Magenta Medical Ltd.

Hagit Zemer Harel

Yosi Tuval

Ehud Schwammenthal

Gad Lubinsky

Avi Rozenfeld

Zev Sohn

Yuri Sudin

Yinnon Elisha

Victor Troshin

Shaul Mustacchi

Shaul Jacob Leisner Mustacchi

Daniel Rosenblum

Ori Friedland

Yoshi Tuval

Apparatus and methods are described including delivering a left-ventricular assist device to a subject's aorta. The device including a distal-tip element that defines a straight proximal portion, and a curved distal portion, the curved distal portion defining first and second curves with an elongated straight portion between the first and second curves. The distal-tip element is centered with respect to the aortic valve using the curved distal portion of the distal-tip element, to thereby guide the device through the subject's aortic valve atraumatically. A pump pumps blood through from the subject's left ventricle to the subject's aorta. Other applications are also described.

Distal tip element for a ventricular assist device

Apparatus and methods are described including delivering a left-ventricular assist device to a subject's left ventricle. A tube is positioned such that a proximal portion of the tube traverses an aortic valve of the subject, and a distal portion of the tube is disposed within a left ventricle of the subject. A pump pumps blood through the tube from the subject's left ventricle to the subject's aorta such as to cause the proximal portion of the tube to be maintained in an open state, and to cause at least a portion of the tube to become curved. Other applications are also described.

Curved tube for a ventricular assist device

Apparatus and methods are described including a ventricular assist device that includes a frame having struts that define a plurality of cells. In its non-radially-constrained configuration, the frame includes a generally cylindrical portion. A tube defines blood outlet openings, and a portion of the tube is disposed outside the frame and is coupled to the generally cylindrical portion of the frame, such that the portion of the tube conforms with a structure of struts of the frame. An inner lining is coupled to an inside of the generally cylindrical portion of the frame, such as to provide the generally cylindrical portion of the frame with a smooth inner surface. An impeller is disposed at least partially inside the generally cylindrical portion of the frame and is configured to pump blood through the tube and out of the one of more blood outlet openings. Other applications are also described.

Impeller housing

Apparatus and methods are described including a blood pump that includes an impeller configured to pump blood through a subject's body, and a frame disposed around the impeller. In a radially-non-constrained configuration of the frame, the frame defines a proximal conical portion and a cylindrical portion disposed distally to the proximal conical portion. During operation of the blood pump, the impeller moves with respect to the frame, and a range of movement of the impeller is such that at least a first portion of the impeller is disposed within the proximal conical portion of the frame during at least some of the operation of the blood pump, and at least a second portion of the impeller is disposed within the cylindrical portion of the frame during at least some of the operation of the blood pump. Other applications are also described.

Impleller and frame for a blood pump

Apparatus and methods are described including a blood pump configured to be placed inside a body of subject. The blood pump includes an impeller, a frame disposed around the impeller, and a distal-tip portion disposed distally with respect to the frame. A duckbill valve is disposed entirely within a distal most 10 mm of the distal-tip portion. The duckbill valve defines a wide inlet and a narrow tip that defines a slit therethrough. The duckbill valve is proximally facing, such that the wide inlet faces a distal end of the distal-tip portion and such that the narrow tip faces away from the distal end of distal-tip portion. Other applications are also described.

Duckbill valve for use with percutaneous medical devices

Apparatus and methods are described, including a left-ventricular assist device that includes an impeller, and a frame disposed around the impeller, the frame having a length of more than 25 mm when disposed in a non-radially constrained configuration. A rigid axial shaft extends from a proximal end of the frame to a distal end of the frame. A motor is disposed outside a body of a subject, and drives the impeller to pump blood within the subject's body, by rotating. A drive cable extends from outside the subject's body to the axial shaft. The drive cable imparts rotational motion from the motor to the impeller by rotating. The drive cable is a flexible cable comprising a plurality of coiled wires. Other applications are also described.

