DRUG ELUTING STENTS WITH PROLONGED LOCAL ELUTION PROFILES WITH HIGH LOCAL CONCENTRATIONS AND LOW SYSTEMIC CONCENTRATIONS
First Claim
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1. A drug eluting stent comprising:
- a stent body;
a polymeric coating disposed on the stent body;
a drug disposed in the polymeric coating, said drug being present at an amount greater than or equal to about 150 ug/cm2; and
wherein the polymeric coating and drug cooperate 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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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 ug/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
26 Claims
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1. A drug eluting stent comprising:
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a stent body; a polymeric coating disposed on the stent body; a drug disposed in the polymeric coating, said drug being present at an amount greater than or equal to about 150 ug/cm2; and wherein the polymeric coating and drug cooperate 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. A drug eluting stent comprising:
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a stent body comprising a superelastic alloy; an ethylenevinylalcohol polymeric coating disposed on the stent body; a therapeutically effective amount of everolimus disposed in the polymeric coating, said drug being present at an amount greater than or equal to about 150 ug/cm2; and wherein the polymer coating and everolimus cooperate to form a lipophilic diffusion pathway with tissue when the stent is disposed in a body lumen such that the everolimus preferentially diffuses into the tissue over a body fluid passing through the body lumen such that a maximum systemic blood concentration of everolimus is less than about 40 ng/ml. - View Dependent Claims (11, 12, 13, 14, 15, 16)
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17. A stent as in claim 17, wherein the polymeric coating is characterized by at least one of the following:
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the primer layer being from about 1% to about 20% of the total coating thickness; the drug-loaded layer being from about 25% to about 90% of the total coating thickness;
orthe topcoat being from about 5% to about 50% of the total coating thickness.
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18. A method of inhibiting occlusion of a body lumen in a subject, the method comprising:
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providing a drug eluting stent comprising; a stent body; a polymeric coating having a lipophilic element disposed on the stent body; a lipophilic drug that inhibits cell proliferation disposed in the polymeric coating, said drug being present at an amount greater than or equal to about 150 ug/cm2; and wherein the polymeric coating and drug cooperate to form a lipophilic diffusion pathway with tissue when the stent is disposed in a body lumen such that the lipophilic 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; and deploying the drug eluting stent into the body lumen. - View Dependent Claims (19, 20, 21, 22, 23, 24, 25, 26)
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Specification