Abstract: Balloon catheter comprises an elongated shaft having a proximal end and a distal end, the elongated shaft including a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D with an inflation lumen defined therein. The balloon catheter also comprises a balloon sealing secured proximate the distal end of the shaft and having an interior in fluid communication with the inflation lumen.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen, and a multilayer balloon on the distal section of the shaft. The multilayer balloon 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 lower than the first shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and an outer-most layer made of a third polymer material having a third Shore durometer hardness lower than the second Shore durometer hardness.

Abstract: Method of making a balloon catheter includes melt-extruding a thermoplastic polymeric material into a tube, cooling the extruded tube, placing the extruded tube within a capture member and biaxially orienting the polymeric material of the extruded tube while simultaneously tapering at least a section of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with an external load applied on at least one end of the tube as an external heat supply traverses longitudinally from a first end to a second end of the extruded tube in the capture member, wherein an overall axial load on the tubing is varied as at least a section of the tube is heated. The method includes cooling the expanded tube to form a tapered biaxially oriented nonporous thermoplastic polymer tubular member and sealingly securing a balloon proximate a distal end of the tubular member.

Abstract: Balloon catheter comprises an elongate catheter shaft having a proximal section, a distal section, and an inflation lumen, and a multilayer balloon on the distal section of the shaft. The multilayer balloon 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 lower than the first shore durometer hardness, wherein the second layer is an inner layer relative to the first layer, and an outer-most layer made of a third polymer material having a third Shore durometer hardness lower than the second Shore durometer hardness.

Abstract: Method of making a balloon catheter includes melt-extruding a thermoplastic polymeric material into a tube, cooling the extruded tube, placing the extruded tube within a capture member and biaxially orienting the polymeric material of the extruded tube while simultaneously tapering at least a section of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with an external load applied on at least one end of the tube as an external heat supply traverses longitudinally from a first end to a second end of the extruded tube in the capture member, wherein an overall axial load on the tubing is varied as at least a section of the tube is heated. The method includes cooling the expanded tube to form a tapered biaxially oriented nonporous thermoplastic polymer tubular member and sealingly securing a balloon proximate a distal end of the tubular member.

Abstract: Methods of manufacturing a medical article that include radial deformation of a polymer tube are disclosed. A medical article, such as an implantable medical device or an inflatable member, may be fabricated from a deformed tube.

Abstract: Balloon catheter comprises an elongated shaft having a proximal end and a distal end, the elongated shaft including a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D with an inflation lumen defined therein. The balloon catheter also comprises a balloon sealing secured proximate the distal end of the shaft and having an interior in fluid communication with the inflation lumen.

Abstract: Methods of manufacturing a medical article that include radial deformation of a polymer tube are disclosed. A medical article, such as an implantable medical device or an inflatable member, may be fabricated from a deformed tube.

Abstract: Method of making a balloon catheter includes providing an elongated shaft having a proximal end and a distal end and an inflation lumen extending therein, providing a multilayer tube, forming a multilayer balloon by blow-molding the multilayer tube such that the multilayer balloon is blown, in at least a first stage, to a final working radial dimension, and securing the multilayer balloon on a distal section of the shaft with an interior of the multilayer balloon in fluid communication with the inflation lumen. The ADDR of the multilayer balloon after formation is approximately 2.0.

Abstract: Balloon catheter comprises an elongated shaft having a proximal end and a distal end, the elongated shaft including a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75 D with an inflation lumen defined therein. The balloon catheter also comprises a balloon sealing secured proximate the distal end of the shaft and having an interior in fluid communication with the inflation lumen.

Abstract: Stents and methods of manufacturing a stents with enhanced fracture toughness are disclosed.

Abstract: Stents and methods of manufacturing a stents with enhanced fracture toughness are disclosed.

Abstract: A catheter balloon and method involves extruded tubing with multiple layers of different durometer values, selected such that the blow up ratio (BUR) at the balloon's inner surface is increased. In one method a two stage blow mold process uses a small radius initial stage where radial growth is limited, followed by a second stage to a final dimension. A single stage blow mold process is also disclosed where the materials and processing are selected to approach the elongation to failure limit of the material. The single stage approach is preferably followed by a modified post-expansion heat set treatment to promote greater axial strength, leading to a preferred failure mode in the axial rather than radial direction.

Abstract: Stents and methods of manufacturing a stents with enhanced fracture toughness are disclosed.

Abstract: Stents and methods of manufacturing a stents with enhanced fracture toughness are disclosed.

Abstract: Method of making a multilayer balloon for a catheter having a nominal working diameter comprises forming a tube having at least a first layer and a second layer having a combined wall thickness. The first layer is made of a first polymer material having a first maximum blow-up-ratio and the second layer is made of a second polymer material having a second maximum blow-up-ratio greater than the first maximum blow-up-ratio. The second layer is an inner layer relative to the first layer. The method also comprises forming the multilayer balloon from the tube in a balloon mold having an inner diameter corresponding to the balloon's nominal working diameter. The at least first and second layers of the multilayer balloon define a compliance less than that of a single layer balloon made of the first polymer material with a wall thickness equal to the combined wall thickness.

Abstract: A balloon catheter having a multi-layered balloon which has a first layer and at least a second layer, and which has noncompliant limited radial expansion beyond the nominal diameter of the balloon. By selecting the polymeric materials forming the balloon layers, and arranging and radially expanding the multiple layers of the balloon in accordance with the invention, a balloon is provided having an improved low compliance, preferably in combination with high flexibility and softness.

Abstract: Balloon catheter comprises an elongated shaft having a proximal end, a distal end, an inflation lumen extending therein, and a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D and having the inflation lumen therein. The balloon catheter also comprises a balloon sealing secured proximate the distal end of the shaft and having an interior in fluid communication with the inflation lumen.

Abstract: Multilayer balloon for a catheter comprising at least a first layer, a second layer, and a third layer having a combined wall thickness. The first layer is made of a first polymer material having a first maximum blow-up-ratio. The second layer is made of a second polymer material having a second maximum blow-up-ratio greater than the first maximum blow-up-ratio. The second layer is an inner layer relative to the first layer. The third layer is made of a third polymer material having a third maximum blow-up-ratio greater than the second maximum blow-up-ratio. The third layer is an inner layer relative to the second layer. The at least first, second, and third layers define a compliance less than that of a single layer balloon made of the first polymer material with a wall thickness equal to the combined wall thickness.

Abstract: A catheter having an elongated shaft with a tubular member which forms at least a portion of the shaft and which is formed of a biaxially oriented thermoplastic polymeric material, and a method of forming the catheter shaft by radially and longitudinally expanding the tubular member to biaxially orient the polymeric material, and, in one embodiment, tapering the tubular member to form a bending stiffness transition. A catheter of the invention has an improved combination of low bending stiffness, high rupture pressure, and high tensile strength, for improved catheter performance.