Abstract: Implants and methods for treating ocular disorders are described. One method involves providing an elongated delivery device and an implant mounted at a distal end of the delivery device. An incision is formed in eye tissue and the implant is inserted the through the incision using the delivery device. The implant is implanted at a location communicating with a physiologic outflow pathway of an eye such that a distal end portion of the implant and a proximal end portion of the delivery device are relatively disposed in a non-linear orientation during implantation. In one method, the implant is non-linear after insertion.

Abstract: An introducer sheath. The introducer sheath includes a tubular body. The tubular body extends from a distal end toward a proximal end. The tubular body includes a lumen. The lumen is defined at least partially by a wall. The tubular body includes a secondary channel. The secondary channel is disposed within the wall. The secondary channel is configured to receive a guidewire.

Abstract: A method of modifying a medical device such as a stent with nano-constructs is disclosed. The method comprises applying a first fluid to the stent; immersing the stent being wet from the first fluid into a second fluid having a suspension of nano-constructs; and removing the stent from the second fluid and allowing the first and second fluid to be removed such that the nano-constructs are carried by the stent for in vivo application of the constructs to a target location of a mammalian subject. The nano-constructs can be attached to the surface of the stent, can be attached to a surface of the coating of the stent, can be embedded into the stent, or can be embedded into the coating.

Abstract: Methods of treating the polymeric surfaces of a stent with a fluid including a solvent for the surface polymer are disclosed.

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 drug-delivering insertable medical device for treating a medical condition associated with a body lumen is disclosed. The drug-delivering insertable medical device includes an outer surface coated with two or more nano-carriers having two or more average diameters. A nano-carrier of the two or more nano-carriers has an average diameter suitable for penetrating one or more layers of two or more layers of the body lumen. The nano-carrier includes a drug surrounded by an encapsulating medium. The encapsulating medium includes one or more of a biological agent, a blood excipient, and a phospholipid.

Abstract: An expandable medical device having a static state and at least one expanded state, the expandable medical device in the static state including at least one first inner layer and at least one second outer layer, the outer layer having an inner surface and an outer surface, the outer layer having a closed lattice in the inner surface or the outer surface of the outer layer, wherein the lattice is open when the expandable medical device is in the at least one expanded state, and methods of making the same.

Abstract: Implantable pressure-actuated systems to deliver a drug and/or other substance in response to a pressure difference between a system cavity and an exterior environment, and methods of fabrication and use. A pressure-rupturable membrane diaphragm may be tuned to rupture at a desired rupture threshold, rupture site, with a desired rupture pattern, and/or within a desired rupture time. Tuning may include material selection, thickness control, surface patterning, substrate support patterning. The cavity may be pressurized above or evacuated below the rupture threshold, and a diaphragm-protective layer may be provided to prevent premature rupture in an ambient environment and to dissipate within an implant environment. A drug delivery system may be implemented within a stent to release a substance upon a decrease in blood pressure. The cavity may include a thrombolytic drug to or other substance to treat a blood clot.

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 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: An apparatus for loading material into a stent strut can comprise a suction pump connected to an opening to a lumen within the stent strut. The stent strut is immersed in the material. As the suction pump draws gas out of the lumen, the material is drawn into side openings to the lumen.

Abstract: According to an aspect of the present invention, a stent is provided, which contains at least one filament that has a longitudinal axis and comprises a bioabsorbable polymeric material. Polymer molecules within the bioabsorbable polymeric material are provided with a helical orientation which is aligned with respect to the longitudinal axis of the filament. The stent is at least partially bioabsorbed by a patient upon implantation or insertion of the stent into the patient.

Abstract: 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. In addition, these therapeutic drugs, agents and/or compounds may be utilized to promote healing, including the formation of blood clots. 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: Devices, systems and methods useable for dilating the ostia of paranasal sinuses and/or other passageways within the ear, nose or throat. A dilation catheter device and system is constructed in a manner that facilitates ease of use by the operator and, in at least some cases, allows the dilation procedure to be performed by a single operator. Additionally, the dilation catheter device and system may be useable in conjunction with an endoscope and/or a fluoroscope to provide for easy manipulation and positioning of the devices and real time visualization of the entire procedure or selected portions thereof. In some embodiments, an optional handle may be used to facilitate grasping or supporting a device of the present invention as well as another device (e.g., an endoscope) with a single hand.

Abstract: Methods of sterilizing medical devices, including implantable medical devices like stents, chemically and with radiation are disclosed. Methods of preparing a sterile, packaged medical device, including a sterile, packaged implantable medical device or stent are disclosed.

Abstract: A medical device that is at least partially formed of a biodegradable polymer. The medical device can be at least partially formed by MEMS technology. The medical device can include one or more micro-structures that are also formed by MEMS technology.

