IP Library › Granted Patent US 12,232,957
Granted Patent B2
US 12,232,957 · App. 18/160,993 · Granted Feb 25, 2025

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

Inventors: Helmut Straubinger (Aschheim, DE); Johannes Jung (Karlsruhe, DE)
Assignee: JenaValve Technology, Inc.
A61F2/2418A61F2220/0016A61F2230/0023A61F2230/0054
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Quick Facts
Patent No.
US 12,232,957
App. No.
18/160,993
Granted
Feb 25, 2025
Kind
B2
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 (31)

1. An endoprosthesis for implantation at a native heart valve, the endoprosthesis comprising:

an expandable stent comprising:

a plurality of retaining arches, each retaining arch comprising a retaining apex and coupled to another retaining arch of the plurality of retaining arches;

a plurality of positioning arches, each positioning arch comprising a positioning apex aligned with a respective retaining apex of a retaining arch of the plurality of retaining arches, and each positioning arch coupled to another positioning arch of the plurality of positioning arches; and

a plurality of connecting struts, each connecting strut coupled at a first end of each connecting strut to at least one positioning arch of the plurality of positioning arches and coupled at a second end of each connecting strut to at least one retaining arch of the plurality of retaining arches, the plurality of connecting struts configured to offset the plurality of retaining arches from the plurality of positioning arches,

a plurality of auxiliary arches, each auxiliary arch coupled at a primary end of each auxiliary strut to a first retaining arch of the plurality of retaining arches and coupled at a secondary end of each auxiliary strut to a second retaining arch of the plurality of retaining arches, the plurality of auxiliary arches uniformly distributed around a lower end of the expandable stent and configured to press against a vascular wall, and the plurality of auxiliary arches and the plurality of retaining arches configured to form a seal with the vascular wall,

wherein the plurality of retaining arches and the plurality of positioning arches are configured to be sequentially expanded to cause the plurality of retaining arches and the plurality of positioning arches to clip at least one native leaflet of the native heart valve.

2. The endoprosthesis of claim 1 , further comprising a valve prosthesis coupled to at least a portion of the plurality of retaining arches, the valve prosthesis comprising a plurality of prosthetic leaflets.

3. The endoprosthesis of claim 2 , wherein each retaining arch of the plurality of retaining arches comprises a plurality of fastening holes and wherein the valve prosthesis is coupled to the at least a portion of the plurality of retaining arches via one or more sutures extending through the fastening holes.

4. The endoprosthesis of claim 1 , wherein the plurality of the positioning arches are configured to at least partially expand while the plurality of retaining arches remain in the collapsed state.

5. The endoprosthesis of claim 4 , wherein the plurality of the positioning arches are configured to be positioned into pockets of the native heart valve.

6. The endoprosthesis of claim 4 , wherein the plurality of retaining arches are configured to expand after the plurality of positioning arches are at least partially expanded.

7. The endoprosthesis of claim 1 , wherein the plurality of retaining arches includes exactly three retaining arches and the plurality of positioning arches includes exactly three positioning arches.

8. The endoprosthesis of claim 1 , wherein each positioning arch of the plurality of positioning arches is coupled to another positioning arch at a junction and each connecting strut of the plurality of connecting struts is coupled to a respective junction.

9. The endoprosthesis of claim 1 , wherein each retaining arch of the plurality of retaining arches is coupled to another retaining arch at a junction and each connecting strut of the plurality of connecting struts is coupled to a respective junction.

10. The endoprosthesis of claim 1 , wherein the each auxiliary arch of the plurality of auxiliary arches is configured to anchor the expandable stent.

11. A method for implanting an endoprosthesis at a native heart valve, the method comprising:

delivering the endoprosthesis to the native heart valve in a compressed state, the endoprosthesis comprising an expandable stent comprising a plurality of retaining arches, a plurality of positioning arches, a plurality of connecting struts coupling the plurality of retaining arches to the plurality of positioning arches, and a plurality of auxiliary arches uniformly distributed around a lower end of the expandable stent and configured to press against a vascular wall, each auxiliary arch coupled at a primary end of each auxiliary arch to a first retaining arch of the plurality of retaining arches and coupled at a secondary end of each auxiliary arch to a second retaining arch of the plurality of retaining arches, the plurality of auxiliary arches and the plurality of retaining arches configured to form a seal with a vascular wall;

causing the plurality of positioning arches to at least partially expand;

positioning, after causing the plurality of positioning arches to at least partially expand, the plurality of positioning arches into pockets of the native heart valve; and

causing, after positioning the positioning arches into pockets of the native heart valve, the plurality of retaining arches to at least partially expand, thereby clipping at least one native leaflet of the native heart valve between at least one of the plurality of retaining arches and at least one of the plurality of positioning arches,

wherein the plurality of connecting struts offset the plurality of positioning arches form the plurality of the retaining arches.

12. The method of claim 11 , wherein the endoprosthesis further comprises a valve prosthesis coupled to at least a portion of the plurality of retaining arches, the valve prosthesis comprising a plurality of prosthetic leaflets.

13. The method of claim 12 , wherein each retaining arch of the plurality of retaining arches comprises a plurality of fastening holes, the method further comprising securing the valve prosthesis to plurality of fastening holes using a suture.

14. The method of claim 11 , wherein the plurality of retaining arches includes exactly three retaining arches and the plurality of positioning arches includes exactly three positioning arches.

15. The method of claim 11 , wherein each positioning arch of the plurality of positioning arches is coupled to another positioning arch at a junction and each connecting strut of the plurality of connecting struts is coupled to a respective junction.

16. The method of claim 11 , wherein each retaining arch of the plurality of retaining arches is coupled to another retaining arch at a junction and each connecting strut of the plurality of connecting struts is coupled to a respective junction.

17. The method of claim 11 , further comprising extracting the expandable stent from a metal tube via laser cutting.

18. The method of claim 11 , wherein each retaining arch of the plurality of retaining arches is U-shaped or V-shaped.

19. The method of claim 11 , wherein each positioning arch of the plurality of positioning arches is U-shaped or V-shaped.

20. The method of claim 11 , wherein the each auxiliary arch of the plurality of auxiliary arches is configured to anchor the expandable stent.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2024
From: STRAUBINGER, HELMUT; JUNG, JOHANNES
To: JENAVALVE TECHNOLOGY, INC.
Reel/Frame 067509/0159 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2024
From: JENAVALVE TECHNOLOGY, INC.
To: JENAVALVE TECHNOLOGY GMBH
Reel/Frame 067509/0165 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2024
From: JVT RESEARCH & DEVELOPMENT CORPORATION
To: JENAVALVE TECHNOLOGY, INC.
Reel/Frame 067527/0261 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 23, 2024
From: JENAVALVE TECHNOLOGY GMBH
To: JVT RESEARCH & DEVELOPMENT CORPORATION
Reel/Frame 067527/0321 →
Continuity (5)
Continuation 16741956 · Jan 14, 2020
Continuation 15850165 · Dec 21, 2017
Continuation 14709909 · May 12, 2015
Continuation 12071814 · Feb 26, 2008
Related Publication 20230172712A1 · Jun 8, 2023
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