Importance

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Abstract

A method for manufacturing balloon catheters, and the catheters manufactured thereby. In accordance with the method, a workpiece comprising a tube-within-a-tube is placed within a mold, and a first region of the outer tube is distended into contact with the mold to form a seamless balloon of a desired configuration. The distension of the first region of the outer tube may be facilitated by electron beam irradiation, heating and/or longitudinal drawing of the workpiece concurrently with the introduction of a pressurized fluid into the space between the inner surface of the outer tube and the outer surface of the inner tube so as to exert the required outwardly distending pressure against the first region of the outer tube. When the method is utilized to form a 'monorail' type of catheter, the inner tube need extend through only a distal portion of the outer tube, and the proximal end of the inner tube is coupled to an aperture formed in the sidewall of the outer tube to create a 'monorail' type of a guide wire lumen. Alternatively, when used to form an over-the-wire type of catheter, the inner tube will extend through the entire length of the outer tube, and a proximal guidewire entry connector or port will be located on the proximal end of the catheter body to facilitate passage of the guidewire through the lumen of the inner tube.

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First Claim