Abstract: A therapeutic intravascular device and method for performing thermal and laser Doppler velocimetry measurements. In one embodiment, the therapeutic intravascular device includes an elongated member having first and second optical fibers longitudinally disposed therethrough, the first optical fiber for performing a laser Doppler velocity measurement of a fluid within a body lumen, the second optical fiber for performing a temperature measurement within the body lumen.

Abstract: A method of forming a catheter component, such as a balloon, in which the component has a thinned skirt section formed by expanding tubing to a radially enlarged outer diameter and then decreasing the inner diameter and the outer diameter of the radially enlarged skirt section before or during bonding of the skirt section to the catheter shaft. The method generally includes blow molding tubing in a balloon mold having a skirt portion with an inner diameter which is larger than an outer diameter of the thinned skirt section of the balloon, so that the balloon mold produces a balloon having a radially enlarged skirt section with a larger outer diameter than is desired for the finished balloon. By then decreasing the diameter of the radially enlarged skirt section, the resulting skirt section is thinned, to provide a balloon catheter having improved flexibility and low profile.

Abstract: An intravascular device for locating a coronary sinus of a patient's heart and method of using the same. In one embodiment, the intravascular device includes an elongated member having at least one lumen and at least one optical fiber coupled to the elongated member. The optical fiber has a distal end configured to contact with a blood flow within the patient's heart and a proximal end coupled to a laser Doppler velocimetry system for performing a plurality of laser Doppler velocity measurements of the blood flow within the heart to locate the coronary sinus of the heart. Incorporating LDV technology into an intravascular device such as a catheter or a guidewire system provides diagnostic information of the physiologic environment of the lesion before, during, or after a therapeutic procedure.

Abstract: An intraluminal balloon catheter with an elongated shaft, and an inflatable balloon on the shaft which has an inner layer and a discontinuous outer layer formed at least in part of an elastomeric polymeric material. In a presently preferred embodiment, the catheter is a stent delivery catheter with a stent disposed on the balloon in contact with at least a section of the discontinuous outer layer of the balloon. The discontinuous outer layer of the balloon may comprise fibers or strands of the elastomeric material woven into a braided, webbed, meshed, wrapped or wound outer layer of the balloon.

Abstract: A method of making a catheter balloon or other tubular medical device or component, in which a sheet of polymeric material is wrapped on a mandrel and heated to fuse sections of the wrapped sheet together to form a tube. The mandrel has a metallic core and a jacket on an outer surface of the metallic core, and the wrapped sheet of polymeric material is heated without corroding the metallic core of the mandrel. In a presently preferred embodiment, the sheet is formed of a fluoropolymeric material, and the resulting fluoropolymeric tube forms at least a layer of a catheter balloon.

Abstract: A balloon catheter and a method of making a balloon catheter, having a balloon with a first layer and a second layer, the first layer having at least one impregnated section impregnated with a polymeric material compatible with a polymeric material forming the catheter shaft. At least a portion of the impregnated section is fusion bonded to the shaft. In a presently preferred embodiment, the impregnated section is adjacent to a section of the first layer which is not impregnated with the compatible polymeric material. The impregnated section provides improved bonding of the balloon to the catheter shaft while minimizing the effect of the bond on catheter performance characteristics such as profile and flexibility.

Abstract: A catheter having an elongated shaft formed of a polymeric tubular member with at least a section having a lubricious inner layer defining the guidewire lumen, a coiled support member at least partially embedded in the lubricious inner layer, and an outer layer on an outer surface of at least a distal portion of the lubricious inner layer. In a presently preferred embodiment, the coil supported polymeric tubular member forms an inner tubular member of a balloon catheter.

Abstract: An angioplasty balloon and method of manufacture are provided. The balloon has a working length and a taper each having a substantially equivalent thickness. This allows the balloon to be steered easily through vasculature to the site of a stenosis prior to inflation during an angioplasty procedure. The taper thickness in particular is achieved through use of a specially designed multi-tubular slug which is molded to form the angioplasty balloon of the present invention.

Abstract: An apparatus and method for providing a co-extruded, tapered multi-layer shaft. A co-extruded, tapered multi-layer shaft may be fabricated by selecting a first material for the inner layer of the shaft and a second material for the outer layer of the shaft. The first and second materials are then co-extruded by a co-extrusion system including a puller with programmable tapering capabilities. The system forms a hollow tubing having an inner layer and an outer layer, wherein the tubing has the desired tapered characteristics. The result is a tapered tubular shaft having an inner layer and an outer layer.

Abstract: A catheter balloon formed of a polymeric material such as expanded polytetrafluoroethylene (ePTFE) bonded to a second layer formed of a low tensile set polymer and/or impregnated with a low tensile set polymer. In a presently preferred embodiment, the low tensile set polymer is an elastomer selected from the group consisting of a silicone-polyurethane copolymer and a diene polymer. The low tensile set polymer has high strength, low modulus, high elongation, and low tensile set, to provide improved balloon performance. The diene or silicone-polyurethane has a low tensile set, which facilitates deflation of the balloon to a low profile deflated configuration. One aspect of the invention provides improved attachment of the diene to the ePTFE. In one embodiment, the second layer is formed of a diene mixed with a bonding promoter such as a vulcanizing agent which is covalently bonded to the diene.

