Abstract: The invention relates to a coating formulation for preparing a medical coating, which coating formulation comprises (a) at least one multifunctional polymerizable compound according to formula (I), wherein G is a residue of a polyfunctional compound having at least n functional groups, wherein each R1 and each R2 independently represents hydrogen or a group selected from substituted and unsubstituted hydrocarbons which optionally contain one or more heteroatoms, and wherein n is an integer having a value of at least 2; and (b) at least one initiator.

Abstract: In a medical device, an antimicrobial agent is combined with an elastomeric polymer material. The antimicrobial agent includes at least one chlorhexidine/fatty acid salt which is a neutralization product of chlorhexidine base and a fatty acid having between 12 and 18 carbon atoms.

Abstract: An adhesive material for medical use comprising gelatin and a non-toxic cross-linking material such as transglutaminase. An optional embodiment of the invention includes dressings in which a layer of a transglutaminase is sandwiched between a first and second layer of gelatin. The hemostatic products are useful for the treatment of wounded tissue.

Abstract: The invention describes the use of an inorganic substance which forms hydrogen cations when in contact with an aqueous medium, which trigger an antimicrobial effect, the substance containing molybdenum and/or tungsten.

Abstract: An improved endotracheal tube that has a modified surface coating that can elute active agents is described. The coated surface and the use of the device according to a new method or regime for a healthcare worker to care for patients can help reduce the likelihood of ventilator acquire pneumonia or other infections in a patient's respiratory passages.

Abstract: The application discloses a method for the preparation (by extruding, injection moulding or powder coating and subsequent cross-linking by irradiation with UV or visible light) of a medical device element involving a coating composition comprising: a) as the only polymer constituent(s), at least 50% by weight of poly(ethylene oxide)(s) optionally in combination with non-thermoplastic hydrophilic polymer(s), and b) low molecular weight scaffold(s) having a plurality of photo-initiator moieties covalently linked thereto and/or covalently incorporated therein, wherein the photo-initiator moieties constitute 0.01-20% by weight of the combined amount of the poly(ethylene oxide)(s), any non-thermoplastic hydrophilic polymers and the low molecular weight scaffolds.

Abstract: It is intended to provide a thrombus-aspiration catheter capable of exerting flexibility and aspiration force even in the case where the tube in the front end side is a triple lumen tube or a contrast marker is provided at the front end. A thrombus-aspiration catheter comprising a basal end side tube of the double lumen type which has an aspiration lumen and a core wire lumen, and a front end side tube of the triple lumen type which has a guide wire lumen in addition to the aspiration lumen and the core wire lumen, wherein the front end of the above-described front end side tube is obliquely cut and a terminal aspiration tube of a flexible double lumen, which has a front end opening inclined in almost the same direction as the cut face, is connected to the cut face.

Abstract: A transcutaneous access shield with an instrument opening and surrounding wall to prevent infection during surgical and other medical procedures. The shield resists the entry of microbes from the skin at the body access point. A shield positioner and skin hook can be used to improve placement of the shield.

Abstract: The subject matter of the invention is an aspiration drainage system for aspirating secretions and other fluids out of the human or animal body using a suction tube and at least one material depot, arranged at the end of the suction tube to be inserted into the body, for dispensing an antibacterial active ingredient material. The surface of the material depot is larger than the envelope of the material depot. The increased surface of the material depot effects a higher level of the antibacterial active ingredient material and permits effective destruction in situ of both sensitive pathological germs and partially resistant germs.

Abstract: An implantable medical device comprising a drug-loaded polymer overlaid with a fabric that promotes tissue ingrowth is useful in a wide variety of tissue engineering applications. The invention includes, for example, prosthetic heart valves, annuloplasty rings, and grafts, having enhanced biocompatibility and biostability. Methods of making and using the implantable medical devices of the invention are also included.

Abstract: A catheter assembly comprises an outer catheter including an outer catheter body and an outer catheter hub at a proximal portion of the outer catheter body; and an inner catheter including an inner catheter body insertable in the outer catheter body, a tip at the distal portion of the inner catheter body which is rich in flexibility, and an inner catheter hub at the proximal portion of the inner catheter body adapted to be coupled to the outer catheter hub. The inner catheter body includes a flexible section connected the tip, a physical property transition section on the proximal side of the flexible section, a first body section on the proximal side of the physical property transition section, a second body section on the proximal side of the first body section, greater than the first body section in flexural rigidity, and having a reinforcing material layer.

