Abstract: The present invention provides for methods and devices suitable for producing a transplantable cellular suspension of living tissue suitable for promoting tissue regeneration in an epithelium-related procedure, as well as compositions produced therefrom. The cellular suspension can include viable and functioning cells at various stages of differentiation, including undifferentiated/progenitor cells and differentiated cells, as well as those in between. In certain embodiments, the cellular suspension can be subjected to a stress to induce a heat shock response therein, or be exposed to an exogenously supplied agent such as heat shock protein or a fragment thereof, hyaluronic acid, platelet-enriched plasma, and/or growth factors. The cellular suspension can be applied directly to a patient's recipient site for in vivo regeneration, or be cultured or seeded to a matrix for in vitro growth/regeneration.

Abstract: The present invention provides for methods and devices suitable for producing a transplantable cellular suspension of living tissue suitable for promoting tissue regeneration in an epithelium-related procedure, as well as compositions produced therefrom. The cellular suspension can include viable and functioning cells at various stages of differentiation, including undifferentiated/progenitor cells and differentiated cells, as well as those in between. In certain embodiments, the cellular suspension can be subjected to a stress to induce a heat shock response therein, or be exposed to an exogenously supplied agent such as heat shock protein or a fragment thereof, hyaluronic acid, platelet-enriched plasma, and/or growth factors. The cellular suspension can be applied directly to a patient's recipient site for in vivo regeneration, or be cultured or seeded to a matrix for in vitro growth/regeneration.

Abstract: The present invention relates to an antibacterial dressing and a method for preparing the same. According to the present invention, there are provided an antibacterial dressing containing a rapid cell membrane-penetrating component that exhibits excellent bactericidal and antibacterial activities by disrupting the structure and synthesis of protein and nucleic acid, and a method for preparing the same.

Abstract: This disclosure provides a method of preparing a hydrocolloid adhesive that includes the steps of mixing one or more components to produce a continuous phase, heating the continuous phased to a predetermined temperature between about 135° C. to 170° C., adding a stabilizer to the continuous phase, reducing a temperature of the continuous phase to a second predetermined temperature below 99° C., adding a discontinuous phase to the continuous phase at the second predetermined temperature, and mixing the components of the discontinuous phase and the continuous phase to produce a uniform mixture. Further, the hydrocolloid adhesive includes a super absorbent material and 0.05% to 2% by weight of a peroxide.

Abstract: To provide a method for producing a calcium carbonate block for medical use which is useful as a bone substitute or a bone substitute raw material needed in medical care, which is a method for producing a calcium carbonate block that satisfies the following desired properties: 1) the calcium carbonate block has excellent mechanical strength; 2) the calcium carbonate block can be produced by a simplified production method; 3) the calcium carbonate block contains no impurity; and 4) the calcium carbonate block has high reactivity. A method for producing a calcium carbonate block, comprising a step of shaping a water-containing calcium hydroxide block and a carbonation step of immersing the calcium hydroxide block in a carbonate ion-containing aqueous solution.

Abstract: The invention relates to a method of forming a tissue scaffold material for controlled release of an agent in situ, or tissue regeneration, and a system of controlling scaffold and scaffold setting properties using various constituents, such as ceramics and/or plasticisers, and carriers. The invention further relates to scaffold material, scaffolds, and kits, and the use of such scaffold material and scaffolds in methods of treatment.

Abstract: The present invention relates to a scaffold for the treatment of stress urinary incontinence, wherein the scaffold comprises three layers of polyurethane: a first layer and a third layer in which the polyurethane fibres are randomly orientated and a second layer between said first and third layers in which the fibres are aligned longitudinally; methods of making such scaffolds and uses thereof.

Abstract: Allograft biomaterials, implants made therefrom, methods of making the biomaterial and implants, methods of promoting disc, cartilage, tissue, or wound healing in a mammal by administering the biomaterial or implant to the mammal, and kits that include such biomaterials, implants, or components thereof. For example, the allograft may include viable cells, which were native to amniotic fluid that the allograft was derived from.