Abstract: The present invention relates to targeted drug delivery of a drug or therapeutic agent through medical devices coated with formulations comprising of therapeutic agent. The coating on medical devices comprises of therapeutic agent(s), affinity vehicle(s) and additives for targeted drug delivery of biologically active material(s). The invention provides a method of manufacturing the formulation, method of coating the medical devices with such formulations to achieve controlled delivery of optimum drug dose at the target site within the body, desirable drug retention on the medical devices in vivo and in vitro and desirable drug release at the target tissue in-vivo. The invention this provides a mechanism to enhance the bioavailability of the therapeutic agent at the target tissue in the treatment of restenosis thereby reduces the actual dose of the therapeutic agent and provides a very thin layer of coating on the surface of the medical device.

Abstract: A method of manufacturing an endoluminal implantable surface, stent, or graft includes the steps of providing an endoluminal implantable surface, stent, or graft having an inner wall surface, an outer wall surface, and a wall thickness and forming a pattern design into the endoluminal implantable surface, stent, or graft. At least one groove is created in the inner surface of the intravascular stent by applying a laser machining method to the inner surface.

Abstract: Embodiments of the present invention provide a device for the local delivery of a substance into a natural tissue conduit in the mammalian body, having a first element capable of contacting the lumen of the conduit and a second element which overlays first element, a reservoir being formed between the first element and the second element, the interior of the reservoir being capable of fluid communication with the conduit such that a substance placed in the reservoir is delivered into the conduit. In embodiments, the first element may be fully or partially microporous or a separate intermediate microporous membrane may be provided. Also provided are methods of mixing or moving a drug within a reservoir using various mixing elements. Also provided are methods of locally delivering a substance into a natural tissue conduit in the mammalian body utilizing a device in accordance with embodiments of the present invention.

Abstract: An agent depot for mechanical connection to a surface of an endovascular implantable body, comprising one or more polymers, one or more bioactive agents, the agent depot being mechanically connectable to the implantable body by a force fit or an adhesive.

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-dl-Iactide 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: Embodiments of a uniformly porous membrane covering an endoprosthetic device, for example, a stent used to treat an aneurysm, are described. Some embodiments have a pore size and spacing that provides a material ratio of between 70-80% in the deployed state. Material ratio is the proportion of the total porous segment of the membrane that corresponds to membrane material, the remainder being pores. In some embodiments, pore size ranges from about 10-100 ?m. In some embodiments, pores are equidistantly spaced with pore spacing in a range of about 40-100 ?m. The combination of pore size and spacing are effective to provide a membrane that substantially prevents flow to the aneurysm, while maintaining flow to perforator vessels. In some embodiments the membrane includes permanently attached agents that promote attachment of endothelial cells or progenitors and healing of the aneurysm, or reduce immune responses detrimental to the healing process.

Abstract: This invention relates to stents, a type of implantable medical device, with an antiproliferative coating and a prohealing luminal coating and methods of fabricating stents with an antiproliferative coating and a prohealing luminal coating.

Abstract: A stent includes a MOF which adjusts pore size upon desorption or adsorption of organic molecules.

Abstract: This invention relates to the use of dual variable domain antibodies to locate naturally-occurring beneficial agents or therapeutic agents at a region of stent implantation in diabetic patients who have undergone stent implantation.

Abstract: Provided herein re a composition and a coating or a device (e.g., absorbable stent) that includes a PEGylated hyaluronic acid and a PEGylated non-hyaluronic acid biocompatible polymer and the methods of use thereof.

Abstract: In one aspect, the present invention provides therapeutic-agent-releasing medical devices which comprise at least one region of piezoelectric material. Therapeutic agent release is initiated or increased when the piezoelectric material is subjected to mechanical stress, which leads to the development of a voltage across the piezoelectric material. This voltage is used to initiate or increase therapeutic agent release.

Abstract: A device delivers a chemical or biological agent, the device comprises an imprint molecule (IM) to be delivered by the device; an electroactive molecularly imprinted polymer (EMIP) imprinted with the imprint molecule, the EMIP having a plurality of binding sites capable of binding the imprint; and an electric potential producing member (EPM), the EPM being capable of producing an electric potential between the EPM and the EMIP; whereby when the EMIP has a predetermined density of imprint molecule bound at the binding sites, and whereby when a sufficient potential is produced between the EPM and the EMIP, the imprint molecule is released from the binding site and thereby delivered by the device.

Abstract: The present invention provides compositions and methods for treating or preventing diseases associated with vascular and non-vascular body passageways, the method comprising the step of delivering to a body passageway a therapeutic agent delivered locally through a polymer matrix from an implanted stent or other structure.

