Abstract: A system and method for determining a coagulation time, e.g., thrombin time, PT, aPTT, and ACT, of a blood sample deposited in a test cartridge is disclosed. The test cartridge includes a blood receptacle that is open to the atmosphere into which a blood sample is to be deposited, a vacuum port that is open to atmosphere, and a spiral capillary within the test cartridge having a capillary length and cross-section area, a first capillary end of the spiral capillary open to the blood receptacle and a second capillary end of the spiral capillary open to the vacuum port, whereby the spiral capillary is closed to atmosphere. When a blood sample is deposited in the blood receptacle, a vacuum is drawn through the vacuum port and the blood is drawn through the spiral capillary until coagulation occurs. A pressure change is detected, and the coagulation time is measured.

Abstract: A system and method for determining a coagulation time, e.g., TT, PT, aPTT, and ACT, of a test sample deposited in a test cartridge is disclosed. A cartridge housing having upper and lower major sides and a minor sidewall encloses a test chamber having a test chamber pivot element and is provided with a cartridge port for introducing a test sample into the test chamber. Ferromagnetic agitator vane leaflets extend from an agitator pivot element supported by the test chamber pivot element intermediate the upper and lower major sides for rotational motion. The agitator vane leaflets can be swept, in response to an external magnetic field, through the test sample in the absence of coagulation. A timer is started when the agitator movement is commenced whereupon the agitator moves freely. Resistance to agitator movement due to coagulation is detected, and the coagulation time is measured.

Abstract: A system and method for determining a coagulation time, e.g., TT, PT, aPTT, and ACT, of a blood test sample deposited in a test cartridge is disclosed. A cartridge housing having upper and lower major sides and a minor sidewall encloses a test chamber having a test chamber pivot element and is provided with a cartridge port for introducing a test sample into the test chamber,. Ferromagnetic agitator vane leaflets extend from an agitator pivot element supported by the test chamber pivot element intermediate the upper and lower major sides for rotational motion. The agitator vane leaflets can be swept, in response to an external magnetic field, through the test sample in the absence of coagulation. A timer is started when the agitator movement is commenced whereupon the agitator moves freely. Resistance to agitator movement due to coagulation is detected, and the coagulation time is measured.

Abstract: The disclosed embodiments include a method, system, and device for conducting ultrasound interrogation of a medium. The novel method includes transmitting a non-beamformed or beamformed ultrasound wave into the medium, receiving more than one echoed ultrasound wave from the medium, and converting the received echoed ultrasound wave into digital data. The novel method may further transmit the digital data. In some embodiments, the transmitting may be wireless. The novel device may include transducer elements, an analog-to-digital converter in communication with the transducer elements, and a transmitter in communication with the analog-to-digital converter. The transducers may operate to convert a first electrical energy into an ultrasound wave. The first electrical energy may or may not be beamformed. The transducers also may convert an echoed ultrasound wave into a second electrical energy.

Abstract: The present invention refers to a novel device for measuring coagulation time and platelet activity wherein the patient can measure his or her coagulation time and platelet activity without the aid of medical professionals due to the fact that this device is fully autonomous. A blood sample (14) is deposited in the dish (3) and reacted with a reactant (16). The display (9) then shows the coagulation time and platelet activity of the patient.

Abstract: An apparatus and method for measuring blood platelet contractility, hereinafter called a “retractometer” is disclosed. Also disclosed is a system apparatus and method for automatically measuring platelet contractility in a plurality of samples, having an array of retractometer units and an electronic solenoid valve controller to fully automate screening in clinical and research situations and save costs in labor.

Abstract: A blood sample sensing apparatus includes a moving device which moves a sample container containing a blood sample to a sensing position, a turning mechanism which is connected to the moving device and tilts the sample container such that a bottom of the sample container is directed upward when the sample container is located in the sensing position, and an optical sensor which is located in the sensing position and determines whether the blood sample in the sample container is coagulated.

Abstract: A microsystem for determining clotting time of blood and a low-cost, single-use device for use therein are provided wherein the device has no moving parts or expensive optical sensors or magnets. The device includes a microfluidic channel and a microsensor at least partially in fluid communication with the channel. By analyzing changes in the sensor as a drop of blood flows down the microfluidic channel, the time at which the blood clots can be determined.

