Abstract: Devices and methods for delivering a therapeutic substance to a patient are provided. Embodiments include infusion sets that include an active agent. Also provided are systems and kits.

Abstract: A condom, including a non-porous sheath member, having an open end and a rounded end, and shaped to cover the glans and body portion of a penis, and at least one rib having at least one outer portion and at least one inner portion, wherein the at least one outer portion is attachedly fixed to said non-porous sheath member, and wherein an inner cylinder formed by at the at least one inner portion is exclusive from said non-porous sheath member, and including at least one lubricant within the inner cylinder and at least one hole extending from the inner cylinder through the outer portion to provide for flow of the lubricant outwardly from the inner cylinder through the at least one hole pursuant to application of a predetermined pressure, wherein the at least one rib extends at least one of substantially from the open end to the closed end and substantially about a circumference of the non-porous sheath member.

Abstract: An indwelling catheter probe, wherein it incorporates, at its external and/or internal surface, an extract of Vaccinium macrocarpon containing proanthocyanidines applied either by adsorption, by absorption, by coating or by any other application process, namely any physico-chemical process, said catheter probe thus treated ensuring the prevention or inhibition of the formation of a bacterial biofilm at its surface.

Abstract: A medical device having a lubricious coating on at least a section of the medical device, and a method of coating a medical device, the lubricious coating being a network of short chain and long chain hydrophilic compounds cross-linked to one another and interlocked with a network of a cross-linked polymerized multifunctional monomer or polymer. The coating can include one or more agents which provide enhanced adhesion of the coating on the device, or which provide faster hydration of the coating and/or improved lubricity. Additionally, the lubricious coating can be provided with one or more therapeutic or diagnostic agents, and in one embodiment the agent elutes relatively quickly in a concentrated release from the lubricious coating upon hydration of the coating.

Abstract: Novel, lubricious coatings for medical devices are disclosed. The coatings provide improved lubricity and durability, and are readily applied in coating processes. The present invention is also directed to a novel platinum catalyst for use in such coatings. The catalyst provides for rapid curing, while inhibiting cross-linking at ambient temperatures, thereby improving the production pot life of the coatings.

Abstract: The present invention relates to balloon catheters with or without crimped stent, whose surface is coated with at least one antirestenotic agent and at least one transport promoting molecular dispersant, as well as a method for the preparation of these medical devices.

Abstract: System and components for inducing pleurodesis while minimizing likelihood of tissue damage from direct application of pleurodesis-enhancing materials. A tube device is provided that is configured to elute pleurodesis-enhancing material. The device includes one or more features configured to prevent or lessen the likelihood that the pleurodesis-enhancing material comes into direct and concentrated contact with patient tissue when a distal length of the device is disposed indwelling a patient.

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: A biodegradable polymer stent with radiopacity and a method of making and using a stent with enhanced mechanical strength and/or controlled degradation for use in a bodily lumen is described.

Abstract: A method of coating a microneedle array by applying a coating fluid using a flexible film in a brush-like manner. A method of coating a microneedle array comprising: providing a microneedle array having a substrate and a plurality of microneedles; providing a flexible film; providing a coating solution comprising a carrier fluid and a coating material; applying the coating solution onto a first major surface of the flexible film; performing a transfer step of bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles; and allowing the carrier fluid to evaporate.

Abstract: Novel antimicrobial compositions and coatings are disclosed. The antimicrobial compositions consist of mixtures of taurolidine and protamine, including protamine salts. The antimicrobial compositions are particularly useful in coatings for implantable medical devices. The antimicrobial compositions are effective against a broad spectrum of microbes.

Abstract: The invention relates to a medical device for delivering a therapeutic agent to a tissue. The medical device has a layer overlying the exterior surface of the medical device. The layer contains a therapeutic agent and an additive. The additive has a hydrophilic part and a hydrophobic part and the therapeutic agent is not enclosed in micelles or encapsulated in particles or controlled release carriers.

Abstract: The present invention relates to compositions which are suitable for selective filling or selective coating of folds of a folded balloon, and especially relates to compositions of a contrast agent and an active agent in a solvent for filling of folds of a folded catheter balloon as well as to methods for selective filling or selective coating of folds of a folded catheter balloon and to filled or coated folded catheter balloons which can be obtained according to one of these methods.

