Abstract: The present invention relates to the design and development of a drug delivery nanoplatform that consists of nanoporous, multi-layer biodegradable polymeric (BP) thin films for controlled release of its payload. The method is used notably to synthesize nanoporous BP coatings as drug delivery vehicles exhibiting uniform nanopores with tailored characteristics for control of drug delivery and release. It enables the multiplex delivery of drugs that can be eluted at desirable time intervals in line with each medical need. Atomic Force Microscopy and Spectroscopic Ellipsometry are applied for determining nanoporosity, thickness, drug loading, structural properties, and quality of the BP films ensuring the quality control of the final product. The complete degradation of the polymers minimizes the toxicity within the human body and such nanoplatform can be used in a wide range of drug eluting and other medical implants and biomedical devices.

Abstract: A system and method for coating an expandable member of a medical device comprises providing a dispenser in fluid communication with a fluid source with the dispenser having at least one outlet to dispense fluid of the fluid source therefrom. The outlet(s) of the dispenser is positioned proximate a surface of an expandable member, with relative movement between the outlet(s) and the surface of the expandable member established along a coating path, and fluid is dispensed from the dispenser to form a substantially continuous bead of fluid between the at least one outlet and the surface of the expandable member along the coating path, and simultaneously drying the fluid while dispensing the fluid from the dispenser to control flow of fluid on the surface of the expandable member. The fluid source can include a variety of therapeutic agents.

Abstract: This invention relates to condoms, prophylactics and contraceptive devices made of silicone rubber having a body comprising a plurality of sections that are capable of folding telescopically, such that each section folds into an adjoining section.

Abstract: A separation membrane includes a membrane comprising a polymer, characterized in that a functional layer is formed on the surface in one side of the membrane, the peak area percentage of carbon derived from ester group measured by the electron spectroscopy for chemical analysis (ESCA) on the surface of the preceding functional layer is 0.1% (by atomic number) or more but not more than 10 (% by atomic number), and the peak area percentage of carbon derived from ester group measured by the electron spectroscopy for chemical analysis (ESCA) on the surface opposite to the functional layer is not more than 10 (% by atomic number). A separation membrane module suffering from little sticking of organic matters, proteins, platelets and so on is provided with the separation membrane as a built-in membrane.

Abstract: A gas mist pressure bath device includes a living-body cover member for covering the living-body's skin or the mucous membrane and forming a space for sealing the gas mist from the gas mist generating device inside of the living-body cover member, and a pressurizing member integrally formed with the living-body cover member pressurizing the gas mist in the living-body cover member. The pressurizing member is in a form of a ring, a hollow gas collection part, or a shielding film.

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: 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 catheter is disclosed, which is capable of delivering embolization beads for treating uterine fibroids. The elongate catheter shaft includes a radially expandable portion at its distal end, which can expand radially locally when an embolization bead passes through it. In some cases, the catheter shaft includes a non-expandable portion, with an inner diameter comparable to the bead diameter, between the handle and the radially expandable portion. In some cases, the radially expandable portion is made from a tubular braid, stretched longitudinally over a mandrel, and encased in a lubricious soft polymer while still stretched. In other cases, the radially expandable portion is made from a slotted nitinol tube, encased in a lubricious soft polymer below the nitinol transition temperature. The polymer is thick enough to prevent the encased element from returning to its unstretched diameter or a larger size above the transition temperature.

Abstract: Methods of making bioabsorbable stents with grooved lumenal surfaces for enhanced re-endothelialization are disclosed. Methods include molding grooves on the lumenal surface of coated bioresorbable and durable stents. Methods further include molding grooves on lumenal surfaces of a bioresorbable tube and forming a scaffold from the tube.

Abstract: Coatings for medical devices, methods of making the coatings, and methods of using them are described.

Abstract: The invention relates to an active-substance-containing coating for the balloon of a balloon catheter, to a balloon of a balloon catheter with the coating, and to a balloon catheter with such a balloon. The invention further relates to the use of the coating for a balloon of a balloon catheter, and to a method for coating an active-substance-coated balloon and for producing an agent for modifying the release of an active substance applied to a surface of the balloon of a balloon catheter. A coating for a balloon of a balloon catheter is proposed which comprises at least one lipophilic active substance and an agent for modifying the release of active substance to a vessel that surrounds the balloon, wherein the agent for modifying the release of active substance is a polysaccharide having a molecular mass of 10,000 Da to 100,000,000 Da.

