Abstract: The present invention provides new and useful features and mechanisms for the localization and transport of biopsy specimens. The invention having a specimen board, an absorbent material in operative engagement and in coplanar alignment with the specimen board, a compression sheet, radio opaque indicia located within the specimen board, and a flexible connection between the compression sheet and the specimen board, and an attachment device which provides for removable engagement of the specimen board and compression sheet. The apparatus further provides for a clear visualization window and operating instructions. The absorbent material is capable of adjustable movement between a first and second position, providing orthogonal positioning relative to the specimen board. As a result, the apparatus may be used to create three dimensional radiographic images allowing tissue analysis resulting in orthogonal views while maintaining original positional reference points.

Abstract: The present invention is generally directed to systems and methods for sampling fluids from subjects. The fluid may be any suitable bodily fluid, e.g., blood or interstitial fluid. In some cases, the subject is a patient. The subject may have a device that can be applied to the skin of the subject (e.g., by the subject, or another person), and the device is able to obtain a sample of fluid. The fluid may be stored within a reservoir in the device, and the fluid may be obtained from the subject at any convenient time, e.g., at home, away from a healthcare setting, etc. In some embodiments, the device, or a portion thereof, may be returned to a clinical and/or laboratory setting to analyze the fluid stored within the device.

Abstract: A device, system and method for in-vivo analysis. An autonomous in-vivo device may include a magnet to detain at least a portion of a sample collected from a body lumen; a sensor to sense a property of the detained sample portion; and a transmitter to transmit data of the sensed property.

Abstract: Muscle cramps can be reduced or avoided by monitoring the concentration of salt in perspiration to indicate the degree of salt depletion. Based on the degree of salt depletion, a sufficient amount of rehydration beverage is consumed to normalize the salt level.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. In one form, a firing mechanism has a blade that punctures and slits the sterility sheet during the firing cycle to reduce the chance of cross contamination between the lancet and the test strip prior to use. This allows an operator to load and subsequently remove an unused integrated lancing test strip without compromising the sterility of the lancet. The lancet includes an engagement opening in which the blade of the firing mechanism engages the lancet. The engagement opening is configured to reduce the chance of the blade becoming dull.

Abstract: A disposable glucometer is disclosed which includes a testing region for receiving a test strip and electronic components to perform blood glucose monitoring, a cell phone interface for relaying test results to a monitoring station or server (which can be through a Bluetooth radio), and a multi-strip test strip holder. The glucometer includes a mechanism to automatically load test strips, one at a time, from the multi-strip test strip holder into the testing region, and a mechanism to eject the strip from the testing region after the test is complete. The test strip holder is preferably encased in a transparent material or otherwise includes a visual indicator so that the number of strips remaining strips and available for testing can be determined. In one embodiment, the entire unit is disposable, and is discarded when all of the strips have been used. In another embodiment, the test strip holder portion of the unit is removed and replaced with a new test strip holder which is loaded with test strips.

Abstract: A body fluid sampling device includes a firing mechanism that is configured to be automatically cocked and fired. In one form, the device includes an electric motor that is operable to cock the firing mechanism and fire an integrated lancet/sampling device to form an incision in skin. Subsequent to formation of the incision, the integrated lancet device is temporarily removed from the skin to promote bleeding from the incision. After a specified period of time, the integrated lancet device is then repositioned against the skin in order to collect a fluid sample.

Abstract: A phlebotomy device includes a needle defining a lumen and having a proximal end portion and a distal end portion. The distal end portion includes a sharpened tip configured to pierce tissue. The phlebotomy device further includes a sensor disposed at least partially within the lumen. The sensor has a first state and a second state and is configured to transition from the first state to the second state upon exposure to blood at physiological temperature.

Abstract: A tissue penetrating system has a housing member. A plurality of penetrating members are positioned in the housing member. A tissue stabilizing member is coupled to the housing. A penetrating member sensor is coupled to the plurality of penetrating members. The penetrating member sensor is configured to provide information relative to a depth of penetration of a penetrating member through a skin surface.

Abstract: A sensor and a lancet are integrated with each other. A thin strip-shaped sensor and a lancet are integrated so that the lancet moves in parallel, along a longitudinal direction of the sensor. A measuring device to which an integrated lancet and sensor is attached is provided with a function of driving the attached lancet.

