Personalized aortic valve prosthesis

• US 10,292,815 B2
• Filed: 06/29/2017
• Issued: 05/21/2019
• Est. Priority Date: 05/01/2013
• Status: Active Grant

• Current Assignee: Aneumed, Inc.
• Original Assignee: Aneumed, Inc.
• Inventors: Thapliyal, Hira V.
• Primary Examiner(s): Dukert, Brian A
• Application Number:
  US15/638,277
• Publication Number:
  US 20170296335A1
• Time in Patent Office: 691 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 personalized prosthetic valve for implantation at native valve treatment site, said personalized prosthetic valve comprising:

a self-expanding mesh having a collapsed configuration and an expanded configuration, the collapsed configuration adapted to be delivered to the native valve treatment site, and the expanded configuration adapted to expand the valve into engagement with the treatment site, wherein the mesh in the expanded configuration is personalized prior to implantation to match the treatment site, wherein the mesh has an outer surface prior to implantation that substantially matches the native valve treatment site shape and size in the expanded configuration, and wherein the self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough, and

wherein the valve further comprises a plurality of valve leaflets coupled to the self-expanding mesh and having an open configuration and a closed configuration,

wherein in the open configuration the blood or the other body fluids are free to pass through the valve, and

wherein in the closed configuration the plurality of leaflets are closer toward one another than in the open configuration, and the blood or the other body fluids are prevented from flowing upstream through the prosthetic valve.

2. The personalized prosthetic valve of claim 1, wherein the self-expanding mesh comprises a nitinol mesh.

3. The personalized prosthetic valve of claim 1, wherein the self-expanding mesh comprises one or more filaments in a helical pattern.

4. The personalized prosthetic valve of claim 1, wherein the self-expanding mesh comprises one or more filaments woven together to form overlapping regions with the one or more filaments overlapping one another at least once.

5. The personalized prosthetic valve of claim 1, wherein the self-expanding mesh comprises one or more filaments woven together to form a first overlapping region and a second overlapping region along a row, wherein in the first overlapping region the filaments overlap with one another a first number of times, and wherein in the second overlapping region the filaments overlap with one another a second number of times different than the first number of times.

6. The personalized prosthetic valve of claim 1, wherein the self-expanding mesh comprises barbs or hooks adapted to engage tissue at the treatment site and anchor the personalized prosthesis.

7. The personalized prosthetic valve of claim 1, wherein the self-expanding mesh comprises a plurality of overlapping filaments forming overlapping regions, and wherein the overlapping regions form raised surfaces adapted to engage tissue at the native valve treatment site and anchor the personalized prosthetic valve.

8. The personalized prosthetic valve of claim 1, further comprising a membrane disposed over the mesh, wherein the membrane is elastic and conforms to the self-expanding mesh, and wherein the membrane has an outer surface that substantially matches the native valve treatment site shape in the expanded configuration, and wherein the membrane forms the central lumen.

9. The personalized prosthetic valve of claim 8, wherein the membrane comprises a resilient polymer.

10. The personalized prosthetic valve of claim 1, further comprising one or more radiopaque markers coupled to the membrane or the self-expanding mesh for facilitating implantation of the personalized prosthetic valve at the native valve treatment site.

11. The personalized prosthetic valve of claim 1, further comprising one or more apertures extending through a sidewall of the personalized prosthetic valve, the one or more apertures fluidly coupled with the central lumen to allow blood flow or other fluids to flow between the central lumen and the one or more apertures, the one or more apertures configured to accommodate side branch vessels or other body passages such that the personalized prosthetic valve does not obstruct blood flow or fluid flow therethrough.

12. The personalized prosthetic valve of claim 11, wherein the one or more apertures are 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.

13. The personalized prosthetic valve of claim 1, wherein the native valve treatment site has a shape, and wherein the lumen has a shape substantially matching the shape of the native valve treatment site.

14. The personalized prosthetic valve of claim 1, wherein the lumen does not substantially alter blood flow path across the treatment site.