Importance

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Abstract

The present invention includes an improved configuration and method of forming an inflatable silicone balloon on a cured silicone catheter that does not require a release agent to free the balloon from the catheter. The method includes a catheter having an inflation lumen therein and an inflation port on the distal end thereof communicating the inflation lumen with the outer surface of the catheter within the interior of the balloon, comprising the following steps: Providing a substantially cured silicone compound sleeve having an inner diameter corresponding to the outer diameter of the catheter and having a length corresponding to the desired length of the inflatable balloon. Positioning the sleeve onto the distal end of the catheter and centered on the inflation port. Overdipping the distal end of the catheter and the sleeve into an uncured silicone dispersion compound to a depth of about 0.25 inches beyond the sleeve, forming an uncured silicone compound layer over the catheter and the sleeve. Drying the silicone compound layer on the sleeve and catheter. Next, Curing the silicone compound layer and the sleeve on the catheter, whereby the compound layer is securely bonded to the outer surface of the catheter and is bonded to the outer surface and ends of the sleeve, and the inner surface of the sleeve does not bond to the surface of the catheter. Finally, releasing the inflatable balloon portion from the catheter, by applying a slight lateral force to the surface thereof, whereby the inner surface of the sleeve is translated a slight distance relative to the surface of the catheter to thereby separate any residual adhesion of the surfaces.

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First Claim