Abstract: A flexible laminate composition and methods for manufacturing same are provided. The flexible laminate composition includes one or more discrete and separate layers of a radiopaque material wherein the radiopaque layer is applied via a solvent to a layer that is composed of a plastic material. The laminate composition can be formed into a radiopaque marker band that can be used with a medical device, such as a catheter, for radiographic imaging. The laminate composition as an alternative can also be utilized to form the catheter or other suitable medical device.

Abstract: New ampholyte biomaterial compounds containing ampholyte moieties are synthesized and integrated into polymeric assemblies to provide hydrophilic polymers exhibiting improved biocompatibility, haemocompatibility, hydrophilicity non-thrombogenicity, anti-bacterial ability, and mechanical strength, as well as suitability as a drug delivery platform.

Abstract: The invention provides methods for forming ultra-thin hydrophilic polymeric coatings on articles, as well as articles formed therefrom. The coatings are formed by irradiating a composition including a polymer having pendent photoreactive groups while the composition is in contact with a surface of the article.

Abstract: A method is disclosed in which a vapor-deposited coating or layer is directly or indirectly applied to at least a portion of the internal wall of the barrel of a capped pre-assembly comprising a barrel, optionally a dispensing portion, and a cap. The cap is secured to the barrel and at least substantially isolates the distal opening of the dispensing portion from pressure conditions outside the cap. A vapor-deposited coating or layer is applied directly or indirectly to at least a portion of the internal wall of the barrel while the pre-assembly is capped. The coating or layer is applied under conditions effective to maintain communication from the barrel lumen to the exterior via the front opening, optionally further via the dispensing portion lumen if present, at the end of the applying step. The capped pre-assembly can be pressure tested easily and rapidly, for example with a test duration between 1 and 60 seconds, to determine whether it has container closure integrity.

Abstract: A vascular stent comprising a drug-eluting outer layer of a porous sputtered columnar metal having each column capped with a biocompatible carbon-containing material is described. This is done by placing the stent over a close-fitting mandrel and rotating the assembly in a sputter flux. The result is a coating that is evenly distributed over the outward-facing side of the stent's wire mesh while preventing the sputtered columnar coating from reaching the inward facing side where a smooth hemocompatible surface is required. The stent is then removed from the mandrel, exposing all surfaces, and finally coated with a layer of carbon such as amorphous carbon or diamond-like carbon. The carbonaceous coating enhances biocompatibility without preventing elutriation of a therapeutic drug provided in the porosity formed between the columnar structures. The result is a stent that is adapted to both the hemodynamic and the immune response requirements of its vascular environment.

Abstract: An elastomeric article, such as a glove or a condom, is coated with a compound containing silicone, collagen and allantoin.

Abstract: The present invention provides a device such as a medical device for the rapid detection, enumeration and identification of microorganisms. It is based on the production and accumulation of absorbent or fluorescent molecules during reactions between artificial substrates and enzymes in micro-channels of a sampling-detecting unit of the device. Enzymes of cells, or enzymes attached to cell bodies through antibody-enzyme conjugates, produce easily detectable concentrations of colored or fluorescent molecules in very small volumes, much faster than what is produced in conventional large volume devices. Microorganisms contained in the micro-channels appear as colored or fluorescent dots when viewed using a light or a fluorescent microscope.

Abstract: Elastomeric articles, such as gloves are disclosed. The gloves include a primary matrix made from one or more elastomeric materials and a foam donning layer. In one embodiment, for instance, the donning layer can be formed from a polyurethane foam. The polyurethane foam can be created from the reaction product of a polyurethane prepolymer and a solution containing water. The resulting foam can be hydrophilic and can absorb moisture for preventing moisture from being trapped between the primary matrix and a user's skin.

Abstract: A hydrophilic, lubricious coating for a substrate includes a first coating layer having a cross-linked polyurethane or polyurea complexed with poly(ethylene oxide) formed by reacting a mixture of an isocyanate, a polyol or polyamine, and a poly(ethylene oxide), and a second coating layer having a cross-linked polyurethane or polyurea complexed with polyvinylpyrrolidone formed by reacting a mixture of an isocyanate, a polyol or polyamine, and a polyvinylpyrrolidone. The first layer is substantially covered by the second layer and the second layer at least partially interpenetrates the first layer. The coating is provided by applying the first coating layer, curing to provide a cross-linked polyurethane or polyurea/poly(ethylene oxide) coating, applying the second layer, and curing to provide a cross-linked polyurethane or polyurea/polyvinylpyrrolidone coating.

