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: 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: 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: 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: 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: 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: 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. A catheter of the invention has an improved combination of low bending stiffness, high rupture pressure, and high tensile strength, for improved catheter performance.

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: 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: The invention is directed to adjustable length mold assemblies for forming inflatable members and methods for using adjustable length mold assemblies for forming inflatable members, such as, for example, balloons for use with balloon catheters and stent delivery systems. The adjustable length mold assemblies comprise at least two mold pieces adapted to fit together, one mold piece having a surface configured to be slidably received by a bore of the other mold piece, the placement of one piece within the other defining a chamber of variable length which forms the mold. Each adjustable length mold assembly of the present invention is effective to form balloons, where if desired different balloons formed by a single mold may have different lengths. The adjustable length mold assemblies may also comprise a positioner to put a mold piece in a desired position relative to the other, and a locking mechanism to secure a mold piece in a desired position.

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. A catheter of the invention has an improved combination of low bending stiffness, high rupture pressure, and high tensile strength, for improved catheter performance.

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.

Abstract: A protector sleeve assembly for a balloon catheter, configured for being removably disposed on at least a section of the catheter and preferably on at least the catheter non-inflated balloon prior to introduction of the catheter in a patient's lumen, including a radially collapsible inner sleeve, and an outer sleeve with a tapered section. The inner sleeve has a relaxed configuration with an inner diameter greater than the outer diameter of the noninflated balloon, and a collapsed configuration with an inner diameter less than the relaxed inner diameter. The outer sleeve is slidably positioned on at least a portion of the inner sleeve and has a tapered first section with an inner diameter tapering towards a nontapered second section, the nontapered second section having a substantially uniform inner diameter less than an outer diameter of the relaxed inner sleeve and configured to hold the inner sleeve in the collapsed configuration.

Abstract: The invention is directed to adjustable length mold assemblies for forming inflatable members and methods for using adjustable length mold assemblies for forming inflatable members, such as, for example, balloons for use with balloon catheters and stent delivery systems. The adjustable length mold assemblies comprise at least two mold pieces adapted to fit together, one mold piece having a surface configured to be slidably received by a bore of the other mold piece, the placement of one piece within the other defining a chamber of variable length which forms the mold. Each adjustable length mold assembly of the present invention is effective to form balloons, where if desired different balloons formed by a single mold may have different lengths. The adjustable length mold assemblies may also comprise a positioner to put a mold piece in a desired position relative to the other, and a locking mechanism to secure a mold piece in a desired position.

Abstract: The invention is directed to adjustable length mold assemblies for forming inflatable members and methods for using adjustable length mold assemblies for forming inflatable members, such as, for example, balloons for use with balloon catheters and stent delivery systems. The adjustable length mold assemblies comprise at least two mold pieces adapted to fit together, one mold piece having a surface configured to be slidably received by a bore of the other mold piece, the placement of one piece within the other defining a chamber of variable length which forms the mold. Each adjustable length mold assembly of the present invention is effective to form balloons, where if desired different balloons formed by a single mold may have different lengths. The adjustable length mold assemblies may also comprise a positioner to put a mold piece in a desired position relative to the other, and a locking mechanism to secure a mold piece in a desired position.

Abstract: A balloon expandable intravascular stent assembly for implantation in a body vessel, such as a coronary artery, is designed to provide stent coverage beyond the balloon working length and minimize damage to the vessel wall during balloon inflation. The stent consists of radially expandable cylindrical rings generally aligned on a common longitudinal stent axis and either directly connected or interconnected by one or more interconnecting links. The stent includes a distal section, proximal section, and center section. The rings within the distal section and proximal section may be configured with a nickel-titanium alloy and may include tabs which extend away from the center section.

Abstract: A protector sleeve assembly for a balloon catheter, configured for being removably disposed on at least a section of the catheter and preferably on at least the catheter non-inflated balloon prior to introduction of the catheter in a patient's lumen, including a radially collapsible inner sleeve, and an outer sleeve with a tapered section. The inner sleeve has a relaxed configuration with an inner diameter greater than the outer diameter of the noninflated balloon, and a collapsed configuration with an inner diameter less than the relaxed inner diameter. The outer sleeve is slidably positioned on at least a portion of the inner sleeve and has a tapered first section with an inner diameter tapering towards a nontapered second section, the nontapered second section having a substantially uniform inner diameter less than an outer diameter of the relaxed inner sleeve and configured to hold the inner sleeve in the collapsed configuration.

Abstract: A balloon catheter including an elongated shaft and a balloon on a digital shaft section having a working section, and tapered sections having an inflated configuration with a non-circular transverse cross section. In one embodiment, the non-circular tapers are triangular, although alternative non-circular cross-sectional designs may be used, such as lobed tapers. The non-circular tapers deflate to form two or more deflated wings along at least a section of the deflated balloon. The deflated wings provide a deflated balloon with a relatively low profile, which facilitates repositioning or removal of the balloon catheter within the patient's vasculature.

Abstract: The invention is directed to adjustable length mold assemblies for forming inflatable members and methods for using adjustable length mold assemblies for forming inflatable members, such as, for example, balloons for use with balloon catheters and stent delivery systems. The adjustable length mold assemblies comprise at least two mold pieces adapted to fit together, one mold piece having a surface configured to be slidably received by a bore of the other mold piece, the placement of one piece within the other defining a chamber of variable length which forms the mold. Each adjustable length mold assembly of the present invention is effective to form balloons, where if desired different balloons formed by a single mold may have different lengths. The adjustable length mold assemblies may also comprise a positioner to put a mold piece in a desired position relative to the other, and a locking mechanism to secure a mold piece in a desired position.

Abstract: A balloon catheter with a balloon having first and second tapered sections adjacent the distal and proximal ends of the working length of the balloon, respectively, and third and fourth tapered sections adjacent the first and second tapered section, respectively. The first and second tapered sections taper at a first angle to a smaller outer diameter than the inflated outer diameter of the working length inflated within a deployment range of the balloon, and the third and fourth tapered sections taper at a second angle larger than the first angle. The balloon has expandable retention sections proximal and the distal to the working length of the balloon for inhibiting migration of a stent mounted on the balloon.