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

• US 9,265,631 B2
• Filed: 09/21/2012
• Issued: 02/23/2016
• 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): Sweet, Thomas J
• Assistant Examiner(s): Schall, Matthew
• Application Number:
  US13/624,148
• Publication Number:
  US 20130079869A1
• Time in Patent Office: 1,250 Days
• Field of Search: 623/1.26
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/008 Means for testing implantable prostheses

Abstract

The present invention relates to a stet for the positioning and anchoring of a valvular prosthesis 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 fastened to a stent will occur relative the stent in the implanted state of the stent, even given the peristaltic motion of the heart, the stent according to the invention comprises at least one fastening portion via which the valvular prosthesis is connectable to the stent. 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 web. The stent moreover comprises at least one auxiliary retaining arch which connects the respective arms of the at least one retaining arch connected to the at least one positioning arch.

Claims

1. A stent, comprising:

a lattice skirt, having a plurality of closed cells extending around a circumference of the stent and disposed at a first end of the stent;

a plurality of first arches, each having an apex projecting toward the first end of the stent and configured to be disposed within a sinus pocket of a native valve radially outward of a plurality of leaflets of the native valve when the stent is implanted;

a first set of retaining arms, wherein respective first ends of each of the retaining arms of the first set are joined to the lattice skirt, and wherein respective second ends of each of the retaining arms of the first set are joined to one another;

a second set of retaining arms, wherein respective first ends of each of the retaining arms of the second set are joined to the lattice skirt, and wherein respective second ends of each of the retaining arms of the second set are joined to one another;

a first pair of struts, wherein respective first ends of each of the struts of the first pair are joined to the lattice skirt, and wherein respective second ends of each of the struts of the first pair of struts are joined to a portion of a retaining arm of the first set of retaining arms between the first and second ends of the respective retaining arm; and

a second pair of struts, wherein respective first ends of each of the struts of the second pair are joined to the lattice skirt, and wherein respective second ends of each of the struts of the second pair of struts are joined to a portion of a retaining arm of the second set of retaining arms between the first and second ends of the respective retaining arm.

2. The stent of claim 1, further including a prosthetic valve attached directly to the first set of retaining arms and the second set of retaining arms and extending transversely across an interior of the stent.

3. The stent of claim 2, wherein:

the prosthetic valve includes a plurality of leaflets, a first commissure disposed between two adjacent leaflets, and a second commissure disposed between two adjacent leaflets; and

the first commissure is circumferentially aligned with the first set of retaining arms and the second commissure is circumferentially aligned with the second set of retaining arms.

4. The stent of claim 2, wherein the prosthetic valve includes three leaflets and three commissures.

5. The stent of claim 1, wherein the second ends of the respective retaining arms of both the first and second sets of retaining arms project away from the lattice skirt toward a second end of the stent opposite the first end.

6. The stent of claim 1, further including a plurality of second arches, having an apex projecting toward a second end of the stent, wherein respective ones of the plurality of second arches are circumferentially aligned with and joined to respective ones of the plurality of first arches.

7. The stent of claim 6, further including a plurality of closed cells, each closed cell formed by a respective one of the plurality of second arches joined to a respective one of the plurality of first arches.

8. The stent of claim 6, wherein the plurality of second arches are disposed at a second end of the stent, opposite the first end, such that the lattice skirt forms a proximalmost end of the stent and the plurality of second arches form at least a portion of the distalmost end of the stent.

9. The stent of claim 1, wherein the lattice skirt includes a first end disposed adjacent and joined to the respective first ends of the retaining arms of the first and second sets of retaining arms and a second end opposite the first end that defines a proximalmost end of the stent.

10. The stent of claim 1, wherein the lattice skirt includes at least two rows of closed cells.

11. The stent of claim 1, wherein the retaining arms of the first and second sets of retaining arms include a plurality of suture holes.

12. The stent of claim 1, further including a first supporting strut circumferentially aligned with the first set of retaining arms and disposed circumferentially and longitudinally between the respective arms of the first set of retaining arms and the respective struts of the first pair of struts.

13. The stent of claim 12, wherein the first supporting strut is connected only to the retaining arms of the first set of retaining arms.

20. The stent of claim 13, further including a plurality of engagement heads respectively joined to respective second ends of the retaining arms of the first and second sets of retaining arms, the plurality of engagement heads forming a portion of the distalmost end of the stent, wherein the plurality of engagement heads are configured to engage and selectively retain the stent to a catheter.

14. A stent, comprising:

a lattice skirt, having a plurality of closed cells extending around a circumference of the stent and disposed at a first end of the stent and defining a proximalmost end of the stent;

a plurality of first arches, each having an apex projecting toward the first end of the stent and configured to be disposed radially outward of a plurality of leaflets of a native valve when the stent is implanted;

a first set of retaining arms, wherein respective first ends of each of the retaining arms of the first set are joined to the lattice skirt, and wherein respective second ends of each of the retaining arms of the first set are joined to one another;

a second set of retaining arms, wherein respective first ends of each of the retaining arms of the second set are joined to the lattice skirt, and wherein respective second ends of each of the retaining arms of the second set are joined to one another;

a plurality of second arches, having an apex projecting toward a second end of the stent, opposite the first end, wherein respective ones of the plurality of second arches are circumferentially aligned with and joined to respective ones of the plurality of first arches and forming at least a portion of a distalmost end of the stent; and

a prosthetic tissue valve attached directly to the first set of retaining arms and the second set of retaining arms.

15. The stent of claim 14, further including:

a first pair of struts, wherein respective first ends of each of the struts of the first pair are joined to the lattice skirt, and wherein respective second ends of each of the struts of the first pair of struts are joined to a portion of a retaining arm of the first set of retaining arms between the first and second ends of the respective retaining arm; and

a second pair of struts, wherein respective first ends of each of the struts of the second pair of struts are joined to the lattice skirt, and wherein respective second ends of each of the struts of the second pair are joined to a portion of a retaining arm of the second set of retaining arms between the first and second ends of the respective retaining arm.

16. The stent of claim 15, further including a first supporting strut circumferentially aligned with the first set of retaining arms and disposed circumferentially and longitudinally between the respective arms of the first set of retaining arms and the respective struts of the first pair of struts.

17. The stent of claim 16, wherein the second ends of the respective retaining arms of both the first and second sets of retaining arms project away from the lattice, toward a second end of the stent opposite the first end.

18. The stent of claim 17, wherein:

the prosthetic valve includes a plurality of leaflets, a first commissure disposed between two adjacent leaflets, and a second commissure disposed between two adjacent leaflets; and

the first commissure is circumferentially aligned with the first set of retaining arms, and the second commissure is circumferentially aligned with the second set of retaining arms.

19. The stent of claim 18, wherein the prosthetic valve includes three leaflets and three commissures.