US-12616568-B2 - Two stage tricuspid valve implant

US12616568B2US 12616568 B2US12616568 B2US 12616568B2US-12616568-B2

Abstract

A prosthetic tricuspid heart valve system includes a collapsible anchor frame and a collapsible prosthetic heart valve. The anchor includes a support structure having a waisted central portion, and atrial and ventricular flared portions sized to clamp a native valve annulus. Atrial and ventricular sheets are coupled to the atrial and ventricular flared portions, and each include a central aperture. A generally cylindrical fabric valve-receiving member has an inflow end coupled to the atrial sheet and an outflow end coupled to the ventricular sheet to provide a conduit through the valve-receiving member between the atrial and ventricular sheet. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame.

Inventors

Randolf Von Oepen
Grayston Licht
Preston James Huddleston
Son Mai

Assignees

ST. JUDE MEDICAL, CARDIOLOGY DIVISION, INC.

Dates

Publication Date: 20260505
Application Date: 20221219

Claims (20)

1 . A prosthetic heart valve system for replacing a native right atrioventricular valve, the system comprising: a collapsible and expandable anchor frame that, in an expanded condition, has a waisted central portion, and atrial and ventricular portions each flared radially outwardly from the central portion, the atrial and ventricular portions sized to clamp an annulus of the right atrioventricular valve therebetween; an atrial sheet coupled to the atrial portion of the anchor frame and extending radially inwardly to a central aperture in the atrial sheet; a ventricular sheet coupled to the ventricular portion of the anchor frame and extending radially inwardly to a central aperture in the ventricular sheet; and a valve-receiving member formed of fabric and being cylindrical, an inflow end of the valve-receiving member coupled to the atrial sheet and an outflow end of the valve-receiving member coupled to the ventricular sheet to provide a conduit from the central aperture in the atrial sheet to the central aperture in the ventricular sheet through the valve-receiving member; and a collapsible and expandable prosthetic heart valve including a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member.
2 . The prosthetic heart valve system of claim 1 , wherein one of the atrial sheet and the ventricular sheet is formed of a porous fabric and the other of the atrial sheet and ventricular sheet is formed of a substantially fluid-impermeable fabric.
3 . The prosthetic heart valve system of claim 1 , further comprising at least one radiopaque marker coupled to the valve-receiving member at the inflow end of the valve-receiving member or the outflow end of the valve-receiving member.
4 . The prosthetic heart valve system of claim 1 , further comprising a stretching member coupled to the valve-receiving member, the stretching member being a rigid material extending in a longitudinal direction of the valve-receiving member, the rigid material configured to reduce slack in the valve-receiving member when the anchor frame is in the expanded condition.
5 . The prosthetic heart valve system of claim 1 , further comprising a support wire coupled to the valve-receiving member and extending along a circumference of the valve-receiving member.
6 . The prosthetic heart valve system of claim 5 , wherein the support wire is formed of metal cable.
7 . The prosthetic heart valve system of claim 5 , wherein the support wire is formed of a suture.
8 . The prosthetic heart valve system of claim 5 , wherein the support wire includes a first support wire at the inflow end of the valve-receiving member and a second support wire at the outflow end of the valve-receiving member.
9 . The prosthetic heart valve system of claim 1 , further comprising a support arm having a first end coupled directly to the anchor frame, and a second end coupled directly to the valve-receiving member.
10 . The prosthetic heart valve system of claim 9 , wherein the support arm is formed of nickel titanium alloy.
11 . The prosthetic heart valve system of claim 9 , wherein the support arm includes an atrial extension coupled to the inflow end of the valve-receiving member, and a ventricular extension coupled to the outflow end of the valve-receiving member, a central portion of the support arm being directly coupled to the central portion of the anchor frame.
12 . The prosthetic heart valve system of claim 11 , wherein the atrial extension includes an aperture therein, and the ventricular extension includes an aperture therein.
13 . The prosthetic heart valve system of claim 12 , further comprising a first support wire coupled to the valve-receiving member at the inflow end of the valve-receiving member and extending along a circumference of the valve-receiving member, and a second support wire coupled to the valve-receiving member at the outflow end of the valve-receiving member and extending along a circumference of the valve-receiving member, the first support wire passing through the aperture in the atrial extension of the support arm, and the second support wire passing through the aperture in the ventricular extension of the support arm.
14 . The prosthetic heart valve system of claim 11 , wherein the support arm includes a first lateral stabilizer and a second lateral stabilizer, the first and second lateral stabilizers extending in opposite directions on opposite sides of the central portion of the support arm.
15 . The prosthetic heart valve system of claim 14 , wherein the first and second lateral stabilizers each includes an expandable cell that can expand and collapse to move the corresponding lateral stabilizer toward or away from the central portion of the support arm.
16 . The prosthetic heart system of claim 11 , wherein the support arm is a diamond-shaped structure, the central portion including two side struts that each coupled the atrial extension to the ventricular extension.
