WO2018130590A1 - Dispositif et procédé pour détecter du sang ou un constituant sanguin ou déterminer la concentration en sang ou en un constituant sanguin dans un liquide - Google Patents

Dispositif et procédé pour détecter du sang ou un constituant sanguin ou déterminer la concentration en sang ou en un constituant sanguin dans un liquide Download PDF

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Publication number
WO2018130590A1
WO2018130590A1 PCT/EP2018/050591 EP2018050591W WO2018130590A1 WO 2018130590 A1 WO2018130590 A1 WO 2018130590A1 EP 2018050591 W EP2018050591 W EP 2018050591W WO 2018130590 A1 WO2018130590 A1 WO 2018130590A1
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WO
WIPO (PCT)
Prior art keywords
light
blood
wavelength
wavelength range
liquid
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Application number
PCT/EP2018/050591
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German (de)
English (en)
Inventor
Andreas Röse
Martin Prinz
Original Assignee
Fresenius Medical Care Deutschland Gmbh
Priority date (The priority date 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 date listed.)
Filing date
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Application filed by Fresenius Medical Care Deutschland Gmbh filed Critical Fresenius Medical Care Deutschland Gmbh
Publication of WO2018130590A1 publication Critical patent/WO2018130590A1/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1692Detection of blood traces in dialysate
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/31Investigating relative effect of material at wavelengths characteristic of specific elements or molecules, e.g. atomic absorption spectrometry
    • G01N21/314Investigating 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3306Optical measuring means
    • A61M2205/3313Optical measuring means used specific wavelengths
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2201/00Features of devices classified in G01N21/00
    • G01N2201/06Illumination; Optics
    • G01N2201/062LED's
    • G01N2201/0627Use of several LED's for spectral resolution
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood

