Abstract: A method and apparatus are presented for non-invasive determination of blood clotting related and blood circulation related parameters of a mammal. At least one stimulus ST is non-invasively induced in a blood containing medium in the mammal for a preset period of time tST. This at least one stimulus is selected to cause at least one of the following to occur: (a) inducing at least two of three Virchow's triad elements including abnormalities of blood flow; abnormalities of blood constituents and abnormalities of the blood vessel wall, and (b) inducing a change in red blood cell (RBC) aggregation or local blood viscosity. Measurements are non-invasively performed at a measurement location in the mammal by applying an external field thereto for a preset time period tm, a response of the measurement location to the applied field is detected, and measured data indicative thereof generated.

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 a patient hemostasis condition.

Abstract: A method of estimating an amount of a substance in a bodily fluid from the color of a tissue surface of a subject includes capturing an image including at least a portion-of-interest of the subject and at least a reference portion of a color reference, the image being a digital image of pixels of at least one color, the image including a component value for each pixel for each of the at least one color, obtaining a first value associated with at least one component value corresponding to the portion-of-interest of the subject, obtaining a second value associated with at least one component value corresponding to the reference portion, and calculating an estimated amount of the substance using the first and second values.

Abstract: According to embodiments, a sensor assembly and/or systems for ultrasound-optical measurements may provide information related to hemodynamic parameters. An ultrasound beam may be used to generate a Doppler field for optical elements of a sensor assembly. By combining information received from ultrasound and optical elements of the sensor assembly, more accurate values for hemodynamic parameters may be determined.

Abstract: A monitoring device may include logic to receive arterial blood pressure data associated with a patient and receive tissue hemoglobin data associated with the patient. The logic may also calculate a linear correlation between the arterial blood pressure data and the tissue hemoglobin data. The correlation may be used to assess vascular reactivity.

Abstract: A method and tool for treating heel pain of a patient. The method includes determining a medical procedure to be performed on the patient based on the number of etiologies, the time span, and the severity of the patient's heel pain. The medical procedure performed may include collecting and processing a sample of the patient's blood to retrieve growth factors therefrom, excising degenerative tissue of the patient's plantar fascia, injecting the patient's growth factors into the patient's plantar fascia, and applying an electrical acoustic shockwave treatment to the patient's plantar fascia. The tool includes a trocar and a rasp configured to be received in the trocar. The rasp includes a file defined at a distal end and configured to extend through an opening of the trocar.

Abstract: A method of determining a prothrombin time is disclosed. A mediator is applied to a stratum corneum. The stratum corneum is penetrated to allow the mediator to enter a region containing interstitial fluid and interact with at least one capillary, causing blood and/or blood components to leak from the at least one capillary into the region containing interstitial fluid. A characteristic affected by the blood and/or blood components is measured in the region containing interstitial fluid which correlates to the prothrombin time. A system for measuring prothrombin time is also disclosed. The system has a mediator, one or more microneedles, and a processor directly or indirectly coupled to the one or more microneedles and configured to determine a coagulation change in blood or blood components in a region around the one or more microneedles after the one or more microneedles penetrate a stratum corneum.

Abstract: An evanescent catheter system is provided as a system having a structure of a tip portion of an optical fiber capable of securely measuring a fluorescence intensity or fluorescence spectrum of a substance around a catheter tip, without being hindered by optical absorption of hemoglobin in erythrocytes in blood, and being capable of calculating an existing amount of a fluorescence-emitting substance existing in an evanescent light generating part. A protecting layer 22 and a cladding 23 are removed from an upper semicircular part of a core 24 at a tip of a catheter 21 to expose the core 24. An optical filter 26 and a photodiode 28 are located opposite to a lower semicircular part. When excitation light 29 is incident, evanescent light 25 is generated on the upper semicircular part of the core 24 and a fluorescent substance generates emits fluorescence 30.

Abstract: Intravenous sensor systems and methods for determining in vivo characteristics are disclosed, as well as systems for cooling bags of intravenous fluid. The intravenous sensor systems include a probe configured for placement in a peripheral vein. The probe includes one or more sensors for obtaining sensed information, such as body temperature, blood oxygen saturation level and blood pressure. An interface unit determines the in vivo characteristics based upon sensed information received from the one or more sensors. The determined in vivo characteristics may be displayed on the interface unit and/or transmitted to a remote computer.

