US-20260124034-A1 - SYSTEMS AND METHODS FOR HEART VALVE THERAPY

US20260124034A1US 20260124034 A1US20260124034 A1US 20260124034A1US-20260124034-A1

Abstract

Prosthetic heart valves described herein can be deployed using a transcatheter delivery system and technique to interface and anchor in cooperation with the anatomical structures of a native heart valve. In some embodiments, composite two-portion prosthetic heart valves in which two expandable components are attached to each other can be arranged in a nested configuration during both the transcatheter delivery process and the deployment process within the heart. Deployment systems and methods for using the deployment systems described herein facilitate implanting the composite two-portion prosthetic heart valves that are attached and arranged in a nested configuration during the transcatheter delivery and deployment processes.

Inventors

Kavitha Ganesan
Ramji Iyer
Lucas T. Schneider
Todd Mortier
Cyril J. Schweich

Assignees

CAISSON INTERVENTIONAL LLC

Dates

Publication Date: 20260507
Application Date: 20260102

Claims (11)

1 . A prosthetic mitral valve comprising: a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame, the expandable valve frame comprising three atrial leaflet arches disposed on a proximal end portion of the expandable valve frame; and an anchor assembly comprising an expandable anchor frame, the expandable anchor frame comprising three anchor arches disposed on a proximal end portion of the expandable anchor frame, wherein, the valve assembly is disposed within an interior space defined by the anchor assembly, and wherein each atrial leaflet arch of the three atrial leaflet arches is affixed to a respective anchor arch of the three anchor arches.
2 . The prosthetic mitral valve of claim 1 , wherein an apex portion of each atrial leaflet arch of the three atrial leaflet arches is affixed to an apex portion of the respective anchor arch of the three anchor arches.
3 . The prosthetic mitral valve of claim 1 , wherein an entirety of each atrial leaflet arch of the three atrial leaflet arches is affixed to an entirety of the respective anchor arch of the three anchor arches.
4 . The prosthetic mitral valve of claim 1 , wherein the expandable anchor frame further comprises a plurality of arched atrial holding features, and wherein, while the expandable anchor frame is in an expanded configuration, each arched atrial holding feature of the plurality of arched atrial holding features extends transversely outward in relation to a longitudinal axis defined by the anchor assembly.
5 . The prosthetic mitral valve of claim 4 , wherein the plurality of arched atrial holding features comprises three arched atrial holding features.
6 . The prosthetic mitral valve of claim 5 , wherein each arched atrial holding feature of the three arched atrial holding features is aligned with a corresponding atrial leaflet arch of the three atrial leaflet arches and with a corresponding atrial leaflet arch of the three atrial leaflet arches.
7 . The prosthetic mitral valve of claim 4 , wherein, while the prosthetic mitral valve is coupled to a native mitral valve, each arched atrial holding feature of the plurality of arched atrial holding features is positioned directly adjacent to, or spaced apart just superior to, an annulus of the native mitral valve.
8 . The prosthetic mitral valve of claim 1 , wherein the expandable anchor frame further comprises: a hub; a first elongate element extending from the hub, the first elongate element including a first sub-annular foot; a second elongate element extending from the hub, the second elongate element including a second sub-annular foot; a third elongate element extending from the first elongate element, the third elongate element including a third sub-annular foot; and a fourth elongate element extending from the second elongate element, the fourth elongate element including a fourth sub-annular foot.
9 . The prosthetic mitral valve of claim 8 , wherein, while the anchor assembly is coupled to a native mitral valve, each of the first foot, the second foot, the third foot, and the fourth foot are positioned within a sub-annular gutter of the native mitral valve.
10 . The prosthetic mitral valve of claim 8 , wherein the hub is located at a distal end of the expandable anchor frame and is threaded for releasable attachment with a delivery device.
