Abstract: A rotational device for removing an occlusion from inside a tubular structure, the device comprising a flexible drive shaft for insertion into a tubular structure and an abrasive element on the drive shaft to abrade an occlusion when the drive shaft rotates. The device includes a solid support element on the drive shaft configured so that, when the device is being used to remove an occlusion from an inner surface of a curved section of the tubular structure, the abrasive element is biased toward the inner surface by the solid support element.

Abstract: A rotational angioplasty device comprising a flexible, elongated drive shaft rotatable about an axis of rotation of the drive shaft, the drive shaft comprising one or more helically wound wires and having an eccentric enlarged diameter section and an abrasive crown mounted on the enlarged diameter section of the drive shaft.

Abstract: A rotational device for removing a stenotic lesion from within a vessel of a patient is disclosed. The device comprises a flexible hollow drive shaft having a distal end insertable into the vessel and an abrasive element located on the drive shaft proximal to the distal end of the drive shaft to abrade a stenotic lesion when the drive shaft rotates. The hollow drive shaft defines a lumen for fluid supplied into the drive shaft to flow in an antegrade direction along the lumen and into the vessel from the drive shaft distal to the abrasive element so that the fluid entering the vessel flows in a retrograde direction over the abrasive element and die drive shaft to entrain debris abraded by the abrasive element for removal of said debris from the patient.

Abstract: A rotational device for removing an occlusion from inside a tubular structure, the device comprising a drive shaft (10) for insertion over a guidewire into a tubular structure and an abrasive element (20) on the drive shaft having its centre of mass offset from a longitudinal axis of the drive shaft. A solid counterweight (30D) is disposed on the drive shaft spaced from the abrasive element and having its centre of mass offset from the longitudinal axis of the drive shaft so that the abrasive element moves in an orbital path around said axis to abrade an occlusion from inside the tubular structure when the drive shaft rotates around the guidewire.

Abstract: A balloon-angioplasty device for dilating a. region of a vessel of a patient which has been at least partially occluded by the presence of a stenotic lesion in the vessel is disclosed. The device comprises an elongate catheter shaft having an inflatable element located around the catheter shaft proximal to its distal end, the inflatable element comprising a dilatation balloon and a membrane which extends in a longitudinal direction around the dilatation balloon and has at least one flushing fluid opening located at or near its distal end. At least a portion of the flushing fluid that has entered the vessel through the or each flushing fluid opening (s) in the membrane is forced to flow in a retrograde direction between the treated stenotic lesion and the membrane.

Abstract: A method for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activated to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Abstract: A method system and controller for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activate to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Abstract: A method system and controller for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activate to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Abstract: A method for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activated to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Abstract: A method system and controller for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activate to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Abstract: A rotational angioplasty device having a handle housing and an exchangeable drive shaft cartridge. The handle housing includes a rotatable prime mover carried by a prime mover carriage which is longitudinally movable with respect to the handle housing. The exchangeable drive shaft cartridge includes a tubular core element, a longitudinally extendible tube, a catheter and a rotatable drive shaft which, near its distal end, has an abrasive tissue removal implement. The cartridge is detachable from the handle housing, the longitudinally extendible tube is detachable from the prime mover carriage, and the drive shaft together with its tissue removal implement may be attached to and detached from the prime mover, thereby permitting the exchangeable drive shaft cartridge to be selectively attached to and detached from the handle housing.

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 guidewire system is disclosed for performing a rotational atherectomy procedure, wherein the system includes a core wire having an elongated wire body defining a flexible distal portion and a more rigid medial portion, and a torquing sheath for positioning the core wire, the torquing sheath having a normally curved, relatively flexible distal portion and an interior lumen dimensioned and configured to accommodate the core wire, wherein the medial portion of the core wire is sufficiently rigid to straighten the normally curved distal portion of the torquing sheath when it is extended therethrough.

Abstract: A rotational angioplasty device comprising a flexible, elongated drive shaft rotatable about an axis of rotation of the drive shaft, the drive shaft comprising one or more helically wound wires and having an eccentric enlarged diameter section and an abrasive crown mounted on the enlarged diameter section of the drive shaft.

Abstract: A method for controlling fluid flow in a rotational atherectomy device. A source of fluid is provided through a pump to the rotational atherectomy device, wherein the pump maintains the fluid flow at a minimal rate during a time period when a drive shaft of the device is not rotating. A first control is activated to increase a rate of the fluid flow and second control is activated to initiate a rotation of the drive shaft during another time period when the fluid flow is at the increased rate.

Abstract: A rotational angioplasty device having a handle housing and an exchangeable drive shaft cartridge. The handle housing includes a rotatable prime mover carried by a prime mover carriage which is longitudinally movable with respect to the handle housing. The exchangeable drive shaft cartridge includes a tubular core element, a longitudinally extendible tube, a catheter and a rotatable drive shaft which, near its distal end, has an abrasive tissue removal implement. The cartridge is detachable from the handle housing, the longitudinally extendible tube is detachable from the prime mover carriage, and the drive shaft together with its tissue removal implement may be attached to and detached from the prime mover, thereby permitting the exchangeable drive shaft cartridge to be selectively attached to and detached from the handle housing.

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.