Abstract: An improved circulating cell counter for generating light, and for delivering this light to a site in vivo for determining the presence, absence, concentration or count of a target cell, in which a light source such as a laser diode (121) and integrated optics (153) produce a beam transmitted to an in vivo target region (165), such as a capillary bed with flowing cells in a living tissue. Based upon the movement of cells in and out of this region, a circulating cell count (192) is generated, allowing determination of the presence, absence, concentration or count of the target cell. Use with optical, magnetic, or nanobot contrast agents, and methods of use are also described.

Abstract: An apparatus for detecting the reproductive status, in particular the oestrus cycle, of a mammal, comprising detecting means (10) to detect a blood amount perfused in a predetermined region of the vagina canal of a mammal, and generating a corresponding main signal (20); the apparatus (1) further comprises a processing unit (40) associated with said detecting means (10) to determine the reproductive status of said mammal depending on said main signal (20). Also disclosed is a method of detecting the reproductive status, in particular the oestrus cycle, of a mammal.

Abstract: A methodology for converting venous blood values to arterial blood values provides the advantage of obviating the need for taking arterial blood samples. The method entails (i) measuring arterial oxygenation, (ii) measuring and estimating values of venous blood acid/base status and oxygenation status of a venous blood sample, and (iii) converting the venous blood values by applying a mathematical model for deriving blood acid/base status and oxygenation status into estimated arterial blood values.

Abstract: Fibres with an extraction phase coated thereon in combination with a positioning device are described to perform adsorption of components of interest from an animal or animal tissue for the investigation of living systems. A number of interfaces to analytical instrumentation are disclosed including mass spectrometry, LC/MS, MALDI and CE as well as direct spectroscopic on-fibre measurement.

Abstract: A method of measuring blood clotting ability of a patient. A known volume of blood is dispensed on a reference disc of blotter paper, such that at least one reference blotch is formed on the reference disc. The surface area of the reference blotch formed on the reference disc, such that a relationship between the volume of blood and the surface area of the reference blotch can be obtained. An incision is made at the patient. A piece of blotter paper to the incision is applied to the incision to collect blood flowing therefrom, such that at least one blotch is formed on the piece of blotter paper. The surface area of the blotch formed on the piece of blotter paper is measured. The volume of the blood absorbed blood by the blotter paper is calculated according to the relationship between the blood volume and the surface area of the blotch.

Abstract: A technique for determining a patient's hematocrit by an electrical impedance measurement is described. An implantable device may be configured to utilize the technique in order to assess a cardiac patient's fluid status. In order to determine the hematocrit, the electrical impedance of the blood is measured and mapped by a mapping function to a corresponding hematocrit value.

Abstract: A scanning fiber endoscope (SFE) system selectively operable in a plurality of different modes. One or more illumination optical fibers convey different types of light to an internal site. A scanner that is resonantly driven in a desired pattern collects light from the internal site. The scanner can be a cantilevered distal end of a scanning optical fiber or a scanning mirror. The illumination optical fiber(s) can be moved in a non-resonant manner to alter the direction at which the light is emitted. In a therapy mode, a relatively high-power light can be applied to the site, while in a monitoring mode, the scanner can be used to image the tissue at the internal site after or during therapy. Exemplary SFE probes are disclosed for measuring scattering angle (which can detect larger cancer cell nuclear-to-cytoplasmic ratio), absorption depth, axial distance to tissue, and other conditions at the internal site.

Abstract: The present invention provides a method for the enzymatic measurement of protein tyrosine kinase inhibitors in biological samples. The present invention also provides assay reagents and packaged kits useful for performing enzymatic measurement of imatinib mesylate and other bcr-abl protein kinase inhibitors in biological samples.

Abstract: A density/solute monitor having at least one ultrasound probe, a signal processing unit, and a computing mechanism, and process for using the same, to measure phase shift between emitting and receiving ultrasound, sound velocity, compressibility, density, and solute concentration of fluid flowing through a fluid processing system. The ultrasound probe emits and receives ultrasound waves through the fluid and the signal-processing unit and computing mechanism process the ultrasound waves to determine phase and time shift. The computing mechanism converts phase shift to density, compressibility, and solute concentration measurements of the fluid. Calibrating fluids calibrate the detected phase shift in terms of sound velocity in the factory. Measurements provide information about passage of solutes and flow to achieve better solute collection efficiency, solution purity, and control of fluid processing systems.