Abstract: A device and method for treatment of intracranial vasospasm is provided. The device is a microcatheter having a steeply tapered end and is thicker walled, and in a preferred embodiment is braided to provide greater pushability. In order to achieve a thicker walled catheter, in one embodiment, the inner lumen diameter can be reduced, leaving the outer diameter the same while in another embodiment the catheter is larger in outer diameter. In one embodiment, the microcatheter is coated with performance enhancing lubricant, such as a hydrophilic coating. Further, the microcatheter can also be coated with drugs and serve as a drug delivery device, drugs being embedded into vessel intima. In the use of the method of treatment, the device is fed into the smaller arterial vessels in the brain simultaneously dilating arteries of various caliber along the path of the catheter to relieve vasospasm; pharmacological agents can then be delivered by the microcatheter to further effect treatment.

Abstract: Disclosed is a system that prevents the development of infection and biofilm establishment in medical devices in general, and in particular Urinary Tract Infections (UTI), including Catheter-Associated Urinary Tract Infections (CAUTI). The system comprises a medical device (such as a catheter) and an antimicrobial composition containing an antimicrobial compound. A medical device delivers the composition both to the inside and/or outside portions of the device, as well as to the inside of the bladder itself and to the urethra. Reduction or elimination of the infection may be accomplished by irrigating the medical device, bathing the bladder, or irrigating the bladder with the composition.

Abstract: A method is provided for securing a fluid meter to a fluid collection bag. The method includes the steps of providing a meter ha6 ving a housing defining a fluid receptacle and at least one drain opening, providing a collection bag defining a fluid reservoir and having at least one inlet opening and securing the meter to the bag using an RF welding device to allow fluid communication between the fluid receptacle and the fluid reservoir. In one embodiment, the housing includes a raised surface positioned about the at least one drain opening to which the collection bag is welded.

Abstract: A long nose manipulatable catheter is described herein. The catheter generally comprises a flexible joint region defining a main lumen and an adjacent wire lumen. The wire lumen has an opening near or at a distal end of the flexible joint region and a push/pull wire can be pushed or pulled through the wire lumen. The catheter assembly may also comprise at least one radio-opaque marker band for securing the push/pull wire. The joint region has a predetermined length sized to affect a flexure of the joint and is generally located at the distal end of the catheter. The joint region itself may be varied to extend distally from where the braid terminates, or it may extend to encompass a portion of the braid. By varying a length of the joint region, the amount of curvature and flexure of the joint region can be controlled.

Abstract: Medical devices can include a lubricious echogenic coating that is slippery when wet and provides visibility during ultrasonic imaging.

Abstract: A method comprises preventing or inhibiting bacterial adhesion and/or bacterial biofilm development by treating a substrate with a composition of a soluble group II capsular polysaccharide obtained from a bacterial strain.

Abstract: Described herein are coatings containing water-soluble oligodynamic metal salts that are formulated and applied from hydrophobic solvents. In particular, articles of manufacture comprising polymer coatings containing oligodynamic metal salts can include hydrophobic polymer coatings made from water-reactive monomers and hydrophilic polymers compounded in hydrophobic solvents which contain a small amount of water that aids in the solubilization and suspension of the oligodynamic metal salts. Methods of preparing these antimicrobial polymer coatings, and methods of coating a substrate to produce an article of manufacture having an antimicrobial polymer coating are also described.

Abstract: A medical device with anti-microbial properties to prevent infections. This medical device, such as an in-dwelling catheter, has a portion that is insertable into the body of a patient and accessible from outside the body once the portion is inserted. The portion has an outer wall, a first active lumen within the outer wall, and a false lumen within the outer wall in which the false lumen has a distal portion and a proximal portion. The false lumen contains an anti-microbial agent that provides the outer wall with anti-microbial properties. The distal portion of the false lumen is sealed. The false lumen may be adjacent to the first active lumen. The medical device may also contain a second active lumen, wherein the first active lumen is an inlet lumen and the second active lumen is an outlet lumen. Alternatively, the false lumen may surround the first active lumen.

