Abstract: This is an implantable medical device assembly for use in surgical procedures. It is most preferably an implantable structure having stenting properties but only partially coated with or partially associated with a material causing a localized angiogenic response. One variation of is an artificial occlusion kit having the inventive implantable stenting structure situatable and vaso-occlusive devices. The implantable stenting structure is typically situated so to prevent migration of artificial occlusion devices or implants from an occlusion site, such as an aneurysm, and into an adjacent body space, such as a blood vessel.

Abstract: Implantable medical device having a structure adapted for introduction into a patient wherein the structure is composed of a base material positioned over the structure. The implantable medical device further includes at least one composite layer of a bioactive agent and a polymer material and at least a barrier layer positioned over the composite layer and being of thickness adequate to provide a controlled release of the bioactive agent. The barrier layer being applied by a low energy plasma polymerization process which includes placing the device with the at least one composite layer in a plasma chamber and introducing at least one monomer gas.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: The inventors have found that both the drug dose and drug release profiles are significant factors for the safety and efficacy of drug coated stents. The inventors have identified optimum dosing and release kinetics for drug coated stents. In particular, the inventors have determined dosing and release kinetics that permit the delivery of the lowest effective drug dosage, thus enhancing patient safety and minimizing any side effects from the drug.

Abstract: The invention features a method for triggering release of a drug from a hydrogel polymer to tissue at a desired location of the body using a catheter. A portion of the catheter is coated on its outer surface with a polymer having the capacity to incorporate a predetermined substantial amount of drug which is immobilized in the polymer until released by a triggering agent or condition that is different from physiological conditions. Upon contact with a triggering agent or condition, the polymer reacts, e.g., swells or contracts, such that the drug is delivered to the desired body tissue. A balloon catheter is shown in which the hydrogel is carried on the exterior surface of the balloon.

Abstract: Method and system for delivery of coated implants is provided. One embodiment encompasses a coated implant delivery system. This system includes an implant delivery device having a first end, a second end, and an inner lumen, wherein the first end has a releasable implant retention region with an accessible surface having a coated implant adhesion-resistant treatment. In another embodiment a method of deploying a coated releasable implant at a target site of a vessel using an implant delivery system is provided. This method includes inserting a portion of an implant delivery device having a releasable implant into the vessel, advancing the implant delivery device to the target site, deploying the releasable implant from the delivery device, and withdrawing the inserted portion of the implant delivery device from the vessel.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: The invention features a catheter and methods for delivering drug to tissue at a desired location of the wall of a body lumen. 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 a controlled pressure to fill the cross-section of the body lumen and press against the wall of the body lumen. In one embodiment, at least a portion of the exterior surface of the expandable portion is defined by a coating of a tenaciously adhered swellable hydrogel polymer. Incorporated in the hydrogel polymer is an aqueous solution of a preselected drug to be delivered to the tissue or plaque. The hydrogel polymer and drug are selected to allow rapid release of a desired dosage of the drug from the hydrogel polymer coating during compression of the hydrogel polymer coating against the wall of the lumen when the expandable portion is expanded.

Abstract: This relates to a composition for forming a biologically active anatomical occlusion typically within the vasculature of a patient. More particularly, it concerns an occlusive agent which may be made from a precursor composition containing at least one biodegradable, polymeric component and at least one biologically active agent. The occlusive agent may further include solid or dissolved radio-opacifiers and known vaso-occlusive devices. The resulting occlusion, a bioactive solid, encourages cellular attachment and growth while maintaining favorable handling, deployment, and visualization characteristics.

