Prosthetic heart valve and systems and methods for delivering the same

• US 10,463,494 B2
• Filed: 09/24/2015
• Issued: 11/05/2019
• Est. Priority Date: 04/02/2013
• Status: Active Grant

• Current Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Tendyne Holdings Inc. (Abbott Laboratories Incorporated)
• Inventors: Christianson, Mark, Tegels, Zachary J., Ekvall, Craig A., Vidlund, Robert M.
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Gabr, Mohamed G
• Application Number:
  US14/864,035
• Publication Number:
  US 20160008131A1
• Time in Patent Office: 1,503 Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/083 Clips, e.g. resilient
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00243 cardiac
• 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped

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.

Claims

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 adapted to capture a native valve leaflet such that the native valve leaflet is directly engaged 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 suture 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 suture configured to allow a user to transition the leaflet clip from the first configuration to the 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 suture is a first suture, 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 heart, 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 suture 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 suture configured to allow a user to transition the second leaflet clip from the first configuration to the 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.

4. The prosthetic heart valve of claim 3, wherein the second leaflet clip is configured to capture a native posterior leaflet.

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 a 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 being greater than the first width.

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

13. The prosthetic heart valve of claim 1, further comprising:

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 suture is disposed in the lumen of the anchoring tether.

15. The prosthetic heart valve of claim 1, wherein the suture has two ends, the suture being configured to be looped through a portion of the leaflet clip when the body is disposed in the native annulus of the atrioventricular valve of the heart such that the two ends of the suture are disposed outside the atrioventricular valve of the heart.

16. The prosthetic heart valve of claim 1, wherein the suture is configured to allow the user to transition the leaflet clip from the first configuration to the second configuration when the body is disposed in the native annulus of the atrioventricular valve of the heart by applying a proximal force to ends of the suture.

17. The prosthetic heart valve of claim 1, wherein the suture is configured to be in direct physical contact with the leaflet clip when the suture is operably coupled to the leaflet clip.

18. The prosthetic heart valve of claim 1, wherein the proximal end of the valve body is flared radially outward when expanded and configured to engage tissue of the atrium when the body is disposed in the native annulus of the atrioventricular valve of the heart.

19. 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 an elongated condition in which the prosthetic valve can be inserted into a heart, and a folded condition in which the leaflet clip is adapted to capture a native valve leaflet such that the native valve leaflet is directly engaged between the leaflet clip and the body when the body is disposed in a native annulus of an atrioventricular valve of a heart;

a suture 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 suture configured to allow a user to transition the leaflet clip from the elongated condition to the folded condition.

20. A prosthetic heart valve comprising:

a self-expanding wire frame body including a proximal end and a distal end, and defining a length between the proximal and distal ends;

a valve disposed in the body;

a leaflet clip having a first end attached to the body and a second free end, the leaflet clip being transitionable between a first condition in which free end extends substantially in a distal direction, and a second condition in which the free end extends in a proximal direction and the leaflet clip is adapted to capture a native valve leaflet such that the native valve leaflet is directly engaged 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 suture 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 suture being configured to allow a user to transition the leaflet clip from the first condition to the second condition.