CN-121971202-A - Prosthetic heart valve with elongate sealing member

CN121971202ACN 121971202 ACN121971202 ACN 121971202ACN-121971202-A

Abstract

The present disclosure relates to prosthetic heart valves having an elongated sealing member. As one example, a prosthetic heart valve includes an annular frame, a leaflet assembly including a plurality of leaflets, and a skirt assembly including an inner skirt, an outer skirt, and/or a third skirt. The frame is radially compressible and expandable between a radially compressed state and a radially expanded state and includes a plurality of apices at the inflow end. The skirt assembly forms a pocket at the inflow end of the frame that creates additional space between the inflow end of the frame and the skirt assembly when the frame is in a radially expanded state. The pocket allows the apex at the inflow end of the frame to move toward the inflow end of the pocket without protruding through the skirt assembly when the frame is radially compressed to the radially compressed state.

Inventors

1. Rosen
B.H.Fan
T.C. Ulrich
T.RUAN
J.Han

Assignees

爱德华兹生命科学公司

Dates

Publication Date: 20260505
Application Date: 20220322
Priority Date: 20210323

Claims (10)

1. A prosthetic heart valve, comprising: an annular frame comprising an inflow end and an outflow end, wherein the frame is radially compressible and expandable between a radially compressed state and a radially expanded state, wherein the frame comprises a plurality of apices at the inflow end; a leaflet assembly positioned within and coupled to the frame, wherein the leaflet assembly comprises a plurality of leaflets positioned entirely within the frame; A skirt assembly, the skirt assembly comprising: an inner skirt extending circumferentially around an inner side of the frame, wherein the inner skirt has an inflow edge portion and an outflow edge portion, and An outer skirt extending circumferentially around an outer side of the frame, wherein the outer skirt has an inflow edge portion and an outflow edge portion, wherein the inflow edge portion of the outer skirt is sewn to the inflow edge portion of the inner skirt; wherein the inflow edge portion of the inner skirt and/or the inflow edge portion of the outer skirt forms a pocket, wherein the apex is disposed in the pocket, and wherein the pocket has an inflow end, and Wherein the apex is spaced from the inflow end of the pocket when the frame is in the radially expanded state, and moves closer to the inflow end of the pocket when the frame is radially compressed from the radially expanded state to the radially compressed state.
2. The prosthetic heart valve of claim 1, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the pocket.
3. The prosthetic heart valve of claim 2, wherein the inflow edge portions of the inner skirt and the outer skirt are sewn together at the inflow end of the pocket.
4. The prosthetic heart valve of any of claims 1-3, wherein the inflow edge portions of the inner skirt and the outer skirt extend axially beyond the inflow end of the frame.
5. The prosthetic heart valve of claim 4, wherein the inflow edge portions of the inner skirt and the outer skirt extend axially beyond the inflow end of the frame by approximately the same amount.
6. The prosthetic heart valve of any of claims 1-5, wherein the apex is spaced at least 0.5mm from the inflow end of the pocket when the frame is in the radially expanded state.
7. The prosthetic heart valve of any of claims 1-6, wherein the pocket extends circumferentially around the inflow end of the frame.
8. The prosthetic heart valve of any of claims 1-7, wherein the outflow edge portion of the inner skirt is sewn to the frame between the inflow end and the outflow end of the frame, and wherein the outflow edge portion of the outer skirt is sewn to the frame closer to the inflow end of the frame than the outflow edge portion of the inner skirt.
9. The prosthetic heart valve of any of claims 1-8, wherein the outflow edge portion of the inner skirt comprises a plurality of slits, and wherein the plurality of slits are axially spaced apart from a junction of two struts of the frame by at most 0.5mm.
10. The prosthetic heart valve of any of claims 1-9, wherein the inner skirt contacts the inner side of the frame, and wherein the outer skirt contacts the outer side of the frame.