11 . The prosthetic mitral valve of claim 8 , wherein the expandable anchor frame further comprises a systolic anterior motion containment member that is configured to be at least partially disposed behind an anterior leaflet of the native mitral valve while the anchor assembly is coupled to the native mitral valve.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. application Ser. No. 17/595,557, filed Nov. 18, 2021, attorney docket no. 475037.001207 and titled SYSTEMS AND METHODS FOR HEART VALVE THERAPY, which is a national stage entry application of international application no. PCT/US2020/033631, filed May 19, 2020, attorney docket no. 475037-001001-PCT and titled SYSTEMS AND METHODS FOR HEART VALVE THERAPY, which claims priority to U.S. Provisional Application No. 62/850,110, filed May 20, 2019, attorney docket no. 40182-0012P01 and titled SYSTEMS AND METHODS FOR HEART VALVE THERAPY, the complete disclosures of which are expressly incorporated herein by reference. TECHNICAL FIELD This document relates to prosthetic heart valves, such as prosthetic mitral valves that can be implanted using transcatheter techniques. This document also relates to systems and methods for implanting composite prosthetic mitral valves having an inner valve portion that is affixed to an outer anchor portion. BACKGROUND The long-term clinical effect of valve regurgitation is recognized as a significant contributor to cardiovascular related morbidity and mortality. Thus, for many therapies intended to treat the mitral valve, one primary goal is to significantly reduce or eliminate regurgitation. By eliminating the regurgitation at the mitral valve, the destructive volume overload effects on the left ventricle can be attenuated. The volume overload of mitral regurgitation (MR) relates to the excessive kinetic energy required during isotonic contraction to generate overall stroke volume in an attempt to maintain forward stroke volume and cardiac output. It also relates to the pressure potential energy dissipation of the leaking valve during the most energy-consuming portion of the cardiac cycle, isovolumetric contraction. Additionally, therapies for MR reduction can have the effect of reducing the elevated pressures in the left atrium and pulmonary vasculature reducing pulmonary edema (congestion) and shortness of breath symptomatology. Such therapies for MR reduction may also have a positive effect on the filling profile of the left ventricle (LV) and the restrictive LV physiology that can result with MR. These pathophysiologic issues indicate the potential benefits of MR therapy, but also indicate the complexity of the system and the need for a therapy to focus beyond the MR level or grade. In some percutaneous access procedures in which a medical device is introduced through a patient's skin and into a patient's blood vessel, such an access can be used to introduce devices into the patient without the use of large cut downs, which can be painful and in some cases can hemorrhage or become infected. A percutaneous access generally employs only a small hole through the skin, which subsequently seals relatively easily, and heals quickly in comparison to a surgical cut down. SUMMARY This document describes prosthetic heart valves, such as prosthetic mitral valves, that interface and anchor in cooperation with the anatomical structures of a native mitral valve. For example, this document describes a composite two-portion prosthetic heart valve in which two expandable components are attached to each other and arranged in a nested configuration during both the transcatheter delivery process and the deployment process within the heart. In addition, systems and methods for implanting such composite two-portion prosthetic heart valves are described herein. In one aspect, this disclosure is directed to a prosthetic mitral valve for a heart. The prosthetic mitral valve includes a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame, and an anchor assembly comprising an expandable anchor frame. The valve assembly is disposed within an interior space defined by the anchor assembly. Such a prosthetic mitral valve may optionally include one or more of the following features. In some embodiments, the expandable valve frame includes three atrial leaflet arches disposed on a proximal end portion of the expandable valve frame. In particular embodiments, the expandable anchor frame includes three anchor arches disposed on a proximal end portion of the expandable anchor frame. In certain embodiments, each atrial leaflet arch of the three atrial leaflet arches is affixed to a respective anchor arch of the three anchor arches. In another aspect, this disclosure is directed to a prosthetic mitral valve that includes: (i) a valve assembly comprising an expandable valve frame and an occluder attached to the expandable valve frame, the expandable valve frame comprising three atrial leaflet arches disposed on a proximal end portion of the expandable valve frame; and (ii) an anchor assembly comprising an expandable anchor frame, the expandable anchor frame comprising three anchor arches disposed on a proximal end portion of the expandable anchor frame. The valve assembly is disposed