US20090321360A1 - Dialysis machine and method for determining the furring in a dialysis machine - Google Patents

Dialysis machine and method for determining the furring in a dialysis machine Download PDF

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US20090321360A1
US20090321360A1 US12/448,979 US44897908A US2009321360A1 US 20090321360 A1 US20090321360 A1 US 20090321360A1 US 44897908 A US44897908 A US 44897908A US 2009321360 A1 US2009321360 A1 US 2009321360A1
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filter
ion concentration
dialysis machine
sensor
calcification
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Andreas Maierhofer
Alfred Gagel
Malte Gross
Michael Koch
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Fresenius Medical Care Deutschland GmbH
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    • 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
    • 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
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • 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
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • A61M1/1607—Physical characteristics of the dialysate fluid before use, i.e. upstream of dialyser
    • 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
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A61M1/1605—Physical characteristics of the dialysate fluid
    • A61M1/1609—Physical characteristics of the dialysate fluid after use, i.e. downstream of dialyser
    • 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
    • A61M1/1621—Constructional aspects thereof
    • A61M1/165—Constructional aspects thereof with a dialyser bypass on the dialysis fluid line
    • 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
    • A61M1/168—Sterilisation or cleaning before or after use
    • A61M1/169—Sterilisation or cleaning before or after use using chemical substances
    • 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
    • A61M2205/3317—Electromagnetic, inductive or dielectric 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3324—PH 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3327—Measuring
    • 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
    • A61M2205/702—General characteristics of the apparatus with testing or calibration facilities automatically during use
    • 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
    • A61M2205/707—Testing of filters for clogging
    • 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
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7554—General characteristics of the apparatus with filters with means for unclogging or regenerating filters

Definitions

  • the present invention relates to a dialysis machine comprising at least one filter for the filtration of the dialysis liquid and comprising means for determining the calcification of the dialysis machine.
  • the invention further relates to a method of determining the calcification of a dialysis machine.
  • a dialysis machine is known from EP 0 834 328 A1 which comprises means via which an automatic decalcification of the dialysis liquid circuit of the machine can be initiated on the finding of a predetermined degree of calcification of the dialysis machine. Provision can be made in this process for the degree of calcification of the dialysis machine to be able to be determined by clouding of a window of a blood leak detector or by the determination of characteristic parameters of the conveying pump for the dialysis liquid. On the presence of criteria for a decalcification, provision can furthermore be made for the dialysis machine to initiate a decalcification cycle in a fully automatic process.
  • the case can thus occur that the patient is treated with a dialysis liquid for a fairly long time whose Ca 2+ -ion concentration is below the concentration of the ionized calcium in the plasma, which can have the consequence that calcium is removed from the patient in an unwanted manner in the dialysis treatment.
  • the ionized Ca is of great significance with respect to nervous conduction, muscular contraction, myocardial contraction and blood pressure. It can therefore be imagined that negative effects on the patient can occur as a consequence of the machine calcification.
  • a dialysis machine having the features of claim 1 .
  • the means for determining the calcification of the dialysis machine furthermore comprise an evaluation or calculation unit which is configured such that it determines the calcification of the dialysis machine on the basis of the ion concentration or parameter value detected by means of the sensor or sensors.
  • the sensor or sensors can, for example, be conductivity sensors, ion-selective electrodes, pH electrodes or sensors working in accordance with spectroscopic processes.
  • the ion concentration, preferably the Ca 2+ concentration, or a parameter representative of the ion concentration or of its change, such as the conductivity, are preferably detected downstream, or also upstream and downstream, of the filter or filters and that a conclusion can be made on the calcification of the filter on this basis.
  • the ion concentration or the said parameter of the dialysis liquid, of a solution provided for decalcification or of another solution can be detected.
  • This other solution can be an ion-containing solution which, for example, contains Ca 2+ or H + ions. Provision can be made in this connection for two sensors to be associated with at least one of the filters, of which one is arranged upstream of the filter and another downstream of the filter.
