Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient

• US 10,575,947 B2
• Filed: 12/21/2017
• Issued: 03/03/2020
• Est. Priority Date: 02/26/2008
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Straubinger, Helmut, Jung, Johannes
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US15/850,165
• Publication Number:
  US 20180360601A1
• Time in Patent Office: 803 Days
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

The present invention relates to a stent (10) for the positioning and anchoring of a valvular prosthesis (100) in an implantation site in the heart of a patient. Specifically, the present invention relates to an expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency. So as to ensure that no longitudinal displacement of a valvular prosthesis (100) fastened to a stent (10) will occur relative the stent (10) in the implanted state of the stent (10), even given the peristaltic motion of the heart, the stent (10) according to the invention comprises at least one fastening portion (11) via which the valvular prosthesis (100) is connectable to the stent (10). The stent (10) further comprises positioning arches (15) and retaining arches (16), whereby at least one positioning arch (15) is connected to at least one retaining arch (16) via a first connecting land (17). The stent (10) moreover comprises at least one auxiliary retaining arch (18) which connects the respective arms (16′, 16″) of the at least one retaining arch (16) connected to the at least one positioning arch (15).

Claims

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

positioning a stent within a native cardiac valve, the stent comprising

a plurality of first arches, each first arch having a closed end portion and an open end portion, the closed end portion pointing in a proximal direction and the open end portion open to a distal end portion of the stent;

a plurality of second arches, each second arch having a closed end portion and an open end portion, the closed end portion of each second arch pointing in the proximal direction, wherein each second arch is circumferentially aligned with and attached to a respective first arch,

a plurality of third arches, each third arch having a closed end portion and an open end portion, the closed end portion of each third arch pointing in the proximal direction, and each third arch circumferentially interspaced between two adjacent second arches, and

a valvular prosthesis attached to the plurality of second arches.

2. The method of claim 1, wherein the native cardiac valve includes a plurality of pockets, and wherein positioning the stent within the native cardiac valve includes positioning the closed end portion of each of the plurality of first arches in a corresponding pocket of the native cardiac valve, and positioning each second arch respective to each first arch radially inward of the corresponding pocket of the native cardiac valve.

3. The method of claim 1, further including releasing the stent;

wherein at least one of the plurality of first arches, the plurality of second arches, and the plurality of third arches is configured to expand radially when the stent is released.

4. The method of claim 1, wherein the valvular prosthesis is attached to the plurality of second arches via a plurality of holes defined in each of the plurality of second arches.

5. The method of claim 4, wherein each of the plurality of third arches is connected to two adjacent second arches distally of the plurality of holes in each second arch.

6. The method of claim 1, wherein each first arch attaches to each respective second arch at a respective connecting portion, each connecting portion including an eyelet at a distal end of the stent.

7. The method of claim 6, wherein each third arch is distal from a respective connecting portion.

8. A method for treating a native cardiac valve, the method comprising:

positioning a stent in a native cardiac valve having a plurality of native valve leaflets, the stent comprising

a plurality of first arches, each arch having an apex pointing towards a proximal end of the stent and an open end facing a distal end of the stent,

a plurality of second arches, each second arch having an apex circumferentially aligned with a respective first arch, the apex of each second arch pointing towards the proximal end of the stent,

a plurality of third arches, each third arch circumferentially interspaced between two adjacent second arches, each third arch having an apex pointing towards the proximal end of the stent, and

a valvular prosthesis attached to the plurality of second arches;

wherein positioning the stent in the native cardiac valve includes positioning each of the plurality of first arches in a corresponding pocket of the native cardiac valve.

9. The method of claim 8, wherein positioning the stent in the native cardiac valve includes releasing the plurality of third arches, the plurality of third arches configured to exert a radially outward force.

10. The method of claim 8, wherein each second arch includes a plurality of holes, and wherein the valvular prosthesis is sutured to the plurality of second arches via the plurality of holes.

11. The method of claim 10, wherein each of the plurality of third arches connects a first second arch to an adjacent second arch distally from the plurality of holes of each second arch.

12. The method of claim 8, wherein the stent comprises an equal number of first arches, second arches, and third arches.

13. The method of claim 8, wherein the stent includes a plurality of head portions, each head portion connected to two adjacent first arches, and each head portion including an eyelet.

14. The method of claim 13, further including deploying the stent;

wherein the stent is self-expandable, and wherein deploying the stent includes releasing the stent from a collapsed shape via the eyelet of each head portion.

15. The method of claim 8, wherein the apex of each first arch includes a radiopaque marker.

16. A method for treating a native cardiac valve, the method comprising:

positioning a stent in a native cardiac valve, the stent comprising

a plurality of first arches,

a plurality of second arches, each second arch circumferentially aligned with and radially offset from a respective first arch,

a plurality of third arches, each third arch circumferentially interspaced between two adjacent second arches, and

a valvular prosthesis attached to the plurality of second arches;

wherein each of the plurality of first arches, the plurality of second arches, and the plurality of third arches includes an open end portion and a closed end portion, each closed end portion pointing towards a heart chamber when the stent is positioned in the cardiac valve; and

wherein positioning the stent in the native cardiac valve includes positioning each of a plurality of leaflets of the native cardiac valve radially between one of the plurality of first arches and each respective second arch.

17. The method of claim 16, wherein the plurality of second arches and the plurality of third arches are uniformly distributed around a circumference of the stent.

18. The method of claim 16, wherein the closed end of each of the plurality of third arches is positioned closer to the heart chamber than the closed end of each of the plurality of first arches.

19. The method of claim 16, wherein the stent includes exactly three first arches, exactly three second arches, and exactly three third arches.

20. The method of claim 16, wherein positioning the stent in the native cardiac valve includes introducing the stent transarterially into a body of a patient using a catheter.

21. The method of claim 16, wherein the stent is self-expanding, and wherein positioning the stent in the native cardiac valve includes releasing the stent from a collapsed shape, the plurality of second arches exerting a radial force against the plurality of leaflets of the native cardiac valve.