Abstract: Disclosed herein is an articulated guidewire for insertion into a blood vessel. The articulated guidewire includes a rotatable sensor cable, a sensor, a connector, and a satellite wire. The sensor cable has a proximal end and a distal end. A sensor connects to the sensor cable near the distal end and rotates with the sensor cable. The satellite wire attaches to the distal end of the sensor cable and holds the sensor cable in the blood vessel. The connector includes a ball and socket joint which aligns the satellite wire and the sensor cable at a variable angle.

Abstract: An athetectomy catheter is disclosed having a composite cutter which is capable of cutting material, including hardened plaque, from a biological conduit. The composite cutter has a cutter and a sensor mount. The cutter has a proximal end and a distal end with a cutting edge. The proximal end of the cutter bonds with the sensor mount. The sensor mount is adaptable for holding a sensor and attaching to a cutter torque cable of an atherectomy catheter. Typically, the atherectomy catheter has a cutter housing with a window. The composite cutter is positioned in the cutter housing and moves in response to movement of the cutter torque cable to cut material from the biological conduit via the window.

Abstract: An elongated flexible housing for an atherectomy or other intracorporeal catheter which is formed of a shape memory alloy such as an alloy formed predominantly of NiTi intermetallic compound. The housing preferably has an inner chamber with a tissue cutter or other diagnostic or therapeutic system provided within the chamber to sever stenotic material which is urged into the chamber through a opening or window in the housing. In one embodiment the housing has at least one section which is relatively flexible with adjacent sections which are relatively stiff to provide an increase in the overall flexibility of the housing.

Abstract: A side-cutting atherectomy catheter with a housing containing a tissue-removal means, a window on one side, and a large volume inflatable support on the opposite side. The large volume inflatable support has a maximum diameter larger than the diameter of the cutter housing, generating a greater degree of contact with a blood vessel's interior diameter than conventional balloon-housing configurations. This feature stabilizes the cutter housing and improves tissue-removal during the atherectomy procedure. Large volume inflatable supports have a maximum inflated diameter at least 1.1 times, and preferably 1.35 times, greater than the diameter of the housing. The supports may be formed from either elastic or inelastic materials. When formed from inelastic materials, the supports have slack material when uninflated which can extend into and become entangled with the cutter window. To prevent this problem, the large volume inflatable support is constrained when uninflated.

Abstract: A flexible composite drive shaft used with a flexible vascular atherectomy catheter for connecting a proximal rotating drive member and a distal rotatable working member. The flexible composite drive shaft includes a core of specially selected highly elastic shape memory alloy surrounded by a flexible torsional reinforcing helical wound member and a covering of a smooth polymeric material penetrating the interstices between the wound member and the outer surface of the core. The material of the core, the relative winding direction of the reinforcing member and the direction of angular offset between the reinforcing member and the core are selected to optimize the consistency of the rotational characteristics of the drive shaft in use.

Abstract: An apparatus and method for forming or shaping an intraluminal stent for low profile delivery into a body lumen. A nickel titanium intraluminal stent has a tubular member formed from a plurality of coils which are bent to form lobe-shaped members, like a cloverleaf, to reduce the profile of the tubular member and form an involuted spring stent. The involuted spring stent will transform to the implanted diameter of the tubular member when exposed to body heat. The involuted spring stent can be attached to a tubular graft, or coated with a polymeric material to form an involuted spring graft, both of which can be used to repair aortic aneurysms.

Abstract: An elongated flexible housing for an atherectomy or other intracorporeal catheter which is formed of a shape memory alloy such ass an alloy formed predominantly of NiTi intermetallic compound. The housing preferably has an inner chamber with a tissue cutter or other diagnostic or therapeutic system provided within the chamber to sever stenotic material which is urged into the chamber through a opening or window in the housing. In one embodiment the housing has at least one section which is relatively flexible with adjacent sections which are relatively stiff to provide an increase in the overall flexibility of the housing.

