Abstract: The invention relates generally to a medical device for delivering a therapeutic agent to the body tissue of a patient, and methods for making such a medical device. More particularly, the invention is directed to a stent, such as an intravascular stent, having an inner and outer coating compositions disposed thereon. In another embodiment, the inner coating composition and outer coating composition are separated by a barrier coating composition.

Abstract: A vascular or endoluminal stent is adapted to be implanted in a vessel, duct or tract of a human body to maintain an open lumen. The stent includes a base layer of a biologically compatible metal. An intermediate metal particle layer of substantial greater radiopacity overlies the base layer, with particles bonded to the base layer and to each other to leave interstices therebetween as a repository for retaining and dispensing drugs or other agents for time release therefrom. The particles are composed primarily of a noble metal—. Exposed surfaces of the particle layer are coated with ceramic-like iridium oxide or titanium nitrate, as a biocompatible material to inhibit irritation of tissue at the inner lining of the vessel when the stent is implanted.

Abstract: This invention relates to processes of preparing heterogeneous graft material from animal tissue. Specifically, the invention relates to the preparation of animal tissue, in which the tissue is cleaned and chemically cross-linked using both vaporized and liquid cross-linking agents, resulting in improved physical properties such as thin tissue and lowered antigenicity, thereby increasing the ease of delivering the tissue during surgery and decreasing the risk of post-surgical complication, respectively.

Abstract: According to an aspect of the present invention, at least one ionic therapeutic agent is delivered from an implantable or insertable medical device that comprises an ion-conductive polymeric region that is disposed on a metallic region. The metallic region is in electrical contact with a dissimilar metallic region, such that a galvanic current is generated by the dissimilar metals when the device is implanted or inserted into a patient. Delivery of the ionic therapeutic agent from the ion-conductive polymeric region may be, for example, either accelerated or retarded by the galvanic current.

Abstract: An expandable stent for use within a body passageway having a body member with two ends and a wall surface disposed between the ends. The body member has a first diameter to permit delivery of the body member into a body passageway and a second expanded diameter. The surface of the stent is coated with a biological agent and a polymer which controls the release of the biological agent.

Abstract: Provided herein are a method, which comprises implanting in a patient an implantable device comprising a coating that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: The present invention provides intravascular prostheses and methods of production and use. An implantable device for treating a vascular disease or disorder includes an intravascular prosthesis containing an inhibitor of smooth muscle cell proliferation and a growth factor. The device can be coated with a biodegradable drug-eluting polymer that is impregnated with the inhibitor of smooth muscle cell proliferation and the growth factor. The device is useful for treating or preventing a vascular disease or disorder such as restenosis, by simultaneously inhibiting vessel blockage and enhancing recovery of the vessel wall following an intravascular intervention.

Abstract: The invention provides an implantable medical device comprising a fibrous polymer body comprising a plurality of electrospun poly(urethane) fibers, a support filament wrapped around the body, an outer layer around the filament for adhering the filament to the body, the outer layer comprising a plurality of electrospun poly(urethane) fibers, and a polymer primer coating at least the fibers of the body. The polymer primer comprises poly(lactide) and is attached to a heparin residue through a link.

Abstract: The present invention comprises a medical device having an underlying structure on which is disposed a fiber meshwork composed of one or more fibers of substantially uniform diameter. The fiber meshwork may optionally have a multi-layer structure disposed upon it. Either or both of the fiber meshwork or the multi-layer structure may have one or more therapeutic agents absorbed within it. The fiber meshwork is permeable to body fluids and thereby permits body fluids to contact the underlying structure to facilitate its controlled disintegration. The fiber meshwork degrades more slowly than the underlying structure thereby permitting release of the therapeutic agent over a timescale longer than that of the lifetime of the underlying structure, while also ensuring that the support function of the underlying structure is not abrogated by the disintegration of the underlying structure.

Abstract: Implantable medical devices fabricated at least in part of a polymer-bioceramic composite having bioceramic particles with radiopaque functional groups grafted to a surface of the bioceramic particles are disclosed. Implantable medical devices fabricated at least in part of a radiopaque material having bioceramic particles with polymer chains grafted onto a surface of the bioceramic particles, the radiopaque functional groups being chemically bonded to the grafted polymer chains, are disclosed.

Abstract: Methods are provided for surface modifying a hydrophobic polymer substrate to increase wettability comprising the steps of pre-treating the hydrophobic polymer substrate with a radio frequency (RF)-generated first plasma and a RF-generated second plasma wherein the first plasma and the second plasma are applied sequentially, coating the hydrophobic polymer substrate with a hydrophilic coating; and polymerizing the hydrophilic coating on the hydrophobic polymer substrate by exposure to a RF-generated third plasma.

