WO2003100416A1 - Procede et dispositif de mesure permettant de determiner une concentration d'hemoglobine extracellulaire - Google Patents

Procede et dispositif de mesure permettant de determiner une concentration d'hemoglobine extracellulaire Download PDF

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Publication number
WO2003100416A1
WO2003100416A1 PCT/EP2003/005434 EP0305434W WO03100416A1 WO 2003100416 A1 WO2003100416 A1 WO 2003100416A1 EP 0305434 W EP0305434 W EP 0305434W WO 03100416 A1 WO03100416 A1 WO 03100416A1
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WO
WIPO (PCT)
Prior art keywords
measuring
blood
receiver
measurement
measuring device
Prior art date
Application number
PCT/EP2003/005434
Other languages
German (de)
English (en)
Inventor
Martina Meinke
Moritz Friebel
Jürgen HELFMANN
Gerhard Müller
Original Assignee
Laser- Und Medizin-Technologie Gmbh Berlin
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Application filed by Laser- Und Medizin-Technologie Gmbh Berlin filed Critical Laser- Und Medizin-Technologie Gmbh Berlin
Priority to AU2003238388A priority Critical patent/AU2003238388A1/en
Publication of WO2003100416A1 publication Critical patent/WO2003100416A1/fr

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths
    • G01N21/3151—Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry with comparison of measurements at specific and non-specific wavelengths using two sources of radiation of different wavelengths
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/47—Scattering, i.e. diffuse reflection
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/65—Raman scattering

Definitions

  • the invention relates to a method for determining an extracellular hemoglobin content in the blood of a blood bank, in which a measurement is carried out in such a way that a measurement signal in the form of electromagnetic radiation is transmitted through the blood of a blood bank. Then the measurement signal transmitted through the blood of the blood preserve is recorded and the recorded measurement signal is evaluated and the extracellular hemoglobin content is determined on the basis of the evaluation result using calibration information.
  • the level of the extracellular hemoglobin released by them in the blood bag can be determined as a measure of hemolysis, since this can only come from the destroyed erythrocytes.
  • the hemoglobin content is typically given in g / dl.
  • EP 0 800 074 A1 describes, for example, a method that determines the total hemoglobin content of a whole blood sample. This is not relevant for use on the blood bag, since the hemoglobin is determined from the intact erythrocytes and therefore no conclusions can be drawn about the suitability for transfusion of the samples. According to this or a modified method, the total hemoglobin concentration of a whole blood sample is determined by numerous laboratory blood counting devices. As a rule, the erythrocytes are completely hemolyzed (also by adding reagents) and the total hemoglobin content is determined by transmission measurements.
  • No. 5,288,646 describes in vitro measurements by means of the concentration-dependent change in the transmission properties of a transparent absorber after immersion in a whole blood sample.
  • a method is known from blood analysis laboratories which determines extracellular hemoglobin in blood serum or plasma samples by optical measurements, but also requires direct contact with the blood products to be examined.
  • the extracellular hemoglobin in blood bags is determined after opening the bag and removing an aliquot with subsequent centrifugation.
  • the supernatant is mixed with a transformation solution and the absorbance at the wavelengths 680 nm and 540 nm is determined.
  • This method is also unsuitable for checking blood bags that can still be used, since opened preserves may no longer be used for transfusion. It is only used for research purposes, or for samples of blood that has already been sorted out from the blood bank.
  • preserved blood is provided with tubes or containers which are filled with the blood when the preserved food is filled and which can be used to determine the blood group. These containers are separated from the contents of the pouch by weld seams when storing the canned food and can therefore be opened for measuring processes in direct contact.
  • sampling is a separate and is a small amount of blood that shows other decay properties and that taking a sample with subsequent laboratory control is too time and cost intensive and is therefore not used.
  • the object on which the invention is based is therefore to substantially minimize the waste of potentially still intact blood supplies.
  • the solution according to the invention is a routine, objective control method for use on a closed blood container of a blood bank, with the aid of which a statement about the usability of the blood bank can be reliably derived.
  • the method according to the solution comprises the following steps, in which:
  • the preserved blood is provided in the form of blood in a closed blood container with a container wall;
  • the blood in the closed blood container is separated into sedimentable and non-sedimentable blood components or is allowed to separate;
  • the measurement is carried out on the closed blood container or on parts of the blood container after sedimentation of the sedimentable blood components in the area of the non-sedimentable blood components;
  • the measurement signal is transmitted at least once through the container wall.
  • the optical measurement method presented here thus serves to ensure the quality of erythrocyte concentrates on the unopened, unmodified standard blood bag.
  • the methodology presented here and the device used are used to measure the extracellular hemoglobin concentration on the blood bag with an objective measurement of the hemoglobin content without the need to open the blood bag. This enables routine, reliable quality assurance of the stored blood and largely prevents warping of intact blood.
  • the method is based on the storage of the blood samples to be checked in a suitable manner and the optical measurement of the free hemoglobin content in the erythrocyte-free storage medium on the unopened blood bag system as well as the use of containers or tubes still connected to the blood bag, or tubes for carrying out the measurements.
  • the supernatant of an erythrocyte concentrate sedimented in a tube segment reflects the hemoglobin concentration of the volume present in the bag and can be reliably determined reproducibly with little error even with simple methods.
  • the measurement is carried out on the erythrocyte-free storage medium (supernatant) in a tube connected to the blood bag or in another external container.