Abstract: Methods and apparatus are disclosed for determining a new anticoagulant therapy factor (nATF) for monitoring oral anticoagulant therapy to help prevent excessive bleeding or deleterious blood clots that might otherwise occur before, during or after surgery. In one embodiment, the new anticoagulant therapy factor is based upon a determination of a new fibrinogen transformation rate (nFTR) which, in turn, is dependent on a maximum acceleration point (MAP) for fibrinogen (FBG) conversion. The new anticoagulant therapy factor quantity is also based upon the time to maximum acceleration from the time of reagent injection (TX) into a plasma sample, but does not require the difficulty of obtaining prior art International Normalized Ratio (INR) and International Sensitivity Index (ISI) parameters. Other embodiments provide methods and apparatus for determining an anticoagulant therapy factor without requiring use of a mean normal prothrombin time determination or ISI.

Abstract: An analyzing method of a blood coagulation reaction by detecting an optical change of a blood sample with an elapse of time, the method includes: setting at least one checkpoint or check region between a starting point of the blood coagulation reaction and the endpoint thereof; and monitoring a reaction state of the blood coagulation reaction at the checkpoint or in the check region to detect an abnormality of the blood coagulation reaction.

Abstract: A method and device for blood hemostasis analysis is disclosed. A blood sample is displaced to reach a resonant state. The resonant frequency of the blood sample is determined before, during and after a hemostasis process. The changes in the resonant frequency of the blood sample are indicative of the hemostasis characteristics of the blood sample.

Abstract: A method and kit for testing a multi-channel blood-testing cartridge. In particular, blood-testing cartridges are tested with plasma samples with clotting times measured to indicate whether a batch of cartridges is suitable for testing the blood of a patient.

Abstract: A system for performing a blood coagulation assay, having: a reaction chamber; at least one moveable member configured to mix contents of the reaction chamber; a sensor configured to detect the presence of a blood clot formed in the reaction chamber; and a timer that measures an interval of time between when a blood sample is received into the reaction chamber and when the sensor detects the blood clot formed in the reaction chamber.

Abstract: Methods for predicting the presence of haemostatic dysfunction in a patient from a time-dependent measurement profile include performing a time-dependent measurement on an unknown sample and measuring a respective property over time so as to derive a time-dependent measurement profile. The slope of the time-dependent measurement profile is computed prior to clot formation. A biphasic waveform is detected in the time-dependent measurement profile based on the computed slope. The presence of haemostatic dysfunction in the patient is predicted based on the detected biphasic waveform.

Abstract: A sample retention apparatus for use in a device for measuring hemostasis. The device for measuring hemostasis may include a sample articulation apparatus including a guide shaft coupled for articulating motion to a drive motor, a sample carrier secured to and axially moveable along the guide shaft between a sample ready position, a sample testing position and a sample ejection position. The sample carrier therefore articulates in unison with the articulating motion of the guide shaft. A measuring apparatus may include a sensing column. The sample retention apparatus may include a sample cup defining a volume within which a sample may be disposed. The sample cup may be adapted to be operably positioned within an aperture formed within the sample carrier. The sample testing apparatus may also include a sample pin that is engageable with the sensing column. The sample pin may include a tip portion for extending into the sample cup.

Abstract: A hemostasis analyzer, such as the Thrombelastograph® (TEG®) hemostasis analyzer is utilized to measure continuously in real time, the hemostasis process from the initial fibrin formation, through platelet-fibrin interaction and lysis to generate blood hemostasis parameters. The measured blood hemostasis parameters permit evaluation of platelet inhibition therapy.

Abstract: A method and apparatus for determining the stability of dispersions and emulsions accelerates the onset of significant particle agglomeration in a sample by stressing the sample by reducing the height of the interparticle potential energy barrier between the particles. This is achieved by adding one or more of three stress factors: changing the pH of the sample to reduce the surface charge on the particles; adding an adsorbing electrolyte so that ions of the appropriate charge are adsorbed onto the surfaces of the particles to reduce the net charge on the particles; and applying a monovalent, divalent, or trivalent salt to partially screen electrostatic repulsions between the charged particles. In a preferred embodiment, the increase in agglomeration is detected with single particle detection, such as SPOS, to generate a PSD from which a figure of merit is derived. Another embodiment detects turbidity or light scattering to generate a value X indicative of the extent of agglomeration.

Abstract: To investigate the flowability of a physiological fluid sample, an uptake passage (12) for the fluid sample (16), an actuator device (18) for the cyclic change in orientation of measuring particles (14) in the fluid sample (16), and a detector device (20, 22) for the preferably optical detection of the change in orientation of the measuring particles (14) are provided. In order to make reliable measurements possible with minimal instrument expense, it is proposed that the actuator device is formed by a pump unit (18) to produce a flow of the fluid sample (16) that travels back and forth along the uptake passage (12) and indicates the change in orientation of the measuring particles (14).

