Abstract: An apparatus and method to perform therapeutic treatment and diagnosis of a patient's vasculature through the use of an intravascular device having an optical fiber disposed therein. In an embodiment, the apparatus includes an intravascular device to perform a therapeutic treatment and at least one optical fiber disposed through the intravascular device. The optical fiber is configured to provide diagnostic information before, during, and after the therapeutic treatment. In an embodiment, diagnostic information includes vessel and blood characteristics such as hemodynamic characteristics, hematological parameters related to blood and blood components, and thermal parameters of the vasculature.

Abstract: A catheter having an elongated shaft with an inflation lumen and a guidewire lumen, a balloon on a distal shaft section, and a proximal intermediate port proximal to the balloon and a distal intermediate port distal to the balloon, the intermediate ports being in communication with the guidewire lumen and being configured to slidably receive a guidewire therethrough so that the guidewire extends into or out of a proximal section of the guidewire lumen through the proximal intermediate port, extends along an outer surface of the balloon, and extends into or out of a distal section of the guidewire lumen through the distal intermediate port. The balloon is inflated in a patient's blood vessel to perform a medical procedure, with the section of the guidewire extending along an outer surface of the balloon providing improved balloon retention at the desired location in the blood vessel during inflation of the balloon.

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: 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: An apparatus for providing support along the length of a catheter is described. The present invention consists of a mandrel fabricated from a non-metal. The mandrel extends through the lumen of a dilatation catheter to provide added support and stiffness to the catheter shaft. The stiffness along the length of the non-metal mandrel may easily be varied by making dimensional or morphological changes to the polymeric mandrel.

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 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 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: 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.

Abstract: A catheter having an elongated shaft which has a multilayered distal tip with a first layer formed of a polyimide first material and a second layer formed of a polymeric second material. In one embodiment the multilayered distal tip is a separate member, distal to the distal end of a proximal portion of the shaft. In another embodiment, the shaft has an outer tubular member, and a multilayered inner tubular member with a distal end which forms the multilayered distal tip of the shaft. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. In one embodiment, the polymeric second material is a polyamide material.

Abstract: A method of treating vulnerable plaque comprising intentionally damaging or rupturing the vulnerable plaque using a wingless balloon which is inflated from a wingless unexpanded diameter to a limited expanded diameter. This process produces significant increase in ECM synthesis at the site of the damage or rupture. As a result, the method strengthens the vulnerable plaque while minimizing or avoiding damage to the surrounding wall of the body lumen or damaging a stable plaque mistakenly believed to be a vulnerable plaque. The method of the invention is particularly useful in treating a fibroatheroma type of vulnerable plaque. In one embodiment, the balloon is self-limiting such that it expands compliantly at initial inflation pressures, and above nominal pressure it expands noncompliantly. In an alternative embodiment, the balloon is inflated using a diameter-limiting device, such as a device which limits the inflation pressure or the volume of inflation fluid in the balloon.

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 a silicone-polyurethane copolymer elastomer or a diene polymer elastomer. The low tensile set polymer has high strength, low modulus, high elongation, and low tensile set. 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: An elongated balloon catheter having a distal tip member on the distal end of the catheter having a sleeve surrounding and secured at least to the proximal end of the distal tip member.

Abstract: Medical devices or components thereof, and particularly intracorporeal devices for therapeutic or diagnostic uses, which are formed at least in part of a polymeric material and a ferromagnetic or paramagnetic material, so that the medical device or component thereof is visible on magnetic resonance imaging (MRI) scans. In one embodiment, the medical device is a balloon catheter having an MRI visible balloon. In a presently preferred embodiment, there is an insufficient amount of the ferromagnetic or paramagnetic material within a wall of the balloon or coated onto a wall of the balloon to make the balloon radiopaque.

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 catheter having an multilayered shaft section with a first layer formed of a polyimide first material and a second layer formed of a second material. In a presently preferred embodiment, the polyimide material is a thermoset polyimide. However, in alternative embodiments, a thermoplastic polyimide is used. The thermoset polyimide has a very high glass transition temperature (Tg) of approximately 400° C. (as measured by differential scanning calorimetry), and excellent dimensional stability at the processing temperature of polyamides commonly used in catheter components. As a result, during formation and assembly of the catheter, production of a thin polyimide layer with controlled dimensions is facilitated. The polyimide has a high modulus and provides a thin walled yet highly pushable shaft section, while the second layer provides kink resistance. In one embodiment, the second material is selected from the group consisting of a polyamide material and a polyurethane material.

Abstract: A catheter having an elongated shaft with an inflation lumen and a guidewire lumen, a balloon on a distal shaft section, and a proximal intermediate port proximal to the balloon and a distal intermediate port distal to the balloon, the intermediate ports being in communication with the guidewire lumen and being configured to slidably receive a guidewire therethrough so that the guidewire extends into or out of a proximal section of the guidewire lumen through the proximal intermediate port, extends along an outer surface of the balloon, and extends into or out of a distal section of the guidewire lumen through the distal intermediate port. The balloon is inflated in a patient's blood vessel to perform a medical procedure, with the section of the guidewire extending along an outer surface of the balloon providing improved balloon retention at the desired location in the blood vessel during inflation of the balloon.

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: A guiding catheter for use in a body lumen having a stiff inner liner that has an uninterrupted length and is fabricated from a material such as polyimide (PI) and polyetheretherketone (PEEK) is disclosed. The inner liner is created by coating or extruding PI or PEEK on a neckable wire mandrel. A polymeric jacket is provided over the inner liner through a coating and bonding processes. A metallic braid, mesh, or lattice reinforcing member is embedded in the polymeric jacket.