Abstract: A device for incising a stenosis in the vasculature of a patient includes a plurality of blades mounted on a resilient base member. The blades are arranged in a pattern to allow for relative movement between adjacent blades. Specifically, at least one end portion of each blade is juxtaposed with an end portion of the next closest blade. The base member includes a first end affixed to a catheter at a location proximal to an inflatable balloon and a second end affixed to the catheter at a location distal to the inflatable balloon. When the balloon is inserted into the vasculature of a patient, positioned across a stenosis and subsequently inflated, the individually moveable blades form an effective cutting edge that conforms to the surface of the stenosis to effectively allow the stenosis to be incised to a substantially uniform depth.

Abstract: A device for incising a stenosis in the vasculature of a patient includes a plurality of blades mounted on a resilient base member. The blades are arranged in a pattern to allow for relative movement between adjacent blades. Specifically, at least one end portion of each blade is juxtaposed with an end portion of the next closest blade. The base member, in turn, is mounted on the external surface of an inflatable angioplasty balloon. When the balloon is inserted into the vasculature of a patient, positioned across a stenosis and subsequently inflated, the individually moveable blades form an effective cutting edge that conforms to the surface of the stenosis to effectively allow the stenosis to be incised to a substantially uniform depth.

Abstract: A single lumen rapid-exchange catheter includes a distal sealing port and a proximal sealing port both dimensioned for receiving a guidewire to establish a fluid-tight seal therewith. Each tubular shaped sealing port has a length, and a diameter, and is made of a hydrophilic polymer. In operation, the guidewire is inserted through the distal sealing port and exits from the catheter tube at the shoulder of the catheter tube and through the proximal sealing port. When fluid is present, each sealing port will enlarge to establish a fluid-tight seal with the guidewire. A diverter can be disposed at the proximal sealing port to redirect the guidewire from the lumen and out of the catheter tube through the proximal sealing port.

Abstract: A device for incising a stenosis in the vasculature of a patient includes a plurality of blades mounted on a resilient base member. The blades are arranged in a pattern to allow for relative movement between adjacent blades. Specifically, at least one end portion of each blade is juxtaposed with an end portion of the next closest blade. The base member, in turn, is mounted on the external surface of an inflatable angioplasty balloon. When the balloon is inserted into the vasculature of a patient, positioned across a stenosis and subsequently inflated, the individually moveable blades form an effective cutting edge that conforms to the surface of the stenosis to effectively allow the stenosis to be incised to a substantially uniform depth.

Abstract: The present invention is directed toward a stent fabricated from an austenitic 300 series stainless steel alloy having improved radiopaque characteristics. The modified stainless steel alloy consists essentially of, in weight percent, about 1 C Mn Si P S 0.030 2.000 0.750 0.023 0.010 max. max. max. max. max. Cr Mo Ni Fe “X” 12.000- 000- 10.000- 46.185- 2.000- 20.000 3.000 18.000 74.000 10.

Abstract: A device for incising a stenosis in the vasculature of a patient includes a plurality of blades mounted on a resilient base member. The blades are arranged in a pattern to allow for relative movement between adjacent blades. Specifically, at least one end portion of each blade is juxtaposed with an end portion of the next closest blade. The base member, in turn, is mounted on the external surface of an inflatable angioplasty balloon. When the balloon is inserted into the vasculature of a patient, positioned across a stenosis and subsequently inflated, the individually moveable blades form an effective cutting edge that conforms to the surface of the stenosis to effectively allow the stenosis to be incised to a substantially uniform depth.

Abstract: A single lumen rapid-exchange catheter includes a distal sealing port and a proximal sealing port both dimensioned for receiving a guidewire to establish a fluid-tight seal therewith. Each tubular shaped sealing port has a length, and a diameter, and is made of a hydrophilic polymer. In operation, the guidewire is inserted through the distal sealing port and exits from the catheter tube at the shoulder of the catheter tube and through the proximal sealing port. When fluid is present, each sealing port will enlarge to establish a fluid-tight seal with the guidewire. A diverter can be disposed at the proximal sealing port to redirect the guidewire from the lumen and out of the catheter tube through the proximal sealing port.

Abstract: A platinum enhanced radiopaque alloy particularly suitable for manufacture of implantable and/or intravascular medical devices. A stent is one preferred medical device which is a generally tubular structure that is expandable upon implantation in a vessel lumen to maintain flow therethrough. The stent is formed from the alloy which has improved radiopacity relative to present utilized stainless steel alloys. This alloy preferably contains from about 2 wt. % to about 50 wt. % platinum; from about 11 wt. % to about 18 wt. % chromium; about 5 wt. % to about 12 wt. % nickel and at least about 15 wt. % iron.

Abstract: The present invention is directed towards an austenitic, stainless steel series 300 alloy having improved radiopaque characteristics. The modified stainless steel alloy consists essentially of, in weight percent, about 1 C Mn Si P S ≦0.030 ≦2.000 ≦0.750 ≦0.023 ≦0.010 Cr Mo Ni Fe “X” 12.000- 0.00- 10.000- 46.185- 2.000- 20.000 3.000 18.000 74.000 10.

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 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: 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 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 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: 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.

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.