Abstract: Disclosed here are devices, systems, and methods for continuous monitoring of biomarkers using a wearable, non-intrusive microneedle sensor patch platform. In some aspects, a wearable, non-intrusive microneedle sensor device includes a microneedle sensor unit couplable to an electronics unit, where the microneedle sensor unit comprises a substrate, an array of spiked microneedle structures configured as electrochemical sensor electrodes, an array of base structures that encase a lower portion of spiked microneedle structures, and electrical interconnections that electrically couple the electrodes to the electronics unit for processing of detectable signals associated with one or multiple biomarkers in a biofluid.

Abstract: The disclosure features non-irritating pharmaceutical compositions containing CD101 in pharmaceutical acceptable salt (e.g., CD101 acetate) or neutral form. The pharmaceutical compositions can be intravenously administered to a subject to treat fungal infections (e.g., candidiasis) in the subject.

Abstract: Embodiments of the invention provide apparatus, systems and methods for stimulating tissue in the urinary tract to initiate or facilitate urination. One embodiment provides an external urinary sphincter stimulation (EUSS) catheter for stimulating the external urinary sphincter (EUS), where the EUSS catheter includes nerve stimulation electrodes (NSES) for delivering current to nerves within or around the EUS in order to relax the EUS prior to urination. Other embodiments provide a system for stimulating the EUS including the EUSS catheter and a controller operatively coupled to the EUSS catheter, where the controller includes a pulse generator for delivering current to the NSES. Other embodiments provide methods for positioning the EUSS catheter in the patient's body including in the EUS using a urethral approach. Embodiments of the invention are particularly useful for initiating and/or controlling urination for patients who have lost the ability to voluntarily urinate due to neurogenic bladder dysfunction.

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: The present invention relates to a composition for preparing a microneedle, a soluble microneedle, and a microneedle percutaneous patch comprising the soluble microneedle. A soluble microneedle contained in a microneedle percutaneous patch of the present invention has a high drug loading capacity and excellent strength and thus may contain an effective amount of donepezil or a pharmaceutically acceptable salt thereof even with a small area of the microneedle. Accordingly, the present invention is economical and produces a lower level of skin irritation.

Abstract: A method of forming a balloon for a medical device is provided including extruding a cylindrical tube of silicone material, partially curing the cylindrical tube, inflating the cylindrical tube, and fully curing the balloon. The cylindrical tube is partially cured by exposing the cylindrical tube to a first ultraviolet light source. The cylindrical tube is inflated within a mold to form the balloon. The balloon is fully cured by exposing the balloon to a second ultraviolet light source.

Abstract: The invention relates to a lubricant coating (5) for a medical injection device (1), comprising successively: —a bottom layer (50) in contact with the medical device surface (21) of the container to be lubricated, comprising a mixture of cross-linked and non-cross-linked poly-(dimethylsiloxane), —an intermediate layer (51) consisting essentially of oxidized poly-(dimethylsiloxane) and having a thickness comprised between 10 and 30 nm and, —a top layer (52) consisting essentially of non-cross-linked poly-(dimethylsiloxane) and having a thickness of at most 2 nm. The invention also relates to a medical injection device comprising such a lubricant coating, and a manufacturing process for said coating.

Abstract: A package including a vessel wherein at least a portion of the vessel wall is made of a double wall material is disclosed. The double wall material comprises an interior polymer layer enclosed by an exterior polymer layer and one of the polymer layers is a layer made of cyclic olefin polymer (COP) resin. The package comprising the double wall, a CVD coating set on the wall, and a medicament comprising at least one protein, peptide, and/or DNA sequence is disclosed. Methods for processing a vessel, for example to provide lubricity or hydrophobicity, are also disclosed. The interior surface of the seated vessel can be processed via the vessel port by PECVD. Vessel barrier, lubricity and hydrophobic coatings and coated vessels, for example syringes and medical sample collection tubes are disclosed.

Abstract: An additive manufacturing system includes an additive manufacturing (AM) device, a first sensor device, and a compute device. The AM device is configured to form a bulk component in a layer-by-layer manner, by at least iteratively depositing a first layer of raw material onto a working surface in a deposition chamber, consolidating the initial layer into an initial additive portion of the bulk component, then forming subsequent additive portions of the bulk component by depositing and consolidating a subsequent plurality of layers of the raw material onto the first additive portion. The first sensor device is configured to measure an actual composition of at least one first byproduct portion formed upon consolidation of one of the first or subsequent layers of raw material in the deposition chamber. The compute device includes a processor and a memory, and is communicatively coupled to the additive manufacturing device and first sensor device.

