Abstract: The invention provides, inter alia, improved lipid formulations used to generate lipid-encapsulated gas microspheres, and methods of their use.

Abstract: The present invention generally relates to methods and system for the synthesis of imaging agents, and precursors thereof. The methods may exhibit improved yields and may allow for the large-scale synthesis of imaging agents, including imaging agents comprising a radioisotope (e.g., 18F). Various embodiments of the invention may be useful as sensors, diagnostic tools, and the like. In some cases, methods for evaluating perfusion, including myocardial perfusion, are provided. Synthetic methods of the invention have also been incorporated into an automated synthesis unit to prepare and purify imaging agents that comprise a radioisotope. In some embodiments, the present invention provides a novel methods and systems comprising imaging agent 1, including methods of imaging in a subject comprising administering a composition comprising imaging agent 1 to a subject by injection, infusion, or any other known method, and imaging the area of the subject wherein the event of interest is located.

Abstract: Provided herein are novel 10Fn3 domains which specifically bind to PD-L1, as well as imaging agents based on the same for diagnostics.

Abstract: This invention concerns a pharmaceutically-acceptable composition of radioactive metals, which are used for treating various diseases in animals or humans, such as cancer and arthritis.

Abstract: The present invention relates to a method for sterilisation of phospholipid suspensions, useful in the preparation of ultrasound contrast agent precursors comprising phospholipid-stabilised perfluorobutane microbubbles. The method provides sterility assurance, without undue thermal degradation of the phospholipid. The method is also amenable to commercial scale manufacture. Also provided are methods of preparing kits and ultrasound contrast agents incorporating the sterilisation method of the invention.

Abstract: Disclosed is a steam sterilizer, and a single use/disposable container for use in the steriliser and a sterilisation method. The container is a rigid or semi-rigid container having a sealable elongate conduit through which steam sterilant may be introduced into the container and steam sterilant and condensate may be removed from the container. Once one or more items to be sterilised are placed in the container a cover is sealed over the mouth of the container. The steam steriliser has a sterilisation chamber adapted to receive the container and provide sterilant within and around the container. Sterilant is provided to the container via the conduit which is sealed at the end of the sterilisation process.

Abstract: Method for sterilising a body fluid drainage system for handling a body fluid ex vivo. The body fluid drainage system comprises a chamber. The method comprises the steps providing a container containing a surface protective fluid to be released into the chamber of the body fluid drainage system, subjecting the container to radiation sterilisation, inserting the container into the chamber of the body fluid drainage system, and subjecting the chamber containing the container to gas sterilisation. A body fluid drainage system for handling a body fluid ex vivo. The body fluid drainage system comprises a chamber. The body fluid drainage system further comprises a container containing a surface protective fluid. The container is arranged to release the surface protective fluid into the chamber. The surface protective fluid is sterilised by radiation sterilisation. An outer surface of the container and at least the chamber of the body fluid drainage system is sterilised by gas sterilisation.

Abstract: A subject of the present invention is a material comprising at least one electronegative fiber having a negative charge density of between 0.01 and 5 mmol/g and a liquid absorption capacity of less than 9.5 g of physiological saline per g of fiber, for the use thereof in wound healing, and preferentially in wound cleaning. Another subject of the invention is a medical device, such as a dressing or a bandage, comprising such a material.

Abstract: The invention relates to methods for fabricating a flowable hemostatic composition. The invention also relates to hemostatic compositions and methods for promoting wound healing. In various embodiments, the hemostatic compositions comprise crosslinkable collagen molecules having a porosity controlled by the ratio of weight percent collagen solids to weight percent crosslinker when crosslinking the collagen. In other embodiments, the hemostatic compositions comprise crosslinkable collagen molecules having a porosity controlled by the temperature and rate of freezing when drying the composition during fabrication. In some embodiments, the compositions contain additional agents, including biological agents.

Abstract: Material webs suitable for use in conjunction with disposable absorbent articles are disclosed herein. The material webs comprise a melt additive that when subjected to thermal energy may be encouraged to bloom across the entirety of the web or in localized areas of the web where localized thermal energy is applied.

