Abstract: Embodiments of the invention include devices, compositions and methods for the controlled release of therapeutic substances, such as drugs. Control over the rate of release of the therapeutic substances from the devices is achieved by the use of nanoporous membranes in which the pore size is matched to the molecular diameter of the therapeutic substances. Some embodiments of the invention achieve zero-order release by the use of membranes with a pore diameter that is more than five times the Stokes' diameter of the therapeutic substance released.

Abstract: The present disclosure provides compositions of a therapeutic agent and a release rate controlling agent for controlling the rate of release of the therapeutic agent from a reservoir of an implantable drug delivery system. The present disclosure also includes an implantable drug delivery systems incorporating the compositions of the present disclosure as well as methods of treating diabetes using the compositions and implantable drug delivery systems.

Abstract: Embodiments of the invention include devices, compositions and methods for the controlled release of therapeutic substances, such as drugs. Control over the rate of release of the therapeutic substances from the devices is achieved by the use of nanoporous membranes in which the pore size is matched to the molecular diameter of the therapeutic substances. Some embodiments of the invention achieve zero-order release by the use of membranes with a pore diameter that is more than five times the Stokes' diameter of the therapeutic substance released.

Abstract: The disclosure pertains to the field of treatment of patients with implantable delivery devices for long-term release of therapeutic agents. In particular, the disclosure provides devices and methods for the stabilization of the therapeutic agents inside the device for the duration of the implantation. The devices control the long-term release of the therapeutic agents by using a nanoporous membrane. The stabilization is achieved by using high-molecular weight stabilizers of a size that is larger than the diameter of the pores of the membrane, thereby preventing the release of the stabilizers.

Abstract: The present invention provides compositions of a therapeutic agent and a polymeric stabilizing agent for stabilizing the reservoir of an implantable drug delivery system. The present invention also includes an implantable drug delivery system incorporating the composition of the present invention, as well as methods of treating diabetes using the compositions and implantable drug delivery system of the present invention.

Abstract: The present invention provides compositions of a therapeutic agent and a polymeric stabilizing agent for stabilizing the reservoir of an implantable drug delivery system. The present invention also includes an implantable drug delivery system incorporating the composition of the present invention, as well as methods of treating diabetes using the compositions and implantable drug delivery system of the present invention.

Abstract: The present invention provides compositions of a therapeutic agent and a polymeric stabilizing agent for stabilizing the reservoir of an implantable drug delivery system. The present invention also includes an implantable drug delivery system incorporating the composition of the present invention, as well as methods of treating diabetes using the compositions and implantable drug delivery system of the present invention.

Abstract: The present invention provides compositions of a therapeutic agent and a polymeric stabilizing agent for stabilizing the reservoir of an implantable drug delivery system. The present invention also includes an implantable drug delivery system incorporating the composition of the present invention, as well as methods of treating diabetes using the compositions and implantable drug delivery system of the present invention.

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.

Abstract: A stent delivery catheter system having a catheter with stent releasably mounted on a stent retention portion of the catheter for delivery and deployment within a patient's body lumen, and a method of mounting the stent on the stent retention portion of the catheter. The method generally includes exposing the stent retention portion and/or the stent to a solvent, the solvent being in the vapor phase. The vapor phase solvent typically softens the stent retention portion of the catheter, and/or, in one embodiment in which the stent has a coating on the stent body, the vapor phase solvent softens the stent coating. In a presently preferred embodiment, the stent polymeric coating has a therapeutic agent, and the method of the invention prevents or inhibits disadvantageously affecting the therapeutic agent coating during mounting of the stent on the catheter.

Abstract: Drug-delivery systems such as drug-delivery stents having an anti-proliferative agent such as everolimus and an anti-flammatory agent such as clobetasol are provided. Also disclosed are methods of treating a vascular impairment such as restenosis or vulnerable plaque.

Abstract: A stent delivery catheter system having a catheter with stent releasably mounted on a stent retention portion of the catheter for delivery and deployment within a patient's body lumen, and a method of mounting the stent on the stent retention portion of the catheter. The method generally includes exposing the stent retention portion and/or the stent to a solvent, the solvent being in the vapor phase. The vapor phase solvent typically softens the stent retention portion of the catheter, and/or, in one embodiment in which the stent has a coating on the stent body, the vapor phase solvent softens the stent coating. In a presently preferred embodiment, the stent polymeric coating has a therapeutic agent, and the method of the invention prevents or inhibits disadvantageously affecting the therapeutic agent coating during mounting of the stent on the catheter.