Abstract: Disclosed is a method for washing a smearing member, the method including: dropping a washing agent on a glass slide; and causing the smearing member to be in contact with the washing agent on the glass slide, to wash the smearing member.

Abstract: A balloon coating method is disclosed for forming a coating layer containing a water-insoluble drug on an outer surface of a balloon of a balloon catheter. The balloon coating method includes an application step in which, where a pipe-shaped dispensing tube formed from a polyolefin 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 end portion side of the dispensing tube is placed in contact with the outer surface 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 of the balloon.

Abstract: The present disclosure relates to a coating for medical devices. The lubricious coating includes a primer layer and a top coating layer as well as methods of making and using the same. The primer layer includes a reaction cured product of a multifunctional acrylate and an acid functionalized monoacrylate. The top coating layer includes a reaction cured product of a mixture that includes a hydrophilic polymer comprising polyvinylpyrrolidone, an acid functionalized monoacrylate, and a hydrophilic monomer. The lubricious coating may be coated onto medical devices to form a sensing guide wire, an ultrasound imaging device, and an intravascular imaging device. Associated devices and methods are also provided.

Abstract: Electrochemical cells, such as those present within flow batteries, can have an electrode and a bipolar plate in at least one half-cell interfacially bonded together with an electrically conductive adhesive. Bonding the bipolar plate to the electrode can decrease contact resistance and sometimes lessen the incidence of parasitic reactions in the electrochemical cell. Flow batteries containing these features can include: a first half-cell containing a first electrode in interfacial contact with a first bipolar plate, a second half-cell containing a second electrode in interfacial contact with a second bipolar plate, and a separator disposed between the first half-cell and the second half-cell. An electrically conductive adhesive interfacially bonds at least one of the first electrode to the first bipolar plate and the second electrode to the second bipolar plate. Each electrode maintains fluid communication with its corresponding bipolar plate.

Abstract: A method of manufacturing a conical-projections-sheet packaging body includes forming a plurality of conical-recess parts on a conical-projections forming sheet; forming, by supplying a conical-projections material to the conical-projections forming sheet, a conical-projections sheet including a base sheet and a plurality of conical projections formed on a surface of the base sheet and disposed inside the plurality of conical-recess parts; forming a plurality of sets of the conical-projections forming sheets and the conical-projections sheets by punching out the conical-projections forming sheets and the conical-projections sheets; and using a package member to package a set of the conical-projections sheets and the conical-projections forming sheets tightly adhered to one another. Thus, the plurality of conical projections of the conical-projections sheet are protected.

Abstract: A gasket includes a flexible packing portion having a recess attached to a coupler of a plunger rod, and a core member harder than the packing portion. The recess has an internal circumferential surface with an internally threaded portion capable of being screwed on and thus engaging with an externally threaded portion provided on an external circumferential surface of the coupler. The core member has a helical shape defining the internal circumferential surface of the recess and the internally threaded portion provided on the internal circumferential surface. The packing portion defines a sliding surface brought into contact with an inner circumferential surface of a barrel, and the packing portion also covers an outer circumferential surface of the core member.

Abstract: Pre-loaded syringes for delivering an embolic agent are disclosed herein. Methods related to syringes pre-loaded with an embolic agent are also disclosed.

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 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 prevention of thrombosis. The drugs, agents, and/or compounds may also be utilized to treat specific disorders, including vulnerable plaque, and atherosclerosis in type 2 diabetic patients. Therapeutic agents may also be delivered to the region of a disease site.

Abstract: A prefilled syringe for injecting medicament into a patient includes a barrel constructed of a polymeric material, a cannula and a hub. The barrel has a diameter, a longitudinal axis, a proximal end and a distal end. The cannula has a proximal end and a tip opposite the proximal end. The proximal end of the cannula is fixed to the distal end of the barrel. The cannula is positioned generally coaxially with the longitudinal axis. The hub is integrally formed with the distal end. The hub includes a rib section and a cap. The rib section has a generally cruciform cross-section taken along a rib plane. The rib plane is generally perpendicular to the longitudinal axis. The cap has a generally U-shaped cross-section taken along a longitudinal plane. The longitudinal plane is generally parallel to the longitudinal axis.

