Abstract: The present invention relates to a stent-graft system comprising a first hollow cylindrical stent-graft body and at least one second hollow cylindrical stent-graft body. The first and the second stent-graft bodies are two structurally separate stent-graft bodies, and each comprise a first end, a second end, and a longitudinal axis. The first and the second stent-graft bodies further each comprise a stent-graft portion and a stent portion. The stent portion of the first stent-graft body and the stent portion of the second stent-graft body are designed in such a way that they can be at least partially inserted into one another in order to form one shared stent portion which is free from prosthesis material.

Abstract: Apparatus for delivering a therapeutic agent to a uterine cavity including an elongated member having a fluid channel for passage of the therapeutic agent into the uterine cavity, a dispensing member extending distally of the elongated member and having at least one perforation for passage of the therapeutic agent into the uterine cavity into contact with the endometrium. An infusion line is in communication with the fluid channel for passage of a fluid into the uterine cavity to assess leakage to determine integrity of the uterine cavity prior to passage of the therapeutic agent into the uterine cavity.

Abstract: Synthetic, bioactive ultra-porous bone graft materials having an engineered porosity, and implants formed from such materials are provided. In particular, these implants comprise bioactive glass and incorporate allograft material for osteoinduction. The implants are suitable for bone tissue regeneration and/or repair.

Abstract: Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: A stent for reducing the passage of emboli into body lumen once deployed includes a structural portion and a barrier portion. The structural portion, when expanded in a conduit, provides sufficient strength to maintain an open lumen in the conduit. The barrier portion reduces migration of emboli from the wall of the conduit through the structural portion and into the lumen. Stent delivery systems capable of delivering and deploying the stent are disclosed.

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: A coating formed of a substituted polycaprolactone and method of making and using the same are disclosed.

Abstract: The present invention relates to a medical product, comprising an antibacterial hard material coating, which is applied to a main body and which comprises biocide. Said hard material coating includes at least one inner layer and one outer layer, wherein the biocide concentration in the outer layer is substantially constant and greater than the biocide concentration in the inner layer and the biocide concentration in the inner layer is greater than or equal to 0.2 at %.

Abstract: A method of treating vascular disease in a patient is disclosed that comprises deploying a bioabsorbable polymer scaffold composed of a plurality of struts at a stenotic segment of an artery of a patient, wherein after the scaffold supports the segment at an increased diameter for a period of time the polymer degrades and is progressively replaced by de novo formation of malleable provisional matrix comprising proteoglycan, wherein as the scaffold becomes more malleable and becomes disconnected as it degrades, wherein following coverage of the struts by a neointima layer and loss of mechanical support provided by the scaffold, the scaffold is pulled outward by positive remodeling of the vessel wall of the scaffolded segment.

Abstract: An implant device identifiable after implantation comprises a main portion of the implant device and a coded portion of the implant device. The coded portion comprises a radiopaque element and indicia on the radiopaque element or indicia as a plurality of radiopaque elements disposed within the coded portion. The indicia are discernible by x-ray, fluoroscopy, computed tomography, electromagnetic radiation, ultrasound, or magnetic resonance imaging.

Abstract: The disclosure provides drug delivery devices and methods of making and using the drug delivery devices. The devices include single and multi-layer polymer films made by a breath figure technique having therapeutic agents associated therewith. For example, the devices may be a dual layer polymer film wherein the first layer includes a therapeutic agent incorporated into it by spin coating the first agent with a polymer solution and the second agent is incorporated into the second layer by loading the agent into pores of the second layer after it is spin coated onto the first layer. In some cases one layer provides a burst release and the second layer provides a slow release drug delivery profile. The devices may take on the form of a surgical mesh with a slow release therapeutic drug.