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: To provide a medical treatment device wherein the antithrombotic property and lubricity of a coating formed on the surface can be maintained in a stable state for a long period and also to provide a method for manufacturing the same. A mixture solution for coating wherein a copolymer of methyl vinyl ether with maleic acid anhydride, a quaternary ammonium salt and a polyether block amide dissolved in an organic solvent are applied upon the surface of a substrate comprising synthetic resin to form a coating and then urokinase and heparin are impregnated in the coating of the medical treatment device. The synthetic resin comprising the substrate is polyurethane, polyvinyl chloride, nylon or nylon elastomer. The quaternary ammonium salt is tridodecylmethylammonium chloride. An alkaline treatment is applied to a predetermined part of a substrate upon which a coating has been formed by application of the mixture solution.

Abstract: The present invention relates to antimicrobial compositions, methods for the production of these compositions, and use of these compositions with medical devices, such as catheters, and implants. The compositions of the present invention advantageously provide varying release kinetics for the active ions in the compositions due to the different water solubilities of the ions, allowing antimicrobial release profiles to be tailored for a given application and providing for sustained antimicrobial activity over time. More particularly, the invention relates to polymer compositions containing colloids comprised of salts of one or more oligodynamic metals, such as silver. The process of the invention includes mixing a solution of one or more oligodynamic metal salts with a polymer solution or dispersion and precipitating a colloid of the salts by addition of other salts to the solution which react with some or all of the first metal salts.

Abstract: A medical device including a coating disposed on at least a portion of a surface of the medical device, the coating including at least one polymer material having reversible wettability.

Abstract: A system and method in accordance with the present invention provides a infusion catheter that is flexible, has such a smooth traction and a low profile to minimize break up of the obstruction when crossing it, can access distal vasculature quickly, is easy to use and readily to be implemented in the conventional PCI. Another object is to provide a method that can be performed within a short period of time and employs the catheter described herein to infuse a therapeutic agent distally to the obstruction before it is removed as a means of reducing reperfusion injury, protecting distal vasculature and microcirculation, preserving myocytes, reducing infarct size and ischemic damages in the heart, brain, lung, liver, kidney and limb. Another object is to provide complementary feature options to the infusion catheter and the aspiration catheter to improve the speed and quality of the vessel clearance.

Abstract: The invention relates to a mixture (a) of fatty acid triglycerides having a slip melting point above 500 C, the fatty acid composition of said mixture (a) comprising at least two different fatty acids and comprising from 20 to 95% by weight of saturated fatty acids and 80 to 5% by weight of unsaturated fatty acids, and wherein at least one fatty acid triglyceride (a1) from said mixture (a) bears the same saturated fatty acid residue on each position of the glycerol moiety and corresponds to at least 10% by weight of said mixture (a). This mixture is useful in the coating of medical devices to improve bio-compatibility, stability, and drug release.

Abstract: A polymer of fluorinated monomers and hydrocarbon monomers is provided. It is also provided a polymer blend that contains a polymer formed of fluorinated monomers and hydrocarbon monomers and another biocompatible polymer. The polymer or polymer blend described herein and optionally a bioactive agent can form an implantable device such as a stent or a coating on an implantable device such as a drug-delivery stent, which can be used for treating or preventing a disorder such as atherosclerosis, thrombosis, restenosis, hemorrhage, vascular dissection or perforation, vascular aneurysm, vulnerable plaque, chronic total occlusion, claudication, anastomotic proliferation for vein and artificial grafts, bile duct obstruction, ureter obstruction, tumor obstruction, or combinations thereof.

Abstract: Antimicrobial and biofilm-inhibiting nitric oxide-releasing medical appliances for installation into a patient, and processes for producing the medical appliances. The medical appliances are configured for conveying materials into and out of the patient's body and may comprise tubings or pouching systems. The medical appliances comprise a gas-permeable cured resin material selected from the group consisting of curable silicones, polyvinyl acetates, thermoplastic elastomers, acrylonitrile-butadiene-styrene copolymer rubber, polyurethanes and selected combinations thereof, wherein the gas-permeable cured resin material comprises a matrix suitable for releasably sequestering therein permeating gases. A plurality of nitric-oxide gas-releasing moieties is sequestered within and through the gas-permeable resin material. Nitric oxide is released from at least a portion of said plurality of nitric oxide gas-releasing moieties upon contact of the medical appliance with a moisture source.

Abstract: Apparatus and methods are provided for substantially continuously forming thin-walled sleeves that may be incorporated into tubular devices sized for introduction into a patient. In one embodiment, a pair of sheets including coated surfaces oriented towards one another are directed through a cutting apparatus to cut the sheets into multiple pairs of strips. The pairs of strips are bonded together to create a plurality of sleeves having lumens defined by the coated surfaces. In another embodiment, a sheet having a coated surface is fed through a cutting tool to separate the sheet into a plurality of strips, and the strips are formed into sleeves, e.g., by feeding the strips through a die or mandrel using a substantially continuous process. Optionally, the sleeves may be subsequently cut into individual tubular devices and/or further processed, e.g., by providing one or more layers around the sleeves to create catheters, sheaths, or other apparatus.