Abstract: Described herein are new methods for making lung bud organoids (LBOs) that have the capacity of developing into branching airways and alveolar structures that a least partially recapitulate human lung development from mammalian, preferably human, pluripotent stem cells including embryonic stem cells (ESCs) and induced pluripotent stem cells (IPSC), either by culturing branched LBO in a 3D matrix or by transplanting the LBO under the kidney capsule of immune deficient mice. Branched LBOs contain pulmonary endoderm and mesoderm compatible with pulmonary mesenchyme, and undergo branching morphogenesis. Also described are LBOs harboring certain mutations that induce a fibrotic phenotype, and methods of making same. The mutated (B)LBOs can be used for screening agents that may treat pulmonary fibrosis.

Abstract: This document provides methods and materials for treating fistulas (e.g., refractory fistulas such as refractory anal fistulas). For example, methods and materials for implanting a synthetic scaffold (e.g., fistula plug) comprising randomly arranged fibers comprising polymers of PGA and TMC and seeded with mesenchymal stem cells (e.g., adipose derived mesenchymal stem cells) located in the spaces between the randomly arranged fibers into a fistula (e.g., refractory anal fistula) of a mammal (e.g., a human) are provided.

Abstract: Described herein are compositions and methods related to derivation of human notochordal cells differentiated from induced pluripotent stem cells (iPSCs). The inventors have developed a two-step process for generating these iPSC-derived notochordal cells (iNCs), which can provide a renewable source of therapeutic material for use in degenerative disc disease (DDD). As iNCs are capable of reversing DDD and supporting regeneration of invertebral disc (IVD) tissue based on the understanding that NC cells maintain homeostasis and repair of other IVD cell types such as nuclear pulposus (NP).

Abstract: Neo-cartilage constructs suitable for implantation into a joint cartilage lesion in situ and a method for repair and restoration of function of injured, traumatized, aged or diseased cartilage. The construct comprises at least chondrocytes incorporated into a support matrix processed according to the algorithm comprising variable hydrostatic or atmospheric pressure or non-pressure conditions, variable rate of perfusion, variable medium composition, variable temperature, variable cell density and variable time to which the chondrocytes are subjected.

Abstract: The present disclosure relates to a dynamic bioactive bone graft material having an engineered porosity. In one embodiment, a bone graft material is provided having bioactive glass fibers arranged in a porous matrix that is moldable into a desired shape for implantation. The material can be substantially without additives and can include at least one nanofiber. The porous matrix may include a combination of one or more pore sizes including nanopores, macropores, mesopores, and micropores. In another embodiment, a bone graft implant is provided having a matrix comprising a plurality of overlapping and interlocking bioactive glass fibers, and having a distributed porosity based on a range of pores provided in the bioactive glass fibers. The distributed porosity can comprise a combination of macropores, mesopores, and micropores, and the matrix can be formable into a desired shape for implantation into a patient.

Abstract: An implant includes a membrane having pores sized in the nanometer range. A surface of the implant is at least partially coated with a plasma polymer. The interior of the pores is uncoated.

Abstract: High strength biomedical materials and processes for making the same are disclosed. Included in the disclosure are nanoporous hydrophilic solids that can be extruded with a high aspect ratio to make high strength medical catheters and other devices with lubricious and biocompatible surfaces.

Abstract: Disclosed herein is a device comprising a PHA based copolymer layer comprising at least one of an electrospun ribbon of fibers of a polyhydroxyalkanoate based copolymer or the polarized polymeric composition obtained by the process of claim 1, wherein the layer is configured to exhibit one or more of a piezoelectric effect, a pyroelectric effect and a ferroelectric effect, wherein each of the electrospun ribbon of fibers and the polarized polymeric composition comprises a ?-form of the PHA based copolymer present in an amount of from about 10% to about 99%, as measured by x-ray diffraction. The device can be configured for use as a sensor, a actuator, a nanomotor, or a biobattery.

Abstract: Implantable devices disclosed herein may be configured to modulate the localized pH at an implantation site of the implantable device. By controlling, modulating, or otherwise adjusting the localized pH, various benefits can be achieved, such as controlling cell proliferation. The implantable device may include a body and one or more metallic features. Generally, the implantable device forms a galvanic cell such that a first metallic feature is configured to be preferentially oxidized to alter the localized pH environment in the vicinity of the implantable device.