Abstract: The invention discloses an absorbable iron-based alloy stent, comprising an iron-based alloy substrate and a degradable polyester in contact with the surface of the substrate, in which the degradable polyester has a weight average molecular weight of between 20,000 and 1,000,000 and a polydispersity index of between 1.2 and 30. With the degradable polyester, the iron-based alloy is capable of corroding rapidly and controllably within a predetermined period. Following implantation into the human body, the degradable stent serves as a mechanical support at early stage, then gradually degrading and being metabolized and absorbed by the human body. During the process of degradation, minimal or no solid product is produced. Ultimately, the configuration of the lumen with an implanted stent as well as the systolic and diastolic functions thereof return to their natural states.

Abstract: A catalyst comprising gold, palladium, and a porous support, in the form of at least one grain, in which: the gold content in the catalyst is in the range 0.5% to 3% by weight with respect to the total weight of catalyst; the mean particle size of the gold, estimated by transmission electron microscopy (TEM), is in the range 0.5 nm to 5 nm; the gold is distributed homogeneously in the porous support; at least 80% by weight of the palladium is distributed in an eggshell at the periphery of the porous support; the gold/palladium molar ratio is more than 2.

Abstract: An intravascular device for keeping open a previously constricted site within a vessel is provided. The device includes an expandable substantially tubular body having a distal end and a proximal end. The device also includes a flexible amorphous glass coated metallic wire netting system that is circumferentially disposed about the body, and extends beyond at least one of the distal end or proximal end. The amorphous glass coated metallic wire netting system can expand along with the body to smooth tissue intrusion and minimize release of tissues debris at the site from closing the lumen of the vessel. The netting system can include a plurality of pores to permit communication between fluid flow within the vessel and the vessel wall, and at least one pharmacotherapeutic agent for the treatment or prevention of certain conditions. A method for placing the device at a site of interest is also provided.

Abstract: The present invention relates to a gene delivery stent using titanium oxide thin film coating and a method for fabricating the gene delivery stent. The gene delivery stent according to the present invention may be loaded with a drug having anti-inflammatory and anti-thrombotic effects and simultaneously deliver a gene capable of inhibiting proliferation of vascular smooth muscle cells. Accordingly, late thrombosis and metal allergy may be reduced, and vascular restenosis in the stent region may be prevented, thereby making it possible to increase treatment effects of the bare metal stent.

Abstract: The present invention provides methods and compositions for treating bladder cancer, including metastatic bladder cancer and non-muscle-invasive bladder cancer, by administering a composition comprising nanoparticles that comprise mTOR inhibitor and optionally an albumin.

Abstract: Various embodiments of a mesh or implant system are provided for treating pelvic conditions such as incontinence, vaginal prolapsed, and other conditions caused by muscle and ligament weakness. Embodiments of the implants can include a material, substrate, configuration or coating adapted to provide immediate or timed release of various therapeutic agents or drugs to treat the surrounding tissue.

Abstract: A biodegradable stent prosthesis formed from a degradable material, having a plurality of luminal, abluminal, and side surface regions, wherein a surface portion extending between the abluminal and luminal surface region of at least some structural elements is convex.

Abstract: A medicament containment device (106) is provided containing a medicament (114) and is associated with an implant, such as an orthopedic implant (102). The medicament containment device (106) can degrade upon exposure to energy, such as energy (112) from an energy source (110). The orthopedic implant (102), including the medicament containment device is implanted or inserted into an environment (100) such as a patient's body. The energy source (110) can be used outside the patient's body, but in proximity to the orthopedic implant (102), to apply energy (112) to the medicament containment device (106). Upon exposure to the energy (112), the medicament containment device (106) can degrade and release the medicament (114) into the environment (100). The medicament (114) can kill and/or disrupt bacterial cells (108) or other infectious cells that form in proximity to the orthopedic implant (102).

Abstract: The present invention relates to inhibitors of VAP-1 and their use as medicaments in treating fibrotic conditions. Furthermore, the present invention relates to a method of diagnosing a fibrotic condition on the basis of elevated level of soluble VAP-1 or SSAO activity in a bodily fluid, and to a kit for use in said diagnostic method.

