EP3583404A1 - Verfahren und anordnung zum kalibrieren von vorrichtungen zur erkennung von blut oder blutbestandteilen in einer flüssigkeit - Google Patents
Verfahren und anordnung zum kalibrieren von vorrichtungen zur erkennung von blut oder blutbestandteilen in einer flüssigkeitInfo
- Publication number
- EP3583404A1 EP3583404A1 EP18710329.6A EP18710329A EP3583404A1 EP 3583404 A1 EP3583404 A1 EP 3583404A1 EP 18710329 A EP18710329 A EP 18710329A EP 3583404 A1 EP3583404 A1 EP 3583404A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- blood
- light
- scattering
- cuvette
- standard
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 210000004369 blood Anatomy 0.000 title claims abstract description 140
- 239000008280 blood Substances 0.000 title claims abstract description 139
- 238000000034 method Methods 0.000 title claims abstract description 31
- 239000000470 constituent Substances 0.000 title abstract description 19
- 239000012530 fluid Substances 0.000 title abstract description 7
- 238000010521 absorption reaction Methods 0.000 claims abstract description 64
- 238000011156 evaluation Methods 0.000 claims abstract description 28
- 230000003287 optical effect Effects 0.000 claims abstract description 28
- 239000000385 dialysis solution Substances 0.000 claims abstract description 27
- 230000003595 spectral effect Effects 0.000 claims abstract description 17
- 230000005855 radiation Effects 0.000 claims abstract description 4
- 239000012503 blood component Substances 0.000 claims description 38
- 239000007788 liquid Substances 0.000 claims description 35
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 19
- 150000001875 compounds Chemical class 0.000 claims description 18
- 238000004382 potting Methods 0.000 claims description 18
- 239000011521 glass Substances 0.000 claims description 17
- 239000002245 particle Substances 0.000 claims description 15
- 238000009826 distribution Methods 0.000 claims description 13
- 238000001514 detection method Methods 0.000 claims description 10
- 238000000411 transmission spectrum Methods 0.000 claims description 10
- 230000002745 absorbent Effects 0.000 claims description 8
- 239000002250 absorbent Substances 0.000 claims description 8
- 239000004793 Polystyrene Substances 0.000 claims description 4
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims description 4
- 229910052602 gypsum Inorganic materials 0.000 claims description 4
- 239000010440 gypsum Substances 0.000 claims description 4
- 150000002632 lipids Chemical class 0.000 claims description 4
- 229920002223 polystyrene Polymers 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 239000011248 coating agent Substances 0.000 claims description 3
- 238000000576 coating method Methods 0.000 claims description 3
- 238000003860 storage Methods 0.000 claims description 3
- NZTGGRGGJFCKGG-UHFFFAOYSA-N 1,4-diamino-2,3-diphenoxyanthracene-9,10-dione Chemical compound C=1C=CC=CC=1OC1=C(N)C=2C(=O)C3=CC=CC=C3C(=O)C=2C(N)=C1OC1=CC=CC=C1 NZTGGRGGJFCKGG-UHFFFAOYSA-N 0.000 claims description 2
- 239000004922 lacquer Substances 0.000 claims description 2
- 239000004408 titanium dioxide Substances 0.000 claims description 2
- 238000005259 measurement Methods 0.000 abstract description 10
- 102000001554 Hemoglobins Human genes 0.000 abstract description 5
- 108010054147 Hemoglobins Proteins 0.000 abstract description 5
- 239000000243 solution Substances 0.000 description 9
- 239000002202 Polyethylene glycol Substances 0.000 description 6
- 229920001223 polyethylene glycol Polymers 0.000 description 6
- 229920003229 poly(methyl methacrylate) Polymers 0.000 description 5
- 239000004926 polymethyl methacrylate Substances 0.000 description 5
- 238000012937 correction Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 238000001228 spectrum Methods 0.000 description 4
- 241000283690 Bos taurus Species 0.000 description 3
- 239000000306 component Substances 0.000 description 3
- 238000000502 dialysis Methods 0.000 description 3
- 230000031700 light absorption Effects 0.000 description 3
- 230000007774 longterm Effects 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000012528 membrane Substances 0.000 description 3
- 239000012482 calibration solution Substances 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 210000003743 erythrocyte Anatomy 0.000 description 2
- 229940028435 intralipid Drugs 0.000 description 2
- 230000002123 temporal effect Effects 0.000 description 2
- 238000012360 testing method Methods 0.000 description 2
- 230000002411 adverse Effects 0.000 description 1
- 238000000149 argon plasma sintering Methods 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000017531 blood circulation Effects 0.000 description 1
- 239000003633 blood substitute Substances 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000013461 design Methods 0.000 description 1
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- 238000005534 hematocrit Methods 0.000 description 1
