Abstract: The present disclosure provides substrates having a lubricious coating thereon. The substrate may be flexible and include, in embodiments, a medical device. The lubricious coating, in embodiments, is applied in a pattern so that the coating avoids delamination and/or fracturing which might otherwise occur as the substrate flexes and/or stretches.

Abstract: An antimicrobial agent delivery system and method are provided for an antimicrobial agent-bearing intervention device. A delivery tube contains the intervention device, where the delivery tube facilitates handling of the intervention device. In one example, the intervention device is a rod, and a hub is coupled to the rod. Longitudinal movement of the hub ejects the rod from the delivery tube.

Abstract: A method of producing a porous biodegradable medical implant device, the method comprising providing a mixed blend comprising a mixture of at least two biocompatible materials having different degradation or solubility characteristics; molding the mixed blend to produce a molded part; and processing the molded part to remove one of the at least two biocompatible materials by a predetermined amount from the molded part to produce the porous biodegradable medical implant device.

Abstract: A catheter lock solution includes a hydrochloric acid solution having a concentration of 0.3 Molar to 1.0 Molar. This hydrochloric acid solution may be used to lock a catheter and/or salvage an infected catheter.

Abstract: An urethral sealing device comprising first and second body portions selectively attacheable to one another to form a unitary element including a first catheter lumen extending therethrough between proximal and distal ends of the unitary element wherein, when the sealing device is in an operative position, the distal end is positioned within a urinary bladder and a sealing element extending radially outward from the unitary element so that, when the sealing device is in the operative position, the sealing element engages one of a wall of the urethra and a wall of the urinary bladder around an orifice at which the urethra opens into the urinary bladder to seal the urethra.

Abstract: An elongate member housing tool assembly includes a distal end side tubular member disposed on the distal end side and a proximal end side tubular member disposed on the proximal end side, which accommodate an elongate member, and a liquid inlet port to which a liquid supplying tool for supplying liquid into the distal end side tubular member is removably connected and which is provided on the distal end side tubular member. The distal end side tubular member and the proximal end side tubular member are wound spirally, and the proximal end of the distal end side tubular member and the distal end of the proximal end side tubular member are disposed in a spaced relationship from each other. A distal portion of the guide wire is accommodated in the distal end side tubular member, except possibly the most distal portion of the elongate member.

Abstract: A disinfecting and pre-opening device is disclosed for use with a female needleless connector. The disinfecting and pre-opening device includes a housing comprising a chamber having a distal opening and configured to fit over the female needleless connector, and an elongated finger attached to the housing and disposed within the chamber such that the elongated finger opens the fluid path through the female needleless connector when the distal opening of the disinfecting and pre-opening device is placed proximally adjacent to the septum and the disinfecting and pre-opening device is advanced in the distal direction.

Abstract: Embodiments of the invention provide swallowable devices, preparations and methods for delivering drugs and other therapeutic agents within the GI tract. Some embodiments provide a swallowable device such as a capsule for delivering drugs into the intestinal wall or other GI lumen. The device comprises a capsule sized to be swallowed and pass through the intestinal tract. The capsule can include at least one guide tube, one or more tissue penetrating members positioned in the guide tube, a delivery member, an actuating mechanism and a release element. The release element degrades upon exposure to various conditions in the intestine so as to release and actuate the actuating mechanism. Embodiments of the invention are particularly useful for the delivery of drugs which are poorly absorbed, tolerated and/or degraded within the GI tract.

Abstract: A device for assisting recovery from dysphagia, and a method of preventing and/or treating dysphagia. The device includes a catheter suitable for insertion into the body of a patient, for the introduction of nutrients to the stomach of said patient, and electrodes located on a surface of the catheter, the electrodes being positioned such that when the catheter is inserted into a patient the electrodes are in a suitable position for applying electrical pharyngeal stimulation.

Abstract: Microbial growth inhibiting solutions and methods of employing the microbial growth inhibiting solutions in flushing and coating medical devices are disclosed. In alternative embodiments, the microbial growth inhibiting solutions include combinations of a chelating agent with a C4-C9 carboxylate antimicrobial agent, for example, such as n-octanoic acid. Methods of using these microbial growth inhibiting solutions for coating a medical device and for inhibiting catheter infection are also disclosed.

