Method of making a balloon catheter shaft having high strength and flexibility
First Claim
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1. A method of making a balloon catheter having an elongated shaft and a balloon on a distal shaft section, comprising:
- a) melt-extruding a thermoplastic polymeric material having a Shore durometer hardness of less than about 75D to form a tube having a lumen, a first inner diameter and a first outer diameter, and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion;
b) placing the extruded tube within a capture member and biaxially orienting the polymeric material of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with a load applied on at least one end of the tube; and
c) cooling the expanded tube to room temperature, the cooled, expanded tube being a biaxially oriented nonporous thermoplastic polymer tubular member; and
d) sealingly securing a balloon to a distal end of the tubular member, such that the tubular member forms at least a portion of the catheter shaft and the balloon has an interior in fluid communication with the tubular member lumen.
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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.
297 Citations
22 Claims
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1. A method of making a balloon catheter having an elongated shaft and a balloon on a distal shaft section, comprising:
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a) melt-extruding a thermoplastic polymeric material having a Shore durometer hardness of less than about 75D to form a tube having a lumen, a first inner diameter and a first outer diameter, and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion; b) placing the extruded tube within a capture member and biaxially orienting the polymeric material of the extruded tube by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with a load applied on at least one end of the tube; and c) cooling the expanded tube to room temperature, the cooled, expanded tube being a biaxially oriented nonporous thermoplastic polymer tubular member; and d) sealingly securing a balloon to a distal end of the tubular member, such that the tubular member forms at least a portion of the catheter shaft and the balloon has an interior in fluid communication with the tubular member lumen. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of making a balloon catheter having an elongated shaft and a balloon on a distal shaft section, comprising:
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a) melt-extruding a thermoplastic polymeric material having a Shore durometer hardness of less than about 75D to form a tube having a lumen, a first inner diameter and a first outer diameter, and cooling the extruded tube to a temperature less than an elevated temperature of the melt-extrusion; b) placing the extruded tube in a lumen of a capture member and biaxially orienting the polymeric material of the extruded tube, by radially expanding the extruded tube with pressurized media in the tube lumen and axially expanding the extruded tube with a load applied on at least one end of the tube; c) cooling the expanded tube to room temperature, the cooled, expanded tube being a biaxially oriented nonporous thermoplastic polymer tubular member, which forms at least a portion of the catheter shaft and which has a Shore durometer hardness of less than about 75D, a Gurley bending stiffness of not greater than about 50 to about 150 mg, a rupture pressure of at least about 20 to about 50 atm, and a tensile strength of at least about 1 to about 5 lbf; and d) sealingly securing a balloon to a distal end of the tubular member such that the balloon has an interior in fluid communication with the tubular member lumen and a rated burst pressure which is significantly less than the rupture pressure of the shaft tubular member and which is at least about 14 atm. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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Specification