Abstract: A flow system device used for testing/creating fluid flow. The system comprises at least one fluid filled loop and a rotor stage for maintaining at least one rotor. The loop is positioned on the rotor. The device also includes a driving motor for rotating the rotor stage and a motion controller for controlling the speed and directional motion of the motor.

Abstract: A method for determining platelet activation by utilizing numeric counts of platelets before a sample of platelets has been activated and after the activatable platelets are activated with a platelet activation agonist and using the difference between such counts as an indication of the platelet activity of the sample. There is also disclosed a method for using the electronic impedance cell counting technique for determining platelet activation wherein EDTA is used as a preservative by counting the platelets in an EDTA preserved sample using an electronic impedance cell counting technique and subtracting from that number the number of platelets remaining after the activatable platelets in a second sample have been activated with a platelet agonist in the absence of EDTA and using that difference as a measure of platelet activity.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are provided. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are provided. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: A method and apparatus for monitoring hemostasis in a connection with a recipient of an artificial surface device provide a multi-phase monitoring protocol. In a first, pre- and intra-operative phase, hemostasis of the recipient is monitored relative to preventing clot formation to achieve artificial surface patency. In a second, post operative phase hemostasis of the recipient is monitored relative to bringing about clot formation to achieve vascular recovery. In a third, stabilizing intensive care phase hemostasis of the recipient is monitored relative to balancing hemostasis toward an anti-coagulation bias. In a fourth, maintenance phase hemostasis is monitored relative to maintaining balanced hemostasis.

Abstract: A procedure for hemostasis and blood management, particularly for cardiovascular procedures, provides: sampling instructions, i.e., when to draw blood samples and how to pre-treat the blood samples, a decision tree to assist the interpretation of hemostasis analysis results allowing for the identification of various coagulopathies, and treatment suggestions related to the hemostasis analysis results. The analysis, interpretation and identification may be conducted by a suitably programmed computer.

Abstract: The invention relates to a method for measuring the aggregation or agglutination of platelets, where a reaction mixture is mixed in a first reaction phase, and is mixed less vigorously or not at all in a second reaction phase following the first, and the measurement is preferably carried out in the second reaction phase.

Abstract: A self-contained analyzer quantitatively detects a clotting event in a biological fluid. The device includes a base having an open reservoir for receiving the biological fluid. A carrier for a dried activator reagent is located in or adjacent to the open reservoir. The biological fluid reconstitutes the dried reagent and starts the clotting process. During the clotting process the fluid travels through a capillary flow channel lined with a precision woven fabric. When clotting is completed, the woven fabric stops the flow of the fluid. A colored bar formed by the fluid flowing through the capillary channel indicates the length of time required for clotting of the sample.

Abstract: Compositions, methods, devices and kits for use in the calibration of coagulation tests. The control compositions include particles capable of aggregating in plasma and calcium ions which, when mixed with plasma, simulate the behavior of whole blood in a coagulation test. The methods include providing calcium ions and particles capable of aggregating in plasma, combining the particles and calcium ions with plasma to form a control composition, and applying the control composition to a coagulation test. The devices include a container having at least two compartments, with one compartment including particles that promote or induce aggregation of a protein or proteins in plasma, and the other compartment includes a solution of calcium ions. The kits include a control composition including a container of calcium ions, a container of particles capable of inducing aggregation of proteins in plasma, and one or more coagulation test devices.

Abstract: The invention is a method, reagent and test cartridge for the determination of the clotting time of a blood sample by means of a reagent containing tissue factor and a sulfatide. In an alternative embodiment, the reagent may contain tissue factor and at least one of the group consisting of a phosphatide and a sulfatide. This invention is preferably used to monitor the effectiveness of heparin therapy in patients that have been administered low to moderate heparin doses to achieve blood heparin levels from 0 to about 3 U/mL, and may also be used for determining clotting time at higher heparin levels of up to about 6 U/mL.

Abstract: The present invention is a container assembly that includes a coating composition on an interior surface of the container assembly and more particularly a coating composition for rapid clotting of a blood sample within a blood collection tube. The coating composition includes an intrinsic coagulation activator and an extrinsic coagulation activator for activating intrinsic and extrinsic pathways for promoting the rapid clotting of the blood sample. In addition, the present invention includes a barrier package for enclosing the container assembly.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably, a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: A method and device for testing a sample of fresh whole blood. In particular the present invention provides a method and device for testing a sample of fresh whole blood to determine whether a patient would benefit from the administration of a blood factor (such as AT III.

