Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: An apparatus for gripping a balloon catheter during folding (i.e., fluting) is provided. The apparatus includes a base unit, a back gripper and a front gripper. The front gripper is configured to straighten an inner lumen of the balloon catheter. A method for gripping a balloon catheter during fluting is also provided. The method can include the steps of straightening an inner lumen of the balloon catheter and aligning the inner lumen with a central axis when straightened. The method further can include the steps of providing a plurality of arms coupled to the base unit and arranged in a pattern about a central axis, translating the plurality of arms in a radial direction toward and away from the central axis, fluting the balloon catheter with a plurality of blades coupled to the plurality of arms.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: A balloon folding apparatus is provided for use in the manufacture of balloon catheters. The balloon folding apparatus includes a plurality of arms and a plurality of blades attached to the plurality of arms such that the plurality of blades is capable of translating in a radial direction. Preferably, a plurality of stepper motors coupled to the plurality of arms provides precise radial movement of the plurality of blades. Each of the plurality of blades is profiled to create a plurality of folds in a balloon catheter. A balloon wrapping apparatus is also provided and operates in a similar manner. The balloon wrapping apparatus includes a plurality of blades configured to wrap a folded balloon catheter around a catheter shaft so as to minimize the diameter of the balloon catheter.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: A multi-layered balloon is provided where each layer is formed such that each layer is made from tubing that optimizes the inner wall stretch thus providing maximum balloon strength. The high pressure, multi-layer balloon is provided with layers that allow for slipping, such that the balloon has a very high pressure rating and toughness, yet excellent folding characteristics. Methods for producing such multi-layer balloons using existing balloon forming equipment are also provided. The multi-layer balloons can have alternating structural and lubricating layers, or layers with low-friction surfaces. The multi-layer balloons are preferably manufactured using a variety of methods including nesting, co-extrusion, or a combination of nesting and co-extrusion. The multi-layer balloons have balloon layers having substantially similar, or the same, high degree of biaxial orientation of their polymer molecules such that each balloon layer of the multi-layer balloon will fail at approximately the same applied pressure.

Abstract: A balloon folding apparatus is provided for use in the manufacture of balloon catheters. The balloon folding apparatus includes a plurality of arms and a plurality of blades attached to the plurality of arms such that the plurality of blades is capable of translating in a radial direction. Preferably, a plurality of stepper motors coupled to the plurality of arms provides precise radial movement of the plurality of blades. Each of the plurality of blades is profiled to create a plurality of folds in a balloon catheter. A balloon wrapping apparatus is also provided and operates in a similar manner. The balloon wrapping apparatus includes a plurality of blades configured to wrap a folded balloon catheter around a catheter shaft so as to minimize the diameter of the balloon catheter.

Abstract: Measurement devices and methods for measuring balloon catheters are provided. Embodiments enable measuring the outer dimensions and burst pressure of a balloon catheter. The measurement apparatus can measure a balloon catheter in ambient air or a balloon catheter submerged in a heated water bath. In ambient air, an axial drive mechanism translates the balloon catheter in an axial direction and a rotary drive mechanism rotates the balloon catheter while a measurement device is used to measure balloon catheter dimensions. In a water tank, an axial drive mechanism translates the balloon catheter in an axial direction while a measurement device is used to measure the burst pressure of the balloon catheter. The devices and methods can utilize a laser micrometer in order to provide such measurements. A control unit provides a user interface and is capable of displaying real time data during the measurement process.

Abstract: A swaging machine is configured to substantially uniformly reduce the diameter of a tubular attachment, such as a marker band, to result in a smooth and repeatable finished part. The swaging machine comprises a feed system, an impact system, and a rotation system. A split die having a compound die cavity is provided for use in conjunction with the swaging machine to receive an impact force from the impact system and, in turn, apply a swaging force to the marker band. The rotation system rotates the impact system, including the die, about the axis of the marker band to apply swaging forces about the circumference of the marker band, while the feed system feeds the marker band through the die thereby applying swaging forces along the length of the marker band.

Abstract: A swaging die is configured to substantially uniformly reduce the diameter of a tubular attachment, such as a marker band, to result in a smooth and repeatable finished part. The swaging die comprises a first block, and a second block, with each of the first and second blocks defining a cavity that cooperate to define a swaging cavity when the first block is juxtaposed with the second block. The first block is configured to receive an impact, thereby varying the volume of the swaging cavity and applying a swaging force onto a tubular attachment located therein. The tubular attachment is preferably fed through the swaging cavity to uniformly and gradually reduce the diameter of the tubular attachment.