Prosthetic heart valve and systems and methods for delivering the same

Patent metadata

Field	Value
Publication number	US-2016008131-A1
Application number	US-201514864035-A
Country	US
Kind code	A1
Filing date	Sep 24, 2015
Priority date	Apr 2, 2013
Publication date	Jan 14, 2016
Grant date	—

Abstract

A prosthetic heart valve includes a self-expanding wire frame body, a valve disposed in the body, a leaflet clip coupled to the body, and a control element operably coupled to the leaflet clip. The body has a proximal end and a distal end. The leaflet clip is configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the wire frame body when the body is disposed in a native annulus of an atrioventricular valve of a heart. The control element extends from the leaflet clip through a ventricle of the heart and out a wall of the ventricle to allow a user to transition the leaflet clip from its first configuration to its second configuration.

First claim

1 . A prosthetic heart valve comprising:
a self-expanding wire frame body having a proximal end and a distal end; a valve disposed in the body; a leaflet clip coupled to the body and configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into a heart, and a second configuration in which the leaflet clip is disposed to capture a native valve leaflet between the leaflet clip and the body when the body is disposed in a native annulus of an atrioventricular valve of a heart; and a control element operably coupled the leaflet clip and having a length sufficient to extend from the leaflet clip through a ventricle of the heart and out a wall of the ventricle when the body is disposed in the native annulus of the atrioventricular valve of the heart, the control element configured to allow a user to transition the leaflet clip from its first configuration to its second configuration when the body is disposed in the native annulus of the atrioventricular valve of the heart.

2 . The prosthetic heart valve of claim 1 , wherein the leaflet clip is a first leaflet clip and the control element is a first control element, the prosthetic heart valve further comprising:
a second leaflet clip coupled to the body and configured to be transitioned between a first configuration in which the prosthetic valve can be inserted into the body, and a second configuration in which the second leaflet clip is disposed to capture a native valve leaflet between the second leaflet clip and the body when the body is disposed in the native annulus of the atrioventricular valve of the heart; and a second control element operably coupled the second leaflet clip and having a length sufficient to extend from the second leaflet clip through the ventricle of the heart and out the wall of the ventricle when the body is disposed in the native annulus of the atrioventricular valve of the heart, the second control element configured to allow a user to transition the second leaflet clip from its first configuration to its second configuration when the body is disposed in the native annulus of the atrioventricular valve of the heart.

3 . The prosthetic heart valve of claim 2 , wherein the first leaflet clip is configured to capture a native anterior leaflet between the first leaflet clip and the body when the body is disposed in the native annulus of the atrioventricular valve of the heart.

4 . The prosthetic heart valve of claim 3 , wherein the second leaflet clip is configured to capture a native posterior leaflet between the first leaflet clip and the body when the body is disposed in the native annulus of the atrioventricular valve of the heart.

5 . The prosthetic heart valve of claim 2 , wherein the first leaflet clip and the second leaflet clip are each configured to capture the same native leaflet when the body is disposed in the native annulus of the atrioventricular valve of the heart.

6 . The prosthetic heart valve of claim 1 , wherein the leaflet clip includes a covering disposed on at least a portion of the leaflet clip.

7 . The prosthetic heart valve of claim 6 , wherein the covering defines an aperture to allow blood to flow through the aperture between the atrium and the ventricle during deployment of the body.

8 . The prosthetic heart valve of claim 1 , wherein the leaflet clip is symmetric with respect to an axis defined by the body.

9 . The prosthetic heart valve of claim 1 , wherein the leaflet clip is asymmetric with respect to an axis defined by the body.

10 . The prosthetic heart valve of claim 1 , wherein the leaflet clip has a first end and a second end, the first end being attached to the body, the leaflet clip having a length that is less than the length of the body such that the second end of the leaflet clip is spaced a non-zero distance from the native annulus in the second configuration.

11 . The prosthetic heart valve of claim 1 , wherein the leaflet clip has a first width in the first configuration and a second width in the second configuration, the second width greater than the first width.

12 . The prosthetic heart valve of claim 1 , wherein the control element is a suture configured to be removable from the leaflet clip after the leaflet clip is transitioned to its second configuration.

13 . The prosthetic heart valve of claim 1 , further comprising:
a plurality of self-expanding atrial anchoring elements distributed circumferentially about, and extending radially outwardly from, the proximal end of the body; and an anchoring tether attached to the distal end of the body and having a length sufficient to extend from the distal end of the body through the ventricle of the heart and out the wall of the ventricle when the body is disposed in a native annulus of an atrioventricular valve of the heart.

14 . The prosthetic heart valve of claim 13 , wherein at least a portion of the anchoring tether defines a lumen and at least a portion of the control element is disposed in the lumen of the anchoring tether.

15 . A method comprising:
delivering to a native annulus of an atrioventricular valve of a heart a prosthetic valve having a self-expanding body having a proximal end and a distal end, a valve disposed in the body, and a leaflet clip coupled to the body and movable between a first configuration and a second configuration, and a control element operably coupled to the leaflet clip, the delivering including disposing the leaflet clip and the control element on a ventricular side of the native annulus; disposing the leaflet clip in the first configuration; allowing the body to self-expand into engagement with the native annulus; disposing a portion of the control element outside the heart; and with the control element, releasing tension to allow the leaflet clip to transition between the first configuration and the second configuration to capture a native valve leaflet between the leaflet clip and the body.

16 . The method of claim 15 , further comprising:
with the control element, applying tension on the control element to transition the leaflet clip from the second configuration to a third configuration to allow repositioning of the prosthetic valve in the native annulus.

17 . The method of claim 15 , wherein the leaflet clip is a first leaflet clip and the prosthetic valve includes a second leaflet clip, the method further comprising:
with the control element, releasing tension to allow the second leaflet clip to transition between a first configuration and a second configuration to capture a native valve leaflet between the second leaflet clip and the body.

18 . The method of claim 15 , wherein the leaflet clip is a first leaflet clip, the control element is a first control element, and the prosthetic heart valve includes a second leaflet clip, the method further comprising:
with the second control element, releasing tension to allow the second leaflet clip to transition between a first configuration and a second configuration to capture a native valve leaflet between the leaflet clip and the body.

19 . The method of claim 18 , wherein the first leaflet clip is configured to capture a first native valve leaflet between the leaflet clip and the body, and the second leaflet clip is configured to capture a second native valve leaflet between the leaflet clip and the body, the second native valve leaflet different than the first native valve leaflet.

20 . The method of claim 19 , wherein the anchoring tether defines an axis when tension is appli

Assignees

• Tendyne Holdings Inc

Inventors

• Christianson Mark
• Tegels Zachary J
• Ekvall Craig A
• Vidlund Robert M

Classifications

• A61F2/2466

  Delivery devices therefor · CPC title

• A61F2002/9528

  for retrieval of stents · CPC title

• A61B17/0644

  penetrating the tissue, deformable to closed position · CPC title

• A61F2/2487

  Devices within the heart chamber, e.g. splints · CPC title

• A61B17/1227

  Spring clips · CPC title