EP2734111A2 - Dispositif permettant de déterminer la concentration d'un composant sanguin dans une tubulure flexible - Google Patents

Dispositif permettant de déterminer la concentration d'un composant sanguin dans une tubulure flexible

Info

Publication number
EP2734111A2
EP2734111A2 EP12738045.9A EP12738045A EP2734111A2 EP 2734111 A2 EP2734111 A2 EP 2734111A2 EP 12738045 A EP12738045 A EP 12738045A EP 2734111 A2 EP2734111 A2 EP 2734111A2
Authority
EP
European Patent Office
Prior art keywords
hose
motor current
receiving elements
blood
unit
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.)
Withdrawn
Application number
EP12738045.9A
Other languages
German (de)
English (en)
Inventor
Wei Zhang
Elke Schulte
Martin Kaiser
Carsten Müller
Tom Klein
Stefan Zerle
Christoph Bardorz
Stefan STÜHLER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Medical Care Deutschland GmbH
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
Publication date
Application filed by Fresenius Medical Care Deutschland GmbH filed Critical Fresenius Medical Care Deutschland GmbH
Priority to EP15183364.7A priority Critical patent/EP2984988B1/fr
Publication of EP2734111A2 publication Critical patent/EP2734111A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
    • A61B5/14551—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases
    • A61B5/14557—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters for measuring blood gases specially adapted to extracorporeal circuits
    • 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
    • A61M1/367—Circuit parts not covered by the preceding subgroups of group A61M1/3621
    • 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
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/03—Cuvette constructions
    • G01N21/05—Flow-through cuvettes
    • 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
    • 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
    • A61M2205/14—Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • 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
    • 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
    • A61M2230/00—Measuring parameters of the user
    • A61M2230/20—Blood composition characteristics
    • 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
    • G01N21/01—Arrangements or apparatus for facilitating the optical investigation
    • G01N21/03—Cuvette constructions
    • G01N2021/0378—Shapes
    • 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
    • G01N2021/3144—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 for oxymetry

