• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    DIALYSIS FLOW CONTROL. The invention relates to a method and an apparatus for controlling the flow of dialysate in a dialysis device. A change in the value of a control factor, caused by a change in a property of the dialysate or blood, or by a change in the flow of dialysate, is determined to control the flow of dialysate. The control factor is a measure for the exchange of substances through the dialyzer and, thus, the effectiveness of the dialyzer. If the change in the control factor value exceeds a limit, the flow of dialysate is increased. On the other hand, the flow of dialysate is reduced if the change in the value of the control factor falls below the limit range. Due to the invention, the flow of dialysate in a dialysate device in relation to the effectiveness of the dialyzer and thus also the blood treatment is optimized regardless of the knowledge of the type of dialyzer used, the blood flow or certain parameters of the patient.
    公开号:BR112014004870B1
    申请号:R112014004870-3
    申请日:2012-08-31
    公开日:2021-03-09
    发明作者:Pascal Kopperschmidt；Alfred Gagel
    申请人:Fresenius Medical Care Deutschland Gmbh；
    IPC主号:
    专利说明:

    Technical field
    [001] The invention relates to a method and an apparatus for controlling the flow of dialysate in a dialysis device. Prior Art
    [002] According to the meaning of the terms used in this document, dialysis devices are particularly devices for the treatment of extracorporeal blood that, for example, can be configured for hemodialysis and / or ultrafiltration.
    [003] During hemodialysis, a patient's blood in a dialysis device is conducted in an extracorporeal blood cycle through a dialyzer blood chamber. The blood chamber is separated by a semipermeable membrane from the dialysis chamber of the dialyzer. The dialysis chamber is perfused by a dialysate. The dialysate contains blood electrolytes in a concentration that corresponds to the concentration in the blood of a healthy individual. During treatment, blood and dialysate pass through opposite sides of the semipermeable membrane, usually in a counterflow, with a predetermined flow rate. The substances, which must be excreted in the urine, diffuse through the membrane of the blood chamber into the dialysis chamber, while, at the same time, the electrolytes that are present in the blood and in the dialysate diffuse from the chamber of greater concentration to the lowest concentration chamber.
    [004] In addition, blood can be dehydrated by the accumulation of a pressure gradient in the semipermeable membrane of the dialyzer, and as a consequence, water is removed by blood pressure towards the side of the dialysate chamber. This process is called ultrafiltration.
    [005] The effectiveness of the dialyzer in the dialysis device and, thus, in the treatment of blood INTER ALIA also depends on the size of the dialysate flow, that is, the flow of the dialysate. A high flow of dialysate can increase the effectiveness of blood treatment to an upper limit, however, this also leads to increased consumption of dialysate and energy.
    [006] In this sense, it is desirable and, therefore, an object of the invention to determine the amount of dialysate flow in a dialysate device, so that the effectiveness of the blood treatment is as high as possible and, at the same time, the dialysate and energy consumption is kept within an acceptable range. Thus, it is additionally desirable that such a definition of the amount of dialysate flow can be carried out regardless of knowledge of the type of dialyzer used, the blood flow or specific parameters of the patient, for example, the presence of a recirculation. Summary of the Invention
    [007] This object is solved by the method and apparatus according to the independent claims. Advantageous modalities of the method and the apparatus will be obtained from the respective dependent claims.
    [008] In accordance with the present invention in a method for controlling the flow of dialysate, a blood chamber of a dialyzer is perfused with blood and a dialysate chamber separated from the blood chamber by a semipermeable membrane is perfused with a dialysate. A change in the value of a control factor, caused by a change in a property of the dialysate or blood, or by a change in the flow of dialysate, is determined to control the flow of dialysate. The control factor is a measure for the exchange of substances through the dialyzer and, thus, the effectiveness of the dialyzer. If the change in the control factor value exceeds a limit, the flow of dialysate is increased. On the other hand, the flow of dialysate is reduced if the change in the value of the control factor falls below the limit.
    [009] According to the invention, an apparatus for controlling a flow of dialysate comprises: a dialyzer with a blood chamber to be perfused with blood and with a dialysate chamber separated from the blood chamber by a semipermeable membrane, which must be perfused with a dialysate, means to generate the flow of dialysate through the dialysate chamber, a unit for determining a control factor, which is a measure for the exchange of substances through the dialyzer and, thus, the effectiveness of the dialyzer, and a means of control to control the flow of dialysate through the dialysate chamber of the dialyzer, if a change in the value of a control factor, caused by a change in a property of the dialysate or blood, or by a change in the flow of dialysate not stay within a limit, where the control medium instructs the means to generate the flow of dialysate to increase the flow of dialysate, if the change in the value of the control factor exceeds the limit and even to reduce the flow of dialysate if the change in the control factor value falls below the limit.