  • the hose or the container consists of a material suitable for the measurement.
  • No special optical components on the blood bag are necessary to carry out the measurement. This is essential because a change to the existing blood bag system, such as the insertion of optical windows or the like, a very profound change in the production process and, in addition, a complete re-validation of the systems with regard to biocompatibility etc. in the institutes that produce blood supplies would do.
  • this tube is stored in a vertical position so that the erythrocytes are sedimented.
  • this storage takes place by fixing the hose end above the bag to a strip to which the bag itself is also fastened with the end facing away from the hose.
  • any other type of storage which has a protrusion in a container connected to the contents of the bag generated or another procedure that leads to sedimentation of the erythrocytes.
  • the optical measurement itself takes place in transmission or reflection.
  • at least two light sources are used in the wavelength ranges suitable for the measurement and one or more detector (s) sensitive in these ranges.
  • a light source is used to determine the hemoglobin concentration, the signals when illuminated with the second light source are required to correct the optical interference caused by the optical irregularity of the tube / container.
  • Either two or more wavelength ranges or the entire spectrum can be used. Surprisingly, initial measurements have shown that it is possible to determine a hemoglobin concentration with an accuracy of ⁇ 0.002 g / dl.
  • the measuring head must be designed in such a way that the hose used arrives securely in a fixed position, so that pinching of the hose and thus a variation in the irradiated layer thickness can be prevented.
  • the measurement can be carried out on a tube connected to the blood container by transmission measurements at two wavelengths. Since these tubes are available with the common blood container systems, no change in the production of the blood container is necessary.
  • the method can include the step of mixing the blood container contents with the tube contents. A subsequent suspension of the blood container with the blood can also take place. The erythrocytes can then sediment over a period of about 24 hours. An erythrocyte-free area of 0.5-1.0 cm is created in the tube, which is sufficient for the measurement with the hemoglobin sensor.
  • the aforementioned solution can be equipped with an additional barcode scanner. This enables the connection of blood-relevant data with measured values. This is also possible in combination with a temperature sensor.
  • the measured value can Output of the stored blood with the measured value after withdrawal of the unused blood are compared and thus provide a sensitive method to be able to conclude an interruption of the cold chain by strong changes in the values.
  • the data transmission from the measuring head to the evaluation and processing station is wireless. Solutions according to the invention are also the wired transmission and the intermediate storage of the data in the measuring head.
  • the senor can be provided with a measuring unit for determining the hematocrit, so that the calculation of the hemolysis rate is possible.
  • the hematocrit can be determined on any part of the blood bag.
  • It can be a determination of the hematocrit by spatially resolved measurement of the incident light of one or more wavelengths.
  • the hematocrit can also be determined by remission and / or transmission measurements on the blood bag system.
  • the remission is detected in the range from 300 to 1500 nm with the help of an integrating sphere, and the data are processed with the aid of statistical methods.
  • Resonance Raman scattering spectroscopy is also an option that can be used to determine the hematocrit.
  • the hematocrit can also be determined with the aid of dynamic light scattering, since the global anisotropy factor depends strongly on the particle number density and thus on the hematocrit.
  • the invention also relates to a measuring device for determining an extracellular hemoglobin content in the blood of a blood preserve, comprising a transmitting unit for a first electromagnetic measuring beam, a receiver for electromagnetic radiation and a receiving device with a measuring space, which is designed to receive a blood container or parts of a blood container.
  • the measuring chamber for the blood container or parts of the blood container is arranged in the beam path between the transmitter unit and the receiver in such a way that the transmitter unit transmits a measuring beam through the measuring chamber in the direction of the receiver and the receiver can generate an output signal proportional to the irradiance.
  • the measuring device further comprises an evaluation unit, which is at least operatively connected to the receiver and designed to form a measuring signal from the output signal such that, in the application, this corresponds to an extracellular hemoglobin concentration of blood.
  • WO 01/17420 A1 discloses a device for the non-invasive determination of blood characteristics, including hemoglobin from a mixture of liquid and blood cells in a translucent vessel.
  • the device comprises two light sources and two light receivers for measuring blood characteristics.
  • the object on which the invention is based is to provide a measuring device which enables a quick statement to be made as to the usability of stored blood.
  • the solution according to the invention is a measuring device which can be operated with one hand and which is designed to determine the extracellular hemoglobin concentration of blood in a closed blood container.
  • the measuring device is designed as a hand-held device and comprises a housing which can be held with one hand, the receptacle Measuring device for a blood container or parts of a blood container comprises a movable measuring chamber closure which can be opened and closed with a hand holding the measuring device.
  • the measuring device preferably has a contact switch for checking the closure of the measuring room. Based on the measurement result, a reliable statement about the further usability of the blood can be made.
  • a measuring device can be used in a versatile and advantageous manner, which has a transmitter unit for a first electromagnetic measuring beam, as well as a receiver for electromagnetic radiation and a recording device with a measuring room, which is designed to receive a measuring sample.
  • the measurement space for the measurement sample is arranged in the beam path between the transmitter unit and the receiver in such a way that the transmitter unit transmits a measurement beam through the measurement room in the direction of the receiver and the receiver can generate an output signal proportional to the irradiance.
  • the measuring device is designed as a hand-held device and has a housing that can be held with one hand, the receiving device for a measuring sample having a movable measuring space lock that can be opened and closed with a hand holding the measuring device.
  • the measuring space closure is preferably designed to fix the blood container or parts of the blood container.
  • the measuring room lock can be designed to be open.