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- 235000016709 nutrition Nutrition 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
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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
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
- G01N21/274—Calibration, base line adjustment, drift correction
- G01N21/278—Constitution of standards
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
- A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
- A61M1/1692—Detection of blood traces in dialysate
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D61/00—Processes of separation using semi-permeable membranes, e.g. dialysis, osmosis or ultrafiltration; Apparatus, accessories or auxiliary operations specially adapted therefor
- B01D61/42—Electrodialysis; Electro-osmosis ; Electro-ultrafiltration; Membrane capacitive deionization
- B01D61/422—Electrodialysis
- B01D61/423—Electrodialysis comprising multiple electrodialysis steps
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01D—MEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
- G01D18/00—Testing or calibrating apparatus or arrangements provided for in groups G01D1/00 - G01D15/00
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
- G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
- G01J3/02—Details
- G01J3/0275—Details making use of sensor-related data, e.g. for identification of sensor parts or optical elements
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
- G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
- G01J3/02—Details
- G01J3/0291—Housings; Spectrometer accessories; Spatial arrangement of elements, e.g. folded path arrangements
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
- G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
- G01J3/02—Details
- G01J3/10—Arrangements of light sources specially adapted for spectrometry or colorimetry
-
- 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
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
- G01N21/274—Calibration, base line adjustment, drift correction
-
- 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
- G01N21/84—Systems specially adapted for particular applications
- G01N21/88—Investigating the presence of flaws or contamination
- G01N21/93—Detection standards; Calibrating baseline adjustment, drift correction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3639—Blood pressure control, pressure transducers specially adapted therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/15—Detection of leaks
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3306—Optical measuring means
- A61M2205/3313—Optical measuring means used specific wavelengths
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/70—General characteristics of the apparatus with testing or calibration facilities
-
- 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
- G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
- G01N21/274—Calibration, base line adjustment, drift correction
- G01N21/276—Calibration, base line adjustment, drift correction with alternation of sample and standard in optical path
Definitions
- the invention relates to a method and an arrangement for calibrating
- Devices for detecting blood or blood constituents in a liquid, in particular dialysis fluid which have a light emitter and a light receiver and an evaluation unit receiving the signal of the light receiver, which is designed such that blood or blood constituents in the fluid based on the weakening of one through the Liquid passing radiation can be detected.
- devices are used to protect the patient, with which the in the event of rupture of the membrane of the dialyzer can not be reliably excluded entry of blood into the dialysis fluid can be detected. These devices are also referred to as blood leak detectors.
- the apparatus includes a light receiver for receiving the light passing through the liquid and an evaluation unit configured to close the presence of blood or a blood component in the liquid based on the difference in absorption of the light in the two wavelength ranges becomes.
- the known devices for detecting blood or blood components must be calibrated after production. First, there is a zero balance with a
- Dialysis fluid or RO water instead.
- a cuvette filled with dialysis fluid or RO water is interposed in the beam path of the blood leak detector
- the invention has for its object to provide a simplified method for calibrating devices for detecting blood or blood components in a liquid, in particular dialysis fluid.
- an object of the invention is an arrangement for calibrating devices for detecting blood or blood constituents in a liquid, in particular dialysis fluid,
- the method according to the invention is based on the fact that the calibration of the devices for the detection of blood or blood components is based on the use of blood, whereby the method is greatly simplified.