Abstract: In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably includes a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Abstract: A coagulation test for determining the activated clotting time (ACT) of blood in the presence of heparin that produces test results that are substantially insensitive to the drug aprotinin. The activator is formulated to be a combination of celite and bentonite. The ACT results obtained with this formulation are similar to celite ACT tests on heparinized blood while simultaneously being unaffected by aprotinin. Additionally, a method for quantifying the aprotinin effect of different ACT formulations is disclosed.

Abstract: Disclosed is The method of in vitro testing of the state of the blood coagulation system. The Accelerated Whole Blood Clotting Time (A. W. B. C. T.) reflects the degree of over or under activity of the coagulation system of the blood.

Abstract: A blood coagulation analyzer, such as the Thrombelastograph® (TEG®) blood coagulation analyzer is utilized to measure continuously in real time, the clotting process from the initial fibrin formation, through platelet-fibrin interaction and lysis to generate blood coagulation parameters. The measured blood coagulation parameters permit confirmation of the attainment of therapeutic level of GPIIb/IIIa receptor blockade; individualized dosing assessment to evaluate attainment of adequate GPIIb/IIIa receptor blockade; individualized dosing assessment required to reach adequate GPIIb/IIIa receptor blockade; illustration of the rate of diminishment of platelet inhibition or inhibition recovery after treatment with platelet-inhibition drugs; evaluation of the interaction effect of a combination of thrombolytic or any other agents or conditions effecting hemostasis and platelet-inhibiting agents on patient hemostasis.

Abstract: The present invention provides methods for inhibiting blood clotting. In general, the methods include adding corn trypsin inhibitor (CTI) to blood or a blood product in an amount sufficient to inhibit the clotting. The CTI can be used alone or in combination with other anti-coagulants. In one aspect, the invention features plasma clotting assays featuring substantially prolonged clotting times. Clotting assays using whole or minimally altered blood are also provided. Further provided are methods for storing blood or blood products at low temperature with the CTI.

Abstract: A method and device for testing a sample of fresh whole blood. In particular the present invention provides a method and device for testing a sample of fresh whole blood to determine whether a patient would benefit from the administration of a blood factor (such as AT III.

Abstract: A method and apparatus are provided for measuring hemostasis. The apparatus includes a torque sensing column having a torque sensing element and a drive ring disposed around a body of the column and in registration with the column so as to allow rotation of the drive ring around a longitudinal axis of the column. The apparatus further includes a first guide shaft rigidly secured to the drive ring, the guide shaft extending parallel to the longitudinal axis of the column and a cup holder movably attached to the guide shaft, allowing the cup holder to move parallel to the longitudinal axis of the column. The apparatus also includes a sample cup adapted to engage the cup holder on a outer surface and the torque sensing element of the torque sensing column on an inner surface.

Abstract: A method and apparatus for foaming and then testing the foamed fluid. The apparatus comprises a cylindrical pressure vessel with upper and lower caps. A circular disk with a plurality of openings, which are preferably circular openings, is placed in the pressure vessel. The apparatus also includes a motor with a shaft extending therefrom. The shaft is attached to the pressure vessel so that when the motor is actuated, the pressure vessel can be rotated in a desired revolutions per minute. The method includes placing a mixture in the pressure vessel and then attaching the caps to the upper and lower ends of the vessel. The upper cap has a pressure gauge and has a pressure inlet and a pressure relief valve. The circular disk is placed in the vessel. The vessel is pressurized to a desired pressure with a gas motor. The motor is then actuated to rotate the vessel.

Abstract: An anticoagulant for blood cell counting containing at least two kinds of the following antiplatelet agents: theophyllines, adenosines and dipyridamoles. The anticoagulant also contains citric acid, an alkali metal salt thereof or a mixture of citric acid and an alkali metal salt thereof.

Abstract: Method and apparatus for measuring oil quality based on the permittivity of the oil comprising a capacitive or radiative sensor for exposure to the oil, and an oscillator circuit including the sensor, wherein the oscillator circuit comprises a LC or crystal oscillator which provides an output signal, the amplitude of which is dependent upon the lossiness of the Tan &dgr; of the oil, and a measuring device that responds to the amplitude of the output signal as a measure of oil quality.