Abstract: A body fluid testing device includes a body member and a tissue penetrator carried by the body member. A test strip holder is carried by the body member, and a test strip is carried by the test strip holder. The test strip is capable of receiving a body fluid thereon and processing the body fluid into a form suitable for yielding test results relating to the content of the body fluid. The body member, tissue penetrator, test strip holder and test strip are designed for a single use and for disposal as a unit without disassembly.

Abstract: Provided are a system and method for in vivo and in situ detection of body lumen conditions. The system comprises at least one interaction chamber for containing an endo-luminal sample, the interaction chamber comprising at least one indicator; at least one light source for illuminating the interaction chamber; and at least one optical detector for detecting in vivo optical changes occurring in the interaction chamber. The reaction between the indicator and sample may result in an optical change, which is detected and possibly imaged by the optical detector.

Abstract: A centralized patient monitoring system configured to enable each of a plurality of technicians to generally simultaneously monitor multiple patients is disclosed herein. The centralized patient monitoring system includes a computer adapted to receive patient data from the monitored patients, and a display configured to visually convey the patient data. The centralized patient monitoring system also includes a directional speaker configured to selectively generate a localized alarm in order to audibly alert one of the technicians when a monitored patient requires attention in a manner that is generally imperceptible to the other technicians.

Abstract: The present invention provides a diagnostic method comprising continuously monitoring and transmitting urine output and urine flow rates of a catheterized patient to means which correlate the same with at least one of renal perfusion, renal function, fluid status, polyuria, oleguria, hypoperfusion, hemorrhage shock and GFR.

Abstract: A body fluid sampling system is provided for use on a tissue site. In one embodiment, the system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members.

Abstract: Arrangements are provided including a fluid transport tube, or a needle, having a first end and a second end opposite the first end, and a lumen having an inner diameter. At least one fluid transport enhancing projection is disposed in the lumen and extends from the second end toward the first end. A discreet, wearable blood glucose monitor including such arrangements is also described.

Abstract: A device (302) for sampling and/or analyzing blood or other body fluid of a subject. A housing (306) contains a plurality of lancets (308) and optionally includes test elements (324) to take up a sample of blood, an evaluation system and a display. A complete system that can be handled as a single device, for example in the form of a wristwatch, includes a multiplicity of test elements (324) and lancets (308), which can be brought successively to a working position to perform multiple measurements. A cassette or carrier (320) includes multiple lancets (308) and/or test elements (324), for insertion into the device.

Abstract: A sample collection container adapted to be connected to, and disconnected from, a sample collection adapter and a sample collection container cap. The sample collection adapter has a downward sloping interior surface that provides a free-flowing path for samples provided by a subject to the sample collection container. The sample collection adapter may have a three-dimensional rim that is curved in two different non-parallel planes.

Abstract: A method for providing decision-assist to medical staff resuscitating a burn patient includes receiving patient information, calculating an infusion rate, outputting the infusion rate, obtaining a urinary output, calculating a new infusion rate using infusion rate model based constants, and outputting the new infusion rate. In some embodiments, the method includes notifying medical staff when problems arise, displaying information regarding the resuscitation, and setting limits regarding the infusion rates.

Abstract: The present invention relates to an analyzing instrument (1A) which includes a capillary (31), a fluid feed port (20) for introducing a sample liquid to the capillary (31), and a fluid feed promoter (6) for promoting the introduction of the sample liquid into the feed port (20). The capillary (31) of the analyzer (1A) may be formed on a substrate (2) for example. The fluid feed promoter (6) may include at lease one of a water-absorbing layer having a higher water-absorbing capacity than the substrate (2) and an adhesive layer having a greater adhesion to the skin than the substrate (2).

Abstract: A lancing member (2) is integrally provided with a cap (29) for covering a needle (21). Upon or after being attached to a holder (5) of a lancing device (A), the lancing member (2) is rotated relative to a cap (29) by a rotator (C). As a result, the boundary (28) between the cap (29) and the lancing member (2) is broken easily to expose the needle (21).

Abstract: Muscle cramps can be reduced or avoided by monitoring the concentration of salt in perspiration to indicate the degree of salt depletion. Based on the degree of salt depletion, a sufficient amount of rehydration beverage is consumed to normalize the salt level.