  • the term of the detection of the “ion concentration of a parameter representative of the ion concentration or of its change” is to be interpreted broadly and comprises, inter alia, also indirect measuring methods for the ion measurement.
  • the measurement of CO 2 which is created in the decalcification is, for example, conceivable and covered by the invention.
  • the CO 2 concentration is related via the chemical balance to the concentration of other ions and thus forms a measure for the ion concentration so that the measurement of, for example, the CO 2 amount, the CO 2 concentration or the CO 2 volume represents an embodiment of the detection of a parameter representative of the ion concentration.
  • a respective sensor is associated upstream and downstream with at least one of the filters both on the primary side of the filter and on the secondary side of the filter. This arrangement makes it possible to detect the calcification of the filter both on the primary side and on the secondary side.
  • At least one bypass line to be arranged which can be cut off and which, in the open state, establishes a flow communication of two sensors while bypassing at least one of the filters. If the influence of the filter on the measured values obtained by means of the sensors should be precluded, they are connected to one another in such a manner while bypassing the filter that the dialysis liquid serving the decalcification or a measuring solution first flows through the one and then the other sensor. This makes it possible to be able to compare the measurement values of the sensor with one another or to be able to carry out a calibration of the sensors.
  • a monitoring of the calcification of the filter is thus also possible using one sensor, for example using a conductivity measuring cell which is located downstream of the filter.
  • a determination of the calcification can now take place, for example, in that the conductivity measured value is determined before the start or at the start of the treatment and a check is made during the treatment or also after the treatment as to whether and to what extent a measured value change has occurred.
  • At least one bypass line is provided which can be cut off and which is arranged such that, in the open state, it supplies the dialysis liquid, the solution serving the decalcification or the other measuring solution to the sensor while bypassing at least one filter. It is thus possible also to determine the ion concentration or the parameter representative of this or of its change upstream and downstream of the filter using only one sensor, for example using a conductivity measuring cell arranged downstream of the filter. If the ion concentration or said parameter should be detected upstream of the filter, the bypass line is opened and the solution extracted upstream of the filter by means of the bypass line is supplied to the sensor. The bypass line is closed and the filter is accordingly flowed through for the detection of the measured value on the flowing through of the filter. It is an advantage of this process that only one sensor per filter is needed or also only one sensor is needed for a plurality of filters with associated electronics. In addition, a calibration of a plurality of sensors relative to one another is dispensed with.
  • the invention furthermore relates to a method of determining the calcification of a dialysis machine, in particular of a dialysis machine in accordance with one of the claims 1 to 8 , with the dialysis machine comprising at least one filter for the filtration of the dialysis liquid.
  • the method is characterized in that the ion concentration or a parameter representative of the ion concentration or of its change of the dialysis liquid or of a solution serving the decalcification or a measuring solution is measured either downstream or upstream and downstream of the filter for the determination of the calcification of the dialysis machine and in that the calcification is determined on the basis of the ion concentration or of the parameter value of the calcification measured.
  • the parameter representative of the ion concentration can, for example, be the conductivity, the pH or a parameter determined by means of an ion-selective electrode or by means of spectroscopic processes, such as the absorption or the transmission, for example.
  • the ion concentration is preferably the Ca 2+ ion concentration or the H + ion concentration.
  • Two sensors can be associated with the at least one filter and are arranged downstream and upstream of the filter.
  • the degree of calcification can be determined by a comparison of the ion concentration or of the parameter representative for it or for its change measured upstream and downstream. Provision can be made in this connection for differences in the measured values of the sensors to be determined at a first point in time, preferably before or at the start of a treatment and for these differences then to be taken into account in the determination of the degree of calcification at a second point in time after the first point in time, in particular during the treatment. It is also feasible that the said measured value differences are eliminated by corresponding calibration of the sensors.