    [010] If the change in the value of the control factor is caused by a change in the flow of dialysate, the control factor preferably has a reason or a difference in values to be assigned after and before the change in the flow of dialysate, in which the values are the property of the dialysate or the blood after the dialyzer. That is, to determine the reason or difference, the value of a dialysate or blood property at the output of the dialyzer, in which the change in the dialysate flow has already occurred when the dialysate or blood enters the dialyzer, and the value of the dialysate or blood, in which the dialysate flow change has not yet occurred when the dialysate or blood enters the dialyzer, are used.
    [011] If the change in the control factor value is caused by a change in a property of the dialysate or blood, the control factor preferably has a ratio or a difference in property values after and before the dialyzer. That is, in terms of a variation of a dialysate property, the reason or difference can be determined, on the one hand, by the value of the property of the dialysate after the dialyzer or the value of the blood property after the dialyzer, and, by on the other hand, by the value of the property of the dialysate before the dialyzer or the value of the property of the blood before the dialyzer. In this sense, in terms of a variation of a blood property, it applies that the reason or difference can also be determined, on the one hand, by the value of the property of the dialysate after the dialyzer or the value of the property of the blood after the dialyzer and, on the other hand, the value of the property of the dialysate before the dialyzer or the value of the property of the blood before the dialyser. The control factor preferably has the ratio of the value of a dialysate property after the dialyzer to the value of the dialysate property before the dialyzer. A difference, contained in the expression of the control factor, is preferably generated outside the value of a dialysate property after the dialyzer and the value of the dialysate property before the dialyzer.
    [012] The property of the dialysate is preferably the electrical conductivity or the temperature of the dialysate, and the property of the blood is preferably the electrical conductivity or the temperature of the blood.
    [013] In order to determine the change in the value of the control factor, the property of the dialysate or blood preferably varies continuously, at least, by a temporal sequence. The change in the value of the control factor itself is preferably determined by a derivation of the control factor for the dialysate flow.
    [014] The limits preferably correspond to a tolerance range of approximately the value of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 percent of the value of the control factor by changing the flow dialysate of 100 mL / min. Thus, the tolerance interval preferably reaches up to one percent of the value of the control factor by changing the flow of dialysate to 100 mL / min, so that, in terms of a value of 10 percent of the value of the control factor by alteration of the dialysate flow of 100 mL / min, the limit varies from 9.5 to 10.5 percent of the value of the control factor by alteration of the dialysate flow of 100 mL / min is sufficient. Alternatively, the tolerance range can also be zero, so that the limit coincides with a limit value such as 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 percent of the control factor value by changing the dialysate flow of 100 mL / min.
    [015] An apparatus to control the flow of dialysate, according to the invention, is preferably used in an apparatus for the treatment of extracorporeal blood such as, for example, a dialysate device.
    [016] In the following, the invention is described in more detail together with the drawings. Brief description of the drawings
    [017] It is shown that:
    [018] Figure 1 are the chronological sequences of the electrical conductivity (left vertical axis) and temperature (right vertical axis) of the dialysate before (graphic C1) and after (graphic C2) of the dialyzer in terms of a variation of the injection of concentrate or in terms of a variation in the heating of the dialysate and a flow of dialysate of 800 mL / min,
    [019] Figure 2 shows the amplitude ratio of the electrical conductivity or temperature values of the dialysate before and after the dialyzer, as a function of the dialysate flow (graph C3 with the left vertical axis), as well as the relative change of the ratio of amplitude as a function of the dialysate flow (graph C4 with right vertical axis). Description of modalities
    [020] The control factor
    it can serve as a measure of the effectiveness of a dialyzer. Thus, Qd describes the flow of dialysate in the dialyzer, while Ad, in and Ad, out describe a property of the dialysate, for example, the electrical conductivity or temperature of the dialysate, before or after the dialyzer. Ad, out (0) indicates the value of the dialysate property in terms of a missing cleaning performance, for example, in terms of the missing blood flow. In terms of an increase in the flow of dialysate, the control factor kd increases if there is a cleaning performance. However, the gain of the control factor kd decreases constantly. That is, in terms of an additional increase in the effectiveness of the dialyzer, the consumption of dialysate and energy increases rapidly due to an increase in the flow of dialysate, so that, after a certain limit, an additional increase in the flow of dialysate for increasing the effectiveness of the dialyzer is no longer sensitive.
    [021] The derivation of the control factor kd divided by the flow of dialysate Qd over the flow of dialysate Qd specifies the change in the control factor kd / Qd and thus specifies the normalized gain in the effectiveness of the dialyzer due to a change in flow of dialysate Qd.