- the calibration is not carried out with a calibration solution containing blood, but with two different calibration standards that take into account the special optical properties of blood.
- the calibration is performed with a Absorption standard, which has given in relation to the absorption of light in blood predetermined optical properties, wherein the absorption standard is arranged in the beam path between the light emitter and the light receiver.
- the absorption standard allows the detection of a defined spectral attenuation of the light as a function of the constituents of the blood, in particular hemoglobin.
- the beam path of the device for detecting blood can be selectively influenced in order to be able to check whether the light receiver or the evaluation unit is capable of recognizing and correctly interpreting the spectral attenuation.
- the absorption standard does not cause any scattering, as a result of which a differentiation of the beam path from blood is produced. Consequently, the absorption standard can not be considered a blood substitute.
- the calibration is performed not only with an absorption standard, but also with a scattering standard that has predetermined optical properties with respect to the scattering of the light in blood.
- the scattering standard like the absorption standard, is arranged in the beam path between the light transmitter and the light receiver.
- the absorption standard and the stray normal do not contain any blood, there is no problem of costly procurement measures and temporal instability.
- the calibration can be done at any time with the blood-free absorption standard and stray normal, which are easy to handle.
- the given optical properties of the absorption standard and stray normal should be the optical properties of the blood, in particular human blood, in view of correspond to the absorption of light or with respect to the scattering of light. But for the calibration it is not necessary that the optical properties of the blood, in particular human blood, in view of correspond to the absorption of light or with respect to the scattering of light. But for the calibration it is not necessary that the optical properties of the blood, in particular human blood, in view of correspond to the absorption of light or with respect to the scattering of light. But for the calibration it is not necessary that the optical properties of the
- Absorption standard and stray normal with those of the blood are identical, but in practice it is sufficient if the absorption standard and stray normal have similar optical properties. If the devices to be calibrated for the detection of blood differ on the evaluation of the different absorption of light
- Absorption standard and the stray normal correspond to the optical properties of blood at least in the wavelength ranges concerned.
- the transmission spectrum of the absorption standard should be at least two
- Wavelength ranges correspond to the transmission spectrum of blood, with one wavelength range between 550 nm and 575 nm and the other wavelength range between 630 to 780 nm.
- the optical properties in terms of absorption and scattering the optical
- Measurement methods are determined and then checked to see whether they agree with those of the blood sufficiently.
- the spectral distribution of the light of the light transmitter exerts an influence on the accuracy of the detection of blood.
- the method according to the invention therefore provides for a measurement of the spectral distribution of the light of the light transmitter.
- Wavelength ranges before.
- a calibration data set describing the characteristic properties of the device for detecting blood or blood constituents is preferably determined.
- the calibration record may contain, for example, correction data that are taken into account in the evaluation of the signal of the light receiver.
- the correction data can be, for example, correction factors.
- the calibration record can also be the spectral distribution of the light of the light sender descriptive data receive.
- the calibration record contains further data for identifying the calibrated device for detecting blood or blood components, so that the determined calibration data sets can be assigned to the individual devices for detecting blood.
- the determined calibration data records are preferably stored in a memory of
- the identification data may be, for example, a serial number or a MAC address.
- the absorption standard comprises an absorption body, which preferably has two parallel surfaces, so that the light can enter the one surface and exit from the other surface.
- the use of a plane-parallel color filter requires an exact positioning and alignment in the beam path, which can be achieved by suitable design measures, for example by a suitable filter holder.
- Absorbent body is a transparent potting compound, in which a dye is embedded. Since the color particles are enclosed in a potting compound, a stable and homogeneous distribution of the color particles can be achieved.
- the embedding of the dye in the potting compound allows the reproducible production of an absorbent body with predetermined optical properties, which is characterized by a high long-term stability.
- PMMA polymethyl methacrylate
- the dye is dissolved in a liquid potting compound, in particular PMMA, and the solution is cured in the form of a body having two parallel surfaces, for example in the form of a flat round or rectangular disk.
