Atherectomy devices and methods
First Claim
1. A rotational atherectomy device for removing stenotic lesion material from a blood vessel of a patient, the device comprising:
- an elongate flexible drive shaft comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis;
first and second abrasive elements attached to a distal end portion of the drive shaft and each having a center of mass offset from the longitudinal axis, the center of mass of the first abrasive element being offset from the longitudinal axis at a first radial angle, the center of mass of the second abrasive element being offset from the longitudinal axis at a second radial angle that differs from the first radial angle; and
a distal stability element fixedly mounted to the drive shaft and having a center of mass aligned with the longitudinal axis, the distal stability element being distally spaced apart from the first and second abrasive elements, wherein the distal stability element comprises a metal cylinder surrounding the torque-transmitting coil of the drive shaft and having a maximum diameter smaller than the first and second abrasive elements, and wherein the distal stability element has an abrasive outer surface.
1 Assignment
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Accused Products
Abstract
Rotational atherectomy devices and systems can remove or reduce stenotic lesions in blood vessels by rotating one or more abrasive elements within the vessel. The abrasive elements can be attached to a distal portion of an elongate flexible drive shaft that extends from a handle assembly that includes a driver for rotating the drive shaft. In particular implementations, individual abrasive elements are attached to the drive shaft at differing radial angles in comparison to each other (e.g., configured in a helical array). The centers of mass of the abrasive elements can define a path that fully or partially spirals around the drive shaft. In some embodiments, a distal stability element with a center of mass aligned with the longitudinal axis is fixedly mounted to the drive shaft.
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Citations
19 Claims
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1. A rotational atherectomy device for removing stenotic lesion material from a blood vessel of a patient, the device comprising:
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an elongate flexible drive shaft comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis; first and second abrasive elements attached to a distal end portion of the drive shaft and each having a center of mass offset from the longitudinal axis, the center of mass of the first abrasive element being offset from the longitudinal axis at a first radial angle, the center of mass of the second abrasive element being offset from the longitudinal axis at a second radial angle that differs from the first radial angle; and a distal stability element fixedly mounted to the drive shaft and having a center of mass aligned with the longitudinal axis, the distal stability element being distally spaced apart from the first and second abrasive elements, wherein the distal stability element comprises a metal cylinder surrounding the torque-transmitting coil of the drive shaft and having a maximum diameter smaller than the first and second abrasive elements, and wherein the distal stability element has an abrasive outer surface. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A rotational atherectomy device for removing stenotic lesion material from a blood vessel of a patient, the device comprising:
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an elongate flexible drive shaft comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis; a helical array of abrasive elements attached to a distal end portion of the drive shaft, each of the abrasive elements having a center of mass that is offset from the longitudinal axis, the centers of mass of the abrasive elements being noncollinear, wherein a proximal-most one of the abrasive elements and a distal-most one of the abrasives element are each smaller than intermediate ones of the abrasive elements; and a distal stability element affixed to the drive shaft and having a center of mass aligned with the longitudinal axis, the distal stability element distally spaced apart from the plurality of abrasive elements. - View Dependent Claims (9, 10, 11, 12, 13, 14, 15)
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16. A system for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the system comprising:
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an elongate flexible drive shaft comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis; one or more abrasive elements attached to a distal end portion of the drive shaft, each of the abrasive elements having a center of mass that is offset from the longitudinal axis, wherein a proximal-most one of the abrasive elements and a distal-most one of the abrasives element are each smaller than intermediate ones of the abrasive elements, and wherein a path defined by the centers of mass of the array of abrasive elements define at least a portion of a helical path around the longitudinal axis; a distal stability element fixed to the drive shaft and having a center of mass aligned with the longitudinal axis, the distal stability element distally spaced apart from the plurality of abrasive elements; an actuator handle assembly configured to drive rotation of the drive shaft about the longitudinal axis, the actuator handle assembly comprising a carriage assembly that is movable in relation to other portions of the actuator handle assembly to translate the drive shaft along the longitudinal axis; a sheath extending from the actuator handle assembly, the drive shaft slidably disposed within a lumen defined by the sheath; and a controller operably coupleable to the actuator handle assembly, the controller configured to provide output to the actuator handle assembly that causes the actuator handle assembly to drive the rotation of the drive shaft about the longitudinal axis, the controller including a user interface with a plurality of selectable inputs corresponding to a plurality of vessel sizes, wherein controller is configured to provide a respective output to the actuator handle assembly that differs for each of the vessel sizes. - View Dependent Claims (17, 18)
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19. A method for performing rotational atherectomy to remove stenotic lesion material from a blood vessel of a patient, the method comprising:
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delivering a rotational atherectomy device into the blood vessel, wherein the rotational atherectomy device comprises; an elongate flexible drive shaft comprising a torque-transmitting coil and defining a longitudinal axis, the drive shaft being configured to rotate about the longitudinal axis; a helical array of abrasive elements attached to a distal end portion of the drive shaft, each of the abrasive elements having a center of mass that is offset from the longitudinal axis, the centers of mass of the abrasive elements arranged along a path that spirals around the longitudinal axis; and a distal stability element affixed to the drive shaft and having a center of mass aligned with the longitudinal axis, the distal stability element distally spaced apart from the plurality of abrasive elements, wherein the distal stability element comprises a metal cylinder surrounding the torque-transmitting coil of the drive shaft and having a maximum diameter smaller than each of the abrasive elements, and wherein the distal stability element has an abrasive outer surface; and rotating the drive shaft about the longitudinal axis such that the abrasive elements orbit around the longitudinal axis.
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Specification