  • the measuring room closure can also be light-shielding. This advantageously ensures that the measurement cannot be influenced by extraneous light.
  • the evaluation unit can be designed to carry out a differential measurement to eliminate the influence of extraneous light.
  • the measuring device has a control unit, which is connected to the measuring space lock as well as the evaluation unit and the
  • Transmitter unit is connected and designed to automatically trigger a measurement after the measuring space lock has been closed. The enables an efficient measurement of a series of blood supplies by eliminating additional operating steps.
  • the transmitting unit is designed to transmit a second measuring beam through the measuring space in the direction of the receiver.
  • the transmitter unit can comprise two transmitters.
  • the second measuring beam is used to record disturbance variables or optical transmission properties of the blood container.
  • the receiving device preferably comprises at least one optical beam deflector in the beam path of the first and / or the second measuring beam.
  • the optical beam deflector is preferably a beam splitter which is designed to split the first measuring beam and / or the second measuring beam into a transmission beam and a reference beam, each with a different direction of propagation.
  • the recording device further comprises a reference receiver for electromagnetic radiation, which is arranged to receive the reference beam and is designed to generate an output signal proportional to the irradiance. Such a reference measurement can advantageously compensate for fluctuations in the beam strength of the transmitters.
  • the beam splitter is preferably a semi-transparent mirror.
  • the emission spectrum of the transmitter for the first measurement beam is such that the first measurement beam experiences a strong absorption due to hemoglobin and the emission spectrum of the transmitter for the second measurement beam is such that the second measurement beam experiences a comparatively low absorption due to hemoglobin.
  • the transmitting unit can generate the first measuring beam and the second measuring beam, each with a narrow-band but different emission spectrum.
  • the transmission unit can comprise at least one luminescent diode or at least one laser diode.
  • the transmitter preferably comprises Deunit two transmitters, which are designed as a luminescent diode or as a laser diode.
  • the first measuring beam preferably has a spectrum essentially in a wavelength range from 300 nanometers to 630 nanometers and the second measuring beam has a spectrum essentially in the wavelength range from 630 nanometers to 1300 nanometers.
  • the first transmitter can be a luminescence or laser diode, which is designed to emit a blue or green measurement beam
  • the second transmitter can be a luminescence or laser diode, which is designed to emit a red or infrared measurement beam.
  • the emitted measuring beam of the first transmitter preferably has a maximum power in the wavelength range between 550 and 570 nanometers.
  • the emitted measuring beam of the second transmitter preferably has a maximum power in the wavelength range between 630 and 720 nanometers, or between 700 and 950 nanometers, particularly preferably between 690 and 700 nanometers.
  • Known light emitting diodes which are suitable as second transmitters have an emission spectrum essentially between 630 and 700 nanometers.
  • At least one of the transmitters can be designed as a diode-pumped solid-state laser.
  • the advantage of the laser is that additional collimating agents for beam bundling can be omitted. It is also advantageous that the radiation from the laser has a high radiance. As a result, the measuring beam can also irradiate longer measuring distances in larger measuring rooms. This means that measurements can also be carried out on larger blood vessels, for example.
  • the radiation emitted by the transmitters can be amplitude modulated, more or less coherent, polarized or pulsed.
  • the transmitter can also be a broadband radiation source, for example an incandescent lamp, more preferably a halogen lamp. Gas discharge lamps are also conceivable as transmitters, preferably metal halide lamps.
  • the transmitter can use a filter to generate a narrowband, for example one blue, green or red radiation.
  • the measuring device can comprise exactly one transmitter.
  • the transmitter can be a broadband emitting radiation source and the receiver can be spectrally resolved.
  • the receiver can comprise an optical grating or a prism, which are designed to image measuring beam portions of different wavelengths in each case at different detection locations.
  • the receiver can comprise at least one or more radiation-sensitive receiver elements, each associated with a wavelength range, for example a receiver line.
  • the receiver can also be a CCD chip.
  • the transmitter can be a gas discharge lamp containing mercury.
  • the measuring beam can then contain a mercury line at 289 nanometers.
  • the evaluation unit is designed to evaluate the output signal of that receiver element at the detection location corresponding to the mercury line.
  • the transmitting unit is preferably designed to transmit the measuring beams in a pulsed manner.
  • the transmission unit is further preferably designed to transmit the first and the second measurement beam alternately.
  • the evaluation unit is designed to evaluate the output signal generated in the receiver isochronously with the respective pulsed measuring beams.
  • the receiver for an electromagnetic measuring beam is designed to generate free charge carriers when an electromagnetic measuring beam strikes the receiver.
  • the receiver is preferably designed to be particularly sensitive in the spectral ranges of the measuring beams emitted by the transmitters.
  • the receiver can comprise a photodiode, for example a silicon diode, a phototransistor, a secondary electron multiplier.
  • the receiver is a large-area receiver with a radiation-sensitive receiver area that is large in comparison with photodiodes. The advantage of the large-area receiver is that further collimation means for a transmitted measuring beam between the measuring room and the receiver can be omitted.
  • such a large-area receiver is a photo resistor.
  • a large-area receiver is preferably a solar cell.
  • the measuring device can comprise a receiver control unit, which is designed to allow a current to flow through the solar cell, which current differs from the charge carrier current generated by irradiation in the solar cell and is superimposed on it.
  • the advantageous effect is to shift the voltage-current characteristic curve of the solar cell in such a way that the solar cell behaves electrically like a photodiode with or without radiation.