Definitions

  • the invention relates to a device for determining the concentration of a
  • the invention relates to a method for detecting a tubing, in particular a tubing of an extracorporeal blood circulation of a
  • Extracorporeal blood treatment device in a clamping unit of a device for determining the concentration of a blood component in the tubing.
  • WO 2008/00433 A1 describes a device for determining the concentration of certain blood components in a blood-filled substantially
  • the Device allows in particular the determination of the hemoglobin concentration and the proportion of red blood cells (erythrocytes) in the total volume of blood.
  • the tubing is clamped between two parallel, flat contact surfaces, so that the tubing deforms on the opposite sides.
  • a light emitter light of a certain wavelength is coupled through the transparent tubing into the blood, while with a light detector the scattered or transmitted light is measured.
  • the hematocrit is then determined from the ratio of the intensity of the light entering the blood and exiting the blood.
  • an apparatus for the determination of blood components which has a clamping unit for clamping the tubing and a measuring unit.
  • the clamping unit is designed such that the clamped hose line has a square cross-section.
  • the measuring unit has several light emitters and light detectors, which are arranged around the circumference of the hose line. The light emitters and light detectors are arranged such that the light emitters lie in a different plane than the light detectors, so that
  • Light emitter and light detectors are not opposite each other. To measure the blood parameters, the tubing is deformed in the clamping unit. Make sure that the hose line does not jam in the clamping unit.
  • Measurement sequence also sets the detection of the inserted into the clamping unit
  • the invention has for its object to provide a device for determining the
  • Another object of the invention is a method for detecting a
  • the inventive device for determining the concentration of a component of blood in a tubing, in particular the tubing of an extracorporeal blood circulation characterized in that the clamping unit a Actuating mechanism which is designed such that upon application of a clamping force, a first and second receiving element from a first releasing the hose line position in a second clamping the hose line position against each other are movable, wherein the drive of the actuating mechanism is carried out with an electric motor.
  • the electromotive drive allows the setting of a specific
  • Feed rate at which the receiving elements are moved is possible to press the hose together with an optimum feed rate, so that the hose line has opportunity between the
  • Hose line avoided as a result of too fast and not uniform movement of the clamping elements.
  • the device according to the invention for determining the concentration of blood components is characterized by a monitoring unit which is designed such that the tube inserted into the receiving elements can be seen. This makes it possible to automate the measurement of blood parameters.
  • the measurement can only be started if and only if the
  • Hose line is inserted in the clamping unit.
  • the lighting duration of the LEDs used as a light emitter can be reduced, so that increases the life of the LEDs. Incidentally, incorrect measurements are avoided when not inserted hose.
  • the motor current of the electric motor to drive the hose in the clamping unit for driving the
  • Motor current correlating size for example, the engine power to be evaluated.
  • the evaluation of the motor current for the detection of the hose can be done in a computing and evaluation unit, without further mechanical components are required.
  • the computing and evaluation unit of the monitoring unit can be part of the computing and evaluation unit of the device for determining the concentration of the blood component. Both arithmetic and evaluation units can also be part of the central control unit or arithmetic and evaluation unit of an extracorporeal
  • the motor current has a characteristic course, which depends on whether a hose is clamped or not.
  • a significant increase in the motor current shows much earlier, when the hose is inserted into the receiving elements.
  • the increase of the motor current is significantly steeper.
  • the time course of the motor current when closing the receiving elements can be used as a criterion for the detection of the hose.
  • the monitoring unit has means for measuring the distance covered by the receiving elements, wherein the computing and evaluation unit of the monitoring unit is designed such that the motor current as a function of the traveled by the receiving elements
  • the arithmetic and evaluation unit is designed in such a way that the integral of the motor current is compared with a predetermined limit value over a predetermined distance covered by the receiving elements, it being concluded when the limit value is exceeded that a hose line is inserted into the receiving elements is.
  • the integration of the motor current does not need continuous, but can also be done in discrete time intervals.
  • the limit value can be specified depending on the material of the hose line used, wherein for different
  • Hose lines also several limits can be specified.
