Abstract: A blood testing apparatus includes a laser source configured to produce a wound from which blood flows and at least one test member. A humidity cover is positioned at the at least one test member. The humidity cover is at least partially removable. Electronics are provided for analysis. The electronics includes an evaluation device for comparisons with previously stored measurements or evaluation data with the evaluation device storing a current test measurement.

Abstract: Apparatus and methods for generating a partial vacuum in a cavity are disclosed. In one method, a suction unit is disposed on a surface and includes a plurality of embedded suction generation devices that suction gas therethrough. The suction generating devices are powered-on to form a cavity defined by at least the surface and the suction unit and gas is evacuated from the cavity to generate the partial vacuum.

Abstract: An integrated meter system for determining information related to an analyte of a fluid sample includes a meter including a housing and a plurality of test sensors. Each of the plurality of test sensors includes a penetrating member, a testing portion, and a channel. The channel is adapted to receive the fluid sample. The test sensors are removably located within the housing. At least one of the test sensors is removably connected to an adjacent test sensor. The integrated meter system also includes a test-sensor advancement mechanism that is configured to advance the test sensors.

Abstract: A device and a method for analyzing an analyte in a liquid sample are provided. The device comprises a detecting chamber included in a detection device for containing a detecting element; a liquid sample transferring chamber; and a film with small pores disposed between the detecting chamber and liquid sample transferring chamber. When the detection device is inserted into a liquid sample collecting chamber, the liquid sample in the collecting chamber enters the liquid sample transferring chamber but can not enter the detecting chamber via the film with small pores. When a piston is inserted into the liquid sample transferring chamber, the piston forces a part of liquid sample in the liquid sample transferring chamber to enter the detecting chamber via the film with small pores. Using the device and the method can determine an analyte in a sample quantitatively and can complete the detection in one step.

Abstract: Aspects of the present invention are directed to a metered dose container that is transit proof. A container of the present invention may comprise a body having a vertical axis; a cap movable along the vertical axis of the body; a removable ring coupled to and between the moveable cap and the body, and a barrier, inside the body and coupled to the moveable cap. The barrier may define a loading chamber and separate the body into a storage chamber and a dispensing chamber. The barrier is adapted to be movable along the vertical axis of the body to form a transit position and a dispensing position.

Abstract: This disclosure provides equipment and processes for blood glucose management. Embodiments may comprise a lancet device that includes a base that supports a lancet and a cover. The cover can move controllably from an un-depressed position to a depressed position when a predetermined force is applied. The cover can provide access to the lancet in the depressed position. In another aspect, a biological test kit may include a reusable module and a disposable module. The disposable module may include one or more lancet devices such as that described above to collect a biological sample, one or more strip stations supporting biological strips and a disposable module connector. The reusable module may support measuring equipment to measure a property of the biological sample and a reusable module connector that engages removably with the disposable module connector.

Abstract: A glucose blood monitor that includes a cartridge releasably insertable into an interior cavity of a housing, said cartridge including a plurality of lancet strips vertically disposed therein, each of said plurality of lancet strips including a hollow needle and a test strip, wherein each of said plurality of lancet strips is cycled from a first cavity within the cartridge, to a prime position for use, to a read position for analysis of a collected blood sample, then to a used position within a second cavity in the cartridge, whereby used needles and test strips are interiorly retained within the cartridge for safe disposal of the cartridge as a whole subsequent use of the last of the plurality of lancet strips.

Abstract: A supply of lancets for a multi-use lancing device are carried by a tape and sequentially brought from a storage position to an activating position by advancing the tape around a bend. In the lancets' activating position they extend from the tape such that their sharp tips are available for lancing tissue. The carrying tape can be arranged in reel-to-reel format in a housing having a lancing opening. The lancets can be integral with the tape and activated to move the lancet through the lancing opening by moving the tape along its tape path or by translating a dedicated service loop of the tape. The lancets can also be independent from the tape and activated through the lancing opening by a separate lancing actuator. A test media can be included on the carrying tape and the housing can contain a sensor to yield an integrated lancing and testing device.

Abstract: The present invention relates generally to systems and methods for measuring an analyte in a host. More particularly, the present invention relates to systems and methods for transcutaneous and subcutaneous measurement of glucose in a host.