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: A method for coating catheter balloons with a defined amount of a pharmacologically active agent, uses a coating device having a volume measuring device for releasing a measurable amount of a coating solution by means of a dispensing device specifically onto the surface of the catheter balloon.

Abstract: The preparation and use of medical devices having radiopaque and echogenic materials including coated tungsten and/or tungsten carbide particles are disclosed herein.

Abstract: A method of manufacturing an implantable medical device, such as a drug eluting stent, is disclosed. The method includes subjecting an implantable medical device that includes a polymer to a thermal condition. The thermal condition can result in reduction of the rate of release of an active agent from the device subsequent to the implantation of the device and/or improve the mechanical properties of a polymeric coating on the device.

Abstract: A medical device includes an implantable structure and a coating layer including a water-insoluble therapeutic agent and one or more additives selected from xylitol, iodine or Ethylenediaminetetraacetic acid (EDTA), and physiologically-acceptable salts thereof. The one or more additives can be present in an amount effective to increase the rate of release of the water-insoluble therapeutic agent from the coating layer. The implantable medical device structure can be an expandable structure such as a balloon or stent. Also described are methods of making and using such implantable medical devices and coating layers.

Abstract: Methods and apparatus for delivering a substance to a target tissue are provided which may include any number of features. One feature is storing a substance or drug in a reservoir or reservoirs over an expandable member. The expandable member can be a balloon catheter, for example. The reservoir(s) can be disposed in a Transforming Reservoirs Matrix layer disposed over the expandable member. Another feature is a mechanical activator or a plurality of mechanical activators positioned near the reservoir(s).

Abstract: Disclosed is a catheter and a method for making a catheter. The catheter has a proximal end and a distal end, and includes from the distal end towards the proximal end a distal section, an intermediate section and a proximal section, wherein the intermediate section is provided with a coating such that the intermediate section experiences less friction in use than the distal section and the proximal section.

Abstract: A method and device for local delivery of a water-insoluble therapeutic agent to the tissue of a normal or diseased body lumen is disclosed. An expandable structure of a medical disposable device, such as a balloon of a balloon catheter, is coated with a non-durable coating which comprises poly(HEMA) complexed with iodine and has a substantially water-insoluble therapeutic agent dispersed therein. The medical disposable device is inserted into a body lumen, and expanded to contact the non-durable coating against the body lumen and deliver the substantially water-insoluble therapeutic agent to the body lumen tissue.

Abstract: The invention is directed to medical device coatings, such as coated guidewires and catheters, containing a visualization moiety providing color to the coating in ambient or applied light. The coating allows for visual or machine inspection of coating properties such as uniformity of coverage. In some embodiments the coatings include the visualization moiety and an activated UV photogroup, which is used to provide covalent bonding in the coating. The visualization moiety can be in particulate form and entrained in the coating, or can be covalently bonded to the hydrophilic polymer backbone. In other embodiments the visualization moiety includes a stilbene chemical group. Exemplary coatings include a hydrophilic vinyl pyrrolidone polymer, which can provide lubricity to the device surface, along with the colored properties.

Abstract: Hydrogel compositions are provided (a) that have a continuous hydrophobic phase and a discontinuous hydrophilic phase, (b) that have a discontinuous hydrophilic phase and a continuous hydrophilic phase, or (c) that are entirely composed of a continuous hydrophilic phase. The hydrophobic phase, if present, is composed of a hydrophobic polymer, particularly a hydrophobic pressure-sensitive adhesive (PSA), a plasticizing elastomer, a tackifying resin, and an optional antioxidant. The discontinuous hydrophilic phase, if present, is composed of a crosslinked hydrophilic polymer, particularly a crosslinked cellulosic polymer such as crosslinked sodium carboxymethylcellulose. For those hydrogel compositions containing a continuous hydrophilic phase, the components of the phase include a cellulose ester composition or an acrylate polymer or copolymer, and a blend of a hydrophilic polymer and a complementary oligomer capable of hydrogen bonding thereto.

Abstract: A medical device includes a base material having an immobilized fibrinolytic enzyme and dextran sulfate. The dextran sulfate has a molecular weight that is less than 40 kilo dalton (kDa). The medical device is formed from at least a base material. A fibrinolytic enzyme is immobilized on the base material. The fibrinolytic enzyme is stabilized with a dextran sulfate having a molecular weight of less than 40 (kDa).