Abstract: A medical dressing is disclosed, comprising a substrate comprising a first chemical compound, said substrate having a first surface, wherein said medical dressing further comprises an adhesive layer having a skin-facing surface to adhere said medical dressing to a dermal surface, wherein at least a portion of said skin-facing surface comprises a coating comprising a second chemical compound. Also disclosed is a method of manufacturing such a medical dressing.

Abstract: A medical dressing (30) is disclosed, comprising an adhesive layer (3) having a skin-facing surface (6) to adhere the medical dressing to a dermal surface, wherein said adhesive layer comprises a first chemical compound incorporated within said adhesive layer, and wherein at least a portion of said skin-facing surface comprises a coating (9) comprising a second chemical compound. Also disclosed is a method of manufacturing such a medical dressing.

Abstract: In one aspect, the present invention includes a haemostat composition that includes a chitosan, chitosan salt or chitosan derivative, and a physiologically acceptable acid, which is present in the amount of 45-70% by weight of the haemostat composition. The haemostat composition is able to safely gradually and fully degrade in a human or animal body within about 30 days and so can be utilised by physicians to stem a flow of blood and promote healing both after as well as during surgical procedures.

Abstract: In one aspect, the present invention includes a haemostat composition that includes a chitosan, chitosan salt or chitosan derivative, and a physiologically acceptable acid selected from the group consisting of lactic acid, formic acid, acetic acid, ascorbic acid, halogen acetic acids, propanoic acid, propenoic acid, acrylic acid, glyoxylic acid, pyruvic acid or a hydroxy propionic/butanoic acid, and combinations of any two or more thereof; or one or more acids selected from hydrochloric acid and sulphuric acid. The haemostat composition is able to safely gradually and fully degrade in a human or animal body within about 30 days and so can be utilised by physicians to stem a flow of blood and promote healing both after as well as during surgical procedures.

Abstract: In alternative embodiments, the invention provides articles of manufacture comprising biocompatible nanostructures comprising PolyEther EtherKetone (PEEK) surface-modified (surface-nanopatterned) to exhibit nanostructured surfaces that promote osseointegration and bone-bonding for, e.g., joint (e.g., knee, hip and shoulder) replacements, bone or tooth reconstruction and/or implants, including their use in making and using artificial tissues and organs, and related, diagnostic, screening, research and development and therapeutic uses, e.g., as primary or ancillary drug delivery devices. In alternative embodiments, the invention provides biocompatible nanostructures that promote osseointegration and bone-bonding for enhanced cell and bone growth and e.g., for in vitro and in vivo testing, restorative and reconstruction procedures, implants and therapeutics.

Abstract: A bioscaffolding can be formed within a post-myocardial infarct region sufficient to cause attenuation of a rate of myocardial infarct expansion. A bioscaffolding may further be formed in the post-myocardial infarct region to cause an increase in posterior left ventricular wall thickness. The gel or bioscaffolding can be formed from a mixture of gel components of different gelation systems. For example, a bioscaffolding can be formed by mixing at least two different components of at least two different two-component gelation systems to form a first mixture and by mixing at least two different components (other than the components that make up the first mixture) of the at least two different two-component gelation systems to form a second mixture.

Abstract: The present disclosure provides modified bone and osteochondral tissues, methods of preparing modified bone and osteochondral tissues, and methods of using the modified bone or osteochondral tissues to repair bone or osteochondral defects in a subject.

Abstract: This disclosure relates to dermal treatment compositions, such as dermal fillers and tissue glues, and injectable compositions that incorporate one or more cationic steroidal antimicrobials (CSAs). The CSAs are incorporated into the dermal treatment compositions to provide effective antimicrobial, anti-inflammatory, analgesic, anti-swelling and/or tissue-healing properties. A treatment composition includes a component formed from a biologically compatible material suitable for injection into and/or application onto tissue at a treatment site. One or more CSA compounds are mixed with the biologically compatible material so that the one or more CSA compounds are incorporated within the composition, forming a reservoir of CSA compounds within the resulting bolus of the treatment composition after injection and/or application.