Abstract: A connector comprising a needless access device and a backflow check valve for transferring fluids and method therefor. The connector may have a first port, a second port, and a third port. A first valve element may be positioned within the first port and a second valve element may be positioned within the second port. The first valve element may be in a first position as a first fluid flows between the first and third ports. The second port may be used to introduce a second fluid into the connector. Upon introduction of the second fluid to the connector, the first valve element may move from the first position to a second position. In the second position, fluid may be prevented from flowing past the first valve element.

Abstract: The present invention includes a system and method for wetting a catheter. The wetting system can include a catheter container, a fluid packet, and a catheter. The fluid packet and catheter container are adapted and configured to require opening the packet and moving the container to wet the catheter. The method includes opening the packet and moving the container to wet the catheter.

Abstract: An ultraviolet curable lubricious coating including at least one lubricious polymer and at least one oxygen-insensitive crosslinkable polymer, methods of making and using the same, and articles coated therewith.

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: Disclosed is a system that prevents the development of infection and biofilm establishment in medical devices in general, and in particular Urinary Tract Infections (UTI), including Catheter-Associated Urinary Tract Infections (CAUTI). The system comprises of a medical device (such as a catheter) and an antimicrobial composition containing an antimicrobial compound. A medical device delivers the composition both to the inside and/or outside portions of the device, as well as to the inside of the bladder itself and to the urethra. Reduction or elimination of the infection may be accomplished by irrigating the medical device, bathing the bladder, or irrigating the bladder with the composition.

Abstract: Multi-lumen catheter devices having at least one split-tipped end are disclosed, together with methods of forming such split tip catheters. In one aspect of the invention, the manufacturing methods can include the steps of: providing a catheter body having at least a first and a second internal lumen extending longitudinally through the catheter body; removing a distal portion of the catheter body to form a first distal tip segment such that the first lumen extends longitudinally within this tip segment beyond the second lumen; and joining a second lumen tip segment to the catheter body in communication with the second lumen. The second tip segment can be joined to the catheter body such that it is at least partially separated from the first tip segment and, in some embodiments, preferably diverges at an angle relative to the first tip segment.

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: 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: A predetermined arrangement of differentially lubricious areas on a balloon catheter for controlling against unexpected movement of a stent carried thereon when in situ in the body.

Abstract: Coated devices for introduction into bodies and methods for making and using them are provided, such as delivery sheaths, guidewire lumen cores, and elongate leads. In one embodiment, a tubular 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 a relatively thin inner polyurethane liner including a coating on an inner surface thereof, e.g., providing a lubricious and/or hydrophilic lumen, and an outer layer surrounding the liner. In another embodiment, a lead is provided that includes a proximal end, a distal end, and at least one electrode on the distal end. A polyurethane cover surrounds at least a portion of an outer surface of the lead that include a coating, e.g., including a lubricious and/or hydrophilic material. Optionally, the cover may be removable from around the lead body.

Abstract: This disclosure relates to a fixed- or variable-length, wire-reinforced catheter for use in a human body or connected to a subcutaneous port implanted in a human body for use under a cyclical internal load and method of adaptation thereof, and more particularly, to a wire-reinforced catheter of increased internal diameter or reduced external diameter of fixed or variable lengths for the optimized transportation of blood under cyclical internal load and without damage.

Abstract: A medical apparatus and method of use for implanting a percutaneous catheter in a patient's body which catheter can be easily positioned, repositioned, and replaced. The apparatus includes an elongate sleeve having a tapered forward portion to facilitate its insertion through an undersized incision. The sleeve provides an interior elongate passageway which extends from a sleeve proximal end to a sleeve distal end. The sleeve is intended to be percutaneously implanted through an incision in the patient's skin so that the sleeve distal end resides subcutaneously. The sleeve outer peripheral surface carries a layer of porous material intended to be placed under the patient's outer skin layer in contact with the dermis to promote tissue ingrowth for anchoring the sleeve and forming an infection resistant barrier. The sleeve passageway is dimensioned to snugly accommodate the outer surface of catheter while permitting the catheter to slide relative to the sleeve.