  • the advantage of this passive mode of operation of the solar cell is that in this mode of operation the solar cell has a linear behavior in comparison to the mere generator operation in relation to a radiation power impinging on the solar cell.
  • the solar cell can be a silicon solar cell, preferably a thin-film solar cell comprising amorphous silicon or copper indium diselenide or copper indium disulfide.
  • the receiver can also be a spectrometer.
  • the measuring device can also be designed to carry out a resonance Raman spectroscopy for determining the hematocrit.
  • the receiving device comprises a second receiver for electromagnetic radiation, which is arranged such that radiation reflected from the blood hits the receiver through the container wall.
  • the transmitter is designed to emit radiation with a strictly monochromatic spectrum.
  • the receiver is of narrow-band design, and the receiver is preferably designed to selectively evaluate individual frequency lines of the reflected radiation.
  • the output signal generated in the receiver can be spectrally weighted.
  • the evaluation unit is designed to evaluate the spectrally weighted output signal with respect to the hematocrit content of the blood in the blood container.
  • the evaluation unit is preferably designed to use the output signal of the first receiver and the output signal of the reference receiver to generate a measurement signal using calibration information, which corresponds to an extracellular hemoglobin concentration in the application.
  • the measuring device can comprise control units for the transmitters and / or a measuring amplifier for the receiver, which are operatively connected to the evaluation unit.
  • the evaluation unit preferably comprises a microprocessor, particularly preferably the microprocessor is designed to be programmable.
  • the receiving device has a pressing device, which is designed to positively receive a hose section with a hose section surface and to press the whole surface of the hose section against a predetermined geometry of the measuring space under pressure.
  • the pressing device can be part of the measuring space lock, or can be integrated into it by special shaping of the measuring space lock.
  • the measuring device can have a hand sensor, which is designed as a clip that can be attached to a hose and the hand sensor comprises the receiving device, the transmitter unit and the receiver.
  • the hand sensor can be connected to the measuring device in a corded or cordless manner.
  • the measuring device can comprise, for example, an infrared interface, preferably according to the IRDA standard, or a Bluetooth interface.
  • the measuring device preferably comprises a bar code scanner.
  • the barcode scanner comprises a reading device and a reading window.
  • the reading window is preferably mounted in a housing of the hand-held device in such a way that the hand-held device for measuring the hemoglobin concentration and for reading a bar code can be held with one hand in exactly one gripping position.
  • the reading window can be attached in such a way that either a maximum swiveling movement of the hand around the wrist is necessary for barcode reading or measuring.
  • the barcode scanner can also be mounted in a housing of the hand sensor.
  • FIG. 6 shows a diagram of such a simple measuring system.
  • Two light-emitting diodes are used as the light source and are designed to emit radiation of different wavelengths.
  • the transmission of the measurement beams through the blood samples are determined one after the other. These values can be standardized using reference measurements.
  • the receivers are silicon diodes.
  • the measured values were recorded and displayed with a lock-in amplifier.
  • a calibration with a hemolysis concentration series was carried out on five different tubes. The tubes were cut from the blood bags and filled with the same solution.
  • the first measurement on standard samples with different hemoglobin concentrations in the range from 0.006 g / dL to 0.60 g / dL in blood bag tubes with the described receiver showed a characteristic dependency.
  • the ratio of power radiated onto the tube surface and power transmitted through the tube is converted into a transmission in the case of both measuring beams, a transmission without a tube being standardized to “1” in the receiving device. It has also been shown that the formation a quotient of green transmission and red transmission (Tgreen / Trot) the variance of the measurement result, caused by the use of different tubes, can be greatly reduced, but a sensitive dependence of the measurement result on the hemoglobin concentration is retained.
  • the device was calibrated using the quotient from 5 measurements on different hoses, so that a prediction of the standard solutions produced can be made.
  • the dependency can be described with a fourth degree polynomial.
  • the prediction using this polynomial is possible with an average absolute error of 0.0047 g / dL.
  • the evaluation already includes the variance through the measurement on 5 different hoses, the variance essentially influencing the measurement accuracy.
  • a threshold value is now set as a function of the green transmission for the red transmission, which is to distinguish between the samples with and without the spreader, many contaminated samples can be discriminated.
  • the threshold value is shown in FIG. 7.
  • the transmitter unit, the transmitter the, the receiver, the beam splitter, the evaluation unit and the receiving device can be realized on the measuring device, the measuring device with a hand sensor or the hand device not only in connection with the other features, but also on their own.
  • the blood bag with the erythrocyte concentrate is attached so that the tube 2 is in contact with the blood sample.
  • the tube 2 is fastened vertically, so that the erythrocytes 3 are separated from the storage medium 4 by sedimentation.
  • the measurement is carried out on the erythrocyte-free zone on the tube with the measuring head 5, which contains the light sources, the detector and the measuring optics.
  • the measuring head is connected to the control unit and evaluation station 6.
  • FIG. 2 shows a section of a possible technical embodiment of the measuring head.
  • the light source 7 illuminates the tube 8, part of the radiation being blocked out by a partially transparent mirror 9 and being picked up by the detector 10 in order to control the light intensity.
  • the transmitted light is registered at the detector 11 and fed to the evaluation electronics.
  • the hose is enclosed by the housing 12 such that it is reproducibly stabilized in a given geometry.
  • FIG. 3 shows a device section of an exemplary embodiment for a hand-held device for determining an extracellular hemoglobin concentration. Essential device components are shown, which are taken into account in the design of a device housing.