Abstract: This invention elates to polysaccharide materials and more particularly to microbial-derived cellulose having the porosity and containing pores of the desired size making it suitable for cellular infiltration during implantation and other desirable properties for medical and surgical applications. The invention also relates to the use of porous microbial-derived cellulose as tissue engineering matrices, human tissue substitutes, and reinforcing scaffolds for regenerating injured tissues and augmenting surgical procedures The invention outlines various methods during and after fermentation to create porous microbial cellulose capable of allowing cell infiltration while preserving the physical properties of the microbial-cellulose.

Abstract: The present invention is directed to a method of producing a tissue graft, comprising at least steps of providing a gel, seeding the gel with cells of at least a first and/or cells of a second type, and culturing of the cells of the first and/or cells of the second type in said gel until the formation of at least one first biostructure in the gel by the cells of the first type and/or the cells of the second type.

Abstract: A medical device includes a base layer, and a lubrication layer supported on at least a part of the base layer, wherein the lubrication layer contains a block copolymer (A) composed of a first constituting unit derived from a reactive monomer that has an epoxy group and a second constituting unit derived from at least one hydrophilic monomer selected from the group consisting of acrylamide and an acrylamide derivative, and a polymer (B) composed of a constituting unit derived from at least one hydrophilic monomer selected from the group consisting of acrylamide and an acrylamide derivative, wherein the block copolymer (A) is contained in a proportion of 20 to 80% by weight relative to the total weight of the block copolymer (A) and the polymer (B), and wherein the block copolymer (A) is crosslinked or polymerized to form a mesh structure.

Abstract: The invention provides compositions featuring chitosan and polyethylene glycol and methods for using such compositions for the local delivery of biologically active agents to an open fracture, complex wound or other site of infection. Advantageously, the chitosan-PEG compositions can be loaded with one or more antimicrobial agents, including hydrophobic agents, and can be tailored to the needs of particular patients at the point of care (e.g., in a surgical suite, clinic, physician's office, or other clinical setting).

Abstract: A device for fixing biological soft tissue is endowed with strength and deformation performance for being used as a device for coupling biological soft tissue that has been cut or separated due to an incision or the like during a surgical procedure, and is completely degraded in vivo and discharged after adhesion of the soft tissue or after healing of the incision tissue. The device is composed of a ternary Mg alloy material of Mg—Ca—Zn. In the Mg alloy material, the Ca and Zn are contained within the solid-solubility limit with respect to the Mg. The remainder is composed of Mg and unavoidable impurities. The Zn content is 0.5 at % or less. The Ca and Zn content has a relationship of Ca:Zn=1:x (where x is 1 to 3) by atom ratio. The crystal grain structure is equiaxed, the crystal grain size according to linear intercept being 30 to 250 ?m.

Abstract: The present invention concerns a process for the production of implants with an ultrahydrophilic surface as well as the implants produced in that way and also processes for the production of loaded, so-called bioactive implant surfaces of metallic or ceramic materials, which are used for implants such as artificial bones, joints, dental implants or also very small implants, for example what are referred to as stents, as well as implants which are further produced in accordance with the processes and which as so-called “delivery devices” allow controlled liberation, for example by way of dissociation, of the bioactive molecules from the implant materials.

Abstract: A polymer-drug conjugate, which can be used in medical applications such as stents, has at least one active agent conjugated through a carboxylic acid moiety to a copolymer derived from at least one isoolefin monomer and at least one copolymerizable monomer, where the copolymerizable monomer is at least one multiolefin monomer, a ?-pinene monomer or a mixture thereof. Such conjugates show improved adhesion to stainless steel and a substantial decrease in burst release of paclitaxel form a drug eluting stent (DES).

