Abstract: A drug delivery balloon is provided, the a balloon having an outer surface, and a tunable coating disposed on at least a length of the balloon surface. The tunable coating includes a first therapeutic agent and a first excipient, and can include a second therapeutic agent and a second excipient. The first and second therapeutic agents have different dissolution rates during balloon inflation and therefore provide a coating that is tunable.

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 block copolymer comprising a fluorinated block and a non-fluorinated block and method of making the block copolymer are provided. Also provided herein are a coating on an implantable device comprising the block copolymer and method of using the implantable device.

Abstract: A drug-eluting stent is disclosed, the stent having an outer cylindrical portion, an inner cylindrical portion disposed within and substantially coaxial with the outer cylindrical portion, a plurality of cross-links connecting the inner cylindrical portion to the outer cylindrical portion, and a first drug affixed to the inner and/or outer cylindrical portions. The stent may further comprise a second drug affixed to the inner and/or outer cylindrical portions. Methods are disclosed for use of a drug-eluting stent for treatment of a region of interest which is located away (downstream) from the location of the stent. Methods are disclosed for the use of the dual drug-eluting stent to provide therapy and adjunctive therapy protocols.

Abstract: A method for depositing a coating comprising a polymer and pharmaceutical agent on a substrate, comprising the following steps: discharging at least one pharmaceutical agent in a therapeutically desirable morphology in dry powder form through a first orifice; discharging at least one polymer in dry powder form through a second orifice; depositing the polymer and/or pharmaceutical particles onto said substrate, wherein an electrical potential is maintained between the substrate and the pharmaceutical and/or polymer particles, thereby forming said coating; and sintering said coating under conditions that do not substantially modify the morphology of said pharmaceutical agent.

Abstract: A method of loading a composition into a structural element of a stent, where the structural element is defined by a lumen and at least one opening to access the lumen. The composition may comprise a therapeutic agent, and wherein at a temperature of 30° C. and at one atmosphere, the composition may be in a solid state or semi-solid state.

Abstract: The present invention relates to a bioresorbable scaffold for a vascular stent comprising a nitric oxide agonist and a polymer comprising a lactide, a glycolide and a lactone. The nitric oxide agonist is a statin or a HMG CoA reductase inhibitor. The nitric oxide agonist may be coated on the polymer, incorporated within the polymer or chemically bonded to the polymer. The invention also relates to a method for treating atherothrombosclerotic occlusive disease of an artery comprising implanting into the artery a stent with a bioresorbable scaffold comprising a nitric oxide agonist and a polymer comprising a lactide, a glycolide and a lactone, wherein the nitric oxide agonist is exuded from or released from the bioresorbable scaffold.

Abstract: Medical device coatings are provided that simultaneously release a therapeutic agent at different rates from different portions of the medical device coating. In a first embodiment, medical device coatings are provided that include particles comprising a therapeutic agent with two or more different particles sizes within a single layer on a surface of the implantable device. In a second embodiment, medical device coatings are provided having a higher concentration of the therapeutic agent in a first region of the coating than in a second region of the coating. In a third embodiment, medical device coatings are provided that are formed by certain coating processes wherein the droplet size of a spray coating solution is changed during the coating process. These coating processes preferably include applying a solution comprising a therapeutic agent and a suitable solvent to a surface of an implantable medical device.

Abstract: A medical device is provided with a porous region including a reservoir zone including a polymer and a protective zone between adjacent tissue and the reservoir zone that restricts the tissue from direct contact with the polymer.

Abstract: This invention provides for a radially expandable stent having superior strength and reduced foreshortening properties. The stents have a mixed configuration of straight and arcuate connector segments that serve to join annular segments that make up the body of the stent. Surprisingly the described mixed configuration provides superior resistance to flip deformation while maintaining desired flexibility.

Abstract: A method of a forming a hollow, drug-eluting medical device includes utilizing a hollow wire having an outer member and a lumen of the outer member, and filling the lumen with a fluid to form a supported hollow wire. The supported hollow wire is shaped into a stent pattern. Openings are formed through the outer member. The supported hollow wire is processed to remove the fluid from the lumen of the outer member without adversely affecting the outer member, leaving the hollow wire shaped into a stent pattern. The lumen is filled with a biologically or pharmacologically active substance.

