Abstract: A prosthetic implantable device that offers a reduction in fluid loss when the device is punctured, such as by a dialysis needle or suture needle, and the needle is subsequently removed. The device may be made to be thin and flexible, and with longitudinal stretch, in order that it also offers good handling and kink resistance to a surgeon. While the device is preferably of tubular form, flat sheets or other forms may also be made. The device includes inner and outer layers of a porous material having a microstructure of nodes interconnected by bent fibrils, and having void spaces between adjacent bent fibrils. The inner and outer layers are joined by an elastomeric adhesive that may interpenetrate the void spaces of the adjacent surfaces of the inner and outer layers, that is, the inner surface of the outer layer and the outer surface of the inner layer.

Abstract: Technologies are generally described for a method and a device for detecting device colonization. Disclosed herein is an indwelling medical device configured to detect a biofilm. The device comprises a substrate configured to contact blood and a detecting material, disposed with the substrate, configured to detect the presence of a biofilm thereon. The detecting material is soluble in blood, removable by kidneys from the blood, and passable to urine by the kidneys for detection in the urine. A method for detecting the growth of a biofilm on an indwelling medical and a method for making an indwelling medical device are also disclosed herein.

Abstract: A stent/graft especially designed to be used in a minimally invasive surgical procedure for treating an abdominal aortic aneurysm (AAA) comprises an innermost tubular structure of a length (L1) formed by braiding a relatively few strands of shape memory alloy wire. The pick and pitch of the braid are such as to provide relative large fenestrations in the tubular wall. A portion of the innermost tubular structure of a length L2<L1 is surrounded by a further braided tubular structure having relatively many strands that occlude the fenestrations of the innermost tubular structure. The composite structure can be stretched to reduce the outer diameter of the stent/graft, allowing it to be drawn into a lumen of a delivery catheter. The catheter can then be advanced through the vascular system to the site of the AAA and then ejected, allowing it to self-expand with the portion L2 bridging the aneurysm.

Abstract: [Object] To provide a medical instrument capable of more effectively inhibiting a cracking and separation than conventional ones. [Solution Means] A stent comprising a substrate layer 10 of which at least the surface is composed of a metal material, a carbon compound layer 12 that is formed so as to coat the surface of the substrate layer 10 and that contains at least one metal element, a first DLC layer 14 that is formed so as to coat the surface of the carbon compound layer 12 and that is free of fluorine, and a second DLC layer 16 that is formed so as to coat the surface of the first DLC layer 14 and that contains fluorine. The stent being constituted to satisfy the relationship defined by the expression of “A1>A2>A3”, wherein A1 is a surface free energy of the carbon compound layer 12, A2 is a surface free energy of the first DLC layer 14, and A3 is a surface free energy of the second DLC layer 16.

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: 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: An implantable medical device includes a radiolucent member provided with an x-ray mirror that reflects incident x-ray radiation to enable visualization of the device. The x-ray mirror includes a multilayer nanolaminate having alternating layers of a first metal or ceramic layer deposited by atomic layer deposition having a first refractive index, and a second metal or ceramic layer deposited by atomic layer deposition having a second refractive index that is different from the first refractive index. The nanolaminate includes a total of at least four layers.

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: Vasculature closure devices, and systems and methods for their use, are provided. In one embodiment, the vasculature closure device includes an expandable support frame deployable within a vessel and a sealing membrane at least partially supported by the expandable support frame. Upon expanding the support frame, the vasculature closure device is configured to intraluminally position the sealing membrane against a puncture site existing in a vessel wall.

Abstract: Biocompatible materials for use in vascular applications or for implantation have been engineered, combining human recombinant tropoelastin with other synthetic or natural biomaterials to form protoelastin. The materials can be in the form of elastin films on metal or polymer substrates, laminates of alternating polymer and elastin, blends of polymer and elastin, or elastin crosslinked with or tethered to polymer or metal. These are mechanically stable, elastic, strong and biocompatible (i.e., not thrombogenic and promoting adhesion of cells, especially human endothelial cells), not eliciting a foreign body response. Plasma polymerization of substrate is shown to enhance biocompatibility, especially when used to bind elastin or other protein to the substrate.