Abstract: Implantable pressure-actuated systems to deliver a drug and/or other substance in response to a pressure difference between a system cavity and an exterior environment, and methods of fabrication and use. A pressure-rupturable membrane diaphragm may be tuned to rupture at a desired rupture threshold, rupture site, with a desired rupture pattern, and/or within a desired rupture time. Tuning may include material selection, thickness control, surface patterning, substrate support patterning. The cavity may be pressurized above or evacuated below the rupture threshold, and a diaphragm-protective layer may be provided to prevent premature rupture in an ambient environment and to dissipate within an implant environment. A drug delivery system may be implemented within a stent to release a substance upon a decrease in blood pressure. The cavity may include a thrombolytic drug to or other substance to treat a blood clot.

Abstract: A medical device for placement in a body of a mammal is provided. The medical device comprises (1) a polymeric matrix forming the device and defining a lumen through the device, the matrix comprising polymer macromolecules and defining spaces between the polymer macromolecules; (2) a drug contained within at least some of the spaces of the matrix; and (3) a material contained within at least some of the spaces of the matrix to affect diffusion of the drug out of the polymeric matrix when the medical device is placed in the body of the mammal.

Abstract: The present invention relates to treating or preventing stenosis at an anastomosis site. In one embodiment, the present invention is a stent is curved along the longitudinal axis for placement in and adjacent to the graft orifice. In a further embodiment, the stent is drug coated to allow delivery of antivasculoproliferative drugs directly to the vicinity of the graft orifice. In a further embodiment, the stent is expandable by use of an external wire. In another embodiment, the present invention is a kit comprising the specially configured stent together with a sleeve comprising a biocompatible matrix material and a pharmaceutical agent, wherein the sleeve is applied to the external surface of the vessel or graft, resulting in extravascular delivery of a pharmaceutical agent. Methods for treating or preventing stenosis at an anastomosis site by applying the extravascular sleeve and the intravascular stent are also provided.

Abstract: A medical device includes a balloon catheter having an expandable member, e.g., an inflatable balloon, at its distal end and a stent or other endoprosthesis. The stent is, for example, an apertured tubular member formed of a polymer and is assembled about the balloon. The stent has an initial diameter for delivery into the body and can be expanded to a larger diameter by inflating the balloon.

Abstract: The present invention relates to devices, articles, coatings, and methods for controlled active agent release and/or for providing a hemocompatible surface. More specifically, the present invention relates to copolymer compositions and devices, articles, and methods regarding the same for controlled active agent release. In an embodiment, the present invention includes a copolymer composition. The copolymer composition can include a copolymer and an active agent. In an embodiment, the copolymer includes an effective portion of a monomeric unit including a polar moiety. The active agent can be polar. The active agent can be charged. The active agent can be non-polar. In an embodiment, the copolymer composition includes a random copolymer. In an embodiment, the random copolymer includes butyl methacrylate-co-acrylamido-methyl-propane sulfonate copolymer, which can provide reduced platelet adhesion.

Abstract: A radially expandable prosthesis for implantation in a lumen comprises a tubular wall having an inner surface and an outer surface. The tubular wall is provided with cuts to form solid struts which have a thickness and which enables the prosthesis to expand. The solid struts have reservoirs made therethrough in the form of perforating holes for containing a therapeutic agent. The perforating holes each have an inner opening and an outer opening of substantially the same size. The prosthesis, including said perforating holes, has a smooth electrochemically polished surface.

Abstract: An apparatus and method to treat vulnerable plaque. In one embodiment, the apparatus has a medical device to treat an occlusive plaque, and is also adapted to release a biologically active agent to treat vulnerable plaque located downstream from the occlusive plaque. In an alternative embodiment, the apparatus has an expandable tube attached to the inner surface of a stent, and a layer of endothelial cells seeded on the inner surface of the expandable tube. The expandable tube shields a vulnerable plaque from a body lumen.

Abstract: Primer coatings for implantable devices or endoluminal prosthesis, such as stents, are provided, including a method of forming the coatings. The primer coatings can include a material with a high content of hydrogen bonding groups, such as some types of epoxy polymers and melamine formaldehydes. Coatings subsequently disposed over the primer coating can be used for the delivery of an active ingredient or a combination of active ingredients.

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. 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. Medical devices include stents, grafts, anastomotic devices, perivascular wraps, sutures and staples.

Abstract: A medical device comprising a plurality of capsules, and a method of administering therapeutic agent to a patient using the same. The capsules further comprise a therapeutic agent and a multilayer polyelectrolyte shell. The medical device is adapted to apply a pressure to the capsules that is greater than or equal to the critical pressure of at least a portion of the capsules, such that therapeutic agent is released from the capsules.

