STENT FOR THE POSITIONING AND ANCHORING OF A VALVULAR PROSTHESIS IN AN IMPLANTATION SITE IN THE HEART OF A PATIENT

• US 20100191320A1
• Filed: 02/25/2010
• Published: 07/29/2010
• Est. Priority Date: 02/26/2008
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Straubinger, Helmut, Girad, Michael, Jung, Johannes, Mayer, Arnulf
• Granted Patent: US 8,398,704 B2
• Time in Patent Office: Days
• US Class Current: 623/1.15
• 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 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 2230/0054 V-shaped

Abstract

The present invention relates to a stent 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.

Claims

1. An expandable stent (10) for implantation in a patient comprising a plurality of positioning arches (15a, 15b, 15c) configured to be positioned within a plurality of pockets (T) of the patient'"'"'s native heart valve and positioned on a first side of a plurality of native heart valve leaflets, and a plurality of retaining arches (16a, 16b, 16c) configured to be positioned on a second side of the plurality of native heart valve leaflets opposite the first side.

2. The expandable stent (10) according to claim 1,

further including at least one auxiliary arch (18a, 18b, 18c) interspaced between two adjacent retaining arches (16a, 16b, 16c), wherein:

the at least one auxiliary arch (18a, 18b, 18c) includes a first arm (18a′

, 18a″

, 18b′

, 18b″

, 18c′

, 18c″

) connected at a first end thereof to a first retaining arch (16a, 16b, 16c) and a second arm (18a′

, 18a″

, 18b′

, 18b″

, 18c′

, 18c″

) connected at a first end thereof to a second retaining arch (16a, 16b, 16c); and

the first and second arms (18a′

, 18a″

, 18b′

, 18b″

, 18c′

, 18c″

) each include respective second ends connected to one another at a joint that includes at least one fastening hole configured to receive a suture.

3. The expandable stent (10) according to claim 2,

further comprising at least one additional fastening portion (11a, 11b) substantially circumferentially aligned with one of the plurality of auxiliary arches (18a, 18b, 18c), the at least one additional fastening portion (11a, 11b) including a plurality of fastening holes configured to receive a suture.

4. The expandable stent (10) according to claim 1,

further comprising at least one radial arch (32a, 32b, 32c) substantially circumferentially aligned with at least one of the plurality of positioning arches (15a, 15b, 15c).

5. The expandable stent (10) according to claim 4,

wherein the at least one radial arch (32a, 32b, 32c) includes a substantially U-shaped or V-shaped structure.

6. The expandable stent (10) according to claim 1,

further comprising a plurality of auxiliary arches (18a, 18b, 18c), each interspaced between two adjacent retaining arches (16a, 16b, 16c) 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.

7. The expandable stent (10) according to claim 6,

wherein the first and second arms of each of the plurality of auxiliary arches (18a, 18b, 18c) include respective second ends connected to one another at a connection defining a head (31) and having at least one fastening hole (12d) defined by the head (31) and configured to receive a suture.

8. The expandable stent (10) according to claim 7,

wherein the connection includes a plurality of fastening holes (12d);

and

wherein a valvular prosthesis (100) is connected to the stent (10) via at least one suture guided through at least a portion of the plurality of fastening holes.

9. The expandable stent (10) according to claim 6,

further comprising a plurality of extra arches (60a, 60b, 60c, 60d, 60e, 60f), each interspaced between a retaining arch (16a, 16b, 16c) and an adjacent auxiliary arch (18a, 18b, 18c) and including a first arm connected at a first end thereof to one arm (16a′

, 16b′

, 16c′

, 16a″

, 16b″

, 16c″

) of a retaining arch (16a, 16b, 16c) and a second arm connected at a first end thereof to one arm (18a′

, 18b′

, 18c′

, 18a″

, 18b″

, 18c″

) of an auxiliary arch (18a, 18b, 18c), wherein the first and second arms of each of the plurality of extra arches (60a, 60b, 60c, 60d, 60e, 60f) include respective second ends connected to one another at a connection defining a head.

10. The expandable stent (10) according to claim 1,

further comprising a plurality of extra arches (60a, 60b, 60c, 60d, 60e, 60f), each interspaced between a first retaining arch (16a, 16b, 16c) and an adjacent second retaining arch (16a, 16b, 16c) and including a first arm connected at a first end thereof to one arm (16a′

, 16b′

, 16c′

, 16a″

, 16b″

, 16c″

) of the first retaining arch (16a, 16b, 16c) and a second arm connected at a first end thereof to one arm (16a′

, 16b′

, 16c′

, 16a″

, 16b″

, 16c″

) of the second retaining arch (16a, 16b, 16c), wherein the first and second arms of each of the plurality of extra arches (60a, 60b, 60c, 60d, 60e, 60f) include respective second ends connected to one another at a connection defining a head.

