Drug releasing coatings for medical devices
First Claim
1. A balloon catheter that delivers a therapeutic agent to a blood vessel, the balloon catheter comprising a coating layer overlying an exterior surface of an expandable inflatable balloon, wherein:
- the coating layer is pressed into direct contact with a vessel wall of the blood vessel when the expandable inflatable balloon is inflated during balloon angioplasty and comprises a therapeutic agent and at least one additive;
the therapeutic agent comprises paclitaxel;
the at least one additive comprises gluconolactone and at least one surfactant selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan laurates, PEG sorbitan palmitates, PEG sorbitan stearates, PEG sorbitan oleates, and combinations thereof;
the ratio of the total weight of additive in the coating layer to the weight of the therapeutic agent in the coating layer is from about 0.05 to 100;
the therapeutic agent is not enclosed in micelles or encapsulated in polymer particles; and
the coating layer does not include an iodine covalent bonded contrast agent, an oil, or a lipid.
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Accused Products
Abstract
The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. In certain embodiments, the additive has a hydrophilic part and a drug affinity part, wherein the drug affinity part is at least one of a hydrophobic part, a part that has an affinity to the therapeutic agent by hydrogen bonding, and a part that has an affinity to the therapeutic agent by van der Waals interactions. In embodiments, the additive is water-soluble. In further embodiments, the additive is at least one of a surfactant and a chemical compound, and the chemical compound has a molecular weight of from 80 to 750 or has more than four hydroxyl groups.
457 Citations
28 Claims
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1. A balloon catheter that delivers a therapeutic agent to a blood vessel, the balloon catheter comprising a coating layer overlying an exterior surface of an expandable inflatable balloon, wherein:
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the coating layer is pressed into direct contact with a vessel wall of the blood vessel when the expandable inflatable balloon is inflated during balloon angioplasty and comprises a therapeutic agent and at least one additive; the therapeutic agent comprises paclitaxel; the at least one additive comprises gluconolactone and at least one surfactant selected from the group consisting of PEG laurates, PEG oleates, PEG stearates, PEG glyceryl laurates, PEG glyceryl oleates, PEG glyceryl stearates, PEG sorbitan laurates, PEG sorbitan palmitates, PEG sorbitan stearates, PEG sorbitan oleates, and combinations thereof; the ratio of the total weight of additive in the coating layer to the weight of the therapeutic agent in the coating layer is from about 0.05 to 100; the therapeutic agent is not enclosed in micelles or encapsulated in polymer particles; and the coating layer does not include an iodine covalent bonded contrast agent, an oil, or a lipid. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28)
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Specification