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

• US 9,168,130 B2
• Filed: 10/08/2008
• Issued: 10/27/2015
• 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:
  US12/285,544
• Publication Number:
  US 20090216310A1
• Time in Patent Office: 2,575 Days
• Field of Search: 623/1.11, 623 211- 242, 606/108
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/844 folded prior to deployment
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0023 triangular

Abstract

An expandable stent including a plurality of positioning arches configured to be positioned within a plurality of pockets of a native heart valve and positioned on a first side of a plurality of native heart valve leaflets, a plurality of retaining arches configured to be positioned on a second side of the plurality of native heart valve leaflets opposite the first side, and at least one radial arch substantially circumferentially aligned with at least one of the plurality of positioning arches.

Claims

1. An expandable stent comprising a plurality of positioning arches configured to be positioned within a plurality of pockets of a native valve on a first side of a 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 opposite the first side, such that the plurality of native valve leaflets are positioned radially inward of at least a portion of the positioning arches and radially outward of at least a portion of the plurality of retaining arches when the expandable stent is implanted, and at least one radial arch substantially circumferentially aligned with at least one of the positioning arches, the at least one radial arch having a closed distal end positioned distally of the retaining arches;

wherein each retaining arch is associated and substantially circumferentially aligned with a corresponding positioning arch and has a distal end portion adjacent and joined to a distal end portion of the corresponding positioning arch; 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 of the plurality of positioning arches and the at least one radial arch includes a substantially U-shaped or V-shaped structure.

3. The expandable stent according to claim 1, wherein each retaining arch includes first and second arms joined to one another at a proximal closed end.

4. The expandable stent according to claim 1, further including a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein the at least one radial arch is configured to press radially against a vascular wall.

5. The expandable stent according to claim 1, further including at least one auxiliary arch between two adjacent retaining arches, wherein the at least one auxiliary arch includes a first arm connected to a first retaining arch and a second arm connected to a second retaining arch.

6. The expandable stent according to claim 5, wherein the first and second arms of the at least one auxiliary arch are connected to one another at a joint that includes a plurality of fastening holes, and wherein the valve prosthesis is connected to the stent via at least one suture extending through at least one of the fastening holes.

7. The expandable stent according to claim 1, wherein the at least one radial arch includes first and second arms joined to one another at a rounded head portion defined by the closed distal end.

8. The expandable stent according to claim 1, wherein the at least one radial arch includes a plurality of radial arches.

9. The expandable stent according to claim 8, wherein the plurality of radial arches comprises three radial arches.

10. The expandable stent according to claim 9, wherein the plurality of positioning arches comprises three positioning arches, and the plurality of retaining arches comprises three retaining arches.

11. The expandable stent according to claim 8, wherein each positioning arch of the plurality of positioning arches and each radial arch of the plurality of radial arches includes a closed end, and the closed end of a respective positioning arch is substantially circumferentially aligned with the closed end of an associated radial arch.

12. The expandable stent according to claim 11, wherein each retaining arch of the plurality of retaining arches has a closed proximal end.

13. An expandable stent comprising:

a plurality of positioning arches configured to be positioned within a plurality of pockets of a native valve on a first side of a 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 opposite the first side, such that the plurality of native valve leaflets are positioned radially inward of at least a portion of the 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 disposed between two adjacent retaining arches and including a first arm connected at a first end thereof to a first retaining arch and a second arm connected at a first end thereof to a second retaining arch, wherein the first and second arms of each auxiliary arch include respective second ends connected to one another at a proximal head portion defining at least one fastening hole and configured to receive a suture,

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,

wherein each respective connecting strut interconnects the distal end of an arm of a positioning arch to the distal end of an arm of a corresponding retaining arch, 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.

14. The expandable stent according to claim 13, wherein the head portion of each auxiliary arch defines a plurality of fastening holes, and the valve prosthesis is connected to the stent via at least one suture extending through at least one of the fastening holes.

15. The expandable stent according to claim 13, wherein each retaining arch of the plurality retaining arches includes a first arm connected at a first end thereof to a first positioning arch and a second arm connected at a first end thereof to a second positioning arch;

and

each of the first and second arms of each retaining arch includes a bent portion having a shape substantially complimentary to at least a part of the head portion of an adjacent auxiliary arch.