    [022] In the above equation, it is predicted that the property of the dialysate before the dialyzer Ad, in does not depend on the flow of dialysate Qd. If the property of the dialysate is, for example, electrical conductivity, then the dialyzer constant value of the electrical conductivity of the dialysate can be maintained, for example, due to a change according to the amount of electrolytes injected into the dialysate. This is particularly important for the case where the dialysate's property varies continuously to determine the change in the control factor value, as shown below.
    [023] Furthermore, in the equation for the derivation of the control factor kd / Qd over the dialysate flow Qd, the term Ad, out (0) can be discarded, which simplifies a determination of the derivation.
    [024] During a blood treatment, the flow of dialysate varies and the change in the control factor kd / Qd is determined. Thus, the variation in the flow of dialysate can originate from a targeted change in the flow of dialysate or from changes in parameters during blood treatment. The determination of the change in the control factor kd / Qd can occur in a directed change in the flow of dialysate by a determination of the control factor kd / Qd, each before and after the change in the flow of dialysate, or by a continuous determination of the derivation of the control factor kd / Qd on the flow of dialysate Qd.
    [025] Then, the change of the control factor determined in advance is compared with a limit value or a limit range with an upper value and a lower value. If the change in the control factor falls below the limit value or the lower value of the limit, the flow of dialysate is reduced. On the other hand, the flow of dialysate increases if the change in the control factor is greater than the limit value or the upper limit value. For the limit value, a value between 10 and 20 percent of the value of the control factor due to a change in the dialysate flow of 100 mL / min was shown to be significantly advantageous. For each of these limit values, a corresponding limit can also be defined, the upper and lower limits of which specify a tolerance range around the limit value. Thus, the tolerance interval preferably reaches one percent of the value of the control factor by changing the flow of dialysate to 100 mL / min, so that, in terms of a limit value of 20 percent of the value of the control by changing the flow of dialysate at 100 mL / min, the lower and upper values of the limit range correspond to a value of 19.5 or 20.5% of the value of the control factor by changing the flow of dialysate at 100 mL / min min. Due to this control, the flow of dialysate is optimized according to the effectiveness of the dialyzer, as well as the consumption of dialysate and energy.
    [026] For a given flow of dialysate, an associated reason is found for a property of a patient's blood such as electrical conductivity, temperature or the concentration of a marker substance such as Na ions, urea, uric acid and beta -2-microglobulin, where the ratio is the value of the corresponding property of the dialysate after the dialyzer, that is, when it leaves the dialyzer, in relation to the value of the corresponding property of the dialysate before the dialyzer, that is, when entering the dialyzer. A change in the dialysate flow causes a change in the value of the corresponding dialysate property at the output of the dialyzer. Thus, a determination of the change in the control factor based on a target change in the dialysate flow can be maintained by determining the control factor before and after the target change in the dialysate flow. In this regard, the value of the corresponding property of the dialysate is determined at a time after the dialyser leaves. Henceforth, it must also be determined when the target change of the dialysate flow occurred at the output of the dialyzer, that is, the hydraulic delay of the dialyzer for the particular dialysate flow must be known in order to be able to assign a factor change of control for a certain change in the flow of dialysate. The prior art establishes methods for determining the hydraulic delay of a dialyzer. The target change in the dialysate flow can be one of a temporary change, that is, it lasts only a short time, periodic or pulse type of the dialysate flow rate.
    [027] As an alternative to the target change of the dialysate flow to determine the change in the control factor, also the property of the dialysate before entering the dialyzer can vary continuously, for example, periodically. A continuous modulation of the dialysate property value, when entering the dialyzer Ad, in leads to a modulation of the dialyzer property value at the output of the dialyzer, Ad, out. In this sense, in a constant state, it is known that the value of the dialysate property must be at the output of the dialyzer at a certain time, so that a change in the flow of dialysate can be quickly attributed to a change in the value of the property of the dialysate. dialyzed at the output of the dialyzer. In addition, therefore, knowledge of the complex transfer function, as being dependent on the dialyzer-dialyzer, the modulation frequency and the geometry of the tube is not necessary.
    [028] For the case that the property of the dialysate is the electrical conductivity or the temperature of the dialysate, the illustration according to Figure 1, for a dialysis treatment in laboratory (IN VITRO) shows the chronological sequence of the electrical conductivity ( left vertical axis) or the temperature (right vertical axis) of the dialysate before (graph C1) and after (graph C2) of the dialyzer in a dialysate flow of 800 mL / min. Thus, the almost harmonious variation of the electrical conductivity or temperature of the dialysate when entering the dialyzer was generated by a variation dependent on the volume of the injection of the concentrate, that is, the injection of electrolytes in the dialysate, or by the variation in the heating of the dialysate. Changes in electrolyte concentrations or concentrations of a single electrolyte in a dialysate or thermal modulation of the dialysate occur within the physiological boundaries that are harmless to a patient.