Definitions

  • the invention relates to a device and a method for the detection of blood or a blood component or the determination of the concentration of blood or a blood component in a liquid, in particular for the detection of hemoglobin or the determination of the concentration of hemoglobin in a dialysis fluid. Moreover, the invention relates to a device for extracorporeal blood treatment with such a device.
  • dialysis devices are used to protect the patient, with which the in the case of a rupture of the membrane of the dialyzer can not be reliably ingress of blood into the dialysis fluid can be reliably detected.
  • These devices are referred to as blood leak detectors.
  • the known blood leak detectors are generally based on a transmission measurement of red and green light passing through the dialysis fluid for detection of the blood.
  • DE 10 2011 108 050.7 describes a measuring device for receiving a transparent hose line, which has two receiving elements equipped with light emitters and light detectors. For clamping the hose, the receiving elements are moved by an electromotive actuating mechanism, which allows the detection of the clamped hose.
  • DE 10 2010 026 723.6 describes a method and an apparatus for determining the concentration of a constituent of blood in a tubing of a
  • the concentration of the blood component is determined on the basis of the relationship that determines the dependence of the concentration of the blood component on the intensity of the transparent tubing
  • decoupled electromagnetic radiation describes.
  • determining the concentration becomes a correction factor for the influence of the hose line considered.
  • a device for determining the concentration of a blood component is known, which takes into account a correction factor for the influence of the blood flow rate.
  • DE 37 26 524 A1 describes a photoelectric arrangement for detecting a substance, in particular hemoglobin, in a liquid, in particular dialysis fluid.
  • the detection of the substance is carried out by determining the absorption ratio of light of different wavelengths as the light passes through the liquid.
  • the photoelectric device has two light sources emitting light of different wavelengths. The different wavelengths are on the
  • the wavelength is 570 nm of one light source (green light) and the wavelength of the other light source is 635 nm (red light).
  • the light sources used are light-emitting diodes whose radiation intensity depends on the temperature. To compensate for changes in the intensity of the light, which have a disturbing influence on the measurement result, has the photoelectric arrangement next to the
  • the device has a light receiver for
  • Evaluation unit which is configured such that based on the
  • oxygenated hemoglobin are at 544 nm and 578 nm (M. Friebel: “Determination of optical properties of human whole blood as a function of various physiological and biochemical state parameters", Dissertation, Berlin, 2007.) The absorption maximum but was not used for the evaluation, as previously It has been suggested that the presence of other absorbing substances, such as bilirubin, could trigger false alarms in certain treatment situations.
  • the invention has for its object to improve the known devices for detecting blood or a blood component, in particular hemoglobin in a dialysis fluid to the effect that the accuracy and safety of the detection of blood or a blood component or the determination of the concentration of blood or a blood component is increased.
  • an object of the invention is a
  • Embodiments of the invention is based on the recognition that the measurement known from the prior art with a light emitter for transmitting light with a first
  • Blood component is increased when the first wavelength is between 400 nm and 450 nm. In this wavelength range are the absolute absorption maxima for blood. It has been shown that the measurement dynamics, i. H. the difference in the two
  • Wavelength ranges measured amplitudes at a first wavelength range of 400 nm and 450 nm compared to the prior art by a factor of 10 can be improved.
  • Blood component is present in the liquid.
  • the evaluation is basically irrelevant how the evaluation of the measurement results, as far as the evaluation is based on the measurement of the intensity of the transmitted light with the first wavelength and the intensity of the transmitted light with the second wavelength.
  • basically all known in the prior art evaluation methods can be used, which are based on the detection of light of different wavelengths to detect blood or blood components and / or the concentration of blood or blood components in the
  • the first wavelength range is close to the range of absolute oxygenated blood absorption maxima, which is about 415 nm, and deoxygenated blood, which is about 430 nm.
  • Wavelength range is therefore preferably between 410 nm and 440 nm, more preferably between 415 nm to 430 nm. With respect to the second wavelength range, it has been found that improved
  • Measurement results are achieved when the second wavelength is shifted to higher values. Improved measurement results have been shown starting at a lower limit for the wavelength of 640 nm (red light). The wavelength can be increased up to the near infrared (NIR) range (780 nm).
  • NIR near infrared
  • a shift to higher wavelengths in the second wavelength range leads to less overlap of the green and red spectrum when using commercially available LEDs as light source, so that changes in the intensity of the red LED have a smaller influence on the measuring effect, since the wavelength is no longer on the steeply falling edge of the absorption curve is.
  • a change in the second wavelength range generally has less influence on the sensitivity, which is essentially determined by the absorption for green light, since the absorption is much greater for green light than for red light. Changes in the
  • Oxygen saturation is in the second wavelength range of 640 to 780 nm, preferably between 640 nm and 675 nm, more preferably between 645 nm and 670 nm, in a smaller order than at a wavelength of 635 nm.
  • an oxygen saturation of 60% are assumed to be the minimum value.
  • a preferred embodiment provides a computing and evaluation unit configured to compare the intensity of the transmitted light at the first wavelength and the intensity of the transmitted light at the second wavelength with one another.
  • the evaluation may be based on the
  • the light emitter includes a first light emitter for transmitting light in the first wavelength range and a second light emitter for transmitting light in the second wavelength range wherein the first and second light emitter each comprise a light emitting diode or a group of light emitting diodes.
  • the device preferably has, in addition to the computing and evaluation unit, a receiving unit for receiving a transparent
  • Hose line wherein the light emitter and light receiver such on the
  • Receiving unit are arranged, that the light can be coupled into the hose and coupled out of the hose. This results in a simple to use in practice measuring unit.
  • the disadvantage is that even a transparent
  • Hose line is not free of disturbing influences on the measurement.