  • the handheld device 20 comprises a housing 22, a first transmitter diode 30, which is designed to emit green light, a second transmitter diode 32, which is designed to emit red light, a transmission receiver 34 and a reference receiver 36, which are designed, the green and the red Receive light.
  • the housing 22 comprises cavities for guiding the red and green measuring beams from Transmitter to the transmission receiver 34 and the reference receiver 36.
  • the hand-held device 20 comprises a cavity 44 for receiving a temperature sensor and a cavity 46 for receiving a start switch and a measuring chamber 49 for receiving a hose 60.
  • the hand-held device 20 further comprises a beam splitter 38, a prism 40 and an interface connection 50 and a reset switch 52.
  • the interface connection is preferably a Sub-D connection.
  • the handheld device 20 also includes a closure 48 for closing the measuring space.
  • the light is preferred through the cavities for beam guidance over a relatively long distance, in this example 65 mm, up to an aperture 42 belonging to the hand-held device, for example 1 mm to 2 mm
  • the aperture limits the usable portion of the emission for illuminating a lumen of a tube 60 with a diameter of 3 mm. Behind the aperture, the beam splitter 42 is attached, which 50% of the incoming light on the reference and
  • Measuring sensor divides.
  • the path lengths from the two transmitter diodes 30, 32 to the beam splitter 38, as well as the beam splitting of the beam splitter 38 onto the transmission receiver 34 and reference receiver 36 are the same.
  • the light of the second transmitter diode 32 is redirected by the prism 40 at a short distance in front of the beam splitter 38.
  • the hose 60 is inserted into the measuring space 49 for measurement. After actuation of the closure 48, the tube is secured against slipping axially by a positive fit and is thus fixed during the measurement. Due to the shape of the receiving space and the closure 48, the tube 60 has a constant shape during the measurement of the hemoglobin concentration.
  • the hand-held device 20 is designed to simultaneously actuate a start switch mounted in the cavity 46 when the closure 48 is closed.
  • the reset button 52 serves to reject measurement data and to restart the measurement.
  • a temperature sensor is in the Measuring head mounted in the cavity 44 provided for this purpose and designed to monitor a device temperature that could lead to a measured value variation.
  • the dimensions of the hand-held device 20 permit one-handed operation, so that the second hand can be used to insert the hose 60.
  • the outer dimension of the hand-held device 20 in this example has a length dimension 54 of 165 mm and a width dimension 56 of 58 mm.
  • the basic principle of the hemolysis sensor is based on the determination of hemoglobin by measuring the extinction of a measuring beam in the wavelength range with strong hemoglobin absorption, preferably green light.
  • the difficulties exist on the one hand in the optical influence of the measurement by the tube geometry and on the other hand in the variation of the optical properties by tubes from different manufacturers and not completely sedimented erythrocytes.
  • the tube 60 acts like a short focal length cylindrical lens when irradiated.
  • the handheld device 20 comprises at least one collimation means 42, which are arranged and formed in the beam path of the first and / or second measuring beam, the first and / or the second measuring beam to 0.5 to 3 mm, preferably 2 mm in diameter collimate in the plane where a sample, preferably its surface, is located in the application.
  • the measurement sample is, for example, a tube 60.
  • the collimation means 42 can be an aperture 42, alternatively at least one lens, preferably at least one convex lens, more preferably at least one biconvex lens.
  • the collimation means can also be an optical device with two lenses, which are preferably arranged in such a way that the lens spaced closer to the transmitter in the beam path images the radiation source of the transmitter in the main plane of the lens further spaced in the beam path from the transmitter.
  • This Meissner arrangement advantageously causes the measuring beam to have a homogeneous light intensity distribution in cross section after it has passed through the collimating agent. That in one direction after radiography of the tube 60 strongly divergent light is measured by the transmission receiver 34 at a short distance behind the tube 60. For this purpose, the transmission receiver 34 is formed over a large area.
  • a second transmission measurement is carried out in order to record disturbance variables such as tube variation and blood that has not completely sedimented, in which the hemoglobin absorption is small, preferably red light.
  • the handheld device preferably comprises small and inexpensive light-emitting diodes.
  • FIG. 4 shows a side device section of the hand-held device 20.
  • the hand-held device 20 comprises the housing 22, the interface connection 50, the transmission receiver 34, the start switch 47 and the beam splitter 38. Furthermore, the hand-held device 20 comprises a cavity 70 for receiving a processor unit, one Cavity 72 for receiving a control unit, a cavity 74 for receiving a display module, a cavity 76 for receiving an accumulator, a cavity 78 for receiving a bar code scanner.
  • the housing 22 includes an opening 80 in the cavity 78 for receiving an exit window.
  • the handheld device includes a barcode scanner mounted in the cavity 78.
  • the scanner comprises an exit window through which a scanner beam can be emitted and the reflection of the scanner beam can be received.
  • the hand-held device is designed such that after the measurement and removal of the tube, a bar code attached to a blood container can be read in with the bar code scanner from the same hand position. If the user has gripped the handset with one hand from below, the user has a clear view of the display module, which is located on the top of the housing and guides the user through the menu.
  • the display module is preferably a 2x16-line display module.
  • the display module can be a LED or an LCD display module.
  • the handheld device comprises a control unit and a processor unit, each of which is located on a separate board or on a common board.
  • the boards are preferably adapted to the geometry of the receiving spaces 70, 72.
