Cardiovalve Ltd.

Mitraltech Ltd. 3 Ariel Sharon Avenue

Michael Albitov

Ilia Hariton

Meni Iamberger

Tal Hammer

Maxim Karalnik

Tal Reich

Yuval Zipory

Aviram Baum

Yaron Herman

Natalia Kruglova

Eran Hoffer

Boaz Harari

Paul Kaye

Oren Shua

Or Cohen

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

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 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 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

Apparatus for crimping a frame of an implant includes a crimping assembly having a bath having a floor, and one or more side-walls extending upward from the floor to a side-wall height. A crimping mechanism that defines a crimping aperture is attached to the bath such that the crimping aperture is disposed within the bath below the side-wall height. The crimping mechanism further comprises a handle and is actuatable by moving the handle circumferentially around the crimping mechanism. Actuation of the crimping mechanism transitions the crimping aperture from its open state to its narrowed state. Other embodiments are also described.

Temperature-control during crimping of an implant

Apparatus includes a delivery tool and a prosthetic valve, the prosthetic valve includes a first frame, and a second frame coupled to the first frame. The delivery tool includes a first catheter, a second catheter, and a rod. A steerable portion of the second catheter extends out of the first catheter, and a steerable distal portion of the rod extends out of the second catheter. An extracorporeal rod-controller is operably coupled to the rod such that operating the extracorporeal rod-controller steers the steerable distal portion of the rod. In a delivery state of the apparatus, the prosthetic valve is compressed onto the rod, distal to the distal end of the second catheter, and the apparatus is transfemorally and transseptally advanceable into a left atrium of a heart of a subject. Other embodiments are also described.

Delivery of a prosthetic valve

An assembly () for crimping a frame () of an implant () comprises a crimping device () with a base () and a crimping mechanism () that defines a crimping aperture (). A bath () having a floor (), and one or more side-walls () extending upward from the floor to a side-wall height defines a receptacle () that is shaped to receive a portion of the crimping device. The apparatus has an assembled state in which the portion of the crimping device has been received by the receptacle, the crimping device is held securely by the bath, and the aperture is below the side-wall height. Other embodiments are also described.

A tool () for use with an implant () includes a housing () and a controller (). The housing includes a tubular wall () that circumscribes a longitudinal axis; is dimensioned to house at least part of the implant; and defines a track () that follows a generally-helical path around the longitudinal axis. The controller includes a rod () that extends from a proximal part of the tool to the housing; and an actuator (). The actuator is fixedly coupled to the rod, includes an engaging element () that engages the track, and is rotatable with respect to the housing. The controller and the housing mechanically cooperate such that rotation of the actuator with respect to the housing slides the housing longitudinally with respect to the actuator. Other embodiments are also described.

A rod () is transfemorally advanceable to the heart. An implant () comprises (i) a first frame (), compressed around a first longitudinal site of a distal portion of the rod, (ii) a second frame (), compressed around a third longitudinal site of the distal portion, (iii) a valve member (), disposed within the second frame, and (iv) a flexible sheet (), coupling the first frame to the second frame, and disposed around a second longitudinal site of the distal portion, the second longitudinal site being between the first longitudinal site and the third longitudinal site. An extracorporeal controller () is coupled to a proximal portion of the rod, and is operably coupled to the distal portion of the rod. Operating the controller bends the distal portion of the rod causing articulation between the frames. Other embodiments are also described.

Articulatable prosthetic valve

A prosthetic valve is advanced to a heart of a subject while the prosthetic valve is in a compressed state thereof, the prosthetic valve including a plurality of snares coupled to a tubular valve body. The prosthetic valve is positioned within the heart such that the plurality of snares is disposed upstream of the leaflets, and the plurality of snares is expanded upstream of the leaflets. Subsequently the prosthetic valve is moved in a downstream direction such that the plurality of snares is disposed downstream of the leaflets. Subsequently, the prosthetic valve is secured at the native valve while the plurality of snares remains disposed downstream of the leaflets.

A tool is configured for transluminal delivery of an implant. The tool has a proximal part and a distal part, and comprises a shaft, a nosepiece, a sheath, and a balloon. The nosepiece is fixed to the shaft, and is arranged with respect to the implant such that the implant extends proximally away from the nosepiece and over the shaft. The sheath houses the implant. The balloon is disposed at the distal part of the tool, and is in fluid communication with the proximal part of the tool. When maximally inflated, the balloon has (i) a widest part that has an inflated diameter that is less than the diameter of the sheath or at most 10 percent greater than the diameter of the sheath, and (ii) a tapered portion that tapers longitudinally away from the widest part and from the nosepiece.

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Kiryat Ono, Israel

Michael Albitov