Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame

• US 10,433,954 B2
• Filed: 12/07/2017
• Issued: 10/08/2019
• Est. Priority Date: 08/30/2013
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Girard, Michael J., Schlun, Martin
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/834,376
• Publication Number:
  US 20180333258A1
• Time in Patent Office: 670 Days
• Field of Search: 623 21- 219
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• 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 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention relates to a radially collapsible frame (1) for a prosthetic valve, the frame (1) comprising an outflow end region (3) at a proximal end of the frame (1) and an inflow end region (2) at a distal end of the frame (1), opposite to the outflow end region (3). The frame (1) further includes at least two radially spaced commissure attachment regions (10, 10′, 10″) and a cell structure (30), composed of a plurality of lattice cells being arranged radially around a flow axis of the frame (1) and connecting the at least two commissure attachment regions (10, 10′, 10″). Finally, at least one anchoring/positioning arch (20, 20′, 20″) is provided, wherein said at least one anchoring/positioning arch (20, 20′, 20″) radially overlaps the cell structure (30) at least partially. In order to form the inventive frame from as a single piece, the invention further relates to a method comprising bending the at least one anchoring/positioning arch (20, 20′, 20″) towards the cell structure (30) of the frame (1).

Claims

1. A method for treating a native heart valve, the method comprising:

positioning a stent within a native heart valve, the stent including a frame and prosthetic valve leaflets, wherein the frame includes

at least two commissure attachment regions located at a proximal outflow end of the frame, wherein each commissure attachment region is attached to commissure edges of the prosthetic valve leaflets,

a plurality of circumferentially arranged retaining arches attached to cusp edges of the prosthetic valve leaflets, each retaining arch including a first arm joined to a second arm at an apex pointing towards a distal inflow end of the frame,

a cell structure comprising a first plurality of cells disposed between the first arm and the second arm of each retaining arch, and a second plurality of cells disposed between adjacent arms of two neighboring retaining arches, and

at least one arch radially outward of at least a portion of the cell structure;

wherein the stent is positioned within the native heart valve so that the first plurality of cells of the cell structure inhibit one or more leaflets of the native heart valve from contacting the prosthetic valve leaflets.

2. The method of claim 1, wherein each of the first plurality of cells and each of the second plurality of cells is formed by a plurality of struts.

3. The method of claim 1, wherein the at least one arch radially outward of at least a portion of the cell structure is formed integrally with the at least two commissure attachment regions as a single piece.

4. The method of claim 1, wherein the at least one arch radially outward of at least a portion of the cell structure comprises a plurality of notches.

5. The method of claim 1, wherein the stent further comprises an annular collar at a distal end of the retaining arches.

6. The method of claim 1, wherein each of the at least one arch radially outward of at least a portion of the cell structure comprises an eyelet.

7. The method of claim 1, wherein the respective first arm and second arm of each retaining arch have a shape that matches the prosthetic valve leaflets.

8. The method of claim 1, wherein a cell density of the first plurality of cells is equal to a cell density of the second plurality of cells.

9. A method for treating a native heart valve, the method comprising:

positioning a frame within a native heart valve, the frame including

at least two commissure attachment regions located at a distal end of the frame, wherein each commissure attachment region is attached to commissure edges of prosthetic valve leaflets,

a plurality of circumferentially arranged retaining arches, each retaining arch including a first arm joined to a second arm at a distal end of the retaining arch,

a first plurality of struts defining a first plurality of cells disposed between the first arm and the second arm of each retaining arch,

a second plurality of struts defining a second plurality of cells disposed between adjacent arms of two neighboring retaining arches, wherein the first plurality of struts prevents at least a portion of a leaflet of the native heart valve from contacting at least one of the prosthetic valve leaflets, and

at least one arch radially outward of at least a portion of the first plurality of cells.

10. The method of claim 9, wherein the at least one arch radially outward of at least a portion of the first plurality of cells is formed integrally with the at least two commissure attachment regions.

11. The method of claim 9, wherein positioning the frame within the native heart valve includes clamping the leaflet of the native heart valve between the at least one arch radially outward at least a portion of the first plurality of cells and one of the retaining arches.

12. The method of claim 9, wherein the frame further comprises at least one annular collar connected to the second plurality of cells.

13. The method of claim 9, wherein at least one retaining arch of the plurality of circumferentially arranged retaining arches comprises a hole receiving a suture.

14. A method for treating a native heart valve, the method comprising:

positioning a stent within a native heart valve, the stent including

a prosthesis having prosthetic valve leaflets;

a frame, the frame including

an outflow end region at a proximal end of the frame and an inflow end region at a distal end of the frame opposite the outflow end region,

at least two commissure attachment regions located at the outflow end, wherein each commissure attachment region is attached to the prosthesis,

a plurality of circumferentially arranged retaining arches, each retaining arch including a first arm joined to a second arm at a distal end of the retaining arch,

a plurality of lattice cells proximal to the distal end of each retaining arch, the plurality of lattice cells comprising a plurality of first cells disposed between the first arm and the second arm of each retaining arch, and a plurality of second cells disposed between adjacent arms of two neighboring retaining arches, wherein the first plurality of cells guard the prosthetic valve leaflets from leaflets of the native heart valve, and

at least one arch radially outward of at least a portion of the plurality of lattice cells;

wherein positioning the stent within the native heart valve includes positioning the at least one arch in a pocket of a the native heart valve.

15. The method of claim 14, wherein the plurality of lattice cells are defined by a plurality of struts.

16. The method of claim 14, wherein the frame further comprises an annular collar at a distal end of at least one of the plurality of retaining arches or the plurality of second cells.

17. The method of claim 14, wherein positioning the at least one arch in the pocket of the native heart valve includes positioning an eyelet of the at least one arch in the pocket of the native heart valve.

18. The method of claim 14, wherein at least one arch radially outward of at least a portion of the plurality of lattice cells comprises three arches, and the plurality of retaining arches comprises three retaining arches.

19. The method of claim 14, wherein the frame of the stent has a scalloped inflow edge.

20. The method of claim 14, wherein the frame is integrally cut from a portion of a tube.