Abstract: A method of manufacturing a rotational atherectomy drive shaft having an asymmetrical tissue removal section. One or more strands of wire are helically wound about an elongated mandrel having an enlarged diameter section with a predetermined shape, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section. A portion of the drive shaft, including the enlarged diameter tissue removal section, is placed into a first clamp and given a first heat treatment to give the wire turns of the enlarged diameter tissue removal section an initial set, thereby preserving the initial shape of the enlarged diameter tissue removal section of the drive shaft. The drive shaft is then removed from the first clamp and the mandrel is dissolved. The enlarged diameter section of the drive shaft is then deformed to an asymmetrical shape by placing a portion of the drive shaft, including the enlarged diameter tissue removal section, into a second clamp.

Abstract: A rotational atherectomy device having a flexible, elongated, rotatable drive shaft with an eccentric enlarged diameter section. At least part of the eccentric enlarged diameter section has a tissue removing surface. The eccentric enlarged diameter section of the drive shaft has a center of mass and/or geometric center spaced radially from the rotational axis of the drive shaft, facilitating the ability of the device to open the stenotic lesion to a diameter substantially larger than the outer diameter of the enlarged diameter section.

Abstract: An atherectomy device for removing tissue from an artery. The device includes a flexible, elongated drive shaft rotatable about a guide wire, the drive shaft having an enlarged diameter tissue removal section. The drive shaft and the enlarged diameter tissue removal section are comprised of helically wound wire. Wire turns of the proximal portion of the tissue removal section have diameters that gradually increase distally at a generally constant rate thereby forming generally the shape of a cone. Wire turns of the distal portion of the enlarged diameter tissue removal section have diameters that gradually decrease distally thereby forming a generally convex distal portion. At least part of the tissue removal section includes an external coating of an abrasive material to define an abrasive segment of the drive shaft.

Abstract: A method of forming an elongate, flexible drive shaft which has utility as a rotational atherectomy device. In accordance with this method, an inner helical coil having a lumen and a proximal end is formed by winding a plurality of wires about a forming mandrel. An outer helical coil having a lumen and a proximal end is formed by winding a single wire with a mandrel-less coil forming machine. The inner helical coil is positioned within the outer helical coil to define a drive shaft. The inner and outer helical coils are oriented such that the inner helical coil is wound in a direction opposite that in which the outer helical coil is wound.

Abstract: A method of manufacturing a rotational atherectomy drive shaft having an asymmetrical tissue removal section. One or more strands of wire are helically wound about an elongated mandrel having an enlarged diameter section with a predetermined shape, thereby forming an elongated, flexible drive shaft which has an enlarged diameter tissue removal section. A portion of the drive shaft, including the enlarged diameter tissue removal section, is placed into a first clamp and given a first heat treatment to give the wire turns of the enlarged diameter tissue removal section an initial set, thereby preserving the initial shape of the enlarged diameter tissue removal section of the drive shaft. The drive shaft is then removed from the first clamp and the mandrel is dissolved. The enlarged diameter section of the drive shaft is then deformed to an asymmetrical shape by placing a portion of the drive shaft, including the enlarged diameter tissue removal section, into a second clamp.

Abstract: An atherectomy device for removing tissue from an artery. The device includes a flexible, elongated drive shaft rotatable about a guide wire, the drive shaft having an enlarged diameter tissue removal section. The drive shaft and the enlarged diameter tissue removal section are comprised of helically wound wire. Wire turns of the proximal portion of the tissue removal section have diameters that gradually increase distally at a generally constant rate thereby forming generally the shape of a cone. Wire turns of the distal portion of the enlarged diameter tissue removal section have diameters that gradually decrease distally thereby forming a generally convex distal portion. At least part of the tissue removal section includes an external coating of an abrasive material to define an abrasive segment of the drive shaft.