Abstract: A disposable intramedullary device for temporary use for treatment of limb infections comprising a solid core of variable cross-section, including a distal portion, a middle portion and a proximal portion, said proximal portion and distal portion including anchoring regions consisting of through-holes being passed through by bone anchoring means. Outside said anchoring regions, said solid core is coated with a polymer layer which also includes antibiotic, the outer diameter of the solid core and polymer layer assembly being equivalent to that of an intramedullary channel, and the outer diameter of said solid core in said anchoring regions being equivalent to that of a said intramedullary channel.

Abstract: A method of increasing blood flow through an obstructed blood vessel includes providing an expandable member substantially made of a mesh having a plurality of interstices. The expandable member is inserted into the blood vessel, positioned within the blood vessel with the proximal member end upstream of the distal member end and the member body located radially adjacent at least a portion of an obstruction, and expanded to bring at least a portion of the member body into contact with the obstruction. An outward radial force is exerted on the obstruction to dislodge at least one fragment from the obstruction and to enhance blood flow through the blood vessel past the obstruction. The at least one fragment is passed through at least one interstice of the member body in the radial direction, and is selectively retained within the expandable member.

Abstract: An antimicrobial 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 an antimicrobial coating to an oral surface, a surface of a construction substrate, a surface of a marine substrate, a surface of a medical device, or a surface of a personal care device. The protective coating may be antimicrobial. A protective coating may include antimicrobial bridged polycyclic compounds. Bridged polycyclic compounds may include quaternary ammonium compounds. Bridged polycyclic compounds based coating systems may impart self-cleaning properties to a surface (e.g., a tooth surface).

Abstract: Embodiments of the invention provide compositions which are effective to inhibit the development of biofilms on a surface of a medical device having the composition applied thereto, to medical devices having the composition applied to a surface thereof and to methods for using the compositions to coat medical devices.

Abstract: A multi-functional wire guide assembly includes an elongate tubular housing having a length and defining a lumen extending from an open proximal end of the elongate tubular housing to an open distal end of the elongate tubular housing. A first mandril is positioned within the lumen, extends a majority of the length of the elongate tubular housing, and has a fixed position relative to the elongate tubular housing. A second mandril is positioned within the lumen, has a length greater than the length of the elongate tubular housing, and is axially movable relative to the elongate tubular housing. The multi-functional wire guide assembly has a first configuration in which a distal tip of the second mandril is proximally spaced from a distal segment of the elongate tubular housing and a second configuration in which the distal tip of the second mandril is axially aligned with the distal segment.

Abstract: A medical device assembly may include an elongated guidewire, an elongated flexible tubular membrane disposed about the guidewire, and a percutaneous medical device, wherein the membrane is configured to permit the percutaneous medical device to pass through the lumen. A method of advancing a medical device through a vessel may include advancing an elongated flexible tubular membrane through the vessel to a treatment site, inserting the medical device into the membrane, and advancing the medical device through the membrane while maintaining the membrane in an axially stationary position relative to the vessel.

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: 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 therapeutic sleeve is disposable about a therapy delivery element. The sleeve has a first opening, a second opening, and a radially elastic body member disposed between the first and second opening. The body member forms a lumen extending from the first opening to the second opening and is configured to be disposed about the therapy delivery element. The sleeve further includes a therapeutic agent releasable from the body member when implanted in a patient.

Abstract: Medical implants are provided which release an anthracycline, fluoropyrimidine, folic acid antagonist, podophylotoxin, camptothecin, hydroxyurea, and/or platinum complex, thereby inhibiting or reducing the incidence of infection associated with the implant.

Abstract: An exemplary medical device for subcutaneous disposal at least partially within a patient is disclosed, comprising an antimicrobial material comprising at least one metal and an agent that inhibits diffusion of the at least one metal from the antimicrobial material. The antimicrobial material comprises a coating formed over at least a portion of a surface of the medical device. Methods for preparing medical devices and methods of using the medical devices having the antimicrobial material are also disclosed.

Abstract: A medical device includes a proximal end, a distal end sized for introduction into a body lumen, and a lumen extending between the proximal and distal ends. The tubular device includes an inner liner including a coating on an inner surface thereof, a reinforcing layer surrounding at least a portion of the liner; and an outer layer surrounding the reinforcing layer and inner liner. The liner and outer layer may include multiple sections having different properties than one another, adjacent sections attached together by seams, which may be offset from one another. Apparatus and methods for making tubular devices with coated liners are also provided.

