Abstract: A yarn reinforced bacterial cellulose hybrid composition includes a two-dimensional yarn mesh stretched and embedded within a BC sheet. Such materials are fabricated by providing a bacterial cellulose-producing bacterium; providing a suitable bacteria nutritional medium; culturing the bacterium in the nutritional medium under conditions to produce bacterial cellulose; and providing a two-dimensional yarn mesh having a defined pattern such that the yarn mesh is embedded within the bacterial cellulose.

Abstract: The present invention relates to a stent that uses a shape memory alloy wire, the stent being an expansion device installed on a part of a body lumen, which is constricted, or which has been constricted, so as to widen the passage of the lumen in response to the lesion part. The purpose of the present invention is to provide a method for manufacturing a stent using a shape memory alloy wire such that the stent maintains a high degree of conformability in a bent portion of a body lumen in which the same is inserted while substantially improving rigidness and durability against continuously applied fatigue, a stent manufactured thereby, and a jig for manufacturing the same.

Abstract: According to the invention there is provided inter alia a medical device for delivering a therapeutic agent to a tissue, the device having a solid surfactant-free particulate coating layer applied to a surface of the device, the coating layer comprising a therapeutic agent and at least one non-polymeric organic additive which is hydrolytically stable; wherein at least a proportion of the particulate coating layer comprising the therapeutic agent and the at least one organic additive melts as a single phase at a lower temperature than the melting point of the therapeutic agent and the at least one organic additive when in pure form; wherein the therapeutic agent is paclitaxel; and wherein the therapeutic agent, when formulated in the coating layer, is stable to sterilization.

Abstract: A method of detecting the presence or absence of a sealant applied to a textile graft includes the steps of: providing a textile graft having a first surface and an opposed second surface; providing a water soluble masking agent; applying the water soluble masking agent to at least a portion of the first surface of the textile graft; providing a sealant solution; providing a visual indicator; applying the water insoluble sealing agent and the visual indicator to the second surface of the textile graft; and removing the water soluble masking agent after the step of applying sealing solution. The second surface has visual indication of the visual indicator and the first surface is substantially free of visual indication of the visual indicator. An implantable textile graft includes the selectively applied visual indicator.

Abstract: Invasive medical devices including a substantially non-eluting antimicrobial treatment are disclosed. One or more external and/or internal surfaces of the medical device include a substantially non-eluting copper-coated surface that assists in preventing microbial colonization of the coated surface. This in turn reduces the incidence of infection to the patient originating from the medical device. In one embodiment, a catheter assembly is disclosed and comprises an elongate catheter tube that defines at least one lumen, at least one extension leg including a luer connector, and a bifurcation hub including at least one fluid passageway that provides fluid communication between the extension leg and the lumen. A substantially non-eluting copper coating is disposed on a surface of at least one of the lumen, the extension leg, the luer connector, and the fluid passageway. The coating is applied via an electroless deposition process. A water-shed coating is disposed on the copper coating.

Abstract: An x-ray marker for an endoprosthesis and an endoprosthesis with an x-ray marker are provided. The endoprosthesis includes a hollow cylinder made of a first radiopaque metal and a marker element, which is fixedly connected to the hollow cylinder and which is arranged inside the hollow cylinder and consists of a second radiopaque metal. The marker element can be a metal powder or in the form of metal particles which is/are embedded in the electrically non-conductive material. The marker element can be solid cylinder with a diameter smaller than the inner diameter of the hollow cylinder and the electrically non-conductive material can form a layer between an inner lateral surface of the hollow cylinder and a lateral surface of the solid cylinder.

Abstract: The invention relates to a method for coating a vascular endoprosthesis, wherein the outside of the vascular endoprosthesis is wetted at least partially with a first solution of an active substance, the vascular endoprosthesis is moved in a rotational movement about the longitudinal axis of the vascular endoprosthesis, and a radially acting mechanical force is applied to the outside of the vascular endoprosthesis. The rotational movement has the effect that the solution is carried outward by the centrifugal force, such that no active substance deposits in the interior of the vascular endoprosthesis. The application of a mechanical force to the outside of the vascular endoprosthesis then has the effect of creating crystallization nuclei, such that the active substance can crystallize out.

Abstract: An electrospinning apparatus according to an embodiment is configured to deposit a fiber on a collector or a member. The electrospinning apparatus includes a first nozzle head provided on one side of the collector or the member, and a second nozzle head provided on the side opposite to the first nozzle head with the collector or the member interposed. The first nozzle head and the second nozzle head are at a section where the collector or the member moves in a direction tilted with respect to a horizontal direction.