Abstract: An implantable stent comprises a tubular member having an interior surface and an exterior surface, with a region of at least one of the surfaces being hydrophobic. The region is provided with an array of microstructures or nanostructures that covers first portions of the surface but leaves second portions exposed in the interstices of the array. These structures cause the region to have a dynamically controllable hydrophobicity. In one embodiment, a control device, which is affixed to the tubular member, varies the hydrophobicity of the region. In another embodiment, which is particularly applicable to the delivery of a medicinal substance to fluids in body vessels, the stent also includes such a medicinal substance that adheres to the exposed portions until the control device alters the hydrophobicity of the region and causes the substance to be released into a body fluid in contact with the stent. Various ways to load the stent are described.

Abstract: The disclosure describes a coating for medical implants, in particular, vascular stents, said coating comprising silicon dioxide, towards medical implants with a coating containing silicon dioxide and towards a method for their production. The coating can contain additional admixtures and have functionalization coats. The substrate of the coating is produced from a durable material, preferably from a stainless steel.

Abstract: The invention relates to a structure having fibres which are adhesively bonded to one another in locations and have a permeability for air of between 0.5 ml/min*cm2 and 1.5 ml/min*cm2, wherein said structure has an at least one-sided coating which reduces the permeability of the structure to below 0.2 ml/min*cm2.

Abstract: Described herein are implantable medical devices for delivering a therapeutic agent to the body tissue of a patient, and methods for making such medical devices. In particular, the implantable medical devices, such as intravascular stents, have a coating which includes at least one coating composition and has an exposed abluminal surface and an exposed luminal surface or exposed side surface.

Abstract: A magnetic delivery system for delivering a magnetizable particle to a location in a body, the device includes a magnetizable object implanted in the body, wherein the magnetizable object includes a plurality of segments distributed throughout the magnetizable object and wherein the segments are configured to provide a magnetic gradient for attracting the magnetizable particle and an external source of a magnetic field capable of (i) magnetizing the magnetizable particle and (ii) increasing a degree of magnetization of the magnetizable object and thereby creating the magnetic gradient. A drug delivery system including the magnetic delivery system and a magnetizable particle associated with a therapeutic agent and/or a cell. A cell delivery system based on the magnetic delivery system and a magnetizable particle associated with a cell. A method of using the magnetic delivery system for delivery of a therapeutic agent and/or a cell to a targeted location in a body.

Abstract: Endoprostheses and methods of making endoprostheses are disclosed. For example, endoprostheses are described that include an endoprosthesis body, a biodegradable metallic tie layer, and a polymer coating about the endoprosthesis body. The biodegradable tie layer and the polymer coating can have a high peel strength from the body.

Abstract: A medical device, for example, an endoscope or catheter, includes local drug delivery capabilities for selectively delivering at least one drug in vivo. The local drug delivery may occur as the medical device is advanced through tortuous passageways of the patient's body or may occur after the medical device has reached its targeted destination. The medical device includes a drug agent, for example, carried in or on a hydrophilic or hydrogel coating disposed on the outside thereof. When the hydrogel or drug agent receives an appropriate signal, e.g., solution containing a triggering agent or triggering condition, e.g., heat or light, the hydrogel contracts or expands to squeeze out the drug from hydrogel. If electric current is provided as the signal, and the drug agent is charged, the drug agent is released by electrophoretic forces.

Abstract: A bioabsorbable implant including an elongated metallic element including more than 50% a metal substantially free of rare earth metals, with the elongated metallic element defining at least a portion of the bioabsorbable implant.

Abstract: The present invention provides an implantable device formed from an amorphous or semi-crystalline PEA polymer with a high Tg and methods of making and using the same.

