Abstract: A self contained biological indicator is disclosed having a housing and an ampule disposed within the housing, the ampule having a first dome, a second dome and a sidewall. A cap may be coupled to the housing. The cap may include a projection that may be coupled to the ampule by, e.g., a friction fit. An insert may be disposed within the housing. The insert may include a well within which at least a portion of the bottom dome of the ampule may be disposed. The insert may also include a ramp that is angled relative to the central longitudinal axis of the ampule. The second dome of the ampule may contact the ramp. The insert may also include an arm or finger that extends above the well and has a stress concentrator disposed thereon such that it is also disposed above the second dome of the ampule and adjacent to the sidewall of the ampule.

Abstract: A receptacle comprises opposed members, a plurality of chambers having perimeter walls defined by seals formed between the opposed members and portals interconnecting the chambers, and a rigid frame supporting the opposed members at their peripheral edges. The frame comprises a front frame portion and a rear frame portion, and the peripheral edges of the opposed members are retained between the front and rear frame portions. An inlet port extends between the front and rear frame portions and is in fluid communication with one of the chambers.

Abstract: A method of processing a sample in a receptacle comprising a plurality of chambers. Each of the chambers is connected to at least one other chamber by a portal and at least a first one of the chambers is formed of a flexible material. The method includes the steps of causing gas bubbles contained in the first chamber to accumulate in a portion of the first chamber, applying a compressive external force to the first chamber to cause some or all of the liquid contents of the first chamber to flow into an interconnected second chamber through a portal connecting the first and second chambers; and preventing the gas bubbles accumulated in a portion of the first chamber from flowing through the portal into the second chamber.

Abstract: The invention relates to a medical device in the form of a cartridge (2) incorporating an assembly permitting the preservation of corneal tissue that has been obtained beforehand by sampling, the device comprising: a storage compartment (24) containing a preserving fluid, at least one input terminal (21) upstream from the storage compartment (24), for injecting a compressed pressurizing gas, at least one control terminal (22) upstream from the storage compartment (24), for injecting a compressed control gas, a pneumatically controlled switching system (26) downstream from the terminals (21, 22), said switching system (26) being controlled by the compressed control gas in order to permit or prohibit the circulation of the compressed pressurizing gas towards the storage compartment (24).

Abstract: The invention relates to a medical device for preservation of corneal tissue (3) that has been obtained beforehand by sampling, the device comprising a base (11), at least one side wall (12), and means for receiving and blocking the corneal tissue (3), characterized in that the device additionally comprises an applanation lid (13) for covering an opening of the device opposite the transparent base (11), the applanation lid (13) comprising: a transparent window (131), and a support (132) between the window (131) and the side wall (12), the support (132) comprising means for moving the window (131) in translation with respect to the side wall (12) of the device.

Abstract: The present invention relates to a gas delivery device comprising a gas releasing molecule and a gas permeable membrane. The invention also relates to the use of the gas delivery device for delivery of gas to an extracorporeal transplant, extracorporeal cells, a brain-dead transplant donor or foodstuff and in therapy. The invention further relates to the use of a gas permeable and liquid and solid impermeable membrane to separate a gas releasing molecule and its non-gaseous degradation products from an extracorporeal transplant, extracorporeal cells, a brain-dead transplant donor or foodstuff.

Abstract: Provided is a culture medium including fibers aligned in one direction, and a method for producing the same. The culture medium includes: a substrate; a frame body that includes a first surface, a second surface opposite therefrom, and one or more through holes extending from the first surface through the second surface, and that is mounted to the substrate such that the first surface is opposed thereto; a plurality of aligned fibers interposed between the substrate and the first surface; and a bonding portion that bonds the substrate, the plurality of aligned fibers, and the frame body, wherein at least a part of the plurality of aligned fibers is exposed from a first opening that is formed in the first surface by the through hole.

Abstract: A cultivation bag assembly for the cultivation of microbes, fungi and other organisms includes an inner bag having first and second walls that are joined together along side edges to define an inner bag interior for containing a food substrate and an organism to be cultivated. At least one of the first and second walls is constructed of a layer of water-vapor permeable material to allow the passage of water vapor therethrough. An outer bag having first and second walls is joined along side edges to define an outer bag interior. The first and second walls of the outer bag are formed from gas impermeable layers. The inner bag and outer bag are coupled together at a first end of each of the inner bag and outer bag. The inner bag is contained within the interior of the outer bag in a cultivation configuration. A window is provided on the inner bag to allow one to view the interior of the inner bag through the window.

Abstract: A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Abstract: An apparatus, a system, and methods for receiving, perfusing and maintaining and assessing excised donor heart physiological functionality. The system generally comprises an apparatus for receiving and holding an excised heart that is interconnected with: (i) a perfusate-processing system, (ii) a bi-directional perfusate pumping system, (iii) flow sensors for monitoring the flow of perfusate to and from an installed heart's aorta, pulmonary artery, pulmonary vein, and vena cava, (iv) an ECG apparatus interconnectable with the installed heart, and (v) probes interconnecting the installed heart with instruments for monitoring the heart's physiogical functionality using load independent indices and load dependent indices.

