Abstract: Disclosed here within is the method of manufacture of a reinforced and flexible tube or catheter that can be used in a variety of applications. The first method of embedding the metallic coil or braided wire comprises the steps of engaging the metallic structure over the outer surface of the tubular member, applying heat through an appropriately sized mold to the outer surface of the tubular member while creating a pressure differential between the inner lumen and the outside surface of the tubular member for a specified period of time.

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream. The invention generally includes a plurality of radially expandable loop elements which are relatively independent in their ability to expand and to flex relative to one another.

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream.

Abstract: The present invention is a device and a method for boring a perfusion channel from a coronary artery into a cardiac muscle of a patient. Structurally, the present invention includes a positioning catheter, anchor means and a cutting catheter. The cutting catheter includes a plurality of blades and is advanceable through a deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes a distal end of the cutting catheter to project laterally from the positioning catheter. In use, the positioning catheter is positioned within the coronary artery. The anchor means is then expanded to anchor the positioning catheter within the artery. The cutting catheter is then advanced through the deployment lumen to bore one or more perfusion channels in the myocardial tissue.

Abstract: The present invention is a device for incision and dilation of stenotic segments within the vascular system of a patient. Structurally, the present invention includes a rigid ellipsoidal dilation probe mounted at the distal end of a catheter. A series of longitudinally oriented blades project radially from the surface of the probe. A tapered inflatable balloon is also mounted on the catheter in a position that is proximal to the dilation probe. In use, the probe and catheter are advanced over a guidewire to reach the targeted stenotic segment. The probe and blades are then advanced through the stenotic segment to incise the stenosis. The balloon may then be inflated to adopt a tapering fusiform shape, allowing the balloon to be advanced through the stenosis to further dilate the stenosis. Alternatively, the balloon may be positioned across the stenosis and inflated to dilate the stenosis.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device 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. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.

Abstract: The present invention is a device and a method for boring a perfusion channel from a coronary artery into a cardiac muscle of a patient. Structurally, the present invention includes a positioning catheter, anchoring structure and a cutting catheter. The cutting catheter includes a plurality of blades and is advanceable through a deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes a distal end of the cutting catheter to project laterally from the positioning catheter. In use, the positioning catheter is positioned within the coronary artery. The anchoring structure is then expanded to anchor the positioning catheter within the artery. The cutting catheter is then advanced through the deployment lumen to bore one or more perfusion channels in the myocardial tissue.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device 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. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.

Abstract: Guidewire comprising an elongated core element manufactured from a martensitic alloy that is heat-treated to render a fully hardened core throughout its cross sectional area. The core has a constant taper or step-down decreasing cross sectional area in a direction towards the distal end which is fully hardened throughout its longitudinal length. A single coil, or two coils are carried by and secured to said core element near the distal end.

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: 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 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 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: 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 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.