  • An accumulator is permanently installed in the handheld device in the cavity 76 and draws its charging current via the interface connection 50, via which the processor unit can communicate with a PC.
  • the device is preferably equipped with a barcode scanner and a rechargeable battery, so that the hemoglobin values can be clearly assigned to the stored blood and the sensor is easy to use.
  • the handheld device 20 preferably includes an interface for data transmission to a PC, which can have an interface connection 50 and is designed to transmit the measured data via the interface connection 50 to a PC for further use.
  • the interface is preferably an RS-232 interface, further preferably a cordless interface, for example an infrared interface, preferably an infrared interface according to the IRDA standard, furthermore the cordless interface can be a Bluetooth interface or preferably a wireless LAN interface his.
  • FIG. 5 shows an embodiment of the receiving device 84 for a tube of a blood container.
  • the receiving device 84 comprises guide rails 92, a lock 48 that can be moved back and forth over guide rails 92, clamping jaws 86, and a spring mechanism that is designed to keep the lock 48 open in the unactuated state.
  • the clamping jaws 86 are preferably attached to the receiving device, for example interchangeable with differently shaped clamping jaws.
  • the positioning of the hose 60 takes place via a weld seam 88 located on the hose 60.
  • the hose 60 is at the
  • the sedimentable blood components must have separated from the lower edge of the weld seam by at least 5 mm before the measurement.
  • the clamping jaws 86 also prevent the incidence of extraneous light during the measurement, since they close the tube 60 in a light-tight manner from above.
  • the closure is held open by the pressure of the spring mechanism 90.
  • the jaws 86 are interchangeable to adapt to other weld seam geometries, preferably attached to the receiving device with screws.
  • the complete closing of the jaws 86 is preferably monitored by a contact switch, which the handheld device 20 can include.
  • the microprocessor is preferably designed to be programmable and can include the control program described below:
  • the display After switching on the device, the date, time, charging capacity of the battery and the temperature appear on the display and after a few seconds the display automatically changes to 'Measure'. After inserting a hose, the slide must be closed so that a signal tone sounds and is held until another signal tone confirms the successful measurement.
  • the reference signal and the transmission signal are measured by the blood sample. This measurement is carried out with red light, with green light and without light. These three measurements are repeated 64 times in a loop and summed up in separate memories.
  • all disturbance variables that negatively influence the measurement with light-emitting diode light are recorded, for example daylight, lamp light (50 Hz), noise voltage and offset voltage of an operational amplifier. Since these disturbances are also included in the measurement with light emitting diodes, they are calculated out by the processor.
  • Norm Of_Transmission Norm Of_Grüntransmission / Nomn Of_Rottransmission.
  • the hemoglobin content in g / dl appears on the display.
  • the display range extends from 0.000 to 1, 300 g / dl with a display error of 0.001 ⁇ 1 display absolute.
  • the prompt appears to read in the barcode and then save the data.
  • a quotient transmission measurement / reference measurement of red and green (Qrot, Qintelligence), a standardized transmission Qintelligence / Qrot, the barcode, the temperature, the date and the hour of the measurement are saved.
  • the display then jumps back to the "Measure" point.
  • the procedure can be terminated after each step by pressing a reset button 52.
  • the sensor for charging the batteries can be placed on the charger. In this position, the saved data can be transferred to the computer.
  • the transmission and reference receivers 34, 36 for the two measurement beams of different spectral composition can be compared using an empty recording space after pressing the reset button 52 using two potentiometers.
  • FIG. 6 shows a schematically illustrated arrangement of optical components in FIG a receptacle for a tube 60 of a blood container.
  • the measuring device comprises a first transmitter 30 for a first measuring beam 100, a second transmitter 32 for a second measuring beam 102, a receiver 34 for a transmitted first measuring beam 106 and / or a transmitted second measuring beam 104.
  • the measuring device further comprises a reference receiver 36 for a first reference beam 108 and a second reference beam 112.
  • the measuring device further comprises a beam splitter 38 for splitting the first measuring beam 100 into a first reference beam 108 and a first transmission measuring beam 110 and / or for splitting the second measuring beam 102 into a second reference beam 112 and one second transmission measuring beam 114.
  • the transmission measuring beams 104, 106 hit the surface of a container wall of a blood container, pass through the container wall and the blood and thereby lose radiation power due to absorption and / or scattering in the blood and the container wall and or by reflection the container wall. After exiting the blood container, the first and / or the second transmitted measurement beam 106, 104 hits the receiver 34.
  • the beam splitter 38 is preferably designed as a semi-transparent mirror and is preferably arranged such that the mirror plane forms an arc angle of 45 degrees with at least one measurement beam.
  • a threshold value in the form of a threshold value line 117 and a diagram legend 118 are also shown.
  • Diagram legend 118 shows measured values on preserved blood with significant influence on the measurement result by scattering the measurement beam on erythrocytes as stars 115, measured values without significant influence on the measurement result. results from the scattering of the measuring beam on erythrocytes are represented by unfilled rhombuses 116.
  • the accuracy of a prediction based on the calibration improves considerably despite contaminated samples.
  • erroneous measurements can nevertheless significantly impair the accuracy of the measurement.
  • the measurement error due to incorrect measurements only affects the scatter of the measured values in one direction in the case of the calculation of the normalized transmission, so that a prediction in the event of contamination always results in higher measured values for the extracellular hemoglobin concentration.
