Importance

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Abstract

An apparatus and method for nonextrusion manufacturing of catheters that can be used to produce catheters having a simple or complex configuration. A polymer material in a particulate preform is applied in a layer over an outer surface of a core member. By applying the polymer material in a particulate preform, a composition of the polymer material can be varied continuously as it is being applied to provide a variable hardness over the length of the catheter. A fibrous reinforcement can be used having a constant or variable pitch and a constant or variable number of fibers and fiber types. Sensors can be easily placed in a wall of the catheter as the catheter is being fabricated, thereby allowing more sensors to be used without placing conductors in the lumen of the catheter. Deflection passages can be provided in a wall of the catheter for inserting a wire to deflect the catheter. The polymer material can be heated into molten form as it is being applied, or the core mandrel or liner can be heated to cause the polymer material to consolidate upon impact. A mandrel in the preferred embodiment is rotated about its longitudinal axis while a spray head and filament winding head traverse the length of the mandrel and apply polymer material and filament, respectively. Other arrangements can also be used, including a spray head and filament winding head that rotate about a continuous core mandrel, and a fluidized bed or other container into which a heated core mandrel is immersed. A plurality of mandrels can be placed side-by-side to form a multiple lumen tubing.

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First Claim