Abstract: An apparatus and method of operation are disclosed for using an expandable balloon catheter to perform a combination angioplasty and atherectomy procedure on a stenotic blood vessel. The expandable balloon has a plurality of atherotomes attached to its outer surface, and longitudinal, transverse, or rotational oscillatory motion is imparted to the atherotomes to assist in incising the stenotic tissue, prior to or during dilatation of the stenotic segment of the blood vessel.

Abstract: A high torque, thin walled guiding catheter has resilient reinforcement material (8, 23, 29, 70, 73) integrally spiraled or braided into monolithic walls (21) of flexible material. A solid lubricant, also referred to as dry lubricant, comprised of either special fluorine containing materials or polymeric organic silicon compounds is embedded into interior and exterior wall surfaces of the catheters. Smooth interior walls (11) are channeled (10) to decrease friction resistance, to trap resistance particles and to dissipate friction heat in the high ratio of surface area to cross-sectional area of small catheters. Number of spirals or braids of reinforcement strands per unit of length, number of layers of strands of the catheters, catheter diameter and progressiveness thereof are designedly different for separate portions of particular catheters. Catheter tips (6) are weldable immediately adjacent to select density of strands of reinforcement material. Perfusion ports are weldable where desired.

Abstract: A stenotic dilitation device includes a plurality of elongated atherotomes with cutters embedded in a substrate mounted on the outer surface of a flexible balloon along predetermined crease lines. The atherotomes are aligned along the longitudinal axis of the catheter. The ends of the balloon are attached to a hollow catheter tube over fluid ports in the catheter which establish fluid communication between the catheter and the internal chamber of the balloon. Fluid flow into and out of the chamber will inflate and deflate the balloon. When the balloon is deflated, retraction of the atherotomes toward the longitudinal axis of the catheter causes the creases and lines to form flaps of the balloon membrane material between adjacent atherotomes. In such deflated configuration, the flaps, rather than the cutters of the atherotomes, contact the vessel wall as the device is manipulated into position adjacent a stenotic site.

Abstract: An apparatus for introducing an atherectomy cutter into a coronary artery for removing a stenosis from the artery, includes a guide wire having a predetermined anatomically shaped configuration. The guide wire may correspond in shape to an arterial path through the aorta and into an artery of the heart such as a right coronary artery (RCA), a left anterior descending artery (LAD), a left circumflex artery (LCX), or a bypass graft. A percutaneously inserted guiding catheter is used to direct the anatomically shaped guide wire into a selected coronary artery and to subsequently retrieve the guide wire from the artery. With the guide wire in place in the artery, and the guiding catheter removed from its engagement with the guide wire, the atherectomy cutter is slidingly engaged to the guide wire and is advanced along the wire into contact with the stenosis.

Abstract: A hand held vibrating device for vibrating a guide wire used in angioplasty and atherectomy procedures. The vibrating device permits the guide wire to be more easily passed through a stenotic segment of a blood vessel. The vibrating device includes a case, an electric motor mounted within the case, and a clamp member coupled to the electric motor for releasably securing and vibrating the guide wire. In use, the guide wire is threaded through a blood vessel to the site of a stenosis. The guide wire can then be clamped to the vibrating device, which is selectively actuated and manipulated to vibrate and push the guide wire through the stenosis.

Abstract: An inflatable angioplasty balloon is formed in an unstressed configuration for inflation into an expanded configuration and deflation into a collapsed configuration. The balloon has a body portion and two hollow end portions, with the end portions being attached to opposite ends of the body portion.In the balloon's unstressed configuration, the body portion has three flat folding regions extending the length of the body portion. Successive folding regions are separated from each other by curved reinforcing regions. The end portions are configured and oriented to guide the folding regions of the balloon into a pleated, collapsed configuration when the interior of the balloon is evacuated.

Abstract: An expandable endarterectomy cutting tool for use in incising plaque at a stenosis in an artery of a patient includes a guide wire, an over-the-wire catheter, and a camming mechanism which is attached near the distal end of the guide wire. The cam mechanism is formed with a plurality of ramps which incline outwardly from the guide wire in a distal direction along the guide wire. A plurality of tethers each have one end attached to the catheter and their other end slidably mounted on one of the ramps in the camming mechanism. A cutting blade is attached to each tether near the end of the tether in the ramp so that as the guide wire is pulled in a proximal direction relative to the catheter, the blades are pushed by the tether up their respective ramp to be radially extended from the cam mechanism. On the other hand, pushing the guide wire in a distal direction relative to the catheter will draw each extended blade back down its respective ramp to retract the blades.

