Balloon Catheter Systems for Delivery of Dry Drug Delivery Vesicles to a Vessel in the Body
First Claim
1. A system for delivery of drugs or therapeutic agents to a blood vessel, said system comprising:
- balloon catheter comprising a catheter body with a distal end adapted for insertion into the vasculature of a patient, a porous balloon disposed on the distal end, and a proximal end adapted for connection to a fluid source, and a lumen extending from the proximal end to the balloon;
a storage chamber with a reservoir of dry drug delivery vesicles;
an inflator;
a suspension chamber in fluid communication with an inflator;
a valve operable to selectively connect the storage chamber to the suspension chamber or the lumen of the catheter;
wherein the inflator is operable to fill the storage chamber with fluid to reconstitute the dry drug delivery vesicles into a fluid suspension of drug delivery vesicles and draw the fluid suspension into the suspension chamber, when the valve is positioned to connect the storage chamber to the suspension chamber, and the inflator is operable to force the suspension from the suspension chamber through the catheter lumen and porous balloon to the blood vessel.
6 Assignments
0 Petitions
Accused Products
Abstract
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.
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Citations
25 Claims
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1. A system for delivery of drugs or therapeutic agents to a blood vessel, said system comprising:
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balloon catheter comprising a catheter body with a distal end adapted for insertion into the vasculature of a patient, a porous balloon disposed on the distal end, and a proximal end adapted for connection to a fluid source, and a lumen extending from the proximal end to the balloon; a storage chamber with a reservoir of dry drug delivery vesicles; an inflator; a suspension chamber in fluid communication with an inflator; a valve operable to selectively connect the storage chamber to the suspension chamber or the lumen of the catheter; wherein the inflator is operable to fill the storage chamber with fluid to reconstitute the dry drug delivery vesicles into a fluid suspension of drug delivery vesicles and draw the fluid suspension into the suspension chamber, when the valve is positioned to connect the storage chamber to the suspension chamber, and the inflator is operable to force the suspension from the suspension chamber through the catheter lumen and porous balloon to the blood vessel. - View Dependent Claims (2, 3, 4, 5, 6, 7)
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8. A method for delivery of drugs or therapeutic agents to a vessel within the body of a patient, said method comprising the steps of:
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providing a catheter system comprising; a balloon catheter comprising a catheter body with a distal end adapted for insertion into the vasculature of a patient, a porous balloon disposed on the distal end, and a proximal end adapted for connection to a fluid source, and a lumen extending from the proximal end to the balloon; a storage chamber with a reservoir of dry drug delivery vesicles; an inflator; a suspension chamber in fluid communication with an inflator; a valve operable to selectively connect the storage chamber to the suspension chamber or the lumen of the catheter; operating the three-way valve to align the inflator and coiled tube suspension chamber with the storage chamber; forcing fluid into the storage chamber to reconstitute the micelles in the micelle storage chamber and create a suspension of drug delivery vesicles; drawing the suspension of drug delivery vesicles into the suspension chamber; operating the three-way valve to align the suspension chamber and inflator with the catheter lumen; operating the inflator to force additional fluid through suspension chamber to the catheter, thereby forcing the suspension of drug delivery vesicles, through the wall of the balloon and into body tissue surrounding the balloon. - View Dependent Claims (9, 10)
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11. A balloon catheter system comprising:
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a catheter body characterized by a distal portion and a proximal portion; a first, outer, balloon disposed on the distal portion of the catheter body, a reservoir of lyophilized micelles with rapamycin encapsulated in the micelles, said reservoir disposed within the catheter; a reservoir of aqueous solution suitable for mobilizing the micelles within the micelle reservoir; a first injection port disposed on the proximal end of the catheter body; and a first lumen communicating from the injection port to the first, outer, balloon. - View Dependent Claims (12, 13, 14, 15, 16, 17)
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18. A method of treating a lesion in a blood vessel of a patient comprising:
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providing balloon catheter system comprising; a catheter body characterized by a distal portion and a proximal portion; a first, outer, balloon disposed on the distal portion of the catheter body, said balloon having a porous wall portion; a reservoir of lyophilized micelles with rapamycin encapsulated in the micelles, said reservoir disposed within the catheter; a reservoir of aqueous solution suitable for mobilizing the micelles within the micelle reservoir; a first injection port disposed on the proximal end of the catheter body; and a first lumen communicating from the injection port to the first, outer, balloon; inserting the distal portion of the catheter into the blood vessel such that the balloon is disposed near the lesion; filling the balloon with an aqueous solution to wet and mobilize the micelles; pressurizing the balloon to force the micelles through the porous wall portion of the balloon into the blood vessel. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25)
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Specification