Balloon catheter for delivering a therapeutic agent

摘要

Catheter balloon assemblies (10) for delivering a therapeutic agent to a body vessel are provided, as well as related methods of manufacturing and methods of treatment. The catheter balloon assemblies may include a concentrically disposed dual balloon assembly at the distal portion of the catheter having an inner balloon (44), a porous outer balloon (42) concentrically arrayed around the inner balloon and a catheter shaft (30) adapted to deliver a therapeutic agent to the body vessel through the apertures in the outer balloon. Radial outward expansion of the inner balloon may urge the outer balloon into contact with the wall of a body vessel, where the therapeutic agent may be delivered from the catheter shaft through apertures in the outer balloon directly to the wall of the body vessel. Preferably, the catheter balloon assemblies include a stiffening' member (210) within the proximal portion and/or a plurality of lumens lined with a fluorinated hydrocarbon to independently inflate the inner balloon, deliver the therapeutic agent through the outer balloon and house a wire guide (50). The catheter balloon assemblies may provide improved tractability and/or pushability characteristics.

主权项

1. A method for making a balloon catheter, comprising:
(a) forming a catheter shaft, said forming including: disposing a first fluorinated hydrocarbon tube in a first lumen of a thermoplastic polymer sleeve material, the first fluorinated hydrocarbon tube having a melting point higher than that of the thermoplastic polymer sleeve material; disposing a second fluorinated hydrocarbon tube in a second lumen of the thermoplastic polymer sleeve material, the second fluorinated hydrocarbon tube having a melting point higher than that of the thermoplastic polymer sleeve material; heating the thermoplastic polymer sleeve material, with the first and second fluorinated hydrocarbon tubes disposed in the first and second lumens, to provide a heated catheter shaft assembly in which the thermoplastic polymer sleeve material is molten; and compressing the heated catheter shaft assembly so as to cause the molten thermoplastic polymer sleeve material to flow around and join together the first fluorinated hydrocarbon tube and the second fluorinated hydrocarbon tube; and (b) mounting a balloon on the catheter shaft with an interior of the balloon in fluid communication with a lumen defined by the first fluorinated hydrocarbon tube.