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: Sampling device for obtaining a sample of an analyte, comprising a feed line (30) and a discharge line (40) as well as an analyte feed chamber (13) in fluidic connection between the feed line and the discharge line, the analyte feed chamber having an opening (14) which is provided with an analyte-permeable membrane (15) to allow the analyte to pass through from a region outside the analyte feed chamber into the analyte feed chamber, the surface area of the opening of the analyte feed chamber being at most 400 times the minimum cross-sectional surface area of the discharge line, more preferably at most 100 times and most preferably 50 to 80 times the minimum cross-sectional surface area of the discharge line. This device will reduce the dead time between the passage of the analyte through the membrane and the detection of said analyte at the sensor.

Abstract: A male contraceptive device includes a condom-like sheath that is placed over the male genital member and has a flavorful formulated solution disposed inside the distal tip. The distal tip is operable to release, eject, or secrete the formulated solution during male ejaculation. The condom-like sheath is shaped to elastically conform to the elongated shape of a male genital member. The sheath has an open proximal end for receiving the male genital member and a distal end that has a distal tip that is selectively closed. The distal tip defines a reservoir containing an ingestible flavored solution and is operable to permit the release of a composition of the flavored solution and any seminal fluid that has entered the reservoir.

Abstract: In a method for producing a bioactive surface on an endoprosthesis or on the balloon of a balloon catheter, the surface of the endoprosthesis or the surface of the balloon is softened. The surface of the endoprosthesis or of the balloon is moistened with a solution of an active ingredient and the solvent is separated from the active ingredient. The solvent can be a water-miscible solvent.

Abstract: An inorganic-organic hybrid coating applied to a polymer and method for forming same to provide improved hydrophilicity and lubricity to the surface of the polymer. The hydrophilic coating is on the order of one micron thick, as is formed by activating the surface of the polymer, reacting the activated surface of the polymer with a Lewis acid metallic composition, and then quenching the coating in salt solution having a pH>7.2 at a temperature above the glass transition temperature (Tg) of the polymer.

Abstract: The present disclosure relates to methods for embedded drug molecules into medical catheters, tubes, and other medical devices. 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 through diffusion from a loading solution. A counterintuitive approach of using undissolved drug particulates in the loading solution is employed in some embodiments. 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. Heat can be used to significantly speed up the drug loading.

Abstract: A method of producing a delivery device for delivering a chemical compound includes i) providing an interpenetrating polymer substrate (IP substrate) having a first continuous polymer comprising rubber and a second polymer having hydrogel or a hydrogelable precursor, where the second polymer is interpenetrating in the first polymer; ii) providing the chemical compound and a loading solvent for the chemical compound; and iii) loading the IP substrate with the chemical compound by subjecting the IP substrate to the loading solvent having the chemical compound under conditions where the loading solvent at least partially swells the second polymer. The chemical compound, the second polymer and the loading solvent are selected such that the work of adhesion (Whc) between the second polymer and the chemical compound during at least a part of the loading is at least about 0 J/m2.

Abstract: The present invention relates to efficient devices for administration of pharmaceutical agents into the skin of the human body. In particular the present invention provides devices for vaccination into the skin. The present invention provides a pharmaceutical agent delivery device having skin-piercing portion comprising a solid reservoir medium containing the pharmaceutical agent, wherein the reservoir medium is coated onto the skin piercing portion. Alternatively, the skin piercing portion may consist of the solid pharmaceutical agent reservoir medium. The pharmaceutical delivery devices are proportioned such that agent is delivered into defined layers of the skin, and preferred delivery devices comprise skin-piercing portions that deliver the pharmaceutical agent into the epithelium or the dermis. Preferred reservoir media comprise sugars, and in particular stabilising sugars that form a glass such as lactose, raffinose, trehalose or sucrose.

Abstract: An in vitro testing process for simulating conditions of a stomach, comprising, in combination: providing an intragastric device to an acetone bath; inducing swelling of the intragastric device; exacerbating weak spots in the intragastric device; observing the results; and estimating the results of an in vivo study. Improvements to an intragastric space filler to reduce failure at a balloon to shaft area including an adhesive fillet, washers, a balloon cuff and collar, a molded in balloon fillet, and a one-piece molded balloon assembly.