Abstract: An expandable and compressible atherectomy cutter for cutting plaque from a stenosis in an artery includes a cutter assembly which, relative to its axis of rotation, has a plurality of radially separated and axially aligned blades. The distal ends of these blades are joined together at a grommet and the proximal ends are free for individual engagement with grooves which are axially oriented on the hub of a rotatable torque tube. Each groove on the hub has a plurality of notches, and each notch in a groove has a corresponding notch in each of the other grooves which lies in the same radial plane and at the same radial distance from the rotational axis of the torque tube. Although notches in different radial planes can have different radial distances, the proximal ends of the blades simultaneously engage with only the notches in the same radial plane.

Abstract: An angioplasty device for dilating the lumen of a human blood vessel has a balloon and a tubular guide wire bonded to one end of the balloon. The guide wire is in fluid communication with the balloon. A guide extension is bonded to the opposite end of the balloon from the guide wire. An elongated spring member is positioned within the balloon, and is bonded at one end of the spring to the guide wire and at the opposite end of the spring to the guide extension to interconnect the wire and the extension. The spring member is attached between the wire and the extension in compression to urge the balloon into a collapsed configuration when the balloon is not inflated with fluid. The guide wire is strengthened by bonding a helical structural member to the outer wall of the guide wire.

Abstract: A rotationally expandable atherectomy cutter assembly for cutting plaque from a stenosis in an artery includes a plurality of radially separated and axially aligned blade elements. The distal ends of each blade element are fixably connected to a hub and the proximal ends of each blade element slidably engage helical slots formed in a distally flared extension tube of the assembly. The extension tube is connectable to a rotatable catheter. The helical slots are oriented in a first direction such that contact of the cutter assembly with the plaque of the stenosis, in conjunction with a second direction rotation of the catheter causes the proximal ends of the blade assembly to slide distally along the helical slots thereby expanding the cutting radius of the cutter assembly.

Abstract: A balloon expandable atherectomy cutter for removing plaque from an artery includes an elongated cutter assembly having a plurality of blades which, with respect to the axis of rotation of the cutter, are radially separated from each other and axially aligned with each other. The assembly is mounted on the distal end of a rotatable catheter and is rotatable about a quide wire to cut plaque from an artery as it is rotated. An inflatable balloon, is mounted between an ovoid space formed between the blades. An inflator is connected with the balloon to inflate the balloon and urge it against the distal portion of the blades. In the operation of the cutter, when the balloon is deflated the blades establish a first radius of rotation which cuts through the plaque of a stenotic segment as the cutter is advanced into the artery.

Abstract: A reinforced tubing has an inner continuous hollow metallic tube. To strengthen the tube, a metallic helical structural member is bonded in tension by nickel or cobalt electroplating to the outside wall of the tube. Thus, a surrounding layer of electroplated material (i.e. nickel or cobalt) covers the tube and the structural member to bond the structural member to the tube. The individual coils of the helical structural member are spaced apart, so that the edges of successive coils do not touch or overlap. Importantly, the angular pitch between successive coils is in the range 20.degree.-60.degree., the pitch being variable throughout the length of the tubing.For applications wherein the tubing is to be used as a rigid platform, a longitudinal stiffening member may be bonded to the inside of the tube.

Abstract: A device for establishing a fluid-tight seal around a rotatable drive shaft has a housing which is formed with a straight bore through which the drive shaft is positioned. The bore has a narrow portion, a wide portion and a tapered portion between the narrow and wide portions. A beveled annular seal is positioned in the wide portion of the bore around the drive shaft with the bevel abutting the side of the tapered portion of the bore. An actuator is engaged to the housing and is movable to urge the seal against the tapered portion of the bore to constrict the seal around the drive shaft and establish a fluid-tight seal between the drive shaft and the annular seal. The housing further includes an expanded conforming portion. A flexible seal valve is positioned in the expanded portion to receive the drive shaft. A seal valve has a deformable wedge-shaped portion terminating in a normally closed slit when the shaft is removed.