Abstract: Implantable medical device having a structure adapted for introduction into a patient wherein the structure is composed of a base material positioned over the structure. The implantable medical device further includes at least one composite layer of a bioactive agent and a polymer material and at least a barrier layer positioned over the composite layer and being of thickness adequate to provide a controlled release of the bioactive agent. The barrier layer being applied by a low energy plasma polymerization process which includes placing the device with the at least one composite layer in a plasma chamber and introducing at least one monomer gas.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

Abstract: Implantable medical device having a structure adapted for introduction into a patient wherein the structure is composed of a base material positioned over the structure. The implantable medical device further includes at least one composite layer of a bioactive agent and a polymer material and at least a barrier layer positioned over the composite layer and being of thickness adequate to provide a controlled release of the bioactive agent. The barrier layer being applied by a low energy plasma polymerization process which includes placing the device with the at least one composite layer in a plasma chamber and introducing at least one monomer gas.

Abstract: This is an implantable medical device assembly for use in surgical procedures. It is most preferably an implantable structure having stenting properties but only partially coated with or partially associated with a material causing a localized angiogenic response. One variation of is an artificial occlusion kit having the inventive implantable stenting structure situatable and vaso-occlusive devices. The implantable stenting structure is typically situated so to prevent migration of artificial occlusion devices or implants from an occlusion site, such as an aneurysm, and into an adjacent body space, such as a blood vessel.

Abstract: A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

Abstract: This is a medical device for forming an embolism within the vasculature of a patient. More particularly, it is a vaso-occlusion device at least partially coated with a bioactive agent, a collagenous material, or a collagenous coating optionally containing or coated with other bioactive agents. A highly flexible vaso-occlusive device coated with such materials also forms a variation of the invention.

Abstract: An inflatable medical device and method for the placement of a stent in a body passageway by means of a two stage expansion of the stent and for the delivery of medications to precise location in the passageway. The device includes a catheter shaft (14) having a plurality of lumens (13, 22, 28) disposed therein. The catheter shaft has a distal end adapted to be disposed within a vascular passageway. An inflatable balloon is defined by a generally cylindrical wall and is adapted to receive inflation fluids. The balloon is disposed on the distal end of the shaft. An array of circumferentially arranged inflation conduits (40) is disposed in the wall. The conduits (40) are spaced from each other within the wall of the balloon whereby to form a annular array. An array of medication delivering conduits (25) can be disposed within the wall of the balloon. These conduits are adapted to deliver medications to predetermined locations within the body passageway being treated.

Abstract: The invention features a catheter assembly and methods for delivering a hydrogel-lined stent to a body lumen, and methods for lining a stent with a hydrogel. The assembly includes a catheter which has a balloon at least a portion of which is coated with a hydrogel and an expansible stent mounted on the balloon in a contracted condition for passage with the catheter to a site of a body. Expansion of the balloon lodges the stent in the body with hydrogel coated on the inner surfaces of the stent as a lining.

Abstract: An inflatable medical device and method for the placement of a stent in a body passageway by means of a two stage expansion of the stent and for the delivery of medications to precise location in the passageway. The device includes a catheter shaft (14) having a plurality of lumens (13, 22, 28) disposed therein. The catheter shaft has a distal end adapted to be disposed within a vascular passageway. An inflatable balloon is defined by a generally cylindrical wall and is adapted to receive inflation fluids. The balloon is disposed on the distal end of the shaft. An array of circumferentially arranged inflation conduits (40) is disposed in the wall. The conduits (40) are spaced from each other within the wall of the balloon whereby to form a annular array. An array of medication delivering conduits (25) can be disposed within the wall of the balloon. These conduits are adapted to deliver medications to predetermined locations within the body passageway being treated.

Abstract: The invention features a catheter and methods for delivering drug to tissue at a desired location of the wall of a body lumen. 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 a controlled pressure to fill the cross-section of the body lumen and press against the wall of the body lumen. In one embodiment, at least a portion of the exterior surface of the expandable portion is defined by a coating of a tenaciously adhered swellable hydrogel polymer. Incorporated in the hydrogel polymer is an aqueous solution of a preselected drug to be delivered to the tissue or plaque. The hydrogel polymer and drug are selected to allow rapid release of a desired dosage of the drug from the hydrogel polymer coating during compression of the hydrogel polymer coating against the wall of the lumen when the expandable portion is expanded.