US-12616569-B2 - Prosthetic heart valve having non-cylindrical frame

US12616569B2US 12616569 B2US12616569 B2US 12616569B2US-12616569-B2

Abstract

An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can have a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction, and each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame, and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.

Inventors

Anatoly Dvorsky
Boaz Manash
Danny M. Garmahi
Tamir S. Levi
Yair A. Neumann
Noa Axelrod Manela
Eitan Atias
Oren Cohen
Elazar Levi Schwarcz
Ofir Witzman
Noam Miller

Assignees

EDWARDS LIFESCIENCES CORPORATION

Dates

Publication Date: 20260505
Application Date: 20220823

Claims (19)

1 . An implantable prosthetic device, comprising: a radially expandable and compressible frame having a first end and a second end, the frame comprising a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction; wherein each strut of the first set of struts is pivotably connected to at least one strut of the second set of struts to define a plurality of circumferentially extending rows of cells comprising at least first, second, and third rows of cells; wherein each strut is curved helically with respect to a first, longitudinal axis of the frame; wherein a projection of each strut in a plane parallel to a longitudinal axis of the frame is curved with respect to a second axis that is perpendicular to the first, longitudinal axis; and wherein a size of the cells increases relative to the size of the cells in the immediately preceding row from the first end of the frame to the second end.
2 . The implantable prosthetic device of claim 1 , wherein each strut is a unitary member that extends from the first end of the frame to the second end of the frame.
3 . The implantable prosthetic device of claim 1 , wherein each strut comprises a plurality of segments between locations where struts are pivotally connected to each other, and each segment of a respective strut is non-parallel to each adjacent segment in the plane parallel to the longitudinal axis of the frame.
4 . The implantable prosthetic device of claim 3 , wherein a length of each segment increases relative to the length of an immediately preceding segment from a first end of the strut to a second end of the strut.
5 . The implantable prosthetic device of claim 3 , wherein adjacent segments of the plurality of segments are connected to each other by intermediate segments, and wherein the intermediate segments each have a width greater than a width of a respective segment of the plurality of segments.
6 . The implantable prosthetic device of claim 1 , wherein each strut has a radially facing inner surface, a radially facing outer surface, and first and second edge surfaces extending between the radially facing inner and radially outer surfaces, and wherein the radially facing inner surface is concave with respect to a longitudinal axis of the frame and the first edge surface is concave with respect to the first end of the frame.
7 . The implantable prosthetic device of claim 1 , further comprising a valve assembly comprising a plurality of leaflets mounted inside the frame.
8 . The implantable prosthetic device of claim 7 , wherein each leaflet comprises a curved cusp edge portion and wherein the curvature of the struts with respect to the second axis corresponds to a portion of the curved cusp edge portion.
9 . An implantable prosthetic device, comprising: a radially expandable and compressible frame having a first end and a second end, the frame comprising a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction; wherein each strut of the first set of struts is pivotably connected to at least one strut of the second set of struts to define a plurality of circumferentially extending rows of cells; wherein each strut is curved helically with respect to a first, longitudinal axis of the frame; wherein a projection of each strut in a plane parallel to a longitudinal axis of the frame is curved with respect to a second axis that is perpendicular to the first, longitudinal axis; and wherein each strut comprises a plurality of segments between locations where struts are pivotally connected to each other, and wherein a curvature of each strut with respect to the second axis is non-constant such that a radius of curvature of one of the segments with respect to the second axis is greater than a radius of curvature of another one of the segments with respect to the second axis.
10 . An implantable prosthetic device, comprising: a radially expandable and compressible frame having a first end and a second end, the frame comprising a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction; wherein each strut of the first set of struts is pivotably connected to at least one strut of the second set of struts to define a plurality of circumferentially extending rows of cells; wherein each strut is curved helically with respect to a first, longitudinal axis of the frame; wherein a projection of each strut in a plane parallel to a longitudinal axis of the frame is curved with respect to a second axis that is perpendicular to the first, longitudinal axis; and wherein a draft angle of the frame is greater than 2 degrees when the frame is in a radially expanded configuration.
