Method of forming hollow tubular drug eluting medical devices

Abstract

A method of a forming a hollow, drug-eluting medical device includes utilizing a hollow wire having an outer member and a lumen of the outer member, and filling the lumen with a fluid to form a supported hollow wire. The supported hollow wire is shaped into a stent pattern. Openings are formed through the outer member. The supported hollow wire is processed to remove the fluid from the lumen of the outer member without adversely affecting the outer member, leaving the hollow wire shaped into a stent pattern. The lumen is filled with a biologically or pharmacologically active substance.

Description

CROSS-REFERENCE TO RELATED APPLICATION[0001]This application claims the benefit of U.S. Provisional Patent Application No. 61 / 244,049 filed Sep. 20, 2009, the contents of which is hereby incorporated by reference.FIELD OF THE INVENTION[0002]The present invention relates to implantable medical devices that release a therapeutic substance and methods of forming such medical devices.BACKGROUND OF THE INVENTION[0003]Drug-eluting implantable medical devices have become popular in recent times for their ability to perform their primary function (such as structural support) and their ability to medically treat the area in which they are implanted.[0004]For example, drug-eluting stents have been used to prevent restenosis in coronary arteries. Drug-eluting stents may administer biologically or pharmacologically active substances such as anti-inflammatory compounds that block local invasion / activation of monocytes, thus preventing the secretion of growth factors that may trigger VSMC prolife...

AI Technical Summary

Problems solved by technology

However, at the conclusion of the elution process, the remaining polymer material in some instances has been linked to an adverse reaction with the vessel, possibly causing a small but dangerous clot to form.

Further, drug impregnated polymer coatings on exposed surfaces of medical devices may flake off or otherwise be damaged during delivery, thereby preventing the biologically or pharmacologically active substance from reaching the target site.

Still further, drug impregnated polymer coatings are limited in the quantity of the biologically or pharmacologically active substance to be delivered by the amount of a biologically or pharmacologically active substance that the polymer coating can carry and the size of the medical devices.

Controlling the rate of elution using polymer coatings is also difficult.

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