Abstract: A body fluid sampling unit includes a puncture device including a needle having a sharp needle point and a drive mechanism for operating the needle to puncture a living body surface with the needle point, a tip including an introducing section for introducing a body fluid flowing out from a puncture portion of the living body surface punctured with the needle point, a test paper for detecting a predetermined component in the body fluid, and a tip body mounted to a component measuring device for measuring the quantity and/or property of the predetermined component detected by the test paper; and a case including a mechanism containing section for containing the puncture mechanism so that the needle point of the puncture mechanism can be moved by the drive means, and a sampling implement containing section for containing the body fluid sampling implement so that the tip can be taken out.

Abstract: The present disclosure provides electrode structures and integrated electrode structures having one or more conductive materials coextruded with one or more dielectric materials. The disclosed electrode structures can be configured for use as analyte sensors. Also provided, are methods of making and using the electrode structures and integrated electrode structures described herein.

Abstract: A method and system for operating a semi-closed loop and/or a closed loop resuscitation of a burn patient in view of patient information and other physiological data gathered as part of the method and/or by the system. The method in at least one embodiment includes receiving patient information, calculating an infusion rate based at least on part on a portion of the received patient information, outputting the infusion rate to an infusion pump, obtaining a urinary output, calculating a new infusion rate using infusion rate model based constants, and outputting the new infusion rate to an infusion pump. In some embodiments, the method includes notifying medical staff when problems arise, displaying information regarding the resuscitation, and setting limits regarding the infusion rates.

Abstract: A foldable instrument (10) adapted to determine an analyte concentration of a fluid sample using a test sensor is disclosed. The instrument comprises a first portion (12) including a display (22) and a second portion (14) pivotally coupled to the first portion by a pivot mechanism (23). The second portion includes a user-interface mechanism (16a-c). One of the first portion (12) and second portion (14) includes at least one opening (18) formed therein. The opening is adapted to receive a test sensor. The instrument is adapted to be folded into a closed position and unfolded into an open position by rotating one of the first portion and second portion about the pivot mechanism (23).

Abstract: Animal waste collections mats comprising a textured layer, an absorbent layer attached to the textured layer, and an impermeable layer attached to the absorbent layer. The textured layer of the waste collection mat can have one or more physical properties that animals find pleasing or acceptable. The absorbent layer acquires and stores moisture from the textured layer. The impermeable layer provides containment for the waste products in the textured and absorbent layers.

Abstract: A self contained disposable test unit for testing body fluid comprises a body member and a support member. The support member is moveable with respect to the body member between a first position and a second position. The support member includes a body part receiving surface for receiving a patient's body part. A lancet is carried by the body member and includes a lancet tip capable of piercing the skin of a patient to produce fluid flow. A test member is capable of interacting with body fluid to aid in the determination of information about body fluid components. A capillary member is capable of directing fluid flow to the test member. A pressure cup is capable of exerting pressure on a body part to foster fluid flow out of a lanced site and into the capillary, and a calibration member is provided for containing information for facilitating calibration of the test unit.

Abstract: A lancet device for generating a puncture wound in a skin surface, comprising a housing, in which a lancet can be moved on a puncturing path, a lancet drive with a drive rotor that can be driven by a drive spring, a lancet coupling mechanism that transforms a rotational motion of the drive rotor into a puncturing and returning motion of the lancet during a working cycle of the lancet drive, a reference element that is mobile relative to the lancet and relative to the housing and is fixed in a defined position relative to the lancet drive during the puncturing and rests against the surface of the skin with a contact surface thereof such that a puncture wound with a reproducible puncturing depth is generated by the puncturing motion, and a reference element coupling mechanism that is coupled to the lancet drive in order to move the reference element. The invention further relates to a suitable lancet drive assembly for a lancet device of this type.

Abstract: A machine for performing a method for immediate identification and rapid comparative assessment of indicators of the presence of infections and/or risk situations related to gastroduodenal pathologies, characterized in that it comprises a measurement unit that is constituted by a container supplied by means for aspirating gastric juices in which an agitator of the mixture of gastric juice, reagents and water operates, and at least one probe for sensing the values of the analysis, a hydraulic section that comprises a set of tanks for the reagents required for the analyses and for the water, which are connected to respective apparatuses for feeding said measurement unit and to a pump for feeding water into the stomach of the patient, an apparatus for controlling the temperature of said container, and an electrical section, which comprises a programmable control unit for actuating and controlling said feeder apparatuses and said measurement unit and is suitable to determine the test execution methods.

Abstract: Provided are skin incision instrument to efficiently incise minimal portions and a method for incising skin with the skin incision instrument.