16. The expandable stent according to claim 15, further including a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein each bent portion of the first and second arms of the retaining arches includes a concave portion to accommodate the head portion of an adjacent auxiliary arch when the stent is in the collapsed configuration.

17. The expandable stent according to claim 13, wherein each auxiliary arch of the plurality of auxiliary arches includes a notch configured to receive a suture.

18. The expandable stent according to claim 17, having a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation, wherein the notch of each auxiliary arch has a shape complementary to at least a portion of an adjacent retaining arch when the stent is in the collapsed configuration.

19. The expandable stent according to claim 13, wherein the plurality of positioning arches comprises three positioning arches, the plurality of retaining arches comprises three retaining arches, and the plurality of auxiliary arches comprises three auxiliary arches.

20. The expandable stent according to claim 13, further including a plurality of radial arches, wherein each radial arch includes a pair of arms connected to one another at distal ends thereof forming a distal closed end and a proximal open end, each arm connected at a proximal end thereof to one of the arms of a respective positioning arch, such that each radial arch defines a single apex between the arms of the positioning arch.

21. An expandable stent comprising:

a plurality of positioning arches configured to be positioned within a plurality of pockets of a native valve radially outward of a plurality of native valve leaflets when the stent is implanted, 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;

a plurality of retaining arches configured to support a valve prosthesis and to be positioned radially inward of the plurality of native valve leaflets when the stent is implanted, 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;

wherein each connecting strut directly interconnects the distal end of an arm of a respective positioning arch and the distal end of an arm of a respective retaining arch;

at least one auxiliary arch between two adjacent retaining arches, the auxiliary arch including 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 retaining arch such that the auxiliary arch defines a single apex between the two adjacent retaining arches; and

at least one radial arch including a pair of arms connected to one another forming a proximal open end and a distal closed end.

22. The expandable stent according to claim 21, wherein the valve prosthesis is made from pericardium.

23. The expandable stent according to claim 21, comprising three auxiliary arches, three radial arches, three positioning arches, and three retaining arches.

24. The expandable stent according to claim 21,

wherein the at least one auxiliary arch includes a plurality of auxiliary arches, each auxiliary arch disposed between two adjacent retaining arches and including 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 retaining arch, such that each auxiliary arch defines a single apex between the two adjacent retaining arches;

and

wherein the proximal closed end of each auxiliary arch defines a head portion having at least one fastening hole formed therein and configured to receive a suture.

25. The expandable stent according to claim 21, wherein the arms of each retaining arch include a plurality of fastening holes configured to receive a suture.

26. The expandable stent according to claim 21, wherein the at least one radial arch includes a plurality of radial arches, each radial arch including a pair of arms connected to one another forming a proximal open end and a distal closed end, each arm connected at a proximal end thereof to one of the arms of a respective positioning arch, such that each radial arch defines a single apex between the arms of the positioning arch.

27. An expandable stent comprising:

a plurality of positioning arches configured to be positioned within a plurality of pockets of a native heart valve on a first side of a plurality of native heart valve leaflets;

a plurality of retaining arches configured to support a valve prosthesis on a second side of the plurality of native heart valve leaflets opposite the first side, such that the plurality of native valve leaflets are positioned radially inward of at least a portion of the positioning arches and radially outward of at least a portion of the plurality of retaining arches when the expandable stent is implanted;

at least one auxiliary arch circumferentially disposed between adjacent retaining arches; and

at least one radial arch substantially circumferentially aligned with a respective positioning arch;

wherein each retaining arch is associated and substantially circumferentially aligned with a corresponding positioning arch and has a distal end portion adjacent and joined to a distal end portion of the corresponding positioning arch, each retaining arch including a pair of arms that include a plurality of fastening holes configured to receive a suture; 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.

28. The expandable stent according to claim 27, having a collapsed configuration for introduction into a patient'"'"'s body and an expanded configuration for implantation.

29. The expandable stent according to claim 27, wherein the valve prosthesis is made from pericardium.

30. The expandable stent according to claim 27, comprising three auxiliary arches, three radial arches, three positioning arches, and three retaining arches.

31. The expandable stent according to claim 27, wherein the at least one auxiliary arch includes a plurality of auxiliary arches, each auxiliary arch being disposed between two adjacent retaining arches and including a pair of arms connected to one another forming a distal open end and a proximal closed end, the closed end defining a head portion having at least one fastening hole formed therein and configured to receive a suture.