Abstract: Method of monitoring a blood bag, the method including monitoring a maximum allowed time dT that the blood bag may be kept outside a controlled-atmosphere enclosure and an expiration date stored in an electronic chip fixed to the blood bag. The method further including indicating whether the blood bag may be transfused to a patient when the time dT and the expiration date have not expired. The instant abstract is neither intended to define the invention disclosed in this specification nor intended to limit the scope of the invention in any way.

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: Apparatus and methods for noninvasively measuring blood density and hematocrit in a human subject can include an appliance for applying pressure around a segment of a subject's limb or appendage that includes a pressure sensing means and encloses an array of impedance sensing devices applied to the subject's skin for independent fluid volume measurements. While applying pressure to the limb segment by the pressure appliance, measurements of blood pressure, blood pulse wave velocity, and limb segment impedance are recorded. The measurements are subsequently processed to yield changes of arterial blood volume during pulse wave passage. Then pressure, wave velocity, and derived volume data are combined to yield the density of the blood. Blood density is converted to hematocrit by means of a linear relationship between the two. Independent of the blood hematocrit, such apparatus and means may also be used to measure the density of enclosed fluid in other pulsed flow non-rigid wall vessel systems.

Abstract: Methods and devices are provided for determining a suitable site for sampling physiological fluid. In the subject methods, a potentially suitable physiological sampling site is selected, the fluid flow of the site is characterized and the site is then determined to be suitable based on the whether the site has high or low flow. Suitability may also be determined based on the type of sample obtainable from the site, where the order of the above-described steps may be altered. The subject devices include at least one site flow characterization element for determining the flow characteristics of a potential physiological sampling site and/or at least one sample type characterization element for determining whether the vasculature is arterial, venous or neither, i.e., an interstitial fluid sampling site. The subject methods and devices are particularly suited for use in the detection of physiological sampling sites in the fingers, arms, legs, earlobes, heels, feet, nose and toes.

Abstract: A method to determine an engrafting cell dose of hematopoietic stem cell transplant units from transplant sources having nucleated cells selected from the group consisting of cord blood, bone marrow, peripheral blood comprising the steps of subjecting the source to a substantially complete erythrocyte lysis, measuring in a cell counter a signal corresponding selectively to white blood cells, assessing essentially quantitatively nucleated red blood cell (NRBC) count as part of the total nucleated cell (NC) count, and determining the number of white blood cells (WBCs) as transplant relevant cells.

Abstract: Apparatus and methods for noninvasively measuring blood density and hematocrit in a human subject can include an appliance for applying pressure around a segment of a subject's limb or appendage that includes a pressure sensing means and encloses an array of impedance sensing devices applied to the subject's skin for independent fluid volume measurements. While applying pressure to the limb segment by the pressure appliance, measurements of blood pressure, blood pulse wave velocity, and limb segment impedance are recorded. The measurements are subsequently processed to yield changes of arterial blood volume during pulse wave passage. Then pressure, wave velocity, and derived volume data are combined to yield the density of the blood. Blood density is converted to hematocrit by means of a linear relationship between the two. Independent of the blood hematocrit, such apparatus and means may also be used to measure the density of enclosed fluid in other pulsed flow non-rigid wall vessel systems.

Abstract: A system, method and apparatus monitoring, recording and reporting physiological data includes an intravenous detection device in communication with at least one central processor. The intravenous detection device is configured to monitor at least one physiological measurement and report the measurement to the central processor via a communication medium. The central processor may store the data or immediately transmit the data to an authorized recipient. The central processor may also analyze the data to determine what further action should be taken, including immediate interventional action, such as, for example, defibrillation. The detection devices are preferably micro- or nano-level devices that are capable of flowing freely through the venous system of a host. The detection devices include a suitable transducer, an optional memory and a transceiver, and are preferably introduced into a host by injection of a fluid including a suspension of the detection devices.

