Abstract: Devices, systems, and methods for treating a heart of a patient may make use of structures which limit a size of a chamber of the heart, such as by deploying one or more tensile member to bring a wall of the heart and a septum of the heart into contact. A plurality of tension members may help exclude scar tissue and provide a more effective remaining ventricle chamber. The implant may be deployed during beating of the heart, often in a minimally invasive or less-invasive manner. Trauma to the tissues of the heart may be inhibited by selectively approximating tissues while a pressure within the heart is temporarily reduced. Three-dimensional implant locating devices and systems facilitate beneficial heart chamber volumetric shape remodeling.

Abstract: The present invention provides apparatus and methods for a conduit, such as an implantable conduit for a vessel. The conduit may comprise a main member and a side branch member. The conduit may be implanted with the side-branch member initially disposed within the main member. When positioned, the side-branch member may then be extended from within the main member and into a vessel side-branch, The materials for the conduit may include circumferentially distensible and/or low recoil materials.

Abstract: Provided herein is a method of reducing a microbial infection of a heparinized surface wherein heparin precipitation is reduced as compared to a control. In some embodiments a composition comprising ethanol and isopropanol is applied to the surface. In other embodiments, two or more ethanol compositions are applied and removed sequentially from the surface prior to contacting the surface with a biological fluid, tissue or vessel, wherein the composition in each successive administration comprises an increased amount of ethanol. Also provided is a method of reducing a microbial infection of a surface comprising applying a mucilage extract from an Opuntia ficus indica species to the surface.

Abstract: A stent is formed from a wire that in cross-section includes an outer member having a lumen and a radiopaque core member partially filling the lumen. A substance for elution through openings formed through the outer member fills the portion of the lumen not filled by the radiopaque core member. In a method of forming the stent, a composite wire including an outer member and a dual core member is shaped into a stent pattern. The dual core member includes a first core member and a second, radiopaque core member. The shaped composite wire is processed to remove the first core member from the outer member without adversely affecting the outer member and the second core member. The portion of the lumen that was occupied by the first core member may be filled with a substance for elution through openings from through the outer member to the lumen.

Abstract: An implantable medical device (10) comprises reservoirs (30) for receiving a water-soluble active agent or medicament (36) in the form of a solid deposit; and at least one biocompatible and biodegradable protecting/retaining layer (38) for protecting the active agent or medicament (36) until it reaches its site of implantation, said biocompatible and biodegradable protecting layer (38) comprising at least one biocompatible and biodegradable film-forming agent, and at least one hydrophobic, biocompatible, agent for controlling the disintegration rate of the protecting/retaining layer. The invention provides better protection of the active agent or medicament and better control of the disintegration rate of the protecting/retaining layer.

Abstract: Stents and methods of fabricating stents with prohealing layers and drug-polymer layers are disclosed.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

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: 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: An expandable medical device includes a plurality of elongated struts, forming a substantially cylindrical device which is expandable from a first diameter to a second diameter. A plurality of different beneficial agents may be loaded into different openings within the struts for delivery to the tissue. For treatment of conditions such as restenosis, different 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 agents may also be used to address different diseases from the same drug delivery device. In addition, anti-thrombotic agents may be affixed to at least a portion of the surfaces of the medical device for the prevention of sub-acute thrombosis. To ensure that the different agents remain affixed to the device as well as to each other, masking and de-masking processes may be utilized.

Abstract: An implantable device having a coating comprising a comb-type anti-thrombotic conjugate to prevent or reduce the formation of thrombosis on the surface of the device. The device includes a frame expandable from a first diameter to a second diameter wherein the frame has an inner surface and an outer surface, a plurality of structural features disposed along the frame and a plurality of polymer anti-thrombotic conjugate particles situated with the plurality of structural features. The particle can be created utilizing the comb type polymer and heparin conjugate as a carrier for a therapeutic agent within its polymer matrix. The structural features allow for particles having differing properties to be placed at various locations along the device. Moreover, particles having at least two different agents can be located within the same structural feature.

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: 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: Implants for treating insufficient blood flow to a heart muscle with transmyocardial revascularization are disclosed. Methods of treating insufficient blood flow to a heart muscle with the implant are also disclosed. The implant can have a body with an inner lumen that supports a channel in the heart muscle to allow for increased blood flow through the lumen upon implantation. The implant can include active agents to prevent or inhibit thrombotic closure of the channel, to promote vascularization, or both.

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 drug delivery device for reducing the likelihood of stent thrombosis following implantation in a subject is provided. A stent is provided including a body having a plurality of struts and one or more coatings applied to the body including at least one polymer, a therapeutic agent for inhibiting restenosis, a loading dose of a first antiplatelet agent and a maintenance dose of the first antiplatelet agent, and a loading dose of a second antiplatelet agent and a maintenance dose of the second antiplatelet agent.