Abstract: Irradiation of a surface of a material with a gas cluster ion beam modifies the wettability of the surface. The wettability may be increased or decreased dependent on the characteristics of the gas cluster ion beam. Improvements in wettability of a surface by the invention exceed those obtained by conventional plasma cleaning or etching. The improvements may be applied to surfaces of medical devices, such as vascular stents for example, and may be used to enable better wetting of medical device surfaces with liquid drugs in preparation for adhesion of the drug to the device surfaces. A mask may be used to limit processing to a portion of the surface. Medical devices formed by using the methods of the invention are disclosed.

Abstract: Bioresorbable scaffolds and methods of treatment with such scaffolds for neurologic disorders including Parkinson's disease, Huntington's disease, Alzheimer's disease, and brain neoplasms are disclosed. The bioresorbable scaffold includes a bioresorbable body and an active agent or drug associated with the body for treating or ameliorating the neurological disorder. The bioresorbable scaffold is implanted in the neurological vasculature brain or brain tissue to provide localized delivery of the drug or active agent. Embodiments of the invention include scaffolds that are partially bioresorbable or completely bioresorbable.

Abstract: Disclosed is the use of serous tissue, such as pericardium, as a component of intracorporeal implants. Particularly, disclosed is a jacketed stent assembly comprising an expandable stent provided with a jacket of processed serous tissue which, in some embodiments, is impregnated with a therapeutic or diagnostic agent. In a preferred embodiment, the jacket of the expandable stent is formed of pericardial tissue, preferably bovine or porcine pericardial tissue.

Abstract: A composition for loading into a structural element of a stent, where the structural element is defined by a lumen and at least one opening to access the lumen. The composition may comprise a therapeutic agent, and a chelator, a precipitation agent, or a combination thereof. Medical devices, such as stents, with a structural element defined by a lumen and at least one opening to access the lumen, filled with the compositions are also described.

Abstract: Disclosed is a stent comprising a bioabsorbable polymeric scaffolding; and a plurality of depots in at least a portion of the scaffolding, wherein the plurality of depots comprise a bioabsorbable material, wherein the degradation rate of all or substantially all of the bioabsorbable polymer of the scaffolding is faster than the degradation rate of all or substantially all of the bioabsorbable material of the depots.

Abstract: The present invention relates to a drug eluting stent for delivering therapeutic agents to a body lumen. The stent includes an expandable substrate configured for implantation in a vessel of a human body and a therapeutic agent composition coated over the stent. The balloon catheter shaft has a resilient unit that helps to transmit a force to the distal end, thereby helping to cross lesions.

Abstract: A radially expandable, endovascular stent designed for placement at a site of vascular injury, for inhibiting restenosis at the site, a method of using, and a method of making the stent. The stent includes a radially expandable body formed of one or more metallic filaments and a liquid-infusible mechanical anchoring layer attached to or formed in outer surface of the filaments. A drug coating in the stent is composed of a substantially polymer-free composition of an anti-restenosis drug, and has a substratum infused in the anchoring layer and a substantially continuous surface stratum of drug that is brought into direct contact with the vessel walls at the vascular site. Thus, the rate of release of the anti-restenosis drug from the surface stratum into said vascular site is determined solely by the composition of said drug coating.

Abstract: A medical device has a structure made of a first biodegradable and/or bioabsorbable material and a second biodegradable and/or bioabsorbable material encapsulating a degradation additive incorporated into the first biodegradable and/or bioabsorbable material. The second biodegradable and/or bioabsorbable material has a degradation rate that is faster than the degradation rate of the first biodegradable and/or bioabsorbable material such that the structure experiences a period of accelerated degradation upon release of the degradation additive following sufficient degradation of the second biodegradable and/or bioabsorbable material.

Abstract: In a method for producing a bioactive surface on an endoprosthesis or on the balloon of a balloon catheter, the surface of the endoprosthesis or the surface of the balloon is softened. The surface of the endoprosthesis or of the balloon is moistened with a solution of an active ingredient and the solvent is separated from the active ingredient. The solvent can be a water-miscible solvent.