Abstract: A balloon catheter having a balloon formed at least in part of a blend of a first polymeric material having a first Shore durometer hardness, and at least a second polymeric material having a second Shore durometer hardness less than the Shore durometer hardness of the first polymeric material. The balloon of the invention has enhanced softness and flexibility due to the presence of the second polymeric material, and a lower than expected compliance. In a presently preferred embodiment, the balloon is formed of a blend of polymeric materials comprising polyether block amides.

Abstract: An intravascular catheter system for properly implanting a stent in a body lumen generally comprising a catheter having an elongated shaft with an inflatable balloon formed of compliant material and a stent mounted on the working length of the balloon. The balloon material is compliant within the working range of the balloon to provide substantial radial expansion. The wingless radially expansive balloon expands in a uniform manner, thereby producing uniform expansion and implantation of the stent. Another embodiment is directed to a balloon catheter having a semi-compliant balloon formed at least in part of a block copolymer.

Abstract: A catheter assembly comprising a shaft and at least one flexible radiopaque marker affixed with the shaft. Flexibility of radiopaque marker is achieved by using a segmented band of radiopaque material or a coiled band formed by winding a wire or hollow tube filled with radiopaque material. The flexible radiopaque marker may be affixed with the shaft by an adhesive, by swaging, by crimping, by soldering, or by spring-action tension fit against the shaft.

Abstract: An angioplasty balloon and method of manufacture are provided. The balloon has a working length and a taper each having a substantially equivalent thickness. This allows the balloon to be steered easily through vasculature to the site of a stenosis prior to inflation during an angioplasty procedure. The taper thickness in particular is achieved through use of a specially designed multi-tubular slug which is molded to form the angioplasty balloon of the present invention.

Abstract: An apparatus and method for providing a co-extruded, tapered multi-layer shaft. A co-extruded, tapered multi-layer shaft may be fabricated by selecting a first material for the inner layer of the shaft and a second material for the outer layer of the shaft. The first and second materials are then co-extruded by a co-extrusion system including a puller with programmable tapering capabilities. The system forms a hollow tubing having an inner layer and an outer layer, wherein the tubing has the desired tapered characteristics. The result is a tapered tubular shaft having an inner layer and an outer layer.

Abstract: A catheter having a polymeric reinforcing member at a junction between shaft sections such as a rapid exchange catheter junction. The polymeric reinforcing member is around or within the tubular member defining the inflation lumen or the tubular member defining the guidewire lumen at the rapid exchange junction to prevent or inhibit damage to the tubular members defining the inflation lumen and/or guidewire lumen during assembly or use of a balloon catheter. In one embodiment, the polymeric reinforcing member is formed of a first polymeric material having a glass transition temperature greater than a glass transition temperature of a second polymeric material forming the distal portion of the proximal tubular member or the proximal portion of the inner tubular member. The first polymeric material forming the polymeric reinforcing member is preferably a high temperature, high modulus material, such as polyimide, and most preferably a thermoset polyimide.

Abstract: A resizable inflatable balloon, primarily for use with balloon catheters. The resizable inflatable balloon comprises a first portion and an adjacent second portion. The first portion is inflatable to a working diameter at a first pressure while the second portion does not substantially expand at the first pressure. The second portion does expand to the working diameter at a second pressure greater than the first pressure, so that subsequent inflation at the first pressure inflates the first portion and the second portion to the working diameter. The methods of resizing the inflatable members include placing the inflatable balloon in a mold and supplying inflation fluid to expand the second member to the working diameter. In practice, a catheter having the resizable inflatable balloon is guided through a patient's vasculature until the inflatable balloon is positioned in a desired region. Inflation fluid is supplied at the first pressure to inflate the first portion to the working diameter.

Abstract: A method of sterilizing a medical device component, such as a catheter balloon, in which an electron beam (i.e., e-beam) is applied to the component in an evacuated or inert gas-filled container. The method of the invention allows for electron beam sterilization without significant degradation of the component polymeric material. In one embodiment, the device component is configured to be pressurized or expanded during use. The method of the invention provides a component with a rupture pressure that is not significantly decreased due to electron beam sterilization. Another aspect of the invention is a medical device component, e-beam sterilized according to a method of the invention. A variety of medical device components can be sterilized by the method of the invention, and particularly intracorporeal devices for therapeutic or diagnostic purposes, such as balloon catheters, catheter shafts and balloons, stent covers, and vascular grafts.

Abstract: An elongated intracorporeal device, more specifically, a balloon catheter having an elongate shaft with a distal section. The distal section of the shaft has a distal inner tubular member with an inflatable balloon disposed about the distal inner tubular member. A radiopaque marker formed at least in part of a polymer is disposed on the distal inner tubular member. The flexible radiopaque marker can be formed either by doping a desired portion of the distal inner tubular member with an appropriate radiopaque material, or preforming the radiopaque marker from a polymer doped with a radiopaque material and subsequently securing the radiopaque marker to the distal inner tubular member.

Abstract: The invention is an elongate intracorporeal member having a polymer jacket secured to a high strength shaft with the polymer jacket having an outer layer of polymeric material and an inner layer formed of polymeric adhesive. In one embodiment, a balloon catheter has a proximal high strength tubular section with a polymer jacket having an polymeric outer layer and an adhesive polymer inner layer. In another embodiment, a guidewire has an elongate core with polymer jacket disposed about at least a portion of the elongate core, wherein the polymer jacket comprises a polymeric outer layer an inner layer of polymeric adhesive disposed between and bonding the outer layer to the elongate core.