Abstract: Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: Provided herein is a drug delivery system comprising: a. substrate; b. a plurality of components combined with the substrate to form the drug delivery system; wherein at least one components comprises a bioabsorbable polymer and at least one other component comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

Abstract: The invention describes a system for the magnetic attraction of objects, which comprises a device with a magnetic element and at least one object having magnetic particles.

Abstract: The invention is directed to producing a shaped cartilage matrix isolated from a human or animal where the cartilage has been crafted to facilitate disinfection, cleaning, devitalization, recellularization, and/or integration after implantation. The invention relates to a process for repairing a cartilage defect and implantation of a cartilage graft into a human or animal by crafting the cartilage matrix into individual grafts, disinfecting and cleaning the cartilage graft, applying a pretreatment solution to the cartilage graft, removing cellular debris using an extracting solution to produce a devitalized cartilage graft, implanting the cartilage graft into the cartilage defect with or without an insertion device, and sealing the implanted cartilage graft with recipient tissue. The devitalized cartilage graft is optionally recellularized in vitro, in vivo, or in situ with viable cells to render the tissue vital before or after the implantation.

Abstract: This system is a system for analyzing blood flow which imposes a boundary condition relating to the blood flow to three dimensional shape data of a target vascular site of a subject and divides a lumen of the target vascular site into meshes for obtaining state quantities of the blood flow at each mesh position by means of computation, having: a labeling unit, by a computer, for reading out the three dimensional shape data on the lumen of the target vascular site, and labeling a plurality of vascular elements included in the target vascular based on a size of the cross-sectional area of each of the vascular elements; wherein, the computation of the state quantities is carried out by varying a level of mesh detail for each vascular element based on the labeling according to the size of the cross-sectional area.

Abstract: A liner support frame is configured to be positioned in a gastrointestinal tract of a human and to support a liner which inhibits nutrient absorption and anchor the liner in place in the gastrointestinal tract, the liner support frame includes a plurality of frame members connected to one another so that the liner support frame possesses a plurality of openings. The liner support frame includes a plurality of frame portions arranged axially and possessing different tapers.

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: Methods of treating a developmental disorder such as Dravet syndrome by administering a pharmaceutical composition of gaboxadol or a pharmaceutically acceptable salt thereof are provided.

Abstract: A device for treating a lesion in a body lumen to enlarge a passageway in the body lumen having at least one cutting member and a tracking member. The at least one cutting member has a cutting surface and a separate material associated therewith. The cutting member and tracking member are connected at a distal portion and insertable into the body lumen as a unit, the cutting member configured for movement in a direction transverse to a longitudinal axis of the tracking member to widen a gap between the cutting member and tracking member at least at a distal region and to apply the separate material to an interior of the lesion.

Abstract: Fixation devices for tissue repair, for example sutures, surgical arrows, staples, darts, bolts, screws, buttons, anchors, nails, rivets, or barbed devices comprise at least one of angiogenic material; angiogenic precursor material which is capable of breaking down in vivo to form angiogenic material; or tissue-engineered material, which tissue-engineered material is capable of producing angiogenic material. In a preferred form, the material is incorporated into a polymer matrix having predetermined hydrophobicity to allow controlled release of angiogenic materials such as butyric or hydroxybutyric acid or salts thereof. Polymer matrix compositions comprising angiogenic materials and methods for tissue repair are also provided.

Abstract: A liner support frame is configured to be positioned in a gastrointestinal tract of a human and to support a liner which inhibits nutrient absorption and anchor the liner in place in the gastrointestinal tract, the liner support frame includes a plurality of frame members connected to one another so that the liner support frame possesses a plurality of openings. The liner support frame includes a plurality of frame portions arranged axially and possessing different tapers.

