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 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: A rotatable atherectomy device having an exchangeable drive shaft cartridge and a rotatable prime mover coupling. The cartridge has a rotatable drive shaft socket carried by a carriage. The coupling radially expands during rotation such that it interlocks with the socket to drive a tissue removal implement on the end of a drive shaft attached to the cartridge. Upon slow or no rotation of the socket, the coupling disengages from the socket to allow for exchange of the cartridge.

Abstract: A rotational atherectomy 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 cartridge housing, a longitudinally extendable tube, a catheter and a rotatable drive shaft which, near its distal end, has an abrasive tissue removal implement. The cartridge housing may be attached to and detached from the handle housing, the longitudinally extendable tube may be attached to and detached 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 an improved optical tachometer which uses a single, monofilament optical fiber to both transmit light from a light source to a light reflector and to return reflected light to a light detector. A fiber optic connector which can be used with such a rotational atherectomy device permits one to releasably optically couple a distal end of an optical fiber to both a light source and a light detector via a beam splitter and a flexible light guide. This fiber optic connector may include a pneumatic clamp which is connected to the same source of compressed gas which drives the prime mover of the rotational atherectomy device.

Abstract: A rotatable intravascular apparatus having a flexible, elongated medical device and a mechanism for controlling the rotational orientation of the distal end of the medical device. The apparatus includes a flexible torquing sheath extending along a substantial length of the elongated medical device. The distal end of the torquing sheath is secured to the distal portion of the medical device, but not to the intermediate or proximal portions of the medical device, so that rotation of the proximal end of the torquing sheath with respect to the proximal portion of the medical device conveys torque to the distal end of the torquing sheath and, therefore, to the distal portion of the medical device, thereby rotating the distal portion of the medical device.

Abstract: A rotational atherectomy device which includes a handle housing and an exchangeable drive shaft cartridge removably attachable to the handle housing. A rotatable prime mover is carried by a prime mover carriage disposed within the handle housing, the prime mover carriage being longitudinally movable with respect to the handle housing. The exchangeable cartridge includes a cartridge housing which is removably attachable to the handle housing, a longitudinally movable tube which is removably attachable to the prime mover carriage, and a rotatable flexible drive shaft which is removably attachable to the prime mover. The rotational atherectomy device includes a cartridge latch, which removably locks the cartridge housing to the handle housing, and a tube latch which selectively locks the longitudinally movable tube against longitudinal movement with respect to the cartridge housing.

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: The invention provides a handle for a rotational atherectomy device, the handle including a guide wire clamp and a turbine brake operatively interconnected with the guide wire clamp so that the brake automatically prevents rotation of the turbine when the guide wire is unclamped. The brake is movable from a brake-released position to a brake-engaged position, in which position the brake prevents rotation of the turbine. A manual override is also provided, permitting unclamping of the guide wire independent of the position of the brake.

Abstract: An atherectomy device having a handle housing, a rotatable prime mover movable longitudinally with respect to the handle housing, a rotatable drive shaft having a proximal end connected to the prime mover for rotation and longitudinal movement therewith, and a distal end portion having a tissue removal implement usable to remove tissue from a bodily passageway. A guide wire clamp is disposed within the handle housing for releasably clamping the proximal portion of a guide wire. An override clamp is removably securable to the handle housing for moving the guide wire clamp to a guide wire-released position and for holding the guide wire clamp in such released position. The override clamp may also include a mechanical linkage to the prime mover so that the override clamp locks the prime mover in a particular longitudinal position with respect to the handle housing.

Abstract: A rotational atherectomy device having directional control for selectively removing tissue from an artery (or other bodily passageway or cavity). The atherectomy device includes a rotational atherectomy apparatus having a flexible, elongated drive shaft disposed in the lumen of a catheter. A central portion of an intermediate segment of the drive shaft is coated with an abrasive material to define an abrasive segment of the drive shaft. The drive shaft has a central lumen for receipt of a guide wire therein, and around which the drive shaft may be rotated. The guide wire has an intermediate portion with a predetermined curved positioning portion such that when the abrasive segment of the drive shaft is located along the curved positioning portion of the guide wire, such curved positioning portion of the guide wire urges the abrasive segment of the drive shaft laterally.

Abstract: A method and apparatus for in vivo removal of calcified deposits from an aortic valve. The apparatus includes an anchoring balloon catheter fixatable across the aortic valve, a tool for removing the deposits, and a mechanism means for securing the tool with respect to the anchoring balloon and the aortic valve. The method involves advancing an anchoring balloon catheter through the aorta and positioning it across the aortic valve, inflating the anchoring balloon to fixate it with respect to the aorta and aortic valve, and then operating a deposit removal tool secured to the anchoring balloon to remove the deposits.

Abstract: An abrasive drive shaft atherectomy device for removing stenotic tissue from an artery. The device includes a rotational atherectomy apparatus having a flexible, elongated drive shaft having a central lumen and a segment, near its distal end, coated with an abrasive material to define an abrasive segment. In one embodiment the device includes a special guide wire having a generally straight proximal portion, a distal end portion, and a flexible intermediate positioning segment. The positioning segment has a predetermined curved shape such that when the abrasive segment of the drive shaft is advanced over the guide wire to a position along the curved positioning segment, such curved segment positions the abrasive segment laterally away from the longitudinal axis of the proximal portion of the drive shaft. In another embodiment a conventional, generally straight guide wire is utilized, along with a separate positioning wire.

Abstract: Apparatus and method for performing an atherectomy. The apparatus includes a rotational atherectomy device having a flexible, elongated drive shaft and an abrasive burr carried on the drive shaft. The drive shaft and abrasive burr each include a central lumen so that they can be advanced over a guide wire. The apparatus further includes a guide wire having a generally straight proximal portion, a flexible distal end portion, and an intermediate, flexible burr positioning segment. The burr positioning segment includes a predetermined curved shape so that when the abrasive burr is advanced over the guide wire to a position along the curved burr positioning segment, the burr positioning segment positions the burr laterally away from the axes of the proximal and distal portions of the guide wire, thus giving control over the lateral position of the burr within an artery.

Abstract: A inflatable sheath for ultrasonic imaging, with a fiber optic endoscope, of a bodily passageway or cavity area of interest. The inflatable sheath, having an ultrasound transducer therein, is introduced into the distal end of an endoscope. Typically the endoscope comprises an elongated shaft that has at least a pair of fiber optic bundles and an open lumen extending therethrough. Fiber optic illumination of the area just distal to the distal end of the endoscope is provided through one of the fiber optic bundles, and observation of the lit area is provided through the other bundle. The open lumen is provided for introducing an inflatable sheath, guided by a pushing shaft, into the illuminated area. Once inserted, the sheath can be inflated with a fluid sonolucent ultrasound coupling medium, and the pushing shaft can then be removed, the distal portion of the inflated sheath holding the sheath in place (with respect to the lumen of the endoscope) as the pushing shaft is removed.

Abstract: An abrasive drive shaft atherectomy device for removing stenotic tissue from an artery. The device includes a flexible, elongated drive shaft having a central lumen for receipt of a guide wire therein and around which the drive shaft may be rotated. The drive shaft is made from one or more helically wound wires. Wire turns of the proximal segment of the drive shaft have a generally constant diameter. Wire turns of a segment of the drive shaft near its distal end have an enlarged diameter. At least part of the enlarged diameter segment includes an external coating of an abrasive material to define an abrasive segment of the drive shaft which, when rotated at high speeds, is usable to remove stenotic tissue from an artery. In a preferred embodiment, the device includes a bushing disposed in the enlarged diameter segment for supporting the enlarged diameter turns of the drive shaft.