Abstract: Substrates may be coated with copolymers of N-vinyl pyrrolidinone and aryl ketones. Processes are described for making the copolymers at high molecular weight with the ketones randomly dispersed on the copolymer.

Abstract: In embodiments, medical devices, such as balloon catheters, can deliver a biologically active material to body tissue of a patient. The medical device includes a sponge delivery layer which can deliver multiple doses of one or more therapeutic agents to the body tissue. The medical device can further include a drug reservoir, which can supply the delivery layer with one or more therapeutic agents.

Abstract: Embodiments described herein concern medical products, which come into contact with the organism, such as short-term implants and long-term implants, coated with at least one layer, containing a molecular-disperse distributed or dissolved active substance in at least one carrier and optionally one or more adjuvants, wherein the at least one layer forms a stably spreadable solution, methods for making this coating of stably spreadable solution and use of the medical products coated with the stably spreadable solution.

Abstract: Described herein are methods of coating both metallic and polymeric surfaces adding hydrophilicity comprising the steps mixing a coating composition comprising at least one polyol, at least one compound having at least two isocyanate groups, and an organic solvent; introducing nucleophilic functional groups on the surface thereby creating an active surface; subjecting the active surface to the coating composition thereby forming a coated surface; and curing the coated surface. Medical devices, for example, implantable medical devices can be coated by the methods described herein.

Abstract: A medical device that includes a coating of a composite material that includes a polymeric material having a void structure and particulate ceragenin material (i.e., ceragenin particles) associated with the void structure. The average particle size of the ceragenin particles in the composite is in a range from 5 nm to 20 ?m, 50 nm to 10 ?m, 100 nm to 5 ?m, or 1 ?m to 10 ?m. The composite has a high loading of ceragenin particles (e.g., about 10% to about 25%, by weight). The composite has good polymer stability, the ability to release ceragenins from the ceragenin particles disposed in the composite over a sustained period of time at a characteristic elution rate, and the ability to kill large numbers of bacteria and other susceptible microbes over the sustained period of time.

Abstract: Disclosed are antifouling compositions that can include a biopolymeric matrix which is substantially zwitterionic. The compositions may include a biopolymer matrix having positively charged functional groups, negatively charged functional groups, zwitterionic functional groups, or a combination thereof, such that the composition is substantially zwitterionic. The compositions can be used as additives and as compositions further containing a base material such as paint or lacquer. Methods of making and using such compounds and compositions are also disclosed.

Abstract: The invention described herein includes a repellent elastomeric article with antimicrobial properties particularly useful in industrial and medical fields, such as gloves. The article contains an elastomeric base and a fluid-repellent coating composition that effectively repels both hydrophilic and lipophilic liquids from its surface and inhibits cross-contamination of surfaces. Articles prepared in accordance with the invention reduce the risk of contamination associated with blood and other body fluids, as well as reduce fluid-based visual obstruction and enhance the clarity of medical procedures. The invention also provides a method of reducing the ability of fluids to adhere to the surface of an elastomeric article.

Abstract: Methods for the deposition of silver-comprising films on nonconducting substrates, and, more particularly, to deposition of such films that are very thin, are provided. The surface of nonconducting substrates is modified with a superabsorbent polymer to increase silver deposition when compared to a non-modified surface. Also provided are films produced using a swelling agent, whereby porosity of the surface of the nonconducting substrate is increased, thereby permitting increased silver deposition when compared to an unmodified surface.

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: Methods for processing a vessel, for example to provide a gas barrier or lubricity, are disclosed. First and second PECVD or other vessel processing stations or devices and a vessel holder comprising a vessel port are provided. An opening of the vessel can be seated on the vessel port. The interior surface of the seated vessel can be processed via the vessel port by the first and second processing stations or devices. Vessel barrier, lubricity and hydrophobic coatings and coated vessels, for example syringes and medical sample collection tubes are disclosed. A vessel processing system and vessel inspection apparatus and methods are also disclosed, for example using material outgassed from a surface to inspect the properties of a surface coating.

Abstract: The invention relates to a hydrophilic coating formulation which when cured results in a hydrophilic coating, wherein the hydrophilic coating formulation comprises a copolymeric polyelectrolyte. The invention further relates to a hydrophilic coating, a lubricious coating, use of a copolymeric polyelectrolyte in a lubricious coating, an article, a medical device or component and a method of forming on a substrate a hydrophilic coating.