  • a particular embodiment of the clamping unit which has its own inventive significance, is characterized in that the first receiving element has two mutually perpendicular planar contact surfaces and the second receiving element has two mutually perpendicular planar contact surfaces, wherein the first and second receiving element on an axis against each other are movable, which forms an angle of 45 ° with the flat contact surfaces of the first and second receiving element. It is irrelevant how the two receiving elements are formed, as long as the mutually perpendicular planar contact surfaces are present.
  • the receiving elements with the flat contact surfaces deform the hose when closing the clamping unit.
  • Transition portion which is formed such that the inner planar contact surfaces continuously merge into the outer semi-cylindrical contact surfaces.
  • a continuous transition is to be understood as meaning any transition which allows a uniform deformation of the hose line, so that the circular cross-section of the hose line changes uniformly into the square cross section and the
  • Hose line is not kinked.
  • the smooth transition from the circular to the square cross-section not only has the advantage that the hose is spared when closing the clamping unit, but also the advantage that turbulent flows are avoided in the transition from the round to square pipe cross-section.
  • the length of the square measuring channel in which light emitters and light detectors are arranged can be kept as low as possible.
  • a shortening of the measuring channel in turn has small closing forces result, which is also beneficial.
  • Blood components preferably include a plurality of light emitters for coupling electromagnetic radiation through the tubing into the blood and more
  • Light detectors for measuring the exiting from the blood by the hose electromagnetic radiation which are arranged in the first and second receiving element.
  • the light emitters and light detectors are arranged in Lichtaustrittsund -in Spotifys, which in the flat contact surfaces of the
  • Receiving elements are provided.
  • the light emitters and light detectors are integrated into the receiving elements.
  • At least one light detector is associated with at least one group of two light emitters. It can be assigned to the at least one light detector, for example 2, 4, 6 or 8 light emitters. In practice, however, the assignment of 2 light emitters to a light detector is sufficient.
  • the use of two light emitters instead of only one light emitter for coupling light into the tubing has the advantage that the luminous efficiency of the LEDs is doubled while the influence of the tubing on the distance traveled by the light is reduced.
  • the disadvantage is that the signal amplitude decreases with increasing distance from the light emitter and the light detector. Therefore, in principle, an increase in the intensity of the injected light is sought. However, this greatly restricts the selection of the components available as light emitters. By contrast, a shorter distance between light emitters and light detectors, which does not require an increase in the intensity of the radiation, impairs the accuracy of the measurement. Join in
  • Fig. 1 shows a device for extracorporeal blood treatment together with a
  • 2A is a greatly simplified schematic representation of the clamping unit and the measuring unit of the device for determining the concentration of a blood constituent, wherein the arrangement of the light emitter and light detectors is shown in a first sectional plane,
  • Fig. 3A shows a receiving element of the clamping unit in a perspective view
  • Fig. 3B the other receiving element of the clamping unit in perspective
  • Fig. 4A shows the time course of the measured at a first clamping unit
  • FIG. 5 shows an evaluation of the measurement results from FIGS. 4A-4C
  • FIG. 6 shows the motor current as a function of the torque
  • FIG. 7 shows the measurement results for six clamping units of the same type and different hose lines
  • Fig. 8D shows the motor current I as a function of the motor distance x for the
  • Fig. 1 shows only the essential components of the invention for a device for extracorporeal blood treatment in a highly simplified schematic representation.
  • the extracorporeal blood treatment apparatus for example a dialysis apparatus, has a dialyzer or filter 1, which is subdivided by a semipermeable membrane 2 into a blood chamber 3 and a dialysis fluid chamber 4. From the patient leads an arterial blood line 5 to the blood chamber 3, while the blood chamber 3, a venous blood line 6 goes off, leading to the patient.
  • An arranged in the arterial blood line 5 blood pump 7 promotes the blood in extracorporeal blood circulation I.
  • Dialysis fluid II of the dialysis machine is shown only hinted. It comprises a leading to the dialysis fluid chamber 4
  • Dialysing fluid supply 8 and one of the Dialysier crampkeitshunt 4 outgoing Dialysier slimkeitsabdies admir 9.
  • Blood line 5, 6 are hose lines that are at least partially permeable to light.
  • the blood treatment device has a central control unit 10 with which the individual components, for example the blood pump 7, are controlled.
  • the device 11 for determining the concentration of certain components in the blood of the patient may be part of the extracorporeal blood treatment device or form a separate assembly.
  • Fig. 1 the hemoglobin concentration (Hb), the hematocrit (Hkt) or the relative blood volume (RBV) has only one hint in Fig. 1 shown
  • Clamping unit 12 for receiving the tubing, in particular the arterial blood line 5, and a measuring unit 13 for coupling light in through the
  • the measuring unit 13 interacts with a computing and evaluation unit 14, which determines the concentration of the blood component from the measured values.
  • a computing and evaluation unit 14 determines the concentration of the blood component from the measured values.