Abstract: A non-animal based mixture of components serves as a control for complete blood count (CBC) analysis instruments and paraphernalia. The centrifugible non-animal based mixture simulates blood, and contains blood cell-simulating and other blood constituent-simulating components which are present in the mixture in controlled and known amounts. The mixture can be gravimetrically separated into its blood constituent-simulating components so as to serve as a control that simulates a centrifuged blood sample, and is thus used to check the accuracy of CBC blood analysis instruments, such as those marketed by Becton Dickinson and Company, under the trademark “QBC”.

Abstract: The invention relates to a method for determining properties of blood, such as the blood viscosity of a person, comprising of generating in vivo for a determined time, by means of an electrical alternating current of a determined frequency, a measurement signal of the impedance of the blood between at least two points centrally in a blood volume, wherein the measurement signal is processed such that variations therein with a frequency in the order of magnitude of the heart frequency are substantially absent therefrom, and comparing the processed measurement signal with predetermined relations between impedance and the properties of the blood, such as the viscosity.

Abstract: A method for obtaining the viscosity of the circulating blood of a living being using an adulterated blood sample and a correlation factor obtained from a circulating blood viscometer.

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: A device and a method to provide a more reliable and accurate measurement of hematocrit (Hct) by noninvasive means. The changes in the intensities of light of multiple wavelengths transmitted through or reflected light from the tissue location are recorded immediately before and after occluding the flow of venous blood from the tissue location with an occlusion device positioned near the tissue location. As the venous return stops and the incoming arterial blood expands the blood vessels, the light intensities measured within a particular band of near-infrared wavelengths decrease in proportion to the volume of hemoglobin in the tissue location; those intensities measured within a separate band of wavelengths in which water absorbs respond to the difference between the water fractions within the blood and the displaced tissue volume. A mathematical algorithm applied to the time-varying intensities yields a quantitative estimate of the absolute concentration of hemoglobin in the blood.

Abstract: A method of enhancing the permeability of a biological membrane, including the skin or mucosa of an animal or the outer layer of a plant to a permeant is described utilizing microporation of selected depth and optionally one or more of sonic, electromagnetic, mechanical and thermal energy and a chemical enhancer. Microporation is accomplished to form a micropore of selected depth in the biological membrane and the porated site is contacted with the permeant. Additional permeation enhancement measures may be applied to the site to enhance both the flux rate of the permeant into the organism through the micropores as well as into targeted tissues within the organism.

Abstract: A device for measuring parameters of medical fluids having a measurement chamber through which the fluid to be measured passes. The chamber is sealed on one side by a flexible membrane, and it also has a measurement plate that has a peripheral seal on its outer edge and is in contact with the flexible membrane. At least one sensor for measuring a parameter of the medical fluid is mounted on the measurement plate, and the measurement plate has a continuous inlet leading to the flexible membrane so that a vacuum can be established between the measurement plate and the flexible membrane.

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 process and a device for improving the determination of the pulse transit time for non-invasive blood pressure measurement. A value, correlating with the blood density, is determined and its influence on the pulse transit time is compensated. In this manner more precise blood pressure data can be obtained. In a further development, a value, correlating with the blood density, is determined by a measuring device for the change in relative blood volume or hematocrit. The device can also be used as part of a hemotherapeutic arrangement such as a hemodialysis device and/or hemofiltration device, in which a blood pressure monitoring as continuous and precise as possible is desired, among other things, because of a blood volume change and thereby a blood density change inherent in the therapy.

Abstract: The present invention provides a highly sensitive biosensor that needs a smaller amount of sample for measurement. The biosensor comprises a first insulating base plate having a working electrode, a second insulating base plate having a counter electrode opposed to the working electrode, a reagent layer comprising at least an oxidoreductase, and a sample supply pathway formed between the first and second insulating base plates, wherein the working electrode, counter electrode and reagent layer are exposed to an inside of the sample supply pathway, and the distance between the working electrode and the counter electrode is 150 &mgr;m or less.

Abstract: When injecting red blood corpuscles it is important to know their elasticity since they can alter from an elastic to a substantially rigid state. The present invention allows it to be ascertained whether the elasticity fulfills the requirements stipulated.

Abstract: A method and system for managing blood products and tracking their movement between a central blood test facility and a plurality of hospitals in which a database is provided for entering information pertaining to each patient, including but not limited to entering blood type information for a blood specimen from each patient, recording blood type for each blood product assigned to each patient and recording the results of remote cross-matching of each of the patient specimens and blood products to indicate their compatibility.