Abstract: An elastomeric condom device including a tubular portion to cover the shaft of the penis, the tubular portion having a first thickness; a pouch portion to cover the scrotum, the pouch portion having a second thickness; and a middle portion provided between the tubular and pouch portions, the middle portion having a thickness that is at least double the thickness of the thickest of the first and second thicknesses. The middle portion includes an opening for insertion of the penis and scrotum, the opening defined by an elastic ring of heavier construction than the middle portion, wherein when the condom is in place over the male genitalia the elastic ring is positioned around the base of the penis and the scrotum at the torso of the body.

Abstract: A porous absorbent structure is disclosed which includes absorbent particles and a superabsorbent polymer material having less than about 1000 parts per million residual monoethylenically unsaturated monomer, the superabsorbent polymer material substantially coating the absorbent particles and connecting the particles into a porous network to form the porous absorbent structure.

Abstract: An implantable portal includes a septum that has embedded therein a plurality of formations that together form an indicia adapted to identify at least one characteristic of the portal. The formations are configured from impressions formed on different layers of the septum spatially separated along the vertical axis of the septum. The impressions are filled with a radiopaque material. The superposed formations do not overlap when viewed from atop the septum. When viewed under radiographic imaging from the top of the septum, a 3-D identification indicia is presented to the viewer. The 3-D indicia may be used as a 3-D marker to focus the location of the septum where a needle to access the fluid reservoir of the portal may be inserted.

Abstract: An intravenous connector is provided having a valve body having first end configured to receive a syringe for administering medicine to a patient; a spike element having a tapered hollow spike terminating in a tip at a first end and having a second end configured for attaching to an intravenous tube, the spike element secured in the valve body such that the tip is disposed proximate the first end of the valve body and the second end of the spike element is located at a second end of the valve body; and a pliable seal member disposed in the valve body around the tapered hollow spike and exposed at the first end of the valve body. An antimicrobial material comprising a silane quaternary ammonium salt is incorporated on or within the seal member and is coated on the valve body and the spike element, and wherein the antimicrobial material.

Abstract: A method for coating a substrate surface such as a syringe part by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising an organosilicon precursor and optionally an oxidizing gas by providing plasma-forming energy adjacent to the substrate, thus forming a coating on the substrate surface by plasma enhanced chemical vapor deposition (PECVD). The plasma-forming energy is applied in a first phase as a first pulse at a first energy level followed by further treatment in a second phase at a second energy level lower than the first energy level. The lubricity, hydrophobicity and/or barrier properties of the coating are set by setting the ratio of the O2 to the organosilicon precursor in the gaseous reactant, and/or by setting the electric power used for generating the plasma.

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.

Abstract: Medical devices and methods for making and using medical devices are disclosed. An example medical device may include a medical device for modulating nerves. The medical device may include an elongate shaft having a distal region. A balloon may be coupled to the distal region. An electrode may be disposed within the balloon. A virtual electrode may be defined on the balloon. The virtual electrode may include a region having a first conductive layer and a second conductive layer.

Abstract: A method of forming a surface layer that includes a hydroxyl polymer on a substrate coating on a medical device is provided.

Abstract: Disclosed are mesh materials adapted for use in an implantable sling. The mesh materials include biodegradable and non-degradable components that may be adapted to facilitate scar-tissue ingrowth as the biodegradable components degrade.

Abstract: Drainage devices for draining a fluid from a patient during treatment of a medical condition body are disclosed. The drainage devices comprise a body defining at least one conduit through the body from a distal end of the body to a proximal end of the body. The body comprises at least one carbon-based structure configured to inhibit growth of fibroblasts in the conduit when the fluid flows through the conduit. Example embodiments of the drainage device may include an ophthalmic shunt, a hydrocephalus shunt, an artificial mesh, an arteriovenous shunt, a thoracic catheter, and a central venous access device.

