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 method and system for removing an organ or piece of tissue severed from its supporting tissue within a patient's body cavity, such as the abdominal cavity, which includes an elongated expandable tubular member with a sealed interior. In one preferred embodiment for morcellation, means are provided within the sealed interior to tear or cut off tissue fragments from the organ or tissue which are small enough to pass out of the patient's body cavity through an inner lumen of an exit trocar sheath disposed within the patient and in communication with the body cavity. The organ or piece of tissue is placed within an inner lumen defined by the sealed interior through an opening provided in a leading portion of the elongated expandable tubular member. The organ or piece of tissue is fragmented into smaller pieces which are withdrawn from the patient's body cavity by the passage of the morcellation system through the inner lumen of the exit trocar sheath.

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 hemostatic sealing assembly comprises a valve housing and a two-stage hemostatic gasket. The gasket is disposed in an enlarged recess within a shell component of the housing and held in place by a terminal plug. The front and rear faces of the gasket are conically tapered as are the mating surfaces and the housing shell and terminal plug, respectively. In this way, the gasket can be radially compressed to provide a desired degree of both sliding seal and static seal.

Abstract: A vascular catheter comprises a catheter body having a fixed guide wire secured to its distal end. The fixed guide wire includes an axial passage which is aligned with a wire lumen within the catheter body so that the vascular catheter can be introduced to the vascular system over a movable guide wire. The catheter body typically comprises flexible tube having a housing secured to its distal end. A variety of interventional devices, including both therapeutic and diagnostic devices, can be disposed within the housing. Use of both a fixed guide wire and a movable guide wire facilitates initial introduction of even large diameter vascular catheters, while allowing subsequent repositioning of the catheters after the movable guide wire has been withdrawn.

Abstract: An atherectomy catheter comprises a flexible tube having a proximal end and a distal end, and a cutter housing secured to the proximal end. A spring tip nose cone is secured to a distal end of the cutter housing and comprises a relatively soft polymeric wall having a spring coil embedded therein. The spring tip nose cone has a controlled flexibility, generally being more flexible toward the distal tip. The spring coil inhibits collapse of the nose cone under the expected conditions of use, and the flexibility and non-collapsibility together assure that the nose cone can be introduced over a movable guide wire without substantial binding. Means may be provided for inhibiting loss of atheroma from the interior of the nose cone.

Abstract: Atherectomy catheters are described having a cylindrical cutting head rotatably mounted at the distal end of a catheter body. The head has an axially elongated aperture and an open interior. A severing means is disposed adjacent the elongated aperture such that atheromatous material invaginated by the head is severed and diverted into the interior of the head. A preferred embodiment has the elongated aperture helically-disposed about the central axis of the cylindrical head and a cutting means formed integrally along the periphery of the aperture. Another preferred embodiment has the cylindrical head provided with a tapered distal end that extends distally from a housing for the head and incorporates an extension of the elongated aperture.

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 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 device for reducing stenosis material from a vascular vessel is provided. The atherectomy device includes an elongated flexible tubular member having at least one lumen extending therethrough and having proximal and distal extremities. A flexible drive means disposed within the tubular members is free to move both rotationally and axially therein. A cutting assembly is carried by the distal extremity of the flexible tubular member with a cutter being carried by the distal extremity of the flexible drive means for removing a portion of the stenosis from the vessel wall. An inflatable dilation balloon is carried by the tubular member proximally of the cutter for further reducing the stenosis after initial reduction by the cutter. A perfusion channel maintains blood flow past the dilation balloon. Methods of the present invention include cutting and dilating a stenosis, cutting then immediately dilating a stenosis, and dilating then immediately cutting a stenosis.

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 simutaneously 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.

Abstract: A catheter system comprises a flexible catheter tube or body having a housing secured to its distal end. A plurality of structurally distinct terminal components are provided to attach to the forward end of the housing, while a plurality of interchangeable interventional elements are provided to attach to a drive member within the catheter. By properly selecting the terminal components and the interventional elements, a wide variety of specific therapeutic and diagnostic capabilities may be provided.