Abstract: A flexible or elastic brachytherapy strand that includes an imaging marker and/or a therapeutic, diagnostic or prophylactic agent such as a drug in a biocompatible carrier that can be delivered to a subject upon implantation into the subject through the bore of a brachytherapy implantation needle has been developed. Strands can be formed as chains or continuous arrays of seeds up to 50 centimeters or more, with or without spacer material, flaccid, rigid, or flexible.

Abstract: Medical articles formed from a polyurethane-based resin including a modifying oligomer provide enhanced properties. A modifying oligomer incorporated into a backbone, as a side chain, or both of the polyurethane-based resin formed by a diisocyanate, a polyglycol, and a diol chain extender has at least one, preferably two, alcohol moieties (C—OH) and a functional moiety. Exemplary modifying oligomers are: a diol-containing perfluoropolyether incorporated into the backbone, a monofunctional polysiloxane (e.g., monodialcohol-terminated polydimethylsiloxane) incorporated as the side chain, and combinations thereof. Medical articles herein are self-lubricating and/or anti-fouling.

Abstract: Embodiments of negative pressure wound therapy systems and methods for operating the systems are disclosed. In one embodiment, a negative pressure wound therapy apparatus can include a wound dressing, a negative pressure source, and a controller. The negative pressure source can provide negative pressure via a fluid flow path to the wound dressing. The controller can monitor a rate of fluid removal from the wound, wirelessly communicate the rate of fluid removal to a remote device, and output an indication when the rate of fluid removal meets a threshold.

Abstract: A breast pump assembly is provided having a housing that is hermetically sealed to define a chamber within the housing, a pump disposed within the housing, wherein the pump is in fluid communication with the chamber and with an atmosphere outside the housing, and a valve system having a first, second, and third port, wherein the first port is in fluid communication with the atmosphere outside the housing, the second port is in fluid communication with the chamber within the housing, and the third port is configured to connect to a pumping kit such that the third port is in fluid communication with the pumping kit.

Abstract: Method and systems control a rotational speed of a blood pump during ventricular diastole. A method includes controlling a blood pump in accordance with a first segment operational mode. A controller monitors the blood flow rate through the blood pump. The controller determines, based on the blood flow rate, whether continued controlling of the blood pump per the first segment operational mode would result in the blood flow rate through the blood pump being less than a target minimum blood flow rate. In response to a determination that continued controlling of the blood pump per the first segment operational mode would result in the blood flow rate through the blood pump being less than the target minimum blood flow rate, the controller controls the rotational speed of the blood pump so that the blood flow rate through the blood pump is approximate to the target minimum blood flow rate.

Abstract: A blood pump system including an optical sensor configured to detect an optical signal during pumping operation of the blood pump, and an optical fiber configured to transmit the optical signal from the optical fiber sensor to an evaluation device communicatively coupled to the optical fiber sensor. The evaluation device is configured to receive as inputs the transmitted optical signal and a signal indicative of the motor current and determine a mechanical failure event associated with the blood pump based on the motor current and the optical signal.

Abstract: This disclosure relates to a medical device including a hard part and a converter. The hard part has fluid paths for conducting a medical fluid through the hard part. The converter is arranged to measure a characteristic of the medical fluid while the medical fluid is present in one of the fluid paths. At least a section of the converter is applied or superimposed to the hard part by at least one additive application method.

Abstract: A blood purification apparatus is provided in which parameters related to ultrafiltration can be changed assuredly and smoothly at the restart of blood purification treatment suspended with the release of the patient from a blood circuit during the blood purification treatment. A blood purification apparatus in which the blood purification treatment that is suspended with a release of the patient from a blood circuit during the blood purification treatment is restartable includes a calculating device capable of calculating a variable amount related to a patients body weight that changes with the suspension and restart of the blood purification treatment; and a changing device capable of changing, in accordance with the variable amount calculated by the calculating device, a parameter related to ultrafiltration that is set by a setting device.

Abstract: A blood purification apparatus is provided in which parameters related to ultrafiltration can be changed assuredly and smoothly at the restart of blood purification treatment suspended with the release of the patient from a blood circuit during the blood purification treatment. A blood purification apparatus in which the blood purification treatment that is suspended with the release of the patient from a blood circuit during the blood purification treatment is restartable includes a touch panel (M) capable of displaying, simultaneously on one particular screen, a plurality of variable amounts related to the patients body weight that changes with the suspension and restart of the blood purification treatment.