Abstract: Fixation and protective components for use with implantable medical devices, such as access ports and catheters, are disclosed. In one embodiment, a protective sleeve is employed about a catheter so as to distribute compressive loads and ensure patency of the catheter lumen, even in areas prone to pinch-off. A catheter assembly in one embodiment thus comprises an elongate catheter tube that defines at least one lumen. A protective mesh sleeve is disposed about an external portion of the catheter tube so as to cover at least a portion of the longitudinal length of the catheter tube. The protective sleeve is configured to distribute a compressive load on the catheter tube so as to ensure patency of the at least one lumen of the catheter tube.

Abstract: An implantable tissue-stimulating device, such as a cochlear implant, having a resiliently flexible elongate member (11) having a plurality of electrodes (12) positioned thereon. The elongate member (11) provides a means of delivering at least one bio-active substance to the implantee following implantation of the elongate member (11). The delivery means can comprise a lumen 21 containing the bio-active substance in a liquid form. The bio-active substance can comprise a steroid or can perform a function of reducing the resting neuron potential of neurons within the cochlea.

Abstract: Some embodiments of a medical anchor device include an elongate body coupled with deployable subcutaneous anchors to secure a catheter instrument (or other medical instrument) in place relative to a skin penetration point. In some circumstances, the elongate body may be in the form of catheter hub body, and the subcutaneous anchors can be deployed from the hub body by adjustment of a movable actuator. A locking member can interact with the actuator so as to retain the actuator in the deployed orientation during the medical procedure.

Abstract: The subject matter relates a catheter having a helical or spiral tip defining an aspiration port for removing obstructions from blood vessels.

Abstract: The invention relates to a preparation for restenosis prevention. The preparations for restenosis prevention known as yet do not reach sufficient active agent concentrations in the affected sections of the vascular walls as higher doses cause undesirable side effects. The present invention is a preparation to which at least one antihyperplastic agent is added that has a distribution ratio between butanol and water .gtoreq.0.5. The lipophilic active agent is absorbed by the vascular wall fast and in sufficient quantity. The preparation may be a liquid that can pass through capillaries and may contain a contrast agent so that the active agent is transferred into the vascular wall without any additional effort while the usually required contrast radiograms are taken. The preparation may also be applied to a catheter.

Abstract: A bio-compatible lumen bearing device such as a catheter formed of a polymeric material having a titanium surface bonded to the underlying exposed catheter surface. The titanium surface is employed in patients to improve bio-compatibility and enhance lubricity during insertion and removal.

Abstract: A trocarless intravenous cannula with a multifilament tip is described. The trocarless intravenous cannula has a tapered, distal multifilament tip that is comprised of a plurality of individual filaments. In one aspect, the distal part of the cannula is fenestrated. The tip and the distal part of the cannula may both be covered in a dry, water-soluble coating.

Abstract: Medical implants are provided which release an anthracycline, fluoropyrimidine, folic acid antagonist, podophylotoxin, camptothecin, hydroxyurea, and/or platinum complex, thereby inhibiting or reducing the incidence of infection associated with the implant.

Abstract: A medical appliance having a slidable coating layer that moves in contact with an inner surface of a medical member or that of a lumen and has the slidable coating layer formed at a part thereof which contacts the medical member or the lumen. The slidable coating layer is formed of a composition which does not contain solid fine particles and contains a silicone-based resin which is a product of an addition reaction between silicone having a vinyl group and silicone having a hydrogen group bonded to a silicon atom.

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 catheter shaft with an improved manifold bond and methods for making and using the same. The catheter shaft may include a sleeve disposed, for example, near its proximal end. The sleeve may include a first layer that is attached to the catheter shaft and a second layer to which a hub or manifold may be attached.

Abstract: A method and apparatus for fluid delivery enables navigation through tortuous, spatially restricted body anatomy to access narrow diameter body lumens for the continuous delivery of fluids, including therapeutic fluids, to the lumen in an atraumatic manner that avoids damage to the body lumen. The fluid delivery device can have a flexible conduit having a proximal end, a distal end, and a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal and distal ends, where the lumen transitions into a micro-lumen exiting through a port through which a high concentration of fluid injected into the lumen exits laterally out along an image viewable zone at the distal end of the flexible conduit. The flexible conduit has a maximum outer diameter sized sufficient to navigate narrow diameter body lumens.