  • Only one sensor can also be provided per filter or for a plurality of filters and is arranged downstream of the filter or filters, with a measured value being determined at a first point in time, preferably before or at the start of a treatment, by means of the sensor and a check can be made at a second point in time, disposed after the first point in time, in particular during the treatment, whether a measured value change has occurred.
  • only one sensor is provided per filter or for a plurality of filters and is arranged downstream of the filter or filters and that at least one bypass line is provided which can be cut off and which is arranged such that, in the open state, it supplies the dialysis liquid, the solution serving the decalcification or the other measuring solution to the sensor while bypassing at least one filter, with the measured value of the sensor being determined with an open bypass line at the start of or during the treatment and this measured value being compared with the measured value obtained after the flowing through of the filter.
  • the ion concentration can, for example, be the Ca 2+ ion concentration or also the H + ion concentration.
  • FIG. 1 time curve of the conductivity on Ca precipitation with still dialysis liquid with contact to the atmosphere;
  • FIG. 2 flow plan of a dialyzer with online preparation of the dialysis liquid
  • FIG. 3 time curve of the Ca 2+ ion concentration and of the conductivity during a dialysis treatment with fresh dialysis liquid before and after decalcification;
  • FIG. 4 time curve of the Ca 2+ ion concentration and of the conductivity on the installation and removal of calcified filters
  • FIG. 5 schematic representation of the calcification monitoring with two conductivity measuring cells per filter
  • FIG. 6 schematic representation of the calcification monitoring with two conductivity measuring cells per filter, and bypass circuit
  • FIG. 7 schematic representation of the calcification monitoring with only one conductivity measuring cell per filter and bypass circuit
  • FIG. 8 flow plan of the dialyzer in accordance with FIG. 2 with calcification monitoring of all filters by additional conductivity measuring cells;
  • FIG. 9 flow plan of the dialyzer in accordance with FIG. 2 with calcification monitoring of all filters by additional conductivity measuring cells with a calibration possibility;
  • FIG. 10 flow plan of the dialyzer in accordance with FIG. 2 with calcification monitoring of all filters by a conductivity measuring cell and bypass circuits.
  • the conductivity of the dialysis liquid is determined by its individual components. The main contribution of the conductivity is due to NaCl, but the Ca 2+ ions present in relatively low concentrations also contribute to the conductivity. If a dialysis liquid containing both Ca 2+ and HCO 3 ⁇ is in contact with the atmosphere, the outgasing of CO 2 results in a consumption of hydrogen carbonate and thus in a pH value shift into the alkaline, which in turn effects a precipitation of calcium carbonate. This is illustrated by the following reaction equation:
  • FIG. 1 shows the drop in conductivity over time with a still dialysis liquid with contact to the atmosphere. As is clearly visible from FIG. 1 , the conductivity of the solution falls over time. As can further be seen from the measured values set forth in FIG. 1 , this is essentially due to the reduction in the content of calcium ions and, parallel to this, the consumption of hydrogen carbonate ions.
  • a quantifying of the change in the Ca 2+ ion concentrations in the dialysis liquid is also possible via the change in the conductivity.
  • ⁇ ⁇ ⁇ c ( 110 ⁇ ⁇ ⁇ S ⁇ / ⁇ cm mmol ⁇ / ⁇ l ) - 1 ⁇ ⁇ ⁇ ⁇ LF
  • the dialysis liquid is generated continuously as fresh using a dialyzer by mixing RO water with an acid component and a bicarbonate containing component, no precipitation is initially to be expected within the short time between the generation and the transport to the dialysis machine.
  • FIG. 2 shows a flow plan of a dialyzer with online preparation of the dialysate from RO water, acid and bicarbonate.
  • two sterile filters D 1 and D 2 are arranged upstream of the dialysis machine D 3 .
  • the sterile filters D 1 and D 2 are arranged such that the dialysis liquid reaching the dialysis machine D 3 moves from the primary side to the secondary side of the first sterile filter D 1 and then flows through the primary side of the second sterile filter D 2 .
