Stent coated with a sustained-release drug delivery and method for use thereof

Abstract

An intraluminal medical device comprises a stent having a coating applied to at least part of an interior surface, an exterior surface, or both. The coating comprises a sustained release formulation of a combination of pharmaceutical compounds dispersed within a biologically tolerated polymer composition. The choice of the combination of pharmaceutical compounds are intended to reduce neointimal hyperplasia restenosis.

Description

RELATED APPLICATIONS[0001]This application claims the benefit of U.S. Provisional Application Nos. 60 / 322,428, filed Sep. 17, 2001 and 60 / 372,761, filed Apr. 15, 2002, the specifications of each of which are hereby incorporated by reference in their entirety.FIELD OF THE INVENTION[0002]The present invention generally relates to an improved intraluminal medical device and to a method for treating tissues. More particularly, the present invention relates to a stent coated with a sustained-release drug delivery system for supporting and reinforcing an enlarged vessel, the system having a therapeutically beneficial advantage of reducing the incidence, recurrence, or both, of restenosis.BACKGROUND OF THE INVENTION[0003]A stent is a generally longitudinal tubular device formed of biocompatible material, preferably a metallic or plastic material. Stents are useful in the treatment of stenosis, strictures or aneurysms in body vessels, such as blood vessels. It is well-known to employ a sten...

AI Technical Summary

Benefits of technology

[0018]In a preferred embodiment, the pharmaceutical agent may be an anti-neoplastic agent such as for example 5-fluorouracil, and its rate of release from the device may be varied as described herein, i.e. by regulating the rate of dissolution, the rate of permeability, or the swelling rates, which in turn may be controlled by controlling the pH, moisture and temperature of the environment, and chemical properties of the polymeric matrix, such as for example its size, shape and thickness. In another embodiment, the 5-fluorouracil may be mixed, dispersed or bonded to another chemical moiety that may reduce its solubility. In yet other embodiments, the 5-fluorouracil may be diffused as a function of the size of the polymeric matrix pores. The matrix diffusion embodiment thus facilitates the delivery by coated device of single drug that ordinarily have high solubility in physiological fluids.

[0021]While exemplary embodiments of the invention will be described with respect to the treatment of restenosis and related complications following percutaneous transluminal coronary angioplasty, it is important to note that the local delivery of drug / drug combinations may be utilized to treat a wide variety of conditions utilizing any number of medical devices, or to enhance the function and / or life of the device. For example, intraocular lenses, placed to restore vision after cataract surgery is often compromised by the formation of a secondary cataract. The latter is often a result of cellular overgrowth on the lens surface and can be potentially minimized by combining a drug or drugs with the device. Other medical devices which often fail due to tissue in-growth or accumulation of proteinaceous material in, on and around the device, such as shunts for hydrocephalus, dialysis grafts, colostomy bag attachment devices, ear drainage tubes, leads for pace makers and implantable defibrillators can also benefit from the device-drug combination approach.

[0022]Devices which serve to improve the structure and function of tissue or organ may also show benefits when combined with the appropriate agent or agents. For example, improved osteointegration of orthopedic devices to enhance stabilization of the implanted device could potentially be achieved by combining it with agents such as bone morphogenic protein. Similarly other surgical devices, sutures, staples, anastomosis devices, vertebral disks, bone pins, suture anchors, hemostatic barriers, clamps, screws, plates, clips, vascular implants, tissue adhesives and sealants, tissue scaffolds, various types of dressings, bone substitutes, intraluminal devices, and vascular supports could also provide enhanced patient benefit using this drug-device combination approach. Essentially, any type of medical device may be coated in some fashion with a drug or drug combination which enhances treatment over use of the singular use of the device or pharmaceutical agent.

[0023]Yet another aspect of the invention provides a method for treating an intraluminal tissue of a patient, the method comprising the steps of: (a) providing a stent having an interior surface and an exterior surface, said stent having a coating on at least a part of the interior surface, the exterior surface, or both; said coating comprising a low-solubility pharmaceutical agent dissolved or dispersed in a biologically-tolerated polymer; (b) positioning the stent at an appropriate intraluminal tissue site; and (c) deploying the stent. In such embodiments, the drug combinations and delivery devices of the present invention may be utilized to effectively prevent and treat vascular disease, and in particular, vascular disease caused by injury.

Problems solved by technology

Inflation of the balloon can rupture the intima and media, dramatically dilating the vessel and relieving the obstruction.

However, because of the high recurrence rate of obstruction, alternative methods may be necessary.

Moreover, the recurrence rate of obstruction is reportedly lower when stents are used.

Stents have proven less useful for treatment of neointimal hyperplasia, which arises out of a complex immune response to expanding and fracturing the atherosclerotic plaque.

While these approaches present some promise, they also suffer certain limitations, such as the tendency for rapamycin and taxanes to quickly disperse from the stent site, thereby both limiting the drugs' effective duration in proximity to the stent and also risking undesirable systemic toxic effects.

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