Paravalvular leak occlusion device for self-expanding heart valves

Patent metadata

Field	Value
Publication number	US-2016256268-A1
Application number	US-201615155451-A
Country	US
Kind code	A1
Filing date	May 16, 2016
Priority date	Mar 12, 2013
Publication date	Sep 8, 2016
Grant date	—

Abstract

A system for replacing native valve function includes a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent. The system further includes an occluder device having an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section.

First claim

1 . (canceled)

2 . A system for replacing native valve function, the system comprising:
a prosthetic heart valve having a collapsible and expandable stent, the stent having a plurality of sections, and a valve assembly disposed in the stent; and an occluder device comprising an expandable body having a first end and a second end, a fastener coupled to the first end of the body and to a portion of the stent at a first position adjacent a first section of the stent, and a disk coupled to the second end of the body and to a portion of the stent at a second position in a section other than the first section.

3 . The system of claim 2 , wherein the stent includes an annulus section, a transition section, and an aortic section.

4 . The system of claim 2 , wherein the disk is expandable from a collapsed configuration to a relaxed configuration.

5 . The system of claim 4 , wherein the stent includes a plurality of cells, and the disk, in the relaxed configuration, has a size larger than a size of at least some of the cells of the stent and incapable of passing therethrough.

6 . The system of claim 2 , wherein the stent includes a plurality of struts and the fastener is coupled to at least one of the plurality of the struts.

7 . The system of claim 2 , wherein the body includes at least one of a metallic mesh or a shape-memory material.

8 . The system of claim 2 , wherein the body has an elliptical longitudinal cross-section.

9 . The system of claim 2 , wherein the body includes a metal mesh and polyester fiber intertwined with the metal mesh.

10 . The system of claim 2 , wherein the fastener includes a loop of wire.

11 . The system of claim 2 , wherein the disk is expandable and includes at least one of a metallic mesh or a shape-memory material.

12 . The system of claim 2 , further comprising:
a connector attached to the disk for coupling to a delivery device.

13 . The system of claim 2 , wherein the body includes multiple segments, each segment being capable of independent radial expansion from the other segments.

14 . The system of claim 2 , further comprising:
a delivery system including an outer sheath, an inner wire disposed within and translatable with respect to the outer sheath, and a connector attached to the inner wire, the connector being configured to couple the inner wire to the disk of the occluder device.

15 . The system of claim 14 , wherein the outer sheath is adapted to house the occluder device in a contracted configuration, and the outer sheath is sized to pass through a cell of the expandable stent.

16 . A method for occluding a gap between a prosthetic heart valve and adjacent body tissue, the method comprising:
delivering an occluder to the heart valve, the occluder including (i) an expandable body, (ii) a fastener coupled to one end of the body, and (iii) an expandable disk coupled to another end of the body; coupling the fastener to one end of the prosthetic heart valve; and coupling the expandable disk to the prosthetic heart valve at a position spaced from the one end.

17 . The method of claim 16 , wherein the step of coupling the fastener includes positioning a loop around an apex of a cell at the one end of the prosthetic heart valve.

18 . The method of claim 16 , wherein the step of coupling the disk includes disposing the disk on an outside of at least one cell of the stent such that the disk cannot pass therethrough.

19 . The method of claim 16 , wherein delivering the occluder comprises disposing the occluder within a delivery system and advancing the delivery system to the heart valve.

20 . The method of claim 19 , further comprising:
coupling the expandable disk to an inner wire of the delivery system.

21 . The method of claim 20 , further comprising:
decoupling the expandable disk from the inner wire after coupling the expandable disk to the heart valve.

Assignees

• St Jude Medical Cardiology Div Inc

Inventors

• Dakin Gregory James

Classifications

• A61F2250/0069

  Sealing means · CPC title

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61B17/12118

  for positioning in conjunction with a stent · CPC title

• A61F2310/00011

  Metals or alloys · CPC title

• A61F2210/0014

  using shape memory or superelastic materials, e.g. nitinol · CPC title