  • the computing and evaluation unit 14 for determining the concentration of a blood component is part of the central
  • Control unit 10 or computing and evaluation unit of the extracorporeal
  • Blood treatment device But it can also be provided separate units.
  • FIGS. 2A and 2B show the clamping unit 12 and the measuring unit 13 of the device 11 in various sectional planes and in a highly simplified schematic representation.
  • the clamping unit 12 has two receiving elements 15, 16, between which the hose 17 is clamped, so that the round hose a
  • Receiving elements 15, 16 are moved along an axis a against each other. For moving the clamping elements 15, 16 from a position releasing the hose line 17 into a position clamping the hose line serves
  • Actuating mechanism 18 which is shown only schematically in Figs. 2A and 2B.
  • the receiving elements 15, 16 and the actuating mechanism 18 can be any suitable receiving elements 15, 16 and the actuating mechanism 18.
  • FIGS. 2A and 2B show the clamping unit 12 in FIG.
  • the receiving elements 15, 16 each have two flat contact surfaces 15A, 15B and 16A, 16B, each including a right angle.
  • the axis a, on which the Receiving elements 15, 16 are moved, enclose an angle of 45 ° with the flat contact surfaces 15A, 15B and 16A, 16B.
  • the measuring unit 13 has a plurality of light emitters 20A, 20B; 21 A, 21 B, which are arranged in a first plane (Fig. 2A) around the circumference of the hose line.
  • the axes of the adjacent light emitters each enclose an angle of 90 °.
  • Light detectors 22A, 22B, 22C, 22D are arranged in a second plane that is different from the first plane ( Figure 2B).
  • the measuring unit has four light detectors which are arranged around the circumference of the hose line.
  • the light emitters and light detectors are light emitting diodes (LEDs).
  • At least one of the light detectors 22A-22D is associated with two light emitters 20A, 20B and 21A, 21B, respectively, which simultaneously emit light which the at least one light detector 22A-22D receives.
  • the two light emitters of a group of light emitters for example the light emitters 20A and 20B, face each other.
  • the associated light detector 22A-22D is disposed in a plane including an angle of 90 ° with the plane in which the light emitters 20A, 20B are arranged.
  • the light output is doubled, since the light is evaluated by two light emitters with the light detectors.
  • the influence of different tube thicknesses within the measuring channel on the measurement result is reduced because the measurement is carried out over different measuring distances.
  • FIGS. 3A and 3B show in a partially sectioned perspective illustration particularly preferred embodiments of FIGS.
  • the two receiving elements 15, 16 are again moved with a in Fig. 3A and 3B better clarity but not shown actuating mechanism, the is driven by an electric motor, not shown.
  • actuating mechanism the is driven by an electric motor, not shown.
  • the receiving elements in the closed position form a measuring channel 23 comprising an inner portion 23A and two outer portions 23B, 23C disposed on either side of the inner portion 23A.
  • the receiving channel has the square cross section shown in Figs. 2A and 2B, while the receiving channel in the outer portions 23B and 23C has a circular cross section corresponding to the cross section of the inserted tube 17.
  • each receiving element 15, 16 has two mutually perpendicular planar contact surfaces and in the outer portions 23 B, 23 C each have a semi-cylindrical contact surface, which is adjacent to the square or
  • Turbulence is avoided when blood flows through the tubing.
  • the light emitters 20A, 20B, 21A, 21B and the light detectors 22A-22C are arranged within the square measuring channel in the inner portions 23A of the receiving elements 15, 16.
  • the planar contact surfaces of the receiving elements have corresponding light exit and entry openings 25, 26.
  • the monitoring unit 27 has only schematically illustrated means 27A for measuring the motor current of the electric motor 19, with which the
  • Actuating mechanism 18 of the clamping unit 12 is driven.
  • Motor current can also be a correlated with the motor current size, eg.
  • the engine power can be measured.
  • the monitoring unit 27 again has only hinted means 27B for measuring the distance on which the receiving elements 15, 16 are moved from the open position to the closed position.
  • the measured values of the means 27A, 27B for measuring the motor current and the traveled distance are evaluated by a computing and evaluation unit 27C, which in the present embodiment is part of the
  • Monitoring unit 27 is.
  • Monitoring unit 27 is connected via a data line 28 to the central control unit 10 of the extracorporeal blood treatment device. She can, too
  • the computing and evaluation unit 27C of the monitoring unit 27 calculates the integral of the measured motor current over a path traveled by the receiving elements 15, 16 during closing of the clamping unit 12. The calculated integral of the motor current is compared with a predetermined limit value. If the limit value is exceeded, the computing and evaluation unit 27C of the monitoring unit 27 determines that a hose line has been inserted into the clamping unit 12. Otherwise, the arithmetic and evaluation unit determines that a hose line is not inserted. In both cases, the computing and evaluation unit generates a corresponding signal, which receives the central control unit of the blood treatment device. More specifically, the arithmetic and control unit 27C of the monitoring unit 27 operates as follows:
  • the course of the motor current is monitored over a certain distance interval.
  • the path difference between the measuring points I (n) and I (n + 1) is ⁇ ( ⁇ ).
  • the arithmetic and evaluation unit calculates the integral for the given distance between Nl and N2 as follows:
  • 4A, 4B and 4C show the measured motor current [0.1 mA] of the electric motor for driving the actuating mechanism as a function of the distance traveled by the receiving elements when closing the clamping unit.
  • Traveling elements covered distance can be detected with a device that generates a certain number of electrical pulses per revolution of the motor.
  • the x-axis shows the number of measured electrical impulses that correspond to the traveled distance.
  • FIGS. 4A-4C show the measurement results for three different clamping units of different configurations, which are designated as module A, module B and module C in the figures.
  • FIGS. 4A-4C show the course of the motor current when closing the clamping unit for four different hose lines which are either empty or filled with H 2 0. The individual curves are designated as follows in FIGS. 4A-4C:
  • the area under the curves is greater when the hose is inserted than when the hose is not in place.
  • FIG. 5 shows the evaluation of the measurement results shown in FIGS. 4A-4C.
  • the measurement results of Fig. 4A are shown with a rectangle, of Fig. 4B with a
  • the value of the integral is between 7500 and 12500, while for the PVC hose (thick wall thickness) 3 the value of the integral is between 8500 and 15000.
  • the value of the integral between 2500 and 6500 is significantly lower. It turns out that the value of the integral is less than 2000 if a hose is not inserted in the clamping unit.
  • the assumed limit for the value of the integral 2000 is assumed. This allows for all hoses, at
  • Embodiment a limit of 3000 is set.
  • blood tubes made of PVC or PUR or other materials can be used. In practice, therefore, not only the problem of detecting a blood tube in the clamping unit of the device to Determination of the concentration of a blood constituent, but also the identification of the type of blood-tubing inserted into the clamping unit.
  • the material constituting the blood tube can have an influence on the accuracy of the measurement of the concentration of a blood constituent. Therefore, the identification of the blood tubing also allows to conclude on the accuracy of the measurement. So it is possible to give an acoustic and / or visual indication of the measurement accuracy. The measurement can also be corrected or even prevented depending on the blood tube used.
  • a blood tube made of PUR which is characterized by a low tolerance of the wall thickness, a high measuring accuracy is achieved in practice.
  • a hose made of PUR is characterized by a greater hardness and a higher elasticity compared to a hose made of PVC. The PUR tube thus exerts a greater restoring force on the receiving elements of the receiving unit.
  • the device according to the invention and the method according to the invention therefore provide that after inserting the hose line into the clamping unit 12
  • Actuating mechanism 18 is set to close the receiving elements 15, 16 in operation, wherein the receiving elements are closed until a predetermined contact force is exerted on the hose, and after a predetermined time interval, the receiving elements are opened again. to Performing the actual measurement, the receiving elements are then closed again. This process can be controlled fully automatically by the monitoring unit 27.
  • I n (m) k n - m
  • m is the torque and k is a constant and n is a designation (number) of the clamping unit used in the measurement.
  • Fig. 6 shows the motor current / [mA], by the means 27 A for measuring the
  • Hose press in which the hose is inserted in the clamping unit.
  • the current difference ⁇ I a between the no-load measurement ⁇ 7 "L and the tube pressure ⁇ I n s increases ( ⁇ > ⁇ I ⁇ > ⁇ Ii). It follows that for the elimination of the influence of the tolerances of the clamping unit on the measurement is not sufficient to consider an offset determined only at an idle measurement. Therefore, a 1-point calibration is performed with a calibration factor k.
  • the monitoring unit 27 is designed such that a measurement is made with the following calibration. All arithmetic operations can be carried out in a microprocessor, not shown, which is part of the monitoring unit 27 or of the arithmetic and evaluation unit 27C. For this purpose, the microprocessor of the arithmetic and evaluation unit 27C is programmed for carrying out the following arithmetic operations.
  • the receiving elements 15, 16 of the clamping unit 27 are opened by an electric motor, if they are not already open in order to carry out an idle measurement in which a hose is not inserted. Thereafter, the Aumahmeimplantation 15, 16 are closed for performing the idle measurement by an electric motor, wherein the motor current IL (X) with the means (27A) for measuring the
  • the measurement for the determination of the idling current need not be carried out before each blood treatment. It is sufficient if the measurement is carried out at predetermined time intervals, for example at intervals of one month. With the idle measurement an inherent system influence is eliminated.
  • the receiving elements 15, 16 of the clamping unit 12 are raised again to insert the hose can.
  • the receiving elements 15, 16 of the clamping unit 12 are raised again to insert the hose can.
  • the actual measurement with tube pressing is preferably a pre-compression of the hose.