Abstract: Arrangements are provided for assembling multiple substrates for coating within a fluidized bed coater so as to deposit a coating of uniform thickness across the entire exterior surface thereof. One embodiment includes a method for coating orthopedic implants having convex and concave surfaces with pyrocarbon by pyrolytic decomposition of a hydrocarbon.

Abstract: Methods are disclosed which combine electrospinning and a sacrificial template, such as with additive manufacturing (AM), to produce fibrous microvascular scaffolds which are biodegradable, porous, and easily handled. In one example, a process for fabricating a fibrous network construct is disclosed. The method includes electrospinning a first layer of fibrous material; printing a micropatterned sacrificial template; transferring the micropatterned sacrificial template onto the electrospun fibers; electrospinning a second layer of fibrous biomaterial onto the micropatterned sacrificial template thereby encapsulating the template and generating a construct with two layers; and removing the sacrificial template, producing a fibrous construct with channels or microstructures formed therein. Also disclosed are fibrous constructs and scaffolds produced by the provided methods.

Abstract: A polymeric master batch for preparing an antimicrobal and antifungal and antiviral polymeric material comprising a slurry of thermoplastic resin, an antimicrobal and antifungal and antiviral agent consisting essentially of water insoluble particles of ionic copper oxide, a polymeric wax and an agent for occupying the charge of the ionic copper oxide.

Abstract: A system for applying a fiber matrix on a tubular member is provided. A mandrel, configured for atraumatic placement within the tubular member, is included. Methods for atraumatic placement of a mandrel into a tubular member are also provided.

Abstract: Embodiments herein include apparatus and methods for coating medical devices. In an embodiment, a coating apparatus is included having a coating application unit including a movement restriction structure, a fluid applicator having a lengthwise major axis, a fluid distribution bar having a body angled with respect to the major lengthwise axis of the fluid applicator between 0 and 20 degrees, a rotation mechanism and an axial motion mechanism. The axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. Other embodiments are also included herein.

Abstract: Introduced here is a plasma polymerization apparatus. Example embodiments include a reaction chamber in a shape substantially symmetrical to a central axis. Some examples further include a rotation rack in the reaction chamber. The rotation rack may be operable to rotate relative to the reaction chamber about the central axis of the reaction chamber. Examples may further include two reactive species discharge mechanisms positioned around a perimeter of the reaction chamber and configured to disperse reactive species into the reaction chamber in a substantially symmetrical manner from the outer perimeter of the reaction chamber toward the central axis of the reaction chamber, such that the reactive species form a polymeric coating on surfaces of the one or more substrates during said dispersion of the reactive species, and a collecting tube positioned along the central axis of the reaction chamber and having an air pressure lower than the reaction chamber.

Abstract: This disclosure describes, inter alia, materials, devices, kits and methods that may be used to treat chronic sinusitis. More specifically, a drug-eluting scaffold is implanted in the middle meatus to treat chronic sinusitis for weeks to months.

Abstract: A tubular prosthesis that includes a scaffolding formed by at least one scaffolding filament; a cover; and at least one controlled ingrowth feature constructed and arranged to abut an inner surface of a lumen wall when the prosthesis is implanted in the body lumen. The controlled ingrowth feature may extend inwards or outwards from the prosthesis outer surface. The controlled ingrowth feature may be formed by a scaffolding filament; by a separate filament; by the cover; and combinations thereof.

Abstract: The present invention is thus directed to methods and apparatus for decreasing pressure in a first portion of a vessel of the cardiac structure of a patient by implanting a shunt communicating with an area outside said first portion, whereby a volume of blood sufficient to reduce pressure in said first portion is released.

Abstract: Arrangements are provided for assembling multiple substrates for coating within a fluidized bed coater so as to deposit a coating of uniform thickness across the entire exterior surface thereof. One embodiment includes a method for coating orthopedic implants having convex and concave surfaces with pyrocarbon by pyrolytic decomposition of a hydrocarbon.

Abstract: A coating device for coating a medical device with a drug-eluting material uses an in-process drying station between coats to improve a drug release profile. The drying station includes a heat nozzle configured for applying a uniform drying gas. A coating process using the dryer includes a closed-loop control for the gas between drying steps and an improved nozzle for producing more consistent spray patterns.