  • Substituate is gained in this which is added to the blood of the patient as required, as is the case with hemofiltration and hemodiafiltration.
  • the present invention is naturally not restricted to hemodiafiltration or hemofiltration, but also includes the process of hemodialysis inter alia.
  • a conductivity measuring cell 20 is arranged upstream of the second sterile filter D 2 and a second conductivity measuring cell 40 is arranged downstream of the dialysis machine D 3 and of the first sterile filter D 1 .
  • the conductivity of the dialysis liquid was measured continuously by means of the conductivity of the measuring cell 20 .
  • the Na + and Ca 2+ ion concentration was determined in samples of the dialysis liquid taken directly downstream of the dialysis machine D 3 .
  • the process shown in FIG. 3 of the drop in conductivity and in the calcium ion concentration can be explained in that the dialysis liquid is oversaturated at a high Ca 2+ ion concentration and HCO 3 ⁇ concentration so that the presence of crystallization nuclei, rough surfaces or pressure fluctuations due to the conveying of the dialysis liquid by means of the conveying pump results in the spontaneous precipitation of CaCO 3 .
  • dialysis liquid filters D 1 and D 2 are not only the preferred sites for calcification, but also promote the further precipitation themselves on starting calcification:
  • the dialysis liquid filters D 1 and D 2 were installed and removed on a dialyzer in running operation in accordance with FIG. 2 .
  • the conductivity was measured continuously by means of the conductivity measuring cells 20 and 40 .
  • the sodium and calcium ion concentrations were additionally determined in dialysate samples taken upstream of the dialysis machine D 3 .
  • the conductivity fell on installation of the filter D 1 at both the sensors 20 (LF 2 ) and 40 (LF 4 ) by approximately 60 ⁇ S/cm with respect to the conductivity without a filter.
  • a fall in the Ca 2+ ion concentration before the dialysis machine D 3 by 0.6 mmol/l could also be found on installation filter D 1 .
  • the conductivity (LF 4 ) at the sensor 40 fell by a further approximate 50 ⁇ S/cm and the Ca 2+ ion concentration by a further 0.4 mmol/l since the flow path to the sensor 40 now contained two calcified filters D 1 , D 2 .
  • the conductivity (LF 2 ) at the conductivity 20 remained constant.
  • the measured curves in accordance with FIG. 3 and FIG. 4 are measurements which were obtained in an in vitro structure, with a comparison liquid being circulated instead of blood in the extracorporeal blood circuit.
  • Favorable and unfavorable compositions for the dialysis liquid exist for the occurrence of calcification, in particular with respect to its content of bicarbonate, calcium and acetate. Such combinations were now selected for the trials in which the calcification tended to proceed fast rather than slow.
  • the data and curves shown are therefore not representative for an average dialysis treatment.
  • the measurements shown are rather extreme situations by means of which the effects playing a role within the framework of this invention can be illustrated better.
  • the values of the Ca 2+ ion concentration are in good approximation with the change in the Ca 2+ ion concentration calculated in accordance with the above equation from the change in conductivity.
  • the Na + ion concentration remained constant in all cases so that changes in the mixture relationship in the generation of the dialysis liquid can be precluded.
  • the recognition of calcification in the embodiment shown here is based on a change in the conductivity with a mixing ratio which remains constant on the generation of the dialysis liquid, with the change in the conductivity being due to the precipitation of the calcium in the form of calcium carbonate. It must therefore be ensured that both the metering system and the conductivity measurement are not subject to any drifts over the duration of the comparison measurements.
  • an apparatus for the recognition of the calcification of the dialysis liquid filter in the dialyzer or the dialysis machine consists of two conductivity measuring cells which are arranged such that the conductivity of the dialysis liquid or also of a solution serving the decalcification or another measuring solution is measured before and after passage through the filter or the dialysis machine.