Abstract: Various embodiments of methods for coating stents are described herein. Applying a composition including polymer component and solvent to a stent substrate followed by exposing the polymer component to a temperature equal to or greater than a Tg of the polymer component is disclosed. Repeating the applying and exposing one or more times to form a coating with the result that the solvent content of the coating after the final exposing step is at a level suitable for a finished stent is further disclosed.

Abstract: The invention includes a medical hydrogel made from polymerized polysaccharide macromers. The macromers are preferably polysaccharides decorated with polymerizable groups, for example, methacrylates. The macromers may also be made into polymers of at least two macromers polymerized together. These polymers are preferably multi-armed or high-molecular weight and used for medical uses, for example, making coatings on medical devices. Macromers of N-vinylpyrrolidone are also disclosed herein.

Abstract: Processes for coating medical devices are provided herein. The processes include contacting a substrate with a sulfur-functional silane and an additional silane. The resulting coating includes a silane layer having improved adherence to the medical device, covering a greater area.

Abstract: A topsheet made of a fibrous web or a perforated film and having a clear top layer containing about 5% to about 50% of jade particles. The jade particles having a mean diameter of from about 50 to about 600 microns and an aspect ratio from about 1 to about 5. Also disclosed is method for manufacturing the topsheet, as well as absorbent articles and facial protection masks containing the topsheet.

Abstract: A condom having an indicia disposed on the lower side of the roll when the condom is in the rolled configuration. Preferably, the indicia is a fluorescent marking disposed on the inner side of the condom disposed at a location so that, when the condom is in the rolled configuration, the indicia is visible from the lower side only. More preferably, the indicia is a ring-shaped marking extending about the inner side of the tubular body. In this configuration, a user holding a rolled condom can easily determine which is the upper side of the roll and which is the lower side of the roll. The user may then quickly orient the condom with the lower side facing toward the penis and unroll the condom in the proper direction.

Abstract: A method for depositing a coating comprising a polymer and at least two pharmaceutical agents on a substrate, comprising the following steps: providing a stent framework; depositing on said stent framework a first layer comprising a first pharmaceutical agent; depositing a second layer comprising a second pharmaceutical agent; Wherein said first and second pharmaceutical agents are selected from two different classes of pharmaceutical agents.

Abstract: Catechol-bearing polycarbonates (catechol polymers) were prepared comprising i) a catechol repeat unit comprising a side chain catechol group, ii) a cationic repeat unit comprising a side chain cationic group selected from the group consisting of quaternary amine groups, quaternary phosphine groups, and combinations thereof, and iii) a PEG repeat unit comprising a side chain poly(ethylene oxide) group having a degree of polymerization of about 5 to about 30. The catechol polymers form antimicrobial and antifouling films on a variety of substrate surfaces, in particular silicone rubber.

Abstract: A medical probe includes a proximal section, a transition region, and a distal section. The proximal section includes a braid that is braided with a cross-braiding configuration. In the transition region, which follows the proximal section, the braid transitions between the cross-braiding configuration and a helical coiling configuration. In the distal section, which follows the transition region, the braid is coiled with the helical coiling configuration.

Abstract: The invention relates to a method for the impregnation of a product consisting of fibrous material and formed from a continuous web (22), the method comprising at least one first step of cutting out a specific zone (24) of the continuous web (22) and at least one second step of applying an impregnation product to the specific zone (24), the first and second steps being carried out simultaneously or virtually simultaneously.

Abstract: A liquid absorbent structure is made by dry laying a fibrous web having incorporated therein a superabsorbent material, and applying an aqueous composite stabilizer to at least one surface of the web. The aqueous composite stabilizer imparts integrity to the resulting structure without substantially impairing the effectiveness of the superabsorbent material to absorb liquid while forming the absorbent structure without removing the water from aqueous composite stabilizer or drying out the absorbent structure. The absorbent composite absorbs the water from the aqueous composite stabilizer. The absorbent composite comprises about 70% by weight of a superabsorbent material.

Abstract: With the subject invention, a method is provided for preparing a filter membrane including the steps of dispersing a liquid which is generally hydrophobic into the pores of a porous membrane, and applying a solution containing lipids onto at least a first surface of the porous membrane containing the liquid. Advantageously, the subject invention allows for filter membranes to be prepared which can be stored for periods of time without degradation in performance. The subject invention may have applicability in various contexts, but is well-suited for preparing filter membranes for permeability screening, particularly Parallel Artificial Membrane Permeability Assay (PAMPA).

