Abstract: Provided herein are compositions, devices and systems comprising thermoresponsive, biodegradable elastomeric materials, and methods of use and manufacture thereof.

Abstract: The present invention describes a combined vaccine that offers broad protection against meningococcal disease caused by the pathogenic bacteria Neisseria meningitidis. The vaccine is comprised of four distinct polysaccharide-protein conjugates that are formulated as a single dose of vaccine. Purified capsular polysaccharides from Neisseria meningitidis serogroups A, C, W-135, and Y are chemically activated and selectively attached to a carrier protein by means of a covalent chemical bond, forming polysaccharide-protein conjugates capable of eliciting long-lasting immunity to a variety of N. meningitidis strains in children as well as adults.

Abstract: The present invention provides a composition comprising an antibody or fragment thereof against oxidized Collagen II (CII) in which the antibody or fragment thereof is conjugated to a pharmaceutically active moiety. The invention also provides a composition comprising an antibody or fragment thereof against oxidized Collagen II (Gil) and a detectable label. The invention further provides the use of such compositions in medicine, in particular for the treatment of an arthropathy, and in methods of diagnosis.

Abstract: The present invention is directed to reagents useful for generating immune responses to Mycobacterium tuberculosis and for diagnosing infection and disease in a subject that has been exposed to M. tuberculosis.

Abstract: The present invention relates to methods and compositions for high content drug screening in Caenorhabditis elegans which may be used to identify compounds that treat disorders associated with protein aggregation. It is based, at least in part, on the discovery that Caenorhabditis elegans, genetically modified to create a model system for disorders of protein aggregation, could be used, in a high throughput screening system, to identify agents that reduce the amount of aggregated protein.

Abstract: The present invention aims at providing a novel indocyanine compound solving problems of conventionally used indocyanine green, such as solubility in water or physiological saline, a synthesis method and a purification method thereof, and a diagnostic composition including the novel indocyanine compound. Further, provided are a method for evaluating biokinetics of the novel indocyanine compound and a device for measuring biokinetics, and a method and a device for visualizing circulation of fluid such as blood in a living body, which utilize the diagnostic composition. Also, found are a novel indocyanine compound in which a hydrophobic moiety in a near-infrared fluorescent indocyanine molecule is included in a cavity of a cyclic sugar chain cyclodextrin to cover the hydrophobic moiety in the indocyanine molecule with the glucose, and a synthesis method and a purification method thereof.

Abstract: The invention relates to a companion diagnostic antibody-like binding protein based on the humanized monoclonal antibody, DS6, to be used as diagnostic tool for in vivo detection and quantification of the tumor-associated MUC1-sialoglycotope, CA6.

Abstract: A solution in which an ultraviolet radiation source is mounted on a flexible substrate is provided. The flexible substrate is capable of having a deformation curvature of at least 0.1 inverse meters. The flexible substrate may be incorporated within an existing enclosure or included in the enclosure. The flexible substrate can be utilized as part of a solution for disinfecting one or more items located within the enclosure. In this case, while the items are within the enclosure, ultraviolet radiation is generated and directed at the items. Wiring for the ultraviolet radiation source can be embedded within the flexible substrate and the flexible substrate can have at least one of: a wave-guiding structure, an ultraviolet absorbing surface, or an ultraviolet reflective surface. A control system can be utilized to manage generation of the ultraviolet radiation within the enclosure.

Abstract: An aroma diffuser using an aroma capsule is disclosed to include a hollow housing including a first opening on a top side thereof, a second opening on a bottom side thereof and an integrated holder member downwardly inwardly extended from a top side thereof and defining therein a holding chamber facing toward the first opening, a heat conduction device mounted in the holding chamber, and a heating element mounted at a bottom side of the heat conduction device and kept in contact with the heat conduction device. Thus, an aroma capsule can be placed in the holding chamber and heated by the heating element to release fragrant vapor. After the aroma contained in the aroma capsule is used up, the aroma capsule can be replaced conveniently and rapidly.