Abstract: Methods for delivery of a compound within a tube.

Abstract: Substrates, optionally coated with an undercoating, having grafted thereto one or more non-fouling materials are described herein. The non-fouling, polymeric material can be grafted to a variety of functionalized substrate materials, particularly polymeric substrates and/or polymeric undercoatings immobilized on a substrate. The compositions described herein are highly resistant protein absorption, particularly in complex media and retain a high degree of non-fouling activity over long periods of time. The compositions described herein may also demonstrate antimicrobial and/or anti-thrombogenic activity. The non-fouling material can be grafted to a functionalized substrate, or optionally from an undercoating on the substrate, preferably without significantly affecting the mechanical and/or physical properties of the substrate material.

Abstract: A medical lumen access device assembly includes a medical lumen access device holder including an elongate tube defining a lumen extending from a proximal opening of the elongate tube to a distal opening of the elongate tube. A check valve is positioned over an opening of the elongate tube and includes a valve member having a biased closed position wherein an internal volume defined by the lumen is fluidly blocked from an exterior of the elongate tube at the opening and an open position defining a fluid path from the exterior to the internal volume through the opening. The medical lumen access device assembly also includes a medical lumen access device disposed at least partially within the lumen and having a proximal segment extending beyond the distal opening. At least a portion of the medical lumen access device includes a hydrophilic coating.

Abstract: Drug delivery systems and biocompatible coatings for use with implantable stimulation devices such as cochlear implants have been developed. These drug delivery systems and coatings comprise polyhydroxyalkanoate (PHA) polymers and copolymers. The drug delivery systems may be used to deliver pharmacologically active substances, for example, directly from a cochlear implant to the inner ear. The coatings can impart lubricity to cochlear devices for ease of insertion of the electrodes. In the preferred embodiment, the drug delivery system comprises a polyhydroxyalkanoate polymer, and in the most preferred embodiment, the PHA polymer comprises poly(4-hydroxybutyrate) (P(4HB)) or copolymer thereof. A particularly preferred embodiment is where the silicone sheath of the cochlear implant electrodes has been surface modified, and coated with P(4HB), and the P(4HB) either contains a pharmacologically active substance or has been coated with such a substance.

Abstract: A degradable, removable, pharmaceutical implant for the sustained release of one or more drugs in a subject, wherein the pharmaceutical implant is composed of a tube comprising an outer wall made of a degradable polymer completely surrounding a cavity, wherein the outer wall has a plurality of openings and wherein the cavity contains one or more sets of micro-particles, which micro-particles contain an active agent or a combination of two or more active agents, and wherein the size of the microparticles is selected such that the majority of the microparticles cannot pass through the openings.

Abstract: A method of manufacturing a coated medical device, such as a medical guide wire, including at least applying a first colored coating to at least a first portion of an outer surface of a medical guide wire, securing a first end of the medical guide wire, and for each a designated quantity of turns, turn a second end of the medical guide wire upon a longitudinal axis of the medical guide wire. The method of manufacturing also includes securing the second end of the medical guide wire, blocking at least a first portion of the coated surface of the medical guide wire, applying a second contrasting colored coating to at least a second, unblocked portion of the outer surface of the medical guide wire and releasing the first end and the second end of the medical guide wire to display at least one spiral marking formed along a length of the medical guide wire.

Abstract: The present disclosure provides a medical instrument with a coating that provides excellent lubricity when wet. The medical instrument possesses a coating including a wet lubricating film with high peel durability and anti-eluting properties. In embodiments, an intermediate film made of bisphenol A type epoxy resin is coated on a base material of a medical instrument made of metal, and a wet lubricant coating produced by alkaline processing of a polymer alloy containing a methyl vinyl ether maleic anhydride copolymer and a polyether block amide is then applied thereto. Methods for making these medical instruments are also provided.

Abstract: This invention relates to a method of providing a coating on a medical device, especially a dilatation balloon, which improves the durability of the balloon.