Abstract: An intravascular device for keeping open a previously constricted site within a vessel and for minimizing tissue debris at such a site from closing off the 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 netting system that is circumferentially disposed about the body, and extends beyond at least one of the distal end or proximal end. The netting system can expand along with the body to 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: 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 present disclosure is directed to tantalum-alloy products, implantable medical devices that incorporate tantalum-alloy products such as stents or other implantable medical devices, methods of making and/or processing the tantalum-alloy products and implantable medical devices, and methods of using the implantable medical devices. In an embodiment, a stent includes a stent body having a plurality of struts. At least a portion of the stent body is made from a tantalum alloy. The tantalum alloy includes a tantalum content of about 77 weight % (“wt %”) to about 92 wt %, a niobium content of about 7 wt % to about 13 wt %, and a tungsten content of about 1 wt % to about 10 wt %. The tantalum alloy exhibits at least one mechanical property modified by heat treatment thereof, such as yield strength, ultimate tensile strength, or ductility.

Abstract: A vascular prosthesis and method are disclosed comprising a first flexible stent having a lattice structure with a compacted configuration and an expanded configuration, a second flexible stent inside the first flexible stent to form a tubular structure, a first film layer of graft material such as expanded polytetrafluoroethylene sandwiched between the first and second flexible stents, and a second film layer of expanded polytetrafluoroethylene sandwiched between the first and second flexible stents, the second layer having a higher rigidity and a lower plasticity than the first layer.

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 catheter deliverable stent/graft especially designed to be used in a minimally invasive surgical procedure for treating a variety of vascular conditions such as aneurysms, stenotic lesions and saphenous vein grafts, comprises an innermost tubular structure and at least one further tubular member in coaxial arrangement. In one embodiment, the innermost tubular structure is of a length (L1) and is formed by braiding a relatively few strands of highly elastic metallic alloy. The pick and pitch of the braid are such as to provide relative large fenestrations in the tubular wall that permit blood flow through the wall and provide the primary radial support structure. A portion of the innermost tubular structure of a length L1 is surrounded by a further braided tubular structure having relatively many strands that substantially inhibit blood flow through the fenestrations of the innermost tubular structure.

Abstract: A stent comprises a metallic, relatively radiolucent carrier structure and at least one marker element which includes comparatively radiopaque material. The radiopaque material is completely enclosed by a cover layer of a material other than the radiopaque material, the cover layer including metal or a metal compound. The stent may be used to treat a patient.

Abstract: An improved stent-graft device is provided that delivers a smooth flow surface over a range of operative expanded diameters by applying a unique cover material to the stent through a technique that allows the cover to become wrinkle-free prior to reaching fully deployed diameter. The unique cover material then allows the device to continue to expand to a fully deployed diameter while maintaining a smooth and coherent flow surface throughout this additional expansion. Employed with a self-expanding device, when the device is unconstrained from a compacted diameter it will self-expand up to a fully deployed diameter with the graft being substantially wrinkle-free over diameters ranging from about 30-50% to 100% of the fully deployed diameter.

Abstract: A bioerodible endoprosthesis erodes by galvanic erosion that can provide, e.g., improved endothelialization and therapeutic effects.

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

Abstract: One example embodiment of the present invention relates to an implant, particularly an intraluminal endoprosthesis, having a body that contains metallic material, preferably iron. The implant body has a first layer with at least one ionic compound that contains ions of at least one halogen, particularly chloride ions and/or bromide ions, on at least part of its surface. Furthermore, a method for the production of such an implant is described.