17 . The prosthetic heart valve system of claim 11 , wherein the fabric forming the valve-receiving member is elastic.
18 . The prosthetic heart valve system of claim 11 , wherein the fabric forming the valve-receiving member is inelastic, and includes a plurality of folds or pleats that can unfold to increase an axial length of the valve-receiving member as the anchor frame transitions from the expanded condition to a collapsed condition.
19 . The prosthetic heart valve system of claim 1 , wherein the anchor frame is devoid of any temporary prosthetic heart valve leaflets within the valve-receiving member.
20 . The prosthetic heart valve system of claim 1 , wherein the anchor frame includes a plurality of temporary prosthetic heart valve leaflets within the valve-receiving member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to the filing date of U.S. Provisional Patent Application No. 63/315,144, filed Mar. 1, 2022, the disclosure of which is hereby incorporated by reference herein. BACKGROUND OF THE DISCLOSURE The heart has four native valves, including the aortic valve, pulmonary valve, mitral valve (also known as the left atrioventricular valve) and the tricuspid valve (also known as the right atrioventricular valve). When these valves begin to fail, for example by not fully coapting and allowing retrograde blood flow (or regurgitation) across the valve, it may be desirable to repair or replace the valve. Prosthetic replacement heart valves may be surgically implanted via an open chest, open heart procedure while the patient is on cardiopulmonary bypass. However, such procedures are extremely invasive and frail patients, who may be the most likely to be in need of a prosthetic heart valve, may not be likely to survive such a procedure. More recently, prosthetic heart valves have been trending to less invasive procedures, including collapsible and expandable heart valves that can be delivered through the vasculature in a transcatheter procedure. Unless otherwise indicated, as used herein, the term “tricuspid valve” refers to the right atrioventricular valve, as opposed to just a generic term for a three-leaflet valve. Initial human trials to replace the native tricuspid valve in a transcatheter procedure (e.g. via the femoral vein) have shown promising results, with patients experience significant improvements in quality of life after the prosthetic valve implantation. It is thought that important characteristics of a successful transcatheter prosthetic tricuspid valve device includes not only a good clinical outcome for the patient, but ease of use of the tricuspid valve, including for example having a small enough size to be able to avoid a surgical cut down of the patient's femoral vein for delivery. BRIEF SUMMARY OF THE DISCLOSURE According to one aspect of the disclosure, a prosthetic heart valve system for replacing a native right atrioventricular valve may include a collapsible and expandable anchor frame and a collapsible and expandable prosthetic heart valve. The anchor may include a support structure that, in an expanded condition, has a waisted central portion, and atrial and ventricular portions each flared radially outwardly from the central portion. The atrial and ventricular portions may be sized to clamp an annulus of the right atrioventricular valve therebetween. It should be understood that, as used herein, the term “clamp” does not require an active mechanical action, but includes sandwiching and similar concepts. An atrial sheet may be coupled to the atrial portion of the support structure and may extend radially inwardly to a central aperture in the atrial sheet. A ventricular sheet may be coupled to the ventricular portion of the support structure and may extending radially inwardly to a central aperture in the ventricular sheet. A valve-receiving member may be formed of fabric and may be generally cylindrical. An inflow end of the valve-receiving member may be coupled to the atrial sheet and an outflow end of the valve-receiving member may be coupled to the ventricular sheet to provide a conduit from the central aperture in the atrial sheet to the central aperture in the ventricular sheet through the valve-receiving member. The prosthetic heart valve may include a stent and a plurality of prosthetic leaflets, the prosthetic heart valve configured to be expanded into and received within the valve-receiving member of the anchor frame. Another aspect of the disclosure involves a method of replacing a native right atrioventricular valve of a patient. The method includes delivering a collapsible and expandable anchor frame to the native right atrioventricular valve while the anchor frame is in a collapsed condition within a first delivery sheath. The anchor frame is deployed from the delivery sheath, and the anchor frame is expanded within the native right atrioventricular valve so that an annulus of the native right atrioventricular valve is clamped between an atrial portion of the anchor frame and a ventricular portion of the anchor frame. After deploying the anchor frame, blood is allowed to flow through a conduit of the anchor frame. The conduit is formed by a fabric valve-receiving member that has an inflow end and an outflow end. The inflow end of the valve-receiving member is coupled to an atrial sheet that is coupled to the atrial portion of the anchor frame. The outflow end of the valve-receiving member is coupled to a ventricular sheet that is coupled to the ventricular portion of the anchor frame. After allowing blood to flow through the conduit of the anchor frame, a collapsible and expandable prosthetic heart valve is delivered to the anchor frame. The prosthetic heart valve is expanded into contact with the valve-receivin