Abstract: Caps can be used to cover and disinfect a male protrusion portion of a medical connector. Some caps can create a seal with the male protrusion to prevent antiseptic from entering a lumen the protrusion. A biasing element can aid in creating or maintaining the seal.

Abstract: Devices and methods are provided for access to the sub-retinal space that lies between the retina and the choroid in order to introduce therapies to the retina and more specifically to the sensory retina and RPE, particularly in the region of the macula. The devices comprise a catheter that incorporates advantageous size, flexibility and tip features to properly, accurately and atraumatically access the sub-retinal space. Ancillary devices to assist in placing catheters into the sub-retinal space are also provided. The catheter devices incorporate a lumen for delivery of therapeutic substances or devices into the eye.

Abstract: The present invention provides a method of applying a drug-polymer coating on a stent. A stent framework is dipped into a first polymeric solution including a first polymer, a first therapeutic agent, and a first solvent. The polymeric solution is dried and the first polymer is cured to form a thin drug-polymer layer on the stent framework. The steps of dipping the stent framework into the first polymeric solution, drying the first polymeric solution, and curing the first polymer are repeated until a target drug-polymer coating thickness is disposed on the stent framework. A drug-polymer coated stent including a stent framework and a laminated drug-polymer coated stent, a system for treating a vascular condition, and a method of treating a vascular condition are also disclosed.

Abstract: A method and apparatus of treating tissue adjacent a bodily conduit using thermotherapy, while preventing obstructions of the bodily conduit due to edema, includes injection of a drug-encapsulated within a heat-sensitive carrier, such as a liposome, within a region of tissue to be treated. The heat produced by the energy-emitting source heats a portion of the tissue surrounding the bodily conduit to a temperature of approximately 43° C. for a time sufficient to destroy the heated portion of the tissue. In addition, the heat produced by the energy-emitting source activates the heat-sensitive carrier to activate the release of the encapsulated drug and the drug targets the tissue to be heated. The focused energy of the energy-emitting source together with the compression acting on the target area can assist in delivering drugs to the target area so that a natural stent has a long term efficacy.

Abstract: Therapeutic device intended for the selective cytoreductive treatment of an obstruction in a natural lumen or passage of the human or animal body, said lumen being obstructed by the effect of a local cell proliferation, said device comprising a tubular element, in particular of cylindrical shape, intended to be placed in said natural lumen and sufficiently flexible to conform to said natural lumen, but sufficiently rigid to maintain an artificial channel in said lumen. The tubular element supports lengthwise a medicinal sleeve which is intended to come into line with, and into contact with, the obstruction once the natural lumen has been intubated, and is designed to deliver locally, at least in its outer surface portion, at least one therapeutic agent which is cytoreductive, in particular cytotoxic, through contact with the cells under whose effect said lumen is obstructed.

Abstract: A vapor hydrated packaged catheter assembly and method of manufacturing and distributing same includes a gas impermeable package housing a catheter within a catheter-receiving cavity. The catheter assembly has a hydrophilic coating applied to at least a portion of the outer surface of a catheter tube or shaft which may be surrounded by a sleeve to provide a no-touch, sure grip feature. The catheter assembly is disposed within the catheter receiving cavity of the package together with a limited amount of a vapor donating liquid provided as a source of vapor to activate the hydrophilic coating. The amount of vapor donating liquid is less than the amount that would otherwise be sufficient to cause a spill hazard. It may be loose liquid as a desired percentage of the volume of a tube-receiving portion of the catheter receiving cavity of the package, or it may be contained in a liquid sequestering element.

Abstract: A dual lumen guidewire support catheter for accurately crossing a chronic total occlusion in a vessel is disclosed. The dual lumen guidewire support catheter includes a first lumen portion and a second lumen portion sharing a common side and a common distal end. The first lumen portion can be a rapid exchange or over-the-wire portion, while the second lumen portion is an over the wire portion. One or both of the portions can include a discontinuity to enable removal of a guidewire following placement through or at an occlusion or lesion.