Abstract: An atherectomy device includes a transparent lumen for providing inflation medium to an inflatable balloon. A dual lumen flexible tube includes an opaque flexible torque member in a first lumen, while the second lumen serves as an inflation lumen. The distal end of the inflation lumen is expanded to define the balloon, and no seals are needed between the balloon and the inflation lumen.

Abstract: A vascular catheter includes a blade tip at its distal end. In the specific embodiments, a blade is mounted within the blade tip and a mechanism provided for extending the blade transversely when the blade tip is located within a region of stenosis. By extending the blade and axially translating the catheter so that the blade forms an incision within the region of stenosis, improved angioplastic treatment can be achieved.

Abstract: An atherectomy device for removing stenosis materials from a vascular vessel is provided. The atherectomy device includes a flexible tubular member, a flexible drive means disposed within the tubular member, and a cutting assembly carried by the distal extremity of the tubular member. The cutting assembly includes a collection chamber which receives a cutting bit carried by the drive means. The cutting bit is rotated to remove materials from the stenosis and cause the removed materials to be withdrawn into the collection chamber as the bit is advanced. A second embodiment of the atherectomy device includes an anchor member coaxially mounted within a tubular cutting blade at the distal end of the catheter. The anchor member is first advanced into a region of stenosis where it becomes embedded, and the tubular blade is subsequently advanced over the anchor member to sever the stenosis.

Abstract: An improved vascular dilation catheter comprises an involuted tubular structure including outer and inner tubular walls which extend the entire length of the catheter. The outer tubular wall is enlarged at a distal end of the catheter to form a dilation balloon, and extends back the remaining length of the flexible tube at a reduced diameter to define an annular lumen which is used to inflate the balloon. Alternatively, the outer tubular wall may conform to the exterior of the inner tubular wall and separate axial lumens may be provided for inflation. By providing means for heating inflation medium within the balloon, the catheter may be utilized for performing thermal ablation therapy.

Abstract: An atherectomy catheter for removal of plaque buildup from the walls of a blood vessel. The atherectomy catheter includes a cutter assembly disposed at the distal end of a flexible guide tube that may be inserted into a vessel and directed to the occlusion. A proximal actuator assembly is adapted to impart both rotary and axial movement to the cutter. The cutter assembly includes a cutter having a forwardly extending annular cutting surface. A guide wire with a flexible spring tip extends forward of the cutter for guiding the cutter as it travels axially through the artery. All of the removed atheroma materials are collected within the device and a retention member carried by the guide wire and positioned in front of the cutter forms a cap to retain the collected atheroma materials. In a disclosed embodiment, the retention member is expandable, and in one of the preferred embodiments, the retention member may be expanded to engage the vessel walls to anchor the device during the cutting stroke.

Abstract: A torque transmitting guiding catheter adapted for insertion into vascular vessels with a body and a method for its construction is disclosed. The guiding catheter includes a flexible tubular member surrounded by a pair of torque transmitting layers that are formed of a flat braided material. A flexible (plastic) casing that initially is applied as a viscous material impregnates and encases the torque transmitting layer to hold them in place and eliminate their rough edges. The ends of the torque transmitting layers are soldered using a radiopaque solder to enhance the catheter's visibility within a body. The tubular member is also folded about the distal end of the catheter over the distal extremity of at least one of the torque transmitting layers to provide a smooth and soft distal catheter tip. The formed catheter has a flexible curving distal tip. The tip's shape memory is enhanced by at least partially curing the casing material while the tip takes the form of its desired final shape.

Abstract: An atherectomy device having a housing at the distal end of a catheter adapted for insertion into the vascular system. The housing has a cutout in one side, and a cutter that is mounted in the housing for both axial and rotary movement with respect to the cutout. At least a portion of the housing is formed of a material which permits bending of the housing as it follows the contours of the vessel. The housing is also adapted to retain the severed atheroma materials.

Abstract: Atherectomy device for removing material from an atheroma in the vascular system. A cutter is mounted in a cylindrical housing having a cutout on one side thereof at the distal end of a catheter. The catheter has a single luminal opening, and a flexible drive cable for operating the cutter passes through this opening. An inflatable balloon is positioned outside the housing opposite the cutout, and a medium for inflating the balloon is introduced through luminal opening of the catheter.