Abstract: A method of treating the surface of a medical device with a biomolecule comprising the steps of: providing a polyolefin substrate forming a medical device; cleaning the polyolefin substrate; exposing the polyolefin substrate to a reactive gas containing acrylic acid and to plasma energy to yield a plasma-deposited polyacrylic acid coating on the polyolefin substrate; and attaching a biomolecule, such as heparin, to the polyolefin substrate following formation of the plasma-deposited polyacrylic acid coating on the polyolefin substrate.

Abstract: A method for electrostatic coating of medical devices such as stents and balloons is described. The method includes applying a composition to a polymeric component of a medical device which has little or no conductivity. The polymeric component could be a material from which the body or a strut of the stent is made or could be a polymeric coating pre-applied on the stent. The polymeric component could be the balloon wall. A charge can then be applied to the polymeric component or the polymeric component can be grounded. Charged particles of drugs, polymers, biobeneficial agents, or any combination of these can then be electrostatically deposited on the medical device or the coating on the medical device. One example of the composition is iodine, iodine, iodide, iodate, a complex or salt thereof which can also impart imaging capabilities to the medical device.

Abstract: The invention discloses a method of coating a medical device. The method includes applying a coating composition on the medical device to form a layer on the medical device. The coating composition includes one or more of one or more biological agents and heparin dissolved in a mixture of a first solvent and a second solvent. The first solvent and the second solvent have different evaporation temperatures. Subsequently, at least a part of one of the first solvent and the second solvent present in the coating composition is evaporated to create a plurality of pores in the layer. Thereafter, one or more drugs are deposited in the plurality of pores. When the medical device is positioned and expanded at a target site, the one or more drugs are released from the plurality of pores.

Abstract: A method for improving the barrier properties of a material. The method includes providing a material, applying a hydrophobic surface coating thereto, and incorporating the material into an absorbent article. The hydrophobic surface coating includes a non-aqueous, solventless, multicomponent silicone composition. The hydrophobic surface coating may be substantially free of aminosilicones.

Abstract: A inert sampling needle is provided for piercing a septum of a vial containing a sample. The sampling needle includes a hollow rigid support member having an inner wall, an outer wall, and a septum-piercing end. The sampling needle also includes a sheath member affixed to the rigid support member. The sheath member covers the septum-piercing end of the support member, the inner wall, and at least a portion of the outer wall adjacent the septum-piercing end to isolate the support member from the sample. Preferably, the sheath member is formed of polyetheretherketone and is affixed to the rigid support member by heat fusing. A method of forming, and a method of using the inert sampling needle is also disclosed.

Abstract: The present invention provides for a dental appliance, mouthguard and/or divers mouthpiece using an anti-microbial composition that combines the use of an elastomeric polymer composition with micronized or submicron sized particles of metal or organo/inorgano metal complexes. In addition, the use of an anti-microbial composition for use with a diver's air delivery hose to prevent breathing of contaminated air is also described.

Abstract: Biological surfactants connected to surfaces of silicone-based materials are provided. Compositions of electrolytes and a biological surfactant are also provided. Methods for increasing the surface wettability of a silicone-based material by contacting the silicone-based material with a biological surfactant, methods for increasing evaporation from a silicone-based material by contacting a surface of the silicone-based material with a biological surfactant, methods for increasing levels of interleukin-8 during inflammation by contacting a cell with a biological surfactant, and methods for decreasing expression of a biological surfactant by contacting a cell with an siRNA are further provided.

Abstract: The present invention provides a method for coating an inner surface of a polyvinyl chloride medical tube containing a plasticizer with an antithrombogenic material composed of a specific (meth)acrylate copolymer. The simple method of the present invention is capable of evenly and efficiently coating an inner surface of a polyvinyl chloride medical tube with a sufficient amount of an antithrombogenic material without causing appearance deterioration or uneven coating due to elution of the plasticizer. The method is performed by passing through a tube a solution that is prepared by dissolving an antithrombogenic material in a solvent composed of water and at least one alcohol that is adjusted to dissolve the copolymer of the antithrombogenic material but does not dissolve the plasticizer, then subsequently passing water through the tube, and finally drying the tube.

Abstract: A substantially anhydrous, spreadable warming lubricant composition comprising a mixture of glycerin, a polyhydric alcohol, and a non-ionic surfactant, the viscosity of the composition being less than that of glycerin but greater than that of the polyhydric alcohol, thereby promoting formation of a useful thin layer on a surface with which the composition is brought into contact, the surfactant improving wetting and spreadability of the composition on skin and latex, such that the composition can be applied to skin or a condom and provide an optimal warming effect upon contact with ambient moisture during use and such that the composition can be added to a condom package and, over the course of about a week, spread and coat nearly the entire internal and external surfaces of the condom.