Abstract: Disclosed is a stent with a drug coating for preventing and treating restenosis, comprising a stent and a drug coating covering the surface of the stent. The active ingredients in the drug coating are guaiane sesquiterpene compounds P1, P2 and P3. P1 is Zedoalactone B, P2 is a stereoisomer of P1, and P3 is Zedoarondiol. Compared with an existing sirolimus eluting stent, the present drug eluting stent can inhibit the intimal hyperplasia and the inflammatory reactions of vascular walls, and promote the endothelialization of blood vessels after the stent is implanted, and thus can prevent the long-term thrombotic complications; and has the advantages of small dosage, low cost, and no toxic side effect.

Abstract: The present invention is thus directed to methods and apparatus for decreasing pressure in a first portion of a vessel of the cardiac structure of a patient by implanting a shunt communicating with an area outside said first portion, whereby a volume of blood sufficient to reduce pressure in said first portion is released.

Abstract: Disclosed are stent holding devices having a support mandrel and one or more stent retaining fixtures disposed on the mandrel. The retaining fixture may include a character identifier to facilitate tracking a stent mounted on the holding device. The retaining fixture may include a conical protrusion and a conical recess to allow any number of retaining fixtures to engage each other and be stacked on the mandrel. The retaining fixture may include a tubular member having a spiral cut that enables the diameter of the tubular member to be adjusted to allow for a frictional fit on the mandrel. The retaining fixture may have a Z-shaped or T-shaped structure configured to retain a stent. The stent retaining fixture may also have a filament for retaining a stent.

Abstract: A balloon coating method is disclosed, which includes an application step in which, where a flexible dispensing tube for supplying a coating solution containing the water-insoluble drug and a solvent is formed at its end portion with an opening portion for discharging the coating solution therethrough and when the opening portion-formed end portion side of the dispensing tube is kept in contact with the outer surface of the balloon in such a manner as to be oriented in a direction opposite to a rotating direction of the balloon while the balloon is rotated about an axis of the balloon, the coating solution is discharged through the opening portion and applied to the outer surface of the balloon while the dispensing tube is moved relative to the balloon in an axial direction X of the balloon.

Abstract: Embodiments of the invention include apparatus and methods for coating drug eluting medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit comprising a movement restriction structure; a fluid applicator; and an air nozzle. The apparatus can further include a rotation mechanism and an axial motion mechanism, the axial motion mechanism configured to cause movement of at least one of the coating application unit and the rotation mechanism with respect to one another. Other embodiments are also included herein.

Abstract: The invention relates to a method for coating a vascular endoprosthesis, wherein the outside of the vascular endoprosthesis is wetted at least partially with a first solution of an active substance, the vascular endoprosthesis is moved in a rotational movement about the longitudinal axis of the vascular endoprosthesis, and a radially acting mechanical force is applied to the outside of the vascular endoprosthesis. The rotational movement has the effect that the solution is carried outward by the centrifugal force, such that no active substance deposits in the interior of the vascular endoprosthesis. The application of a mechanical force to the outside of the vascular endoprosthesis then has the effect of creating crystallization nuclei, such that the active substance can crystallize out.

Abstract: A leaflet for a prosthetic valve formed of at least one layer that includes a composite material containing at least one expanded fluoropolymer membrane having serpentine fibrils and an elastomer is provided. The fluoropolymer may be polytetrafluoroethylene. In at least one embodiment, the elastic properties are present in an axial direction the leaflet. The leaflets may be single layered or multi-layered. The leaflets may be coupled to a support structure and movable between open and closed configurations relative to the support structure to form a heart valve. The elasticity within the leaflets permits, among other things, the leaflets to bend with a reduced occurrence of wrinkles as the valve opens and closes. The elastic properties of the leaflet also, among other things, improve bending properties and reduce closure stresses, thereby extending the life of the leaflet.

Abstract: A soil analysis device is configured to create a soil sample solution. The device includes a reservoir configured to store an extractant, a mixing chamber coupled to the reservoir and configured to receive extractant from the reservoir and to receive a raw soil sample, and a control system. The control system is configured to determine an amount of extractant needed to produce, from the raw soil sample, a soil sample solution with a particular soil-to-extractant ratio and configured to cause the determined amount of extractant to be transferred from the reservoir to the mixing chamber.

Abstract: The drug eluting folded stent and a stent delivery system, which includes a stent having a plurality of struts interconnected to form a tubular body. At least one of the struts includes a U-shaped strut having in cross-section a first leg, a second leg, and a closed end connecting the first leg and the second leg, wherein the first leg, the second leg, and the closed end define a recess having a drug release opening opposite the closed end; and a drug coating disposed on the first leg, the second leg, and the closed end within the recess. The drug release opening is sized to release a drug from the drug coating at a predetermined drug elution rate.