Abstract: An antimicrobial lubricant combines an antimicrobial agent, preferably silver based, with a silicone lubricant. This is achieved by first formulating a lubricant solution that has a non-volatile silicone lubricant and a volatile solvent carrier. An antimicrobial agent is added to the lubricant solution. The solution is then subjected to ultrasonic energy so that the antimicrobial agent is uniformly mixed with the lubricant in the solution. The solution containing the antimicrobial lubricant may be sprayed onto a medical device, for example the outer surface of the catheter of a peripheral IV catheter. After the solvent flashes off, a coat of uniform antimicrobial lubricant is formed on the catheter surface. The antimicrobial lubricant coating facilitates the insertion of the catheter to a patient, and at the same time prevents the growth of microorganisms from the device and infection to the patient.

Abstract: Systems, devices, methods, and compositions are described for providing an actively controllable implant configured to, for example, monitor, treat, or prevent microbial growth or adherence to the implant.

Abstract: A guidewire lumen for a catheter includes a tubular member. At least a portion of the tubular member is formed of a compound comprising a polymer and particles or fibers. The particles or fibers can reduce a friction coefficient of the portion of the tubular member while having minimal to no adverse effects with respect to bondability, flexibility, and processability.

Abstract: This invention provides a modified catheter 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), 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.

Abstract: A non-metallic medical device treated with a antimicrobial agents is provided. Different combinations of antimicrobial agents can be used for different types of non-metallic medical devices depending on the types of infections related to each device. The combination of different antimicrobial substances has a synergistic effect against certain bacteria and fungi. An antimicrobial agent can be used to treat a non-metallic medical device by mixing the antimicrobial agent with an acid solution and glycerol and exposing the non-metallic medical device to the resulting mixture such that an enough of the antimicrobial agent binds to a portion of the non-metallic medical device to inhibit the growth of bacterial and fungal organisms.

Abstract: A catheter product package and method of forming same in which the package comprises a sheet material wrapped about the catheter product to form a package for the catheter product. The catheter product extends generally longitudinally within the package, and the sheet material extends from a point beyond the proximal end to a point beyond the distal end of the catheter product. The sheet material of the package is wrapped about the catheter product in a manner defining confronting proximal end edges, confronting distal end edges, and confronting side edges. The confronting proximal end edges, distal end edges and side edges of the sheet material are joined by a seal after the sheet material is wrapped about the catheter product to define a sealed cavity. The sheet material has a tear strip affixed to it which causes the sheet material to tear along the tear strip to thereby cause the package to open along an intended opening line.

Abstract: Medical devices are described that comprise surface capillary (SCF) fibers, which can impart desirable properties to the devices. For example, implantable prostheses are described comprising SCF fibers. In other embodiments, catheters are described having SCF fibers along the surface of the catheters. In addition, SCF fibers can be useful for the delivery of bioactive agents in association with the fibers. Due to the fluid flow capabilities of the fibers, medical devices are described that incorporate fiber matrices to facilitate blood delivery to cells within the structure.

Abstract: An elongate medical device configured for at least partial implantation or insertion into a subject. The medical device has at least one surface that contains one or more depressions, which are at least partially filled with a soluble material. Also described methods of making such devices.

Abstract: Apparatus and methods are provided for creating tubular devices, e.g., as components for catheters, sheaths, and or other devices sized for introduction into a patient. In one embodiment, a method is provided for making a tubular device using a sheet of material including a coated first surface. The sheet is rolled around a mandrel until longitudinal edges of the sheet are disposed near or adjacent one another, e.g., without attaching the longitudinal edges together. A tubular braid is positioned over the sheet-wrapped mandrel, one or more tubular segments are positioned over the tubular braid, and heat shrink tubing is positioned over the tubular segments. The resulting assembly is heated to cause the tubular segments to at least partially reflow and/or otherwise laminate the tubular segments to the tubular braid and sheet. The heat shrink tubing and mandrel are then removed to create the tubular device.

