Abstract: A method for manufacturing an atherectomy cutter having a positive angle of attack which includes the following steps: forming a rod having a longitudinal axis into a cutter blank having a first cylindrical section, a second cylindrical section, and a uniformly tapered section therebetween; boring an axial passageway through the cutter blank to create walls of substantially similar thickness in each section of the cutter blank; grinding a pair of diametrically opposed flats on the external surface of the uniformly tapered section of the cutter blank; and removing the wall portions of the tapered section between the flats to create a pair of blades.

Abstract: A device for incising and dilating a stenosis in a vessel of a patient includes a catheter having an inflatable balloon near its distal end. A laser rod formed with a light groove on its distal portion is bonded to the catheter with the light groove positioned on the balloon. In the operation of the device, the catheter and laser rod are inserted through the vessel to place the balloon and light groove in contact with the stenosis. Laser light is then directed through the laser rod for emission from the light groove to incise the stenosis. Simultaneously, the balloon is inflated. This inflation of the balloon causes further incision of the stenosis and dilatation of the stenosis.

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: 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 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 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: 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 cutter penetrates at its forward end into, and excises, obstructive tissue in a lumen in a living being by providing two spaced external segments of a conical generally hollow portion with cutting surfaces at their edges. The cutter may have a forward portion of restricted dimensions to facilitate the penetration of the cutter into the obstructive tissue. A progressively expanding portion such as a truncated cone extends rearwardly from the portion of restricted dimensions. In this way, the cutter expands the area of excision of the obstructive tissue from the lumen wall at progressive positions rearwardly from the forward end. The obstructive tissue in the lumen at the progressively expanding positions may be excised at the positions of penetration of the obstructive tissue by rotating the cutter manually or by a motor. The cutter may then be moved forwardly to penetrate the obstructive tissue through an additional distance in the lumen.

Abstract: A cutter penetrates at its forward end into, and excises, obstructive tissue in a lumen in a living being by providing two spaced external segments of a conical generally hollow portion with cutting surfaces at their edges. The cutter may have a forward portion of restricted dimensions to facilitate the penetration of the cutter into the obstructive tissue. A progressively expanding portion such as a truncated cone extends rearwardly from the portion of restricted dimensions. In this way, the cutter expands the area of excision of the obstructive tissue from the lumen wall at progressive positions rearwardly from the forward end. The obstructive tissue in the lumen at the progressively expanding positions may be excised at the positions of penetration of the obstructive tissue by rotating the cutter manually or by a motor. The cutter may then be moved forwardly to penetrate the obstructive tissue through an additional distance in the lumen.

Abstract: A cutter penetrates at its forward end into, and excises, obstructive tissue in a lumen in a living being by providing two spaced external segments of a conical generally hollow portion with cutting surfaces at their edges. The cutter may have a forward portion of restricted dimensions to facilitate the penetration of the cutter into the obstructive tissue. A progressively expanding portion such as a truncated cone extends rearwardly from the portion of restricted dimensions. In this way, the cutter expands the area of excision of the obstructive tissue from the lumen wall at progressive positions rearwardly from the forward end. The obstructive tissue in the lumen at the progressively expanding positions may be excised at the positions of penetration of the obstructive tissue by rotating the cutter manually or by a motor. The cutter may then be moved forwardly to penetrate the obstructive tissue through an additional distance in the lumen.