JPWO2020152611A5

JPWO2020152611A5 -

Info

Publication number: JPWO2020152611A5
Application number: JP2021533242A
Authority: JP
Publication date: 2023-01-30
Anticipated expiration: 2040-01-23

Claims

A device comprising a left ventricular assist device configured to assist left ventricular function in a subject, comprising:
The left ventricular assist device comprises:
a tube configured such that a proximal portion of the tube traverses the subject's aortic valve and a distal portion of the tube is positioned within the subject's left ventricle;
a frame disposed within at least the distal portion of the tube;
A pump disposed within the frame, the pump pumping blood into the tube through at least one blood inlet defined by the tube and configured to be positioned within the subject's left ventricle. into the subject's left ventricle and out of the subject's left ventricle via at least one blood outlet defined by the tube and configured to be positioned within the subject's aorta. a pump configured to pump blood through the tube to the aorta;
a linear proximal portion defining a longitudinal axis; and a linear proximal portion extending along the longitudinal axis of the linear proximal portion before passing through an inflection point and bending in a second direction with respect to the longitudinal axis of the linear proximal portion. a curved distal portion having a shape curved in a first direction relative to one of the longitudinal axes of the straight proximal portion; a distal tip element defining a bulge in
apparatus, including

The distal tip element is configured to separate at least one blood inlet from the posterior wall of the subject's left ventricle when the distal tip element is positioned against the apex of the subject's left ventricle. 2. The device of claim 1, wherein the device is configured as:

2. The device of claim 1, wherein the distal tip element has a question mark shape.

2. The device of claim 1, wherein the distal tip element has a tennis racket shape.

The curved distal portion of the distal tip element, after passing the point of inflection, continues to curve such that the curved distal portion returns across the longitudinal axis defined by the straight proximal portion. 2. The device of claim 1, wherein the device is shaped to.

The curved distal portion of the distal tip element is shaped such that after passing the inflection point, the curved distal portion does not return across the longitudinal axis defined by the straight proximal portion. 2. The device of claim 1, wherein:

said blood pump comprising an impeller disposed on an axial shaft;
The distal tip element includes an axial shaft receiving tube configured to receive the axial shaft of the blood pump and a distal tip configured to define the curved distal portion of the distal tip element. 2. The device of claim 1, comprising a positional tip.

The distal tip element is configured to separate the at least one blood inlet from the septal wall of the subject's left ventricle when the distal tip element contacts the apex of the subject's left ventricle. 8. Apparatus according to any one of claims 1 to 7, wherein

The distal tip element presses against the apex of the subject's left ventricle when the distal tip element is inserted into the left ventricle such that the bulge bulges toward the septal wall. 9. The device of claim 8, wherein the blood inlet is configured to be pushed away from the septal wall and toward the free wall of the subject's left ventricle in response to being applied.

The straight proximal portion of the distal tip element pivots about the curved distal portion of the distal tip element in response to being pressed against the apex of the subject's left ventricle. 10. The device of claim 9, configured to push the blood inlet away from the septal wall and toward the free wall of the subject's left ventricle by a portion.

8. The distal tip element is configured such that, when placed in the subject's descending aorta, the distal tip element centers itself relative to the subject's aortic valve. A device according to any one of the preceding claims.

The curved distal portion defines an elongated straight portion after bending in the first direction and before bending in the second direction such that the elongated straight portion is a proximal straight line of the distal tip element. 12. A device according to claim 11, shaped to protrude at an angle to the longitudinal axis of the portion.

8. The device of any one of claims 1-7, wherein a duckbill valve is positioned within the most distal 10 mm of the distal tip element.

The duckbill valve defines a wide inlet and a narrow tip, the narrow tip defining a slit therethrough, the duckbill valve having the wide inlet facing the distal end of the distal tip element and the narrow tip. 14. The device of claim 13, wherein is oriented proximally by pointing away from the distal end of the distal tip element.

the left ventricular assist device configured to use a guidewire;
the distal tip element defines a guidewire lumen;
the left ventricular assist device further comprising a guidewire guide disposed within the guidewire lumen at a location proximal to the duckbill valve;
The guidewire guide is shaped to define a bore that narrows in diameter from its proximal end to its distal end, and the shape of the guidewire guide is such that the guidewire extends from the proximal end of the left ventricular assist device. 15. The device of claim 14, configured to guide the tip of the guidewire, when inserted, toward a slit in the narrow proximal end of the duckbill valve.

The duckbill valve is shaped to define a converging guide at its proximal end, the converging guide converging toward the slit to direct the tip of the guidewire toward the slit. 16. The device of claim 15, further configured to guide.

1. A device comprising a left ventricular assist device configured to assist left ventricular function in a subject, comprising:
The left ventricular assist device comprises:
a tube that traverses the subject's aortic valve such that a proximal end of the tube is positioned within the subject's aorta and a distal end of the tube is positioned within the subject's left ventricle; a tube configured to
a generally cylindrical portion disposed within at least a portion of said tube defining a plurality of cells, in a radially unconstrained configuration, each cell within said cylindrical portion measured about the circumference of said cylindrical portion; a frame configured to be less than 2 mm wide;
a liner lining at least a portion of the cylindrical portion of the frame;
positioned within the frame so as to be positioned within the cylindrical portion of the frame, in a radially unconstrained configuration, at the position of maximum span, with a clearance of less than 1 mm between its outer edge and the lining an impeller positioned within the cylindrical portion of the frame so as to
The impeller is
rotating to pump blood from the left ventricle to the aorta;
A device configured to be stabilized with respect to the frame such that a gap between the outer edge and the lining is maintained and substantially constant during rotation.

forming a structure having first and second bushings at proximal and distal ends, wherein at least one elongated element connects the first and second bushings together;
radially expanding the at least one elongated element to form at least one helical elongated element by at least partially axially compressing the structure;
The at least one helical elongated element bonded to the elastomeric material by bonding the elastomeric material to the at least one helical elongated element defines the blades of the impeller, and the at least one layer of material manufacturing an impeller by effecting said bonding so as to be disposed around the radially outer edges of two helical elongated elements, said layers of material forming effective edges of said blades of said impeller; a method,
The method includes performing the step of strengthening the coupling of the elastomeric material to the at least one helical elongated element so as not to cause the blades of the impeller to protrude from the effective edges. Method.

an impeller configured to pump blood through a subject;
and a frame positioned about the impeller, and using a delivery catheter, comprising:
The impeller and frame define a radially unconstrained configuration in which the impeller is configured to pump blood within the subject body, and a delivery catheter is used to insert and remove the impeller and frame from the subject body. defining a radially constrained configuration,
The frame defines struts having a structure that passes through a Y-branching junction from a single strut to a pair of struts as it transitions from the proximal end of the frame toward the center of the frame. ,
The structure of the struts of the frame is such that the frame is radially constrained by axial extension in response to movement of the distal end of the delivery catheter and the frame into an overlapping position. and to cause the impeller to assume an axially extended and radially constrained configuration.

Placing a lining around the mandrel,
disposing a cylindrical portion of a frame including struts defining a generally cylindrical shape around the liner;
disposing a distal portion of an elongated tube including a proximal portion defining at least one blood outlet about at least a portion of the frame;
heating the liner, the frame, and the distal portion of the elongated tube via the mandrel while the distal portion is disposed about the at least a portion of the frame;
heating the lining, the frame and the distal portion of the elongated tube while conforming the distal portion of the elongated tube to the structure of the struts of the frame and the distal portion of the lining and the elongated tube. fabricating a housing for a blood pump impeller by applying external pressure to the distal portion of the elongated tube to couple the tube to the frame.