Advanced Cardiovascular Systems, Inc.

Abbott Cardiovascular Systems, Inc.

Kenneth L Wantink

Jeong Soo Lee

Barbara E Stamberg

Alan A Tannier

Mina W B Chow

Chi Le Long

Edward A Estrada

Emmanuel C Biagtan

Stephen J Tiernan

Darrin James Kent

Bruce M Wilson

Christopher C Andrews

Justin K Mann

Plaridel Kimpo Villareal

Daniel G Brown

Roseminda J White

Vincent Bavaro

Jeremy Stigall

Mark Harris

Tung-Liang Lin

Shahin Sarkissian

Christopher McMurtry

Jeremy L Stigall

Balloon catheter includes an outer shaft including a hypotube and a monolithic multilayer distal outer member and having an inflation lumen defined therethrough, a balloon in fluid communication with the inflation lumen, and an inner tubular member having a guidewire lumen defined therethrough. The monolithic multilayer distal outer member has a proximal end portion and a distal end portion. The monolithic multilayer distal outer member has an inner layer comprising a first polymer having a tensile strength greater than about 8,000 psi and an outer layer comprising a second polymer having a flexural modulus of less than about 130,000 psi at room temperature. A proximal end of the monolithic multilayer distal outer member is coupled to the hypotube. The monolithic multilayer distal outer member is necked to a reduced diameter along at least a portion of a length thereof. The balloon has a proximal balloon shaft coupled to a distal end of the monolithic multilayer distal outer member. The inner tubular member extends distally from a proximal port in the proximal end portion of the monolithic multilayer distal outer member through at least a portion of the balloon.

Catheter having monolithic multilayer distal outer member

A balloon catheter having a soft distal tip member having a non-tacky inner (liner) layer material and a soft flexible outer layer material, with both materials being readily thermally bondable to the catheter balloon.

Catheter having a readily bondable multilayer soft tip

Method for fabricating a balloon catheter including providing an inner tubular member having a distal section and a distal end with a lumen extending therein and forming a balloon having a distal leg with a first segment having a first diameter and a first wall thickness and a second segment having a second wall thickness. The second diameter is greater than the first diameter and the first wall thickness is greater than the second wall thickness. The distal end section of the inner tubular member can be positioned in the balloon and bonded to the first segment while reducing the diameter of the second segment. Method also provided for fabricating a multilayer balloon catheter including removing at least a portion of an outer layer from the distal leg of the balloon.

Soft tip balloon catheter

Methods for forming a 'coating gradient' on medical devices, such as a balloon catheter or guidewire are disclosed. The balloon portion of the catheter has a protective covering initially placed over it to prevent the balloon from receiving a first hydrophilic coating. After a first hydrophilic coating is applied, the protective covering is removed. A second hydrophilic coating could be applied to the catheter. A guidewire having less lubricity at the distal end portion also can be created. A first hydrophilic coating is applied to the elongated shaft and distal shaft section of the guidewire. After the first hydrophilic coating cures, the first hydrophilic coating is removed from a portion of the distal shaft section of the guidewire. A second hydrophillic coating can then be applied to the elongated shaft and distal shaft section of the guidewire. The second hydrophilic coating can be allowed to cure.

Manufacturing processes for making medical devices having a coating gradient

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

A method of mounting a drug delivery stent on a balloon of a balloon catheter. The method securely mounts the drug delivery stent on the balloon without damaging the drug delivery layer of the stent. In one embodiment, the method generally comprises positioning a drug delivery stent on a balloon of a balloon catheter, and positioning the balloon with the drug delivery stent thereon within a polished bore of a mold formed at least in part of a metallic material. The balloon is pressurized and heated within the mold as the mold radially restrains the stent from expanding, to mount the stent on the balloon without damaging the drug delivery layer of the stent.

Method of stent mounting to form a balloon catheter having improved retention of a drug delivery stent

A catheter having a distal tip with an inner layer formed of a polymeric material having a coefficient of friction and surface energy which are relatively low, such that the inner layer has a lubricious, non-polar inner surface repulsive to polar liquids. As a result, blood coagulation in the distal tip, and adherence of the distal tip on the guidewire are prevented or minimized.

Balloon catheter having a multilayered distal tip

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.

Balloon catheter having an external guidewire

A balloon catheter, and preferably to a rapid exchange type balloon catheter, having a proximal shaft section, and a distal shaft section with an inner tubular member and an outer tubular member, the outer tubular member having a section which is bonded as by fusing or otherwise bonding. The bonded section extends along a thickened wall portion of the outer tubular member at the rapid exchange junction. A reinforcing member or tube extends within at least a section of the bonded section of the outer tubular member. In one embodiment, the reinforcing tube extends within at least a section of the thickened wall portion of the outer tubular member. The configuration provides a rapid exchange junction with improved kink resistance and flexibility for excellent trackability, and with a minimal decrease in the size of the inflation lumen at the rapid exchange junction for an improved shortened balloon inflation/deflation time.

Catheter having improved rapid exchange junction

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.

Method of sterilizing a medical device

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.

Catheter shaft junction having a polymeric reinforcing member with a high glass transition temperature

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.

Growing community of inventors

Temecula, CA, United States of America

Kenneth L Wantink