Abstract: Leak location devices and methods of using leak location devices that can be used in conjunction with negative pressure wound therapy systems are disclosed. In some embodiments, a leak location device can include a microphone for detecting sound pressure produced by a leak. Detected sound pressure can be compared to a threshold, which can correspond to background or ambient sound pressure. Background or ambient sound pressure can correspond to sound produced by a negative pressure source. The leak detection device can include a display configured to visually depict the detected sound, and a light source which creates a visual depiction of the coverage angle of the microphone.

Abstract: Disclosed herein are apparatuses and methods for treating a wound by applying reduced or negative pressure to the wound. The apparatus can include a wound cover, a fluid collection container, a vacuum pump, an inflation pump, and one or more conduits. The wound cover can be configured to move between at least a relatively rigid, generally raised position and a relatively flexible, generally collapsed position according to a predetermined program or in response to input from a user or one or more sensors. In some embodiments, the wound cover can be configured to move between at least the relatively rigid, generally raised position and the relatively flexible, generally collapsed position by adjusting the air pressure in one or more channels in the wound cover or by adjusting the length of piezoelectric or other length changing material supported by the wound cover.

Abstract: A wound treatment appliance is provided for treating all or a portion of a wound. In some embodiments, the appliance includes an impermeable flexible overlay for applying a reduced pressure to the covered portion of the wound. The wound treatment appliance may also include a vacuum system to supply reduced pressure to the wound in the area under the flexible overlay, a wound packing means to prevent overgrowth of the wound or to encourage growth of the wound tissue into an absorbable matrix including the wound packing means, a suction drain, a collection chamber to collect and store exudate from the wound, and/or a suction bulb which may be used to provide a source of reduced pressure to an impermeable overlay that covers all or a portion of the wound. Finally, methods are provided for using various embodiments of the wound treatment appliance.

Abstract: Materials and methods related to blood pump systems are described. These can be used in patients to, for example, monitor arterial pressure, measure blood flow, maintain left ventricular pressure within a particular range, avoid left ventricular collapse, prevent fusion of the aortic valve in a subject having a blood pump, and provide a means to wean a patient from a blood pump.

Abstract: The present specification describes systems and methods for detecting an occlusion in a tubing carrying a patient's blood through a manifold and into a dialyzer in a dialysis system. A controller measures pressures value of the blood at a predetermined point after exiting the manifold and before entering the dialyzer, calculates a historical running average, calculates a weighted sum of the most recent pressure values, and determines whether to trigger an occlusion alarm based on a function of the historical running average and the weighted sum of the most recent pressure values.

Abstract: A method of displaying a predicted state of a medical apparatus, and a medical apparatus employing the method are disclosed. The method comprises receiving a sensor signal from a sensor of the medical apparatus, filtering the sensor signal by an adaptive filter such that a predicted signal is achieved, determining a state from the predicted signal, and displaying an indication through a user interface of the medical apparatus based on the determined state.

Abstract: A hemofiltration device capable of surely performing highly-efficient hemofiltration. The hemofiltration device of the present invention is adapted to be implanted in a mammalian body for filtering blood, and includes a blood flow path layer having a blood flow path, a filtrate flow path layer having a filtrate flow path disposed along the blood flow path, and a filtration membrane interposed between the blood flow path layer and the filtrate flow path layer, for filtering the blood flowing through the blood flow path. A filtrate outlet of the filtrate flow path is provided at a position closer to a blood outlet than to a blood inlet of the blood flow path. The blood inlet, blood outlet, and filtrate outlet are provided only on one side or separately on opposite sides of a main body portion in the direction in which the layers are stacked.

Abstract: An artificial lung including a housing having a circular outer wall being enclosed by a first surface and a second surface to define an interior volume, a blood inlet port to permit inlet flow of blood to the housing, a blood outlet port to permit outlet flow of the blood from the housing, a gas inlet port to permit inlet flow of a gas to the housing, a gas outlet port to permit outlet flow of the gas from the housing, and a plurality of baffles concentrically disposed within the housing. The baffles are positioned to define a flow path between the blood inlet port and the blood outlet port. Each of the baffles includes a gate opening to permit flow of the blood along the flow path. A fiber bundle is disposed between the baffles within the flow create mixing and improve gas exchange efficiency.