- a liquid potting compound in particular PMMA
- the solution is cured in the form of a body having two parallel surfaces, for example in the form of a flat round or rectangular disk.
- the surfaces of the absorbent body may be treated by suitable methods, for example, ground or polished to achieve smooth surfaces.
- the optical properties of the dye should substantially match the optical properties of the blood.
- the transmission spectrum of the dye should correspond to the transmission spectrum of blood, at least for the wavelength ranges used, in particular two wavelength ranges, one lying between 550 nm and 575 nm and the other between 630 and 780 nm.
- ROTVIOLETT R known dye of the company Lanxess Germany GmbH is particularly suitable.
- the transmission spectrum of this dye is not with the
- a further preferred embodiment of the absorption standard provides that the transparent potting compound is cast between two parallel glass plates, whereby an optically homogeneous light path through the glass plates and the potting compound is formed.
- a particularly preferred embodiment of the absorption standard has a cuvette filled with a liquid, in which the absorption body is arranged.
- the cuvette is preferably a glass cuvette, in particular a cylindrical glass cuvette.
- the cuvette can be filled with dialysis fluid, which is characterized by optical
- a particularly preferred embodiment provides a filling with water that has been treated with a reverse osmotic cleaning method (RO water).
- RO water reverse osmotic cleaning method
- PEG polyethylene glycol
- the addition of polyethylene glycol (PEG) can reduce the risk of
- the formation of nuclei in the RO water can be additionally reduced, whereby the long-term stability is further increased.
- the filling of the cuvette with RO water also has the advantage that the refractive index between the transition from the cuvette to the absorption body of the absorption standard is matched to the calibration standard for the zero adjustment of the apparatus for detecting blood, which is also preferably with RO Water is filled, but does not contain the absorbent body.
- a preferred embodiment of the stray standard provides a diffuser that is frosted or roughened on one side.
- the scattering body may be, for example, a rectangular or round disc.
- the disc is preferably a glass sheet.
- the matting of the disc can be done by suitable processing methods.
- the surface of the disc may be sandblasted or etched.
- the frosted side of the disc can be provided with a seal of a transparent lacquer or a transparent coating, so that the optical properties can not change by a liquid, in which the disc can be introduced.
- the coating is preferably a layer of epoxy resin.
- a particularly preferred embodiment of the stray standard which is characterized by an improved measuring effect, provides that the straightening standard has a diffuser having two discs, of which one disc is matted or roughened on one side, whereby both discs are arranged on top of each other, that the frosted or roughened side of the one disc lies inside.
- An alternative particularly preferred embodiment provides a diffuser having two discs, which are frosted or roughened on one side, wherein both discs are arranged one above the other so that the frosted sides of the two discs are inside. The two discs can be glued together. Even in these embodiments, the frosted or roughened side of the one disc or the frosted or roughened sides of the two discs can not come in contact with a liquid.
- the scattering standard can also have a scattering body made of a transparent potting compound in which scattering particles, in particular insoluble salts, polystyrene particles or gypsum, are embedded.
- the scattering standard like the absorption standard, has one with a liquid,
- the cuvette of the scattering standard like the cuvette of the absorption standard, is introduced into the beam path between the light emitter and the light receiver of the device for detecting blood.
- the straightening standard comprises a cuvette filled with a liquid containing scattering particles.
- the cuvette is preferably filled with lipids dissolved in a liquid.
- the cuvette can be filled, for example, with the parenteral nutritional solutions of Fresenius Kabi AG known under the trade name Smoflipid or Intralipid.
- a scattering body by introducing liquids containing a scattering particle into an intermediate space between two transparent panes, in particular glass panes, wherein the intermediate space is sealed to the outside.
- This scattering body can in turn be introduced into the beam path of the device for detecting blood or blood constituents in a cuvette filled with a liquid, in particular dialysis fluid or RO water.
- a beam deflection unit in particular a deflection mirror, is preferably arranged in the beam path between the light transmitter and the light receiver.