  • Such an aspect of the invention is shown in FIG. 5 , with the conductivity measuring cells being shown with the reference numerals 1 , 2 and the filter with the reference symbol D.
  • the conductivity measuring cells 1 , 2 must be calibrated to one another beforehand. If the influence of the filter D is to be reliably precluded, a bypass 100 must be provided which surrounds the filter D, as can be seen from FIG. 6 .
  • the bypass line 100 can be cut off by a valve.
  • the line leading to the filter D can equally be cut off by a valve. Accordingly, depending on the switching of the valves shown in FIG. 6 , either the filter D or the bypass line 100 can be flowed through.
  • bypass line 100 is flowed through; if the calcification of the filter D should be determined, the bypass line 100 is closed, the filter is flowed through and it is determined by means of the conductivity measuring cells 1 , 2 whether a difference can be found in the conductivity values determined upstream and downstream of the filter D.
  • FIG. 7 It is also possible alternatively to this to carry out the monitoring of the calcification by only one conductivity measuring cell which is shown with the reference numeral 2 in FIG. 7 .
  • This measuring cell is located downstream of the filter D.
  • a bypass line 200 is provided which surrounds the filter D.
  • the bypass line 200 can likewise be cut off by a valve. The same applies to the line leading to the filter D. If the ion concentration or a parameter representative of this should be determined upstream of the filter D, the bypass line 200 is opened and the conductivity value is detected by means of the conductivity measuring cell 2 . If the conductivity should be detected after flowing through the filter D, the line leading to the filter D is opened and the bypass line 200 is closed.
  • the arrangement in accordance with FIG. 7 provides the advantage that only one conductivity measuring cell with associated electronics is required and, additionally, a calibration of a plurality of measuring cells can also be dispensed with. It must be mentioned as a disadvantage that stabilization times occur here on the switching of the flow paths to measure the conductivity. Furthermore, fairly long times arise in which no dialysis may be possible if the flowing through of the filter D is required for the treatment of the patient.
  • FIG. 8 shows the flow scheme in accordance with FIG. 2 with an arrangement of conductivity measuring cells according to the principle described in FIG. 5 .
  • the conductivity measuring cells 10 , 20 serve the calcification monitoring of the sterile filter D 1 and the measuring cells 10 , 40 serve the calcification monitoring of the primary side of the sterile filter D 1 .
  • the conductivity measuring cells 20 , 30 serve the monitoring of the sterile filter D 2 and the measuring cells 30 , 40 serve the monitoring of the dialysis machine D 3 .
  • a flow plan in accordance with FIG. 9 results with a simultaneous calibration possibility in accordance with the principle described in FIG. 6 .
  • bypass lines 100 are respectively provided which are arranged such that each of the conductivity measuring cells 10 , 20 , 30 can be connected in series with the conductivity measuring cell 40 .
  • the calibration of the conductivity measuring cells takes place here by corresponding valve circuits in that the conductivity measuring cells 10 , 20 and 30 are connected in series with the conductivity measuring cell 40 while bypassing the respectively subsequently disposed filter D 1 , D 2 , D 3 .
  • This calibration is possible before the start of the dialysis.
  • the valves are switched during the dialysis so that the flow plan in accordance with FIG. 8 results.
  • the conductivity measuring cell 40 is arranged downstream of the filters D 1 , D 2 and of the dialysis machine D 3 .
  • the bypass lines 200 with the valves V 3 , V 6 and V 7 are opened and the valves V 2 , V 5 and V 8 in the feed lines to the filters D 1 , D 3 as well as the dialysis machine D 3 are closed so that the dialysis liquid flows around the filters D 1 , D 2 and the dialysis machine D 3 in the bypass.
  • the valves V 10 and V 9 are likewise closed.
  • valves V 2 , V 6 and V 7 are opened so that the dialysis liquid only flows through the filter D 1 from the primary side to the secondary side, whereas a bypass around the filter D 2 and the dialysis machine D 3 takes place with open valves V 6 and V 7 . All other valves are closed in this case.