Abstract: Methods of colon cleansing and/or inspection are described which safely maintain the colon in an uncollapsed state. Balanced replacement of the volume of fluid, gas and/or solids evacuated during cleansing of a colon is described. Replacement volume comprises, for example, cleansing fluid, jetting gas, and/or inflation gas. In some embodiments, the balancing of evacuated and replacement volume is achieved under automatic control, based on monitored volume of material exchange, and/or measurement of resulting pressures.

Abstract: An ophthalmic irrigator-aspirator has a handpiece with aspiration and irrigation openings through its distal end. A tip component connects to the handpiece and has an aspiration cannula. A flexible sleeve has an annular hub for watertight connection to the handpiece or a base portion of the tip. The sleeve has an intermediate portion that forms a channel for an irrigation fluid along the exterior of the cannula to an irrigation port in the sleeve. The distal end portion of the sleeve is sized for a watertight connection over the distal portion of the cannula. Such distal end portion of the sleeve has an aspiration port in communication with the cannula aspiration port. The sleeve proximate, intermediate, and distal portions are integral with each other and are formed of a resilient material that allows the sleeve to be tightly fitted on the handpiece or tip base portion and the cannula.

Abstract: A medical device packaging comprising: a container having an opening; a medical device disposed within the container, the medical device including an energy storage apparatus; a first layer comprising a main part disposed at least partially over a peripheral edge of the opening of the container; and a second layer disposed over the main part of the layer, wherein the first layer is in electrical contact with the energy storage apparatus and the separation of the lining layer from the conductive layer generates electrostatic energy for charging the energy storage apparatus.

Abstract: A system and method for correcting a volume of fluid delivered by a fluid injector during an injection procedure is described. The method included determining and compensating for a volume factor associated with compliance of the fluid injector system and correcting for the volume by one of over-driving the distance that the drive member travels in a fluid reservoir, under-driving the distance that the drive member travels in the fluid reservoir, or lengthening or shortening a fluid delivery time.

Abstract: An assembly nest for transporting a tubular sub assembly of a drug delivery device on an automated production line, in which the tubular sub assembly includes a tubular body and a cap that is wider than the tubular body. The assembly nest includes a base against which a sub assembly of a drug delivery device is mountable to orientate said sub assembly in a predetermined position; and locking mechanism having a resilient member to urge the locking mechanism into one of: an unlocked position, in which a sub assembly of a drug delivery device can be mounted to the base; or a locked position, in which the locking mechanism engages a mounted sub assembly to retain it in its predetermined position on the base.

Abstract: A medical procedure accessory components holding unit and methods of using thereof. The accessory holder is designed to hold and store one or more components or medical devices that could be used in a medical procedure, particularly medical devices, for applying an anesthetic. The accessory holder may include four (4) medical device storage or use modules: a syringe disposal device module, a dispensing tool module, a canister module, and a syringe attachment module.

Abstract: A drip chamber assembly that functions irrespective of its orientation and in the presence of increased internal pressure is provided.

Abstract: An improved device delivers a fluid medicament to the subcutaneous tissue of a user. The device is better suited for patients with Parkinson's Disease and other central nervous system disorders, than conventional infusion devices. The device can include a reusable part including a drive component (e.g., motor) and control electronics and a disposable part including a medicament reservoir. Medicament can be evacuated from the medicament reservoir by a plunger assembly that includes a plunger attached to a lead screw that is rotated by a nut, all within the disposable part. The device can be fluidically coupled with the tissue via a flexible cannula. Various embodiments relate to an improved cannula insertion mechanism that delivers the cannula under a force applied by a spring. Various embodiments relate to improved filling of the device, for example, using a vial adapter and an automated filling station.

Abstract: A disposable noninvasive strap is disclosed for use in securing a medical appliance such as an I.V. line, gauze pad, or the like, to a patient. The disposable strap is removably secured to the patient, and in a particular embodiment, may be applied to a patient's torso or a limb, such as a wrist, arm or leg, and holds the medical appliance without undesirable movement. An exemplary strap comprises a layer of soft, porous, elastomeric material and particularly, is prepared from a spun bond laminate of polypropylene. In a further exemplary embodiment, the strap may applied to the site of a venipuncture after the withdrawal of the needle, to hold in place a cotton or gauze pad or the like, that is applied to the site to absorb and curtail the flow of any blood or other fluid from the same.

