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

• US 10,702,382 B2
• Filed: 11/26/2018
• Issued: 07/07/2020
• Est. Priority Date: 02/26/2008
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Straubinger, Helmut, Jung, Johannes, Girard, Michael J., Mayer, Arnulf
• Primary Examiner(s): Stewart, Jason-Dennis N
• Application Number:
  US16/199,763
• Publication Number:
  US 20190224007A1
• Time in Patent Office: 589 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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

A method of placing an implant including a stent at a native heart valve site includes orienting an expandable body of the stent such that a first open end of the stent is upstream a second open end of the stent relative to a direction of blood flow through a native heart valve. The native heart valve includes native leaflets and an annulus. The method also includes radially expanding a plurality of positioning arches positioned around an outer perimeter of the expandable body. The method additionally includes inserting the plurality of positioning arches respectively within a plurality of pockets defined by leaflets of the native heart valve and a heart structure from which the native leaflets extend. The method further includes radially expanding the first open end of the stent into a position upstream of the annulus and out of contact with nerve bundles.

Claims

1. A method of placing an implant comprising a stent at a native heart valve site, the method comprising:

orienting an expandable body of the stent such that a first open end of the stent is upstream a second open end of the stent relative to a direction of blood flow through a native heart valve, the native heart valve comprising native leaflets and an annulus;

radially expanding a plurality of positioning arches positioned around an outer perimeter of the expandable body;

inserting the plurality of positioning arches respectively within a plurality of pockets defined by the native leaflets and a heart structure from which the native leaflets extend; and

radially expanding the first open end of the stent into a position upstream of the annulus and out of contact with nerve bundles.

2. The method of claim 1, wherein radially expanding the first open end into the position upstream of the annulus comprises radially expanding the first open end into a position that is less than about 10 mm upstream from the annulus.

3. The method of claim 1, wherein radially expanding the first open end into the position upstream of the annulus comprises radially expanding the first open end into a position that is less than about 6 mm upstream from the annulus.

4. The method of claim 1, wherein radially expanding the first open end comprises radially expanding a plurality of retaining arches into contact with a vascular wall.

5. The method of claim 4, wherein radially expanding the plurality of retaining arches comprises positioning the native leaflets between the plurality of positioning arches and the plurality of retaining arches.

6. The method of claim 1, wherein radially expanding the first open end comprises radially expanding an annular collar into contact with a vascular wall.

7. The method of claim 6, wherein radially expanding the annular collar comprises radially expanding at least one row of closed cells, the closed cells being circumferentially disposed around a longitudinal axis of the stent.

8. The method of claim 1, wherein the native heart valve is an aortic valve and the native leaflets are aortic cusps, and wherein inserting the plurality of positioning arches respectively within the plurality of pockets comprises contacting outflow surfaces of the aortic cusps with the plurality of positioning arches.

9. The method of claim 1, wherein radially expanding the plurality of positioning arches comprises radially expanding three positioning arches.

10. The method of claim 9, wherein inserting the plurality of positioning arches respectively within the plurality of pockets comprises inserting each of the three positioning arches within a respective pocket defined by one of the native leaflets and the heart structure from which the native leaflet extends.

11. The method of claim 1, wherein radially expanding the first open end of the stent comprises radially expanding the first open end to a diameter ranging from about 22 mm to about 33 mm.

12. A method of placing an implant comprising a stent at a native heart valve site, the method comprising:

orienting an expandable body of the stent such that a first stent segment of the stent is upstream of a second stent segment of the stent relative to a direction of blood flow through a native heart valve, the native heart valve comprising native leaflets and an annulus;

aligning regions of the second stent segment having a first strut density with respective commissures of the native heart valve; and

aligning regions of the second stent segment having a second strut density with respective cusps of the native heart valve, wherein the first strut density is different than the second strut density.

13. The method of claim 12, wherein the first strut density is higher than the second strut density.

14. The method of claim 12, further comprising radially expanding the first stent segment against a vascular wall of the native heart valve site.

15. The method of claim 12, further comprising radially expanding an inflow end of the stent more than an oppositely disposed, outflow end of the stent.

16. The method of claim 15, wherein radially expanding the inflow end of the stent comprises radially expanding the inflow end of the stent to a diameter ranging from about 22 mm to about 33 mm.

17. The method of claim 12, wherein the implant comprises a valvular prosthesis carried by the stent, the valvular prosthesis comprising a plurality of prosthetic valve leaflets attached to the stent and further comprising:

locating the regions of the second stent segment having the first strut density on an inflow side of the valvular prosthesis; and

locating the regions of the second stent segment having the second strut density on an outflow side of the valvular prosthesis.

18. The method of claim 12, further comprising:

applying a first radial force against a first portion of a vascular wall with the first stent segment; and

applying a second radial force against a second portion of the vascular wall with the second stent segment, wherein the first radial force is greater than the second radial force.

19. The method of claim 18, wherein applying the first radial force comprises uniformly distributing the first radial force along the first portion of the vascular wall via a plurality of closed cell structures of the first stent segment.

20. The method of claim 12, wherein aligning the regions of the second stent segment having the first strut density with the respective commissures of the native heart valve comprises minimizing blood leakage through the native heart valve.