Abstract: An improved atherectomy catheter and methods of making and using a catheter are disclosed. In one embodiment, the catheter comprises a housing shaft having a torsionally-reinforced outer layer concentrically disposed over a polymeric inner layer, with an inflation tube disposed concentrically over the housing shaft to define an annular inflation lumen. A housing is attached to the distal end of the housing shaft, and may contain interventional means such as a cutting blade. The balloon for urging the housing against a vessel wall, such as a balloon, is attached to the housing opposite the interventional means and is in communication with the inflation lumen. A drive shaft may be rotatably disposed through a longitudinal lumen in the housing shaft, the drive shaft being coupled at its distal end to the interventional balloon.

Abstract: An atherectomy catheter includes a catheter body having a cylindrical housing at its distal end. The cylindrical housing includes an elongate cutting aperture on one side thereof and a mechanism for severing atheroma which enters within the opening. In a first embodiment, the cutting mechanism comprises a circular cutting blade which is advanced over an elongate guide member which defines a path for the blade. Use of the guide means helps assure that the cutting blade will not be lost from the housing during use. In a second embodiment, a rotatable helical cutting blade is mounted within the housing. In that particular embodiment, the helical cutting blade can serve as the guide member for the circular cutting blade.

Abstract: A system for delivering a probe into a body part to perform a therapeutic or diagnostic procedure therein which includes an elongated probe device which is disposed within a protective sheath and which has a rotary drive unit connected to its proximal extremity to rotate the probe about its longitudinal axis, preferably at a rate above 50 rpms while applying axial pressure thereto to cause the distal end of the probe to penetrate through the patient's tissue to a desired location in the body part where the procedure is to occur. In a presently preferred embodiment, the probe is an optical fiber which is delivered into a male patient's prostate gland through the patient's prostatic urethral wall. The optical fiber is optically connected to a source for laser energy (815 nm) which is emitted from the distal end of the optical fiber to ablate prostatic tissue surrounding the distal end.

Abstract: An improved atherectomy catheter and methods of making and using a catheter are disclosed. In one embodiment, the catheter comprises a housing shaft having a torsionally-reinforced outer layer concentrically disposed over a polymeric inner layer, with an inflation tube disposed concentrically over the housing shaft to define an annular inflation lumen. A housing is attached to the distal end of the housing shaft, and may contain an interventional device such as a cutting blade. Apparatus for urging the housing against a vessel wall, such as a balloon, is attached to the housing opposite the an interventional device and is in communication with the inflation lumen. A drive shaft may be rotatably disposed through a longitudinal lumen in the housing shaft, the drive shaft being coupled at its distal end to the interventional device.

Abstract: An elongated flexible housing for an atherectomy or other intracorporeal catheter which is formed of a shape memory alloy such as an alloy formed predominantly of NiTi intermetallic compound. The housing preferably has an inner chamber with a tissue cutter or other diagnostic or therapeutic system provided within the chamber to sever stenotic material which is urged into the chamber through a opening or window in the housing. In one embodiment the housing has at least one section which is relatively flexible with adjacent sections which are relatively stiff to provide an increase in the overall flexibility of the housing.

Abstract: Improved atherectomy catheters and methods of use are disclosed. The catheter includes a flexible body with a longitudinal passage therethrough. A housing is mounted at the distal end, with an elongated aperture formed in a lateral side. A drive cable is disposed in the passage of the catheter body, and a working element is disposed in the housing, attached to the distal end of the drive cable. Passages and openings are provided for flowing blood into the housing and for flowing blood from a proximal to a distal side of the cutting blade. An impeller can be provided proximal to the cutting blade to impel blood into the housing and past the blade. Blood flows through the housing and past the blade so as to perfuse tissue downstream from the device.