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: 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: The invention concerns oligosaccharides and polysaccharides as well as the use of these oligosaccharides and/or polysaccharides, which contain the sugar unit N-acylglucosamine or N-acylgalactosamine for the production of hemocompatible surfaces as well as methods for the hemocompatible coating of surfaces with said oligosaccharides and/or polysaccharides, which imitate the common biosynthetic precursor substance of heparin, heparan sulphates and chitosan. The invention further describes methods for producing said oligosaccharides and/or polysaccharides and discloses various possibilities of using hemocompatibly coated surfaces. The invention relates particularly to the use of said oligosaccharides and/or polysaccharides on stents with at least one according to invention deposited hemocompatible coating, which contains an antiproliferative, antiinflammatory and/or antithrombotic active agent, methods for the preparation of said stents as well as the use of said stents for the prevention of restenosis.

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: 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: 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: 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: 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: 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: 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: A drug-eluting stent having a first cell pattern at one end and a second cell pattern on an opposite end. The cells in the first cell pattern have a smaller MCUSA than those in the second cell pattern. An anti-restonic drug can be coated on the first cell pattern and an anti-thrombotic drug on the second, with the anti-thrombotic drug overlaying and covering both the first and second cell patterns. The stent is operatively positionable at a distal graft-vein anastomosis with the first cell pattern adjacent the stenosis, and with the second cell pattern positioned adjacent the vein or the graft.

Abstract: According to an aspect of the present invention, medical devices are provided that contain at least one polymeric region which contains (a) at least one block copolymer that contains at least three polymer blocks that differ from one another and (b) at least one therapeutic agent.

Abstract: Stents and methods of fabricating stents with prohealing layers and drug-polymer layers are disclosed.

Abstract: An expandable slide and lock stent comprises a tubular member that can be expanded from a collapsed state to an expanded state. The tubular member can comprise a reversing helical backbone and at least one rail member extending from the helical backbone in a circumferential direction. The backbone can have at least one engagement element that can be configured to receive a rail member to form the tubular member. In some embodiments, the reversing helical backbone can comprise a plurality of discrete segments having a variable profile and/or wave form.

Abstract: An implantable device having a coating comprising a comb-type anti-thrombotic conjugate to prevent or reduce the formation of thrombosis on the surface of the device. The device includes a frame expandable from a first diameter to a second diameter wherein the frame has an inner surface and an outer surface, a plurality of structural features disposed along the frame and a plurality of polymer anti-thrombotic conjugate particles situated with the plurality of structural features. The particle can be created utilizing the comb type polymer and heparin conjugate as a carrier for a therapeutic agent within its polymer matrix. The structural features allow for particles having differing properties to be placed at various locations along the device. Moreover, particles having at least two different agents can be located within the same structural feature.

Abstract: The implantable structural element for in vivo controlled 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. Control over elution of the bioactive agents occurs through a plurality of cantilever-like cover members which prevent drug elution until an endogenous or exogenous stimulus causes the cover members to open and permit drug elution.

Abstract: The present invention relates to a medical device or implant made at least in part of a high strength, low modulus metal alloy comprising Niobium, Tantalum, and at least one element selected from the group consisting of Zirconium, Tungsten, and Molybdenum. The medical devices according to the present invention provide superior characteristics with regard to bio-compatibility, radio-opacity and MRI compatibility.

Abstract: The invention relates to an intraluminal device, in particular an intraluminal prosthesis, shunt, catheter or local drug delivery device. In order to increase the bio-compatibility of this device, it is provided with at least one coating. The coating contains a therapeutic agent which is comprised in a matrix that sticks to the intraluminal device. Instead of being formed by a little bio-compatible polymer, the matrix is formed by a bio-compatible oil or fat, such as cod-liver oil or olive oil. Preferably, the bio-compatible oil or fat further comprises alfa-tocopherol.

Abstract: The present invention relates to methods for inhibiting subacute thrombosis and/or intimal hyperplasia following an interventional vascular procedure by contacting a blood vessel or a synthetic material with a mitogen-activated protein kinase (MAPK) pathway inhibitor. The present invention further relates to vascular devices comprising a MAPK pathway inhibitor.

Abstract: The present invention relates generally to the maintenance of blow flood using drug eluting stents and/or other coated medical devices to increased length of time of blood flow. Further, the present invention relates to drug-releasing coated devices for reducing smooth muscle cell proliferation and platelet activity to further limit restenosis utilizing resveratrol and quercetin, polyphenols that are linked to the cardioprotection of red wine consumption. The present invention also provides products and methods for treating or preventing atherosclerosis, stenosis, restenosis, smooth muscle cell proliferation, platelet cell activation and other clotting mechanisms, occlusive disease, or other abnormal lumenal cellular proliferation condition in a location within the body of a patient.

