Coated implantable medical device

Abstract

Bioactive-coated medical devices are provided, including coated vascular stents. The medical device coating can include a coating layer posited over at least a portion of the medical device surface, and can include a butyl methacrylate polymer or an ethylene-vinyl acetate copolymer in combination with a bioactive material that can function as both an immunosuppressive agent and an antiproliferative agent. Optionally, multilayer coatings can further include an adhesion promoting layer comprising parylene positioned between the coating layer and the medical device surface, a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer, or both. The coating layer preferably comprises between about 0.5 and 2.0 μg / mm2 of the bioactive material on the outer surface of the medical device. The bioactive material can be absorbed into the coating layer, which can have a thickness of between about 0.5 μm to about 5 μm.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation application of co-pending U.S. patent application Ser. No. 10 / 218,308, filed Aug. 14, 2002, which is a continuation of U.S. patent application Ser. No. 09 / 027,054, filed Feb. 20, 1998 and issued as U.S. Pat. No. 6,774,278 on Aug. 10, 2004, which is a continuation-in-part application of U.S. patent application Ser. No. 08 / 645,646, filed May 16, 1996 and issued as U.S. Pat. No. 6,096,070 on Aug. 1, 2000, which is in turn a continuation-in-part application of U.S. patent application Ser. No. 08 / 484,532, filed Jun. 7, 1995, now U.S. Pat. No. 5,609,629, issued Mar. 11, 1997. U.S. patent application Ser. No. 09 / 027,054 also claimed priority to provisional application Ser. No. 60 / 038,459, filed Feb. 20, 1997.TECHNICAL FIELD [0002] This invention relates generally to human and veterinary medical devices, and more particularly to devices incorporating drugs or bioactive agents. BACKGROUND OF THE INVENTION [0003...

AI Technical Summary

Benefits of technology

The patent text describes a way to prevent the degradation of a drug or other substance when it is applied to a medical device. This is achieved by coating the device with a layer of material that controls the release of the substance. The coating layer can be made of a non-porous material called parylene or a parylene derivative. The coated device can also have a porous layer made of a polymer called polyamide or parylene. The use of a coating layer can promote the controlled release of the substance and can protect the device from damage during use. The patent also mentions that the coated device can be used in the vascular system or other locations in the body.

Problems solved by technology

However, when such a device is introduced into and manipulated through the vascular system, the blood vessel walls can be disturbed or injured.

Clot formation or thrombosis often results at the injured site, causing stenosis or occlusion of the blood vessel.

Moreover, if the medical device is left within the patient for an extended period of time, thrombus often forms on the device itself, again causing stenosis or occlusion.

As a result, the patient is placed at risk of a variety of complications, including heart attack, pulmonary embolism, and stroke.

Thus, the use of such a medical device can entail the risk of precisely the problems that its use was intended to ameliorate.

As the obstruction increases, a critical level of stenosis is reached, to the point where the flow of blood past the obstruction is insufficient to meet the metabolic needs of the tissue distal to (downstream of) the obstruction.

The result is ischemia.

While PTA presently enjoys wide use, it suffers from two major problems.

First, the blood vessel may suffer acute occlusion immediately after or within the initial hours after the dilation procedure.

Such occlusion is referred to as “abrupt closure.” Abrupt closure occurs in perhaps five percent or so of the cases in which PTA is employed, and can result in myocardial infarction and death if blood flow is not restored promptly.

A second major problem encountered in PTA is the re-narrowing of an artery after an initially successful angioplasty.

However, like the attempts to prevent thrombotic acute closure, the results of attempts to prevent restenosis in this manner have been mixed.

Restenosis of these lesions occurs at a high rate following angioplasty, however, due to the fibrotic nature of the diseases.

Medical therapies to treat or obviate them have been similarly disappointing.

Unfortunately, even when the implantation of the stent is accompanied by aggressive and precise antiplatelet and anticoagulation therapy (typically by systemic administration), the incidence of thrombotic vessel closure or other thrombotic complication remains significant, and the prevention of restenosis is not as successful as desired.

Furthermore, an undesirable side effect of the systemic antiplatelet and anticoagulation therapy is an increased incidence of bleeding complications, most often at the percutaneous entry site.

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