Abstract: Since all methods of applying a drug liquid to a tip portion of a microneedle are application of the drug liquid in an open system, evaporation of the solvent from the drug liquid is unavoidable, such that the concentration of the drug liquid changes easily, and a large amount of the drug liquid is necessary. The invention provides a method of applying a drug to a pin-frog-shaped microneedle by using a small amount of the solution and without variation of the concentration of the drug liquid. A member having plural grooves is produced, and one end thereof is immersed in a drug liquid tank to fill the grooves with the drug liquid. The drug can be uniformly applied to a tip portion of the microneedle by setting the pin-frog-shaped microneedle to pass through the drug liquid in the grooves.

Abstract: This invention relates to components useful for medical articles, such as a syringe assemblies, having sliding contact surface (s) coated with at least one coating layer, wherein the contact surface has an average surface roughness (Ra) ranging from about 10 nm to about 1700 nm and/or the coating layer has crystalline domains, the mass of the crystalline domains being at least about 20% of the total mass of the coating layer, and methods of making the same.

Abstract: Methods and apparatus for coating a medical device are provided. In one embodiment, the method for preparing a substantially uniform coated medical device includes (1) preparing a coating solution comprising a solvent, a therapeutic agent, and an additive; (2) loading a metering dispenser with the coating solution; (3) rotating the medical device about the longitudinal axis of the device and/or moving the medical device along the longitudinal or transverse axis of the device; (4) dispensing the coating solution from the metering dispenser onto a surface of the medical device and flowing the coating solution on the surface of the medical device while the medical device is rotating and/or linearly moving; and (5) evaporating the solvent, forming a substantially uniform coating layer on the medical device.

Abstract: The present disclosure relates to medical catheters, tubes, and other medical devices, systems, and methods. The catheter, tube, or other medical device is capable of releasing drugs for extended periods of time. Drugs can be loaded into the wall thereof with a loading solution. The drug in the wall of the device and in the loading solution can be in dynamic equilibrium, yielding stable and easy-to-manufacture products.

Abstract: Embodiments of the invention include lubricious medical device coatings. In an embodiment the invention includes a coating for a medical device including a first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; and a first cross-linking agent comprising at least two photoreactive groups; a second layer disposed on the first layer comprising polyvinylpyrrolidone derivatized with a photoreactive group; a second cross-linking agent comprising at least two photoreactive groups; and a polymer comprising polyacrylamide, the polymer derivatized with at least one photoreactive group. Other embodiments are included herein.

Abstract: The present invention is a process for surface treatment of a fluid-contacting device where a continuous organo-silicon or organo-silicon and oxygen plasma coating is applied at a low temperature by a plasma deposition technique to at least one contacting surface of the device and devices with the process applied. The plasma coating inhibits bacterial attachment to the device and prevents biofilm formation on said device. The coating preferably has a thickness from about 1 nm to about 100 nm, more preferably from about 20 nm to about 30 nm. The trimethylsilane and oxygen gas mixture is an approximate ratio of 1 to 4. The invention demonstrates that bacterial cells on the organo-silicon or organo-silicon/O2 coated surface are more susceptible to antibiotic treatment than their counterparts in biofilm formed on uncoated surface.

Abstract: A method of surface treating a fluid dispenser device, said method comprising a step of modifying at least one surface to be treated of at least a portion of said device in contact with said fluid by ionic implantation using multi-charged and multi-energy ion beams, said modified surface to be treated having non-stick properties for said fluid, said multi-charged ions being selected from helium (He), nitrogen (N), oxygen (O), neon (Ne), argon (Ar), krypton (Kr), and xenon (Xe), ionic implantation being carried out to a depth of 0 ?m to 3 ?m.

Abstract: Compositions and methods are provided for producing a medical device such as a stent, a stent graft, a synthetic vascular graft, heart valves, coated with a biocompatible matrix which incorporates antibodies, antibody fragments, or small molecules, which recognize, bind to and/or interact with a progenitor cell surface antigen to immobilize the cells at the surface of the device. The coating on the device can also contain a compound or growth factor for promoting the progenitor endothelial cell to accelerate adherence, growth and differentiation of the bound cells into mature and functional endothelial cells on the surface of the device to prevent intimal hyperplasia. Methods for preparing such medical devices, compositions, and methods for treating a mammal with vascular disease such as restenosis, artherosclerosis or other types of vessel obstructions are disclosed.

Abstract: Catheters and a method of preparation thereof comprising a catheter body and at least one connector. The catheter body has an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon, the hydrophilic polymer layer has an average dry thickness of at least about 50 nanometers.