Abstract: A bioerodible composition for delivery of a bioactive agent is the reaction product of a reaction mixture which includes an oxidized dextran solution, and a mixture of solids containing a dihydrazide, a bioactive agent, and optionally a pH adjusting agent in an amount sufficient to achieve a pH of the reaction mixture of 6 or less. The composition may include a release agent for controlled release of the bioactive agent from the composition.

Abstract: A flow regulating implant is provided with one or more grooves for allowing fluid flow. One or more grooves may have a constant or varying cross-section along its length. One or more grooves may have in it biodegradable material, absorbable material, and/or threads or sutures. A resilient band or coating may be placed around the implant or one or more grooves, to act as a pressure regulator. The implant may have a side projection, such as a side pin, for engaging tissue. The implant may comprise two or more parts that are held at a distance from each other to allow fluid flow between the parts.

Abstract: A catheter includes a proximal portion and a distal portion, the distal portion including an arcuate portion. The catheter further includes a rotating portion, the rotating portion connecting the proximal portion and distal portion, the rotating portion including a first piece and a second piece, wherein the first piece and second piece create a snap fit. Methods of using the catheter include threading the inserted catheter through the vasculature and allowing the distal portion to freely rotate about an axis defined by the rotating portion responsive to any tortuosity in the vasculature.

Abstract: Methods are provided for surface modifying a hydrophobic polymer substrate to increase wettability comprising the steps of pre-treating the hydrophobic polymer substrate with a radio frequency (RF)-generated first plasma and a RF-generated second plasma wherein the first plasma and the second plasma are applied sequentially, coating the hydrophobic polymer substrate with a hydrophilic coating; and polymerizing the hydrophilic coating on the hydrophobic polymer substrate by exposure to a RF-generated third plasma.

Abstract: There is provided a device comprising a body structure having one or more surfaces wherein at least one of the surfaces comprises a pH sensitive layer comprising a linear polymer, wherein the water solubility of the linear polymer increases from a first water solubility to a second water solubility at a pH trigger. A method of forming a device, and a method of preventing or mitigating infection is also described.

Abstract: The device made in a resorbable material intended to be placed in urethra for Treatment of stricture has the shape of a tube (1), the wall of which has offices (2).

Abstract: A catheter is disclosed that has a detachable tip for delivery of a therapeutic substance to a chronic total occlusion (CTO) within a body vessel. The tip is made from a biodegradable material and includes an active agent dispersed therethrough. The detachable tip pierces into the calcified lesion, detaches from the catheter, and remains embedded within the lesion as the tip degrades, thereby releasing the active agent. The active agent is a therapeutic substance effective to treat of a CTO. The active agent may be a drug, an enzyme, bacteria, or a parasite that degrades or softens the calcified lesion.

Abstract: A vapor hydrated packaged catheter assembly includes a gas impermeable package housing a catheter within a catheter-receiving cavity. The catheter assembly has a hydrophilic coating on at least a portion of the outer surface of a catheter tube which may be surrounded by a sleeve. The catheter assembly is disposed within the catheter receiving cavity of the package with 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. The catheter assembly is ready to use due to exposure of the hydrophilic coating to a vapor produced by the vapor donating liquid.

Abstract: Systems, devices, methods, and compositions are described for providing an actively controllable implant configured to, for example, monitor, treat, or prevent microbial growth or adherence to the implant.

Abstract: Systems, devices, methods, and compositions are described for providing an actively controllable implant configured to, for example, monitor, treat, or prevent microbial growth or adherence to the implant.

Abstract: The present invention relates to provide a catheter tube having excellent insertability into the body, excellent operability and an excellent anti-thrombogenic property, and also provide a catheter having the tube. For the purpose, a catheter tube of the present invention comprises a mixture of an isobutylene block copolymer and a thermoplastic polyurethane resin, wherein the isobutylene block copolymer is composed of a polymer block mainly comprising isobutylene and a polymer block mainly comprising a monomeric component other than isobutylene; and a catheter using the tube.

