Stent for the positioning and anchoring of a valvular prosthesis

• US 9,044,318 B2
• Filed: 02/26/2008
• Issued: 06/02/2015
• Est. Priority Date: 02/26/2008
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology GmbH (JenaValve Technology, Inc.)
• Inventors: Straubinger, Helmut, Jung, Johannes
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US12/071,814
• Publication Number:
  US 20090216313A1
• Time in Patent Office: 2,653 Days
• Field of Search: 606/1.11, 606 211- 242, 606/108, 623/1.11, 623 211- 242
• US Class Current: 1/1
• 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

An expandable stent for an endoprosthesis used in the treatment of a narrowing of a cardiac valve and/or a cardiac valve insufficiency for reducing longitudinal displacement of a valvular prosthesis relative a stent when implanted. In one embodiment, the stent may comprise at least one fastening portion by which the valvular prosthesis is connectable to the stent. In another embodiment, the stent further comprises positioning arches and retaining arches, whereby at least one positioning arch is connected to at least one retaining arch via a first connecting land. In another embodiment, the stent may comprise at least one auxiliary arch which connects the respective arms of the at least one retaining arch connected to the at least one positioning arch.

Claims

1. An expandable stent for treating a native heart valve having a plurality of native valve leaflets, comprising:

a plurality of positioning arches configured to be positioned within a plurality of pockets of a native valve on a first side of the plurality of native valve leaflets, a plurality of retaining arches configured to support a valve prosthesis on a second side of the plurality of native valve leaflets such that the plurality of native valve leaflets are positioned radially inward of at least a portion of the plurality of positioning arches and radially outward of at least a portion of the plurality of retaining arches when the expandable stent is implanted, and a plurality of auxiliary arches, each auxiliary arch circumferentially interspaced between two adjacent retaining arches;

wherein each retaining arch is associated with a corresponding positioning arch and has a distal, open end portion axially aligned, along a longitudinal direction of the expandable stent, with and joined to a distal, open end portion of the corresponding positioning arch;

wherein each positioning arch, each retaining arch, and each auxiliary arch has a closed proximal end forming an apex; and

wherein the valve prosthesis is attached to the plurality of retaining arches such that at least a portion of the valve prosthesis extends from the plurality of retaining arches transversely across an interior of the expandable stent.

2. The expandable stent according to claim 1, wherein each positioning arch, each retaining arch, and each auxiliary arch includes a substantially U-shaped or V-shaped structure.

3. The expandable stent according to claim 1, having a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein each auxiliary arch is configured to press radially outward when implanted.

4. The expandable stent according to claim 1, wherein each retaining arch includes a first arm and a second arm, and at least one of the first arm or the second arm of at least one of the retaining arches includes at least one fastening portion.

5. The expandable stent according to claim 4, wherein the at least one fastening portion includes a plurality of holes, and the valve prosthesis is connected to the at least one fastening portion via a suture extending through at least a portion of the plurality of holes.

6. The expandable stent according to claim 4, wherein the at least one fastening portion includes a plurality of fastening portions, each fastening portion being disposed in the first arm or the second arm of a retaining arch.

7. The expandable stent according to claim 4, wherein the at least one fastening portion includes a plurality of fastening portions, and each of the first and second arms of each retaining arch includes one of the fastening portions.

8. The expandable stent according to claim 1, wherein the stent includes an equal number of auxiliary arches and retaining arches.

9. The expandable stent according to claim 1, wherein the closed end of each positioning arch is substantially circumferentially aligned with the closed end of a corresponding retaining arch.

10. The expandable stent according to claim 1, wherein the stent is configured to transition from a collapsed configuration when being introduced into a patient to an expanded configuration when implanted relative to the native valve.

11. The expandable stent according to claim 1, further including at least one retaining head configured to releasably engage a catheter system.

12. The expandable stent according claim 11, wherein the at least one retaining head has an oval shape.

13. The expandable stent according to claim 1, wherein the stent includes exactly three positioning arches and exactly three retaining arches.

14. The expandable stent according to claim 1, wherein the stent includes exactly three retaining arches and exactly three auxiliary arches.

15. The expandable stent according to claim 1, having a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein each positioning arch of the plurality of positioning arches is substantially circumferentially aligned with, and radially offset from, a respective retaining arch when the stent is in the expanded configuration.

16. An expandable stent for supporting a valvular prosthesis, the stent comprising:

a plurality of positioning arches configured to be positioned within a plurality of pockets of a native valve on a radially-outward side of a plurality of native valve leaflets of the native valve;

a plurality of retaining arches configured to support the valvular prosthesis on a radially-inward side of the plurality of native valve leaflets, at least one of the retaining arches comprising at least one fastening portion including a plurality of holes; and

a plurality of auxiliary arches, each auxiliary arch circumferentially interspaced between two adjacent retaining arches;

wherein each positioning arch includes a pair of arms connected to one another forming a distal open end and a proximal closed end, each arm connected at a distal end thereof to a respective connecting strut, such that each positioning arch defines a single apex between two adjacent connecting struts;

wherein each retaining arch includes a pair of arms connected to one another forming a distal open end and a proximal closed end, each arm connected at a distal end thereof to a respective connecting strut, such that each retaining arch defines a single apex between two adjacent connecting struts; and

wherein the valvular prosthesis is attached to the plurality of retaining arches such that at least a portion of the valvular prosthesis extends from the plurality of retaining arches transversely across an interior of the expandable stent.

17. The expandable stent according to claim 16, wherein the valvular prosthesis is connected to the stent via the at least one fastening portion.

18. The expandable stent according to claim 17, wherein the valvular prosthesis is connected to the at least one fastening portion via a suture extending through at least one of the holes.

19. The expandable stent according to claim 16, wherein each auxiliary arch is configured to press radially outward when the stent is implanted in a patient.

20. The expandable stent according to claim 16, wherein each positioning arch and each retaining arch includes a substantially U-shaped or V-shaped structure.

21. The expandable stent according to claim 16, further including at least one retaining head configured to releasably engage a catheter system.

22. The expandable stent according to claim 16, wherein the plurality of holes are disposed in an arm of the at least one of the retaining arches.

23. The expandable stent according to claim 16, wherein the at least one fastening portion includes a plurality of fastening portions, and each arm of each retaining arch includes one of the fastening portions.

24. The expandable stent according to claim 16, having a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein each hole of the plurality of holes has a substantially same shape in the collapsed and expanded configurations.

25. The expandable stent according to claim 16, wherein the stent includes exactly three positioning arches and exactly three retaining arches.

26. The expandable stent according to claim 16, wherein the stent includes exactly three retaining arches and exactly three auxiliary arches.

27. The expandable stent according to claim 16, having a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein each positioning arch is substantially circumferentially aligned with, and radially offset from, a corresponding retaining arch when the stent is in the expanded configuration.

28. A stent configured to transition from a collapsed configuration when being introduced into a patient'"'"'s body to an expanded configuration when implanted, comprising:

three positioning arches configured to be positioned within respective pockets of a native valve on a radially-outward side of a plurality of native valve leaflets of the native valve when the stent is in the expanded configuration;

three retaining arches, each retaining arch substantially circumferentially aligned with, and radially offset from, a corresponding positioning arch, the retaining arches configured to be positioned on a radially-inward side of the plurality of native valve leaflets, wherein at least one of the retaining arches includes at least one fastening portion comprising a plurality of holes formed in an arm of the at least one of the retaining arches; and

a plurality of auxiliary arches, each auxiliary arch interspaced between two adjacent retaining arches.