Abstract: The disclosure provides biodegradable implantable devices such as a stent comprising a biodegradable polymeric wherein the polymeric material is treated to control crystallinity and/or Tg. The stent is capable to expand at body temperature in a body lumen from a crimped configuration to a deployed diameter and have sufficient strength to support a body lumen.

Abstract: An endoprosthesis, a method for imaging an endoprosthesis, a method of making an endoprosthesis involve a polymeric substrate that has been modified to have voids embedded within the substrate. The voids are sized to scatter optical radiation from within the substrate so that an optical coherence tomography (OCT) image can be obtained in which an interior region of the substrate can be easily differentiated from empty space and other structures that surround the endoprosthesis. The voids allow for OCT visualization of the polymeric substrate which may be difficult to visualize by other methods such as fluoroscopy.

Abstract: An image sensor integrated circuit may contain image sensor pixels. A channel for receiving a fluid with samples may be formed on top of the image sensor. The image sensor pixels may form light sensors and imagers. The imagers may gather images of the samples as the fluid passes over the imagers or when the samples from the fluid adhere to the surface above an imager array. A protective coating may be formed on surfaces of the channel to protect the image sensor pixels and integrated circuit from potentially damaging materials in the fluid, samples, or materials provided for evaluating the samples. The protective coating may be a base-resistant material such as a silylating agent. A cover glass may be attached above the image sensor integrated circuit to form a portion of the channel. The protective coating may be formed on surfaces of the cover glass.

Abstract: A coating device for coating a medical device with a drug-eluting material uses an in-process drying station between coats to improve a drug release profile. The drying station includes a heat nozzle configured for applying a uniform drying gas. A coating process using the dryer includes a closed-loop control for the gas between drying steps and an improved nozzle for producing more consistent spray patterns.

Abstract: Devices and methods for controlling the flaking of coating fragments from medical implants and improving the delivery of therapeutic agents from such coatings are described.

Abstract: The disclosure provides biodegradable implantable devices such as a stent comprising a biodegradable polymeric wherein the polymeric material is treated to control crystallinity and/or Tg. The stent is capable to expand at body temperature in a body lumen from a crimped configuration to a deployed diameter and have sufficient strength to support a body lumen.

Abstract: A method of making a stent includes a three-dimensional printer receiving a dataset corresponding to a three-dimensional precursor stent. The three-dimensional printer forms a precursor stent. The precursor stent comprises a plurality of bands disposed adjacent to each other, wherein each band comprises a plurality of struts connected by a plurality of crowns, and a plurality of connectors connecting each band to an adjacent band. The precursor stent is processed to remove a selected number of the plurality of connectors between adjacent bands such that at least one connector between each set of adjacent bands is removed. In an embodiment, only one connector remains between each adjacent band after the selected number of connectors have been removed.

Abstract: Methods are provided to make a prosthetic valve having a thin, biocompatible, high-strength, composite material. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a heart valve leaflet. The composite material includes a porous expanded fluoropolymer membrane and an elastomer, wherein the elastomer is present in the pores of the porous expanded fluoropolymer.

Abstract: A method of making a stent, including preparing a solution containing a composition, the composition comprising a biodegradable polymer and a vascular intimal hyperplasia inhibitor of a kind, including argatroban, which does not inhibit proliferation of endothelial cells, the weight compositional ratio of the polymer to the vascular intimal hyperplasia inhibitor being within the range of 8:2 to 3:7, the composition dissolved in a solvent selected from the group consisting of a mixture of a lower alkyl ketone and methanol, a mixture of a lower alkyl ester and methanol or a mixture of a lower halogenated hydrocarbon and methanol; coating at least an outer surface of a stent body of a cylindrical configuration having outer and inner surfaces with a diamond-like thin film coated on the surfaces; and after the coating, removing the solvent to complete a first coated layer.

Abstract: The object of the present invention is to provide a joint prosthesis, bearing material and a production method thereof, which suppresses wear in a sliding section and suppresses the production of abrasive powder even during repeated daily operation. To achieve the object, there is provided a biomaterial comprising: a substrate made of metal, alloy or ceramic; and a biocompatible material layer laminated on the substrate, wherein hydroxyl groups are formed on the substrate by surface-treating, while the biocompatible material layer comprises a polymer containing phosphorylcholine groups, the substrate and the biocompatible material layer are bound via a binder layer which is combined with the hydroxyl groups of the substrate and with the biocompatible material layer.