  • valves V 2 and V 10 are opened and all other valves are closed. In this case, the dialysis liquid flows through the valve V 2 , then through the primary side of the sterile filter D 1 and then the valve V 10 to finally reach the conductivity measuring cell 40 .
  • a check of the calcification state of the sterile filter D 2 takes place by opening the valves V 3 , V 5 , V 7 and by closing all further valves.
  • a check of the dialysis machine D 3 takes place with open valves V 3 , V 6 , V 8 , V 9 , while all further valves are closed.
  • V3, V6, V7 V2, V5, V8, V9, V10 LF1 (10) D1 V2, V6, V7 V3, V5, V8, V9, V10 LF2 (20) D1, primary V2, V10 V3, V5, V6, V7, V8, V9 / side only D2 V3, V5, V7 V2, V6, V8, V9, V10 LF3 (30) D3 V3, V6, V8, V9 V2, V5, V7, V10 /
  • the conductivity can now be measured continuously for the continuous monitoring of the machine calcification. For this purpose, drifts in the conductivity measurement must possibly be compensated to be able to recognize changes in the conductivity (not the absolute value of the conductivity) with a precision of 0.01 mS/cm.
  • the procedure of the continuous monitoring of the machine calcification in an arrangement in accordance with FIG. 9 has the following structure:
  • the conductivity is measured continuously with them.
  • the monitoring of the filters D 1 and D 2 takes place by a comparison of the conductivity respectively measured directly before or after the respective filter.
  • a calcification of the filter is present when the conductivity measured after the filter is less than the conductivity measured before the filter.
  • a conclusion on the degree of calcification can be concluded by means of the equation set forth above in the form of a concentration difference. It is important that sufficiently long stabilization times are waited through on changes to the dialysate composition during the treatment.
  • the dialysis machine D 3 should be monitored, it is necessary to eliminate the influence on the patient by stopping the blood pump. At the same time, the flow of the dialysis liquid should be set as high as possible for the fast stabilization of the conductivity at the conductivity measuring cells 30 , 40 . The evaluation then takes place as described above as for the filters D 1 and D 2 .
  • any measuring differences of the individual conductivity measuring cells 10 , 20 , 30 , 40 must be determined at the start of the treatment without the influence of the patient with stable conductivity. The monitoring is then possible as described above while taking account of these initial measuring differences. However, a calcification already present at the start of the treatment cannot be detected precisely in this manner, which represents a disadvantage with respect to the arrangement in accordance with FIG. 9 .
  • the one conductivity measuring cell can also be associated with a plurality of filters, as is shown in FIG. 10 .
  • a measuring cell in accordance with FIG. 7 or FIG. 10 disposed downstream of this filter is required. If no bypasses bypassing the filter should be provided, as is the case, for example, in FIG. 7 , and if the composition of the dialysis solution remains constant during the total treatment, an initial value of the conductivity LF 0 is determined and stored at the start of the treatment. A fall in the conductivity measured continuously in the further course with respect to the value LF 0 then indicates an increase in calcification.
  • an expected value for the conductivity change can be calculated by means of an empirically determined formula on the basis of the concentration composition and on the conductivity measured at the start. If the measured conductivity falls below the expected conductivity, this is an indication of calcification.
  • the full extent of a continuous calcification monitoring and an initial calcification monitoring of all filters can be achieved as described above.
  • the cause of the presence of calcified filters can be found, for example, in the fact of an insufficient decalcification between treatments.
  • Other causes are the use of already calcified filters or the multiple use of dialysis machines.
  • the calcification recognition can consist of a concentrate mixture being set such that an oversaturated solution is present and that then the conductivity measured values are recorded upstream and downstream of the filter and/or of the dialysis machine to be checked. If bypass circuits are used, a sufficiently long stabilization time must be observed in each case. If the conductivity measured downstream is less than the conductivity measured upstream, calcification can be concluded, with its degree being able to be determined via the aforesaid equation.
