Pi-Cardia Ltd.

Clear-Cut Medical Ltd.

Pi-Cardia Lid.

Pi-R-Squared Ltd.

Erez Golan

Ofir Gal-Or

Raphael Benary

Ronnie Levy

Oded Meiri

Shai Karni

BenZion Spector

Darr Or

Shai Kami

Ofir Gal Or

A method for heart valve treatment includes providing a first heart valve treatment member movable along a first shaft portion, providing a second heart valve treatment member movable along a second shaft portion. The first and second heart valve treatment members are movable along the first and second shaft portions, respectively. The first heart valve treatment member is positioned on one side of a heart valve leaflet and the second heart valve treatment member is positioned on an opposite side of the heart valve leaflet. A portion of the heart valve leaflet is fracture by movement of the first heart valve treatment member with respect to the second heart valve treatment member.

Fracturing calcifications in heart valves

A transcatheter valve laceration device () includes a leaflet support frame () and a leaflet cutting assembly (), both of which are movably mounted on a guiding structure () and movable between contracted and expanded orientations. In the expanded orientation, a blade protector () of the leaflet support frame () is positioned over a cutting element () of the leaflet cutting assembly ().

Transcatheter valve laceration device and method

A device () for fracturing calcifications in heart valves includes a first heart valve treatment member () that extends from a first shaft () and which includes a scoring portion (). A second heart valve treatment member () extends from a second shaft () and has a counterforce member (). The second heart valve treatment member () and counterforce member () are coupled to the second shaft () with a brace () arranged to bear a force applied by scoring portion () to the counterforce member ().

Heart valve treatment members with changeable orientation

A device for fracturing calcifications in heart valves including an expandable stabilizer and expandable impactor arms assembled on and deployed by a delivery system, wherein the delivery system is operable to move the impactor arms, while in an expanded position, with respect to the stabilizer with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between the stabilizer and the impactor arms.

A device for fracturing calcifications in heart valves includes a stabilizer and an impactor movable towards each other. The impactor includes one or more impactor arms, each of which extends distally from a proximal cap. The impactor further includes one or more lever arms each of which is distally coupled to a lever cap and proximally coupled to a corresponding one of the one or more impactor arms. The lever cap slides on a shaft which extends towards the proximal cap. Proximal movement of the lever cap towards the proximal cap causes the one or more lever arms to deform and to push against the one or more impactor arms and to cause the one or more impactor arms to deform.

Impactor and stabilizer for fracturing calcifications in heart valves

A device for fracturing calcifications in heart valves includes a tube formed with at least two longitudinal slits that form at least two struts. Each of the struts includes two or more pairs of notches formed on opposite sides of the strut. The struts have a contracted orientation in which the struts are not expanded outwards from the tube and an outwardly expanded orientation in which the struts are expanded outwards from the tube and have sufficient strength and rigidity to impact and fracture a calcification in a heart valve.

Impactor for fracturing calcifications in heart valves

A calcification treatment device includes an outer body () including an inner cavity and at least one outer calcification treatment member () facing towards the inner cavity. An inner body () is movable into the inner cavity and includes at least one inner calcification treatment member () facing towards an inner surface of the outer body. One of the outer and inner calcification treatment members includes an expandable treatment member and one of the outer and inner calcification treatment members includes one or more fracturing elements capable of fracturing a calcification of a valve tissue.

Remodeling of calcified aortic valve leaflets

A device for fracturing calcifications in heart valves includes a tube formed with at least two longitudinal slits that form at least two struts (). Each of the struts includes two or more pairs of notches () formed on opposite sides of the strut. The struts have a contracted orientation in which the struts are not expanded outwards from the tube and an outwardly expanded orientation in which the struts are expanded outwards from the tube and have sufficient strength and rigidity to impact and fracture a calcification in a heart valve.

A device for fracturing calcifications in heart valves characterized by a stabilizer assembly and an impactor assembly assembled on and deployed by a delivery system, wherein said delivery system is operable to cause relative motion between said impactor assembly and said stabilizer assembly with sufficient energy so as to fracture a calcification located in tissue which is sandwiched between said stabilizer assembly and said impactor assembly, wherein said impactor assembly and said stabilizer assembly have shaped impact delivery portions of which the footprint on the valve leaflets is shaped in accordance with a shape of desired fracture sites.

A device for fracturing calcifications in heart valves includes a stabilizer assembly () for use with an impactor assembly (). Relative motion between the impactor assembly () and the stabilizer assembly () with sufficient energy fractures a calcification located in tissue which is sandwiched between the stabilizer assembly () and the impactor assembly (). The stabilizer assembly () includes a plurality of distal stabilizer struts () connected by stabilizer loops () which extend proximally backwards.

Stabilizer assembly for fracturing calcifications in heart valves

A device includes a protection sleeve () and a retractable sheath () operatively connected to the protection sleeve (), and a catheter () that passes through a main lumen () of the sleeve (). The catheter () includes a heart valve treatment device arranged to pass into a lumen of the catheter ().

Percutaneous emboli protection sleeve

A device for fracturing calcifications in heart valves including a catheter () configured for percutaneous delivery to a heart valve, an fracture-producing element () disposed at a distal portion of the catheter and operative to vibrate and mechanically fracture calcifications when brought into contact with a calcification at a leaflet of the heart valve, and an energy source () operative to vibrate the fracture-producing element so that the fracture-producing element fractures the calcification without necessarily removing the calcification from the leaflet. The device may further comprise a valvuloplasty balloon (), an embolic protection net () and a protective sleeve ().

A system for margin assessment of an ex-vivo tissue () is provided, including a magnetic resonance imaging (MRI) scanner () controlled by a control unit (), and a tissue container () for holding a sample of an ex-vivo tissue (). The MRI scanner () includes a coil-magnet assembly () including magnets (), wherein the tissue (), placed in the container (), is placed under a constant static magnetic field (Bo), which is induced by the magnets (), and the container () is positioned so the sensitive region is within a measured field of view (FOV) excited by one or more transmit/receive coils () operative to generate a time-varying RF Belectro-magnetic field pointing towards the tissue (), and wherein the container () is fixed on a moving table ().

MRI system for margin assessment of ex-vivo sample

A device for fracturing calcifications in heart valves including an expandable stabilizer () and expandable impactor arms () assembled on and deployed by a delivery system (), wherein the delivery system () is operable to move the impactor arms (), while in an expanded position, with respect to the stabilizer () with sufficient energy so as to fracture a calcification located in tissure which is sandwiched between the stabilizer () and the impactor arms ().

Growing community of inventors

Rehovot, Israel

Erez Golan