Abstract: A system and method for perfusing an organ with a normothermic extracorporeal perfusion system is disclosed. The perfusion system is an active flow system using a centrifugal pump to aid in circulation. The system includes a dialyzer that removes excess fluid and impurities, while maintaining the pH, which allows the perfusion system to be used for an extended period that may exceed 24 hours. The system includes a parallel circuit, which includes at least one centrifugal pump, a membrane oxygenator comprising a heat exchanger; a dialyzer; a measurement cell for real-time monitoring of oxygen saturation and hematocrit in the liver; more than one flow probe; and an organ chamber.

Abstract: A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

Abstract: An incubator which can uniformly maintain a temperature/humidity in a culture chamber and prevent dew condensation from occurring in the culture chamber is provided. Further, an incubator which raises an air pressure in a culture chamber higher than that of the external environment to maintain an aseptic environment and prevents water vapor to be supplied from adversely affecting the inner aseptic environment is provided. An incubator includes a culture chamber including an insulated door and insulated wall, circulating means for circulating air in the culture chamber, temperature regulating means for regulating a temperature of the air in the culture chamber, and humidifying means for humidifying the air in the culture chamber.

Abstract: A method for counting blood cells in a sample of whole blood. The method comprises the steps of: (a) providing a sample of whole blood; (b) depositing the sample of whole blood onto a slide, e.g., a microscope slide; (c) employing a spreader to create a blood smear; (d) allowing the blood smear to dry on the slide; (e) measuring absorption or reflectance of light attributable to the hemoglobin in the red blood cells in the blood smear on the slide; (f) recording a magnified two-dimensional digital image of the area of analysis identified by the measurement in step (e) as being of suitable thickness for analysis; and (g) collecting, analyzing, and storing data from the magnified two-dimensional digital image. Optionally, steps of fixing and staining of blood cells on the slide can be employed in the method.

Abstract: A compact device for measuring incubation of living cells with molecules attached to superparamagnetic nanoparticles consisting of iron cores by magnetizing the nanoparticles with an external pulsed field, measuring the time dependence of decaying magnetic fields of the nanoparticles as they attach to the cells by a magnetic sensor, extracting number of attached nanoparticles per cell and rate of incubation by mathematical analysis of the magnetic field emitted by the incubating cells versus time.

Abstract: Systems and methods for continuous flow polymerase chain reaction (PCR) are provided. The system comprises an injector, a mixer, a coalescer, a droplet generator, a detector, a digital PCR system, and a controller. The injector takes in a sample, partitions the sample into sample aliquots with the help of an immiscible oil phase, dispenses waste, and sends the sample aliquot to the mixer. The mixer mixes the sample aliquot with a PCR master mix and diluting water, dispenses waste, and sends the sample mixture (separated by an immiscible oil) to the coalescer. The coalescer coalesces the sample mixture with primers dispensed from a cassette, dispenses waste, and sends the reaction mixture (separated by an immiscible oil) to the droplet generator. The droplet generator converts the sample mixture into an emulsion where aqueous droplets of the reaction mixture are maintained inside of an immiscible oil phase and dispenses droplets to the digital PCR system.

Abstract: Apparatus and associated methods relate to an optimizable cellular growth chamber, where growth conditions are optimized by adjusting gas pressures through a gas permeable membrane. In an illustrative example, an apparatus may provide a volume to contain growth medium and the cells under propagation, where the volume has limited but non-zero pneumatic communication with a pressure-controlled chamber via a gas-permeable membrane. Associated apparatus and methods are proposed to manage desired growth conditions via deliberate control of parameters, such as partial pressures, for example.

Abstract: A fluidic device holder configured to orient a fluidic device. The device holder includes a support structure configured to receive a fluidic device. The support structure includes a base surface that faces in a direction along the Z-axis and is configured to have the fluidic device positioned thereon. The device holder also includes a plurality of reference surfaces facing in respective directions along an XY-plane. The device holder also includes an alignment assembly having an actuator and a movable locator arm that is operatively coupled to the actuator. The locator arm has an engagement end. The actuator moves the locator arm between retracted and biased positions to move the engagement end away from and toward the reference surfaces. The locator arm is configured to hold the fluidic device against the reference surfaces when the locator arm is in the biased position.

Abstract: A method and automated apparatus for rapid non-invasive detection of a microbial agent in a test sample is described herein. The apparatus may include one or more means for automated loading, automated transfer and/or automated unloading of a specimen container. The apparatus also includes a detection system for receiving a detection container, e.g., container or vial, containing a biological sample and culture media. The detection system may also include one or more heated sources, holding structures or racks, and/or a detection unit for monitoring and/or interrogating the specimen container to detect whether the container is positive for the presence of a microbial agent therein. In other embodiment, the automated instrument may include one or more, bar code readers, scanners, cameras, and/or weighing stations to aid in scanning, reading, imaging and weighing of specimen containers within the system.

Abstract: A multiple-bore solute cartridge carrier 10) for use in a sterile fluid delivery system. The carrier includes a rotary housing (12) adapted for connection to the sterile fluid delivery system. The rotary housing has one or more bores (30) configured to receive a solute cartridge. The rotary housing, when connected to the sterile fluid delivery system, is selectively rotatable to facilitate creation of a desired sterile solution when sterile water from the fluid delivery system is flowed through the solute cartridge.