Abstract: Disclosed herewithin is a method of fabricating a stent which involves processing a tubular member whereby no connection points to join the edges of a flat pattern are necessary. The method includes the steps of a) removing contaminates from a tubular member, b) coating the outside surface of the tubular member with a photo-sensitive resist material, c) placing the tubular member in an apparatus designed to simultaneously rotate the tubular member while passing a specially configured photographic frame negative between a UV light source and the tubular member, thereby exposing a specified pattern of UV light to the resist coated tubular member, d) exposing the outside surface of the tubular member to a photoresist developer for a specified period of time, e) rinsing the excess developer and uncured resist from the outside surface of the tubular member, f) treating the tubular member with a electro-chemical process to remove uncovered metal.

Abstract: The present invention is a device and a method for boring a perfusion channel into the myocardial tissue of a patient. Structurally, the present invention includes a positioning catheter and a cutting catheter. The positioning catheter is formed with an inflation lumen and a deployment lumen and has an inflatable balloon mounted at its distal end. The cutting catheter has a sharpened distal end and is advanceable through the deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes the distal end of the cutting catheter to be directed radially outward from the positioning catheter. In use, the positioning catheter is positioned within a target vessel. The inflatable balloon is then expanded to anchor the distal end of the positioning catheter.

Abstract: A balloon activated force concentrator for use in cooperation with an inflatable angioplasty balloon includes at least one elongated flexible panel, an elongated cutting blade mounted on the outside surface of the elongated flexible panel, and an elastic circular band attached to each end of the elongated flexible panel for securing the elongated flexible panel to an angioplasty balloon. Use of this balloon activated force concentrator requires mounting the device on an inflatable angioplasty balloon by inserting the distal end of the angioplasty balloon through one of the circular bands. The balloon activated force concentrator is then advanced over the balloon until the second circular band reaches the distal end of the balloon. At that point, the elasticity of the circular bands straddle the balloon to retain the activated force concentrator securely against the outer surface of the angioplasty balloon.

Abstract: A method of manufacturing polymeric material having enhanced structural integrity includes heating the material to a temperature between the material's glass transition temperature and the material's melt temperature. Once heated, the material is highly overstretched in a first direction and moderately overstretched in a second direction. The material is then held in the overstretched condition while it is allowed to cool to room temperature. Cooling is followed by reheating to a curing temperature. After curing for a predetermined period, the material is again allowed to cool. The completed material has high polymeric orientation in the first direction and moderate polymeric orientation in the second direction. Therefore, the material is characterized by enhanced structural integrity and absence of pinhole defects common to highly oriented polymeric materials.

Abstract: A device for injecting medication into a vessel wall includes an inflatable balloon mounted on a catheter. Additionally, a tubular sleeve surrounds the balloon to create an infusion chamber between the sleeve and the balloon, and a plurality of injectors are mounted on the sleeve in fluid communication with the infusion chamber. During use of the device, the balloon is first positioned in a vessel and then inflated to embed the injectors into the vessel wall. Next, a fluid medicament is introduced into the infusion chamber for further infusion from the chamber and through the injectors into the vessel wall.

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 injecting medication into a vessel wall includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. A plurality of injectors are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel. The push-pull wire is then partially withdrawn forcing the grommet to advance towards the multi-lumen catheter. The advancing grommet forces the flexible tubes to bow outwardly, embedding the injectors into the vessel wall. A fluid medication is then introduced through the multi-lumen catheter, into the flexible tubes and out of the injectors for infusion into the vessel wall.

Abstract: The present invention is a device for creating a transection in a coronary artery. Structurally, the present invention includes an inflatable balloon mounted at the distal end of a catheter. A single blade is mounted to project radially from the surface of the balloon and is aligned with the balloon's longitudinal axis. Additionally, a series of radio-opaque markers are distributed on the balloon's surface. Operationally, the balloon is advanced, using the catheter, until it is positioned at the approximate site of the desired transection. An X-ray imaging system is then used to visualize the radio-opaque markers, allowing the balloon and blade to be oriented radially and longitudinally at the location required for the transection. The balloon is then inflated, forcing the blade to incise the artery wall and creating the desired transection. The transection creates a new artery composed partially of the old artery and partially of the surrounding fibrous tissue.

Abstract: A device for incising and dilating a stenosis in a vessel of a patient includes a dilator housing and a plurality of blades which can be selectively extended from the housing. Specifically, the housing is formed to surround a chamber and the chamber contains an inflatable balloon. The plurality of blades are mounted on the inflatable balloon and pass through slits in the housing. The housing is attached to a placement catheter which includes a lumen for inflating and deflating the balloon. In the operation of the device, the balloon is selectively inflated within the chamber to move the device between a retracted and an expanded configuration. In the retracted configuration, the balloon is deflated and the blades are withdrawn into the housing and the housing is used as a dilator. In the expanded configuration, the balloon is inflated and the blades are extended through the slits in the housing and the device is used as an incisor.

Abstract: A device for injecting medication into a vessel wall includes an inflatable balloon mounted on a catheter. Additionally, a plurality of tubular fluid passageways are longitudinally mounted on the balloon, and a plurality of injectors are mounted on each tubular passageway and in fluid communication therewith. During use of the device, the balloon is first positioned in a vessel. The balloon is then inflated to embed the injectors into the vessel wall. Next, a fluid medicament is introduced through each of the fluid passageways for further infusion through the passageways and through the injectors into the vessel wall.