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: The medical stent includes: a main body formed into an approximately tubular shape along a longitudinal axis with a first resin material; an elastic member formed of a second resin material which is larger in flexural modulus than the first resin material, and configured to have one end portion connected to an end portion of the main body and the other end portion formed to extend to the central portion side of the main body along the longitudinal axis and also to direct to the radial direction of the main body; and a treated layer formed between the end portion of the main body and the one end portion of the elastic member and configured to have a functional group for joining the end portion of the main body and the one end portion of the elastic member to each other.

Abstract: A hybrid stent (100) includes at least one resilient ring (105) comprising a superelastic wire (102) formed in a sinusoidal pattern of alternating crests (110) and troughs (115) about a circumference of the ring (105). A plurality of malleable cannula segments (120) overlie the superelastic wire at the crests and troughs. Each of the cannula segments (120) includes a bend (125) and has an inner diameter sized to allow relative motion between the wire (102) and the cannula segment (120). The hybrid stent (100) may also include a plurality of gaps (130), where each gap (130) is defined by a spacing between opposing cannula segments (120). Deformation of the malleable cannula segments (120) dominates a response of the stent to substantially uniform radial forces, and deformation of the resilient ring (105) dominates a response of the stent to radially nonuniform crushing forces.

Abstract: A medical appliance or prosthesis may comprise one or more layers of rotational spun nanofibers, including rotational spun polymers. The rotational spun material may comprise layers including layers of polytetrafluoroethylene (PTFE). Rotational spun nanofiber mats of certain porosities may permit tissue ingrowth into or attachment to the prosthesis. Additionally, one or more cuffs may be configured to allow tissue ingrowth to anchor the prosthesis.

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: Described are medical devices which are or can be used to form tubular medical devices, and related methods. Preferred devices include tubular grafts of biomaterial having lumen walls which present no seam edge that traverses the entire length of the lumen, illustratively including devices having lumen walls which have a discontinuous seam presenting multiple seam edges. Such a device may include a tubular structure formed by inserting a plurality of extensions of a biomaterial sheet through a plurality of corresponding apertures of the sheet.

Abstract: A self-sealing vascular graft with kink resistance is described. The vascular graft includes a substrate that can be ePTFE, having a self-sealing region that may include several layers of material. The central section of the vascular graft may be constructed differently from surrounding self-sealing regions, in order to provide kink resistance following the clamping of the graft. Also described is a graft with a flared cuff attached to one or both ends, the attachment or transition region including reinforcement beading.

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: Implant provided with a coating, with the implant being provided with an amino-functionalized parylene coating, an oligonucleotide and/or an oligopeptide having a specific bonding affinity with CD34-positive cells.

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

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: A medical stent comprising a coil formed by winding a wire around an axis, an outer layer formed substantially tubular made from a first resin material, provided on an outer peripheral side of said coil and coaxial to said coil, and an inner layer formed substantially tubular made from a second resin material, provided on an inner peripheral side of said coil and coaxial to said coil.

Abstract: A stent comprising a degradable metal stent main body; a partition layer which is applied to the surface of the stent main body so that at least parts of the surface of the luminal side are not covered; and an agent-containing layer which is applied to the surface of the partition layer at least partially on the abluminal side of the stent main body and comprises one or more agents and possibly one or more polymers.

Abstract: The intravascular stent is formed from a composite wire includes an inner core of radiopaque metal, a polymer layer coaxially disposed about the inner core, and an outer metal layer coaxially disposed about the polymer layer. The intermediary polymer layer acts as a barrier material between the inner core and the outer sheath, so that the inner core and outer sheath may be made of dissimilar metallic layers, and the intermediary polymer layer will prevent a galvanic reaction between the inner core and the peripheral metal layer. The intravascular stent has ends flared radially outwardly to prevent radially and longitudinally inward deformation of the ends of the stent when the stent is disposed in a desired location in a patient's vasculature.

