Cardiovalve Ltd.

Edwards Lifesciences Corporation

Medtronic, Inc.

Medtronic Ventor Technologies Ltd.

Valtech Cardio Ltd.

Mitraltech Ltd.

Other

Mitraltech Ltd. 3 Ariel Sharon Avenue

Edwards Lifesciences Innovation Ltd.

Ilia Hariton

Boaz Harari

Meni Iamberger

Aviram Baum

Tamir S Levi

Netanel Benichou

Tal Reich

Son V Nguyen

Bella Felsen

Diana Nguyen-Thien-Nhon

Itai Pelled

Rajesh A Khanna

Yaacov Nitzan

Michael Albitov

Igor Kovalsky

Maxim Karalnik

Tal Hammer

Yossi Tuval

Nadav Yellin

Yaron Herman

Yosi Tuval

Yuval Zipory

Meir Kutzik

Haim Brauon

Natalia Kruglova

Paul Kaye

Yelena Kasimov

Eran Hoffer

Daniel Glozman

Jason L Quill

Tal Sheps

Ehud Iflah

Alexei Koifman

Rajesh Khanna

Alon Fogel

Michael Levin

Oren Shua

Eli Ben-Hamou

Diana Nguyen-Thien-Nh

Or Cohen

Son Nguyen

Tamir Levi

Som Nguyen

A valve frame includes a tubular portion defining a plurality of valve-frame coupling elements disposed circumferentially around a longitudinal axis of the valve frame, and a plurality of arms, extending radially outward from an upstream portion of the tubular portion to define an arm span, and configured to engage tissue in the atrium. An outer frame is coupled to the valve frame, and includes a ring circumscribing the tubular portion, and a plurality of flanges that extend radially outward from the ring to define a flange span, and are configured to engage ventricular tissue. Each arm defines a rigid portion and a flexible portion that is disposed radially outward from the rigid portion, and is more flexible than the rigid portion. The majority of the flexible portion is disposed further radially outward than the flange span. Other embodiments are also described.

Prosthetic valve with arms and flanges

A delivery tool including a shaft and a proximal capsule and a distal capsule is dimensioned for percutaneous delivery to the heart. An open end of the proximal capsule faces the open end of the distal capsule. The capsules are coupled to the shaft in a manner that allows axial movement of the capsule with respect to the shaft. A prosthetic heart valve includes a tubular portion that defines a lumen and prosthetic leaflets disposed within the lumen. The prosthetic heart valve is restrainable in a compressed state by the delivery tool, such that a downstream end of the tubular portion is disposed within the distal capsule. The distal capsule is shaped so as to define an opening for visualizing ensheathing of at least a portion of the downstream end of the tubular portion within the distal capsule. Other embodiments are also described.

Transluminal delivery system

A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts, has an upstream end and a downstream end, and defines a lumen. The valve body is shaped so as to define a circumferential row of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. Exactly two of the four sides of each of the four-sided closed cells are double-strutted. Other embodiments are also described.

Prosthetic heart valve

An expandable prosthetic valve is implantable within a native mitral valve by terminal ends of ventricular anchors of the prosthetic valve moving outwardly from a constrained delivery position of the ventricular anchors, while the ventricular anchors are positioned within the atrium. Then, a portion of the expandable prosthetic valve containing the ventricular anchors is advanced through the native mitral valve into the ventricle. Terminal ends of atrial anchors of the prosthetic valve move outwardly relative to a portion of an annular valve body of the prosthetic valve while the atrial anchors are at least partially positioned within the atrium. Next, the annular valve body is radially expanded while the ventricular anchors are in the ventricle and the atrial anchors are in the atrium, thereby anchoring native heart valve tissue between the atrial anchors and ventricular anchors. Other embodiments are also described.

Systems and methods for implanting a prosthetic valve within a native heart valve

Embodiments of the present disclosure include a method for conditioning ex vivo pericardial tissue that has a parietal side and a fibrous side from which fibers extend. A blade assembly includes a blade head having a blade array and a face that defines gaps therein. The parietal side of the tissue is placed downward against a support plate, and a motor is operated to move the blade array with respect to the face. The face contacts the tissue such that the fibers protrude through the gaps and into the blade head. The blade array shears the fibers that protrude through the gaps into the blade head, yielding sheared fibers. Other embodiments are also described.

Device for conditioning ex vivo pericardial tissue

A prosthetic valve includes a tubular portion coupled to an upstream support portion, and ventricular legs. The prosthetic valve is transitionable from a compressed state into a partially-expanded state in which (1) a downstream surface of the support portion defines (i) an annular concave region extending radially between a concave-region inner radius and a concave-region outer radius, and (ii) an annular convex region, radially outward from the annular concave region, extending radially between a convex-region inner radius and a convex-region outer radius, and (2) the tip of each leg is disposed radially between the concave-region inner radius and the concave-region outer radius. In a fully-expanded state each leg's tip is disposed radially between the convex-region inner radius and the convex-region outer radius. Other embodiments are also described.

