Prosthetic Heart Valve And Systems And Methods For Delivering The Same

Patent metadata

Field	Value
Publication number	US-2020022809-A1
Application number	US-201916587753-A
Country	US
Kind code	A1
Filing date	Sep 30, 2019
Priority date	Apr 2, 2013
Publication date	Jan 23, 2020
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 method of implanting a prosthetic valve, comprising:
delivering the prosthetic valve to a native annulus of an atrioventricular valve of a heart, the prosthetic valve including a self-expanding body having an atrial end and a ventricular end, a valve disposed within the body, a first leaflet clip coupled to the body and a first control element operably coupled to the first leaflet clip; disposing a portion of the control element outside the heart; allowing the body to self-expand into engagement with the native annulus; and transitioning the first leaflet clip from a first condition in which the first leaflet clip is not engaged with a first native leaflet to a second condition in which the first native leaflet is captured and engaged between the first leaflet clip and the body.

2 . The method of claim 1 , wherein the first leaflet clip is substantially elongated in the first condition and bent in the second condition.

3 . The method of claim 1 , wherein the transitioning step comprises releasing tension from the first control element.

4 . The method of claim 1 , wherein the prosthetic valve further includes a second leaflet clip and a second control element, the method further comprising:
transitioning the second leaflet clip from a first condition in which the second leaflet clip is not engaged with a second native leaflet to a second condition in which the second native leaflet is captured and engaged between the second leaflet clip and the body.

5 . The method of claim 4 , further comprising:
applying tension to the first control element to transition the first leaflet clip from the second condition to the first condition; applying tension to the second control element to transition the second leaflet clip from the second condition to the first condition; and repositioning the prosthetic valve relative to the native annulus.

6 . The method of claim 4 , wherein the step of transitioning the first leaflet clip from the first condition to the second condition and the step of transitioning the second leaflet clip from the first condition to the second condition are performed sequentially.

7 . The method of claim 4 , wherein the step of transitioning the first leaflet clip from the first condition to the second condition and the step of transitioning the second leaflet clip from the first condition to the second condition are performed concurrently.

8 . The method of claim 1 , wherein the prosthetic valve further includes a tether adapted to anchor the prosthetic valve to a ventricle of the heart, the tether defining an axis when tension is applied to the tether and the prosthetic valve is positioned in the native annulus, the method further comprising:
offsetting the body from the axis of the tether prior to transitioning the first leaflet clip from the first condition to the second condition.

9 . The method of claim 8 , wherein the step of offsetting the body comprises canting the body away from a wall of the heart to provide additional space between the body and the wall to allow the first leaflet clip to transition from the first condition to the second condition.

10 . The method of claim 8 , further comprising:
applying tension to the tether; and securing the tether to a wall of the ventricle.

11 . The method of claim 1 , wherein the atrial end of the body is flared and extends radially outwardly from the body, and the prosthetic valve includes a tether having a first end attached to the ventricular end of the body and a second end, wherein the delivering step further comprises:
disposing the flared atrial end on an atrial side of the native annulus; disposing the tether on a ventricular side of the native annulus; and disposing the second end of the tether outside the heart.

12 . A method of implanting a prosthetic valve, comprising:
delivering the prosthetic valve to a native annulus of an atrioventricular valve of a heart, the prosthetic valve including a self-expanding body having an atrial end and a ventricular end, a valve disposed within the body, a first leaflet clip coupled to the body and a first control element operably coupled to the first leaflet clip; allowing the body to self-expand into engagement with the native annulus; and transitioning the first leaflet clip from a first condition in which the first leaflet clip is substantially elongated to a second condition in which the first leaflet clip is bent to engage the first native leaflet and capture the first native leaflet between the first leaflet clip and the body.

13 . The method of claim 12 , further comprising the step of disposing the first control element outside the heart.

14 . The method of claim 12 , wherein the transitioning step comprises releasing tension from the control element.

15 . The method of claim 12 , wherein the prosthetic valve further includes a second leaflet clip and a second control element, the method further comprising:
transitioning the second leaflet clip from a first condition in which the second leaflet clip is substantially elongated to a second condition in which the second leaflet clip is bent to engage the second native leaflet and capture the second native leaflet between the second leaflet clip and the body.

16 . The method of claim 15 , further comprising:
applying tension to the first control element to transition the first leaflet clip from the second condition to the first condition; applying tension to the second control element to transition the second leaflet clip from the second condition to the first condition; and repositioning the prosthetic valve relative to the native annulus.

17 . The method of claim 15 , further comprising:
decoupling the first control element from the first leaflet clip; decoupling the second control element from the second leaflet clip; and removing the first and second control elements from the heart.

18 . The method of claim 12 , wherein the prosthetic valve further includes a tether adapted to anchor the prosthetic valve to a ventricle of the heart, the tether defining an axis when tension is applied to the tether and the prosthetic valve is positioned in the native annulus, the method further comprising:
offsetting the body from the axis of the tether prior to transitioning the first leaflet clip from the first condition to the second condition; applying tension to the tether; and securing the tether to a wall of the ventricle.

19 . The method of claim 18 , wherein the step of offsetting the body comprises canting the body away from a wall of the heart to provide additional space between the body and the wall to allow the first leaflet clip to transition from the first condition to the second condition.

20 . The method of claim 12 , wherein the step of transitioning the first leaflet clip from the first condition to the second condition and the step of transitioning the second leaflet clip from the first condition to the second condition are performed sequentially or concurrently.

Assignees

• Tendyne Holdings Inc

Inventors

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

Classifications

• 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

• A61F2/2487

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

• A61F2230/005

  Rosette-shaped, e.g. star-shaped · 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