Abstract: A male contraceptive device includes a condom-like sheath that is placed over the male genital member and has a flavor-infusing agent disposed within the distal end. The distal end is operable to release, eject, or secrete the flavor-altered semen during male ejaculation. The condom-like sheath is shaped to elastically conform to the elongated shape of a male genital member. The sheath has an open proximal end for receiving the male genital member and the distal end has a distal tip that is selectively closed. The distal tip defines a reservoir containing the flavor-infusing agent and is operable, upon pressure of seminal fluid entering the reservoir, to cause the flavor profile or characteristic of the seminal fluid to be altered and to permit the release of the seminal fluid that has entered the reservoir.

Abstract: By using an oxidative process, it is possible to apply an adhesive material to silicone. The process is controlled, allowing selective oxidative treatment to a silicone structure, thus enabling treatment to the inside of a tubular structure.

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

Abstract: Described are methods for modifying a substrate by exposing the substrate to a densified fluid. The substrate may be a polymer or a metal alloy, and the densified fluid may be carbon dioxide. Uses of such substrate modification include impregnation of the substrate with one or more drugs, impregnation of microcellular particles, and formation of microcellular compositions.

Abstract: A method of modifying a medical device such as a stent with nano-constructs is disclosed. The method comprises applying a first fluid to the stent; immersing the stent being wet from the first fluid into a second fluid having a suspension of nano-constructs; and removing the stent from the second fluid and allowing the first and second fluid to be removed such that the nano-constructs are carried by the stent for in vivo application of the constructs to a target location of a mammalian subject. The nano-constructs can be attached to the surface of the stent, can be attached to a surface of the coating of the stent, can be embedded into the stent, or can be embedded into the coating.

Abstract: A drug-delivering medical device for delivering a drug to a target site in a body lumen is disclosed. The drug-delivering medical device includes a balloon catheter and an inflatable balloon positioned on the balloon catheter. The inflatable balloon has a hydrophilic surface. One or more portions of the hydrophilic surface are coated with two or more nano-carriers. A nano-carrier of the two or more nano-carriers includes a drug surrounded by an encapsulating medium. As the drug is surrounded by the encapsulating medium, the surface of the nano-carrier is devoid of the drug. When the inflatable balloon is inflated upon coming in proximity to a target site in the body lumen, about 30% to 80% of the two or more nano-carriers are released from the hydrophilic surface within 15-90 seconds.

Abstract: An embolization device for treating ischemic stroke is disclosed, having a surface, wherein the body portion is configured to have a radiopaque and electropositive surface under physiological conditions when the device is emplaced, which ionically binds a blood component in an amount effective to promote stability of device in situ to bind to a tissue component in an amount effective to increase adhesion of the device as compared to a device without an electropositive surface. Embolic coils being so delivered are electrolytically detachable in under 10 seconds, according to the disclosed vascular implant systems.

Abstract: A flexible undergarment that is worn prior to a date under a normal undergarment. The flexible undergarment has a front portion connected with a back portion, forming a hip portion and two leg portions. The flexible undergarment covers at least a portion of the wearer's lower body. The flexible undergarment includes an integral front extension or an integral middle extension. The flexible undergarment has an integral back extension. The flexible undergarment provides protection from diseases associated with contact of bodily fluid, other people's skin, or the like.

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 nanofiber is formed by combining one or more natural or synthetic polymeric materials and one or more than one cross-linking agents having at least two latent reactive activatable groups. The latent reactive activatable nanofiber may be used to modify the surface of a substrate by activating at least one of the latent reactive activatable groups to bond the nanofiber to the surface by the formation of a covalent bond between the surface of the substrate and the latent reactive activatable group. Some of the remaining latent reactive activatable group(s) are left accessible on the surface of the substrate, and may be used for further surface modification of the substrate. Biologically active materials may be immobilized on the nanofiber modified surface by reacting with the latent reactive groups that are accessible on the surface of the substrate.