Abstract: A portable analytical device is provided for analysis of a component of a body fluid. A measuring facility within the device may carry out the analysis on a test element inserted therein. The test element may contain a reagent that reacts with a liquid sample of the body fluid when the test element is contacted thereby to produce a change that is characteristic of the analysis. A processor may process measuring values determined by the measuring facility to yield analytical measuring data taking into account calibration values. A standardized, wire-based computer interface may be provided on the analytical device via which the analytical device can be operated by a computer, the analytical measuring data can be transmitted from the analytical device to the computer, the analytical device can be supplied with electrical power by the computer, and the analytical device can provide software to be read-out by the computer.

Abstract: Unique characteristic sounds produced as urine impacts the surface of the water are used to monitor men's urinary flow patterns and their dynamics. By detecting the intensity at selected acoustic frequencies, it is possible to accurately and precisely measure the urine flow rate. Techniques for analyzing urine flow and its dynamics employ sound levels that are detected with digital filters at two or more distinct frequency regions or channels of the sound spectrum. One frequency region that is designated the measurement channel is where the sound measurement intensity strongly depends on urine flow levels. Another frequency region that is designated the reference channel is where the sound measurement intensity is not dependent on urine flow levels. By using a combination of measurements from the measurement channel and the reference channel, the urine flow monitoring apparatus compensates for variations in operating conditions and other factors during use.

Abstract: The invention relates to body fluid measuring strip cartridges and apparatuses. A cartridge of the present kind comprises a body having a housing zone for a plurality of stacked test strips, a first opening on the wall of the body for bringing the test strips out of the body one at a time, and first means for sealing the first opening. According to the invention, the cartridge further comprises a second opening on the wall of the housing, the second opening allowing an external actuator to enter the housing and to move within the housing for bringing a test strip out of the body, and second means for sealing the second opening. In addition, means are arranged on said body for providing electrical connection between the reading terminals of at least one strip and external meter electronics. The invention offers a convenient way of achieving sealed storage and reading of analytical test strips for small-sized body fluid measuring apparatuses.

Abstract: A collection device includes a base housing member having at least one chamber. A cover housing member has at least one aperture therein, and the cover housing member is configured to cover the base housing member such that the at least one aperture is positioned in fluid communication with the at least one chamber. The cover housing member includes a cartridge holding interface configured to releasably engage with a cartridge that is configured to cover and receive a fluid from the at least one chamber via the at least one aperture.

Abstract: In some aspects, an analyte sensor is provided for obtaining and detecting an analyte concentration level in a bio-fluid sample. The analyte sensor has a sensor body including a semiconductor material, an active region coupled to the sensor body, and a lancet provided on the analyte sensor. The conductor may include a fiber having a core of a conductive material and a semiconductor cladding surrounding the core. Numerous other aspects are provided.

Abstract: A bagless catheter and incontinence device, which reduces maceration, microbial skin infiltration and infection, urinary tract infection, and offers the user a normal, odor-free, active lifestyle, is provided.

Abstract: A sweat sensing device includes a plurality of sweat collection pads communicating with a sensor. Each of the pads is activated by a timing circuit which allows one or more of the pads to be activated at a selected time and subsequent deactivated after a defined period of time. This allows for selective collection of sweat from a plurality of pads over a prolonged period of time. An impedance measuring circuit can be employed to determine if one or more of the pads becomes disconnected, in order to avoid irritation. Further, the devices can use a common microfluidic device which both transports sweat activating substance, such as pilocarpine, to the surface of the skin and directs sweat away from the skin to a sensing device.

Abstract: The invention provides a urine flow meter of gravitation or capacitance type in which a container is connected to a weight transducer or a capacitance sensor. An arrangement is provided to sense the level of urine in the container. An arrangement of siphon tube & solenoid valve is also provided to start and stop rinsing of the container automatically. The invention is easily adapted to a male or female type urinal. The collected urine in beaker is flushed by siphon after completion of test.

Abstract: A fluid handling module that is removably engageable with a bodily fluid analyzer is provided. The module may comprise a fluid handling element, and a fluid component separator that is accessible via the fluid handling element and configured to separate at least one component of a bodily fluid transported to the fluid component separator. The fluid handling element may have at least one control element interface.

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: The present invention provides devices, systems and methods for RNA isolation from biological samples containing white blood cells, such as whole blood. The devices have a device body that includes a first chamber having a first membrane that selectively binds white blood cells, a second chamber having a second membrane that reversibly binds RNA and a plurality of ports that are removably attached to a reagent pack and waste receptacle via a valving system controlled by a control unit.

Abstract: A placental blood extraction device comprises a receptacle for receiving a placenta with umbilical cord, the receptacle comprising a compartment arranged to receive the placenta; and a tube extending from the compartment for receiving the umbilical cord; wherein the receptacle is selectively removable from the device for receiving the placenta. The placental blood extraction device may comprise a pressure application device for applying pressure to a placenta, the pressure application device comprising a plurality of pressing members for applying pressure on a plurality of regions of the placenta.

