Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: In one exemplary embodiment, an angioplasty device may include a flexible shaft. The angioplasty device may also include an expandable wire mesh structure extending from the flexible shaft. At least one actuator, connected to the expandable wire mesh structure, the actuator being configured to cooperate with the wire mesh structure to transfer angioplasty forces to a vessel obstruction.

Abstract: An intraluminal device including an elongated structure formed of a plurality of wires may be provided. The intraluminal device may include a plurality of sets of looped wires longitudinally located at an intermediate area of the elongated structure. The sets of looped wires may be spaced circumferentially about the elongated structure and may be configured to cooperate with each other to form a plurality of clot entry openings. The intraluminal device may also include at least one grouping of woven wires that may be longitudinally located adjacent to the intermediate area and may be configured such that when an opening force is exerted on the elongated structure, the at least one grouping of woven wires may provide structural support to hold open first interstices between the plurality of sets of looped wires.

Abstract: In one exemplary embodiment, an endovascular device may include a hollow shaft having a proximal end and a distal end, and sized for insertion into a blood vessel. The endovascular device may also include a control line having a proximal end and a distal end, and extending through the hollow shaft. The endovascular device may also include an actuatable working element located proximate the distal end of the hollow shaft, and configured to receive an actuation force transmitted via the distal end of the control line. The endovascular device may further include an actuator configured to exert the actuation force on the proximal end of the control line, to thereby cause relative movement between the control line and the hollow shaft and to actuate the working element. The hollow shaft may also include a cable formed of a plurality of wound wires and including a proximal segment, at least one transition segment, and a distal segment.

Abstract: n endovascular device including a hollow shaft having a proximal end and a distal end, and sized for insertion into a blood vessel, may be provided. The endovascular device may also include a control line configured to extend through the hollow shaft and an actuatable working element situated distally from the distal end of the hollow shaft and configured to receive an actuation force transmitted via the control line. The endovascular device may further include an actuator configured to exert the actuation force on the control line to cause relative movement between the control line and the hollow shaft and to actuate the working element. The endovascular device may also include a rotation restriction element configured to substantially impede the control line from rotating relative to the working element, while permitting relative axial movement between the control line and the hollow shaft.

Abstract: A clot removal device and method for removing a dot from a blood vessel may include an expandable clot engagement element, an expandable dot capture element, and a sheath surrounding and compressing the capture element and the engagement element. The sheath may be removable to thereby enable the capture element to expand in a blood vessel in which the sheath is deployed, and to enable the engagement element to expand within the capture element.

Abstract: A loading tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for pushing the stent-mounted valve from the delivery catheter into a native heart valve orifice. The loading tool comprises at least one connector adapted for being removably connected to the stent of the stent-mounted valve. A crimping tool having a generally converging shape is adapted for use with the loading tool. Following connection of the loading tool to the stent-mounted valve, the loading tool operates to allow the stent-mounted valve to be drawn through the crimping tool, and loaded, in, a crimped state, into a delivery catheter. Also disclosed is a kit of the of the various components for effecting the delivery of the stent-mounted valve and a method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure.

Abstract: In one exemplary embodiment, an intraluminal device may include elongated structure formed of a plurality of wires. The intraluminal device may also include a plurality of sets of looped wires longitudinally located at an intermediate area of the elongated structure and the plurality of sets may be spaced circumferentially about the structure and being configured to cooperate with each other to form a plurality of clot entry openings. At least one grouping of woven wires may be longitudinally located adjacent the intermediate area and the at one grouping of woven wires may be configured such that when an opening force is exerted on the elongated structure, the at least one grouping provides structural support to hold open first interstices between the plurality of sets of looped wires.

Abstract: Intraluminal devices and methods for removing an obstruction from a blood vessel using an intraluminal device are provided. The intraluminal device can include a flexible shaft and an expandable wire mesh structure extending from the flexible shaft, the wire mesh structure including at least one first expandable section having a first wire arrangement pattern and at least one second expandable section having a second wire arrangement pattern different from the first wire arrangement pattern. In addition, interstices in the at least one first expandable section can differ in size from interstices in the at least one second expandable section.

Abstract: A treatment device (500) is provided including a shaft (507), an expandable member, a first elongated control member (508) and a second elongated control member (502). The expandable member can further include at least a first controllable portion (504) and a second controllable portion (503), where the expandable member, including the first controllable portion and the second controllable portion, is configured to transition between at least a partially retracted configuration and an expanded configuration under control of at least the first elongated control member (508). Further still, the first controllable portion can be configured to transition between at least a partially retracted configuration and an expanded configuration, while the second controllable portion (503) is configured to remain substantially unchanged, under control of at least the second elongated control member (502).

Abstract: An intravascular device (100) includes an elongated shaft (3) extending in an axial direction and an expandable braided arrangement (110) of a plurality of filaments. The braided arrangement has a proximal end, a distal end (1), and an intermediate region therebetween. The intravascular device can include an endpiece (112-1) located proximate an intersection of the elongated shaft and the braided arrangement. The endpiece can be configured to orient the filaments in a substantially single file continuum. At a junction with the endpiece, the filaments can initially extend in a substantially parallel, non-crossing manner, and as the filaments extend toward the intermediate region, the initially extending non-crossing filaments can cross each other.

Abstract: A loading tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for pushing the stent-mounted valve from the delivery catheter into a native heart valve orifice. The loading tool comprises at least one connector adapted for being removably connected to the stent of the stent-mounted valve. A crimping tool having a generally converging shape is adapted for use with the loading tool. Following connection of the loading tool to the steal-mounted valve, the loading tool operates to allow the stent-mounted valve to be drawn through the crimping tool, and loaded, in, a crimped state, into a delivery catheter. Also disclosed is a kit of the of the various components for effecting the delivery of the stent-mounted valve and a method for withdrawing, crimping, and loading a steel-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure.

Abstract: A loading tool for withdrawing, crimping, and loading a stent-mounted valve into a delivery catheter, and for pushing the stent-mounted valve from the delivery catheter into a native heart valve orifice. The loading tool comprises at least one connector adapted for being removably connected to the stent of the stent-mounted valve. A crimping tool having a generally converging shape is adapted for use with the loading tool. Following connection of the loading tool to the stent-mounted valve, the loading tool operates to allow the stent-mounted valve to be drawn through the crimping tool, and loaded, in a crimped state, into a delivery catheter. Also disclosed is a kit of the various components for effecting the delivery of the stent-mounted valve and a method for withdrawing, crimping, and loading a stent-mounted valve from a storage container into a delivery catheter for the performance of a transcatheter valve implantation procedure.

Abstract: A process for making a product including an expandable member is provided. The process can include braiding a plurality of wires to form a tubular structure that is capable of being manipulated such that a region of the tubular structure changes in diameter from a first dimension to a second dimension different from the first dimension. The process can also include initially heat-treating the tubular structure while the region is in the first dimension, changing the diameter of the tubular structure such that the region achieves the second dimension, and subsequently heat-treating the tubular structure while the region is in the second dimension.

Abstract: A treatment device (500) is provided including a shaft (507), an expandable member, a first elongated control member (508) and a second elongated control member (502). The expandable member can further include at least a first controllable portion (504) and a second controllable portion (503), where the expandable member, including the first controllable portion and the second controllable portion, is configured to transition between at least a partially retracted configuration and an expanded configuration under control of at least the first elongated control member (508). Further still, the first controllable portion can be configured to transition between at least a partially retracted configuration and an expanded configuration, while the second controllable portion (503) is configured to remain substantially unchanged, under control of at least the second elongated control member (502).