Abstract: A coating composition for drug eluting medical devices, which is capable of forming a drug coating layer that is not susceptible to peeling during delivery to a target tissue is provided. This coating composition contains: a water-insoluble drug; at least one selected from the group consisting of hyaluronic acid, alkanoyl hyaluronic acids obtained by substituting at least part of hydrogen atoms in the hydroxyl groups of hyaluronic acid with an alkanoyl group, and salts of hyaluronic acid and the alkanoyl hyaluronic acids; and at least one selected from the group consisting of amino-acid esters and salts thereof. A drug coating layer, a medical device and a method of treatment are also provided.

Abstract: The present invention is directed to a magnesium alloy containing 5.0% by wt.-25.5% by wt. dysprosium, 0.01% by wt.-5.0% by wt. neodymium and/or europium, 0.1% by wt. 3.0% by wt. zinc, 0.1% by wt.-2.0% by wt. Zirconium, and balance to 100.0% by wt. magnesium, being degradable under physiological conditions and which is particularly suitable for the production of absorbable stents and to stents made thereof.

Abstract: An implantable prosthesis can comprise a strut having a lumen, radiopaque particles within the lumen, and a polymer binder. The polymer binder retains the radiopaque particles within the lumen. The strut may have side holes through which a therapeutic agent may pass and through which the radiopaque particles are incapable of passing. The polymer binder may be absent or optional. The radiopaque particles can have sizes that prevent them from escaping out of the lumen through the side holes. The radiopaque particles placed within the lumen can improve visualization of the prosthesis during an implantation procedure.

Abstract: The present invention pertains to implantable or insertable medical devices which comprise a substrate and one or more therapeutic-agent-containing regions contain one or more therapeutic agents. In various aspects of the invention, one or more characteristics of such therapeutic-agent-containing regions are controlled. Further aspects of the invention relate to methods of forming such devices and to methods of using such devices.

Abstract: The present invention relates to materials having therapeutic compositions releasably contained within the materials. The materials are configured to release therapeutic compositions at a desired rate. The present invention also relates to devices incorporating the materials.

Abstract: The invention provides method of fabricating a scaffold comprising a fluidic network, including the steps of: (a) generating an initial vascular layer for enclosing the chamber and providing fluid to the cells, the initial vascular layer having a network of channels for fluid; (b) translating the initial vascular layer into a model for fluid dynamics analysis; (c) analyzing the initial vascular layer based on desired parameters selected from the group consisting of a characteristic of a specific fluid, an input pressure, an output pressure, an overall flow rate and combinations thereof to determine sheer stress and velocity within the network of channels; (d) measuring the sheer stress and the velocity and comparing the obtained values to predetermined values; (e) determining if either of the shear stress or the velocity are greater than or less than the predetermined values, and (f) optionally modifying the initial vascular layer and repeating steps (b)-(e).

Abstract: The present invention relates to a polylactic acid resin and a packaging film comprising the same, wherein the polylactic acid resin is useful as a packaging material due to excellent properties including heat resistance as well as optimized flexibility. The polylactic acid resin comprises: a hard segment including a predetermined polylactic acid repeating unit; and a soft segment including a polyurethane polyol repeating unit in which certain polyether-based polyol repeating units are linearly connected in a medium of a urethane bond. In addition, the polylactic acid resin has a glass transition temperature (Tg) of 25-55° C.

Abstract: Ureteral stent devices having improved drug delivery capabilities are provided. The ureteral stent device includes a ureteral stent comprising two opposed ends, and a drug delivery component associated with at least one end of the ureteral stent. The drug delivery component includes a drug housing defining a drug reservoir containing a drug, wherein the drug housing is configured to release the drug in-vivo.

Abstract: A prosthesis for intraluminal drug delivery can comprise a plurality of interconnected struts and links that form a tubular structure. The struts and links can have luminal surfaces facing radially inward, abluminal surfaces facing radially outward, and side surfaces connecting the luminal surfaces to the abluminal surfaces. At least some of the struts and links have through-holes in the side surfaces. At least some of the through-holes contain a drug, which can be carried in a polymer matrix.