Abstract: In one embodiment described herein, a bodily fluid separation material is provided comprising a formed component capture region and a bodily fluid pass-through region. The pass-through region has structures with a reduced liquid leaching quality relative to than the capture region, wherein during separation material use, bodily fluid enters the capture region prior to entering the pass-through region. Optionally, a bodily fluid pass-through region has a reduced amount of liquid leaching material relative to than the capture region.

Abstract: Methods for inhibiting a biomaterial-associated thrombotic event comprise reducing the number of platelets that bind to the biomaterial, or inhibiting platelet activation, by attaching CD47 or the Ig domain thereof to the surface of the biomaterial. Methods of the present invention inhibit thrombi formation on or near a biomaterial that is on the surface of an implant, medical device, tube, or therapeutic delivery vehicle. Also provided are kits for practicing these methods and the modified biomaterials.

Abstract: Disclosed is a respiration-assisting tube whereby tissue damages in vivo can be prevented and, as a result, inflammatory reactions and infections can be avoided. The respiration-assisting tube is developed based on the finding that adhesion of cells to a respiration-assisting tube can be inhibited by coating the respiration-assisting tube with a polymer containing 2-methacryloyloxyethyl phosphorylcholine (MPC). Also, the respiration-assisting tube is developed based on the finding that, by coating a respiration-assisting tube with a polymer containing MPC, mucosa peeling and tissue damages, which occur after using the respiration-assisting tube, can be prevented and, as a result, inflammatory reactions can be avoided.

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: A medical device is disclosed, comprising a substrate and a hydrophilic surface coating arranged on said substrate. The substrate has, on its surface coated with said hydrophilic surface coating, a surface texture with an arithmetical mean deviation of the surface profile (Ra) of at least 3 ?m and/or a profile section height difference (Rdc (1-99%)) of at least 18 ?m. It has surprisingly been found that the increased surface roughness of the substrate provides significant improvements in e.g. water retention for the hydrophilic coating.

Abstract: Embodiments of the present invention are directed toward devices, systems, and method for conducting sandwich assays using sedimentation. In one example, a method includes generating complexes on a plurality of beads in a fluid sample, individual ones of the complexes comprising a capture agent, a target analyte, and a labeling agent. The plurality of beads including the complexes may be transported through a density media, wherein the density media has a density lower than a density of the beads and higher than a density of the fluid sample, and wherein the transporting occurs, at least in part, by sedimentation. Signal may be detected from the labeling agents of the complexes.

Abstract: A coating comprised of a polymeric material and a bioactive agent where the properties of the casting solvent dictate the dispersion of the embedding bioactive agent. In preferred embodiments, controlled release of the bioactive agent is achieved by homogeneous dispersion of the bioactive agent within the coating. A further aspect of the invention is directed to formulations where the heterogeneous dispersion of the bioactive agent provides an initial rapid release of the bioactive agent. Methodology for production of coating formulations of the desired properties and the application of the coating to an article are also described.

Abstract: A system and method for coating an expandable member of a medical device comprising a support structure to support the expandable member and a dispenser positioned with at least one outlet proximate a surface of an expandable member. A drive assembly establishes relative movement between the at least one outlet and the surface of the expandable member to apply fluid on the surface of the expandable member along a coating path. A guide maintains a substantially fixed distance between the at least one outlet and the surface of the expandable member during relative movement therebetween by displacing the expandable member relative to the at least one outlet.

Abstract: The disclosure provides polymers having antimicrobial activity and articles with the polymers coated thereon. The polymers include a first pendant group comprising a first cationic component, a second pendant group comprising a nonpolar component, and a third pendant group comprising an organosilane component. The disclosure also includes methods of coating medical device articles and body fluid-receiving substrates with the antimicrobial polymers. The methods further include the use of adhesion-promoting components.

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: In at least one embodiment of the present invention, a method for making an occluding device for occlusion of fluid flow through a lumen of a body vessel is provided. The method comprises attaching a coating to an embolization coil that is substantially straight. The coating is nominally strained on the substantially straight embolization coil. The embolization coil has a pre-curled tension to facilitate the embolization coil being curled within the lumen of the body vessel when deployed. The embolization coil is restrained from curling until deploying to reduce pre-deployment straining of the coating.