Abstract: A method of inhibiting vascular intimal hyperplasia including: placing a stent within a blood vessel, the stent having a stent body of a cylindrical configuration having outer and inner surfaces with a diamond-like thin film coated on the surfaces, a first coated layer coating at least the outer surface of the stent body, the first coated layer being prepared of a first composition comprising a biodegradable polymer and a vascular intimal hyperplasia inhibitor of a kind, comprising argatroban, which does not inhibit proliferation of endothelial cells, the weight composition ratio of the polymer to the vascular intimal hyperplasia inhibitor being within the range of 8:2 to 7:3, and a second coated layer; and causing argatroban to be released from the stent to thereby inhibit the vascular intimal hyperplasia without inhibiting proliferation of endothelial cells.

Abstract: An improvement in drug-eluting stents, and method of their making, are disclosed. The surface of a metal stent is roughened to have a surface roughness of at least about 20 ?in (0.5 ?m) and a surface roughness range of between about 300-700 ?in (7.5-17.5 ?m). The roughened stent surface is covered with a polymer-free coating of a limus drug, to a coating thickness greater than the range of surface roughness of the roughened stent surface.

Abstract: The invention relates generally to an implantable medical device for delivering a therapeutic agent to the body tissue of a patient, and a method for making such a medical device. In particular, the invention pertains to an implantable medical device, such as an intravascular stent, having a coating comprising a first coating composition comprising a therapeutic agent and, optionally, a polymer; and a second coating composition comprising a metallic material.

Abstract: A drug eluting implantable device includes an exterior surface on the device and at least one recess formed in the exterior surface. The device further include at least one sidewall protruding from the exterior surface adjacent the at least one recess defining a channel with the recess into which the drug may be loaded, the sidewall including a perpendicular portion substantially perpendicular to the exterior surface and the sidewall further including a parallel portion extending from the perpendicular portion, the parallel portion extending from the perpendicular portion at an angle greater than about 90 degrees as measured with reference to the exterior surface.

Abstract: Medical devices, and in particular implantable medical devices such as stents and stent delivery systems including catheters, may be coated to minimize or substantially eliminate a biological organism's reaction to the introduction of the medical device to the organism or to treat a particular condition. A dip coating process is utilized to minimize waste and to customize coating thickness and drug loading directly at the clinical site just prior to therapeutic use on a patient. An aqueous latex polymeric emulsion is utilized to coat any medical device to a desired thickness by allowing for successive dipping and drying cycles at the clinical site. In addition, aqueous latex polymeric emulsions pose less of a chance of the bridging phenomenon associated with organic solvent based polymers.

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-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: 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 may 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. In addition, anti-thrombotic agents may be affixed to at least a portion of the surfaces of the medical device for the prevention of sub-acute thrombosis.

Abstract: In various embodiments, a coated device comprises: a substrate; a film coating at least part of the substrate, which film comprises a multilayer unit comprising a first layer and a second layer associated with one another via a hydrogen bond, wherein the first layer comprises a first natural polymeric material and a hydrogen bond donor and wherein the second layer comprises a second natural polymeric material and a hydrogen bond acceptor; and an agent for delivery associated with the coated device. In various embodiments, a coated device comprises: a substrate; a film coating at least part of the substrate, which film comprises a multilayer unit comprising a tetralayer with alternating layers of opposite charge; and an agent for delivery associated with the coated device.

Abstract: The invention has for its object the provision of an intravascular implant that has mechanical characteristics and physiological characteristics and is very low in cell cytotoxicity and provides an intravascular implant having an implant body made of a metal material that contains gadolinium and magnesium and is free of yttrium.

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: Methods and devices for coating a medical device, such as a stent, including the steps of coating the medical device with a photoresist polymeric coating, irradiating a portion of the medical device, optionally applying a post-exposure bake step, and removing all or a portion of the coating from the irradiated portion of the medical device, if a positive photoresist coating material is used, or from a portion of the medical device not exposed to the radiation, if a negative photoresist coating material is used. The photoresist polymeric coating may optionally include a drug.

Abstract: The invention relates to a stent, in particular intended for cardiovascular applications, provided with a bioresorbable polymer coating containing a restenosis-inhibiting agent, with said stent below its polymer coating having a metal surface which is smoothed by electropolishing and passivated and into which carbonium ions are implanted, with said polymer coating containing a (homo- or copolymer of hydroxycarboxylic acids which is terminally esterified.

Abstract: The present invention includes biocompatible polymeric coatings, membranes, matrices, and films to be used with implantable medical devices. Medical devices containing such materials applied to a surface thereof contain a film-forming fluorous homo-polymer or copolymer containing the polymerized residue of a fluorous moiety, wherein the relative amounts of the polymerized residues of one or more moieties are effective to provide the coating and films with properties effective for use in coating implantable med devices.