Abstract: Methods of manufacturing a medical article that include radial deformation of a polymer tube are disclosed. A medical article, such as an implantable medical device or an inflatable member, may be fabricated from a deformed tube.

Abstract: The present invention relates to a polylactic acid resin and a packaging film comprising the same, wherein the polylactic acid resin is useful as a packaging material due to excellent properties including heat resistance as well as optimized flexibility. The polylactic acid resin comprises: a hard segment including a predetermined polylactic acid repeating unit; and a soft segment including a polyurethane polyol repeating unit in which certain polyether-based polyol repeating units are linearly connected in a medium of a urethane bond. In addition, the polylactic acid resin has a glass transition temperature (Tg) of 25-55° C.

Abstract: A prosthesis for intraluminal drug delivery can comprise a plurality of interconnected struts that form a tubular scaffold structure. The struts include through-holes with an inner surface configured to retain a bioabsorbable depot. The bioabsorbable depot includes a drug-polymer composition that hydrolytically degrades upon implantation. The inner surface of the through-hole can be an entirely smooth and continuous area that is concave or convex, with no geometric discontinuities. The inner surface of the through-hole can include any number of constricted and distended regions to form grooves of a size and shape carefully selected to engage a corresponding geometric feature of the bioabsorbable depot.

Abstract: Provided herein is a device comprising: a. stent; b. a plurality of layers on said stent framework to form said device; wherein at least one of said layers comprises a bioabsorbable polymer and at least one of said layers comprises one or more active agents; wherein at least part of the active agent is in crystalline form.

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. The drugs, agents, and/or compounds may also be utilized to treat specific diseases, including vulnerable plaque. Therapeutic agents may also be delivered to the region of a disease site.

Abstract: Embodiments of the present invention provide improved methods and apparatus suitable for use with hearing devices. A vapor deposition process can be used to make a retention structure having a shape profile corresponding to a tissue surface, such as a retention structure having a shape profile corresponding to one or more of an eardrum, the eardrum annulus, or a skin of the ear canal. The retention structure can be resilient and may comprise an anatomically accurate shape profile corresponding to a portion of the ear, such that the resilient retention structure provides mechanical stability for an output transducer assembly placed in the ear for an extended time. The output transducer may couple to the eardrum with direct mechanical coupling or acoustic coupling when retained in the ear canal with the retention structure.

Abstract: The present invention relates to a combination of agents, including an anti-proliferative agent, an anti-inflammatory agent, an anti-growth factor, and an extracellular matrix (ECM) molecule coated on a stent to prevent acute and subacute thrombosis, enhance endothelial in-growth, and prevent neointimal hyperplasia, and/or suppress neovascularization, and thereby reduce restenosis rates for drug eluting stents. The present invention also relates to methods of using such multiple drug eluting stents for the treatment of heart disease and other vascular conditions.

Abstract: Provided are devices for bone tissue engineering, comprising a metal or metal-based composite member comprising an interior macroporous structure with porosity varying from 0-90% (v), the member comprising a surface region having a surface pore size, porosity, and composition designed to encourage cell growth and adhesion thereon, to provide a device engineered for a particular recipient subject. Engineered devices may further comprises a gradient of pore size, porosity, and material composition extending from the surface region throughout the interior of the device, wherein the gradient transition is continuous, discontinuous or seamless to promote cell in-growth.

Abstract: A composition containing a macrophage inhibitor may be administered in an effective amount to prevent, inhibit or reduce restenosis, thrombus or aneurysm formation in implanted polymeric vascular grafts. The composition may be administered prior to vascular graft implantation, at the same time as vascular graft implantation, following vascular graft implantation, or any combination thereof. Exemplary macrophage inhibitors include bisphosphonates, anti-folate drugs and antibodies, preferably in a controlled release or liposomal formulation.

Abstract: The present invention relates to materials having therapeutic compositions releasably contained within the materials. The materials are configured to release therapeutic compositions at a desired rate. The present invention also relates to devices incorporating the materials.