Abstract: Catheters and a method for preparation thereof, the catheter comprising as component parts thereof a catheter body, a juncture hub, at least one extension line and at least one connector, each of said component parts comprising an exterior surface, at least one lumen having an intraluminal surface and a bulk polymer, wherein the intraluminal or external surface of a first of said component parts and the exterior or intraluminal surface of a second of said component parts comprise a hydrophilic polymer layer thereon having an Average Dry Thickness of at least about 50 nanometers and the first and second component parts comprise bulk polymers having different chemical compositions

Abstract: Catheters and a method of preparation thereof, the catheter comprising a catheter body, a juncture hub, extension lines and connectors, the catheter body having a proximal end, a distal end, an exterior surface, a tip region having a length of 10 cm measured from the distal end of the catheter body, and at least two lumen, each of the catheter body lumen having a proximal end, a distal end, a Lumen Aspect Ratio of at least 3:1, and an intraluminal surface, the distal ends of the at least two catheter body lumen being (i) non-coterminus or (ii) laser-cut, the exterior surface of the catheter body in the tip region or the intraluminal surface of the two catheter body lumen comprising a hydrophilic polymer layer having an Average Dry Thickness of at least about 50 nanometers.

Abstract: The present disclosure provides a brush polymer, including: a linear polymer main chain; and brush structural side chains, including: a hydrophobic molecular branch, and a hydrophilic molecular branch and/or an anti-biofilm/or an anti-microbial molecular branch, wherein the linear polymer main chain is conjugated to the side chains by covalent bonds formed between a hydroxyl group and a reactive functional group, wherein the reactive functional group includes: isocyanate, carboxyl, or epoxy. The present disclosure also provides a medical application of the brush polymer.

Abstract: The invention generally relates to systems and methods for making gelatin shunts. In certain embodiments, the invention provides methods that may involve moving a wire through a bath including a bottom layer of liquid gelatin and a top layer of water, thereby coating the wire with gelatin, moving the gelatin coated wire through an aperture, and drying the gelatin on the wire in a humidity controlled space, thereby manufacturing a gelatin shunt. In other embodiments, the invention provides systems that may include a motor, a wire operably coupled to the motor for movement of the wire, a temperature controllable bath, an aperture plate situated in a top portion of the bath, and an ultrasonic fogger, in which the system is configured such that the wire moves through the bath, through the aperture plate, and into the ultrasonic fogger.

Abstract: A sustained release antimicrobial cannula or catheter for residence within a portion of a human body through which aqueous biological fluids can pass and including a tube. The tube has a polymeric matrix and an antimicrobial agent residing within at least a portion of the polymeric matrix. The polymeric matrix includes cured silicon rubber and the antimicrobial agent is a finely divided nitrofuran compound, a paraben antifungal, or combinations thereof. The antimicrobial agent can diffuse out of the polymeric matrix and into an aqueous biological environment when the polymeric matrix comes into contact with such an aqueous biological environment. Methods of making a sustained release antimicrobial cannula and of catheterizing a patient are also disclosed.

Abstract: Methods for forming a “coating gradient” on medical devices, such as a balloon catheter or guidewire are disclosed. The balloon portion of the catheter could have a protective covering initially placed over it to prevent the balloon from receiving a first hydrophilic coating. After a first hydrophilic coating is applied to the catheter, the protective covering can be removed exposing the uncoated surface of the balloon. Next, after the protective covering has been removed, a second hydrophilic coating could be applied to the catheter. A guidewire having less lubricity at the distal end portion of the guidewire than the shaft portion which extends proximally away from the distal end section can be created. The method includes the application of a first hydrophilic coating on the elongated shaft and distal shaft section of the guidewire. This first hydrophilic coating is then allowed to cure. Next, the first hydrophilic coating is removed from a portion of the distal shaft section of the guidewire.

Abstract: A tubular conduit is disclosed. The tubular conduit comprises a tubular portion made from a flexible material and an axially extending external helical formation located around the outside of the tubular portion. The external helical formation is for supporting the tubular portion. Optionally the tubular portion also comprises an axially extending internal helical protrusion, which imparts a helical flow to a fluid passing through the tubular portion. It is preferred that the tubular conduit is a vascular graft.

Abstract: This invention relates to methods of applying to a substrate a hydrophilic coating that becomes lubricious when activated with water or water vapor, and to substrates having such a hydrophilic coating.