  • the device according to the invention or the method according to the invention have proved to be particularly advantageous in the measurement with a transparent hose line.
  • the device has a cuvette for receiving the dialysis fluid, for example a glass cuvette or a preferably injection-molded plastic cuvette, wherein the light emitter and
  • Light receiver are arranged on the cuvette such that the light can be coupled into the cuvette and out of the cuvette auskoppelbar.
  • a glass cuvette is optimally optically transparent and free of interference.
  • the cuvette is part of a cassette system, which can be connected, for example, as a disposable article with a dialysis machine.
  • Fig. 1 shows a device for extracorporeal blood treatment together with a
  • FIG. 2 shows an embodiment of the receiving unit of the device for detecting blood or a blood component or determining the concentration of blood or a blood component, in particular hemoglobin, in the dialysis fluid
  • Fig. 3 shows the absorption spectrum of hemoglobin as a function of
  • 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.
  • a blood pump 7 arranged in the arterial blood line 5 conveys the blood in the extracorporeal blood circulation I.
  • the arterial and venous blood lines 5, 6 are substantially transparent hose lines which are permeable to light.
  • the Dialysier thoroughlykeitszweig II of the dialysis machine is shown only hinted.
  • the Dialysier thoroughlykeitszweig II includes a to the
  • the blood treatment device has a central control and computing unit 10, with which the individual components, for example the blood pump 7, are controlled.
  • the individual components for example the blood pump 7, are controlled.
  • blood of the patient can enter the dialysis fluid.
  • the device 11 according to the invention for detecting blood or a blood component or determining the concentration of blood or a blood component, in particular hemoglobin, in the dialysis fluid can form part of the extracorporeal
  • An embodiment of the device 11 according to the invention has a
  • Receiving unit 12 with four mutually perpendicular, planar contact surfaces 12A, between which the Dialysier crampkeitsabschreibtechnisch 9, in this
  • Embodiment is a flexible, transparent hose line, can be firmly clamped (Fig. 2).
  • a light transmitter 13 and a light receiver 14 are arranged at two opposite contact surfaces 12A of the receiving unit 12.
  • the light transmitter 13 has a first and a second light emitter 13A, 13B, wherein the first or second light emitter may comprise one or more LED's.
  • Receiving unit can accommodate the transparent hose over
  • the two light emitters 13A, 13B are connected via a signal line 14 to a computing and evaluation unit 15 of the device 11, which in turn is connected via a data line 16 to the central computing and control unit 10 of the blood treatment device.
  • the computing and evaluation unit 15 of the device 11 may also be part of the central computing and control unit 10 of the blood treatment device.
  • the central control and processing unit 10 and the computing and evaluation unit 15, which may be part of the central control and processing unit 11, for example, a general processor, a digital signal processor (DSP) for continuous processing of digital signals, a microprocessor, an application-specific integrated circuit (ASIC), an integrated logic element Circuit (FPGA) or other integrated circuits (IC) or hardware components to the individual process steps to control the DSP digital signal processor
  • ASIC application-specific integrated circuit
  • FPGA integrated logic element Circuit
  • IC integrated circuits
  • a data processing program (software) can be run on the hardware components to carry out the method steps.
  • the first light emitter 13A which preferably has one LED or several LEDs, emits blue light having a wavelength which is between 400 nm and 450 nm, preferably between 410 nm and 440 nm, particularly preferably between 415 nm and 430 nm, during the second light emitter 13B of the light emitter 13, which preferably comprises one or more LED's, emits red light or near infrared (NIR) light having a wavelength between 640 nm and 780 nm, preferably between 640 nm and 675 nm, especially preferably between 645 nm and 670 nm.
  • NIR near infrared
  • the computing and evaluation unit 15 is configured such that the following
  • Dialysis fluid can be made.
  • the computing and evaluation unit 15 can run a data processing program that performs the necessary steps for the measurements.
  • the arithmetic and evaluation unit 15 may have a microprocessor.
  • the light coupled by the first and second light emitters 13A and 13B into the transparent tubing 6 and passing through the dialysis fluid is coupled out to the light receiver 14.
  • c is the concentration of the fluid
  • d is the inner diameter of the clamped hose line
  • the arithmetic and evaluation unit 15 receives the signals proportional to the intensity of the absorbed light and compares the intensity of the transmitted light with the first wavelength and the intensity of the transmitted light with the second wavelength with each other. Based on the comparison of the measured intensities, the entry of blood or a blood constituent, i. H. of hemoglobin, in the
  • characteristic limit values are specified.
  • the evaluation can be carried out in the wavelength ranges according to the invention, for example, with a method which is described in DE 37 26 524 AI.
  • the logarithmic decrease in the intensity of the light of different wavelengths as it passes through the liquid has the advantage that interferences that have the same effect on both wavelengths, such as changes in the
  • Amplification factor of the evaluation circuits on the receiver side allow to calculate in the evaluation.
  • the concentration of the blood can then be very easy
  • ⁇ ⁇ ⁇ - ⁇ ⁇ 2 ( ⁇ ⁇ 1 - ⁇ ⁇ 2 ) cd, where c is the blood concentration and d is the internal diameter of the clamped
  • Hose line is.
  • Fig. 3 shows the absorption spectrum of hemoglobin at a concentration of 2.67 g / dl (M. Friebel: "Determination of optical properties of human whole blood as a function of various physiological and biochemical
  • the local absorption maxima of oxygenated hemoglobin are at 544 nm and 578 nm. From Fig. 3, the higher absorption of hemoglobin of the first light emitter for the blue light in the region of the absorption maxima, and the lower absorption of hemoglobin for the red light of the second light emitter can be seen.
  • Fig. 4 shows an alternative embodiment of the measuring arrangement, wherein the corresponding parts are provided with the same reference numerals.
  • the measuring arrangement has a light emitter 13, which has only one light emitter 13A, which is a bi-color LED, which alternately emits light having a first and a second wavelength.
  • the light is decoupled via a prism 18 and onto a
  • Reference receiver 19 passed, which forms the input of a reference channel.
  • Reference channel controls the light intensity of the two colors so that they are in a fixed relationship to each other.
  • the remaining light radiates through a cuvette 20 in which the dialysis fluid is located. Subsequently, this light impinges on the light receiver 14. This measuring arrangement is described in detail in EP 1 275 408 A1.