Abstract: A coating system for coating an Insertable Medical Device (IMD) with one or more drugs is disclosed. The coating system includes a spray nozzle unit for coating the IMD with one or more drugs. The IMD includes a guiding member, a coating member and a supporting member. The IMD is passed through a protection tube such that the guiding member is located within the protection tube and an end of the supporting member is connected to a holder to expose the coating member of the IMD to the spray nozzle unit. The protection tube is received by a mandrel fixture which includes a circular disc for holding and rotating the protection tube and the IMD within the protection tube. When the protection tube along with the IMD is rotated, the spray nozzle unit coats the coating member of the IMD with the one or more drugs.

Abstract: A medical device, such as a medical wire, which includes a coating applied to the surface of the medical wire. The coating includes a base layer bonded to the surface of the medical wire and an at least partially transparent low-friction top coat applied to the base layer. The base layer includes heat activated pigments that change color when heated above a color shifting temperature. In one embodiment, the color of the pigment in one area contrasts with the color of the pigment in an adjacent area without otherwise affecting the low-friction surface of the coating. The areas of different color created in locations along the length of the low-friction coated medical wire form markings which, as an example, enable a surgeon to determine the length of the medical wire inserted into a body by observing the markings on the portion of the marked medical wire located exterior to the body.

Abstract: An expandable medical balloon useful for treatment at a vessel bifurcation, the balloon having at least one expanded state, the balloon having at least one inner layer and at least one outer layer, the outer layer having at least one cavity therein through which the inner layer protrudes when the balloon is in its at least one expanded state, and methods of making and using the same.

Abstract: A device for promoting the clotting of blood comprises a clay material in particle form and a receptacle for containing the clay material. At least a portion of the receptacle is defined by a mesh. Another device comprises a gauze substrate and a clay material disposed on the gauze substrate. Another device is a bandage comprising a substrate, a mesh mounted on the substrate, and particles of a clay material retained in the mesh. A hemostatic sponge comprises a substrate, a hemostatic material disposed on a first surface of the substrate, and a release agent disposed on a second surface of the substrate. The release agent is disposed on the wound-contacting surface of the substrate. When treating a bleeding wound, application of the hemostatic sponge causes at least a portion of the hemostatic material to come into contact with blood through the release agent and through the substrate.

Abstract: A medical device includes a base material and chlorhexidine or a pharmaceutically acceptable salt thereof disposed in the base material sufficient to reduce microbial growth. The base material includes a polymer having a silicone monomer and a urethane monomer. To make the medical device having an antimicrobial agent, a silicone-urethane-carbonate polymer is dissolved in Dimethylformamide/Tetrahydrofuran (DMF/THF) to generate a coating solution, a chlorhexidine or a pharmaceutically acceptable salt thereof is mixed into the coating solution, a base material is coated with the coating solution, and the coating solution is dried to remove the solvent. The chlorhexidine is present in concentration sufficient to reduce microbial growth.

Abstract: An apparatus for coating medical devices at the point of care with a polymer and/or therapeutic agent comprising an environmentally controlled device coating chamber in which the device may be delivered by the manufacturer as the device packaging, or the device may be placed into the chamber at the point of care. The environmentally controlled chamber can provide a sterile enclosure in which the polymer and/or a therapeutic agent can be applied to an uncoated or previously coated device and converted to another form (such as a liquid to a film or gel) if desired, under controlled and reproducible conditions. The environmentally controlled chamber can accommodate and provide for coating the device by immersion, spray and other methods of covering the device surface with a liquid or powder. The chamber can provide for energy sources, both internally, such as heat produced by film heaters, and externally, such as UV light or microwave passing through the enclosure.

Abstract: A process for reducing solvent contents in drug-containing polymeric compositions may be utilized to reduce the solvent content in implantable medical device wherein the compositions are in reservoirs. 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 weight percent to about 10 weight percent of the total weight of the polymeric composition. Subsequently, the drug-containing polymeric compositions are further treated by a low temperature drying method for further reduction of the solvent content.

Abstract: A medical device, polymer composition, and method for delivering substantially water-insoluble drugs to tissue at desired locations within the body. At least a portion of the exterior surface of the medical device is provided with a polymer coating. Incorporated in the polymer coating is a solution of at least one substantially water-insoluble drug in a volatile organic solvent. The medical device is positioned to a desired target location within the body, whereupon the drug diffuses out of the polymer coating.