  • the measurement of the conductivity can take place before and after the carrying out of the decalcification cycle or also during the decalcification.
  • the degree of the calcification can be determined for the filter to be monitored by the method described above (measurement of the conductivity upstream and downstream of the filter) before carrying out the decalcification procedure. After carrying out the decalcification, a renewed determination of the conductivity takes place upstream and downstream of the filter. The filter is completely decalcified when the conductivity upstream and downstream of the filter is identical.
  • An evaluation of the decalcification is also possible when only one conductivity measuring cell is arranged downstream of the filter. This applies, for example, to the filter D 1 and to the conductivity measuring cell 20 in FIG. 2 .
  • a concentrate mixture may have to be set such that an oversaturated solution is present. Then the measurement of the conductivity is carried out by means of the conductivity measuring cell located downstream and then the decalcification procedure is carried out. Subsequently, the said concentration mixture is again established, the stabilization of the conductivity waited for and the conductivity measured value measured again by means of the downstream measuring cell.
  • a decalcification was at least partly successful when the conductivity after the decalcification is larger than that before the calcification.
  • a conclusion on the degree of the elimination of the calcification can be made by means of the aforesaid equation. This process can be repeated so often until the conductivity before and after the decalcification no longer changes.
  • the process of the decalcification can now be monitored by a comparison of the conductivity before and after the filter by an arrangement in accordance with FIG. 6 , for example:
  • the acid solution before the filter has a higher conductivity than that after the filter due to the high H + ion concentration when a consumption of H + ions has occurred by reaction with CaCO 3 .
  • the decalcification is ended exactly when the conductivity upstream and downstream of the filter is identical.
  • a measurement of the conductivity of the dialysate before and after the decalcification is necessary with this process.
  • the monitoring can also be carried out by pH sensors during decalcification. As stated above, a consumption of H + ions takes place during the decalcification and thus a shift of the environment into the alkaline. If the pH no longer changes, the decalcification is ended since then a consumption of the H + ions by CaCO 3 no longer takes place.

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DE102011114912B8 (de) * 2011-09-24 2018-10-11 Vivonic Gmbh Vorrichtung zur Erzeugung von Reinstwasser
CN104133043A (zh) * 2014-08-04 2014-11-05 骐骥生物科技（广州）有限公司 血透机透析液检测仪
DE102014012423A1 (de) * 2014-08-20 2016-02-25 Fresenius Medical Care Deutschland Gmbh Dialysemaschine mit der Fähigkeit zur Bestimmung einer prädialytischen Eigenschaft im Blut eines Dialysepatienten
EP3204064B1 (de) 2014-10-10 2020-12-02 NxStage Medical, Inc. Flussausgleichsvorrichtungen, verfahren und systeme dafür
JP6490493B2 (ja) * 2015-05-18 2019-03-27 日機装株式会社 血液浄化システム
DE102015120216A1 (de) * 2015-11-23 2017-05-24 B. Braun Avitum Ag Verfahren zur Kalibrierung eines Messsignals und zum Nachführen einer quantitativen Größe
JP7086926B2 (ja) 2016-07-18 2022-06-20 ネクステージ メディカル インコーポレイテッド フローバランシングの装置、方法、及びシステム
WO2018045102A1 (en) 2016-08-30 2018-03-08 Nxstage Medical, Inc. Parameter monitoring in medical treatment systems
DE102018133664A1 (de) * 2018-12-28 2020-07-02 Fresenius Medical Care Deutschland Gmbh Dialysemaschine enthaltend eine Vorrichtung zur Aufbereitung von Flüssigkeiten, insbesondere Wasser, und Verfahren zur Überwachung der Vorrichtung auf Kontamination
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CN101610800A (zh) 2009-12-23
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US10155077B2 (en) 2018-12-18
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JP5115867B2 (ja) 2013-01-09
KR101594518B1 (ko) 2016-02-16

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