Abstract: A composite stent and a method for making the same are provided.

Abstract: An endoprosthesis, such as a stent, includes a ceramic, such as IROX, having a select morphology and composition.

Abstract: A method of forming a coating on a medical device having a controlled morphology is described. A method of treating a disorder in a patient using the medical device is described.

Abstract: The present invention provides inflatable porous implants, such as grafts, stent-grafts, and bladders, as well as methods and kits for drug delivery. In particular, the grafts and stent-grafts of the present invention provide for the delivery of a therapeutic agent into a flow conduit in the body. The inflatable porous implants provide for direct delivery of larger, more precise dosages of drugs over longer administration periods into the body. Moreover, these inflatable porous implants are often flexible when inserted and have a low profile delivery configuration for easy placement. The implants of the present invention further provide a mechanical or structural function in addition to drug delivery in a single integrated structure.

Abstract: A stent for delivering therapeutic agents to a body lumen includes a plurality of circumferential serpentine bands with each band comprising a plurality of struts. At least one strut has at least one first well region and at least one second well region. The at least one first well region has a first thickness, the at least one second well region has a second thickness, the first thickness being greater than the second thickness. Each well region defines a well having a depth. At least some of the wells contain a therapeutic agent.

Abstract: A magnetically opaque medical device is disclosed wherein a contrast agent is incorporated into the actual device. The medical device is generally comprised of a base material forming the structure of the device and a contrast agent, such as tocopherol and tocopherol derivative solutions or suspensions, gadolinium, or nickel sulfate integrated into the base material itself or posited on a substantial portion of an exterior surface of the device. The device may include other additional functional agents and layers.

Abstract: Implantable medical devices fabricated at least in part of a polymer-bioceramic composite having bioceramic particles with radiopaque functional groups grafted to a surface of the bioceramic particles are disclosed. Implantable medical devices fabricated at least in part of a radiopaque material having bioceramic particles with polymer chains grafted onto a surface of the bioceramic particles, the radiopaque functional groups being chemically bonded to the grafted polymer chains, are disclosed.

Abstract: A porous prosthesis for delivering a medication to the site of implantation, and a method of making the same, is disclosed.

Abstract: A method of delivering an agent into a bodily lumen, the method comprising: implanting an implantable medical device into a treatment site of a lumen, the device having an abluminal face and a luminal face, wherein the device includes depots that extend from an open end at a luminal face to an open end at an abluminal face; and introducing an agent into the open end of the depots at the luminal face such that the agent is delivered to the treatment site through the open end at the abluminal face.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of an immunosuppressive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of immunosuppressive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of immunosuppressive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a coronary stent. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: The present relates to artificial vascular grafts and for methods for performing hemodialysis with the same. The grafts comprise an inner surface on which cells genetically altered to express or over-express one or more cell adhesion factors, such as fibulin-5, or one or more cell adhesion factors and one or more cell proliferation growth factors, such as VEGF, are seeded and cultured.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of a bioactive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of bioactive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of bioactive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a stent graft. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition.

Abstract: Compound of formula (I), wherein the symbol have the meaning reported in the text; for preparing a medicament for the prevention and/or treatment of obstructive vascular lesions following vascular surgery and for the prevention and/or treatment of diseases due to organ fibrosis.

Abstract: A stent includes a stent framework and a coating disposed on the stent framework. The coating includes an inner surface and an outer surface. The coating has a circumferential therapeutic concentration zone near the inner surface and a circumferential washed zone near the outer surface.

Abstract: The present invention relates to providing a porous, hydrophobic polymer with a hemocompatible substance and to the materials produced thereby. One embodiment of the present invention relates to the providing of expanded poly(tetrafluoroethylene) with one or more complexes of heparin, typically containing heparin in combination with a hydrophobic counter ion. The hemocompatible substance is dissolved in a mixture of solvents in which a first solvent wets the polymer to be coated and the second solvent enhances the solubility of the hemocompatible substance material in the solvent mixture. Typical first solvents wetting hydrophobic polymers include non-polar such as hydrochlorofluorocarbons. Typical second solvents include polar solvents such as organic alcohols and ketones. Azeotropic mixtures of the second solvent in the first solvent are used in some embodiments of the present invention although second solvents may be employed in a range of concentration ranges from less than 0.1% up to saturation.

Abstract: A system for treating a vascular condition includes a delivery catheter, a balloon disposed at a distal end of the delivery catheter, a stent having a stent framework, the stent disposed on an outer surface of the balloon; and at least one restraining filament attached to an outer surface of the stent. a method of treating a vascular condition includes delivering a self-expanding stent including a restraining filament to a treatment site via a balloon catheter, the stent disposed over the balloon; inflating the balloon to fracture at least one fracture point disposed along the length of the restraining filament; expanding the self-expanding stent at the treatment site; contacting an outer surface of the self-expanding stent with a vessel wall at the treatment site; and trapping the fractured restraining filament between at least a portion of an outer surface of the stent and the vessel wall.