  • the relative error is small in the range of a limit value for discarding the blood concentrates. In the lower concentration range, a very good, usable blood sample would be classified as not as good but still usable.
  • the measurement device preferably comprises a threshold value discriminator.
  • the threshold discriminator can be part of the control program.
  • FIG. 8 shows a schematic exemplary embodiment of the interconnection of components of a hand-held device for determining an extracellular hemoglobin concentration, as already explained in FIG. 3 and FIG. 4.
  • the hand-held device comprises a transmission unit 33, with a first transmitter 30, a second transmitter 32 and a transmitter-hand control unit 31.
  • the hand-held device further comprises a receiver 34, a reference receiver 36 and a start switch 47 which is arranged such that it closes when a 5 is actuated in FIG. 5.
  • the hand-held device also includes a measuring space 49 and a beam splitter 38, which are shown schematically in this example.
  • the hand-held device further comprises a control unit 120 with a signal processing unit 122 and a receiver control unit 35.
  • the hand-held device comprises an evaluation unit 124, a display 130, an interface unit 132, a barcode scanner 128 and a reset button 52.
  • the evaluation unit 124 is preferably a processor unit, more preferably a microprocessor unit, particularly preferably a programmable microprocessor unit.
  • the transmitter control unit 31 is connected to the first transmitter 30 via a control line 152 and to the second transmitter 32 via a control line 154.
  • the signal processing unit 122 is connected to the transmitter control unit 31 via a control line 156, to the receiver control unit 35 via a connection line 155 and to the evaluation unit 124 via a bidirectional data bus 140.
  • the evaluation unit 124 is connected to the barcode scanner 128 via a data bus 142, to the display 130 via a connecting line 144, to the interface unit 132 via a bidirectional data bus 146 and to the reset button 52 via a connecting line 160.
  • the handheld device further comprises an input keypad 162, which is connected to the evaluation unit 124 via a connecting line 164.
  • the input keypad can advantageously be plug-connected to the hand-held device as an alternative, for example via the interface 50 shown in FIG. or be connected wirelessly to the handheld device.
  • the start switch 47 is connected to the signal processing unit via a connecting line 158.
  • the receiver control unit 35 is connected to the receiver 34 via a connecting line 150 and to the reference receiver 36 via a connecting line 148.
  • connection lines, control lines and data buses listed in this example are designed to be electrically conductive.
  • the control unit 120 is designed to detect an actuation of the start switch 47 via the connecting line 158 and to send a start signal via the data bus 140 to the evaluation unit 124.
  • a control program is then started in the evaluation unit 124, which was previously selected, for example, via the input keypad 162.
  • the evaluation unit 124 is designed to generate a control signal for measuring a transmission value and the control signal is sent to the signal processing unit 122 via the data bus 140.
  • the evaluation unit 124 can generate such a control signal, for example, if the control program specifies, for example, the measurement of an extracellular hemoglobin concentration of a blood reservoir located in the measuring chamber 49.
  • the signal processing unit is designed, on the basis of such a control signal for measuring a transmission value, to send a transmission signal via the control line 156 to the transmitter control unit 31 for activating either the first transmitter 30 or the second transmitter 32.
  • the transmitter control unit 31 is designed to generate a first control signal on the basis of the control signal predetermined by the evaluation unit 124 for measuring a transmission value, and via the control line 152 the first transmitter 30 for transmitting a first one Control measuring beam.
  • the transmitter control unit 31 is designed to generate a second control signal upon receipt of a signal generated in the evaluation unit 124 for determining a transmission value and to control the second transmitter 32 via the control line 154 to emit a measurement beam.
  • the transmitters 30, 32 are designed to emit a measuring beam when a control signal is received.
  • the beam splitter 38 is designed to split a measuring beam into a transmission measuring beam and a reference measuring beam of the same radiation power in each case and to direct the reference measuring beam onto the reference receiver 36 and to direct the transmission measuring beam through the measuring chamber 49 onto the receiver 34.
  • the receiver 34 and the reference receiver 36 are designed to generate an output signal proportional to the irradiance.
  • the receiver control unit 35 is designed to process, for example amplify, the output signals of the receiver 34 and of the reference receiver 36.
  • the reference receiver 36 and the receiver 34 are preferably designed as large-area receivers, for example a solar cell.
  • the receiver control unit 35 is preferably designed to allow an electrical current to flow through the reference receiver 36 and the receiver 34.
  • the receiver control unit 35 is designed to send a processed signal via the connecting line 155 to the signal processing unit, which signal represents the output signal of the reference receiver 36 and the output signal of the receiver 34.
  • the connecting line 155 can be designed with two channels.
  • the signal processing unit 122 preferably comprises an AD converter, which is designed to convert the output signal of the receiver control unit 35 into a digitally coded signal.
  • the signal processing unit 122 is designed to send this converted digital signal to the evaluation unit via the data bus 140.
  • the evaluation unit is designed, for example, in the manner described above. se alternately to control the first transmitter 30 and the second transmitter 32, and to evaluate the output signals of the receivers 36, 34 received by the signal processing unit 122.
  • the evaluation unit 124 is preferably designed, controlled by a control program, to calculate the normalized green transmission, the normalized red transmission and the normalized transmission from the received output signals.
  • the evaluation unit 124 is preferably designed to display a measurement result and / or calculated measurement values for an extracellular hemoglobin concentration on the display 130 via the connection line 144.