Abstract: A drug-delivery system is provided including at least 100 ?g of everolimus and clobetasol, such that the ratio of everolimus to clobetasol is at least 10:1 (w/w) or the amount of everolimus by weight is at least 10 times more than clobetasol. The system can be a stent. Also provided a method of treating restenosis or vulnerable plaque of a blood vessel, the method includes locally administering to a patient a first drug selected from a group consisting of rapamycin (sirolimus), Biolimus A9, deforolimus, AP23572, tacrolimus, temsirolimus, pimecrolimus, zotarolimus (ABT-578), 40-O-(2-hydroxy)ethylrapamycin (everolimus), 40-O-(3-hydroxy)propylrapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethylrapamycin, 40-O-tetrazolylrapamycin and 40-epi-(N1-tetrazolyl)rapamycin, and locally administering to a patient a second drug consisting of clobetasol, wherein the minimum amount of the first drug that is locally administered is 100 ?g, and wherein the ratio of the first drug to the second drug is, for example, 10:1 to 100:1 (w/w).

Abstract: A method of delivering an arteriogenic factor. The factor is delivered in a medically effective manner to structurally enlarge blood vessel. A distal portion of a catheter can be advanced to an existing blood vessel to deliver the arteriogenic factor.

Abstract: Devices and methods for managing access through tissue is disclosed. The device includes a body. The body is movable from a pre-deployed configuration towards a deployed configuration. The device includes a plurality of tissue engaging portions that extend from the body. At least a portion of the tissue engaging portions are obtuse. At least two of the tissue engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration. The first distance is smaller than the second distance. The method includes deploying a closure element to tissue adjacent a tissue opening to substantially close the opening following a first procedure. The method also includes selectively opening the opening in the tissue by advancing a distal end of a medical device through the deployed closure element as a part of or before a second procedure.

Abstract: Biocompatible copolymers are manufactured to include a zwitterionic monomer and an alkoxy acrylate monomer. The alkoxy acrylate monomer can be a 2-methoxyethyl methacrylate (MOEMA) or 2-ethoxyethyl methacrylate (EOEMA). Alternatively, the alkoxy acrylate can be 2-methoxyethyl acrylate (MOEA) or 2-ethoxyethyl acrylate (EOEA). The alkoxy acrylate monomers advantageously give the zwitterionic copolymers greater ductility, strength, and toughness while maintaining a desired amount of hydrophilicity. The improved toughness allows the zwitterionic copolymers to be processed without cross-linking, which improves the elongation properties of the zwitterionic copolymer, and reduces the risk of cracking during use.

Abstract: A drug-delivery system is provided including at least 100 ?g of everolimus and clobetasol, such that the ratio of everolimus to clobetasol is at least 10:1 (w/w) or the amount of everolimus by weight is at least 10 times more than clobetasol. The system can be a stent. Also provided a method of treating restenosis or vulnerable plaque of a blood vessel, the method includes locally administering to a patient a first drug selected from a group consisting of rapamycin (sirolimus), Biolimus A9, deforolimus, AP23572, tacrolimus, temsirolimus, pimecrolimus, zotarolimus (ABT-578), 40-O-(2-hydroxy)ethylrapamycin (everolimus), 40-O-(3-hydroxy)propylrapamycin, 40-O-[2-(2-hydroxy)ethoxy]ethylrapamycin, 40-O-tetrazolylrapamycin and 40-epi-(N1-tetrazolyl)rapamycin, and locally administering to a patient a second drug consisting of clobetasol, wherein the minimum amount of the first drug that is locally administered is 100 ?g, and wherein the ratio of the first drug to the second drug is, for example, 10:1 to 100:1 (w/w).

Abstract: A method of delivering an arteriogenic factor. The factor is delivered in a medically effective manner to structurally enlarge an existing blood vessel. A distal portion of a catheter can be advanced to an existing blood vessel to deliver the arteriogenic factor.

Abstract: Devices and methods for managing access through tissue is disclosed. The device includes a body. The body is movable from a pre-deployed configuration towards a deployed configuration. The device includes a plurality of tissue engaging portions that extend from the body. At least a portion of the tissue engaging portions are obtuse. At least two of the tissue engaging portions are separated by a first distance in the deployed configuration and a second distance in the pre-deployed configuration. The first distance is smaller than the second distance. The method includes deploying a closure element to tissue adjacent a tissue opening to substantially close the opening following a first procedure. The method also includes selectively opening the opening in the tissue by advancing a distal end of a medical device through the deployed closure element as a part of or before a second procedure.

Abstract: A method of delivering an arteriogenic factor. The factor is delivered in a medically effective manner to structurally enlarge blood vessel. A distal portion of a catheter can be advanced to an existing blood vessel to deliver the arteriogenic factor.