Abstract: A stent assembly including a stent configured to be positioned in a body lumen, and a knitted stent jacket including an expansible mesh structure having a coverage area of less than 25%, having approximate aperture diameters greater than 20 micrometers, and surrounding an external surface of the stent and coaxially associated therewith, wherein the stent assembly elutes an amount of an active pharmaceutical agent.

Abstract: Provided is a stent wherein the water-swellable polymer fine particles applied thereto rarely peel off even when the stent is deformed or when the water-swellable polymer fine particles are swollen. A stent wherein a plurality of water-swellable polymer fine particles are chemically fixed on the stent surface in a dispersed state is provided.

Abstract: The present invention consists of an implantable structural element for in vivo delivery of bioactive active agents to a situs in a body. The implantable structural element may be configured as an implantable prosthesis, such as an endoluminal stent, cardiac valve, osteal implant or the like, which serves a dual function of being prosthetic and a carrier for a bioactive agent. Alternatively, the implantable structural element may simply be an implantable article that serves the single function of acting as a time-release carrier for the bioactive agent.

Abstract: The present disclosure pertains to stents having a coating applied thereto, wherein the coating comprises a biocompatible polymer/drug mixture, as well as devices comprising a metallic stent, a biocompatible polymeric carrier and a drug.

Abstract: A method for depositing a coating comprising a polymer and at least two pharmaceutical agents on a substrate, comprising the following steps: providing a stent framework; depositing on said stent framework a first layer comprising a first pharmaceutical agent; depositing a second layer comprising a second pharmaceutical agent; Wherein said first and second pharmaceutical agents are selected from two different classes of pharmaceutical agents.

Abstract: The present invention provides a drug eluting stent including a metallic stent framework, an electro-grafted primer coating disposed on the stent framework; and a biodegradable polymer coating hosting a drug disposed on the electro-grafted primer coating and a method of manufacturing said biodegradable drug eluting stent.

Abstract: The present invention provides a multilayer-coated stent for controlled drug release, comprising: a first base layer formed on a stent support and made of poly(ethylene-co-vinylacetate) or polystyrene-ethylene-butylene rubber polymer; a second coating layer formed on the first base layer and made of a biocompatible or a bioabsorbable polymer and a drug component; and a third coating layer formed on the second coating layer and made of a biocompatible or a bioabsorbable polymer and a drug component different from the drug component of the second coating layer. The inventive stent can deliver a broad range of therapeutic substances for a long time and prevent the early rapid release of the drug components in blood. Also, unlike the existing drug-coated stents, the inventive stent includes two kinds of drugs complementary to each other, but can optimize the efficacy of the drugs by differentiating the control of drug release according to time.

Abstract: Medical devices, and in particular implantable 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. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. Also, the devices may be modified to promote endothelialization. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned. In addition, various polymer combinations may be utilized to control the elution rates of the therapeutic drugs, agents and/or compounds from the implantable medical devices.

Abstract: A bioabsorbable biomedical implant is disclosed. The implant includes a tubular scaffold comprising a plurality of interconnected polymer struts. The interconnected polymer struts defines a plurality of deformable cells. The polymer struts have an average thickness of no more than 120 ?m. Methods for making the bioabsorbable biomedical implant, including the methods for making the polymer materials for the tubular scaffold, are also disclosed.

Abstract: The present invention relates to systems for and corresponding methods of delivering a therapeutic agent to a vessel wall of a body lumen by providing a compound capable of being crosslinked after intraluminal release onto a vessel wall so that the therapeutic agent is temporarily retained at the site of delivery by the crosslinked compound.

Abstract: A therapeutic formulation is described for a drug delivery balloon comprising a therapeutic formulation which includes a therapeutic agent and an adhesion additive. The adhesion additive promotes adhesion of the therapeutic formulation a vessel wall of a subject. A system and a method of manufacturing a system including an expandable member having a working length with the therapeutic formulation disposed along at least a portion of the working length is also provided.

Abstract: Coating methods and related devices are provided. Such devices can include stents. For example, the device can comprise a sidewall and a plurality of pores in the sidewall that are sized to inhibit flow of blood through the sidewall into an aneurysm to a degree sufficient to lead to thrombosis and healing of the aneurysm when the tubular member is positioned in a blood vessel and adjacent to the aneurysm. The device can also comprise an anti-thrombogenic coating distributed over at least a portion of the device such that the pores are substantially free of webs formed by the coating.