Abstract: A sacrificial catheter assembly and method of use for placing a functional catheter within the body of a patient, such as into the patient's vasculature, is disclosed. In one embodiment, the sacrificial catheter assembly comprises a sacrificial catheter including an elongate body that defines a longitudinally extending lumen. A stylet is removably received within the lumen of the sacrificial catheter such that the catheter and stylet can be advanced together to a target destination within the body of the patient. The sacrificial catheter is configured so as to then be proximally slid over the stylet to remove the sacrificial catheter from the body while the stylet remains in place at the target destination. A functional catheter can then be distally slid over the stylet to place the functional catheter at the target destination. The stylet can then be removed from the body of the patient.

Abstract: This invention relates to achieving or improving uniform distribution of fluid flow in medical devices such as when combined with antibiotics impregnated in a catheter and/or with a drug-eluting catheter to further inhibit the catheter from becoming occluded by debris in the CSF or by bacterial biofilm formation or tissue proliferation in the catheter.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: The present invention generally relates to a medical surgical device and specifically a wire guide for percutaneous placement within a body lumen. The wire guide includes an elongated mandrel having sufficient flexibility and kink resistance and a cannula having a stiffness greater than the mandrel stiffness for sufficient pushability. The mandrel extends through the cannula and has a portion extending distal thereto to form a distal tip of the wire guide. The wire guide can further include a slotted cannula to improve the flexibility of the wire guide at the proximal portion of the wire guide. The slots can be arranged in various patterns for increased flexibility along the longitudinal length of the cannula, as well as increased circumferential flexibility along the wire guide. The mandrel may also have a proximally tapered portion to improve the flexibility of the wire guide at the proximal portion of the wire guide.

Abstract: The invention relates to a silicone catheter including chlorhexidine gluconate, methods of making this catheter, and methods of using it. The method of making the catheter includes contacting a silicone catheter with a liquid containing chlorhexidine gluconate. Chlorhexidine gluconate is stably incorporated into the silicone catheter. The invention also relates to a silicone medical device or article including chlorhexidine gluconate and methods of making this such a medical device or article.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: Systems, devices, methods, and compositions are described for providing an actively-controllable disinfecting implantable device configured to, for example, treat or prevent an infection in a biological subject.

Abstract: A medical instrument to be inserted into a living body before being used. The medical instrument is provided with a medical instrument main body including a long linear body having flexibility on which a coating layer covering at least the outer periphery on the distal side thereof is formed. The coating layer composes of a first layer which includes a material containing a low-friction resin material capable of lowering friction and a binder resin material serving as a binder; a second layer which is formed on the first layer and includes a material containing a low-friction resin material and a pigment and in which the content of a binder resin material is lower than the binder resin material content of the first layer or nil; and a third layer which is formed on the second layer and includes a material containing a low-friction resin material.

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: The present invention relates to antimicrobial agents, methods for the production of these agents, and the use of these agents. The antimicrobial agent of the present invention includes a water-soluble polymer and oligodynamic metal ions which interact with counter-ions of the polymer such that the metal ions are bound to corresponding counter-ions. The water-soluble polymer controls a sustained release of the metal ions. The oligodynamic metal ions preferably include small size metal particles (e.g., nano-sized silver particles) that interact to the water-soluble polymer as well as metal ions derived from one or more water-soluble oligodynamic metal compositions (e.g., metal sulfates and/or metal nitrates). The agent may also include one or more acids, including organic acids (such as sulfates, carboxylic acids, amines, hydroxyls, nitrates, and phosphates) and/or non-organic acids (such as boric acid and dioctylborate).

Abstract: An entry port cuff for providing antimicrobial properties to a medical device having a portion that is insertable into the body of a patient is disclosed. The cuff, which is charged with an antimicrobial agent, is removably attached to the medical device immediately prior to or immediately after insertion of said medical device into the body. The cuff is attached to the medical device in a manner such that the cuff is located outside of the body and in the proximity of the point of entry of the medical device into the body. Also, the cuff is substantially free of an adhesive for adhering the cuff to the body. Methods for using and making the entry port cuff are also described.