Flexible drive cable with rigid axial shaft

Apparatus and methods are described including a blood pump configured to be placed inside a body of subject, the blood pump including an impeller configured to pump the subject's blood by rotating, and an axial shaft upon which the impeller is disposed. Proximal and distal radial bearings are configured to stabilize the axial shaft radially during rotation of the impeller. An atraumatic distal-tip portion is disposed distally with respect to the impeller, the atraumatic distal-tip portion including an inflatable portion. A purging fluid is pumped toward the distal-tip portion, such as to (a) purge the distal bearing, and (b) inflate the inflatable portion of the distal-tip portion. Other applications are also described.

Atraumatic balloon for blood pump

Apparatus and methods are described including manufacturing an impeller by forming a structure having first and second bushings at proximal and distal ends that are connected to one another by at least one elongate element. The elongate element is made to radially expand and form a helical elongate element. An elastomeric material is coupled to the helical elongate element, such that the helical elongate element with the elastomeric material coupled thereto defines a blade of the impeller. The coupling is performed such that a layer of the material disposed around a radially outer edge of the helical elongate element forms the effective edge of the impeller blade. A step is performed to enhance bonding of the elastomeric material to the helical elongate element in a manner that does not cause a protrusion from the effective edge of the impeller blade. Other applications are also described.

Manufacturing an impeller

Apparatus and methods are described including coupling a rigid tube to a drive cable that comprises a plurality of coiled wires, by placing ends of the drive cable and the rigid tube at a given location within a butt-welding overtube. The ends of the drive cable and the rigid tube are visible when they are disposed at the given location within the butt-welding overtube, via a window defined by the butt-welding overtube. The placement of the drive cable within the butt-welding overtube is such that a helical groove within a portion of the butt-welding overtube is disposed over the drive cable. Welding rings are formed around the butt-welding overtube. Other applications are also described.

Welding overtube

Apparatus and methods are described including a blood pump that includes an impeller configured to pump blood through a subject's body, and a frame disposed around the impeller. The frame defines struts having a structure that is such that, as the frame transitions from a proximal end of the frame toward a center of the frame, the struts pass through junctions, at which the two struts branch from a single strut, in a Y-shape. The structure of the struts of the frame is configured such that, in response to a distal end of a delivery catheter and the frame being moved into overlapping positions with respect to each other, the frame assumes a radially-constrained configuration by becoming axially elongated, and the frame causes the impeller to assume a radially-constrained configuration by becoming axially elongated. Other applications are also described.

Frame for blood pump

Apparatus and methods are described including manufacturing a housing for an impeller of a blood pump by placing an inner lining around a mandrel, placing a cylindrical portion of a frame around the inner lining, and placing a distal portion of an elongate tube around a portion of the frame. While the distal portion of the elongate tube is disposed around the portion of the frame, the inner lining, the frame, and the distal portion of the elongate tube are heated, via the mandrel, and pressure is applied from outside the distal portion of the elongate tube, such as to cause the distal portion of the elongate tube to conform with a structure of the struts of the frame, and to cause the inner lining and the distal portion of the elongate tube to become coupled to the frame. Other applications are also described.

Apparatus and methods are described including a left-ventricular assist device that includes a tube configured to traverse a subject's aortic valve, with a distal portion of the tube within the subject's left ventricle. A frame disposed within the distal portion of the tube defines cells, and a width of each of the cells within a cylindrical portion of the frame is less than 2 mm. An inner lining lines at least some of the cylindrical portion of the frame. An impeller is disposed inside the frame such that a gap between an outer edge of the impeller and the inner lining is less than 1 mm. The impeller is stabilized with respect to the frame, such that, during rotation of the impeller, the gap between the outer edge of the impeller and the inner lining is maintained and is substantially constant. Other applications are also described.

Ventricular assist device with stabilized impeller

Apparatus and methods are described including a left-ventricular assist device that includes a tube configured to traverse a subject's aortic valve, with a distal portion of the tube disposed within the subject's left ventricle. A frame is disposed within the distal portion of the tube. A pump disposed within the frame pumps blood through the tube. A distal-tip element defines a straight proximal portion that defines a longitudinal axis, and a curved distal portion that is shaped such as to curve in a first direction with respect to the longitudinal axis before passing through an inflection point and curving in a second direction with respect to the longitudinal axis, such that the curved distal portion defines a bulge on one side of the longitudinal axis. Other applications are also described.

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Kfar Saba, Israel

Hagit Zemer Harel