11. The expandable stent (10) according to claim 1,

wherein each of the plurality of positioning arches (15a, 15b, 15c) includes first and second arms (15a′

, 15a″

;

15b′

, 15b″

;

15c′

, 15c″

) joined to one another at a head portion (30), and

wherein the expandable stent (10) further comprises a plurality of leaflet guard arches (50a, 50b, 50c), each interspaced between the two arms (15a′

, 15a″

;

15b′

, 15b″

;

15c′

, 15c″

) of one of the plurality of positioning arches (15a, 15b, 15c) and including a first arm and a second arm, wherein the first and second arms of each of the plurality of leaflet guard arches (50a, 50b, 50c) are connected to one another at a connection defining a head, and wherein each of the plurality of leaflet guard arches (50a, 50b, 50c) extends in the same direction as the positioning arch (15a, 15b, 15c) in between the corresponding leaflet guard arch (50a, 50b, 50c) is provided.

12. The expandable stent (10) according to claim 11,

wherein each of the plurality of leaflet guard arches (50a, 50b, 50c) includes a first arm connected at a first end thereof to the first arm (15a′

, 15b′

, 15c′

) of one positioning arch (15a, 15b, 15c) and a second arm connected at a first end thereof to the second arm (15a″

, 15b″

, 15c″

) of the positioning arch (15a, 15b, 15c), wherein the first and second arms of each of the plurality of leaflet guard arches (50a, 50b, 50c) include respective second ends connected to one another at a connection defining a head.

13. The expandable stent (10) according to claim 11,

further including at least one radial arch (32a, 32b, 32c) substantially circumferentially aligned with at least one of the plurality of positioning arches (15a, 15b, 15c), the at least one radial arch (32a, 32b, 32c) including first and second arms (32′

, 32″

) joined to one another at a radiused head portion, and

wherein each of the plurality of leaflet guard arches (50a, 50b, 50c) includes a first arm connected at a first end thereof to a first arm (32′

) of one of the at least one radial arch (32a, 32b, 32c) and a second arm connected at a first end thereof to the second arm (32″

) of the one of the at least one radial arch (32a, 32b, 32c), wherein the first and second arms of each of the plurality of leaflet guard arches (50a, 50b, 50c) include respective second ends connected to one another at a connection defining a head.

14. The expandable stent (10) according to claim 13,

wherein each arm of the plurality of leaflet guard arches (50a, 50b, 50c) merges at about the mid-point of the length of an arm of a radial arch (32a, 32b, 32c) into the arm of an opposing radial arch (32a, 32b, 32c).

15. The expandable stent (10) according to claim 1,

wherein, in the expanded state of the stent (10), the respective arms (16a′

, 16a″

, 16b′

, 16b″

, 16c′

, 16c″

) of the retaining arches (16a, 16b, 16c) have a shape that matches the leaflets of a valvular prosthesis (100) attached to the stent (10).

16. The expandable stent (10) according to claim 1,

further comprising a structure of lattice cells (70) formed by a plurality of struts in the area between the arms (16a′

, 16a″

, 16b′

, 16b″

, 16c′

, 16c″

) of two adjacent retaining arches (16a-c).

17. The expandable stent (10) according to claim 16,

further comprising a structure of lattice cells (70) formed by a plurality of struts in the area between the arms (16a′

, 16a″

, 16b′

, 16b″

, 16c′

, 16c″

) of two adjacent retaining arches (16a-c), and at least one annular collar (40) connected to each or a part of the lower end sections of the struts which are forming the structure of lattice cells (70).

18. The expandable stent (10) according to claim 17,

further comprising a plurality of eyelets (12f) uniformly distributed around the lower end section of the at least one annular collar (40) for fixing a valvular prosthesis (100) to the stent (10).

19. The expandable stent (10) according to claim 47,

wherein at least one flared or tapered section is provided only near the locations of the positioning arches (15a, 15b, 15c), wherein no flared or tapered section is provided near the regions in between the two arms (15a′

, 15a″

, 15b′

, 15b″

, 15c′

, 15c″

) of two neighboring positioning arches (15a, 15b, 15c).

20. A method of treating a native valve with a valve prosthesis (100) supported on a stent (10) including a plurality of first arches each having an open end joined to an open end of an adjacent first arch, a plurality of second arches each having an open end joined to an open end of an adjacent second arch, and at least one third arch having an open end and being interspaced between and joined to two adjacent first arches, the method comprising the steps of:

positioning the plurality of first arches within pockets of the native heart valve;

positioning at least a portion of the native heart valve between the plurality of first arches and the plurality of second arches; and

applying a radial force against a portion of a vascular wall with the at least one third arch.