prosthetic heart valve comprising a first portion and a second portion;

after positioning the prosthetic heart valve in the annulus of the native heart valve, longitudinally guiding the first portion of the prosthetic heart valve towards the second portion of the prosthetic heart valve along a plurality of longitudinally extending guide wires; and

fastening the first portion to the second portion, thereby replacing the native heart valve.

14. The method of claim 13, wherein the guide wires extend through respective first coupling features on the first portion and respective second coupling features on the second portion, and wherein the act of fastening the first portion to the second portion comprises mating the first coupling features with the second coupling features.

15. The method of claim 13, wherein fastening the first portion to the second portion comprises fastening the first portion to the second portion to provide a final expanded configuration of the prosthetic heart valve.

16. The method of claim 13, wherein fastening the first portion to the second portion comprises engaging tabs to apertures.

17. The method of claim 13, wherein positioning the prosthetic heart valve in a radially contracted configuration comprises positioning the prosthetic heart valve disposed in a distal end portion of a delivery tube.

18. The method of claim 13, wherein longitudinally guiding the first portion of the prosthetic heart valve towards the second portion of the prosthetic heart valve comprises longitudinally guiding a first end portion towards a second end portion.

19. The method of claim 13, wherein the first portion of the prosthetic heart valve comprises a self-expanding, nickel-titanium alloy body and three bovine pericardium leaflets fastened to the body along the guide wires.

20. The method of claim 13, further comprising expanding the prosthetic heart valve within the annulus of the heart valve prior to the act of longitudinally guiding the first portion of the prosthetic heart valve towards the second portion of the prosthetic heart valve and prior to the act of fastening the first portion to the second portion.

21. The method of claim 20, wherein expanding the prosthetic heart valve comprises expanding the first portion and the second portion.