Abstract: The present invention relates to a method for preparing a hydrogel, including the steps of: preparing an enzyme-immobilized support; making contacting with a polymer having a phenol or aniline functional group at a side change and the support in the presence of hydrogen peroxide to cross-link the same; and obtaining a hydrogel by separating the enzyme-immobilized support. According to the present invention, a hydrogel is formed by cross-linking a polymer having a phenol or aniline functional group at a side chain through an enzyme-immobilized support, and thus a hydrogel containing no enzymes is obtained. Therefore, the biomedical application range of a hydrogel can be expanded since it is possible to overcome an in vivo safety problem such as immune reaction caused by an enzyme.

Abstract: Exemplary embodiments of the present invention provide adhesion barriers having anti-adhesion and tissue fixating properties. The adhesion barriers are formed of fatty acid based films. The fatty acid-based films may be formed from fatty acid-derived biomaterials. The films may be coated with, or may include, tissue fixating materials to create the adhesion barrier. The adhesion barriers are well tolerated by the body, have anti-inflammation properties, fixate, well to tissue, and have a residence time sufficient to prevent post-surgical adhesions.

Abstract: Methods of treating with a biodegradable polymeric stent made from poly(L-lactide) and a low concentration of L-lactide monomer is disclosed. The concentration of L-lactide is adjusted to provide a degradation behavior that is suitable for different treatment applications including coronary, peripheral, and nasal.

Abstract: An irrigation and aspiration system is disclosed. The system can be configured to aspirate and irrigate alone, sequentially or concurrently. The system can be configured to aspirate and irrigate the nasal cavity. The system can be manually controlled. The system can have removable and easily cleanable reservoirs for aspirant and irrigant.

Abstract: This relates to a wound therapy device, including an outer part and an inner part facing surface provided with an inner part facing opening, and a first connection channel to establish fluid communication between the inner part facing opening and a connector opening adapted to be connected to an external device. The wound therapy device can also be a part of a wound therapy arrangement, which can further include, a wound filler, an external device, a wound cover film, and tubing connections. Methods of using the wound therapy arrangement are also disclosed.

Abstract: A system and methodology for the preservation of red blood cells is described in which red blood cells are oxygen or oxygen and carbon dioxide depleted, treated and are stored in an anaerobic environment to optimize preparation for transfusion. More particularly, a system and method for extended storage of red blood cells from collection to transfusion that optimizes red blood cells prior to transfusion is described.

Abstract: A system is disclosed for managing a supply of breast milk. In one form the system includes a codified container for receiving expressed breast milk. A computing device receives an image of the expressed milk in the codified container. The codification allows for software to recognize the size and type of the container, as well as scale and orientation, to translate the image into an accurate volume. The milk data is then processed and analyzed to produce feedback regarding the pumping session, such as logs, charts, or reminders. In other embodiments, nipple positioning may be analyzed as well.

Abstract: Various “contactless” bearing mechanisms including hydrodynamic and magnetic bearings are provided for a rotary pump as alternatives to mechanical contact bearings. In one embodiment, a pump apparatus includes a pump housing defining a pumping chamber. The housing has a spindle extending into the pumping chamber. A spindle magnet assembly includes first and second magnets disposed within the spindle. The first and second magnets are arranged proximate each other with their respective magnetic vectors opposing each other. The lack of mechanical contact bearings enables longer life pump operation and less damage to working fluids such as blood.

Abstract: Apparatus and methods for providing extracorporeal blood circulation and oxygenation control include seven-stage de-airing of blood to provide automated cardiopulmonary replacement to sustain patient life during a medical procedure comprising repairing or replacing the heart valve in a patient.