Abstract: An atherectomy system includes a guide wire which can be inserted into an artery of a patient to a region of occlusion, a torque tube having a cutter device affixed to its distal end which is insertable into the artery over the guide wire, and a protective support sheath surrounding the guide wire and the torque tube. A retraction device controllably retracts the support sheath so as to allow the cutter on the distal end of the torque tube to extend progressively greater distances beyond the distal end of the support sheath. The system also includes means for rotating the torque tube, thereby simultaneously rotating the cutter, and vacuum means connected to the torque tube for extracting dislodged cuttings from the patient's bloodstream. The guide wire is preferably provided with an abutment on its distal end which both mechanically limits the distance the cutter can advance into the patient's body and assists in retrieving the cutter from the patient's body following the atherectomy operation.

Abstract: A rotatable atherectomy cutter for removing obstructive tissue from a body vessel includes a hollow cylindrical base having an outer wall, a hollow cylindrical guide tip coaxially distanced from the base for slidably receiving a guide wire and a pair of dismetrically opposed blades each having a distal end and a proximal end. The distal end of each blade is connected to the guide tip and the proximal end connected to the base for alternately cutting the tissue with a first cutting edge and a second cutting edge longer than the first cutting edge. The proximal end of each blade is connected to an ovoid portion formed in the base for allowing the second cutting edge of the blade to extend beyond the outer diameter of the cylindrical base to cut a diameter of tissue larger than the diameter of the base. The base includes a straight wall portion connecting the pair of blades to establish the first cutting edge on each of the blades.

Abstract: An atherectomy probe for incrementally advancing a torque tube with a rotating cutter through an artery to remove obstructive tissue from the lumen of the artery comprises a fixed distal support and a moveable proximal support for slideably restraining the torque tube. The torque tube is rotated about a longitudinal axis by a motor which is slideably mounted inside a housing of a drive unit. A rod extending substantially parallel to the torque tube interconnects the distal support and the motor. The rod selectively secures the torque tube from longitudinally sliding with respect to the distal support. Adjacent to the rod is an elongated advancement tape having juxtaposed dual layers attached between the distal support and the proximal support. In its operation, a tape divider operatively engages with the advancement tape for aligning the tape.

Abstract: An apparatus for manufacturing atherectomy torque tubes includes a mechanism for rotating a tube liner about its longitudinal axis at a rotational velocity. A carriage is translatably positioned along the longitudinal axis. A mechanism for winding a wire about the tube liner is mounted on the carriage. A mechanism for coating the tube liner with an epoxy material is also mounted on the carriage. In a preferred embodiment, wire is wound onto the tube liner inside a reservoir of urethane epoxy bath which is moved along the tube liner. A laser sensor measures the coated tube to provide a signal representative of the final outside diameter of the tube and a computer uses this signal to control the angular velocity of the rotating tube liner and the linear velocity of the carriage which moves the wire winding and coating mechanism along the tube.

Abstract: An atherectomy device for cutting obstructive tissue from the lumen of a body vessel comprises a rotatable cutter having a blade. A hollow, generally cylindrical housing defines a central longitudinal axis and has a side opening. The cutter is mounted in the housing for rotation about an axis that is substantially parallel to the longitudinal axis of the housing. During rotation of the cutter, the blade cyclically projects from the side opening to cut obstructive tissue from the lumen.

Abstract: An expandable atherectomy cutting device comprises a flexible blade having one end connected to a torque tube and the other end connected to a tip. The tip and torque tube are rotatably positioned about a guide wire, and the torque tube is coupled to a drive element for rotating the flexible blade about the guide wire. A mechanism is associated with the tip and torque tube for pulling the tip toward the torque tube to cause the flexible blade to bow outwardly away from the guide wire to expand its radius of cutting action. The mechanism for causing the flexible blade to bow outwardly includes a base rotatably mounted in slidable relation in the torque tube, and a series of desmodromic filaments connecting the base to the tip for pulling the tip toward the torque tube. The flexible blade includes a bend so that it bows outwardly rather than inwardly.

Abstract: An atherectomy cutting device for removing obstructive tissue from the lumen of a body vessel comprises a guide wire positionable in the lumen of the vessel, and a rotatable cutter supported on an eccentric wire. The eccentric wire has a distal portion extension establishing a substantially right angle with the eccentric wire and having a ring to permit sliding movement of the eccentric wire and cutter along the guide wire. The extension and eccentric wire also permit manipulative movement of the rotatable cutter in an arc around the guide wire. There is included a dual lumen sheath having a first lumen for supporting the guide wire and a second lumen for supporting the eccentric wire carrying the rotatable cutter.Also included is a method for removing obstructive tissue which involves manipulating the eccentric wire about the guide wire to move the cutter in an arc about the guide wire and thus increase the portion of obstructive tissue contacted by the cutter.