Abstract: An activated partial thromboplastin time (APTT) test is described which employs fresh, whole blood that has not been anticoagulated. The method employs a disposable cuvette having specific reagents placed therein. A sample of whole blood is introduced into the cuvette which is drawn into at least one conduit by a pneumatic pump. Initially, the calcium in the sample is chelated at a first reaction site in the conduit, and thereafter is moved through the conduit to a second reaction site where the sample is coagulated by an APTT reagent. After a predetermined incubation time, the sample is moved to a third reaction site where it is recalcified. Clotting time is measured from the time that the sample is recalcified to the time that clot formation is visibly detected.

Abstract: A method which may be used to determine haemostatic dysfunction in a patient is carried out by (a) adding a reagent to a test sample, wherein the test sample includes at least a component of a blood sample from a patient; and then (b) measuring the formation of a precipitate due to the reaction of the test sample and the reagent, over time so as to derive a time-dependent measurement profile, the reagent forming a precipitate in the test sample without causing substantial fibrin polymerization.

Abstract: The present invention is directed to a method and apparatus for detection of a diagnostically significant amount of clot in an aliquot of blood. In a preferred embodiment, the method uses a cocktail of activators to facilitate and proctor absolute activation of Factor XII (the contact factor for the intrinsic pathway of coagulation). Possible activators include Celite®, kaolin, glass beads, colloidal silica, and diatomaceous material. This cocktail formulation is important because some individuals respond differently to different activators and hence, the cocktail formulation facilitates standardization of the patient population by reducing the patient-activator sensitivity artifacts.

Abstract: A method for determining platelet activation by utilizing numeric counts of platelets before a sample of platelets has been activated and after the activatable platelets are activated with a platelet activation agonist and using the difference between such counts as an indication of the platelet activity of the sample. There is also disclosed a method for using the electronic impedance cell counting technique for determining platelet activation wherein EDTA is used as a preservative by counting the platelets in an EDTA preserved sample using an electronic impedance cell counting technique and subtracting from that number the number of platelets remaining after the activatable platelets in a second sample have been activated with a platelet agonist in the absence of EDTA and using that difference as a measure of platelet activity.

Abstract: The present invention provides methods for inhibiting blood clotting. In general, the methods include adding corn trypsin inhibitor (CTI) to blood or a blood product in an amount sufficient to inhibit the clotting. The CTI can be used alone or in combination with other anti-coagulants. In one aspect, the invention features plasma clotting assays featuring substantially prolonged clotting times. Clotting assays using whole or minimally altered blood are also provided. Further provided are methods for storing blood or blood products at low temperature with the CTI.

Abstract: The invention relates to a method and a measuring arrangement for measuring the gas content of a fluid (13). The fluid (13) comprises gas bubbles. In the method, microwave radiation (20) is transmitted through the fluid (13) and a signal (7) indicating the travel time, phase or amplitude of the radiation (20) is formed in a microwave measuring device (16), and a gas measuring equipment (18) determines the gas content of the fluid (13) by means of the signal (7).

Abstract: A method for producing tofu is disclosed which includes the step of detecting the concentration of a coagulant in soybean milk. The coagulant concentration is detected by a coagulant concentration detector disposed downstream of a stirring apparatus in a soybean milk transfer circuit. The amount of addition of the coagulant is controlled by a coagulant concentration adjuster in accordance with the coagulant concentration detected by the coagulant concentration detector. This enables the mass production of tofu having a bouncy taste and excellent flavor.

Abstract: This invention relates to diagnostic methods and test kits for rapidly assessing the coagulant activity of blood by measuring the rate of blood clotting in the presence of certain metal ions. A modulator of coagulation may also be included. The coagulation activity of the blood of the patient in the presence of metal ions and an optional modulator is an indication of the presence or development of certain pathological conditions relating to the procoagulant activity of blood, including platelet function. The effect of metal ions on the viscosity of blood is also diagnostically useful.

Abstract: A method and apparatus are provided for measuring hemostasis. The apparatus includes a torque sensing column having a torque sensing element and a drive ring disposed around a body of the column and in registration with the column so as to allow rotation of the drive ring around a longitudinal axis of the column. The apparatus further includes a first guide shaft rigidly secured to the drive ring, the guide shaft extending parallel to the longitudinal axis of the column and a cup holder movably attached to the guide shaft, allowing the cup holder to move parallel to the longitudinal axis of the column. The apparatus also includes a sample cup adapted to engage the cup holder on a outer surface and the torque sensing element of the torque sensing column on an inner surface.