Abstract: Extracorporeal blood treatment systems and methods to detect the connection of one or more components (e.g., of an extracorporeal blood set) thereto (e.g., to one or more pressure transducers contained in the system housing) by, for example, controlling an air pump apparatus to provide air to a connection port at which the component is to be connected and monitoring pressure resulting therefrom to detect whether the component is operatively connected (e.g., based on a detected change in the monitored pressure due to the increased resistance, based on a monitored rate of decay of pressure of injected air, etc.).

Abstract: A separation material includes a matrix that is bound to a saccharide, enabling the separation from a liquid of substances that selectively bind the saccharide. A method for preparing the separation material and a method for separating substances from a liquid that selectively bind a saccharide of the separation material are also described. A device employs the separation material for separating from a liquid substances that selectively bind to the saccharide of the separation material.

Abstract: A syringe for use with a medical injector system includes a barrel and a semi-rigid hub, the hub having an outer surface adapted to slidingly move within the barrel, and an inner surface having a continous circumferential wall. The hub further includes an annular engaging portion recessed within at least part of the continous circumferential wall forming a groove, at least one radially extendable and retractable retention member disposed at partially within a proximal cylindrical portion of the hub, and the elastometric seal engaged with a seal engaging portion on the hub and slidingly engaged with the barrel of the syringe. The semi-rigid hub and the elastomeric seal are reciprocally slidable within the barrel, and the at least one radially entendable and retractable retention member is configured to releasably engage the groove upon retraction of the plunger to permit the semi-rigid hub to be selectively withdrawn within the barrel.

Abstract: A method of implanting a penis erection stimulation system into a patient's body comprises cutting the skin of the patient body, dissecting free an area near the left and right corpus cavernosum, placing a drug delivery device within the dissected area and placing at least one infusion needle of the drug delivery device in a first position in the patient's body in between the left and right corpus cavernosum.

Abstract: A needle guard assembly having a resilient arm extending from a base situated to slide along the shaft of a needle. In one implementation the needle guard has an elongate containment member that rides with the resilient arm and is co-operable with the resilient arm to effectuate a covering of the entire distal tip of the needle upon the needle being retracted into the needle guard.

Abstract: Hydrophilic flat-sheet membrane based on a hydrophobic first polymer from the group consisting of aromatic sulfone polymers and a hydrophilic second polymer, wherein the membrane has a thickness in the range between 30 and 200 ?m, a first and a second surface and a supporting layer having a three-dimensional sponge-like network structure, wherein the supporting layer has a first cover layer on the side thereof facing the first surface and a second cover layer on the side thereof facing the second surface, which cover layers are formed integrally with the supporting layer, and wherein the first and second surfaces have approximately oval or circular openings which penetrate the first and second cover layers, respectively, and are connected to the supporting layer, wherein the average diameter of the openings in the surfaces differ by a factor of less than 2, wherein the three-dimensional network structure of the supporting layer is made up of thick branches and a continuous pore system, and the predominant pro

Abstract: An IV flow rate regulator for precision dosage of medical liquids including a first part, a second part with an integrated outlet tubular connector and a mating attachment part with an integrated inlet tubular connector, coupled to one another in a rotatable manner with a first elastic gasket in a depression in the base wall of the second part, a second elastic gasket in a depression in the base wall of the mating attachment part, a dosing passage groove provided between the first and second gaskets, the dosing groove opening progressively the communication between the inlet tubular connector and the outlet tubular connector by rotation of the first and second parts. Also provided is a method for the fabrication of the IV flow regulator.

Abstract: Some embodiments an infusion pump system can be configured to modify alarm limit parameters as the user's insulin load increases or decreases. Moreover, in particular embodiments, the infusion pump system can be configured to provide a “missed bolus” or “missed meal” alarm in response to the user's blood glucose characteristics, the user's insulin load information, or the like.

Abstract: A cartridge-based computer controlled self-injection device automatically regulates time and dosage administered to a patient. Cartridges can be electronically tagged so the injection device can determine the content, volume, expiration date, and physician prescribed dosage timetable. Authentication verifies the device and ensures the proper patient is using the device with the appropriate therapeutic injectant. Authentication further provides information controlling device operation including expiration dates and clock synchronization. Therapeutic injectant administration statistics, such as date and time of administration of a therapeutic injectant are stored and provide to a health care provider for monitoring. Patients can be notified of nearing or missed administrations.

