Abstract: The invention provides a rotational atherectomy device having a flexible, elongated, rotatable drive shaft with an abrasive section comprising an enlarged diameter section of the drive shaft or, alternatively, a solid abrasive crown which may be attached to the drive shaft. The device further comprises a proximal and/or a distal counterweight attached to the drive shaft, spaced from the abrasive section wherein each counterweight has its center of mass offset from the longitudinal axis of the drive shaft to stimulate orbital motion by the abrasive section. When placed within an artery against stenotic tissue and rotated at sufficiently high speeds (e.g., in the range of about 20,000 rpm to about 200,000 rpm) the orbiting nature of the abrasive section causes such section to rotate as to open the stenotic lesion to a diameter substantially larger than the resting outer diameter of the abrasive section.

Abstract: A guide wire for assisting in implantation and balancing of an orbital atherectomy device is disclosed. The guide wire is generally configured to be received within a driveshaft and cutting region of the orbital atherectomy device. The guide wire is sufficiently flexible to minimize trauma to the vessel walls is positioned within a patient. The distal end of the guide wire can include on or more weighted elements movable along the distal region of the guide wire to permit the balancing of an a rotating drive shaft and cutting region of an orbital atherectomy device. The guide wire can also include an atraumatic tip located on the end of the guide wire to reduce trauma to the vessels during implantation. Lubricious coatings are also provided to reduce friction between the driveshaft and cutting region of the atherectomy device and guide wire.

Abstract: The invention provides a rotational atherectomy device having a flexible, elongated, rotatable drive shaft with an abrasive section comprising an enlarged diameter section of the drive shaft or, alternatively, a solid abrasive crown which may be attached to the drive shaft. The device further comprises a proximal and/or a distal counterweight attached to the drive shaft, spaced from the abrasive section wherein each counterweight has its center of mass offset from the longitudinal axis of the drive shaft to stimulate orbital motion by the abrasive section. When placed within an artery against stenotic tissue and rotated at sufficiently high speeds (e.g., in the range of about 20,000 rpm to about 200,000 rpm) the orbiting nature of the abrasive section causes such section to rotate as to open the stenotic lesion to a diameter substantially larger than the resting outer diameter of the abrasive section.

Abstract: A guide wire for assisting in implantation and balancing of an orbital atherectomy device is disclosed. The guide wire is generally configured to be received within a driveshaft and cutting region of the orbital atherectomy device. The guide wire is sufficiently flexible to minimize trauma to the vessel walls is positioned within a patient. The distal end of the guide wire can include on or more weighted elements movable along the distal region of the guide wire to permit the balancing of an a rotating drive shaft and cutting region of an orbital atherectomy device. The guide wire can also include an atraumatic tip located on the end of the guide wire to reduce trauma to the vessels during implantation. Lubricious coatings are also provided to reduce friction between the driveshaft and cutting region of the atherectomy device and guide wire.

Abstract: A guide wire for assisting in implantation and balancing of an orbital atherectomy device is disclosed. The guide wire is generally configured to be received within a driveshaft and cutting region of the orbital atherectomy device. The guide wire is sufficiently flexible to minimize trauma to the vessel walls is positioned within a patient. The distal end of the guide wire can include on or more weighted elements movable along the distal region of the guide wire to permit the balancing of an a rotating drive shaft and cutting region of an orbital atherectomy device. The guide wire can also include an atraumatic tip located on the end of the guide wire to reduce trauma to the vessels during implantation. Lubricious coatings are also provided to reduce friction between the driveshaft and cutting region of the atherectomy device and guide wire.

Abstract: A terminal guide for a helically wound drive shaft for use in an rotational atherectomy device. The terminal guide is atraumatic to prevent perforation of the arterial wall or the embedding of the device into the arterial wall. The terminal guide may be pre-machined, cast, molded or formed in any manner that maintains the required dimensions and tolerances and may be fabricated from any biocompatible material and coated with radiopaque material to more accurately position the rotational atherectomy device without going past the distal end of the pre-positioned guide wire.