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  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Biomedical Technology (AREA)
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Abstract

L'invention concerne un dispositif et un procédé pour détecter du sang ou un constituant sanguin ou déterminer la concentration en sang ou en un constituant sanguin dans un liquide, en particulier pour détecter l'hémoglobine dans un liquide de dialyse. Le dispositif selon l'invention dispose d'un émetteur de lumière (13) pour émettre de la lumière dans une première plage de longueurs d'onde et pour émettre de la lumière dans une deuxième plage de longueurs d'onde, la longueur d'onde de la lumière dans la première et dans la deuxième plage de longueurs d'onde étant adaptée aux propriétés d'absorption, dépendant de la longueur d'onde, du sang ou du constituant sanguin de manière telle que la lumière qui traverse le liquide dans la première plage de longueurs d'onde est absorbée plus fortement que la lumière qui traverse liquide dans la deuxième plage de longueurs d'onde. En outre, le dispositif présente un récepteur de lumière (13) pour recevoir la lumière qui traverse liquide et une unité de calcul et d'évaluation (15), qui est conçue de manière telle que, sur base de l'absorption différente de la lumière présentant la longueur d'onde dans la première plage et dans la deuxième plage de longueurs d'onde, la présence de sang ou d'un constituant sanguin dans le liquide peut être déduite. On obtient une précision de mesure et une sécurité d'évaluation particulièrement élevées, en particulier pour la détection d'hémoglobine dans un liquide de dialyse, lorsque la première plage de longueurs d'onde se situe entre 400 nm et 450 nm.
PCT/EP2018/050591 2017-01-13 2018-01-10 Dispositif et procédé pour détecter du sang ou un constituant sanguin ou déterminer la concentration en sang ou en un constituant sanguin dans un liquide WO2018130590A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017000226.6A DE102017000226A1 (de) 2017-01-13 2017-01-13 Vorrichtung und Verfahren zur Erkennung von Blut oder eines Blutbestandteils oder der Bestimmung der Konzentration von Blut oder eines Blutbestandteils in einer Flüssigkeit
DE102017000226.6 2017-01-13

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111110939A (zh) * 2018-11-01 2020-05-08 李韦辰 血液分析模块及其血液收集装置
CN116942941A (zh) * 2023-09-14 2023-10-27 苏州森斯缔夫传感科技有限公司 一种光强比照传感器、光强比照方法

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102019122366A1 (de) * 2019-08-20 2021-02-25 B.Braun Avitum Ag Vorrichtung zur Erkennung von Blut
CN112051264B (zh) * 2020-06-13 2021-06-01 中南大学湘雅医院 透析废液血红蛋白检测平台

