Cardiovalve Ltd.

Mitraltech Ltd.

Cardiovale Ltd.

Gil Hacohen

Yossi Gross

Tal Reich

Eran Miller

Yuval Zipory

Rotem Neeman

Meir Kutzik

Natalia Kruglova

Amir Gross

Tal Hammer

Yaron Herman

Marco Papa

First and second atrial arms and first and second ventricular arms are advanced to the heart. The first ventricular arm is moved distally by applying a pulling force to the first ventricular arm at a first fixed connection point that is at a portion of the first ventricular arm that is farthest from a first articulation site of the first atrial arm and the first ventricular arm, and the second ventricular arm is moved distally by applying a pulling force to the second ventricular arm at a second fixed connection point that is at a portion of the second ventricular arm that is farthest from a second articulation site of the second atrial arm and the second ventricular arm. Subsequently, the first native leaflet is clamped between the first arms, and the second native leaflet is clamped between the second arms. Other embodiments are also described.

Method for use at a heart valve

A method, for use at a mitral valve of a heart of a subject, is provided which includes advancing a transluminal sheath into a femoral vein of the subject, through an inferior vena cava of the subject, into a right atrium of the subject, and transseptally into a left atrium of the subject. A surrounding-sheath is advanced out of a distal end of the transluminal sheath, into the left atrium, and toward a commissure of the mitral valve. An anchor is implanted by advancing the anchor out of the surrounding-sheath into a left ventricle of the subject, such that the anchor helically wraps around left ventricular mitral valve tissue. The surrounding-sheath is then extracted from the heart and then, a guide wire is advanced through the transluminal sheath. Other embodiments are also described.

Helical anchor implantation

An implant includes a central body and anchoring arms that extend proximally from the implant's downstream end portion and that are movable with respect to an upstream end portion of the implant. The implant is advanced into the heart using a catheter and is implanted at a native atrioventricular valve by positioning: (i) the anchoring arms in the ventricle, (ii) the central body between the native valve's leaflets, and (iii) a distal end of an elongate element into the ventricle. The elongate element is (1) pulled to apply a proximally-directed force to the anchoring arms to move the anchoring arms' distal ends axially with respect to the upstream end portion while the distal ends of the anchoring arms remain radially fixed with respect to a central longitudinal axis of the implant, and (2) removed from the subject's body. Other embodiments are also described.

Prosthetic heart valves and methods of use of prosthetic heart valves may be provided. In one implementation, a prosthetic heart valve may include an annular spacer configured for implantation with a native heart valve opening and a central valve section configured for disposal within the annular spacer. The central valve section may include at least one anchoring protrusion configured to anchor the central valve section against axial movement relative to the annular spacer. During deployment, the central valve section may be expanded radially within the heart into an at least partially-expanded configuration while at least a portion of the central valve section is situated outside of a space opening of the annular spacer, and moved upstream while remaining in the at least partially-expanded configuration until the anchoring protrusion engages the annular spacer.

Valve prosthesis configured for deployment in annular spacer

A heart valve repair system includes a delivery sheath and an implant that includes a frame including a braided structure of intertwining strands and having a surface configured to contact an upstream surface of a native heart valve. First and second gripping members are coupled to the frame, each including atrial and ventricular arms. The implant is disposed in the sheath in a delivery state in which the frame defines a wall fully surrounding a central longitudinal axis of the implant. The distal end of the wall defines a distal opening of the frame. The distal end of the wall is disposed proximally to the second end of the ventricular arm of each of the gripping members. The second end of each ventricular arm moves toward the axis of the implant more than the first end moves toward the axis. Other embodiments are also described.

Implant for heart valve

A heart valve repair system includes a delivery sheath and an implant that includes a frame having a surface configured to contact an upstream surface of a native heart valve. First and second gripping members are coupled to the frame and each (1) includes first and second arms and (2) is configured to clamp a respective native leaflet. The implant is disposed in the sheath in a delivery state in which the frame defines a wall fully surrounding a central longitudinal axis of the implant. The distal end of the wall defines a distal opening of the frame. The distal end of the wall is disposed proximally to the entire first tissue-engaging surface of each of the gripping members and proximally to the entire second tissue-engaging surface of each of the gripping members. Other embodiments are also described.

A prosthetic heart valve includes a valve ring, which includes metal segments, and which is cylindrical when in an expanded state. A valve ring fabric sleeve is coupled to the valve ring. A leaflet frame is disposed within the valve ring. A plurality of prosthetic leaflets are coupled to the leaflet frame. An upper skirt includes an upper skirt fabric, coupled to the valve ring fabric sleeve; and a flexible upper skirt frame, coupled to the upper skirt fabric such that the upper skirt fabric separates a downstream end of the upper skirt frame from an upstream end of the metal segments of the valve ring. When the prosthetic heart valve is in an expanded state, the upper skirt extends radially outward from the valve ring in an upstream direction and is configured to rest against an atrial surface of the heart. Other embodiments are also described.