Abstract: This invention relates to a lancing apparatus (A1) used for inserting an insertion element (21) into a human skin (Sk) for sampling a body fluid. The lancing apparatus (A1) includes a housing (1) with a cylindrical portion (12) brought into contact with the skin (Sk), a negative pressure generator (6) that generates a negative pressure inside the cylindrical portion (12) to cause the skin (Sk) to swell upward, and a detector (5) that detects that the skin (Sk) has been raised to a predetermined height inside the cylindrical portion (12).

Abstract: The present invention provides a method and a device for piercing a body part and determining whether a sufficient volume of blood has been withdrawn. A lancing element is rapidly inserted into a body part in a forward phase and retracted quickly to a lesser puncturing depth. Subsequently, the lancing element is retracted slower than during the first retraction movement and the distance retracted during the second retraction is shorter than the first retraction movement. During the second retraction movement, body fluid is collected in a collection phase by a capillary structure of the lancing element. Contact between the lancing element and the body fluid is detected after the forward phase at the beginning and the end of a waiting period.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Abstract: A device and method for lancing a patient, virtually simultaneously producing and collecting a small fluid sample from a body. The device comprises a blood collection system including a lancing needle (16), drive mechanism (11), kneading or vibration mechanism (25), optional suction system (7), and sample ejection mechanism. The device is preferably sized to be hand-held in one hand and operable with one hand. The device can optionally contain integral testing or analysis component (83) for receiving the sample and providing testing or analysis indication or readout for the user. A method involves piercing the skin at a rapid rate, kneading the surrounding area by ultrasonic action, piezoelectric or mechanical oscillation to stimulate the blood flow from the wound, drawing the fluid using a pumping system.

Abstract: A method and apparatus for non-invasive analysis of saliva includes a user friendly lolli-pop like apparatus that is self contained and provides the user with a method to stimulate saliva by sucking on the pop head. The saliva activates a color change reaction on the apparatus that results in a visual response that can be compared to a user gauge for analysis in monitoring health conditions and concerns.

Abstract: Body fluid sampling device comprising a skin-piercing element having a collection zone for receiving body fluid, and the device further comprising a fluid receiving means remote spaced apart from the collection zone so that body fluid in the collection zone will not contact the fluid receiving means initially. The collection zone takes up a very small volume of body fluid of about 10 to 500 nl in a very short time period of less than 0.5 seconds. The fluid receiving means may have a test zone for performing an analytical reaction. Fluid sample from the collection zone is automatically or manually transported to the fluid receiving means to contact the fluid with the test zone.

Abstract: A urinary directional device for improving the directional urination and health of a male user is provided, in which the device comprises a conduit for the passage of urine and having a proximal end adapted for engagement with the penis of the user and a distal end having a distal aperture to enable the passage of urine from the conduit, the device having an interior surface providing one or more of a cleansing, an anti-bacterial or antiseptic or an anti-fungal function whereby the penis of the user can be cleansed by wiping on the interior surface of the device after urination and the device optionally further comprising a health detection indicator capable of indicating abnormalities in urine indicative of disease or health-related conditions.

Abstract: An integrated lancing test strip includes a test strip and a lancet packet coupled to the test strip. The lancet packet includes a sterility sheet enclosing a lancet to maintain the sterility of the lancet and prevent cross-contamination between the test strip and the lancet. The sterility sheet allows the lancet to be sterilized separately from the test strip. The sterility sheet gives the integrated strip a low profile, which is attractive for packaging multiple integrated strips in cassettes, drums, magazines or the like. In one form, the integrated strip is loaded in a meter that includes an adjustment mechanism that adjusts the position of the test strip relative to the skin being sampled. This allows the user to adjust the position of the test strip so as to not apply excessive pressure against skin, which could hamper bleeding from the incision in the skin.

Abstract: Systems, methods and devices are provided for invasive reduced-pain blood sampling and testing, the devices including, a horizontally-disposed finger support element configured to support the finger thereupon, a finger holding element adapted, in a closed position, to radially grip the finger on said support element near to a tip thereof and configured to force blood into said tip, a lancet housing element disposed vertically underneath the finger support element for piercing the finger tip with a lancet while said finger tip is gripped by said finger holding element and supported by said finger support element; and a test strip conveying element adapted to be received by the finger support element after retraction of the lancet housing element thereby bringing a test strip into direct contact with a predetermined volume of blood from said finger support element thereby effecting a blood test.