- the deflection mirror can deflect the light by 45 ° so that the light can simply be coupled into a spectrometer.
- the reflectance of the mirror should be in the relevant wavelength range of about 350 nm to 800 nm
- the arrangement according to the invention is intended for calibrating devices for detecting blood or blood constituents in a liquid, which have a receptacle for a cuvette, which is designed such that a receptacle inserted into the receptacle Cuvette is arranged in the beam path between the light emitter and the light receiver.
- the arrangement according to the invention comprises an absorption standard which can be inserted into the receptacle of the cuvette and which has optical properties predetermined in relation to the absorption of the light into blood, and an insertable into the receptacle of the cuvette
- the arrangement comprises an evaluation unit for determining a characteristic properties of the device for detecting blood or blood component descriptive calibration record, which contains data for identifying the device for detecting blood or blood components.
- the arrangement may also comprise a spectrometer for measuring the spectral distribution of the light of the light emitter of the device for detecting blood or blood constituents.
- Fig. 1 is a simplified schematic representation of an apparatus for
- extracorporeal blood treatment comprising a device for detecting blood or a blood component in the dialysis fluid,
- Fig. 2 is a sectional view of the device for detecting blood or a
- Fig. 3 is a sectional view of the device for detecting blood or a
- 5 is a simplified representation of an absorption standard
- 5A is a simplified illustration of a first embodiment of an absorption body of the absorption standard
- 5B is a simplified representation of a second embodiment of a
- 6A is a simplified representation of a first embodiment of a
- 6B is a simplified representation of a second embodiment of a
- Fig. 7 shows another embodiment of a stray normal in a simplified
- FIG. 1 shows, in a highly simplified schematic representation, a device for extracorporeal blood treatment, for example a dialysis device.
- Extracorporeal blood treatment device has a dialyzer or filter 1, which passes through a semipermeable membrane 2 into a blood chamber 3 and a
- Dialysis fluid chamber 4 is divided. From the patient leads an arterial blood line 5 to the blood chamber 3, while from the blood chamber 3 a venous
- Blood line 6 which leads to the patient.
- An arranged in the arterial blood line 5 blood pump 7 promotes the blood in extracorporeal blood circulation I.
- Dialysis fluid branch II of the dialysis machine is shown only schematically.
- the Dialysier thoroughlykeitszweig II includes a leading to the dialysis fluid chamber 4 Dialysierckenkeitszuschreibtechnisch 8 and one of the
- the blood treatment apparatus has a central control unit 10 with which the individual components, for example the blood pump 7, are controlled.
- the blood treatment device has a device 11 for detecting blood or a blood component, in particular
- Hemoglobin in the dialysis fluid.
- Fig. 2 shows the essential components of the device 11 for detecting blood or a blood constituent.
- the device has a housing body 12 with a receptacle 13 into which a cuvette 14 can be suitably inserted.
- the receptacle 13 for the cuvette 14 has a first apertured diaphragm 15 and a second apertured diaphragm 16.
- a light transmitter 17 is arranged in front of one of the two apertured diaphragms 16 and a light receiver 18 in front of the other apertured diaphragm 17 so that the beam path 19 passes through an apertured diaphragm 16. enters the cuvette 14, exits the cuvette, passes through the other pinhole 15 and strikes the light receiver 18.
- the cuvette is part of the Dialysier deviskeitsabloomtechnisch 9, so that through the cuvette
- the light emitter 17 for example a bi-color LED, alternately emits green light having a wavelength which is between 550 nm and 575 nm, preferably between 555 nm and 570 nm, particularly preferably between 560 nm and 565 nm, and red light or in near-infrared (NIR) light having a wavelength between 630 nm and 780 nm, preferably between 630 nm and 675 nm, more preferably between 640 nm and 660 nm.
- the light receiver 18 generates a
- an evaluation unit 20 is provided, which is shown only schematically in Fig. 2.
