Methods of treatment with drug eluting stents with prolonged local elution profiles with high local concentrations and low systemic concentrations
First Claim
1. A method of treating peripheral vascular disease in a subject, the method comprising:
- implanting in a peripheral artery of a subject a drug eluting stent comprising;
a self-expanding stent body of 130 mm to 170 mm in length, the self-expanding stent body being a design of annular elements and interconnectors where the annular elements are connected adjacently by at least one interconnector;
a polymeric coating disposed on the stent body, the polymeric coating being 2 μ
m to 50 μ
m in thickness;
a lipophilic drug disposed in the polymeric coating, the lipophilic drug being present at an amount between about 4 mg to about 8 mg;
wherein the maximum systemic blood concentration of the lipophilic drug in the subject is about 30 ng/ml or less than 30 ng/ml.
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Accused Products
Abstract
A drug eluting stent can include a stent body having a polymeric coating with a lipophilic and/or hydrophilic element. A drug that has a bioactivity that inhibits cell proliferation can be disposed in the polymeric coating. The drug can be present in the polymer at an amount greater than or equal to about 150 μg/cm2. The polymeric coating and drug are configured to cooperate so as to form a diffusion pathway with tissue when the stent is disposed in a body lumen such that the drug preferentially diffuses into the tissue over a body fluid passing through the body lumen such that a maximum systemic blood concentration of the drug is less than about 40 ng/ml.
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Citations
22 Claims
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1. A method of treating peripheral vascular disease in a subject, the method comprising:
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implanting in a peripheral artery of a subject a drug eluting stent comprising; a self-expanding stent body of 130 mm to 170 mm in length, the self-expanding stent body being a design of annular elements and interconnectors where the annular elements are connected adjacently by at least one interconnector; a polymeric coating disposed on the stent body, the polymeric coating being 2 μ
m to 50 μ
m in thickness;a lipophilic drug disposed in the polymeric coating, the lipophilic drug being present at an amount between about 4 mg to about 8 mg; wherein the maximum systemic blood concentration of the lipophilic drug in the subject is about 30 ng/ml or less than 30 ng/ml. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15)
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16. A method of treating peripheral vascular disease in a subject, the method comprising:
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implanting in a peripheral artery of a subject a drug eluting stent comprising; a self-expanding stent body of Nitinol, the self-expanding stent body being a design of annular elements and interconnectors where the annular elements are connected adjacently by at least one interconnector; a polymeric coating disposed on the stent body, the polymeric coating being 5 μ
m to 20 μ
m in thickness; andeverolimus disposed in the polymeric coating; wherein the maximum systemic blood concentration of everolimus in the subject is about 30 ng/ml or less than 30 ng/ml; and wherein the stent is 28 mm in length and 10 mm in diameter, and the amount of everolimus is about 1.07 mg;
orthe stent is 100 mm in length and 7 mm in diameter, and the amount of everolimus is about 3.5 mg. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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Specification