Mitral valve inversion prostheses

Patent metadata

Field	Value
Publication number	US-11504238-B2
Application number	US-202017081128-A
Country	US
Kind code	B2
Filing date	Oct 27, 2020
Priority date	Sep 14, 2012
Publication date	Nov 22, 2022
Grant date	Nov 22, 2022

Abstract

Systems, devices and methods for resizing a valve annulus are described. An implant is delivered proximate a mitral valve, the implant comprising a tubular body and a plurality of piercing helical anchors, the tubular body comprising an proximal diameter and a distal diameter. Tissue proximate the mitral valve is engaged by rotating the plurality of anchors with corresponding rotational drivers. The tubular body may be transitioned from a first structural configuration having the proximal diameter smaller than the distal diameter to a second structural configuration having the proximal diameter larger than the distal diameter.

First claim

The invention claimed is:

1. A method for reducing the diameter of a mitral valve, the method comprising:
inserting an implant proximate a mitral valve, the implant comprising a tubular body having an upper portion and a lower portion and a plurality of piercing members extending from the lower portion;
engaging the plurality of piercing members with tissue proximate the mitral valve on a first side of the mitral valve;
coupling at least one of the plurality of piercing members with a location ring that is positioned on a second side of the mitral valve; and
reducing the diameter of the lower portion of the tubular body of the implant to reduce the diameter of the mitral valve.

2. The method of claim 1 , further comprising transitioning the tubular body from a collapsed structural configuration allowing the tubular body to fit into a sheath to an expanded structural configuration to engage tissue proximate the mitral valve.

3. The method of claim 2 , wherein transitioning the tubular body to an expanded structural configuration further comprises applying an expansive force to the tubular body.

4. The method of claim 3 , wherein applying an expansive force comprises applying an expansive force via a ring positioned within the tubular body.

5. The method of claim 4 , wherein the ring is expandable, the method further comprising expanding the expandable ring to transition the tubular body to the expanded structural configuration.

6. The method of claim 1 , wherein engaging tissue further comprises applying vibration to at least one of the plurality of piercing members, the tissue proximate the mitral valve on a same side of the mitral valve as the implant, or the tissue proximate the mitral valve on a side of the mitral valve opposite the implant.

7. The method of claim 1 , wherein at least one of the plurality of piercing members is covered during the insertion of the implant proximate the mitral valve.

8. The method of claim 1 , wherein at least one of the plurality of piercing members engages the tissue proximate the mitral valve before another of the plurality of piercing members.

9. The method of claim 1 , further comprising positioning the implant where the mitral valve hinge meets the left ventricle and the left atrium meets the mitral valve.

10. The method of claim 1 , further comprising viewing the location ring via fluoroscopy or echo guidance to confirm a positive location for the implant to be located with respect to the mitral valve annulus.

11. The method of claim 1 , further comprising coupling at least one of the plurality of piercing members to the location ring by extending the piercing member through the heart valve annulus to connect the piercing member with the location ring.

12. The method of claim 1 , wherein:
engaging the plurality of piercing members with tissue proximate the mitral valve is performed from within the left atrium; and
coupling at least one of the plurality of piercing members with a location ring comprises engaging the location ring within the left ventricle.

13. A system comprising:
a guide wire;
a sheath for sliding over the guide wire;
an implant for delivery to a body by traveling through the sheath and along the guide wire,
the implant comprising a tubular body comprising an upper portion and a lower portion;
a plurality of piercing members connected to the lower portion of the tubular body; and
a location ring configured to be located on a side of the mitral valve opposite the implant and viewable via imaging guidance to confirm the location of the implant with respect to the location ring.

14. The system of claim 13 , wherein at least one of the plurality of piercing members is coupled to the location ring.

15. The system of claim 13 , wherein at least one of the plurality of piercing members is coupled to the implant with a hinged attachment.

16. The system of claim 13 , further comprising a catheter configured to be introduced through the sheath for engaging the plurality of piercing members to cause the plurality of piercing members to penetrate the tissue proximate the mitral valve.

17. The system of claim 13 , where the location ring is configured to be removed from the heart after the implant is positioned and the piercing members penetrate the heart valve annulus.

18. The system of claim 13 , further comprising an intracardiac echo catheter for visualizing a position of at least one of the implant or the location ring.

19. An implant for reducing the size of a heart valve annulus, the implant comprising:
a tubular body having an upper portion and a lower portion, the upper portion configured to be free in the left atrium and the lower portion configured to engage tissue around a heart valve, the tubular body including a plurality of piercing members connected to the lower portion of the tubular body and configured to engage tissue proximate the heart valve annulus; and
a location ring configured to be located on a side of the mitral valve opposite the tubular body;
wherein at least one of the plurality of piercing members is positioned to first extend through tissue of the mitral valve and then to couple with the location ring.

Assignees

• Boston Scient Scimed Inc

Inventors

• Lashinski Randall

Classifications

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2466 Primary

  Delivery devices therefor · CPC title

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2445

  Annuloplasty rings in direct contact with the valve annulus · CPC title

• A61F2/2442

  Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve · CPC title