Abstract: An injection device (100), including a base (104), a sliding body (116) slidably connected to the base (104), a double-ended needle (120) fixed to the sliding body (116), a biasing member (124) for proximally biasing the sliding body (116) with respect to the base (104), and for retracting the needle (120) into the device (100) subsequent to activation of the device (100), a medicament cartridge (128) for holding a medicament, slidably connected to the sliding body (116), and a stopper (132) slidably disposed within the medicament cartridge (128). The base (104) has a proximal end (108) and a surface (164) disposed at a distal end (112) thereof for contacting a patient's skin. The base (104) also has a first locking mechanism. The sliding body, (116) has a locking feature and a second locking mechanism. The second locking mechanism locks the medicament cartridge (128) relative to the sliding body (116) upon completion of displacement of the medicament cartridge (128) relative to the sliding body (116).

Abstract: A locking mechanism is provided for use with a reservoir and a reservoir holder so as to prevent unwanted tampering with the reservoir. The mechanism comprises a main body with an aperture that is coupled to the reservoir. A hinged flange is provided on the main body. The flange folds inwards at the pivot point provided by the hinge, toward the aperture of the main body, allowing the mechanism to pass over the ferrule of the reservoir. Once the mechanism is placed over the cartridge, the flange folds toward the reservoir at the pivot point, flexing away from the main body. The flange rests against the underside of the reservoir ferrule, thereby retaining the reservoir within the locking mechanism. The locking mechanism may be for use with either a disposable or a reusable delivery device.

Abstract: A self-injection device with a miniaturized drug delivery portion is provided. The device includes a housing (10) having an interior volume and the drug delivery portion (20) has a volume enclosed within the housing. The drug delivery portion includes a reservoir (30) containing a fluid to be delivered to a user and a microneedle (22) in fluid communication with the reservoir and extendable through the housing. The drug delivery portion also includes a drive mechanism for expelling fluid from the reservoir through the microneedle, wherein the volume of the drug delivery portion is less than 40% of the interior volume of the housing. The volume of the drug delivery portion may be less than 30% of the interior volume of the housing.

Abstract: A cap assembly for a drug delivery device is present having a cap body to protect and to receive a distal dispensing end of the drug delivery device, an interlock member operably engaged with the cap body and being further adapted to releasably engage with a distal end section of the device's dispensing end to provide a safety lock for the cap body.

Abstract: It is an object of the present invention to provide a syringe which is capable of preventing an accident such that a patient inadvertently sticks her/his hand with an injection needle when improperly performing a needle retracting operation. A sleeve (10) is fitted around a syringe barrel (2) so as to be axially movable from an administration position such that the injection needle (5) projects to a distill side to an accommodation position such that the injection needle (5) is accommodated. A coil spring (16) for biasing the sleeve (10) toward the accommodation position is provided between the sleeve (10) and the syringe barrel (2), and is held in a compressed state in a spring holder (17). The spring holder (17) is disposed in association with the syringe barrel (2) so as to release the coil spring by further pushing the syringe barrel (2) to the distal side after completion of the administration of a liquid drug.

Abstract: An automatic needle device comprises a body into which a needle assembly and needle are mounted. The device also includes a needle guard to cover the needle until it is used and to lock over the needle after use so the needle is not re-exposed. The locking is accomplished with a coil spring action locking device. A container for holding the automatic needle device also facilitates the viewing of the distal end of the needle prior to use on a patient.

