Prosthetic heart valve and systems and methods for delivering the same

• US 10,463,489 B2
• Filed: 01/26/2017
• 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:
  US15/416,353
• Publication Number:
  US 20170128208A1
• Time in Patent Office: 1,013 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 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• 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 2/2487 Devices within the heart chamber, e.g. splints
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• 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 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 first condition in which the body can be inserted into a native annulus 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 heart.

15. The system of claim 14, further comprising:

a tubular body coupled to the first end of the first control element and configured to mate with the elongate member.

16. The system of claim 15, wherein the second end of the first control element is coupled to a mandrel, the mandrel configured to be disposed in a slot defined by the tubular body.

17. The system of claim 14, wherein the valve further includes an anchoring tether attached to the distal end of the body, the anchoring tether disposed in the tether lumen and extending out the second end of the elongate member.

18. The system of claim 14, wherein the tether lumen is located along a longitudinal axis of the elongate member.

19. The system of claim 18, wherein the at least one control element lumen is radially spaced from the tether lumen.