  • the receiving elements 15, 16 are fed with inserted hose to a predetermined distance x to exert a predetermined contact pressure on the hose, which depends on the material and diameter and wall thickness of the hose.
  • the pre-compression of the tubing preferably takes place during the filling or rinsing process of the blood treatment device.
  • the hose is with a liquid filled, which has a predetermined temperature.
  • the temperature of the rinsing liquid is, for example, 36 °, the flow rate of the liquid being, for example, 400 ml / min.
  • the duration of pre-pressing can be 3 minutes.
  • the receiving elements 15, 16 are raised again for carrying out the actual measurement and closed in order to measure the motor current Is (x) during tube pressing as a function of the distance x.
  • k is a calibration factor
  • xi and x 2 satisfy the condition 7 (xi)> 0 and 7 (x 2 )> 0, and Io is a predetermined current, for example 5 mA.
  • a reference value for the integral AR £ / is calculated in several measurements with several clamping units of the same type, the mean value of the determined integrals A "being calculated for calculating the reference value.
  • the integral A 0 is calculated for the clamping unit 12 to be calibrated.
  • the integral A calculated according to equation (3) is compared in the arithmetic and evaluation unit 27C with a predetermined limit value.
  • the arithmetic and evaluation unit 27C has a comparison unit, not shown.
  • the calculated integral A is greater than the predetermined limit, it is determined that a hose of a first type is inserted, the hose is, for example, a PUR hose. If, however, the calculated integral is smaller than the predetermined limit value, it is determined that a hose line of a second type is inserted, the hose line being, for example, a PVC hose.
  • Material properties is not met if the calculated integral A is in a range of values between a predetermined first limit, for example, for a PUR tube, and a predetermined second limit, for example, for a PVC hose, the first limit for the PUR hose is greater than the second limit for the PVC hose.
  • a PUR tube is thus identified when the integral is greater than the upper first limit, while a PVC tube is identified when the integral is less than the lower second limit.
  • a first or second control signal is generated.
  • the type of hose line used can be represented for example on a display unit, not shown, of the monitoring unit 27. Also, it may be displayed on the display unit when the integral A is smaller than the upper first limit value and larger than the second lower limit value, that is, in the above-mentioned value range, so that determination of the kind of the hose line used is not possible with high certainty , Tests have shown that comparing the integral with an upper and lower limit reliably identifies the tubing type. to
  • the maximum value I max of the measured current can also be determined by identifying a hose line type, wherein the maximum value of the current I max is compared with a limit value. If the maximum value I max of the measured current is above the limit value, then the one hose line type, for example the PUR hose, is used, and the maximum value I max of the measured current is below the one
  • Limit value is closed to the other hose line type, for example the PUR hose. Also, the slope of the slope of the current rise can be compared to a threshold to identify the tubing type. These operations can again be performed by the comparison unit.
  • the monitoring unit will close on a particular tubing only if a particular tubing type is closed in an evaluation based on two sizes or on the basis of all sizes.
  • the evaluation unit provides to close a PUR hose when the maximum value of the current I, nax is greater than a predetermined limit while closing on a PVC hose when the maximum value of the current ⁇ max is smaller than the predetermined limit.
  • the evaluation unit provides to close to a PUR hose when the slope of the slope of the current increase, i. the derivative of the function in the area of the current rising edge, greater than one
  • predetermined limit is, while closing on a PVC hose, when the slope of the edge of the current increase is less than a predetermined limit.
  • Fig. 7 shows the measurement results for six Einspanniseren 1 to 6 of the same type and four different PVC hoses and four different PUR hoses and another hose CBN of a different material, the PVC hoses are marked in Fig. 7 with rectangles and the PUR hoses with circles.
  • the range of values in which reliable identification of the type of hose is not guaranteed lies between the upper limit value, which is marked in FIG. 7 by the upper horizontal line (limit value (PUR)), and the lower limit value, which is indicated by the lower line (FIG. Limit value (PVC)).
  • the safety distance between the upper and lower lines is calculated from the quotient of the difference between the upper limit (PUR) and the lower limit (PVC) and the mean of the limit values.
  • the measurement procedure described above was tested with four Clamping Units A, B, C, D, using a thin PUR hose with a small wall thickness, a thick PUR hose with a large wall thickness and a standard PVC hose.
  • the tube was filled with water, which has a temperature of 36.6 °. The water would be pumped through the hoses.
  • FIGS. 8A to 8D show the motor current / [mA] smoothed over 10 points as a function of the motor distance x for the individual clamping units A, B, C, D, wherein the thin PUR tube with a small wall thickness with PURdu, the thick PUR Hose with a large wall thickness is called PURdi and the standard PVC hose is PVC.
  • the predetermined constant current I 0 is 5 mA.