Abstract: An infusion set has a retraction dial that can be removably assembled with the infusion set and access a threaded needle hub contained therein such that the dial can be used to advance or retract a needle hub and an inserted needle to a more precisely controlled insertion depth to deliver insulin or other medicament intradermally (i.e. to the upper 3 mm of skin surface). Position of the inserted needle can be maintained by providing a separated and isolated needle hub, main base and main hub of the infusion set that can isolate the inserted needle from external forces such that the needle can be maintained at a depth to deliver content to the upper 3 mm of skin surface during normal use.

Abstract: A pressure support device such as a CPAP machine, is provided, which includes a housing, and a controller enclosed by the housing. The controller operates the CPAP machine independently or in combination with an accessory such as, for example and without limitation, a humidifier. A user interface is operably coupled to the controller and includes a primary display, a secondary display and a single control. The single control is operable in a first mode of operation to adjust operating parameters of the CPAP machine, and in a second mode of operation to adjust operating parameters of the humidifier. The secondary display preferably comprises a dead front, which is operational (e.g., without limitation, visible) only in the second mode of operation. A method of operating a pressure support device is also disclosed.

Abstract: A signaling apparatus for an anesthesia machine, the signaling apparatus comprising an user input sub-module for receiving input information from an user, an available gas sub-module for signaling types of currently available gases according to information of the user input sub-module, and an available gas outlet sub-module for signaling currently available gas outlets according to information of the user input sub-module.

Abstract: Various embodiments of a patient interface device, such as a mask, nasal pillow, or nasal cannula, that includes an adhesive layer provided on a surface thereof that is structured to temporarily bond to the skin of a user of the patient interface device. The adhesive layer may include a bonding agent, such as a polymer gel, having a residual extraction force of between about 50 grams and about 200 grams.

Abstract: A vent assembly for use with a mask assembly includes a first vent and a second vent having at least one different flow characteristic wherein the vent assembly can be switched between the first vent and the second vent to alter flow of exhaled gas from a patient.

Abstract: A method for performing a medical procedure in an intestine of a patient is provided. The method comprises providing a system comprising: a catheter for insertion into the intestine, the catheter comprising: an elongate shaft comprising a distal portion; and a functional assembly positioned on the shaft distal portion and comprising at least one treatment element. The catheter is introduced into the patient, and target tissue is treated with the at least one treatment element. The target tissue comprises mucosal tissue of the small intestine, and the medical procedure can be configured to treat polycystic ovarian syndrome (PCOS).

Abstract: A microcatheter system is disclosed which may include a microcatheter, one or more microcatheter extensions, and/or a microcatheter hub. In an embodiment, the microcatheter has a plurality of zones where the outside diameter of each zone from the distal to the proximal end has an outside diameter that is the same as or greater than the previous zone while the inside diameter is constant throughout the microcatheter length. In a further embodiment, a unique joining mechanism is employed for coupling a microcatheter to a microcatheter extension or to a microcatheter hub.

Abstract: A neuromodulation catheter includes an elongate shaft and a neuromodulation element. The shaft includes two or more first cut shapes and two or more second cut shapes along a helical path extending around a longitudinal axis of the shaft. The first cut shapes are configured to at least partially resist deformation in response to longitudinal compression and tension on the shaft and torsion on the shaft in a first circumferential direction. The second cut shapes are configured to at least partially resist deformation in response to longitudinal compression on the shaft and torsion on the shaft in both first and second opposite circumferential directions.

Abstract: A surgical apparatus is disclosed for delivering a therapeutic device to a desired location within the vasculature of a patient, which includes an elongated tubular body defining a longitudinal axis and having opposed proximal and distal end portions, the tubular body including an outer wall surrounding an interior lumen, wherein an elongated target opening is formed through the outer wall of the tubular body within the distal end portion thereof in communication with the interior lumen. At least one distal sensing electrode is provided on the tubular body adjacent a distal side of the target opening, and at least one proximal sensing electrode is provided on the tubular body adjacent a proximal side of the target opening, wherein the sensing electrodes allow placement of the target opening within the vasculature of a patient for the delivery of a therapeutic device to a desired location.