Abstract: Systems for and methods of assessing urinary flow rate via sound analysis. Embodiments of the uroflow measurement systems include a computer and a telephone or a digital recording mechanism to capture the sound of one or more urination events, which are stored as audio files in a database The uroflow measurement systems may include sound analysis software for analyzing the strength and duration of each urination event and may include a web-based uroflow software application for viewing the results via the Internet or other network In one embodiment, the sound analysis software performs the steps of reading in the raw data of a selected audio file, generating a plot of the audio signal amplitude vs.

Abstract: A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Abstract: Apparatus and methods in which very small volumes of material may be extracted, delivered, interrogated or stimulated via optical, electromagnetic or mechanical means, in vivo or in vitro, for site-specific detection, characterization, stimulation, diagnostics or therapy, comprising optical, fluidic, chemical, electromagnetic and biological techniques applied via a microprobe in a single intra-parenchymal tissue perforation procedure in the brain. The primary use of the device is in neuroscience research, clinical diagnostics and therapeutics applications in the brain, however, the device may also be beneficially applied to other organs and biological systems. Human clinical applications may include neurosurgical intra-operative monitoring, extra-operative chronic monitoring of devices introduced in an operation, and diagnostic monitoring combined with simultaneous neuroimaging.

Abstract: A method and a blood oxygen tester for determining whether a blood sample is arterial or venous blood are disclosed. A blood oxygen tester for determining whether a blood sample is arterial or venous blood comprises a housing and a blood sample receptacle defined by the housing. A blood oxygen sensor is in communication with the blood sample receptacle and a test result indicator is in communication with the blood oxygen sensor. The indicator is responsive to the blood oxygen sensor for indicating whether a tested blood sample is arterial blood or venous blood.

Abstract: These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. An analyte detecting member is positioned to receive fluid from a wound created by the penetrating member. The detection member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 ?L of the fluid.

Abstract: A bodily fluid sampling device includes a piercing device and a sensor enclosed in a housing. A cassette, which contains test media, is positioned proximal to the sensor so that the sensor is able to analyze a bodily fluid sample collected on the test media. The cassette includes a supply portion from which unused test media is supplied and a storage portion in which contaminated test media is stored after exposure to the bodily fluid. The cassette is adapted to collect a series of bodily fluid samples without requiring disposal of the test media.

Abstract: It is an object of the present invention to provide a component measuring instrument with which a predetermined component in blood can be measured securely and in a short time. The component measuring instrument, which is used by mounting therein a chip having a puncture needle, includes: a specimen sampling portion application portion to which a specimen sampling portion to be punctured is applied; a puncturer for moving the puncture needle; pressure reducer for putting the punctured portion of the specimen sampling portion punctured by the puncture needle, together with a containing space for the puncture needle, into a reduced-pressure condition; measurer for measuring the amount of a predetermined component in the blood sampled from the punctured portion; and a chip retracting mechanism for moving the chip in a direction away from the specimen sampling portion while maintaining the reduced-pressure condition generated by the pressure reducer.

Abstract: A blood sampling device includes a lancet having a skin piercing member disposed at an end thereof. The lancet is slidable within and releasably engaged with an elongated lancet guide that remains stationary with use of the device. A shell is axially movable relative to the lancet guide between a rest position and an actuate position, with the lancet being spring loaded within the lancet guide by movement of the shell from the rest position to the actuate position.

Abstract: A body fluid collecting device which is easy to operate to collect body fluid and which is capable of detecting specific components in body fluid with a small amount of sample includes a sensor to detect a prescribed component in the body fluid, and a first supporter to support the vicinity of the measuring part of the sensor and a second supporter to support the sensor at a place closer to the proximal end than the first supporter. The first and second supporters form between them a non-contact space, wherein the first supporter has at its proximal end a concave that communicates with the non-contact space.

Abstract: A needle assembly includes a transparent or translucent housing with a fluid inlet end, a fluid outlet end, a flashback chamber, and a venting mechanism therebetween. Substantially axially aligned inlet and outlet cannulas extend from the housing and communicate with the chamber. A sealable sleeve covers the external end of the outlet cannula. Relative volumes of the cannulas, the chamber, and the sleeve are selected to provide rapid reliable flashback indicative of venous entry with an internal vent positioned within the housing so as to divide the interior into first and second chambers, with the second chamber being adapted to maintain a negative pressure therein relative to the external environment so as to inhibit leakage of blood from the needle on withdrawal from the patient.