Rotational atherectomy device with fluid inflatable support elements and distal protection capability

摘要

A rotational atherectomy device for abrading a stenotic lesion from a vessel of a patient comprises a flexible drive shaft which extends towards a distal end of the device, a distal fluid inflatable support element located at a distal end of the drive shaft and an abrasive element mounted to the drive shaft proximal to and spaced away from the distal fluid inflatable support element. Both the abrasive element and the distal fluid inflatable support element are rotatable together with the drive shaft and the drive shaft comprises a torque transmitting coil which defines a long lumen of the drive shaft.

主权项

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, the drive shaft defining a central lumen and a longitudinal axis, the drive shaft configured to rotate about the longitudinal axis; an abrasive element that is fixed to a distal region of the drive shaft such that a center of mass of the abrasive element is offset from the longitudinal axis of the drive shaft; a proximal stability element that is disposed at the distal region of the drive shaft and that has a center of mass coaxial with the longitudinal axis of the drive shaft, the proximal stability element being proximally spaced apart from the abrasive element by a proximal separation distance; a distal stability element that is disposed at the distal region of the drive shaft and that has a center of mass coaxial with the longitudinal axis of the drive shaft, the distal stability element being distally spaced apart from the abrasive element by a distal separation distance; and a fluid impermeable membrane along the drive shaft and surrounding an outer diameter of the torque-transmitting coil from a proximal region of the drive shaft to the distal region of the drive shaft, the fluid impermeable membrane surrounding the outer diameter of the torque-transmitting coil between the proximal stability element to the distal stability element, wherein the central lumen of the drive shaft is configured to provide a fluid impermeable path to the distal region of the drive shaft surrounding an outer diameter of the drive shaft at least from the proximal stability element to the distal stability element, wherein the proximal separation distance is less than a distance between the abrasive element and a distal end of the rotational atherectomy device.