Methods of using 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 17066.15.1.2 (“METHODS OF MANUFACTURING 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 ...

AI Technical Summary

Benefits of technology

[0015] In one embodiment, the active agent is comprised of at least one of analgesics, antipyretics, antiasthamatics, antibiotics, antidepressants, antidiabetics, antifungal agents, antihypertensive agents, anti-inflammatories including non-steroidal and steroidal, antineoplastics, antianxiety agents, immunosuppressive agents, antimigraine agents, sedatives, hypnotics, antianginal agents, antipsychotic agents, antimanic agents, antiarrhythmics, antiarthritic agents, antigout agents, anticoagulants, thrombolytic agents, antifibrinolytic agents, hemorheologic agents, antiplatelet agents, anticonvulsants, antiparkinson agents, antihistamines, anti-restenosis agents, antipruritics, agents useful for calcium regulation, antibacterial agents, antiviral agents, antimicrobials, anti-infectives, bronchodilators, steroidal compounds and hormones, or combinations thereof. Preferably, the active agent comprises at least one of rapamycin, rapamycin analog, zotarolimus, sirolimus, everolimus, dexamethasone, prednisone, hydrocortisone, estradiol, acetaminophen, ibuprofen, naproxen, sulidac, heparin, taxol, paclitaxel, and combinations thereof.

[0016] In one embodiment, the present invention includes a method of treating and/or preventing a disease in an animal. Such as method can include the following: providing a medical device (e.g., endoprosthesis, stent, etc.) configured and dimensioned to be used within a body of an animal, as described herein; deploying the medical device into the body of the animal; and allowing the active agent to elute from the pores into th...

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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