11 . An implantable prosthetic device, comprising: a radially expandable and compressible frame having a first end and a second end, the frame comprising a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction; wherein each strut of the first set of struts is pivotably connected to at least one strut of the second set of struts to define a plurality of circumferentially extending rows of cells; wherein each strut comprises a radially facing inner side, a radially facing outer side, an inflow edge, and an outflow edge; wherein the radially facing inner and outer sides have a helical, first curvature with respect to a first, longitudinal axis of the frame; and wherein the inflow and outflow edges have a second curvature with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame.
12 . The implantable prosthetic device of claim 11 , wherein a projection of each strut in a plane parallel to a longitudinal axis of the frame has the second curvature.
13 . The implantable prosthetic device of claim 11 , wherein each strut comprises a plurality of segments between locations where struts are pivotally connected to each other, and each segment of a respective strut is non-parallel to each adjacent segment in a plane parallel to the longitudinal axis of the frame.
14 . The implantable prosthetic device of claim 13 , wherein a length of each segment increases relative to the length of an immediately preceding segment from a first end of the strut to a second end of the strut.
15 . The implantable prosthetic device of claim 13 , wherein each strut comprises at least four segments.
16 . The implantable prosthetic device of claim 13 , wherein each segment has a curved shape causing a projection of each strut in a plane parallel to a longitudinal axis of the frame to have the second curvature.
17 . The implantable prosthetic device of claim 13 , wherein adjacent segments of the plurality of segments are connected to each other by intermediate segments, and wherein the intermediate segments each have a width greater than a width of a respective segment of the plurality of segments.
18 . The implantable prosthetic device of claim 11 , wherein when the frame is in a radially expanded configuration angles formed between pivotably connected struts of each row of cells progressively increase from one end of the frame to the other.
19 . The implantable prosthetic device of claim 11 , wherein each strut is a unitary member that extends from the first end of the frame to the second end.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 16/788,090 filed on Feb. 11, 2020, which is a continuation of International Application No. PCT/US19/56865 filed on Oct. 18, 2019, which claims the benefit of U.S. Provisional Application 62/799,678 filed on Jan. 31, 2019, and U.S. Provisional Patent Application 62/748,284 filed on Oct. 19, 2018, all of which are incorporated by reference herein in their entirety. FIELD The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and to methods and assemblies for assembling collapsible frames for, and including, such prosthetic devices. BACKGROUND The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size. Prosthetic valves that rely on a mechanical actuator for expansion can be referred to as “mechanically expandable” prosthetic heart valves. The actuator typically takes the form of pull cables, sutures, wires and/or shafts that are configured to transmit expansion forces from a handle of the delivery apparatus to the prosthetic valve. Most expandable, transcatheter heart valves comprise a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. Typically, the leaflets are attached to the frame in such a manner that the articulating or coaptation edges of the leaflets are spaced radially inward of the frame to prevent leaflet abrasion when the leaflets open under the flow of blood. In such valves, the effective outflow orifice typically is narrower than the inflow orifice, resulting in eddies and turbulence downstream at the outlet of the prosthetic valve, which can produce a relatively high-pressure gradient across the prosthetic valve when the leaflets are open and blood is flowing through the prosthetic valve. The presence of additional components adjacent the outflow end of the frame, such as actuators for expanding the valve, can further increase the pressure gradient across the prosthetic valve. The increased pressure gradient can lead to prosthesis-patient-mismatch (PPM) where the prosthetic valve is essentially undersized for the patient, which has been shown to be associated with worsened hemodynamic function, more cardiac events, and lower survival rates. Accordingly, a need exists for improved prosthetic heart valve frame designs and methods for implantation. SUMMARY Described herein are embodiments of improved implantable medical devices, such as prosthetic heart valves, as well as methods for implanting such devices. An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can comprise a first set of a plurality of struts extending in a first direction, and a second set of a plurality of struts extending in a second direction. Each strut of the first set of struts can be pivotably connected to at least one strut of the second set of struts. Each strut can be curved helically with respect to a first, longitudinal axis of the frame and each strut can be curved with respect to a second axis that is perpendicular to the first, longitudinal axis of the frame. In some embodiments, each strut can be concave with respect to an outflow end of the frame. In other embodiments, each strut can be convex with respect to an outflow end of the frame. In some embodiments, when the frame is in a radially expanded configuration, the frame can taper from a first diameter at a first location on the frame to a second diameter at a second location on the frame axially spaced from the first location. The first diameter can be greater than the second diame