Abstract: A method is provided for treating a cardiovascular disease, such as pulmonary arterial hypertension, an arrhythmia, or heart failure. One step of the method includes providing an apparatus. The apparatus includes an expandable support member having oppositely disposed proximal and distal end portions and a main body portion extending between the end portions. The proximal end portion includes a plurality of wing members extending from the main body portion. At least a portion of the expandable support member is treated with at least one therapeutic agent for eluting into a blood vessel. The expandable support member is inserted into the pulmonary vasculature and then advanced to a bifurcation in the pulmonary vasculature. The bifurcation includes the intersection of a first pulmonary vessel, a second pulmonary vessel, and a third pulmonary vessel. The expandable support member is secured at the bifurcation to treat pulmonary arterial hypertension, for example.

Abstract: A biodegradable, bioabsorbable medical device with a coating for capturing progenitor endothelial cells in vivo and delivering a therapeutic agent at the site of implantation. The coating on the medical device is provided with a biabsorbable polymer composition such as a bioabsorbable polymer, copolymer, or terpolymer, and a copolymer or terpolymer additive for controlling the rate of delivery of the therapeutic agent.

Abstract: A method of manufacturing a stent includes applying a coating to the stent and changing an amount of the coating being applied to the stent by modifying the diameter of the stent.

Abstract: This invention relates in one aspect to the treatment of a vascular vessel with a biomaterial. The biomaterial can be a remodelable material that strengthens and/or supports the vessel walls. Additionally the biomaterial can include a variety of naturally occurring or added bioactive agents and/or viable cellular populations.

Abstract: A stent includes a stent body of a cylindrical configuration having outer and inner surfaces, a first coated layer coating at least the outer surface, and a second coated layer coating substantially completely over the first coated layer. The first coated layer is prepared of a first composition comprising a polymer and a vascular intimal hyperplasia inhibitor (preferably argatroban) of a kind, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the inhibitor being within the range of 8:2 to 3:7. On the other hand, the second coated layer is prepared of a polymer alone or a second composition comprising a polymer and a drug, the weight compositional ratio of the drug to 80% by weight of the polymer being less than 20% by weight.

Abstract: The present invention relates to implantable medical devices coated with polymer having hemocompatible and/or prohealing moieties appended thereto and to their use in the treatment of vascular diseases.

Abstract: A biologically engineered stent for treating patients suffering from acute myocardial infarction/ischemia. The stent is inserted in a vessel upstream to and proximal the damaged muscle/ischemic area. The stent elutes Stromal Derived Factor (SDF1)/CXCR4 complex and/or Vascular Endothelial Growth Factor (VEGF) to attract autologous stem cell for the repair of damaged myocardium or tissues and inducing vascularization (creation of collateral vessels) to the ischemic area. The SDF1/CXCR4 acts as a homing mechanism for stem cells. Stem cell mobilizing agents such as Gm-CSF, GCSF and Plerixafor, as a CXCR4 blocker, may be added systemically to assist in stem mobilization. A protocol consisting of multiple doses of Gm-CSF or GCSF may be given in order to mobilize stem cells from the patient. Optionally, stem cells may be injected into the patient. The treatment stimulates repair and improves survival of damaged myocardium and prevents ventricular remodeling.

Abstract: The drug eluting rolled stent and a stent delivery system, which includes a catheter; a balloon operably attached to the catheter; and a stent disposed on the balloon. The stent includes a rectangular metal foil sheet having a first side and a second side, the rectangular metal foil sheet being rolled to form a cylindrical tube having a central axis and a spiral cross section perpendicular to the central axis; a polymer drug coating disposed between and adhering the first side and the second side; and at least one opening formed through the cylindrical tube generally perpendicular to the central axis, the at least one opening being shaped to form at least one strut having in cross section polymer drug layers between metal foil layers, polymer drug layer edges of the polymer drug layers being in communication with the at least one opening.

Abstract: The invention is to methods of deploying polymeric biodegradable or non biodegradable stents by use of stepwise creases in the pressure placed upon the inner diameter of the stent to slowly increase the stent diameter. In one embodiment, the pressure on the interior stent diameter is slowly increased. The stent is allowed to acclimate to this diameter for a set period of time, and then the pressure is again increased. This series of steps continues until the stent reaches its final diameter and a final period of acclimatization is maintained prior to the removal of the deployment/delivery device.

Abstract: Methods for modulating the release rate of a drug coated stent are disclosed.

Abstract: Methods of making bioabsorbable stents with grooved lumenal surfaces for enhanced re-endothelialization are disclosed. Methods include molding grooves on the lumenal surface of coated bioresorbable and durable stents. Methods further include molding grooves on lumenal surfaces of a bioresorbable tube and forming a scaffold from the tube.