Abstract: A kit is used for the modular configuration of a medical pump device for delivering a medical fluid. Such a medical pump device can be used in infusion therapy.

Abstract: Systems and methods for controlling fluid delivery via a manually administrable medication container to a patient through a fluid delivery pathway are provided. The systems and methods described herein incorporate rules-based clinical decision support logic to drive a flow control valve within a flow pathway based on a determination of whether or not an IV fluid connected to an input port on the pathway is appropriate for patient administration by considering such factors as patient-specific clinical circumstances, current medical orders, and accepted delivery protocols. Related apparatus, systems, methods and articles are also described.

Abstract: Infusion systems, infusion devices, and related patient monitoring systems and methods are provided. A method of monitoring a physiological condition of a patient involves providing, on a display device, a graphical user interface display depicting forecast values with respect to different time periods in the future and including graphical user interface elements to allow a user to adjust a characteristic of an event likely influence the physiological condition of the patient at a respective time period. In response to an adjustment to a graphical user interface element, the method continues by dynamically updating the forecast values on the graphical user interface display using a forecasting model associated with the patient.

Abstract: An apparatus for regulating the concentration of glucose in the blood of a person includes: at least one glucose sensor that is arranged to measure the glucose concentration of the person, for example in the interstitial fluid or blood; a pump for selectively introducing at least one substance influencing the blood glucose levels into the body of the person, for instance by at least one cannula or catheter to be inserted into the body of said person, and a control for controlling said at least one substance influencing the blood glucose levels to be introduced to the person based on data received from said glucose sensor. Said apparatus includes at least one further sensor that is arranged to monitor a further characteristic of the person. The at least one further sensor may include an accelerometer, a heart rate sensor, a temperature sensor, a pH sensor, a ketone sensor, a GPS receiver, and/or a skin resistance sensor.

Abstract: The present invention relates to a device for recognising, measuring and quantitatively determining at least one exogenous substance in an endogenous liquid. According to the invention, the device comprises: —a means for suctioning (1) an endogenous liquid containing at least one exogenous substance; —a means for collecting (2) the endogenous liquid containing at least one exogenous substance; —a spectrometer (3), preferably a Raman or infrared spectrometer, capable of acquiring and analysing said collected liquid; —a database-type data storage means comprising spectra relating to at least one exogenous substance; —a means for comparison between the spectrum or spectra acquired and the spectrum or spectra of the database; —a means (4) for controlled introduction of at least one exogenous substance into the endogenous liquid, as a function of the result of said comparison. The invention also relates to the method implemented by such a device.

Abstract: Methods and devices for the diagnosis and treatment of microvascular dysfunction, such as microvascular obstruction (MVO) and other dysfunctional diseases of the microvasculature of many organs, including the heart. The present subject matter provides novel devices and methods to successfully diagnose, restore patency, open and preserve flow, and limit reperfusion injury in organs and cases with microvascular dysfunction. The present subject matter provides apparatus and method to detect, measure and treat microvascular dysfunction in real time during scenarios such as invasive angiographic/therapeutic procedures. Such procedures include therapy for organ systems including the heart (acute myocardial infarction—primary percutaneous coronary intervention (PPCI)), brain stroke (CVA), bowel ischemia/infarction, pulmonary emboli/infarction, critical limb ischemia/infarction, renal ischemia/infarction, and others.

Abstract: A method of adapting an auto injector configured to actuate a prefilled syringe, the auto injector having a biasing member having a spring constant, the prefilled syringe being filled with a volume of therapeutic fluid, the prefilled syringe including a barrel, stopper, and a needle, the stopper having a path of travel, the biasing member arranged to move the stopper along the path of travel. An auto injector having an injection spring adapted to an aged prefilled syringe.