Abstract: A device and method for clearing a stenosis in a vessel of a patient requires a catheter having a rigid, cone-shaped probe at its distal end. The probe has a distally diminishing taper and also has a plurality of blades which are mounted on the probe and longitudinally aligned with the catheter. The probe is formed to include a series of grooves which span the length of the probe. Advancement of the probe through the vessel to the stenosis can be accomplished either over a prepositioned guidewire or through a prepositioned guide catheter. At the stenosis, the probe with mounted blades are reciprocally moved back and forth across the stenosis to incise and dilate the stenosis and, thus, clear the stenosis. Blood flow is maintained within the vessel by the grooves formed in the surface of the probe. Movement of the probe across the stenosis can be facilitated by selectively activating a rigidizer which is located on the catheter immediately proximal to the probe.

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: A method of manufacturing, extruding, milling and welding a high torque, thin monolithic walled guiding catheter having resilient reinforcement material (8, 23, 29, 70, 73) integrally spiralled 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.

Abstract: A device for incising and dilating a stenosis in a vessel of a patient includes a dilator housing and a plurality of incising blades which can be selectively extended distally from the housing. Specifically, the plurality of blades are mounted on a base member which is attached to the distal end of a push-pull catheter. The housing has a plurality of slits which are positioned distally from the base member with the blades on the base member in alignment with the slits in the housing. A placement catheter is positioned in a surrounding relationship over the push-pull catheter, and the distal end of the placement catheter is attached to the housing to create a chamber between the placement catheter and the housing in which the base member is located. In the operation of the device, the push-pull catheter is manipulated distally and proximally in the placement catheter to move the base member within the chamber between a first position and a second position.

Abstract: An expandable and compressible atherectomy cutter for cutting plaque from a stenosis includes a distal hub and a proximal hub joined by a plurality of resilient blades. The blades are shaped to describe a cutting radius which may be compressed to allow the cutter to be inserted into a guide catheter during insertion and removal of the cutter from the patient. The proximal hub is attached to the distal end of a torque tube. A conically-shaped, flexible funnel extends distally from the distal end of the torque tube with the resilient blades located partially within the funnel. In use, the cutter is rotated and advanced to clear a stenosis in a vessel of a patient. At the same time, fluid is withdrawn from the torque tube causing debris to be gathered through the funnel and removed from the patient. Debris removal is enhanced by the channeling effect of the funnel.

Abstract: A hand held vibrating device which imparts a combination of transverse and longitudinal vibrations to a guide wire, to assist in advancing the guide wire through a blood vessel and through a stenosis in a blood vessel. The vibrating device contains a motor which drives a set of gears, rotating an eccentric pin. The rotation of the eccentric pin is translated to pivoting of an oscillating arm by the essentially longitudinal movement of a connector bar. The oscillating arm is attached to the guide wire by a releasable collet. Pivoting of the collet by the oscillating arm results in the introduction of a combination of transverse and longitudinal motion to the guide wire.

Abstract: A method of using a hand held vibrating device for transversely vibrating a guide wire in performing angioplasty and atherectomy procedures. The sinusoidal vibrations introduced into the wire by the vibrating device permit the guide wire to be more easily passed through a blood vessel or a stenotic segment of a blood vessel. The guide wire is threaded through a blood vessel until resistance is met. The guide wire can then be clamped to the vibrating device, which is selectively actuated and manipulated to sinusoidally vibrate the wire, overcoming the resistance, and facilitating the further advancement of the guide wire.

Abstract: A device for introducing a rotatable atherectomy catheter into an artery of a patient comprises an elongated hollow introducer sheath attached to the distal end of a housing formed with a bore in which is mounted a seal. The seal is formed with an expandable opening to selectively prevent fluid flow through the seal. The seal includes a plurality of penetrable disks serially mounted in the bore. A permutation of slits and holes in the disks provides an assembled relationship allowing penetration of the seal by a catheter, while also preventing fluid leakage from the seal. The device includes a seal expander and a rear connector. The seal expander is engageable with the housing attached to the sheath, and the connector is engageable with the expander. The expander provides an insertion tube for penetrating the seal which expands to form a fluid tight seal around the insertion tube. The connector provides a second seal for preventing fluid leakage from the connector during operation of the rotatable catheter.

Abstract: A stock feeder has a housing for supporting both the stock and an advancer which coaxially extends through the housing and is formed as a collet which, when clamped, grips the stock and holds the advancer in a fixed relationship with the stock. At the extreme distal end of the advancer the collet is formed with a radially extending lip, and proximal to the collet the advancer is formed with a radially extending ring. A chuck which is formed with a radial groove slidingly surrounds the collet and is movable relative to the advancer. Specifically, the chuck can be moved on the collet between a first position wherein the chuck clamps the collet onto the stock and a second position wherein the collet is released to allow a sliding movement of the stock through the advancer. In either collet configuration, the stock may be rotated. An actuator is engaged with the groove on the chuck and is manipulable to move the chuck between the first and second positions.

Abstract: A catheter balloon is provided for medical dilation procedures which is formed from a polymeric composite having an enhanced integrity. The balloon comprises an expandable central body and two tapered termini positioned at opposing ends of the body which are formed from a structural layer of continuous polymeric materials characterized as biaxially oriented in the body, but not in the tapered termini. A layer of an imide-containing polymer is provided external to the structural layer of the tapered termini to coat the termini and strengthen or otherwise enhance the integrity of the termini not having a biaxial orientation. The imide-containing polymer coating may further be continuously extended to the body of the balloon. The imide-containing polymer is applied to the structural layer of the balloon, in a liquid state and heat cured over time to produce a high-integrity coating.