Abstract: Cartridge for a testing device and method of testing using the testing device with the cartridge is disclosed. The cartridge includes a plurality of lancet needles and a mechanism allowing the cartridge to be mounted to the testing device. The method provides for puncturing a surface of skin using the testing device by arranging the testing device adjacent or against a user's skin, triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user's skin, and rotating the cartridge to another position. This Abstract is not intended to define the invention disclosed in the specification, nor intended to limit the scope of the invention in any way.

Abstract: A lancet wheel having a rim with a plurality of lancets extending radially inward from the rim is dropped in a circular frame having a plurality of spokes forming a plurality of chambers for facilitating drop-in assembly of the modular lancet wheel with the frame. A test ring having a plurality of test sections is assembled on the frame such that one test section is located adjacent each lancet to form an integrated cartridge. Each lancet includes a lancet tip defining a capillary groove sized to collect a body fluid sample from the incision via capillary action. The lancet tip exits the chamber to form the incision in skin, the capillary groove collects the body fluid sample, the lancet tip retracts into the chamber, and a portion of the lancet contacts the test section to transfer the sample from the capillary groove to the test section to analyze the sample.

Abstract: A blood sample test device has a continuous strip sensor which is advanced through the device so that multiple blood sample tests can be conducted on a single strip. The device is provided with a sprocket having an encoder which engages sprocket holes on the strip to precisely control the advancement of the strip through the device.

Abstract: A body fluid sampling device is provided. A mesh (120) may be used to guide blood or fluid to travel directly form the wound to an analyte detecting port on the cartridge (121). Thus the volume of blood or body fluid produced at the wound site irregardless of its droplet geometry can be reliable and substantially completely transported to the analyte detecting member (150) for measurement.

Abstract: An improved electrode layout for a continuous strip sensor is provided which reduces misalignment of the electrodes with the contacts which read the position of the strip. Better contact with the electrodes reduces or eliminates transient signals between stop positions of the sensor strip.

Abstract: A puncturing system for obtaining a sample of body fluid comprises a magazine that comprises a lancet carrier that carries several lancets, a puncturing device comprising a compartment for the magazine, an incremental advancing mechanism for moving the lancets successively to a puncturing position, and a puncturing drive for accelerating one of the lancets that is positioned in the puncturing position in a puncturing motion. The magazine comprises a coupling facility with a receptacle for the lancet carrier. The receptacle is mobile with respect to a magazine housing The lancets that are carried by the lancet carrier can be moved relative to the receptacle by actuating the incremental advancing mechanism The receptacle is adapted to couple the puncturing drive to one of the lancets positioned in the puncturing position for transmitting a driving force generated by the puncturing drive during a puncture to the lancet positioned in the puncturing position.

Abstract: A cartridge for a testing device and method of testing using the testing device with the cartridge is disclosed. The cartridge includes a plurality of lancet needles, a plurality of test strips, and a mechanism allowing the cartridge to be mounted to the testing device. The method provides for puncturing a surface of skin using the testing device by arranging the testing device against a user's skin, triggering the testing device so that one of the plurality of lancet needles is caused to penetrate the user's skin, placing an amount of blood on one of the plurality of test strips, and rotating the cartridge to another position.

Abstract: A body fluid sampling system for use on a tissue site includes a single drive force generator. A plurality of penetrating members are operatively coupled to the force generator. The force generator moves each of the members along a path out of a housing with a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. A flexible support member couples the penetrating members to define a linear array. The support member is movable and configured to move each of the penetrating members to a launch position associated with the force generator.

Abstract: An article suitable for conducting one or more assays with an apparatus, e.g., a meter, for determining the presence or concentration of an analyte in a sample of biological fluid. The article contains a plurality of biosensors arranged in such a manner that each of the biosensors can be utilized before the article must be removed from the apparatus.

Abstract: Analysis system for determining an analyte in a body fluid is presented. The system comprises a reusable analysis instrument and a magazine having a plurality of integrated sample acquisition and analyzing elements. Each element comprises a puncturing element and an analyzing element. A coupling unit couples the integrated sample acquisition and analyzing element to a drive. The magazine comprises a housing having a plurality of elongate neighboring chambers separated by two side walls running in a longitudinal. The chambers contain the integrated sample acquisition and analyzing element. The chambers have an exit opening allowing for the at least partial exiting of the puncturing element. The chambers of the magazine are accessible to a coupling element that can be formfitting coupled to the coupling structure of the puncturing element, when the puncturing element is in the chamber of the magazine and the magazine is located in a holder.

