Cardiovalve Ltd.

Maxim Karalnik

Ilia Hariton

Meni Iamberger

Michael Albitov

Boaz Harari

Oren Shua

Tal Hammer

Or Cohen

Paul Kaye

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 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

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

A method includes percutaneously advancing an implant to a native heart valve of a subject, the implant being housed in a compressed state within a delivery tool. Next, the method includes unhousing a longitudinally-intermediate portion of the implant, the longitudinally-intermediate portion being longitudinally between a longitudinally-proximal portion of the implant and a longitudinally distal portion of the implant. Subsequently, the longitudinally-proximal portion of the implant is unhoused. Subsequently, the longitudinally-distal portion of the implant is unhoused. By unhousing flanges of the implant, the flanges automatically expand. Upon the flanges expanding, a proximal end of each flange extends radially outward from a central longitudinal axis of the implant and longitudinally in a proximal direction. Other applications are also described.

Techniques for deployment 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 delivery tool includes a delivery capsule, disposed at a distal portion of the tool. The delivery capsule includes a proximal capsule-portion dimensioned to house a first part of an implant, and a distal capsule-portion dimensioned to house a second part of the implant; and an extracorporeal control portion, disposed at a proximal portion of the tool, the control portion including one or more controllers and one or more locks. The controllers are operatively coupled to the proximal and distal capsule-portions such that the proximal and distal capsule-portions are movable with respect to the implant via actuation of the controllers. The tool has sequential states in which movement of the proximal and distal capsule-portions is variously inhibited or facilitated.

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.

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.

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Karmiel, Israel

Maxim Karalnik