Abstract: A system for long-term remote medical monitoring is especially suitable for the medical supervision of astronauts onboard a space station. The system includes at least one autonomous sensor unit (SU) with a sensor (1) and transmit/receive electrodes (2) connected to a microchip (3) and mounted on a carrier (4) in the form of an adhesive bandage that can easily be applied to the skin of the subject astronaut (11). The system further includes a body transceiver (10) that is worn on the body of the subject and acts as a centralized transmitting and receiving unit, and a portable data logger (12). Medical data such as the pulse rate and the like, as well as environmental data such as the ambient surrounding air temperature, are sensed by respective allocated sensor units (SU) and transmitted from the sensor units as electrical signals via the skin and other body tissues of the subject (11) to the body transceiver (10).

Abstract: A liquid sampler includes: a metering pump which is composed of a cylinder having opposite end openings and a cylindrical cavity, a piston inserted in the cavity from one of the openings of the cylinder, and a driving source for reciprocally and linearly moving the piston; and a pipette directly connected to the other opening of the cylinder.

Abstract: A method and apparatus are provided for data management authentication in a clinical analyzer. The clinical analyzer includes a sensor for receiving a user sample to be measured and a processor for performing a predefined test sequence for measuring a predefined parameter value. A memory is coupled to the processor for storing predefined parameter data values. An authentication password is associated with each data transmission by the clinical analyzer and read by an associated computer system to validate each data transmission. The authentication password is generated by the clinical analyzer utilizing predetermined information in each data transfer.

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 system and method is described that enables a health care provider to monitor and manage a health condition of a patient. The system includes a health care provider apparatus operated by a health care provider and a remotely programmable patient apparatus that is operated by a patient. The health care provider develops a script program using the health care provider apparatus and then sends the script program to a remotely programmable patient apparatus through a communication network such as the World Wide Web. The script program is a computer-executable patient protocol that provides information to the patient about the patient's health condition and that interactively monitors the patient health condition by asking the patient questions and by receiving answers to those questions. The answers to these health related questions are then forwarded as patient data from the remotely programmable patient apparatus to the health care provider apparatus through the communication network.

Abstract: The present invention relates to methods for determining the time of a myocardial infarction in a patient by measuring the ratio of oxidized to reduced troponin I in a blood sample obtained from the patient. This ratio is measured through the use of two or more distinct components which specifically bind oxidized troponin I, reduced troponin I, and/or both forms of troponin I present in the blood sample. Each distinct component may be an antibody or an antibody fragment. The measured ratio reflects the time elapsed from the time of the myocardial infarction.

Abstract: A modular self-care health monitoring system employs a compact microprocessor-based unit such as a video game system of the type that includes switches for controlling device operation and a program cartridge. In accordance with the invention, the program cartridge adapts the microprocessor-based unit for operation with a glucose monitor (or another type of health monitor). The microprocessor-based unit processes data supplied by the glucose monitor to supply signals for displaying relevant information on a display unit that may be included in the microprocessor-based unit or may be a separate unit such as a television or video display monitor. The system provides for transmission of signals to a remote clearinghouse or a healthcare facility via telephone lines or other transmission media. The clearinghouse includes signal processing capability for transmission of reports to a remotely located healthcare professional via facsimile transmission.

Abstract: This invention involves a method of analyzing a body fluid such as blood from a patient to determine whether or not there is a significant difference or change in the comparative determinants of viscosity in the body fluid sample, the comparative determinants being derived using a probe which provides increased sensitivity and corresponding improved relative viscosity values when used together with a suitable viscosity device, in order to identify the presence or incipiency of a symptomatic or asymptomatic pathology caused by or leading to said differences or changes in viscosity.

Abstract: A method of analyzing samples of whole blood from a patient is disclosed which involves determining whether or not there is a significant difference or change in the comparative determinants of hypercoagulability in the sample. The comparative determinants are derived using two or more different detection systems, or two or more components of a single detection system, especially two or more probes, which provide variable force-induced energy inputs to the samples being measured in order to identify the presence of incipiency of a symptomatic or asymptomatic pathology caused by, or leading to, differences or changes in hypercoagulability.