Abstract: A catheter with three distinct compression resistance coils, including a body coil and two pull wire coils, is disclosed. The triple coil system can provide maximal resistance to compression of the catheter's proximal shaft, as well as maximization of the curve angle that the catheter tip can achieve. Additionally, the tri-coil catheter can allow for a lower initial compression load and a more flexible proximal shaft. A gap between the outer diameter of the pull wire and the inner diameter of the pull wire compression coil that is equal to about 10-30% of inner diameter of the pull wire compression coil can provide optimal catheter performance.

Abstract: A closed IV catheter system, includes a needle shield assembly positioned proximally of a catheter hub and distally of the needle hub. The needle shield assembly cooperates with the catheter hub on the outer circumferential and peripheral surface of the catheter hub. The needle shield adds additional length and width to the closed IV catheter system. An improved manufacturing process with unique materials is also presented.

Abstract: A spring clip needle tip shielding device for arrangement in a catheter hub of an intravenous catheter assembly is provided. The spring clip needle tip shielding device comprises a base plate with a hole extending therethrough and at least one resilient arm extending at an attachment point at said base plate. The at least one resilient arm has a resting state, from which it may be urged to yield free passage through said hole in an axial direction of said base plate in a tension state, said at least one resilient arm being adapted for clamping a needle tip of a needle extending through said hole when said resilient arm is in said resting state. Any straight imaginary line extending longitudinally through said hole in the axial direction of said base plate coincides with said at least one resilient arm when said resilient arm is in said resting state of said body. The spring clip needle tip shielding device is of a rigid material, and at least a part thereof is coated with a solid lubricant.

Abstract: A medical safety needle includes a needle body having a needlepoint, a covering body having a detent portion slidable on the needle body to catch the needlepoint so as to cover the needlepoint, and a resilient cantilever supporting the detent portion, a collar portion slidably fitting on the covering body, which is configured to get in contact with the cantilever to press the cantilever radially inwardly, and a housing being formed in a unitary body with the collar portion or having an end face on which the collar portion is capable of being seated, the housing being configured to carry the covering body from a first position to have the needlepoint exposed to a second position to have the needlepoint covered by the covering body.

Abstract: A telescopic wire guide is disclosed. The telescopic wire guide comprises an outer wire having a proximal end and a distal end. The outer wire has a lumen formed from the proximal end through the distal end. The telescopic wire guide further comprises a core wire disposed within the lumen and slidably movable therealong relative to the outer wire for distally telescopically extending the wire guide a predetermined length.

Abstract: A guide wire (1) for use with a catheter comprises a core wire (3) terminating in a distal portion (18) of flat ribbon-like construction having respective opposite major surfaces (29,30). A spring (24) is brazed to a distal end (27) of the distal portion (18) and to the core wire (3) at a tapering portion (14). A reinforcing member (38) extends axially along the distal portion (18) from a proximal end (26) of the distal portion (18) to a location (40) for reinforcing the distal portion (18) for in turn increasing its torsional rigidity in order to minimize axial twisting of the distal portion (18).

Abstract: A balloon in which a rupture in a circumferential direction can be prevented from occurring, and a method of manufacturing the same is disclosed. The balloon is configured to be arranged on a medical catheter, and includes a dilatable cylindrical portion formed with a birefringent polymer material. A ratio of the number of orientation distributions, calculated by dividing the number of orientation distributions of the cylindrical portion in a circumferential direction by the number of orientation distributions of the cylindrical portion in an axial direction, is less than 2.

Abstract: In a stent kit in which a stent tube has an arc-shaped part at one or both ends, an inner catheter includes an arc-shaped part fitting in, and conforming to, each arc-shaped part of the stent tube. Because of the conforming shapes, the stent tube is not deformed by the inner catheter even if the inner catheter remains within the stent tube over a long time. Consequently, the arcuate shape of the arc-shaped part or parts of the stent tube are reliably restored when the inner catheter is pulled out.