- c is the concentration of the fluid
- d is the inner diameter of the cuvette
- the evaluation unit 20 receives the proportional to the intensity of the light
- Wavelength range with each other On the basis of the comparison of the measured intensities of the light, it is concluded that blood or a blood component, in particular hemoglobin, enters the dialysis fluid. Characteristic limit values can be specified for the evaluation of the measuring signals. The evaluation can be carried out for example by a method which is described in DE 37 26 524 AI.
- the evaluation unit 20 takes into account in one
- Calibration record containing data which may include, for example, the spectral distribution of the light of the light emitter 17 or in the calibration determined correction factors.
- the calibration data record is stored in a memory 20A of the evaluation unit 20.
- the calibration dataset contains further data, for example a serial number or MAC address.
- the calibration data record can be transmitted via a data line (not shown) into the memory 20A of the evaluation unit 20 of the device 11 for detecting blood or blood constituents can be read, so that the evaluation of the measured values for the detection of blood or blood components can be made on the basis of the calibration record.
- the calibration data set can also be stored in the memory of a central storage device (server), not shown, from which the data is then stored in the
- Evaluation unit 20 of the device 11 for detecting blood or blood components or a memory of the central control unit 10 of the blood treatment device can be read, so that the evaluation unit 20 can access the data.
- prepared cuvettes are used, which are inserted into the receptacle 13 of the device 11 for the detection of blood or blood components in order to be able to carry out various measurements.
- Calibration takes place in individual calibration zones, which are run through one after the other. The individual measurements are carried out in the calibration zones, the measured values being evaluated in the evaluation unit 21 of the calibration stand.
- the spectrum of the light emitter 17 of the device 11 for detecting blood or blood components is measured, in particular the spectrum of the green and red light.
- a cuvette instead of a cuvette, a
- Beam deflection unit 22 fits into the receptacle 13 of the device 11 for detecting blood or blood components used.
- FIG. 3 shows the device 11 for detecting blood or blood components together with the beam deflection unit 22.
- the beam deflection unit 22 has a housing body 23 in which a
- Deflection mirror 24 is arranged, which forms an angle of 45 ° with the beam path 19. Instead of a mirror but also a prism can be arranged in the beam path.
- a pinhole 25 In the beam path 19 in front of the mirror 24 is a pinhole 25 and in one embodiment, behind the mirror, a cosine corrector 26, via which the light is coupled into a spectrometer 27, which via a data line 28A to the
- Evaluation unit 22 is connected.
- the spectral measurement serves to assess the position of the spectra in terms of the absorption of hemoglobin.
- a NuU adjustment takes place on RO water, to which preferably PEG is admixed (1% PEG solution).
- the intensity of the light of the light emitter 17 can also be measured.
- a cuvette is in the beam path of the device for detecting blood or
- Blood components between light emitter 17 and light receiver 18 used which is filled with RO water, so that the light of the light emitter can pass through the cuvette and impinge on the light receiver.
- the output signal of the light receiver 18 is evaluated with the evaluation unit 21 of the calibration.
- the evaluation unit receives the signal of the light receiver 18 via a data line 28B.
- Fig. 4 shows a side view and top view of the cylindrical glass cuvette 29 for zero balance, which is sealed at the top and bottom with a closure member 29A, 29B.
- Absorption standard can pass and impinge on the light receiver 18.
- the output signal of the light receiver 18 is evaluated in the evaluation unit 21.
- Fig. 5 shows the absorption standard 30, which has a cylindrical glass cuvette 31, which is sealed at the top and bottom with a closure part 31A, 31B.
- the glass cuvette 31 is filled with RO water or a solution of RO water and PEG.
- An absorption body 32 is arranged in the cuvette.
- the two closure parts 31A, 31B are designed as a holder for the absorption body 32.
- Fig. 5A shows a first embodiment of the absorbent body 32.
- the absorbent body is a surface polished disc 33 of a potting compound containing the dye MACROLEX® Red Violet R in a homogeneous distribution.
- the potting compound is polymethyl methacrylate (PMMA).
- PMMA polymethyl methacrylate
- FIG. 5B shows an alternative embodiment, in which the disk 33 is enclosed between two parallel glass plates 34, 35.
