Advanced Cardiovascular Systems, Inc.

Abbott Cardiovascular Systems, Inc.

Roseminda J White

Jeong Soo Lee

Edwin Wang

Tim Kitchen

Tung-Liang Lin

Jose A Romero

Kenneth L Wantink

John Schreiner

Vidya J Nayak

Gary Heinemann

Christine Gutting

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&#xb0; 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.

Catheter with a multilayered shaft section having a polyimide layer

Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen defined therein and a multilayer balloon on the distal section of the shaft comprising a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a balloon catheter is also provided.

Multilayer balloon for a catheter

Multilayer balloon for a catheter comprises a first layer made of a first polymer material having a first Shore durometer hardness, a second layer made of a second polymer material having a second Shore durometer hardness greater than the first Shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and a third layer made of a third polymer material having a third Shore durometer hardness less the first Shore durometer hardness, wherein the third layer is an inner layer relative to the second layer. Method of making a multilayer balloon for a catheter and a balloon catheter are also provided.

A catheter which has an elongated shaft having a layer of an ultra high molecular weight polyolefin, such as a melt-extruded ultra high molecular weight polyethylene (UHMWPE). The UHMWPE, forming at least in part a surface of the shaft, facilitates sliding a blood/contrast coated device along the shaft surface, and preferably substantially prevents or inhibits agglomerations of blood and contrast from adhering to the surface of the shaft in a patient's body lumen. In a presently preferred embodiment, the layer has a lubricious coating, such that the coated surface of the UHMWPE layer significantly decreases the force produced by the blood/contrast coated device sliding along the coated surface.

Catheter shaft with a lubricious surface

An elongated balloon catheter having a distal tip member on the distal end of the catheter and having a sleeve surrounding and secured at least to the proximal end of the distal tip member.

Catheter having an improved distal tip

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.

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.

MRI visible catheter balloon

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.

Method of making a catheter balloon

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.

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Wildomar, CA, United States of America

Roseminda J White