Personalized aortic valve prosthesis

• US 9,717,592 B2
• Filed: 05/01/2014
• Issued: 08/01/2017
• Est. Priority Date: 10/29/2012
• Status: Active Grant

• Current Assignee: Aneumed, Inc.
• Original Assignee: Aneumed, Inc.
• Inventors: Thapliyal, Hira V.
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US14/267,453
• Publication Number:
  US 20140330367A1
• Time in Patent Office: 1,188 Days
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/856 Single tubular stent with a side portal passage
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses
• CPC Class Codes: A61F 2240/004 Using a positive or negative model, e.g. moulds
• CPC Class Codes: D04C 1/08 Tulle fabrics
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A personalized prosthetic valve for implantation at a native valve treatment site includes a self-expanding mesh and a plurality of valve leaflets coupled to the mesh. The mesh may be delivered to the native valve in a collapsed configuration, and in an expanded configuration the mesh engages the native valve. The mesh in the expanded configuration is also personalized to match the treatment site, such that the outer mesh surface substantially matches the treatment site shape and size. The self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough. In the open configuration, blood passes through the prosthetic valve, and in the closed configuration, the plurality of leaflets are closer together and blood is prevented from flowing upstream through the prosthetic valve.

Claims

1. A method for treating a damaged or diseased native aortic valve, said method comprising:

providing a personalized prosthetic valve having a central lumen, an expanded configuration and a collapsed configuration, wherein the personalized prosthetic valve is biased to expand into the expanded configuration, and wherein the personalized prosthetic valve is personalized to match a shape and a size of the native aortic valve prior to implantation thereof in the native aortic valve, and wherein the central lumen is configured to allow blood flow or other body fluids to pass therethrough, and wherein the personalized prosthesis comprises one or more apertures extending through a sidewall thereof, the one or more apertures personalized prior to implantation of the personalized prosthetic valve to align with an anatomical location of one or more coronary ostia to permit the blood flow between the one or more apertures and the one or more coronary ostia without obstructing the one or more coronary ostia with the personalized prosthetic valve;

advancing the personalized prosthetic valve in the collapsed configuration to the native aortic valve;

self-expanding the personalized prosthetic valve into the expanded configuration, wherein in the expanded configuration the personalized prosthetic valve has a shape that substantially matches the size and shape of the native aortic valve such that the personalized prosthetic valve expands substantially into engagement with the native aortic valve;

reducing retrograde blood flow across the native valve; and

preventing perivalvular leaks around the personalized prosthetic valve.

2. The method of claim 1, wherein the personalized prosthetic valve comprises a self-expanding wire mesh surrounded by a polymer cover.

3. The method of claim 1, wherein the personalized prosthetic valve comprises a self-expanding wire mesh.

4. The method of claim 1, wherein the personalized prosthetic valve comprises a resilient polymer.

5. The method of claim 1, wherein the central lumen has a shape substantially matching the shape and the size of the native aortic valve.

6. The method of claim 1, wherein the central lumen has a cylindrical shape.

7. The method of claim 1, wherein the central lumen does not substantially alter blood flow path across the treatment site.

8. The method of claim 1, wherein advancing the personalized prosthetic valve comprises advancing the personalized prosthetic valve through a blood vessel.

9. The method of claim 1, wherein self-expanding the personalized prosthetic valve comprises retracting a sheath away from the personalized prosthetic valve, thereby allowing the personalized prosthetic valve to self-expand into the expanded configuration.

10. The method of claim 1, further comprising reinforcing tissue at the native aortic valve by anchoring the personalized prosthetic valve to the tissue.

11. The method of claim 1, wherein reducing retrograde flow comprises directing blood flow through a plurality of prosthetic valve leaflets coupled to the personalized prosthetic valve, wherein the plurality of prosthetic valve leaflets have an open configuration and a closed configuration, wherein in the closed configuration the plurality of prosthetic valve leaflets are adjacent one another to prevent the retrograde flow, and wherein in the open configuration the plurality of prosthetic valve leaflets are disposed away from one another and the blood flow freely passes therethrough, and wherein reducing perivalvular leaks comprises preventing fluid leakage between an outer surface of the personalized prosthetic valve and tissue in the native aortic valve.

12. The method of claim 1, further comprising reinforcing tissue at the native aortic valve by anchoring the personalized prosthetic valve in the native aortic valve.

13. The method of claim 12, wherein anchoring the personalized prosthetic valve comprises engaging barbs on the personalized prosthetic valve with the tissue.

14. The method of claim 1, wherein the personalized prosthetic valve comprises one or more radiopaque markers, the method further comprising aligning the one or more radiopaque markers with one or more anatomical features at the native aortic valve.

15. The method of claim 1, wherein the personalized prosthetic valve comprises an outer surface comprising a plurality of peaks or valleys, and the method further comprising conforming the plurality of peaks or valleys of the outer surface to the size and shape of the treatment site when the personalized prosthetic valve is in the expanded configuration.

16. The method of claim 1, further comprising conforming the personalized prosthesis in the expanded configuration to an aortic sinus in the aortic valve.

17. The method of claim 1, wherein the one or more apertures abut against the one or more coronary ostia so that the blood flow flows directly therebetween.

18. The method of claim 1, wherein the personalized prosthesis is a single integral piece.