Controlled drug delivery using a zein layer modified with levulinic acid
AssigneeCook Medical Technologies LLC
InventorsAshley P. Lindsay, Waleska Perez-Segarra, Patrick H. Ruane, Christine Casterline
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Abstract
The disclosure relates to medical devices coated with zein admixed with levulinic acid. The medical device may further include a therapeutic agent in contact with zein admixed with levulinic acid. Zein admixed with levulinic acid allows the therapeutic agent to be retained on the device during delivery and also controls the elution rate of the therapeutic agent following implantation. The disclosure further relates to methods of delivering a therapeutic agent on said medical devices as well as their use especially in the form of stents for prevention of restenosis.
Claims20
An expandable medical device comprising a frame and a coating, wherein the coating comprises from about 0.05 to about 40 μg of zein or modified zein admixed with levulinic acid per mm2 of the coated surface of the medical device, wherein levulinic acid increases flexibility of the coating to accommodate deformations of the expandable medical device.
A medical device comprising a frame and a coating, the coating being the product of deposition of zein or modified zein solution comprising 1 to 3 drops of levulinic acid per 10 mL of the solution, and wherein from about 0.05 to about 40 μg of zein is present per mm2 of the coated surface of the medical device, the coating comprising about 1:1 to about 1:20 weight ratio taxane therapeutic agent to zein or modified zein admixed with levulinic acid.
A method of delivering a therapeutic agent to a patient in need thereof comprising the steps of
- providing an expandable medical device and
- implanting the medical device in a patient wherein the medical device comprises
- at least one therapeutic agent and
- a coating comprising from about 0.05 to about 40 μg of zein admixed with levulinic acid per mm2 of the coated surface of the medical device with a ratio of about 1:1 to about 1:20 by weight of the at least one therapeutic agent to zein admixed with levulinic acid, and wherein levulinic acid increases flexibility of the coating to accommodate deformations of the expandable medical device during the implanting step.
Dependencies are inferred from the claim text.