Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Having plural layers
Reexamination Certificate
1998-10-14
2001-10-23
Kennedy, Sharon (Department: 3763)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Having plural layers
C623S001420
Reexamination Certificate
active
06306166
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to methods and devices for the localized delivery of substantially water-insoluble drug agents within the body.
BACKGROUND
The systemic administration of drug agents, such as by transoral or intravenous means, treats the body as a whole even though the disease to be treated may be localized. In such a case, systemic administration may not be desirable because, for example, the drug agents may have unwanted effects on parts of the body which are not to be treated, or because treatment of the diseased part of the body requires a high concentration of drug agent that may not be achievable by systemic administration.
It is therefore often desirable to administer drug agents at a localized site within the body. Common examples include cases of localized disease or occluded body lumens. Various methods have been proposed for such localized drug administration. For example, U.S. Pat. No. 5,304,121, hereby incorporated by reference, discloses a method of delivering water-soluble drugs to tissue at desired locations of a body lumen wall. The method generally includes the steps of impregnating a hydrogel polymer on an expandable catheter with an aqueous drug solution, inserting the catheter into a blood vessel to a desired location, and expanding the catheter against the surrounding tissue allowing the release of the drug to the tissue. This method of localized drug delivery using hydrogel polymer impregnation has a limitation of being applicable to drug agents which are dissolved in water at concentrations sufficient for therapeutic gel loading levels. There thus exists a need for a method and apparatus for the localized delivery of drug agents within the body, where the drug agents are substantially water-insoluble. Moreover, there exists a need for a method and implantable device that provides a sustained release of such substantially water-insoluble drug agents over a time frame effective to inhibit proliferative disease.
SUMMARY OF THE INVENTION
One objective of the present invention is to provide a method and apparatus for the localized delivery of substantially water-insoluble drug agents to predetermined locations within the human body.
A further objective of the present invention is to provide a method and apparatus to facilitate gradual, localized release of drug agents at predetermined locations within the human body.
A further objective of the invention is to administer drug agents by diffusion directly into the tissue requiring treatment. The drug is preferably applied in a manner that does not further injure the tissue to be treated, and administration is selectively and evenly distributed over the treated area such that the drug can be taken up by the tissue, without, for example, being washed away by body fluids.
The present invention provides methods and medical devices for the localized delivery of substantially water-insoluble drugs agents.
A particular embodiment of the present invention features a catheter and method for delivering substantially water-insoluble drug agents to tissue at a desired location along body lumen walls. The catheter is constructed for insertion in a body lumen and has a catheter shaft and an expandable portion mounted on the catheter shaft. The expandable portion is expandable to fill the cross-section of the body lumen. At least a portion of the exterior surface of the expandable portion is defined by a polymer coating. Incorporated into the polymer coating is at least one substantially water-insoluble drug. The catheter is positioned to a desired target location within the body, whereupon the polymer coating absorbs water, thus dissolving the drug and resulting in the diffusion of the drug out of the polymer coating. The polymer and drug are selected to allow controlled release of a desired dosage of the drug from the polymer.
Another particular embodiment of the present invention features a stent for the localized delivery of substantially water-insoluble drug agents to tissue at a desired location along body lumen walls. The stent is at least partially coated with a polymer coating having at least one substantially water-insoluble drug therein. The stent configuration, polymer and drug are selected to allow for the controlled release dosage and release rate of the drug from the polymer.
In a most preferred embodiment, the stent is a patterned stent for the localized delivery of paclitaxel to tissue at a desired location along body lumen walls. The stent is at least partially coated with a polymer/paclitaxel matrix that provides sustained release of paclitaxel at the desired site within the lumen wall.
In another aspect of the invention, there is provided a method for preventing or inhibiting proliferative disease in a patient comprising implanting a patterned stent comprising an outer coating of polymer/paclitaxel at a site of cellular proliferation, wherein the paclitaxel is released from the outer coating at a release rate and for a period of time sufficient to inhibit or prevent cellular proliferation at the site.
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Barry James J.
Palasis Maria
Kennedy Sharon
Kenyon & Kenyon
Sci-Med Life Systems, Inc.
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