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

Abstract: The intravascular stent is formed from a composite wire includes an inner core of radiopaque metal, a polymer layer coaxially disposed about the inner core, and an outer metal layer coaxially disposed about the polymer layer. The intermediary polymer layer acts as a barrier material between the inner core and the outer sheath, so that the inner core and outer sheath may be made of dissimilar metallic layers, and the intermediary polymer layer will prevent a galvanic reaction between the inner core and the peripheral metal layer. The intravascular stent has ends flared radially outwardly to prevent radially and longitudinally inward deformation of the ends of the stent when the stent is disposed in a desired location in a patient's vasculature.

Abstract: Methods for increasing the fracture resistance of a polymer stent's drug-polymer coating and scaffolding including applying a coating and crimping using techniques that increase the resistance to fracture in the coating layer and scaffolding and scaffolding.

Abstract: An intravascular device for keeping open a previously constricted site within a vessel and for minimizing tissue debris at such a site from closing off the vessel is provided. The device includes an expandable substantially tubular body defined by a framework having a plurality of openings. The device also includes a flexible netting system having a structural design for extending across each of the openings. Such a design allows the netting system to expand along with each opening in the framework to 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 method for manufacturing an implant, in particular an intraluminal endoprosthesis, having a body containing metallic material, preferably iron. For controlling the degradation of the implant the method includes the following steps: (a) providing a first part of the implant body; and (b) performing heat treatment which alters the carbon content and/or the boron content and/or the nitrogen content in the structure of a near-surface boundary layer in the first part of the implant body in such a way that strain on the lattice or a lattice transformation, optionally following a subsequent mechanical load, is achieved in the near-surface boundary layer. Such an implant is also described.

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

Abstract: The present disclosure provides composite prosthetic devices comprising two or more layers of electrospun polymers and methods of preparation thereof. In some embodiments, the two or more layers can be porous and in other embodiments, one or more components is nonporous. The composite prosthetic devices can comprise various materials and the properties of the prosthetic devices can be tailored for use in a range of different applications.

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: Methods and devices relating to polymer-bioceramic composite implantable medical devices are disclosed.

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

Abstract: The present invention relates to a method for manufacturing an implant, in particular an intraluminal endoprosthesis, having a body containing metallic material, preferably iron. For controlling the degradation of the implant the method includes the following steps: (a) providing a first part of the implant body; and (b) performing heat treatment which alters the carbon content and/or the boron content and/or the nitrogen content in the structure of a near-surface boundary layer in the first part of the implant body in such a way that strain on the lattice or a lattice transformation, optionally following a subsequent mechanical load, is achieved in the near-surface boundary layer. Such an implant is also described.

Abstract: Medical devices, such as stents, fabricated at least in part from a polymer composite including a biodegradable elastomeric phase dispersed within a biodegradable polymeric matrix are disclosed. The composite is composed of a polyurethane block copolymer including soft polymer blocks and a hard polymer blocks.

Abstract: Implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the implantable or insertable medical devices include at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device. Methods of manufacturing such devices under conditions that substantially prevent preferential partitioning of any of said bioactive agents to a surface of the biocompatible matrix polymer and substantially prevent chemical modification of said bioactive agents.

Abstract: A stent includes a tubular stent body 11, a diamond-like carbon film 12 formed on the surface of the stent body 11 and having an activated surface, and a polymer layer 13 immobilized on the surface of the diamond-like carbon film. The polymer layer 13 contains a drug 14 having an effect to prevent restenosis, and the drug 14 is gradually released from the polymer layer 13.

Abstract: Implantable grafts, particularly for arteriovenous access that may be punctured by an object such as a needle and, following removal of the object, will reseal the resulting hole to the extent of reducing fluid leakage through the graft at the puncture site to an amount less than would be typical for a conventional graft. More particularly, the grafts comprise three layers; an inner layer of implantable graft material such as ePTFE, a middle layer of self sealing elastomeric material such as silicone, and an outer layer of implantable graft material such as ePTFE. Following manufacture, the tubular form of the three-layer graft is everted to put substantially the entire wall thickness of the elastomeric material layer under circumferential compression.