Balloon Catheter Systems for Delivery of Dry Drug Delivery Vesicles to a Vessel in the Body

摘要

Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

主权项

1. A method of treating a lesion in a blood vessel of a patient comprising the steps of:
providing balloon catheter system comprising:
a catheter body characterized by a distal portion and a proximal portion;a first balloon disposed on the distal portion of the catheter body, said first balloon having a porous wall portion, said porous wall portion having pores with a diameter of about 0.1 to 5 microns; providing a reservoir of lyophilized micelles with rapamycin encapsulated in the micelles; providing a reservoir of aqueous solution suitable for mobilizing the micelles within the micelle reservoir; mixing the aqueous solution with the micelles to wet and mobilize the micelles, such that the micelles have a particle size of 40 to 250 nm (0.04 to 0.250 micron); and delivering the micelles to the lesion, through the wall of balloon, by injection the micelles into the balloon and pressurizing the balloon to a pressure of 6 to 12 atmospheres to force the micelles through the porous wall portion of the balloon into the blood vessel.