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: Disclosed herein is a catheter device which is operably positionable for use in a biological conduit. The catheter device includes a catheter body having a proximal end and a distal end; a flexible housing; a work element and a sleeve. The housing connects to the distal end of the catheter body and holds the work element. The sleeve slidably mounts with the housing for selectively reinforcing the housing to inhibit bending. Accordingly, the housing is normally flexible to facilitate insertion of the catheter device into a biological conduit. When the sleeve moves with respect to the housing, the sleeve reinforces the housing to facilitate operation of the work element.

Abstract: A method and system for recanalizing a totally or near totally occluded body lumen such as an artery which has an elongated catheter shaft with means such as a cutting or ablating element at the distal end of the shaft to remove occluding material and with ultrasonic imaging means preferably located on the shaft proximal to the cutting or ablating element to allow the operator to maintain the radial position of the distal end of the catheter shaft within the body lumen so that no contact is made between the cutting or ablating means and the wall defining the body lumen. The imaging system preferably includes one or more ultrasonic transducers which emit ultrasound in a direction having a substantial radial component, or a substantial axial component or both.

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: Disclosed herein is a guidewire migration controller for use with catheter devices such as atherectomy catheters. The guidewire migration controller includes a housing, a gripper insertable in the housing and a locking member. The locking member holds the gripper within the housing. The gripper has an opening for receiving a guidewire. The gripper permits the guidewire to rotate and holds the guidewire to control guidewire migration.

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: Disclosed herein is an intravascular universal catheter having interchangeable work elements and methods of use thereof. The catheter comprises a flexible catheter body having a distal end, a proximal end and a lumen extending between the ends. A housing having an open interior and an aperture on a lateral side is attached to the distal end of the catheter body by a coupling element. A work element is movably disposed within the housing and operative through the aperture. A work element connector is disposed in a lumen of the catheter body and has a distal end connected to the work element. At least the distal portion of the lumen defines a receiving space within the catheter body, and the coupling element is configured to allow retraction of the work element from the housing through the open proximal end into the receiving space. In a preferred embodiment, perfusion ports are disposed in the catheter body and the housing proximate to the junctional region of the catheter body with the housing.

Abstract: A device and method for the localized treatment of vasculature with drugs and medicaments is described herein. Centrifugal force is used to drive a material from a reservoir to the outer surface of the application device and thereby deliver the treatment substance to the chosen area.

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 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: Disclosed herein is a catheter device for use in a biological conduit. The catheter device has a catheter body with a housing and a torque cable lumen, a torque cable, a work element, and a connector. The housing is flexible. The torque cable extends through the catheter body to the housing via the torque cable lumen and is capable of rotation and translation with respect to the catheter body. The work element is slidably positioned in the housing. The housing has an interior which guides the work element in response to rotation and translation of the torque cable. The connector attaches the work element to the torque cable. The connector is flexible to facilitate flexion between the work element and the torque cable when the housing flexes.

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: Disclosed herein is an intravascular universal catheter having interchangeable work elements and methods of use thereof. The catheter comprises a flexible catheter body having a distal end, a proximal end and a lumen extending between the ends. A housing having an open interior and an aperture on a lateral side is attached to the distal end of the catheter body by a coupling element. A work element is movably disposed within the housing and operative through the aperture. A work element connector is disposed in a lumen of the catheter body and has a distal end connected to the work element. At least the distal portion of the lumen defines a receiving space within the catheter body, and the coupling element is configured to allow retraction of the work element from the housing through the open proximal end into the receiving space. In a preferred embodiment, perfusion ports are disposed in the catheter body and the housing proximate to the junctional region of the catheter body with the housing.

Abstract: A device and method for the localized treatment of vasculature with drugs and medicaments is described herein. Centrifugal force is used to drive a material from a reservoir to the outer surface of the application device and thereby deliver the treatment substance to the chosen area.

Abstract: An intravascular directional atherectomy device is disclosed. The apparatus comprises a catheter body having a distal end, a proximal end and an axial lumen therebetween. A housing having an open interior and an aperture on a lateral side thereof is attached to the distal end of the catheter body. An atheroma severing device is disposed within the housing. The device includes a cutter that is slidably disposed on a saddle which is connected to the housing. A track member is disposed in the axial lumen of the catheter body and has a distal end connected to the housing. Slidable movement of the atheroma severing device severs the stenotic material that has been urged within the aperture. The saddle enables the inflexible portion of the housing to be minimized in order to fit in the very tortious regions of biological conduits.

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.