Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which includes an amphiphilic polymer or copolymer, in embodiments polyethylene glycol, having a substantially water-insoluble therapeutic agent dispersed therein. In some embodiments, the coating may also include iodine. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which includes an amphiphilic polymer or copolymer, in embodiments polyethylene glycol, having a substantially water-insoluble therapeutic agent dispersed therein. In some embodiments, the coating may also include iodine. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which includes an amphiphilic polymer or copolymer, in embodiments polyethylene glycol, having a substantially water-insoluble therapeutic agent dispersed therein. In some embodiments, the coating may also include iodine. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: One embodiment provides a medical device comprising a base material and a bioactive in contact with the base material, the bioactive having a proton binding site with a non-ionic form and an ionic form, the bioactive being less soluble in water when the proton binding site is in the non-ionic form than when the proton binding site is in the ionic form, wherein at least 5% w/w of the bioactive is present with the proton binding site in the non-ionic form and wherein the bioactive is not an anesthetic. Another embodiment provides such a medical device where the bioactive is an anesthetic and where the device is not a ureteral stent. Another aspect provides method of manufacturing such devices.

Abstract: Non-metallic implantable medical devices including an anesthetic having a proton binding site with a non-ionic form and an ionic form. At least 5% w/w of the anesthetic is present with the proton binding site in the non-ionic form and the remainder of the anesthetic is present with the proton binding site in the ionic form. Methods of preparing such devices are also provided.

Abstract: This disclosure relates to endolumenal medical devices coated with a taxane therapeutic agent in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous paclitaxel, dihydrate paclitaxel, or combinations thereof that provide durable coatings that release paclitaxel over a desired period of time, which can be on the order of hours, days or weeks. Preferred embodiments relate to medical device coatings of paclitaxel, or paclitaxel analogs or derivatives, having one or more polymorph solid forms that provide a prolonged release of paclitaxel within a body vessel without requiring a polymer carrier or barrier layer to achieve the desired rate of paclitaxel elution.

Abstract: An implantable medical device including a nanocomposite coating deposited on at least a portion of a surface of at least one structural element of the device to provide a controlled release of a bioactive agent in one or more dosages is described. The nanocomposite coating includes a matrix, a bioactive agent and inorganic particles. The inorganic particles respond to a stimulus, preferably by generating heat. The response of the particles to the stimulus causes the matrix of the nanocomposite coating to undergo a volume change by, for example, contracting or swelling, thereby releasing at least a portion of the bioactive agent. A method of providing a controlled release of a bioactive agent from a nanocomposite coating on an implantable medical device is described. A method for providing a nanocomposite coating for the controlled release of a bioactive agent on the implantable medical device is also described.

Abstract: An endoluminal medical device comprises a drug release system that releases a cathepsin inhibitor at a predetermined location within a lumen of a patient. The endoluminal devices and methods of treatment of disease can treat illnesses such as aneurysms and aortic dissections.

Abstract: Metallic stents are treated with a gaseous species in a plasma state under conditions causing the species to polymerize and to be deposited in polymerized form on the metallic stent surface prior to the application of a drug-polymer mixture, which is done by conventional non-plasma deposition methods. The drug-polymer mixture once applied forms a coating on the stent surface that releases the drug in a time-release manner and gradually erodes, leaving only the underlying plasma-deposited polymer. In certain cases, the plasma-deposited polymer itself erodes or dissolves into the physiological medium over an extended period of time, leaving only the metallic stent. While the various polymers and drug remain on the stent, the plasma-deposited polymer enhances the adhesion of the drug-polymer anchor coating and maintains the coating intact upon exposure to the mechanical stresses encountered during stent deployment.

Abstract: This invention relates to medical devices and an elastin-stabilizing compound, such as a phenolic tannin, the medical device being adapted to release the elastin-stabilizing compound within a body of a patient. This invention also relates to medical devices and methods of treatment of disease, such as aneurysms and aortic dissection. Medical devices may include coated stents, grafts, stent grafts, balloons and catheters.

Abstract: This disclosure relates to implantable medical devices coated with a taxane therapeutic agent, such as paclitaxel, in one or more solid form(s) having varying dissolution rates. Particularly preferred coatings comprise amorphous and/or solvated solid forms of taxane therapeutic agents that provide durable coatings that release the taxane over a desired period of time, which can be varied in the absence of a polymer by selecting the type and amount of solid forms of the taxane therapeutic agent in the coating. Other preferred embodiments relate to methods of coating medical devices and methods of treatment. The coatings can provide a sustained release of the taxane therapeutic agent within a body vessel without containing a polymer to achieve the desired rate of paclitaxel elution.

Abstract: The invention relates to medical devices coated with zein. The medical device may include further a therapeutic agent in contact with zein. Zein allows the therapeutic agent to be retained on the device during delivery and also controls the elution rate of the therapeutic agent following implantation. The invention further relates to methods of delivering a therapeutic agent on said medical devices as well as their use especially in the form of stents for prevention of restenosis.

Abstract: The present invention provides an implantable medical device comprising a bioactive agent and poly(alkyl cyanoacrylate) polymer. In one embodiment of the invention, the bioactive agent is a water-soluble material, such as an antisense agent.

Abstract: A coated medical device, such as a stent, that elutes a therapeutic agent in a controlled manner is provided. The medical device may be coated with a layer of therapeutic agent and a layer of bioabsorbable elastomer over the layer of therapeutic agent. Methods of manufacturing a coated medical device and of coating a medical device are also provided.

Abstract: Methods of making coated implantable medical devices are provided. The methods include positioning a first layer comprising a bioactive on at least a portion of a structure, and positioning at least one porous layer over the first layer. The at least one porous layer has a thickness adequate to provide a controlled release of the bioactive.

Abstract: An intraluminal device is provided with a porous structure. The porous structure may be loaded with a bioactive substance to treat surrounding tissues after the intraluminal device has been implanted. The porous structure may be made by depositing a metal film on a foam structure using chemical vapor deposition. Porous structures may also be made by sintering or applying a ceramic layer to the intraluminal device. An intraluminal device is also provided with a ceramic material applied to generally straight portions of the device structure but not to portions adapted to bend. One advantage is that the ceramic material is less likely to fracture since it is applied to regions that experience less strain.