A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts arranged in a cellular structure defined by first and second circumferential rows of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. The struts are joined at four corners of the four-side closed cell. Each of the four sides of each of the four-sided closed cells is double-strutted. Other embodiments are also described.

A prosthetic valve includes a tubular valve body, snares, and an upstream support. A native valve of a heart of a subject is disposed between an atrium and a ventricle of the heart, and has an annulus and leaflets. The prosthetic valve is advanced to the heart while in a compressed state. The prosthetic valve is positioned within the heart such that the snares are disposed upstream of the annulus and leaflets. The snares are expanded radially outwardly upstream of the leaflets. Subsequently, the prosthetic valve is moved in a downstream direction such that the snares become disposed downstream of the leaflets. While the snares remain downstream of the leaflets, the upstream support is expanded within the atrium, and the upstream support is placed against an upstream surface of the annulus. Other embodiments are also described.

Anchoring of a prosthetic valve

A delivery tool includes a nosepiece that is fixed to a shaft, and distal to an implant, and an expandable element proximal to the nosepiece. Maximally-expanded, the expandable element (i) has an expanded external diameter at its widest part that is smaller than the expanded internal diameter of a lumen of the frame of the implant, (ii) tapers proximally away from the widest part and from the nosepiece, and (iii) is dimensioned to slide proximally through the lumen of the implant in its expanded state, between leaflets of the implant, and out of the lumen. When non-expanded, the widest part of the expandable element has a non-expanded external diameter that is smaller than the expanded external diameter of the expandable element. In a compressed state of the implant a portion of the expandable element is disposed within the lumen of the frame. Other applications are also described.

Minimally-invasive delivery systems

A prosthetic valve is provided that includes a tubular valve body and a plurality of prosthetic leaflets disposed within a lumen of the valve body. The valve body includes struts, has an upstream end and a downstream end, and defines a lumen. The valve body is shaped so as to define a circumferential row of four-sided closed cells. Each of the four-sided closed cells is defined by some of the struts, which are shaped so as to collectively define the following four sides: a left upstream side, a right upstream side, a left downstream side, and a right downstream side. Each of the four sides of each of the four-sided closed cells is double-strutted. Other embodiments are also described.

A prosthetic valve for implantation within a native mitral valve may be provided. The prosthetic valve may include an annular valve body. The prosthetic valve may also include a plurality of tissue anchors arranged about the valve body and configured to extend from connection points on the valve body. The prosthetic valve may also include at least one protective fabric covering extending over each of the connection points between each tissue anchor and the valve body.

Prosthetic valve with protective fabric covering around tissue anchor bases

A method for testing a prosthetic heart valve leaflet is provided. The method includes using a vertical post having a longitudinal axis and a horizontal bar having a bar-axis that lies on a vertical bar-plane. The bar supports the leaflet along the bar-axis such that the leaflet drapes over the bar. A linear actuator movably couples the bar to the post, and actuation of the actuator moves the bar vertically in the bar-plane. A light source emits a beam of light and is oriented to direct the beam through the bar-plane. A gauge measures an elevation of the bar above the beam. A detector is positioned to detect the beam and generates a detection-signal indicative of detection of the beam. Other applications are also described.

Techniques for use with prosthetic valve leaflets

During a medical procedure, a transseptal fenestration is made at a septum of the heart and a shunt is implanted into the transseptal fenestration. During the same medical procedure, a transapical puncture is made into a left ventricle of the heart. A prosthetic valve is delivered via the transapical puncture and implanted at a mitral valve of the heart. Subsequently to delivering the prosthetic valve and making the transseptal fenestration, the transapical puncture is closed. Other embodiments are also described.

Techniques for providing a replacement valve and transseptal communication

A prosthetic heart valve implant is provided including a frame shaped so as to define upstream and downstream openings at upstream and downstream ends of the frame, respectively, when the implant is in an expanded state for implantation at a heart native valve. A sheet is coupled to the frame. When the implant is in the expanded state, the frame is shaped so as to define the following longitudinal portions arranged along a central longitudinal axis of the prosthetic heart valve implant: a substantially cylindrical mid portion having a diameter greater than respective diameters of the upstream and the downstream ends of the frame; an upstream portion, extending upstream and radially inward from the mid portion; and a downstream portion, extending downstream and radially inward from the mid portion. Other embodiments are also described.

Prosthetic heart valve implant

Embodiments of the present disclosure include a method for use at a native valve of a heart of a subject. At a distal portion of a delivery tool, a balloon is coupled to a shaft. The distal portion is advanced to the heart with an implant and the balloon disposed within a capsule. The implant includes a tubular frame and one or more shape-memory flanges. The tubular frame is compressed around the balloon, and the flanges are constrained within a downstream capsule-portion of the capsule. The flanges are exposed from the downstream capsule-portion such that the flanges automatically deflect radially outward. Subsequently, the flanges are pressed against a downstream surface of the native valve by moving the implant in an upstream direction. While the flanges are in contact with the downstream surface, the tubular frame is plastically expanded radially by inflating the balloon. Other embodiments are also described.

Prosthetic valve and delivery tool therefor

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Zichron Yaackov, Israel

Ilia Hariton