Abstract: Lubricous coatings, methods for making an using lubricous coatings, and medical device that include lubricious coatings. An example lubricous coating may include includes a hydrophilic polymer, a flow modifier, an acrylic monomer, a photoinitiator, and a solvent. The coating can be used to coat a medical device along an inner surface, an outer surface, or an intermediate surface.

Abstract: A method for making a tubular device includes coating a first surface of a thin sheet, rolling the sheet such that side edges of the sheet are disposed adjacent one another with the coating disposed inwardly, creating a longitudinal seam along the side edges to create a sleeve, and attaching a tubular structure around the sleeve. In another embodiment, the method includes coating a first surface of a thin sheet, wrapping the sheet partially around a mandrel with the coating disposed inwardly, positioning a slotted tube around the sheet and mandrel, attaching the tube to the thin, and trimming any excess material of the sheet. In another embodiment, the method includes coating an outer surface of a thin sleeve, inverting the sleeve, and attaching a tubular structure around the inverted sleeve, thereby providing a tubular device including a lubricious, hydrophilic, and/or otherwise coated inner surface.

Abstract: The present invention is directed to compositions and methods for preventing or inhibiting biofilm formation on a solid substrate comprising an antimicrobial agent and a biofilm-degrading enzyme embedded in a matrix material.

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

Abstract: Disclosed herein are biodegradable solid microneedles and a fabrication method thereof. The microneedles are small in diameter and are long and hard enough to pass through the stratum corneum. Thus, the biodegradable solid microneedles can be used for painless transdermal drug delivery, the detection of biological samples such as blood, and biopsy.

Abstract: A catheter having a plurality of longitudinal lumens for removing biological, natural and/or man-made materials from cavities, ducts, vessels, or other locations in a patient's body. The multi-lumen catheter comprises a longitudinally-extending suction lumen with suction holes through which materials pass into the lumen in response to suction forces generated by a source of negative pressure coupled to a proximal end of the lumen. A longitudinally-extending vent lumen coupled to a source of at least neutral vent pressure through, for example, an opening to ambient air at the proximal end of the lumen, and preferably, through vent holes disposed along a length of the catheter. A dividing septum between the adjacent lumens has one or more ports fluidically coupling the lumens.

Abstract: A medical device for use in connection with a connector of an indwelling line for cleansing a surface of a septum of the connector is provided. The medical device includes a housing including a proximal portion defining a cavity containing a quantity of microbial reducing agent, a distal portion defining a cavity for selective coupling with the connector of the indwelling line, and a partition separating the proximal and distal cavities, wherein the proximal and distal cavities are in fluid communication with one another; and a deformable member overlying an end of the proximal portion for maintaining the microbial reducing agent within the proximal cavity thereof. The microbial reducing agent being dispensable into the distal cavity, at least when the medical device is connected to the connector of the indwelling line, to awash a surface of the connector of the indwelling line and reduce microbes present thereon.

Abstract: The invention is directed to an apparatus, such as a medical device, having a surface coated or covered with a decellularized extracellular matrix or having a component comprising the decellularized extracellular matrix for implantation into a subject, preferably a human. In one embodiment of the invention, a decellularized extracellular matrix is used to form a bodily implant such as a vein, an artery, an esophagus, or a ventricular restraining device. In some embodiments of the invention, the decellularized extracellular matrix is configured to be a time released therapeutic. In another embodiment of the invention, a decellularized extracellular matrix forms an aneurysm treatment device, such as an aneurysm coil, a seal, a pouch, or a filler. In a further embodiment of the invention, decellularized extracellular matrix is used to embolize lesions, tumors, or vessels.

Abstract: A device for sterilizing a tubular medical line IV port. The device includes a cap having an open tubular cavity on a distal end which is dimensioned to receive the medical line port therein. A handle is provided on the proximal end of the device for grasping and manipulating the cap. An outer disinfectant-impregnated member is coaxially secured in the distal cavity and dimensioned for engaging and scrubbing exterior surfaces or threads of the tubular port when inserted into the cavity. An inner disinfectant-impregnated member may also be coaxially secured in the cavity to simultaneously scrub internal surfaces of the port.

Abstract: A medical device for insertion into the human body has improved sliding characteristics. The medical device for insertion into the human body includes a substrate having given shape, and an agent for improving the sliding characteristics having a hydrophilic block and a hydrophobic block, and coating the hydrophobic surface.