Abstract: The present invention provides antibiofilm composition comprising two or more agents selected from the group consisting of DispersinB™, 5-Fluorouracil, Deoxyribonuclease I and Proteinase K for preventing growth and proliferation of biofilm-embedded microorganisms in wound care, oral care, and disease-related infections and methods of treatment in mammals. The invention further provides methods for preparing medical devices, and wound care devices using an antibiofilm composition comprising two or more antimicrobial agents selected from the group consisting of DispersinB™, 5-Fluorouracil, Deoxyribonuclease I and Proteinase K.

Abstract: The present invention relates to a method for covalently attaching a compound to a stainless steel, tin, iron, or titanium substrate, by contacting exposed surface(s) of the substrate with a synthetic pilin peptide containing a disulfide loop derived from the C-terminal receptor binding protein of Type IV P. aeruginosa (T4P) pilin, to bind the pilin peptide to the exposed surface(s), and covalently attaching the compound to the pilin peptide. Also disclosed are a substrate formed by the method and a biosensor device that uses the uses. Also disclosed are methods for improving the corrosion resistance, adhesive force, hardness and electron work function of certain metals.

Abstract: Methods are provided for surface modifying a hydrophobic polymer substrate to increase wettability comprising the steps of pre-treating the hydrophobic polymer substrate with a radio frequency (RF)-generated first plasma and a RF-generated second plasma wherein the first plasma and the second plasma are applied sequentially, coating the hydrophobic polymer substrate with a hydrophilic coating; and polymerizing the hydrophilic coating on the hydrophobic polymer substrate by exposure to a RF-generated third plasma.

Abstract: This invention relates to the placement of nasogastric tubes. Specifically, the present invention relates to devices, methods, and kits for assisting intubation and insertion.

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 coating composition in the form of a one or multi-part system, and method of applying such a composition under conditions of controlled humidity, for use in coating device surfaces to control and/or improve their ability to release bioactive agents in aqueous systems. The coating composition is particularly adapted for use with medical devices that undergo significant flexion and/or expansion in the course of their delivery and/or use, such as stents and catheters. The composition includes the bioactive agent in combination with a first polymer component such as polyalkyl(meth)acrylate, polyaryl(meth)acrylate, polyaralkyl(meth)acrylate, or polyaryloxyalkyl(meth)acrylate and a second polymer component such as poly(ethylene-co-vinyl acetate).

Abstract: A catheter extending from a distal end which, when in an operative position is inserted within a body of a patient, to a proximal end, the catheter comprising a charge holding cavity to which a therapeutic compound is to be supplied and a wall including inner and outer portions, an inner surface of the inner portion surrounding the charge holding cavity with an outer portion surrounding at least a portion of an outer surface of the inner portion, wherein the inner portion is formed so that a first diffusion rate of the therapeutic compound therethrough is different from a second diffusion rate through the outer portion.

Abstract: Self-dissolving needle-like or filamentous shape percutaneously absorbable preparations, by which inherently poorly absorbable drugs into the body through the skin is efficiently administered. The preparations are made of at least one material selected from the group consisting of proteins, polysaccharides, polyvinyl alcohols, carboxyvinyl polymers and sodium polyacrylic acids. An active substance contained therein is released in a sustained-release fashion (1) by forming a water-insoluble layer on its surface, (2) by holding the active substance in porous materials, or (3) by imparting a long-acting characteristic to the active substance. The present invention also provides a sheet-like carrier for holding the preparations on at least one of the sides thereof, and a piece of equipment for holding the preparations so as to facilitate the administration of them.

Abstract: The present invention relates to medical devices that are inserted or implanted into patients and that have antimicrobial coatings that release free radicals into the vicinity of the device. These devices may have coatings that alter their rate of flow release or elution release of an antibacterial agent from a coating on the device upon external stimulation. The coating should therefore be responsive to external control such as by heating, external RF stimulus, sonic control, visible or ultraviolet light exposure and the like. By having control of the release rate, and in some structures without invasion of the patient by mechanical means in addition to the device itself, the release rate can be in response to need at the implant site. The class of compounds to be released are free radical generating or initiating compounds, or compounds that release free radicals upon immersion or stimulation, the free radicals acting as the antimicrobial agent.