Abstract: Embodiments of the disclosure include lubricious coatings. In an embodiment the disclosure includes a lubricious coating for a medical device including first and second coated layers. The first coated layer is between the second coated layer and the device surface and includes a vinyl pyrrolidone polymer and a photo reactive group. The second coated layer is in direct contact with the first coated layer and is a top coating that includes an acrylic acid polymer. The second coated layer can optionally include photoreactive groups. The coating was found to have a very low number of particulates (e.g., 10 ?m or greater) which is very desirable for in vivo use.

Abstract: The present invention provides a method of coating microneedles by which the microneedles mounted on a microneedle device are coated accurately and easily in a mass-producible manner. In this method, a microneedle device (22) with a plurality of microneedles (21) is mounted on a table (23), while a mask plate (25) with a plurality of apertures (24) is fixed to a frame member (26), and a coating solution (27) is drawn in the direction of arrow A on the mask plate (25) using a spatula (28) to fill the apertures (24) with the coating solution. The microneedles (21) are inserted in the apertures (24) before or after the filling of the apertures (24) with the coating solution (27) to coat the microneedles (21).

Abstract: Condoms having an elastomeric layer and coating containing an anhydrous warming lubricant and at least one or more ingredients dispersed therein, the coating being disposed on one or both surfaces are provided. The ingredients disposed on the elastomeric layer can be solid particles or encapsulated ingredients that are insoluble in the anhydrous warming lubricant and soluble in water. Methods of producing and using these condoms are also provided.

Abstract: The present invention relates to an absorbent article such as a diaper or sanitary napkin, and pantiliner. Specifically, the present invention relates to a lotion formulation which is applied on at least a portion of the body-facing surface of the topsheet in a specific manner. The present invention also provides a process for manufacturing an absorbent article comprising the lotion composition applied in a specific manner.

Abstract: A method for producing a medical device comprising the steps of: providing a tubular substrate, said tubular substrate enclosing an internal lumen and being provided with at least one recess in the outer surface, wherein said recess does not form a through going hole into the internal lumen; treating the outer surface of said tubular substrate, preferably by means of surface modification and/or by coating; and forming, after said treating of the outer surface, an opening within said at least one recess to form an access opening to said internal lumen.

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.

Abstract: A polymer blend is provided that includes a polycarbonate polyurethane polymer component having a water contact angle greater than 75 degrees and a polyurethane polymer component having a water contact angle less than 75 degrees. The polycarbonate polyurethane component and the other polyurethane polymer can be immiscible with respect to one another, and thus are phase separated in the polymer blend. The weight percentage of the polycarbonate polyurethane polymer component is greater than the weight percentage of the other polyurethane polymer component in the blend. The polymer blend is well suited for realizing a low friction surface of a variety of medical and non-medical devices.

Abstract: Fluid repellent coatings including a silicone coating for elastomeric gloves, and methods for treating gloves having elastomeric coatings, are disclosed.

Abstract: A method and apparatus for plasma modifying a workpiece such as a syringe barrel, cartridge barrel, vial, or blood tube is described. Plasma is provided within the lumen of the workpiece. The plasma is provided under conditions effective for plasma modification of a surface of the workpiece. A magnetic field is provided in at least a portion of the lumen. The magnetic field has an orientation and field strength effective to improve the uniformity of plasma modification of the interior surface of the generally cylindrical wall. A vessel made according to the process or using the apparatus described above. A pharmaceutical package comprising the syringe barrel or vial containing a pharmaceutical preparation, secured with a closure.

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: Nanoparticles can be embedded into a medical device by accelerating them to a speed of between 100 m/s and 1,000 m/s and embedding the particles into a polymer surface of a medical device or a precursor thereof. In some cases, the nanoparticles can be embedded until the nanoparticles accumulate in sufficient number to adhere together to form a coating over the polymer surface. The nanoparticles can provide a conductive pathway, an abrasion resistant surface, a pro-healing surface, and/or an anti-bacterial surface.

Abstract: A method of manufacturing a balloon catheter involves applying a first application liquid, which contains a hydrophilic coating material, to the outer periphery of a balloon which is disposed on an elongated catheter and is held in an expanded state; folding the balloon; and applying a second application liquid, which contains the hydrophilic coating material, to the balloon with the balloon folded.