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4017190A (en) * 1975-07-18 1977-04-12 Halbert Fischel Blood leak detector comparing intensities of high absorption band and low absorption band of a single beam of light passing through a sample
DE3726524A1 (de) 1987-08-10 1989-02-23 Fresenius Ag Haemoglobindetektor
EP1275408A1 (fr) 1996-09-06 2003-01-15 Fresenius Medical Care Deutschland GmbH Appareil de dialyse avec moyens de détartrage du circuit de dialysat et méthode pour déterminer son niveau de calcification
US20070259436A1 (en) * 2006-05-04 2007-11-08 Michael Tarasev Blood Hemolysis Analyzer
DE102009036044A1 (de) * 2009-08-04 2011-02-10 Fresenius Medical Care Deutschland Gmbh Vorrichtung und Verfahren zur Erkennung von Blut oder Blutbestandteilen im Flüssigkeitssystem einer Vorrichtung zur extrakorporalen Blutbehandlung
DE102010026723A1 (de) 2010-07-09 2012-01-12 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zum Bestimmen der Konzentration eines Blutbestandteils in einer mit Blut gefüllten Schlauchleitung
DE102011108050B3 (de) 2011-07-21 2013-01-17 Fresenius Medical Care Deutschland Gmbh Vorrichtung zur Bestimmung der Konzentration eines Bestandteils von Blut in einer Schlauchleitung und Verfahren zur Erkennung einer Schlauchleitung in einer Einspanneinheit
DE102011119824A1 (de) 2011-12-01 2013-06-06 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Bestimmung eines Blutbestandteils
DE202013011936U1 (de) 2013-06-27 2014-11-17 Fresenius Medical Care Deutschland Gmbh Vorrichtung zur Erkennung von Blut oder eines Blutbestandteils in einer Flüssigkeit

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4017190A (en) * 1975-07-18 1977-04-12 Halbert Fischel Blood leak detector comparing intensities of high absorption band and low absorption band of a single beam of light passing through a sample
DE3726524A1 (de) 1987-08-10 1989-02-23 Fresenius Ag Haemoglobindetektor
EP1275408A1 (fr) 1996-09-06 2003-01-15 Fresenius Medical Care Deutschland GmbH Appareil de dialyse avec moyens de détartrage du circuit de dialysat et méthode pour déterminer son niveau de calcification
US20070259436A1 (en) * 2006-05-04 2007-11-08 Michael Tarasev Blood Hemolysis Analyzer
DE102009036044A1 (de) * 2009-08-04 2011-02-10 Fresenius Medical Care Deutschland Gmbh Vorrichtung und Verfahren zur Erkennung von Blut oder Blutbestandteilen im Flüssigkeitssystem einer Vorrichtung zur extrakorporalen Blutbehandlung
DE102010026723A1 (de) 2010-07-09 2012-01-12 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zum Bestimmen der Konzentration eines Blutbestandteils in einer mit Blut gefüllten Schlauchleitung
DE102011108050B3 (de) 2011-07-21 2013-01-17 Fresenius Medical Care Deutschland Gmbh Vorrichtung zur Bestimmung der Konzentration eines Bestandteils von Blut in einer Schlauchleitung und Verfahren zur Erkennung einer Schlauchleitung in einer Einspanneinheit
DE102011119824A1 (de) 2011-12-01 2013-06-06 Fresenius Medical Care Deutschland Gmbh Verfahren und Vorrichtung zur Bestimmung eines Blutbestandteils
DE202013011936U1 (de) 2013-06-27 2014-11-17 Fresenius Medical Care Deutschland Gmbh Vorrichtung zur Erkennung von Blut oder eines Blutbestandteils in einer Flüssigkeit

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Title
M. FRIEBEL: "Bestimmung optischer Eigenschaften von humanen Vollblut in Abhängigkeit von verschiedenen physiologischen und biochemischen Zustandsparametern", DISSERTATION, 2007

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN111110939A (zh) * 2018-11-01 2020-05-08 李韦辰 血液分析模块及其血液收集装置
CN116942941A (zh) * 2023-09-14 2023-10-27 苏州森斯缔夫传感科技有限公司 一种光强比照传感器、光强比照方法
CN116942941B (zh) * 2023-09-14 2023-12-29 苏州森斯缔夫传感科技有限公司 一种光强比照传感器、方法及血液净化机

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