Abstract: The present invention relates to a process for reducing solvent contents in drug-containing polymeric compositions. Specifically, the solvent contents in the drug-containing polymeric compositions are first reduced by one or more conventional drying methods, to a range from about 0.5 wt % to about 10 wt % of the total weight of the polymeric composition. Subsequently, the drug-containing polymeric compositions are further treated by one or more low temperature (i.e., having processing temperatures of less than 60° C.) drying methods for further reduction of the solvent content to less than 10,000 ppm.

Abstract: A method of modifying the surface of a medical device to release a drug in a controlled way by providing a barrier layer on the surface of one or more drug coatings. The barrier layer consists of modified drug material converted to a barrier layer by irradiation by an accelerated neutral beam derived from an accelerated gas cluster ion beam. Also medical devices formed thereby.

Abstract: The present invention relates to a surface treatment method for an implant, comprising: providing an implant; and forming a ceramic layer on a surface of the implant by atomic layer deposition, wherein the ceramic layer has a thickness of 5-150 nm; a root mean square roughness increase in a range of 15 nm or less; and a friction coefficient of 0.1-0.5. The ceramic layer formed on the surface of the implant can fully encapsulate the surface of the implant with excellent uniformity to effectively block the free metal ions dissociated from the implant. Moreover, it has anti-oxidation and anti-corrosion effects, and greatly enhances the biocompatibility of the implant.

Abstract: A metal-organic compound containing polymer matrix includes a polymer and a three-dimensional metal-organic framework includes a polydentate organic linker. The metal-organic compound containing polymer matrix is configured to continuously produce nitric oxide when exposed to a physiological fluid including a nitric oxide-releasing compound via a catalytic reaction catalyzed by the three-dimensional metal-organic framework.

Abstract: A functionalized polymer system is described herein for preparing and/or modifying biological implants and prostheses. In one aspect, the polymer system once applied to the surface of a biological implant or prosthesis, or once used in preparing a biological implant or prosthesis comprises a surface that is more hydrophilic, more wettable, more comfortable, resists cell adhesion, resists protein deposition, or a combination thereof. In one embodiment, a coated biological implant or prosthetic is described herein. The coated biological implant or prosthetic comprises a substrate forming the basic structure of the implant or prosthetic, and a coating comprising a polymer, where the coating is capable of resisting cell adhesion, protein deposition, or a combination thereof.

Abstract: An endoprosthesis comprising a stent, a cover fully covering the stent wherein the cover has variable porosity in the radial direction; and an adhesion layer connecting the stent to the cover. Another aspect of the invention is a method of implanting an endoprosthesis which includes a stent, providing a cover with variable porosity in the radial direction, connecting the stent to the cover with an adhesion layer to form a covered stent, and implanting the covered stent within a body lumen of a patient.

Abstract: A bone implantable medical device made from a biocompatible material, preferably comprising titania or zirconia, has at least a portion of its surface modified to facilitate improved integration with bone. The implantable device may incorporate a surface infused with osteoinductive agent and/or may incorporate holes loaded with a therapeutic agent. The infused surface and/or the holes may be patterned to determine the distribution of and amount of osteoinductive agent and/or therapeutic agent incorporated. The rate of release or elution profile of the therapeutic agent may be controlled. Methods for producing such a bone implantable medical device are also disclosed and employ the use of ion beam irradiation, preferably gas cluster ion beam irradiation for improving bone integration.

Abstract: Coatings are provided in which surfaces may be activated by covalently bonding a combination of silane derivatives (A) to the metal surface, covalently bonding a lactone polymer (B) to the silane derivative by in situ ring opening polymerization, and depositing at least one layer of a polyester (C) on the bonded lactone polymer. Biologically active agents or therapeutic compounds may be deposited with any of the polyester layers. Such coated surfaces may be useful in medical devices, in particular stents.

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

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

Abstract: A system for delivery of a beneficial agent in the form of a viscous liquid or paste allows holes in a medical device to be loaded in a single step process. The loading of a beneficial agent in a paste form also provides the ability to deliver large and potentially sensitive molecules including proteins, enzymes, antibodies, antisense, ribozymes, gene/vector constructs, and cells including endothelial cells.

Abstract: Described are embolization devices which carry M1 macrophage promoting agents and/or M2 macrophage inhibiting agents, as well as methods for their manufacture and use. An illustrative embolization device of the disclosure comprises an embolic body and one or more M1 macrophage promoting agents and/or M2 macrophage inhibiting agents carried by a surface of the embolic body. In certain embodiments the embolic body of the present disclosure comprises an embolic coil or an embolic bead.