Prosthetic heart valve and systems and methods for delivering the same

Patent metadata

Field	Value
Publication number	US-10463489-B2
Application number	US-201715416353-A
Country	US
Kind code	B2
Filing date	Jan 26, 2017
Priority date	Apr 2, 2013
Publication date	Nov 5, 2019
Grant date	Nov 5, 2019

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

What is claimed is:

1. A system comprising:
a collapsible and expandable prosthetic heart valve body having a proximal end and a distal end;
first and second leaflet clips, each of the first and second leaflet clips being coupled to the prosthetic heart valve body and configured to be transitioned between a first condition in which the body can be inserted into a native annulus of an atrioventricular valve of a heart, and a second condition, in which the leaflet clip is adapted to capture a native valve leaflet such that the native valve leaflet is engaged between the leaflet clip and the body when the body is disposed in the native annulus of the atrioventricular valve of the heart;
first and second control elements, the first control element being operably coupled to the first leaflet clip and the second control element being operably coupled to the second leaflet clip, each of the first and second control elements having a length sufficient to extend through the 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 first control element being configured to allow a user to transition the first leaflet clip from the first condition to the second condition and the second control element being configured to allow the user to transition the second leaflet clip from the first condition to the second condition; and
an elongate member having a proximal end and a distal end, the distal end configured to be disposed in the ventricle of the heart during deployment of the prosthetic heart valve body and the proximal end configured to extend outside the heart, the elongate member defining a first control element lumen extending from the proximal end to the distal end, and a second control element lumen extending from the proximal end to the distal end, the second control element lumen being separate from the first control element lumen,
wherein the first control element is disposable in the first control element lumen and extendable out the proximal end of the elongate member, and the second control element is disposable in the second control element lumen and extendable out the proximal end of the elongate member.

2. The system 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 the native annulus of the atrioventricular valve of the heart,
the elongate member further defining a tether lumen, the anchoring tether disposed in the tether lumen and extending out the proximal end of the elongate member.

3. The system of claim 1 , wherein the first control element is disposed in the first control element lumen and the second control element is disposed in the second control element lumen.

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

5. The system of claim 1 , wherein each of the first control element and the second control element is a suture.

6. The system of claim 1 , wherein the elongate member further defines a third control element lumen and a fourth control element lumen.

7. The system of claim 6 , wherein the first control element has first and second free ends and the first control element is routed from a proximal end of the first control element lumen to a distal end of the first control element lumen, operably coupled to the first leaflet clip and then routed from a distal end of the third control element lumen to a proximal end of the third control element lumen such that the first free end of the first control element is disposed outside of the first control element lumen and the second free end of the first control element is disposed outside of the third control element lumen.

8. The system of claim 7 , wherein the second control element has first and second free ends and the second control element is routed from a proximal end of the second control element lumen to a distal end of the second control element lumen, operably coupled to the second leaflet clip and then routed from a distal end of the fourth control element lumen to a proximal end of the fourth control element lumen such that the first free end of the second control element is disposed outside of the second control element lumen and the second free end of the second control element is disposed outside of the fourth control element lumen.

9. The system of claim 8 , wherein the first and second free ends of the first control element are tied together to form a first loop and the first and second free ends of the second control element are tied together to form a second loop.

10. The system of claim 9 , further comprising a first manipulator having a hook configured to removably couple the first manipulator to the first loop and a second manipulator having a hook configured to removably couple the second manipulator to the second loop, wherein releasing tension on the first manipulator allows the first leaflet clip to transition from the first condition to the second condition, and releasing tension on the second manipulator allows the second leaflet clip to move from the first condition to the second condition.

11. The system of claim 10 , wherein the first manipulator further includes a handle coupled to a rotatable actuator knob configured to adjust tension on the first leaflet clip, and wherein the second manipulator further includes a handle coupled to a rotatable actuator knob configured to adjust tension on the second leaflet clip.

12. The system of claim 10 , further comprising a first connecting member coupling the first control element to the first manipulator and a second connecting member coupling the second control element to the second manipulator, wherein the first connecting member is slidably coupled to the first control element and a second connecting member is slidably coupled to the second control element.

13. The system of claim 10 , further comprising a first knot coupling the first control element to the first manipulator and a second knot coupling the second control element to the second manipulator.

14. A system for delivering a prosthetic heart valve to a native valve annulus of a heart, the valve including a self-expanding wire frame body having a proximal end and a distal end, and a leaflet clip, the system comprising:
an elongate member having a first end and a second end, the first end configured to be disposed in a ventricle of a heart during deployment of the prosthetic heart valve and the second end configured to extend outside the heart, the elongate member defining a tether lumen extending from the first end to the second end of the elongate member and at least one control element lumen extending from the first end to the second end of the elongate member, the at least one control element lumen being separate from the tether lumen; and
a first control element having a first end and a second end, the first control element being disposed in the at least one control element lumen and operably coupled to the leaflet clip, the first control element having a length sufficient to extend from the leaflet clip through the at least one control element lumen and out a wall of the ventricle when the body is disposed in the native valve annulus of the heart,
wherein the first control element is configured to allow a user to transition the leaflet clip between a f

Assignees

• Tendyne Holdings Inc

Inventors

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

Classifications

• A61F2/2457

  Chordae tendineae prostheses · CPC title

• A61B17/068

  Surgical staplers {, e.g. containing multiple staples or clamps}({staplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105;} for performing anastomosis A61B17/115; {staplers in general B25C5/00}) · CPC title

• A61F2/2487

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

• A61B17/0644

  penetrating the tissue, deformable to closed position · CPC title

• A61B17/00234

  for minimally invasive surgery (A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence) · CPC title