Abstract: Disclosed herein is a cutter capable of removing soft and hard tissue when used with an atherectomy catheter of the type having a cutter housing attached to the distal end of a catheter having a torque cable. A circular cutting blade is disposed within the housing and is secured to the distal end of a rotatable torque cable. An elongated aperture formed along one side of the hosing allows the intrusion of stenotic material which may then be severed by rotating and axially translating the cutting blade. The cutting blade may be made from a cemented tungsten carbide compound of 90 percent tungsten carbide (WC) and 10 percent cobalt (Co) which is heated, injection molded and sintered to produce a hard, durable cutting edge. The cutting edge is coated with titanium carbonitride using a physical vapor deposition process to further increase durability. Cutting edge hardness is further increased by application of an ion implantation of nitrogen using an ion-beam assisted deposition process.

Abstract: The invention provides a motor drive unit for use in conjunction with an atherectomy device which limits the torque exerted on a drive cable for rotating a cutting blade in the device. In a preferred embodiment, a motor drive unit includes a motor having a shaft coupled to the drive cable for rotating the cutting blade, a power supply coupled to the motor and a switch for selectively connecting the power supply to the motor. A torque control circuit connected to the power supply and the motor controls the torque exerted by the motor when the switch is closed, whereby the current to the motor is continuously increased from zero to a start-up level, the start-up level being the minimum current sufficient to turn the cutting blade.

Abstract: A vascular catheter includes a flexible catheter body having proximal and distal ends and an elongate housing secured to the distal end of the catheter body. An interactional device is disposed on one side of the housing, and at least two spaced-apart inflatable chambers are located on the other side of the housing generally at its proximal and distal ends, respectively. The inflatable chambers may be expanded simultaneously or separately, and the spaced-apart positioning of the chambers provides for stable positioning of the housing during atherectomy procedures, imaging procedures, and the like. The balloon is conveniently connected to the housing by an integral flange structure which is secured through an inflation aperture on the housing side. The balloon may be inflated through an annular inflation which is defined by a separate isolation tube disposed in the central lumen of the catheter body.

Abstract: An atherectomy catheter having ultrasound imaging capability provided by an acoustic transducer disposed within a catheter housing which includes a circular cutting edge for removal of stenotic tissue. Risk of induced emboli is reduced by arrangements of transducer and cutter maneuvering members which permit the cutting edge to remain shielded by the housing during catheter positioning and scanning. Both single and array transducers are employed in a variety of configurations.

Abstract: Disclosed herein is a catheter apparatus which supports high resolution imaging of the interior of a biological conduit. The apparatus includes an imaging atherectomy catheter of the type having a cutter housing attached to the distal end of a catheter. A tissue cutting member and an ultrasonic imaging transducer are disposed within the housing and are secured to the distal end of a rotatable torque cable. An elongated aperture formed along one side of the housing allows ultrasonic imaging and the intrusion of stenotic material which is removed by axially rotating and translating the cutting member. A miniature rotary encoder is slidably coupled to the end of the torque cable within the housing for precisely determining the rotational orientation of the ultrasonic imaging transducer with respect to the elongated aperture. The rotary encoder is read optically via a fiber optical cable which extends through the catheter.

Abstract: A vascular catheter includes a catheter body, an inflatable balloon disposed at the distal end of the catheter body, and an inflation conduit extending from the proximal end of the catheter body to the inflatable balloon. The inflation conduit is disposed on the exterior of the catheter body, minimizing the total cross-sectional area but imparting a non-circular periphery. Catheter whip resulting from the non-circular periphery is reduced by arranging the inflation conduit in a helical pattern over at least a distal portion of the catheter body.

Abstract: An atherectomy catheter includes a catheter body having a cylindrical housing at its distal end. The cylindrical housing includes an elongate cutting aperture on one side thereof and a mechanism for severing atheroma which enters within the opening. In a first embodiment, the cutting mechanism comprises a circular cutting blade which is advanced over an elongate guide member which defines a path for the blade. Use of the guide means helps assure that the cutting blade will not be lost from the housing during use. In a second embodiment, a rotatable helical cutting blade is mounted within the housing. In that particular embodiment, the helical cutting blade can serve as the guide member for the circular cutting blade.