Abstract: This invention provides a modified catheter/indwelling device biomaterial that provides both immediate, and long-term microbiocidal effects on otherwise antibiotic-resistant strains of microorganisms. The material, which exhibits good mechanical performance characteristics for medical devices, is composed of a hydrophobic polyurethane (PU), a hydrophilic polyethylene vinyl acetate (PEVA) as an option, a soluble silver salt and a sparsely-soluble silver salt. The hydrophobic polyurethane provides the good physical properties, the PEVA the hydrophilicity necessary to allow some water ingress into the catheter, the soluble silver salt for an immediate burst effect, and the sparsely-soluble silver salt for sustained-release over many months postimplantation. Alternatively, the sparsely soluble silver salt can be silver iodate and is combined with silver sulfadiazine. Chlorhexidine can also be included in the material.

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.

Abstract: A vascular access device may include a body and a layer of the body that communicates with a pathogenic environment to discourage adhesion of a pathogen to the layer and thus repress pathogenic activity. A method of repressing pathogenic activity in a vascular access device includes providing the device with a body, and coating the body with a layer that discourages adhesion of a pathogen to the layer.

Abstract: A pressure activated valve comprises a valve housing defining a lumen for receiving bodily fluids therein and a flexible membrane disposed in the valve housing. The flexible membrane includes a slit extending therethrough so that the flexible membrane may be moved between an open and a closed configuration based on fluid pressure within the lumen. A nonthrombogenic coating may be formed on fluid contacting surfaces of the flexible membrane.

Abstract: Disclosed are implantable or insertable medical devices that provide resistance to microbial growth on and in the environment of the device and resistance to microbial adhesion and biofilm formation on the device. In particular, the invention discloses implantable or insertable medical devices that comprise at least one biocompatible matrix polymer region, an antimicrobial agent for providing resistance to microbial growth and a microbial adhesion/biofilm synthesis inhibitor for inhibiting the attachment of microbes and the synthesis and accumulation of biofilm on the surface of the medical device.

Abstract: An improved needle-free intravenous injection port assembly is disclosed. Embodiments include a boot valve with a helical surface, a boot valve and septum which mate with mechanical interference, a spike with a rough outer surface coated with a lubricant, a septum having a shoulder and a single continuous swabbable surface, a septum and a boot valve which are pre-punctured, a septum with a frustroconical extension and a combination single piece septum and boot valve. The injection port assembly provides zero fluid displacement during coupling and uncoupling.

Abstract: Microneedle device is provided, which include microneedles that can be easily inserted into skin and dissolve or swell in skin. The microneedle devices comprise a substrate and cone-shaped or pyramid-shaped microneedles for skin insertion set on the substrate. The microneedles for skin insertion contain over 50 weight percent of one or multiple biomaterials chosen from chitosan, collagen, gelatin, hyaluronic acid, and they are fabricated from the materials that can dissolve or swell in the body.

Abstract: The invention provides a durable, lubricious coating for a medical article that can be prepared from a first polymer that is synthetic, soluble in a polar liquid, and having first reactive groups, and a second polymer that is synthetic, hydrophilic, and that includes second reactive groups. The first reactive groups and a portion of the second reactive groups react to bond the first polymer to the second polymer. A portion of the second reactive groups remains unbonded which, upon neutralization, provide lubricious properties to the coating. In some aspects the coating is formed using a crosslinking agent having latent reactive groups. The coatings provide particularly long dry out times and are very useful for catheterization processes. In addition, the coatings can be subject to sterilization with ethylene oxide and retain very good durable and lubricious properties.

Abstract: A luer adapter includes a body including an inner surface defining a lumen and first and second ends. Each end is adapted to connect to a medical device. An antimicrobial material is positioned at least on a portion of the inner surface. A barrier is positioned between the lumen and the antimicrobial material and permits the passage of the antimicrobial material therethrough upon exposure to moisture. The barrier may include hydrophilic material.

Abstract: A vascular access device for communicating with the vascular system of a patient may include a status indicator. The status indicator may detect and signal whether and to what extent at least a portion of the vascular access device has been cleaned.

Abstract: The invention relates to an article comprising a coating, which coating comprises at least two layers, of which the inner layer is a primer layer, comprising a supporting polymer network which is composed of a supporting polymer selected from the group consisting of polyethers and polythioethers, including copolymers thereof, the supporting network optionally comprising a functional non-ionic hydrophilic polymer entangled in the supporting polymer network; and the outer layer is a functional layer comprising a functional non-ionic hydrophilic polymer and a polyelectrolyte.