Abstract: A medical device implantable within a peripheral vessel of the body composed of a bioresorbable polymer is disclosed. The device has a high resistance to fracture, is very flexible, and has a high crush recovery when subjected to crushing, axial, or torsional forces.

Abstract: Systems and methods related to polymer foams for the treatment of blood vessel dissections are generally described. Some embodiments relate to compositions and methods for the preparation of polymer foams, and methods for using the polymer foams. The polymer foams can be applied to or within a dissection caused by an intimal tear in a blood vessel, sealing the dissection and preventing further perfusion thereof. In some embodiments, the polymer foam can be formed within a body cavity (i.e., in-situ foam formation). The foam may be used to fill the dissection as a thrombosing agent. In addition, the foam may be used in conjunction with medical devices such as stents, stent-grafts, balloons, and catheters.

Abstract: A one step method for drug coating an interventional device is disclosed by mixing a drug with a phosphorylcholine-linked methacrylate polymer in a liquid and applying the mixture to an interventional device, such as a stent, in a single step.

Abstract: Provided herein is a device comprising a stent and a coating on the stent; wherein the coating comprises at least one polymer and at least one active agent; wherein at least part of the active agent is in crystalline form.

Abstract: The present invention provides a method of fabricating a drug delivery stent. In one embodiment, the method involves forming a stent pattern in a flat sheet, where the stent pattern includes reservoirs, generating a flat map of the reservoirs, filling the reservoirs with a composition based on the flat map, and then forming the filled stent pattern into a tubular shape and joining the sides. In another embodiment, the method involves forming a stent pattern in a flat sheet, generating a flat map of discrete portions of the stent pattern that are desirable locations for coating, coating the discrete portions with a composition based on the flat map, and then forming the coated stent pattern into a tubular shape and joining the sides.

Abstract: In accordance with an aspect of the invention, implantable or insertable medical devices are provided that comprise (a) a substrate and (b) a porous layer comprising close packed spherical pores disposed over the substrate. The porous layer may also comprise a therapeutic agent. In another aspect, the present invention provides methods of forming implantable or insertable medical devices. These methods comprise forming a predecessor structure that comprises (i) a substrate over which is disposed (ii) an assembly of microspheres. This assembly of microspheres is then used as a template for the formation of a porous layer, which may be subsequently loaded with a therapeutic agent.

Abstract: A medical device for surgical implantation adapted to serve as a drug delivery system has one or more drug loaded holes with barrier layers to control release or elution of the drug from the holes or to control inward diffusion of fluids into the holes. The barrier layers are non-polymers and are formed from the drug material itself by beam processing. The holes may be in patterns to spatially control drug delivery. Flexible options permit combinations of drugs, variable drug dose per hole, multiple drugs per hole, temporal control of drug release sequence and profile. Methods for forming such a drug delivery system are also disclosed. Gas cluster ion beam and/or accelerated Neutral Beam derived from an accelerated gas cluster ion beam may be employed.

Abstract: The present invention relates to implantable medical devices and methods that employ these medical devices to treat heart valves. In one embodiment, a medical device is provided comprising a body. The body may have a portion thereof including therapeutic agent and can be configured to support the device proximate a heart valve. Methods in accordance with embodiments of the present invention may also include providing a medical device having a body with at least a portion thereof including a therapeutic agent. These methods may also include positioning the medical device in a location proximate to a downstream surface of the heart valve and securing the device. The therapeutic agent released may then be delivered to the heart valve.

Abstract: Embodiments provide a drug delivery cuff including a drug reservoir. In an embodiment, an integrated drug pump may be provided. A drug delivery cuff in accordance with an embodiment may be placed around any suitable vascular graft (e.g., ePTFE) or directly around any natural tissue conduit (e.g., perivascularly), at any position along the graft/conduit or overlapping a graft and conduit, either at the time of graft surgical placement or separate therefrom.