Methods of manufacturing medical devices for controlled drug release

Abstract

The present invention is a medical device for controlling the release of an active agent. The medical device has a supporting structure having a porous body disposed therein. At least one elution rate controlling matrix containing an effective amount of at least one active agent is disposed within the pores of the porous body in a manner that protects the matrix from mechanical damage. The medical device may therefore be used for controlled drug release applications. Additionally, the present invention discloses a method for using the medical device for the treatment and prevention of diseases in mammals. This invention further relates to a method for using the medical device for treating and preventing vascular diseases.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This U.S. patent application claims benefit of U.S. provisional patent applications having Ser. Nos. 60 / 823,057, 60 / 823,061, 60 / 823,063, 60 / 823,067, and 60 / 823,069 and 60 / 823,071 each filed on Aug. 21, 2006, each entitled “MEDICAL DEVICES FOR CONTROLLED DRUG RELEASE,” and each having Wouter Roorda as the inventor, which U.S. provisional patent applications are incorporated herein in their entirety by specific reference. Additionally, this U.S. patent application cross-references related U.S. patent applications filed herewith and having Attorney Docket Numbers 17066.15.1.1 (“MEDICAL DEVICES FOR CONTROLLED DRUG RELEASE”) and 17066.15.1.3 (“METHODS OF USING MEDICAL DEVICES FOR CONTROLLED DRUG RELEASE”), which cross-referenced applications are incorporated herein in their entirety by specific reference.BACKGROUND [0002] I. Technology Field [0003] The present invention relates to medical devices, endoprostheses, stents, and methods for the ...

AI Technical Summary

Benefits of technology

The present invention is a medical device that controls the release of an active agent. The device has a supporting structure that is designed to be used within the body of an animal. It includes a porous body that is made up of a first biocompatible material with a plurality of pores. The porous body is disposed on and at least partially covers the supporting structure. The device also includes an elution rate controlling matrix that is disposed on at least one surface of the porous body. The matrix includes a second biocompatible material that controls the elution rate of the active agent from the pores. The device can be used in various medical applications such as endoprostheses, drug delivery stents, drug delivery catheters, grafts, drug delivery balloons, guidewires, orthopedic implants, dental implants, fixation screws, indwelling catheters, ocular implants, pharmacotherapeutic implants, blood-contacting components of extracorporeal devices, staples, filters, needles, tubes, coils, wires, clips, screws, sensors, plates, conduits, and combinations thereof.

Problems solved by technology

These polymeric materials are typically applied as coatings to the medical devices, raising issues regarding coating adhesion, mechanical properties, cracking, delamination, and material biocompatibility.

However, problems occur when mechanical forces are applied on an endoprosthesis during manufacture (e.g., crimping, endoprosthetic retention procedures, packaging etc.) as well as during actual use (e.g., unsheathing, catheter preparation, advancement through catheter and vasculature), which may result in damaging the polymeric coating.

In addition, many polymers with desirable controlled release properties, like the family of biodegradable polymers based on polylactide, polyglycolide and their copolymers are difficult candidates for a polymeric endoprosthetic coating, because of poor adhesion to metals and / or poor elongation and brittle character.

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