Abstract: Disclosed herein are methods to create medical devices and medical devices including bioactive composite structures. The methods include using template-assisted electro- or electroless deposition or codeposition methods for providing implantable medical devices coated with bioactive composite structures and also include layering deposited or codeposited metal layers with layers of bioactive materials. In one use, the implantable medical devices of the present invention include stents with bioactive composite structure coatings.

Abstract: An expandable medical device includes a plurality of elongated struts, forming a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. A plurality of different beneficial agents can be loaded into different openings within the struts for delivery to the tissue. For treatment of conditions such as restenosis, different beneficial agents are loaded into different openings in the device to address different biological processes involved in restenosis and are delivered at different release kinetics matched to the biological process treated. The different beneficial agents may also be used to address different diseases, such as restenosis and acute myocardial infarction from the same drug delivery device.

Abstract: An implant having a coating comprising a polymer matrix is swollen in a pharmaceutical solution whereby pharmaceutically active compound is imbibed into the polymer matrix. When the product is implanted, release of the pharmaceutically active compound from the coating takes place. The polymer is preferably formed from ethylenically unsaturated monomers including a zwitterionic monomer, most preferably 2-methacryloyloxyethyl-2?-trimethylammoniumethyl-phosphate inner salt. The monomers from which the polymer is formed may further include surface binding monomers, such as hydrophobic group containing monomers, and crosslinkable monomers, the content of which may be used to control the swellability. Preferably the implant is a stent and the coating of polymer on the exterior wall surface is thicker than the coating of polymer on the interior surface. Release of the drug may be controlled by selection of comonomers. The implant is suitably a stent for use in the cardiovascular system.

Abstract: Provided herein is a PEA polymer blend and coatings or implantable devices formed therefrom.

Abstract: The present invention relates to compounds and compositions useful for inhibiting and/or reducing platelet deposition, adhesion and/or aggregation. The present invention also relates to methods for screening compounds and compositions useful for inhibiting or reducing platelet deposition, adhesion and/or aggregation. The present invention further relates to methods for the treatment or prophylaxis of thrombotic disorders, including stroke, myocardial infarction, unstable angina, peripheral vascular disease, abrupt closure following angioplasty or stent placement and thrombosis as a result of vascular surgery.

Abstract: An intravascular stent and method for inhibiting restenosis, following vascular injury, is disclosed. The stent has an expandable, linked-filament body and a drug-release coating formed on the stent-body filaments, for contacting the vessel injury site when the stent is placed in-situ in an expanded condition. The coating releases, for a period of at least 4 weeks, a restenosis-inhibiting amount of a monocyclic triene immunosuppressive compound having an alkyl group substituent at carbon position 40 in the compound. The stent, when used to treat a vascular injury, gives good protection against clinical restenosis, even when the extent of vascular injury involves vessel overstretching by more than 30% diameter. Also disclosed is a stent having a drug-release coating composed of (i) 10 and 60 weight percent poly-di-lactide polymer substrate and (ii) 40-90 weight percent of an anti-restenosis compound, and a polymer undercoat having a thickness of between 1-5 microns.

Abstract: A method of creating a porous carbon coating on a medical device by applying a precursor carbon material on the medical device and then pyrolysing the precursor carbon material by laser irradiation. The laser irradiation may be focused to carbonize only certain portions of the medical device and any uncarbonized areas can be removed by solvent washing. Also provided is a medical device having a carbonized coating created according to the method of the present invention.

Abstract: A stent has a plurality of members made from a first material. At least one of the plurality of members defines at least one hole. Each hole extends from a first surface of a member. Each hole has a first opening and a depth. Each hole has a barrier dividing the hole into a first reservoir and a second reservoir. The first reservoir extends from a first side of the barrier to the first opening of the hole and the second reservoir extends from a second side of the barrier to the second opening of the hole. The barrier is made from a material different from the first material. The barrier is semi-permeable and non-biodegradable and has a thickness which is less than the depth of the hole.

Abstract: A stent is provided which has a relatively less porous support structure that includes a first set of consolidated particles and at least one relatively more porous reservoir that includes a second set of consolidated particles that differ in composition from the first set of consolidated particles.

Abstract: Stents and a method of using the stents to increase blood flow to ischemic tissues in a patient are disclosed.

Abstract: This invention provides a stent for implantation in a blood vessel or other tissue, wherein the stent is coated with or contains C3 exoenzyme, a chimeric version thereof or an inhibitor of RhoA. This invention also provides a method for treating or inhibiting the onset of restenosis in a subject which comprises implanting one of the instant stents in the subject's blood vessel.