Abstract: Injection monitoring circuitry is provided for coupling to part of an injection device having a syringe and a plunger rod. The injection monitoring circuitry has an input to receive force measurement data from a force sensor, the force measurement data includes a plurality of timestamped force measurements of force applied by a user to the injection device when an injection is administered to an injection site. Processing circuitry is provided to determine from the force measurement data when an end of injection has been reached, the end of injection corresponding to the plunger rod having reached an end position in a distal portion of the barrel of the syringe during administration of the injection by the user. Machine readable instructions and an injection monitoring method are also provided.

Abstract: An injection device including a barrel having a medicament reservoir therein capable of fluid communication with a needle assembly at a distal end thereof and sealed at a proximal end thereof with a stopper. The injection device further includes a plunger rod having a distal rod end which is couplable with said stopper, wherein, when the plunger rod is coupled to the stopper, forward axial movement of the plunger rod causes forward axial movement of the stopper coupled thereto into the medicament reservoir in order to expel medicament through the needle assembly. Further, the plunger rod can be decoupled from the stopper by applying a rearward axial force on the plunger rod, said rearward axial decoupling force being less than a rearward axial force required to move the stopper rearwardly with respect to the barrel.

Abstract: A needle guard grip device may include a body extending from a first end to a second end along a central longitudinal axis of the body. The body may include a plurality of ribs extending perpendicularly to the central longitudinal axis. The plurality of ribs may include a first set of longitudinally spaced ribs disposed on a first side of the central longitudinal axis, and a second set of longitudinally spaced ribs disposed on a second side of the central longitudinal axis that is opposite of the first side. Moving along the central longitudinal axis, ribs of the first set of longitudinally spaced ribs may alternate with ribs of the second set of longitudinally spaced ribs.

Abstract: Provided are a medicine injecting tip, which injects a medicine into a hole in a skin formed by a needle while invading the needle to a preset depth of a deep portion of the skin, a hand piece equipped with the medicine injecting tip, and a skin treatment device using the medicine injecting tip. The medicine injecting tip includes a cylinder, a plunger that reciprocates downward and upward, and has a first space and a second space formed inside the cylinder, and a needle disposed in the plunger and disposed in the second space of the cylinder. The needle is inserted into a skin and a negative pressure state is formed in the second space when the plunger moves downward, and the needle is discharged from the skin and a positive pressure state is formed in the second space, when the plunger moves upward.

Abstract: A cover for placement over a portion of a body of a patient having a plurality of openings extending therethrough for injection of a drug into the body. The cover is customized to the portion of the body and the plurality of openings are customized to the desired locations of injection of the drug through the openings and into the body. Systems and methods for creating the cover are also provided.

Abstract: A hand-held dispenser to dispense fluid includes a casing to fit into a hand of a user, a nozzle in the casing to dispense a mist, a fluid reservoir contained in the casing to hold a fluid to be turned into the mist, a filament extension atomizer contained in the casing to generate the mist, an air source contained in the casing to provide air flow to direct the mist to the nozzle, a motor contained in the casing to operate the filament extension atomizer, an actuator positioned on the casing to activate the dispenser, a control circuit contained in the casing to receive a signal from the actuator and to send a signal to the motor to cause the motor to actuate, and a power source contained in the casing to provide power to the motor upon receive a signal from the control circuit.

Abstract: A medical instrument with an aerosol outlet, which is fluidically connected—via an aerosol line—to a generation device. The generation device is adapted to generate aerosol for dispensing by means of the medical instrument. In addition, a generation device is stated, which, in embodiments of the generation device, for example can be used in a device with the instrument according to the invention. The generation device comprises a mixing unit for mixing a liquid and a gas together, which mixing unit is connected to a liquid container for supplying the mixing unit with a liquid, in which case the generation device is adapted to utilize the gas pressure of a gas under pressure subjecting the liquid to a pressure in order to press the liquid out of the liquid container to the mixing unit.

Abstract: The disclosure discloses an electronic cigarette atomizer and an electronic cigarette, including an outer casing, wherein the outer casing is provided inside with an atomization cavity, a gas outlet is provided at a top end of the atomization cavity, a gas inlet is provided at a bottom end of the atomization cavity, the atomization cavity is provided inside with an atomization assembly, and the atomization assembly includes an oil guiding cotton swab, an electric heating wire wound around outer periphery of the oil guiding cotton swab, and an oil guiding cotton cloth layer covering the top of the oil guiding cotton swab.