Sustained drug-releasing stent

Abstract

A stent includes a stent body of a cylindrical configuration having outer and inner surfaces, a first coated layer coating at least the outer surface, and a second coated layer coating substantially completely over the first coated layer. The first coated layer is prepared of a first composition comprising a polymer and a vascular intimal hyperplasia inhibitor (preferably argatroban) of a kind, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the inhibitor being within the range of 8:2 to 3:7. On the other hand, the second coated layer is prepared of a polymer alone or a second composition comprising a polymer and a drug, the weight compositional ratio of the drug to 80% by weight of the polymer being less than 20% by weight.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is a continuation of U.S. patent application Ser. No. 12 / 733,460, filed Mar. 3, 2010, now pending, which is a continuation application, under 35 U.S.C. §111(a), of international application No. PCT / JP2008 / 002410, filed Sep. 3, 2008, which claims priority to Japanese patent application No. 2007-228788, filed Sep. 4, 2007, the disclosures of which are incorporated by reference in their entirety into this application.BACKGROUND[0002]1. Field[0003]The present invention relates to a sustained drug-releasing stent useful for treatment of a constricted blood vessel, a method of making the same and a method of controlling the rate of release of the sustained release drug from the stent. More specifically, the present invention relates to a stent carrying a vascular intimal hyperplasia inhibitor, which does not inhibit proliferation of endothelial cells, a method of making such stent and a method of controlling the rate of release...

AI Technical Summary

Benefits of technology

"The present invention provides a stent carrying a vascular intimal hyperplasia inhibitor that does not inhibit the proliferation of endothelial cells. The stent is coated with a first coated layer and a second coated layer. The first coated layer is made of a polymer and a vascular intimal hyperplasia inhibitor, while the second coated layer is made of a polymer alone or a second composition containing the drug. The stent is designed to release the drug in a controlled manner and can be expanded to secure a required lumen region. The invention also provides a method for making the stent."

Problems solved by technology

However, placement of such a stent in the coronary artery, of which constriction or occlusion is highly fatal, has been found involving the probability of postoperative treatment required reaches 20 to 30% because even though the stent has been placed, vascular intimal hyperplasia occurs with the vascular lumen narrowed consequently.

However, since those drugs have an effect of inhibiting the proliferation of vascular cells (endothelial cells and smooth muscle cells) by acting on the cell cycle thereof, not only can the vascular intimal hyperplasia resulting from an excessive proliferation of the smooth muscle cells be suppressed, but proliferation of the endothelial cells once denuded during placement of the stent is also suppressed, resulting in an adverse effect of the repair or treatment of the inner wall of a blood vessel being retarded.

In view of the fact that thrombosis tends to occur easily at the site of the inner wall of a blood vessel that are not covered with endothelial cells, an antithrombotic drug must be administrated for a prolonged time, say, half a year or so and, even though the antithrombotic drug is administrated, there is a risk that the late thrombosis may result in accompanied by a sudden death.

At present, however, no drug releasing stent capable of accomplishing a sustained release of a vascular intimal hyperplasia inhibitor, which is free from injury to the endothelial cells, has yet been made available.

In any event, however, no surprising effect of inhibiting the vascular intimal hyperplasia while the drug is carried by the stent has yet been observed.

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