- the scattering effect of blood is imitated with a stray normal, which is used instead of the absorption standard 30 in the receptacle 13 of the device 11 for detecting blood or blood constituents.
- the output signal of the light receiver 18 is evaluated again with the evaluation unit 21.
- Fig. 6 shows the stray normal 36, the one at the top and bottom with a
- Closing part 37A, 37B tightly closed cylindrical glass cuvette 37, in which a scattering body 38 is arranged.
- the two closure parts 37A, 37B are designed as a holder for the scattering body 38.
- the cuvette 37 is filled with RO water or a solution of RO water and PEG.
- Fig. 6A shows a first embodiment of the scattering body 38.
- the scattering body 38 is a glass plate 39, which is frosted or roughened on one side 40.
- FIG. 6B shows an alternative embodiment of the diffuser body 38 comprising two glass sheets 41, 42 which are glued together.
- the two glass sheets 41, 42 are matted or roughened on the inner sides 41A, 42B. But it is also possible that the inside of only one of the two glass sheets is frosted or roughened.
- the scattering body can also be made as the absorption body of a transparent potting compound, which are added instead of a dye scattering particles in a homogeneous distribution.
- the scattering particles may be insoluble salts, polystyrene particles, titanium dioxide or gypsum.
- FIG. 7 shows an embodiment of a straightening standard 43, which contains a scattering liquid 44 instead of a scattering body.
- the scattering liquid is, for example, a lipid-containing solution.
- lipid-containing solution for example, those under the trade name
- the straightening standard 44 has a cuvette 45, which is filled with the scattering liquid 44.
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Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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DE102017001484.1A DE102017001484A1 (de) | 2017-02-16 | 2017-02-16 | Verfahren und Anordnung zum Kalibrieren von Vorrichtungen zur Erkennung von Blut oder Blutbestandteilen in einer Flüssigkeit |
PCT/EP2018/053797 WO2018149921A1 (de) | 2017-02-16 | 2018-02-15 | Verfahren und anordnung zum kalibrieren von vorrichtungen zur erkennung von blut oder blutbestandteilen in einer flüssigkeit |
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EP3583404A1 true EP3583404A1 (de) | 2019-12-25 |
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EP18710329.6A Pending EP3583404A1 (de) | 2017-02-16 | 2018-02-15 | Verfahren und anordnung zum kalibrieren von vorrichtungen zur erkennung von blut oder blutbestandteilen in einer flüssigkeit |
Country Status (6)
Country | Link |
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US (1) | US10987459B2 (de) |
EP (1) | EP3583404A1 (de) |
JP (1) | JP7203739B2 (de) |
CN (1) | CN110300885B (de) |
DE (1) | DE102017001484A1 (de) |
WO (1) | WO2018149921A1 (de) |
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WO2022026455A1 (en) * | 2020-07-27 | 2022-02-03 | Custom Sensors & Technology | Flow cell for fiber optic spectrometers and photometers |
EP4368219A1 (de) * | 2022-11-08 | 2024-05-15 | Haermonics BV | System zum spülen einer wunde und/oder körperhöhle, insbesondere der perikardhöhle |
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-
2018
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- 2018-02-15 EP EP18710329.6A patent/EP3583404A1/de active Pending
- 2018-02-15 JP JP2019543975A patent/JP7203739B2/ja active Active
- 2018-02-15 US US16/485,470 patent/US10987459B2/en active Active
- 2018-02-15 CN CN201880011860.1A patent/CN110300885B/zh active Active
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US20190388601A1 (en) | 2019-12-26 |
DE102017001484A1 (de) | 2018-08-16 |
JP7203739B2 (ja) | 2023-01-13 |
CN110300885A (zh) | 2019-10-01 |
CN110300885B (zh) | 2022-08-02 |
JP2020509361A (ja) | 2020-03-26 |
US10987459B2 (en) | 2021-04-27 |
WO2018149921A1 (de) | 2018-08-23 |
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