Abstract: A medical tube in which an intermediate layer composed of a composition containing (a), (b), and (c1) listed below and a lubricant layer composed of a composition containing (a), (b), and (c2) listed below are sequentially laminated on a surface of an insertion member to be inserted into a living body: (a) 1 to 35 weight % of at least one of aromatic diisocyanate, aliphatic diisocyanate, and alicyclic diisocyanate; (b) 1 to 35 weight % of trifunctional or higher functionality polyol; (c1) 30 to 98 weight % of polyalkylene glycol and/or monomethoxypolyalkylene glycol; and (c2) 30 to 98 weight % of polyalkylene glycol (including polyalkylene glycol larger in weight-average molecular weight than polyalkylene glycol in (c1)) and/or monomethoxypolyalkylene glycol (including monomethoxypolyalkylene glycol larger in weight-average molecular weight than monomethoxypolyalkylene glycol in (c1)), (where each of the glycols in (c1) and (c2) is diol).

Abstract: A protective coating solution, liquid, gel, or film and a method of using such a material to provide a sterile covering for fingers, hands, arms or other selected skin surface for use as a glove substitute.

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: Technologies are generally described for indwelling medical devices for detection of luminal catheter colonization. A substrate for use as an indwelling medical device includes an elevated biofilm releasing medium including a dye for release into urine on the occurrence of an elevated biofilm build-up on the substrate in the urine; and an elevated pH releasing medium including a dye on the substrate different from the dye used to detect biofilm build-up for release into urine on the occurrence of an elevated pH level in the urine. Methods of manufacture and use of the disclosed indwelling medical devices are also described.

Abstract: A method of manufacturing a coated low-friction medical device, such as low-friction medical tubing, including applying a coating to one or more selected portions of a surface of low-friction medical tubing to indicate at least one marking formed along the surface of the low-friction medical tubing, and simultaneously or substantially simultaneously: (a) curing the applied coating to a designated temperature (which is above the temperature at which the low-friction medical tubing begins to decompose and shrink) to adhere the applied coating to the surface of the low-friction medical tubing, (b) utilizing one or more anti-shrinking devices to counteract or otherwise inhibit the shrinking of the low-friction medical tubing, and (c) exhausting any harmful byproducts resulting from curing the low-friction medical tubing to a temperate above the temperature at which the low-friction medical tubing begins to decompose.

Abstract: Microneedle devices are spray coated by nozzles which jet dispense dots onto the individual needles of a microneedle device from a spray nozzle which is angled with respect to the plane of the microneedle device. An angle of between 70° and 45° is preferred and can be achieved by providing the microneedle devices on a support which is inclined at 20° to 45° to the horizontal and using a spray nozzle with a vertical axis.

Abstract: The present invention relates to a method of treating an article surface. The method includes removing a metal oxide surface from the metal substrate to expose a metal surface; and delivering particles including a dopant from at least one fluid jet to the metal surface to impregnate the surface of the article with the dopant. The method also includes delivering substantially simultaneously a first set of particles comprising a dopant and a second set of particles comprising an abrasive from at least one fluid jet to a surface of an article to impregnate the surface of the article with the dopant.

Abstract: A condom comprises, on one or more surfaces thereof, a self-lubricating coating comprising a dry powder having a particle size of 300 microns or less. The self-lubricating coating becomes lubricious when the coating comes into contact with a liquid environment. A method of making a self-lubricating condom comprises providing a dry condom and coating said condom, on one or more surfaces thereof, with a self-lubricating coating comprising a dry powder. The invention also provides the use of a dry powder such as xanthan gum to provide a self-lubricating coating for a condom.

Abstract: A medical device including an array of microneedles and a coating disposed on or within the microneedles and a method of making such a device are disclosed. The coating includes a peptide therapeutic agent and an amino acid. A method of stabilizing a peptide therapeutic agent with an amino acid on an array of microneedles is also disclosed. In some cases, the peptide therapeutic agent and the amino acid either both have a net positive charge or both have a net negative charge. In some cases, the peptide therapeutic agent is histidine.

Abstract: The present invention discloses a liquid precursor composition adapted for application on a on a desired surface, this composition comprising: a. at least one therapeutic agent suitable for the treatment or prevention of a disorder or pathological condition, wherein said disorder or pathological condition excludes oral disorders, b. at least one acidic-pH sensitive polymer, c. at least one hydrophobic polymer, and d. a pharmaceutically acceptable volatile solvent, wherein a weight ratio between the at least one hydrophobic polymer and the at least one acidic-pH sensitive polymer is larger than 1.