Abstract: The devices and methods taught in this disclosure are directed to facilitate the observation, collection, transportation, storage, and preservation of specimens possibly containing DNA, said specimens potentially constituting evidence of sexual assault. The devices and methods described further allow for a means of minimizing the possibility of specimen contamination, dilution, or degradation during the collection and storage processes. The disclosed devices may contain electrical components that provide for the generation and recordation of information (specifically, times, dates, and locations) related to circumstances surrounding the collection of such specimens. This information may serve as evidence corroborating the circumstance of specimen collection, it may help to maintain a known and identifiable Chain of Custody (CoC), and it may additionally be used for unique device identification (UDI), inventory control, and current procedural terminology (CPT) coding purposes.

Abstract: A lancing system comprising a lancing elements carrier tape carrying a plurality of lancing elements, a tape transport unit for moving the lancing elements consecutively into a usage position by transporting the lancing elements carrier tape, a lancing drive for causing a lancing element located in the usage position to perform a lancing movement, and test elements with detection reagents for analyzing a body fluid sample obtained by a puncture is presented. Additionally, a test elements carrier tape is provided, which carries the test elements. The lancing elements carrier tape and the test element carrier tape are located on top of one another with tape sections that carry unused test elements or unused lancing elements.

Abstract: A method for diagnosing a body malfunction is provided. At least one change in urinary parameter values, being indicative of the body malfunction, is monitored and detected. A volumetric urinary output of kidneys is monitored using a urine flow monitoring apparatus having a low flow metering device. It is determined whether a change exists in at least one of a volume value of the volumetric urinary output, and a trend of the corresponding urinary parameter value during a predetermined period. Signals are received from a plurality of electrodes, representing the urinary parameter values. The body malfunction is detected based on the determination of the change in at least one of the volume value and the trend.

Abstract: A test tape device is disclosed herein for use with a replaceable analytical tape cassette, where the device includes a housing having a cassette compartment covered by a cassette door and a housing opening for sample application, a protective cover that can be moved between a closed position covering the housing opening and a release position allowing access to the housing opening and a door lock for retaining the cassette door in the closed position, wherein the protective cover is coupled with the door lock via an interlocking mechanism, such that the door lock can only be unlocked in the release position of the cover.

Abstract: The present invention relates to the diagnosis and treatment of urinary incontinence. The diagnosis and treatment involves the use of a multiple sensor-enabled catheter capable of providing real-time data regarding the patient's physiology, such as urinary flow and muscular function of the bladder of the bladder sphincter, as well as the position and movement of the catheter within the patient.

Abstract: Method and apparatus for providing an integrated analyte sensor and data processing unit assembly is provided.

Abstract: A lancing device for generating a puncture wound in a body part to obtain a body fluid sample for analytical or diagnostic purposes, in particular, by using integrated disposables that comprise a lancing element as well as an associated test element is disclosed. In order to achieve a high success rate in obtaining the body fluid sample, a drive can be designed such that the lancing element or the test element can be moved into a contact position while remaining in a position near the body part contact opening during a deployment period. If the amount of sample obtained in a lancing movement is inadequate to carry out the analysis or diagnosis, the lancing element can be brought into contact with the sample by a user by manual positioning the lancing device to manually take up a sample obtained by manually milking the sampling site in the region of the puncture wound.

Abstract: A lancet housing assembly comprising multiple lancets for use in a portable handheld medical diagnostic device for sampling bodily fluids from a skin site of a patient is provided. The lancet housing assembly includes a housing structure comprising multiple lancet compartments. At least one of the lancet compartments comprises an outer facing side and an inner facing side. An opening is located at the outer facing side that is arranged and configured to align with a lancet port of the medical diagnostic device. A floor extends between the outer facing side and the inner facing side. A reagent material is located on the floor and within the lancet compartment. A lancet structure is located in the at least one lancet compartment. The lancet structure comprises a skin penetrating end and a blood transport portion adjacent the skin penetrating end. The skin penetrating end, when extended through the opening, is shaped and sized to penetrate the patient's skin at the skin site to provide an amount of blood.