Abstract: Embodiments of the invention include apparatus and methods for coating medical devices. In an embodiment, the invention includes a coating apparatus including a coating application unit including a fluid applicator; a first rotation mechanism and a second rotation mechanism; and a controller, wherein the controller causes the first rotation mechanism and the second rotation mechanism to rotate a medical device at substantially the same speed, wherein the speed is greater than 500 rotations per minute. In an embodiment, the invention includes a method of coating a medical device including rotating a medical device with a rotation mechanism at a speed of greater than 500 rotations per minute; contacting the medical device with a fluid applicator; and applying a coating solution to the device. In an embodiment, the invention includes a medical device. In some embodiments a surface of a shaft of the device comprises high points and low points.

Abstract: A method of making a metered dose valve or a component including the step of forming a coating on at least a portion of a surface of the valve or the component, wherein said coating comprises a particulate material selected from the group consisting of Magnesium Stearate, Calcium Stearate, Zinc Stearate, Aluminium Stearate, Stearic acid, Magnesium Palmitate, Calcium Palmitate, Zinc Palmitate or Aluminium Palmitate, Palmitic acid, and mixtures thereof.

Abstract: System and method for coating an expandable member of a medical device comprising a support structure to support the expandable member and an applicator 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 positioning device maintains a substantially fixed distance between the at least one outlet and the surface of the expandable member during relative movement therebetween by ejecting a pressurized medium against the surface of the expandable member.

Abstract: The present invention provides a medical tube mainly comprising a thermoplastic resin wherein the surface contacting the blood has been subjected to a heparinizing treatment and wherein quality defect due to whitening and oil defect is reduced. According to the present invention, there is provided a medical tube wherein an antithrombotic material is coated on the inner surface of a tube prepared by a melt extrusion molding of a composition comprising a thermoplastic resin and a plasticizer, characterized in that the difference (?L) between the brightness of the medical tube before coating and the brightness of the medical tube after coating measured in accordance with JIS Z 8722 is 1 or less.

Abstract: A method of making catheters is disclosed in which the wall of the catheter has a porous structure for carrying additional agents, such as therapeutic agents, diagnostic agents and/or device enhancements. The method includes applying a base polymer material and an inert material over the outer surface of a core, and curing or consolidating the base polymer material to form a catheter having a porous polymer layer with the inert material contained within the pores thereof. The inert material can be applied with the base polymer material or in a separate step after the base polymer material has been partially cured or consolidated to form the porous polymer layer. Additional agents can be mixed with the inert material before it is applied to the catheter, or can be applied to the porous polymer layer of the catheter in a separate step after the inert material is removed therefrom.

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

Abstract: Drug-eluting rotational spun coatings that include one or more therapeutic agents may be used to coat a medical device. The medical devices include, for example, balloon catheters, vascular grafts and stents, which are coated with drug-eluting rotational spun materials that may be used to deliver a therapeutic agent to a target tissue or body lumen.

Abstract: A coated stent (20) for use in a medical procedure and methods of manufacturing the coated stent (20) are described. A stent component (30) has an expanded state in which an inner diameter (ds) of the stent (30) is less than or equal to an outer diameter (dc2) of a coating (40), thereby causing an inner surface (35) of the stent (30) to engage the outer surface (42) of the coating (40). In one exemplary method of manufacture, the stent (30) is disposed over the coating (40) when the coating (40) is provided with a first, smaller outer diameter (dc1). The coating (40) then is radially expanded to a second, larger outer diameter (dC2), which is greater than or equal to the inner diameter (ds) of the stent (30), to cause the outer surface (42) of the coating (40) to engage the inner surface (35) of the stent (30).

Abstract: A coated medical device (10) including a structure (12) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material (14) having a bioactive material layer (18) disposed thereon. The medical device is preferably an implantable stent or balloon (26) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material (58) positioned between the base and bioactive material layers of the balloon.