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 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: 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 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 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: 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 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: Medical devices, and particularly intracorporeal devices for therapeutic or diagnostic uses, having a component chemically modified by plasma polymerization. The medical device comprises a substrate with a plasma polymerized functionality bonded to a surface of at least a section thereof. The plasma polymerized film on a first component of the medical device allows for bonding an agent or a second component to the first component. In one embodiment, the plasma polymerized film facilitates fusion or adhesive bonding of a first component to a second component formed of a material which is dissimilar to, incompatible with, or otherwise not readily bondable to the substrate material of the first component. In another embodiment, a bioactive agent is bonded to the plasma polymerized film on the component, for presenting or delivering the bioactive agent within a body lumen of the patient.

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: An inflatable member such as a balloon which is formed at least in part of a polyamide/polyether block copolymer thermoplastic elastomer, commonly referred to as polyether block amide (PEBA). The presently preferred PEBA copolymer is polyamide/polyether polyester copolymer, such as PEBAX®. The balloon of the invention exhibits high tensile strength, high elongation, and low flexural moduli. The balloon may be formed as a single layer of PEBA, or as a multilayer coextrudate having at least one PEBA layer. The balloon may be 100% PEBA or a blend of PEBA with another polymer, such as nylon.

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.

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.

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.

Abstract: A catheter and/or balloon for a medical catheter is formed from a blend of polymeric components, including a first crystalline polymeric component and a second softening polymeric component. The polymeric material can also include a third compatibilizing agent to facilitate blending the first two polymeric components together. The first polymeric component can be a polyester or a polyamide, and the second polymeric component can be a polyolefin, or an ethylene copolymer. The third polymeric component is preferably an ethylene copolymer containing a reactive group that forms a covalent bond with the first polymeric component. The polymeric material forming the balloon or catheter also can include a catalyst to catalyze a reaction between the compatibilizing ethylene copolymer and the second polymer component.