Abstract: A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

Abstract: A urine flow measuring apparatus that includes a container for receiving urine, measuring means for measuring the weight and/or volume of urine received by the container, and memory means for recording the weight and/or volume measured by the measuring means. Through a controller the measuring means: continually measures the weight and/or volume of the container at regular sampling intervals; and at each sampling interval, identifies if a positive change in the weight and/or volume of the container has occurred and then compares results within a data set, the data set including a result from the current sampling interval and results from all the sampling intervals during a given period. If a number of sampling intervals indicating a positive change in the weight and/or volume is above a certain threshold, the memory means is instructed to begin recording data, else the memory means is instructed to cease recording data.

Abstract: A diagnostic method and apparatus for detecting at least one change in a urinary parameter indicative of a body malfunction, the method comprising at least semi-continuously monitoring in real time at least one of a sodium level, an oxygen level, a potassium level, and combinations thereof in the urine of a catheterized patient; whereby at least one parameter is monitored so as to detect one or more changes in the at least one parameter to reflect at least one of a fluid state, an electrolyte balance, a kidney state, a kidney perfusion and an organ perfusion in the patient, indicative of the body malfunction in the patient, in which the monitoring is preferably performed through electrodes that are arranged perpendicularly to the flow of urine through a patient's catheter system.

Abstract: A tape cassette for a medical handheld device is disclosed as comprising a carrier tape, which carries test fields for assaying a sample of a human or animal bodily fluid and/or lancets as functional elements, a supply chamber, in which a supply section of the carrier tape comprising unused functional elements is positioned, a winding unit, in order to wind up the carrier tape and draw it through a tape exit opening of the chamber, so that the functional elements may be brought sequentially into a usage position. The carrier tape in the tape exit opening is oriented transversely to the supply section positioned in the supply chamber.

Abstract: A system is provided for withdrawing small amounts of body fluid from an animal or human. The system includes a holder and a disposable lancing unit attached to the holder. The lancing unit also includes an open capillary channel for transporting the body fluid and piercing the skin.

Abstract: A lancing device integrated with a sensing strip and method of making and using the same are provided. A lance and analyte sensing strip are combined in a single, preferably disposable, device. In a preferred embodiment, a slot is provided in a support member so the lance can be engaged by a lance driver and driven into the skin producing a bodily fluid sample from a wound. The sensing area of the sensing strip is adjacent to the wound location reducing dexterity requirements for patients.

Abstract: Arrangements are provided including a base having a bore disposed therein extending from a first surface of the base through a second surface of the base, a fluid transport tube having a first end, a second end opposite the first end, and a lumen having an inner diameter, at least the second end of the tube being received within the bore of the base, and at least one fluid transport enhancing groove having at least a first section disposed in the second surface of the base and in fluid communication with the bore.

Abstract: A meter system for analyzing body fluids includes a supply magazine for storing a stack of test elements, a meter for analyzing fluid samples, and a transport system for transporting test elements from the supply magazine to the meter. The test element in one embodiment includes a lancet integrated test element that has a lancet coupled to a test strip. The transport system is configured to minimize damage to the test element. In one form, the transport system includes a shuttle that slides the top-most test element from the stack onto a connection portion of the meter. In another form, the transport system includes a drum that rotates to transport test elements from the supply magazine to a testing position and, once used, to a waste magazine for disposal. In a further form, the transport system includes a disc that rotates to transport the test elements.

Abstract: A puncturing system includes a carrier tape carrying multiple lancets and having position marks, a housing comprising a conveying facility for positioning the lancets and a housing opening, a puncturing drive for accelerating a lancet positioned in a usage position, a storage medium for storing distance values that depend on distances between the lancets of the carrier tape and position marks allocated to the respective lancets, a sensor for detecting position marks in a detection position through which the position marks proceed upon motion of the carrier tape, and a control unit that controls the conveying facility. To position a lancet in the usage position, the control unit stops the conveying facility upon the carrier tape moving a positioning distance. The length of the positioning distance depends on the distance between the lancet to be positioned and the detected position mark and is determined by the control unit.

Abstract: An arrangement for producing a sample of body fluid from a wound opening created in a skin surface at a sampling site includes at least one skin-penetration member having a first end configured to pierce the surface of the skin, and a inner lumen in communication with the first end; at least one actuator operatively associated with the at least one skin-penetration member; and at least one catalyst device configured to cause perfusion of body fluid at the sampling site; wherein the at least one actuator is configured to locate the at least one skin-penetration member so as to obstruct the wound opening while transporting body fluid through the inner lumen. Associated methods are also described.

Abstract: A body fluid sensing device with a body fluid capture structure and a body fluid measurement sensor positioned in the body fluid capture structure. A capacitance sensor is coupled to the body fluid measurement sensor. The capacitance sensor is used to assist in the positioning of a body part relative to the body fluid capture structure.