RADIALLY COLLAPSIBLE FRAME FOR A PROSTHETIC VALVE AND METHOD FOR MANUFACTURING SUCH A FRAME

• US 20160213465A1
• Filed: 07/23/2014
• Published: 07/28/2016
• Est. Priority Date: 08/30/2013
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: SCHLUN, Martin, GIRARD, Michael J.
• Granted Patent: US 9,867,694 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 radially collapsible frame for a prosthetic valve, the frame comprising:

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

at least two radially spaced commissure attachment regions located at the outflow end region of the frame and being configured to receive commissure edges of at least two prosthetic valve leaflets;

a cell structure composed of comprising a plurality of lattice cells being arranged radially around a flow axis of the frame and connecting the at least two commissure attachment regions;

at least one anchoring/positioning arch, wherein said at least one anchoring/positioning arch radially overlaps the cell structure at least partially,

wherein the frame further comprises a plurality of circumferentially arranged retaining arches, each including first and second arms joined to one another at a distal end of the retaining arches, the two arms being joined by a rounded structure, and

wherein the cell structure comprises a first cell region comprising a plurality of first cells, said first cells being arranged between the respective first and second arms of each retaining arch, and a second cell region comprising a plurality of second cells, said second cells being arranged between adjacent arms of two neighboring retaining arches.

2. The frame according to claim 1, wherein the at least one anchoring/positioning arch is rigidly attached to the at least two radially spaced commissure attachment regions.

3. The frame according to claim 1, wherein the at least one anchoring/positioning arch is formed integrally with the at least two radially spaced commissure attachment regions as a single piece.

4. The frame according to claim 1, wherein the two arms of each retaining arch are joined to one another at a connection having a substantially U- or V-shaped structure.

5. The frame according to claim 1, wherein an entirety of three anchoring/positioning arches and an entirety of three retaining arches is provided.

6. The frame according to claim 1, wherein adjacent arms of two neighboring retaining arches merge at one of the at least two commissure attachment regions, near the outflow end region of the frame.

7. The frame according to claim 1, wherein each of the first cells and/or second cells is formed by a plurality of struts.

8. The frame according to claim 1, wherein each of the positioning arches and each of the retaining arches includes a closed end, and wherein the closed end of a respective anchoring/positioning arch is substantially circumferentially aligned with respect to the closed end of an associated retaining arch.

9. The frame according to claim 1, further comprising at least one fastening portion provided in at least one of the plurality of retaining arches, the at least one fastening portion including a plurality of fastening holes configured to receive a suture.

10. The frame according to claim 9, wherein the at least one fastening portion further includes a plurality of notches configured to receive a suture.

11. The endoprosthesis according to claim 27, wherein, in an expanded state of the frame, the respective arms of the retaining arches have a shape that matches a plurality of leaflets of the prosthetic valve attached to the frame.

12. The frame according to claim 1, wherein at least one annular collar is connected to a part of the rounded structure at distal end sections of the respective arms of the retaining arches arms.

13. The frame according to claim 12, wherein the at least one annular collar is connected to each or a part of lower end sections of struts which form the second cells of the second cell region arranged between the adjacent arms of the retaining arches of two neighboring retaining arches.

14. The frame according to claim 12, further comprising a plurality of eyelets uniformly distributed around a lower end section of the at least annular collar for fixing a prosthetic valve to the frame.

15. The frame according to claim 12, wherein, in an expanded state of the frame, a lower end section of the annular collar constitutes at least one flared or tapered section of the frame.

16. The frame according to claim 1, wherein, in an expanded state of the frame, the frame is provided with at least one flared or tapered section at its inflow end region.

17. The frame according to claim 16, wherein the at least one flared or tapered section of the frame has a circular cross-section.

18. The frame according to claim 17, wherein the at least one flared or tapered section is provided only near the location of the retaining arches, wherein no flared or tapered section is provided near the regions in between the two arms of neighboring retaining arches.

19. The frame according to claim 1, wherein the frame has a scalloped inflow edge design at its lower end section when the frame is in an expanded state.

20. The frame according to claim 1, wherein the frame exhibits a structure integrally cut from a portion of a tube, in particular from a small metal tube.

21. The frame according to claim 1, wherein the frame a first collapsed mode for introduction into a patient'"'"'s body and a second expanded mode for implantation.

22. The frame according to claim 21, wherein the frame comprises a shape memory material such that the frame is configured to transform from a temporary shape into a permanent shape under influence of an external stimulus, wherein the temporary shape of the frame corresponds to the first mode of the frame and the permanent shape of the frame corresponds to the second mode of the frame.

23. The frame according to claim 22, wherein the external stimulus is a switching temperature between room temperature and a normal human body temperature.

25. The frame according to claim 1, wherein the at least one anchoring/positioning arch is configured to be positioned within a pocket of a native cardiac heart valve and positioned on a first side of a plurality of native heart valve leaflets, and wherein the plurality of retaining arches is configured to be positioned on a second side of the plurality of native heart valve leaflets opposite the first side.

26. The frame according to claim 1, wherein the at least one anchoring/positioning arch includes a substantially U-shaped or V-shaped structure.

27. An endoprosthesis comprising a radially collapsible frame according to claim 1 and a valvular prosthesis attached to an inner surface of the frame.

28. The endoprosthesis according to claim 27, wherein the valvular prosthesis is made from pericardium.

24. (canceled)

29-31. -31. (canceled)