Abstract: A coating system and method are described. In some embodiments, a system may include a composition. The composition may include one or more bridged polycyclic compounds. At least one of the bridged polycyclic compounds may include at least two cyclic groups, and at least two of the cyclic groups may include quaternary ammonium moieties. In some embodiments, a method may include applying a coating to a surface of a medical device. The coating may be antimicrobial. A coating may include antimicrobial bridged polycyclic compounds. In some embodiments, bridged polycyclic compounds may include quaternary ammonium compounds. In some embodiments, bridged polycyclic compounds may include guanidinium moieties. Bridged polycyclic compounds based coating systems may impart self-cleaning properties to a surface.

Abstract: A covalently crosslinked hydrogel comprises a) three or more divalent poly(alkylene oxide) chains P? covalently linked at respective first end units to a branched first core group C?, b) three or more divalent poly(alkylene oxide) chains P? covalently linked at respective first end units to a branched second core group C?, the chains P? comprising respective second end units which are covalently linked to between 0% and 100% of respective second end units of chains P? by divalent linking groups L?, and c) at least one pendant cationic block copolymer chain A?-B?. A?-B? comprises i) a divalent block A? comprising a poly(alkylene oxide) backbone chain having an end unit covalently linked to a second end unit of one of the chains P? by a divalent linking group L?, and ii) a monovalent block B? comprising a first repeat unit, the first repeat unit comprising a backbone carbonate group and a cationic side chain group.

Abstract: A mechanism for preventing or inhibiting bubbles of dissolved gasses from outgassing due to phase change phenomenon of the pressure differential inside a liquid-filled incompressible line can be provided. This mechanism may be useful in a variety of applications, such as coating of stents and scaffolds.

Abstract: A treatment method for treating the surface of a fluid dispenser device, said method comprising the step of using chemical grafting to form a thin film on at least one support surface of at least one portion of said device that is in contact with said fluid, said thin film having bactericidal and/or bacteriostatic properties.

Abstract: The present invention relates to methods of modifying the chemical structure of a surface by covalently attaching molecules containing desired functional groups on the surface using plasma energy. In these methods, chemical compounds containing the desired functional groups and having a vapor pressure lower than 0.001 bar are exposed in the plasma chamber together with the substrate. Surface area of the chemical compound is optimized to generate adequate evaporation rate. The modification of the substrate surface is achieved in a plasma state generated from the vapor of the chemical compounds; while the evaporation of the chemical compounds is accelerated by the plasma energy. Methods for producing non-fouling surface by covalently attaching ethylene glycol oligomers on the surface are disclosed.

Abstract: An implant having a preferably hollow cylindrical main structure comprising a large number of continuous openings and a coating which releases at least one pharmaceutically active substance. To attain a better distribution of the pharmaceutically active substance, at least 20% of the cross-sectional area, preferably at least 50% of the cross-sectional area, of at least a portion of the openings in a predetermined section of the main structure is covered with the coating which releases at least one pharmaceutically active substance. Furthermore, a system composed of a catheter and such an implant, a simple method for manufacturing such an implant or such a system is provided.

Abstract: The invention described herein relates to the preparation of silver compounds prepared from pectin and pectin derivatives and the process for preparing them. The silver derivatives thus prepared are amenable for use in the preparation of medical and/or veterinary dressings or implants.

Abstract: The present invention concerns highly swellable absorption mediums with a reduced caking tendency at high humidity and/or high temperatures, wherein a swellable polymer is coated with a non-ionic, nitrogen-containing surfactant and optionally a Lewis acid and then reacted by heating.

Abstract: A wet shaving system is disclosed including a blade member and a skin-engaging portion in proximity to said blade member, the skin-engaging portion comprising a solid polymeric shaving aid composite including an exposed portion containing a water-soluble shaving aid dispersed in a water-insoluble polymeric matrix, the water soluble shaving aid being coated with mineral oil.

Abstract: The present disclosure provides improved packaged condoms that enable the use of a large quantity of a composition inside the condom. In addition, a sufficient quantity of certain spermicidal and/or microbicidal compositions is provided for efficient inactivation of sperm and pathogens. The present disclosure also provides condoms with reduced tendency to slip or break. Compositions associated with different surfaces of the condom can be effectively segregated to their intended condom surface according to the present disclosure.

Abstract: An IV set is disclosed that includes a silicone rubber tube coated with a layer of a gas barrier material. The coated tube is resilient and has low gas permeability and is suitable for use with peristaltic IV pumps.