Abstract: A blood anticoagulant material is provided which has high expandability, reduced influence on living bodies, and can efficiently prevent blood coagulation. A multiblock copolymer having at least a structural unit represented by Formula (1), a structural unit represented by Formula (2), and a structural unit represented by Formula (3) is used: wherein, R1, R2, and R3 in Formulas (1) to (3) each independently represent a divalent organic group, and m and n each independently represent an integer of 2 to 5000.

Abstract: Methods of coating a stent subsequent to mounting or crimping of the stent on a balloon of a catheter assembly are disclosed. One method includes forming a sacrificial layer on a balloon of a catheter assembly; followed by mounting a stent on the balloon, the stent including struts separated by gaps; followed by forming a stent coating on the stent; and followed by removal of the sacrificial layer. Another method includes mounting a stent on a balloon, the stent including struts separated by gaps; followed by forming a sacrificial layer on the balloon in the areas of the gaps between struts of the stent; followed by forming a coating on the stent; and followed by removing the sacrificial layer, wherein the coating remains on an outer surface of the stent.

Abstract: According to an aspect of the present invention, at least one ionic therapeutic agent is delivered from an implantable or insertable medical device that comprises an ion-conductive polymeric region that is disposed on a metallic region. The metallic region is in electrical contact with a dissimilar metallic region, such that a galvanic current is generated by the dissimilar metals when the device is implanted or inserted into a patient. Delivery of the ionic therapeutic agent from the ion-conductive polymeric region may be, for example, either accelerated or retarded by the galvanic current.

Abstract: A stent having a multi-layered coating adhered to its surface which can prevent restenosis and thrombosis at the implant site. The stent coating is comprised of two layers. The first layer is a polymeric coating with one or more biologically active agent(s) dispersed therein. The second layer is comprised of a hydrophobic heparinized polymer that inhibits blood coagulation and provides a hydrophilic surface for reducing the friction between stent and lesion site. In preferred embodiments of the invention, the multi-layered stent is effective in deterring restenosis and thrombosis at the implant site. In these same preferred embodiments, the multi-layered stent is capable of reducing the burst release of the biologically active agents from the first layer and sustaining a release of an effective amount of these agents for a relatively extended period of time. Methods of applying the multi-layered coating to the stent surface are also part of this invention.

Abstract: A method of coating an implantable medical device, such as a stent, is disclosed. The method includes applying a formulation on a first polymer layer containing a therapeutic substance to form a second layer. The formulation can contain a highly hydrophobic polymer or a solvent which is a poor solvent for the drug or the polymer of the first layer. The formulation can have a low surface tension value or a high Weber number value.

Abstract: Disclosed in one embodiment is a medical device including an expandable metal vascular stent including at least one surface. A coating layer including parylene or a parylene derivative is positioned on the at least one surface. At least one layer comprising a bioactive agent is positioned on the coating layer, wherein the bioactive agent is selected from the group consisting of an immunosuppressive agent, anti-inflammatory agent and an anti-proliferative agent. A porous layer is positioned on the at least one layer including a bioactive agent, wherein upon implantation into a patient, the porous layer controls release of the bioactive agent from the at least one layer including the bioactive agent.

Abstract: A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of an immunosuppressive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of immunosuppressive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of immunosuppessive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a coronary stent. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition.

Abstract: A method for modifying an ePTFE surface by plasma immersion ion implantation includes the steps of providing an ePTFE material in a chamber suitable for plasma treatment; providing a continuous low energy plasma discharge onto the sample; and applying negative high voltage pulses of short duration to form a high energy ion flux from the plasma discharge to generate ions which form free radials on the surface of the ePTFE material without changing the molecular and/or physical structure below the surface to define a modified ePTFE surface. The step of applying the high voltage pulses modifies the surface of the ePTFE without destroying the node and fibril structure of the ePTFE, even when the step of applying the high voltage pulses etches and/or carburizes the surface of the ePTFE. The modified surface may have a depth of about 30 nm to about 500 nm. The ions are dosed onto the ePTFE sample at concentrations or doses from about 1013 ions/cm2 to about 1016 ions/cm2.

Abstract: Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism's reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Abstract: The present invention provides intravascular prostheses and methods of production and use. An implantable device for treating a vascular disease or disorder includes an intravascular prosthesis containing an inhibitor of smooth muscle cell proliferation and a growth factor. The device can be coated with a biodegradable drug-eluting polymer that is impregnated with the inhibitor of smooth muscle cell proliferation and the growth factor. The device is useful for treating or preventing a vascular disease or disorder such as restenosis, by simultaneously inhibiting vessel blockage and enhancing recovery of the vessel wall following an intravascular intervention.