Abstract: The present specification describes a modular, portable hemofiltration system, for providing improved clearance levels of blood toxins, which includes at least one roller pump that is designed and operated to generate a rapidly varying pressure profile of fluid within at least a blood circuit of the hemofiltration system.

Abstract: An extracorporeal blood circulation system reduces the risk of generation of air bubbles entering the circulation circuit associated with placement of a pressure sensor that detects a patient's blood pressure at a blood removal line. Instead of directly measuring pressure at the blood removal line where suction exists, an intermediate part pressure sensor detects pressure between a centrifugal pump and an oxygenator. A controller identifies a discharge pressure specific to the centrifugal pump based on a rotation speed of the pump and a blood flow rate. The discharge pressure and the intermediate pressure values are combined to estimate the pressure at the blood removal line.

Abstract: The present invention relates to a rotary blood pump with a double pivot contact bearing system with an operating range between about 50 mL/min and about 1500 mL/min, wherein the force on the upper bearing is less than 3N during operating speeds up to 6000 rpm. The rotary blood pump is part of a blood pump system that includes blood conduit(s), a control system with optional sensors, and a power source.

Abstract: A method of predicting peak pressure within a fluid path, which includes a tubing set and a catheter into which at least one fluid is introduced under pressure by a pressurizing system of a fluid injection apparatus, includes (a) inputting an initial injection protocol into the fluid injection apparatus according to which the at least one fluid is intended to be introduced into the fluid path; (b) predicting an expected peak pressure level that would result in the fluid path if the initial injection protocol were to be used as intended to introduce the at least one fluid into the fluid path. The expected peak pressure level is determined before commencement of the initial injection protocol according to at least one model on the basis of a flow rate of the at least one fluid, at least one catheter characteristic, and a viscosity of the at least one fluid.

Abstract: Disclosed are various embodiments for illuminated medical infusion including, for example, a medical infusion system which includes a source of illumination and an illuminating infusion line and wherein the illuminating infusion line includes an integrated fluid transmission channel and light transmission channel.

Abstract: A medical line organizer that can include multiple attachable guides for separating and visually distinguishing between attached medical line guides is provided. The guides can be attached to each other or to one or more couplers for attachment to a structure. Various identification techniques can be used to distinguish the guides from each other for identification of individual lines. Additional guides or markers with similar indicia can be placed on the lines to aid in identifying the path of a line within a particular guide.

Abstract: An infusion pump can include a syringe receptacle, a retention mechanism, a drive mechanism, and a keyed lock. The retention mechanism can inhibit removal of the syringe from the receptacle when in an engaged state, and enable removal of the syringe when in a disengaged state. The drive mechanism can include a pusher to selectively couple to a thumb press of the syringe, a motor coupleable to the pusher, and a clutch to couple and decouple the motor to the pusher. The keyed lock can operate in coordination with the retention and drive mechanisms such that, if: the keyed lock is locked, the retention mechanism is in the engaged state, and the pusher is coupled to the thumb press of the syringe, then as long as the keyed lock remains locked, the retention mechanism is constrained to the engaged state and the clutch to the coupled state.

Abstract: An infusion pump system comprises a pump for infusing a drug into a patient, a storing unit for storing therapy data, drug data, protocol data, profile data, care type data, and feedback data received from said pump and/or other sources including information about particularities of therapies already carried out or currently running, an input unit for selecting therapy data, drug data, profile data, and care type data, an associating unit for associating the selected therapy data, drug data, profile data and care type data provided by said input unit and further adapted to determine based on said association specific protocol data and specific feedback data, wherein said storing unit also stores said association with said specific protocol data and said specific feedback data; and an output unit for outputting said specific protocol data with said specific feedback data.