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Abstract

L'invention concerne un dispositif permettant de déterminer la concentration d'un composant sanguin dans une tubulure flexible, en particulier dans la tubulure du circuit sanguin extracorporel d'un système de traitement extracorporel du sang. En outre, l'invention concerne un procédé de détection d'une tubulure flexible, en particulier d'une tubulure du circuit sanguin extracorporel d'un système de traitement extracorporel du sang, dans une unité de serrage d'un dispositif de détermination de la concentration d'un composant sanguin dans la tubulure. Le dispositif de détermination de la concentration d'un composant sanguin dans une tubulure d'un circuit sanguin extracorporel se caractérise par une unité de serrage (12) qui comporte un mécanisme actionneur (18) adapté pour déplacer l'un vers l'autre, en appliquant une force de serrage, un premier et un deuxième élément de réception (15, 16) depuis une première position dans laquelle la tubulure est libre dans une deuxième position dans laquelle la tubulure est serrée, l'entraînement du mécanisme actionneur étant assuré par un moteur électrique (19). En outre, le dispositif de l'invention se caractérise par un module de surveillance (27) adapté pour détecter la tubulure (17) placée dans les éléments de réception (15, 16). Ceci permet d'automatiser la mesure des paramètres sanguins.
EP12738045.9A 2011-07-21 2012-07-20 Dispositif permettant de déterminer la concentration d'un composant sanguin dans une tubulure flexible Withdrawn EP2734111A2 (fr)

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EP15183364.7A EP2984988B1 (fr) 2011-07-21 2012-07-20 Dispositif et procede de reconnaissance d'une conduite flexible inseree dans des elements de reception d'une unite de serrage destinee a serrer une conduite flexible

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US201161510104P 2011-07-21 2011-07-21
DE102011108050A DE102011108050B9 (de) 2011-07-21 2011-07-21 Vorrichtung zur Bestimmung der Konzentration eines Bestandteils von Blut in einer Schlauchleitung und Verfahren zur Erkennung einer Schlauchleitung in einer Einspanneinheit
PCT/EP2012/003087 WO2013010677A2 (fr) 2011-07-21 2012-07-20 Dispositif permettant de déterminer la concentration d'un composant sanguin dans une tubulure flexible

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EP12738045.9A Withdrawn EP2734111A2 (fr) 2011-07-21 2012-07-20 Dispositif permettant de déterminer la concentration d'un composant sanguin dans une tubulure flexible

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US10525182B2 (en) 2014-10-10 2020-01-07 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US10898635B2 (en) 2016-07-18 2021-01-26 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US11865243B2 (en) 2016-08-30 2024-01-09 Nxstage Medical, Inc. Parameter monitoring in medical treatment systems

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US10525182B2 (en) 2014-10-10 2020-01-07 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US10835657B2 (en) 2014-10-10 2020-11-17 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US10835658B2 (en) 2014-10-10 2020-11-17 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US10835659B2 (en) 2014-10-10 2020-11-17 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US10869958B2 (en) 2014-10-10 2020-12-22 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US11406744B2 (en) 2014-10-10 2022-08-09 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US11850341B2 (en) 2014-10-10 2023-12-26 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US10898635B2 (en) 2016-07-18 2021-01-26 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US11607482B2 (en) 2016-07-18 2023-03-21 Nxstage Medical, Inc. Flow balancing devices, methods, and systems
US11865243B2 (en) 2016-08-30 2024-01-09 Nxstage Medical, Inc. Parameter monitoring in medical treatment systems
CN110312538A (zh) * 2017-02-23 2019-10-08 费森尤斯医疗护理德国有限责任公司 夹紧软管管路的设备和具有夹紧软管管路的设备的医学治疗设备和监控夹紧软管管路的设备的方法

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DE102011108050B9 (de) 2013-08-14
EP2984988A3 (fr) 2017-01-18
EP2984988B1 (fr) 2022-06-08
EP2984988A2 (fr) 2016-02-17
WO2013010677A3 (fr) 2013-06-06
US8792089B2 (en) 2014-07-29
WO2013010677A2 (fr) 2013-01-24
DE102011108050B3 (de) 2013-01-17
US20130033697A1 (en) 2013-02-07

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