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 or a noncompliant balloon formed at least in part of a block copolymer.

Abstract: A method of making a catheter balloon or other expandable tubular medical device or component thereof, in which an assembly of heat shrink material on an outer surface of coaxially disposed first and second tubes is heated to radially shrink the heat shrink material and reduce the outer diameter of the first tube. In a presently preferred embodiment, the heat shrink material extends at least along a central section of the first tube to reduce the outer diameter of the first tube at least along the central section of the first tube. The first and second tubes form the outer and inner layers, respectively, of a multilayered balloon, which has an improved low profile outer diameter.

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: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved strong bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer has at least a section with a gas plasma-etched or chemical solution-etched surface for improved bondability. Another aspect of the invention is directed to a balloon in which the balloon first layer has a proximal end section bonded to an outer surface of the shaft and the balloon second layer has a proximal end section bonded to an inner surface of the shaft, and, in one embodiment, at least a section of the balloon first layer has a gas plasma-etched or chemical solution-etched surface.

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 or a noncompliant balloon formed at least in part of a block copolymer.

Abstract: A balloon catheter and a method of making the balloon catheter, having a balloon which is bonded to an elongated shaft, and which has a first layer and a second layer and an improved strong bond between the balloon and the shaft. One aspect of the invention is directed to a balloon in which the balloon first layer has at least a section with a gas plasma-etched or chemical solution-etched surface for improved bondability. Another aspect of the invention is directed to a balloon in which the balloon first layer has a proximal end section bonded to an outer surface of the shaft and the balloon second layer has a proximal end section bonded to an inner surface of the shaft, and, in one embodiment, at least a section of the balloon first layer has a gas plasma-etched or chemical solution-etched surface.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

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 system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section. Dual lumen and concentric distal shaft sections are describes.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.

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 or a noncompliant balloon formed at least in part of a block copolymer.

Abstract: A balloon catheter system generally having an elongated catheter shaft with enhanced flexibility to facilitate more distal advancement within a patient's body lumen. The catheter shaft has a relatively stiff proximal shaft section, a relatively flexible distal shaft section and an intermediate shaft section which provides a smooth, flexible transition between the proximal and distal shaft sections. The intermediate shaft section has an improved construction with a tubular reinforcing member secured by its proximal end to the distal extremity of the proximal shaft section and a distal end secured within the proximal end of the distal shaft section. The tubular reinforcing member preferably has an inner tubular support member which has a proximal end secured to the distal end of the proximal shaft section. Preferably, the proximal shaft section has an outer jacket which extends over the tubular reinforcing member of the intermediate shaft section.