Abstract: A skin attachable drug injection device (1), comprising an accelerometer (26) able to detect the user tapping against the housing (2) of the device and to generate an electrical signal to the device controller (16), which recognizes the signal as a user request for information regarding the ongoing delivery of the medicament, and a transmitter (30) which in response wirelessly transmits said information (e.g. the expected remaining during of the injection) to a separate portable user device having a display (e.g. mobile phone). A user carrying the injection device under clothing can thus receive feedback about the status of the injection in a discreet way.

Abstract: An apparatus includes a body, a cannula, and a needle. The cannula is flexible and extends distally from the body. The needle is slidably disposed in the cannula. The needle includes a sharp distal tip and a curved portion. The needle is configured to translate relative to the cannula between a proximal position and a distal position. The distal tip is configured to be positioned inside the cannula when the needle is in the proximal position. The distal tip is configured to be positioned outside the cannula when the needle is in the distal position. The needle is resiliently biased to extend along a curve through the curved portion.

Abstract: An insertion device for use with an insertion set is provided. The insertion device includes a first housing having a rail. The insertion device includes a hub having a first end coupled to the rail and a second end including a projection. The hub is movable relative to the first housing along the rail. The insertion device includes a locking carrier in the first housing and movable between a first position and a second position. The locking carrier is coupled to the projection in the first position and the projection is released in the second position. The insertion device includes a second housing coupled to the insertion set and surrounding at least a portion of the first housing to define a gap. The locking carrier is received in the gap in the second position to release the projection of the hub and to enable the insertion set to be uncoupled.

Abstract: A protective cover type safety device for syringes includes a first buckle seat, a second buckle seat which can be engaged with the first buckle seat, and a protective cover which is pivotably connected with the first buckle seat. The first buckle seat and the second buckle seats are clamped and positioned to a needle seat of a syringe, and the protective cover is able to swing between a first position and a second position, and limited at a third position. The protective cover at the third position covers a needle body of the syringe to prevent the needle body from being exposed or piercing or hurting people.

Abstract: A valve and a method for administering a plurality of drug fluids to a patient are disclosed. For each drug fluid, the valve may be rotated into a selected drug position associated with the drug fluid. With the valve being in the selected drug position, a backpriming may be performed of a connector line of a drug container containing the drug fluid. Thereafter, the drug fluid may be administered with the valve being in the same selected drug position. Thereafter, the valve may be flushed, optionally while maintaining the same selected valve position.

Abstract: Disclosed herein are method for controlling an insulin injection pump, a related control unit, and an injection pump. The control unit comprises an expected plasma insulin concentration value acquiring module, a current subcutaneous and interstitial insulin concentration value acquiring module, a supposed injection value acquiring module, an injection instruction sending module, and a counting module. The injection pump comprises a pump body and the control unit. The control unit is disposed in the pump body.

Abstract: A system and method is provided for detecting fluid low-volume and occlusion in a device using force sensing resistor (FSR) sensor. One or more force sensing resistors are positioned in communication with a fluid channel at one or more of a pump intake and pump outlet to detect pressure in the fluid channel. The pressure is detected through communication with the force sensing resistor and indicates an irregular system condition including but not limited to, fluid low-volume level and occlusion. Also provided are a fluid flow sensor (e.g., FSR or MEMS sensor) disposed relative to an embedded fluid channel in the base of a wearable medicine delivery pump.

Abstract: An injection device (100) comprises: a needle insertion mechanism (111); a medicament delivery arrangement (123) configured to cause injection of a medicament into a patient; and a cavity (102) having an opening (103) for receiving a key device (104). The injection device is configured to respond to detecting the presence of the key device in the cavity by triggering operation of the injection device. The specification also provides a method of controlling an injection device (100) including a needle insertion mechanism (111); a medicament delivery arrangement (123) configured to cause injection of a medicament into a patient; and a cavity (102) having an opening (103) for receiving a key device (104), the method comprising: responding to detecting the presence of the key device in the cavity by triggering operation of the injection device.

Abstract: Embodiments disclosed herein are directed to systems and methods of dispensing one or more medicaments to a subject. The systems and methods utilize at least one flexible compression garment having one or more medicament dispensers therein.