Prosthetic heart valve with upper skirt

An implant includes a primary structural element, and two clips coupled to the primary structural element, on opposite lateral sides of the primary structural element from each other, each of the clips having a first clip element and a second clip element. The implant is transluminally advanced to a heart valve of a subject. The implant is coupled to leaflets of the valve (i) by, for each of the clips, closing the clip around a central part of a respective leaflet of the valve by causing deflection between the first clip element and the second clip element, thereby sandwiching the central part of the respective leaflet between the first clip element and the second clip element, and (ii) such that the leaflets form a double orifice configuration, with the primary structural element disposed between the central parts of the leaflets. Other embodiments are also described.

Clip-secured implant for heart valve

A transluminal sheath is advanced transseptally into a left atrium of the subject. A distal end of a surrounding-sheath, having an anchor disposed therein, is advanced via a distal end of the transluminal sheath, into a left ventricle of the subject via a commissure of the mitral valve. While the distal end of the surrounding-sheath is in the left ventricle, the surrounding-sheath is pulled proximally with respect to the anchor to expose the anchor. While the distal end of the surrounding-sheath is in the left ventricle, mitral valve tissue that is within the left ventricle is encircled by helically wrapping the anchor around the mitral valve tissue. Subsequently, the surrounding-sheath is extracted from the heart. Other embodiments are also described.

A system includes a core and a catheter for use with (A) a first atrial arm and a first ventricular arm articulatable with respect to each other at a first articulation site to clamp one leaflet of a patient's native heart valve, and (B) a second atrial arm and a second ventricular arm articulatable with respect to each other at a second articulation site to clamp another native leaflet of the native valve. The core tapers in a distal direction toward its smallest perimeter, defining a minimum nonzero angle of the atrial arms with respect to a central longitudinal axis of the core. The catheter advances the core and the arms toward the native valve. The catheter and the core have an advancement configuration in which the smallest perimeter of the core is adjacent to the first and second articulation sites. Other embodiments are also described.

Apparatus for use at a heart valve

An implant includes a clip and a clip-controller interface. The clip is disposed laterally from a central longitudinal axis of the implant, includes first and second arms articulatably coupled to each other, and sandwiches a leaflet of a heart valve between the first and second arms by articulation between the first and second arms, such that the second arm is disposed laterally from the first arm. The clip-controller interface is reversibly coupled to a clip controller of a delivery tool, and includes first and second portions. The first portion is linearly slidable by the clip controller. The second portion is articulatably coupled to the first portion and to the second arm, such that linear sliding of the first portion causes the second portion to (i) articulate with respect to the first portion, and (ii) push the second arm to articulate toward the axis. Other embodiments are also described.

A transluminal sheath is advanced into a femoral vein of a subject, through an inferior vena cava of the subject, into a right atrium of a heart of the subject, and transseptally into a left atrium of the heart. A surrounding-sheath is advanced out of a distal end of the transluminal sheath, into the left atrium, and toward a commissure of a mitral valve of the heart. A commissural helix is implanted at the commissure by advancing the commissural helix out of the surrounding-sheath and through the commissure into a left ventricle of the heart, such that the commissural helix wraps around at least some chordae tendineae at the commissure and facilitates sealing of the commissure. Subsequently to the implantation of the commissural helix, the surrounding-sheath is extracted from the heart. Other embodiments are also described.

A method includes advancing apparatus including a core toward a patient's heart valve. The core tapers in a distal direction toward the smallest perimeter of the core. The apparatus includes a first ventricular arm, which is articulatable with respect to a first atrial arm at a first articulation site, and a second ventricular arm, which is articulatable with respect to a second atrial arm at a second articulation site. The articulation sites are adjacent to the smallest perimeter. The tapering of the core defines a minimum nonzero angle of the atrial arms with respect to a central longitudinal axis of the core. The method also includes clamping the first and second leaflets between the respective atrial arms and the respective ventricular arms. Other embodiments are also described.

Apparatus is provided for use at a native atrioventricular valve of a heart of a subject. A prosthetic valve structure includes prosthetic leaflets configured to facilitate upstream-to-downstream bloodflow longitudinally through the prosthetic valve structure. The apparatus includes an annular portion configured to be positioned at the native atrioventricular valve and curved anchors that point in a circumferential direction around the annular portion. The anchors each having a leading tip configured to gather chordae tendineae of the heart between the anchors and the annular portion. Rotation of the prosthetic valve structure in the circumferential direction causes the anchors to gather the chordae tendineae between the anchors and the annular portion by the anchors moving, leading tip first, in the circumferential direction. Other embodiments are also described.

Rotation-based anchoring of an implant

Implantable first atrial and ventricular arms are articulatable at a first articulation site to clamp a first heart valve leaflet. A first implantable elongate transitioning member is (a) connected at a fixed connection point at a portion of the first ventricular arm farthest from the first articulation site, (b) has a portion that faces an opposite surface of the first ventricular arm, and (c) is controllable to move the first ventricular arm. Implantable second atrial and ventricular arms are articulatable at a second articulation site to clamp a second leaflet. A second implantable elongate transitioning member is (a) connected at a fixed connection point at a portion of the second ventricular arm farthest from the second articulation site, (b) has a portion that faces an opposite surface of the second ventricular arm, and (c) is controllable to move the second ventricular arm. Other embodiments are also described.

Growing community of inventors

Ramat Gan, Israel

Gil Hacohen