  • the evaluation unit 124 is preferably further developed to detect the closing of the reset button 52 via the connecting line 160, and to influence the control program and / or to restart the measurement process depending on the closing of the reset button 52.
  • the evaluation unit 124 is preferably further developed to send a signal to the bar code scanner 128 via the connecting line 166 and to receive a signal which is read in by the bar code scanner and represents a bar code via the data bus 142.
  • the evaluation unit 124 is preferably designed to store a signal representing a bar code as a bar code value.
  • the evaluation unit is designed, controlled by a control program, to assign a measured value representing a hemoglobin concentration to a barcode value.
  • the evaluation unit 124 preferably comprises a memory for many barcode values and hemoglobin measured values.
  • the evaluation unit 124 is preferably designed to transmit the hemoglobin measurement values and barcode values to an interface unit 132 and / or to receive data from the interface unit 132 via a bidirectional data bus 146. Such data can be a control program, for example.
  • the interface unit 132 is, for example, an RS232 interface, a Bluetooth interface, or an infrared interface, preferably according to the IRDA standard.
  • the first transmitter 30 and the second transmitter 32 are preferably designed as luminescent diodes or as laser diodes.
  • a hand-held device can also be implemented independently of the other features on a handheld device, a measuring device, preferably with a handheld sensor.
  • the hand-held device is designed to determine the extinction of other samples or measurement objects.

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  • Physics & Mathematics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Health & Medical Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Toxicology (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Investigating Or Analysing Materials By Optical Means (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un dispositif de mesure (5) destiné à déterminer la teneur d'hémoglobine extracellulaire du sang conservé dans un flacon (1) et comprenant une unité d'émission (7) destinée à un premier rayon de mesure électromagnétique, un récepteur (11) destiné à un rayonnement électromagnétique, un dispositif de réception doté d'un compartiment de mesure qui est conçu pour pouvoir abriter un contenant de sang ou des parties (2, 8) d'un contenant de sang. Le compartiment de mesure du contenant de sang ou des parties du contenant de sang est placé dans le trajet du faisceau entre l'unité d'émission et le récepteur de telle manière que l'unité d'émission transmette un faisceau de mesure à travers le compartiment de mesure en direction du récepteur et que le récepteur produise un signal de sortie proportionnel à l'intensité des rayons. Un dispositif d'évaluation (6) permet de former un signal de mesure à partir du signal de sortie de telle manière qu'en cas d'utilisation, il corresponde à une concentration d'hémoglobine extracellulaire. Le dispositif de mesure peut également être réalisé sous forme d'appareil portatif (20) et comprendre un boîtier (22) tenant dans la main. Le dispositif de réception comprend une fermeture mobile (48) du compartiment de mesure, qui permet d'ouvrir et de fermer avec la main tenant le dispositif de mesure.
PCT/EP2003/005434 2002-05-23 2003-05-23 Procede et dispositif de mesure permettant de determiner une concentration d'hemoglobine extracellulaire WO2003100416A1 (fr)

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AU2003238388A AU2003238388A1 (en) 2002-05-23 2003-05-23 Method and measuring device for determining an extracellular haemoglobin concentration

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DE2002123450 DE10223450A1 (de) 2002-05-23 2002-05-23 Optisches Verfahren zur Bestimmung des extrazellulären Hämoglobingehaltes in Blutkonserven
DE10223450.7 2002-05-23

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Cited By (3)

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WO2011015228A1 (fr) * 2009-08-04 2011-02-10 Stepra Ltd Appareil pour vérifier l'identité d'un produit fluide final à usage médical ou pharmaceutique
DE102013018284A1 (de) 2013-10-31 2015-04-30 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Erfassung der Hämolyse oder zur Bestimmung eines den Einfluss der Hämolyse auf eine Messung des Hämatokrits korrigierenden Korrekturfaktors
DE102014003386A1 (de) * 2014-03-07 2015-09-10 Celltool Gmbh Verfahren und Vorrichtung zur Qualitätskontrolle eines Blutprodukts

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BRPI0802336A2 (pt) * 2008-04-17 2009-12-29 Gomes Paulo Alberto Paes processo, equipamento portátil e dispositivo para a determinação fotométrica in vitro da concentração de hemoglobina em uma amostra de sangue diluìda em uma só etapa
DK3377878T3 (da) 2015-11-18 2020-03-02 Radiometer Medical Aps Optisk sensor til detektering af frit hæmoglobin i en helblods prøve
DE102017218846A1 (de) 2017-10-23 2019-04-25 Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. Nicht-invasive Blutanalytik von Blutkonserven

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011015228A1 (fr) * 2009-08-04 2011-02-10 Stepra Ltd Appareil pour vérifier l'identité d'un produit fluide final à usage médical ou pharmaceutique
US8881980B2 (en) 2009-08-04 2014-11-11 STEPRA Ltd. Apparatus for verifying the identity of a final fluid product for medical or pharmaceutical use
DE102013018284A1 (de) 2013-10-31 2015-04-30 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Erfassung der Hämolyse oder zur Bestimmung eines den Einfluss der Hämolyse auf eine Messung des Hämatokrits korrigierenden Korrekturfaktors
DE102014003386A1 (de) * 2014-03-07 2015-09-10 Celltool Gmbh Verfahren und Vorrichtung zur Qualitätskontrolle eines Blutprodukts
DE102014003386B4 (de) * 2014-03-07 2016-06-23 Celltool Gmbh Verfahren und Vorrichtung zur Qualitätskontrolle eines Blutprodukts

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