IP Library Granted Patent US 12685637
Granted Patent B2
US 12685637 · App. 18/489,666 · Granted Jul 21, 2026

Heart valve sealing devices and delivery devices therefor

Inventors: Mark Chau (Laguna Hills, CA); David M. Taylor (Lake Forest, CA); Alexander J. Siegel (Irvine, CA); Christopher J. Olson (Laguna Hills, CA); Sergio Delgado (Irvine, CA); Alexander H. Cooper (Costa Mesa, CA); Lauren R. Freschauf (Mission Viejo, CA); Asher L. Metchik (Rolling Hills Estates, CA); Matthew T. Winston (Aliso Viejo, CA); Cristobal R. Hernandez (Santa Ana, CA); Emil Karapetian (Huntington Beach, CA); Bao Khuu (Irvine, CA); Eric Robert Dixon (Villa Park, CA); Amanda French (San Francisco, CA); Philip P. Corso, Jr. (Laguna Hills, CA)
Assignee: Edwards Lifesciences Corporation
A61F2/246A61F2/2454A61F2/2463A61F2/2466A61F2220/0016A61F2310/00023
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Quick Facts
Patent No.
US 12685637
App. No.
18/489,666
Granted
Jul 21, 2026
Kind
B2
Abstract

In one example, an implantable prosthetic device comprises a spacer body portion configured to be disposed between native leaflets of a heart, and an anchor portion configured to secure the native leaflets against the spacer body portion. The prosthetic device can be movable between multiple configurations. A size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets. A delivery apparatus can have a first shaft and a second shaft, wherein movement of the first shaft relative to the second shaft moves the anchor portion relative to the spacer body.

Claims (35)

1 . An implantable prosthetic device configured for connection to native heart valve leaflets, comprising:

a spacer body that is configured such that the spacer body can:

(i) be disposed between native valve leaflets of a heart,

(ii) block blood flow through the spacer body from an atrial side of the spacer body to a ventricular side of the spacer body,

(iii) block blood flow through the spacer body from the ventricular side of the spacer body to the atrial side of the spacer body,

(iv) divide an orifice between a ventricle and an atrium such that the native heart valve leaflets can (a) open at two sides of the spacer body into two orifices during diastole to allow blood flow from the atrium to the ventricle through the two orifices, and (b) coapt to inhibit blood flow from the ventricle to the atrium during systole; a pair of anchors coupled to the spacer body, wherein each anchor of the pair of anchors is configured to be placed against a ventricular surface of a corresponding one of the native heart valve leaflets; and

a shaft that extends through the spacer body;

wherein a size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets by rotating the shaft.

2 . The implantable prosthetic device of claim 1 wherein adjustability of the size of the spacer body is configured for use with varying degrees of mitral regurgitation.

3 . The implantable prosthetic device of claim 1 wherein the device is configured to correspond to various coaption lines by expanding and contracting the spacer body.

4 . The implantable prosthetic device of claim 1 wherein adjustability of the size of the spacer body is configured for use with both central and eccentric jet mitral regurgitation.

5 . The implantable prosthetic device of claim 1 wherein the pair of anchors and the spacer body can be positioned independently.

6 . The implantable prosthetic device of claim 1 wherein each anchor of the pair of anchors have an inner atrial arm and an outer ventricular arm.

7 . The implantable prosthetic device of claim 1 wherein the spacer body and the pair of anchors are covered with a blood impervious material.

8 . The implantable prosthetic device of claim 1 wherein each anchor of the pair of anchors includes an upper leg portion coupled to the spacer body and a lower leg portion connected to the upper leg portion by a joint.

9 . The implantable prosthetic device of claim 1 further comprising a cap coupled to the pair of anchors.

10 . The implantable prosthetic device of claim 1 wherein the spacer body is made from a single piece of braided self-expandable metallic thread.

11 . The implantable prosthetic device of claim 1 wherein each anchor of the pair of anchors is made from a single piece of braided self-expandable metallic thread.

12 . The implantable prosthetic device of claim 1 wherein the spacer body is covered with a blood impervious material.

13 . The implantable prosthetic device of claim 1 wherein the pair of anchors are covered with a blood impervious material.

14 . The implantable prosthetic device of claim 1 wherein the spacer body is configured such that compressing ends of the spacer body axially foreshortens the spacer body axially and expands the spacer body radially.

15 . An assembly, comprising:

an implantable prosthetic device configured for connection to native heart valve leaflets, comprising:

a spacer body that is configured such that the spacer body can:

(i) be disposed between native valve leaflets of a heart,

(ii) block blood flow through the spacer body from an atrial side of the spacer body to a ventricular side of the spacer body,

(iii) block blood flow through the spacer body from the ventricular side of the spacer body to the atrial side of the spacer body,

(iv) divide an orifice between a ventricle and an atrium such that the native heart valve leaflets can (a) open at two sides of the spacer body into two orifices during diastole to allow blood flow from the atrium to the ventricle through the two orifices, and (b) coapt to inhibit blood flow from the ventricle to the atrium during systole;

a pair of anchors coupled to the spacer body, wherein each anchor of the pair of anchors is configured to be placed against a ventricular surface of a corresponding one of the native heart valve leaflets;

a shaft that extends through the spacer body:

wherein a size of the spacer body is configured to be adjusted after the spacer body is placed between the native valve leaflets and the pair of anchors are placed against the ventricular surfaces of the native heart valve leaflets by rotating the shaft that extends through the spacer body;

a delivery apparatus having a first shaft and a second shaft; and

wherein movement of the first shaft of the delivery apparatus relative to the second shaft of the delivery apparatus moves the pair of anchors relative to the spacer body.

16 . The assembly of claim 15 wherein adjustability of the size of the spacer body is configured for use with varying degrees of mitral regurgitation.

17 . The assembly of claim 15 wherein the device is configured to correspond to various coaption lines by expanding and contracting the spacer body.