Description

Prosthetic heart valve with elongate sealing member The present application is a divisional application of chinese patent application 202210282138X, filed on 22, 2022, and 03, entitled "prosthetic heart valve with elongate sealing member". Cross Reference to Related Applications The present application claims priority from U.S. provisional application No. 63/164,663, filed 3/23 at 2021, which is incorporated herein by reference. Technical Field The present invention relates to collapsible and expandable prosthetic heart valves having an elongated sealing member. Background For many years, doctors have attempted to repair and/or replace defective heart valves through open heart surgery. However, due to the risks and complications of open heart surgery, collapsible prosthetic heart valves have been developed that can be crimped to a sufficiently thin profile (e.g., less than 8mm in diameter) to be advanced through the vasculature (e.g., veins and/or arteries) of a patient over a delivery catheter. In particular, a physician may make a small incision near a blood vessel (e.g., the surgeon may make an incision in the groin of the patient to access a femoral vein or artery), and then may use a delivery catheter to advance the collapsible prosthetic heart valve in a crimped state through the vasculature of the patient until the prosthetic heart valve reaches the defective native heart valve. Once at the defective native valve, the prosthetic heart valve may be expanded to its functional size by an inflatable balloon, mechanical actuator, shape memory material, or the like. In this way, the physician may indirectly access the heart (e.g., through a small incision in the patient's groin) without having to open the patient's chest. This transcatheter approach is much less invasive than open heart surgery and may reduce and/or avoid the risks and complications associated with open heart surgery. Transcatheter prosthetic heart valves typically include a radially compressible and expandable annular metal frame supporting two or more prosthetic leaflets (typically made of animal (e.g., bovine) pericardial tissue) that open and close to regulate blood flow through the valve. The transcatheter prosthetic heart valve may also include an outer fabric skirt (e.g., made of polyethylene terephthalate or PET for short) that cushions and seals the rigid frame against surrounding natural heart tissue. The transcatheter prosthetic heart valve may also include an inner fabric skirt that may be used to mount the prosthetic leaflets to the frame and/or to seal the openings in the frame. Some frames of transcatheter prosthetic heart valves may lengthen or elongate in the axial direction when radially compressed (such as when crimped onto a balloon of a delivery device). In some cases, elongation of the frame during crimping may cause the apex of the frame to protrude through or extend beyond one end of the skirt of the prosthetic valve. The exposed apex may contact an inner surface of an introducer sheath used to introduce the prosthetic valve and delivery device into the vasculature of a patient. This may increase the thrust required to push the prosthetic valve through the introducer sheath and may deform the exposed apices, potentially damaging the valve. Accordingly, there is a need for assemblies, devices, and/or methods for a sealing member (e.g., a fabric skirt) that can protect the apex of the frame of a prosthetic heart valve during an implantation procedure. Disclosure of Invention The present disclosure relates to examples of a sealing member (e.g., a fabric skirt) for a prosthetic heart valve, the sealing member configured to protect an apex of a frame from damage due to contact with components of a delivery system. In particular, the present disclosure relates to an elongate sealing member for a prosthetic heart valve that extends beyond one end of the frame of the prosthetic heart valve when the valve is uncrimped (i.e., when the valve is radially expanded) to accommodate axial elongation of the frame during crimping. The elongate sealing member may form a pocket at one end of the frame that prevents the frame from protruding past the sealing member when the valve is crimped. Maintaining the frame fully contained within the sealing member even in its crimped state may prevent damage to the frame and/or the remainder of the valve and/or reduce the force required to push the valve through the introducer sheath of the delivery assembly. In one representative example, a prosthetic heart valve includes an annular frame, a leaflet assembly, and a skirt assembly. The annular frame includes an inflow end and an outflow end and is radially compressible and expandable between a radially compressed state and a radially expanded state. Further, the frame includes a plurality of vertices at the inflow end. The leaflet assembly is positioned within and coupled to the frame and includes a plurality of leaflets positioned entirely withi