Method and apparatus for loading a beneficial agent into an expandable medical device

Abstract

The present invention relates to method and apparatus for dispensing a beneficial agent into an expandable medical device. The method includes the step of placing an expandable medical device on a mandrel, the medical device forming a cylindrical device having a plurality of openings and dispensing a beneficial agent into the plurality of openings.

Description

[0001] This application claims priority to U.S. Provisional Patent Application Serial No. 60 / 412,489, filed on Sep. 20, 2002, which is incorporated herein by reference in its entirety.[0002] The invention relates to a method and apparatus for loading a beneficial agent, such as a drug into an expandable medical device, and more particularly, the invention relates to a method and apparatus for dispensing a beneficial agent into an expandable medical device such as a stent.DESCRIPTION OF THE RELATED ART[0003] Implantable medical devices are often used for delivery of a beneficial agent, such as a drug, to an organ or tissue in the body at a controlled delivery rate over an extended period of time. These devices may deliver agents to a wide variety of bodily systems to provide a wide variety of treatments.[0004] One of the many implantable medical devices which have been used for local delivery of beneficial agents is the coronary stent. Coronary stents are typically introduced percuta...

AI Technical Summary

Problems solved by technology

Restenosis is a major complication that can arise following vascular interventions such as angioplasty and the implantation of stents.

To treat this condition, additional revascularization procedures are frequently required, thereby increasing trauma and risk to the patient.

Surface coatings, however, can provide little actual control over the release kinetics of beneficial agents.

However, the increased coating thickness results in increased overall thickness of the stent wall.

This is undesirable for a number of reasons, including increased trauma to the vessel wall during implantation, reduced flow cross-section of the lumen after implantation, and increased vulnerability of the coating to mechanical failure or damage during expansion and implantation.

Coating thickness is one of several factors that affect the release kinetics of the beneficial agent, and limitations on thickness thereby limit the range of release rates, duration of drug delivery, and the like that can be achieved.

In addition to sub-optimal release profiles, there are further problems with surface coated stents.

Since these beneficial agents are frequently highly cytotoxic, sub-acute and chronic problems such as chronic inflammation, late thrombosis, and late or incomplete healing of the vessel wall may occur.

Additionally, the carrier polymers themselves are often highly inflammatory to the tissue of the vessel wall.

On the other hand, use of biodegradable polymer carriers on stent surfaces ...

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