    [029] Due to the volume size of the dialyzer, there is a mixture of volumes of different concentrations within the dialyzer, that is, volumes with different values of the dialysate property. This mixture leads to a modulation dampening, that is, the variation of the electrical conductivity or the temperature of the dialysate that leaves the dialyzer, so that the amplitude of the electrical conductivity or the temperature of the dialysate that leaves the dialyzer is reduced depending on the period of modulation and volume of the dialyzer. In addition, a part of the modulated volume is obtained by the semipermeable membrane in the extracorporeal cycle (blood stream), whereby the modulation of the electrical conductivity or temperature of the dialysate that leaves the dialyzer is further reduced. The modulation damping can be clearly recognized in the illustration according to figure 1 by comparing the C1 and C2 curves, in particular by comparing the amplitudes.
    [030] The electrical conductivity or temperature values of the dialysate before and after the dialyzer can be detected using measuring cells. From the data of the measuring cells, the effect of a change in the flow of dialysate can be detected directly, so that a control and, therefore, the optimization of the flow of dialysate can be carried out very quickly.
    [031] In the illustration according to figure 2, the amplitude ratio of the electrical conductivity or temperature values of the dialysate before and after the dialyzer are represented as a function of the dialysate flow (C3 curve with left vertical axis) and the change The relative amplitude ratio is represented as a function of the dialysate flow (C4 curve with right vertical axis).
    [032] The C3 curve shows that the increase and, therefore, the change in the ratio of the amplitude of the electrical conductivity values or the temperature of the dialysate before and after the dialyzer decreases even more with the increase in the dialysate flow. Therefore, the C4 curve shows that the relative change in the amplitude ratio decreases with increasing dialysate flow. Already from a value of the dialysate flow of about 650 mL / min, the relative change and, thus, the increase in the effectiveness of the dialyzer is only less than 10 percent.
    [033] As an alternative for determining a change in the control factor by detecting the dialysate property value at the output of the dialyzer and the dialysate property value before entering the dialyzer, that is, by detecting a alteration of the dialysate property on the dialysate side, a property transferred in the dialysate dialysate to the blood can also be measured on the blood side, that is, by detecting the proper blood property at the exit of the dialysate and before entering the dialyzer. For example, the transfer of a bolus of temperature in the dialysate to the dialyzer in the blood can be measured within a system of venous tubes. The control factor that also contains the mass of the treatment according to the readings of the dialysate flow, in this case

    [034] In this formula Qb describes the flow of blood, that is, the flow of blood, and Qd describes the flow of dialysate in the dialyzer. Ab, in describes a blood property, such as electrical conductivity or blood temperature before entering the dialyzer, and Ab, out describes the respective blood property at the outlet of the dialyzer. Ab, out (0) provides the value of the blood property at the output of the dialyzer in the missing cleaning performance.
    [035] Here, again, it is advantageous not to use the control factor kb directly, but to use the derivation of the control factor kb, divided by the blood flow Qb, in the dialysate flow Qd, therefore, the change of the control factor kb / Qb due to the change in the flow of dialysate Qd.
    [036] Thus, the invention also allows a control of the flow of dialysate through a variation of a property of the dialysate and detection of a change of the property of blood according to the blood side.
    [037] Also in the case of a determination of the change in the control factor due to a target change in the flow of dialysate, the necessary detection for this of a change in a property of the dialysate or blood can be carried out on the side of the dialysate or the blood side.
    [038] In order to determine a change in the control factor alternatively to a change in a dialysate property before entering the dialyzer, a blood property before entering the dialyzer can also vary continuously, for example, periodically, and the effect of treatment on the property of the blood at the outlet of the dialyzer can be measured on the blood side or, alternatively, on the dialysate side. In this way, the variation of a blood property before entering the dialyzer can consist of a small compatible variation in the patient's blood temperature. Variation of the heparin entry into the blood before entering the dialyzer is also possible. In the case of hemodialysis, heparin or an alternative anticoagulant drug (citrate) is added continuously to the patient's blood before entering the dialyzer in order to prevent the dialyser from clotting. This occurs, for example, with a syringe pump that contains the appropriate medicine. The flow rate of this pump (heparin pump) can be modulated accordingly. As an alternative, the replacement rate can also be modulated. For the pre-dilution preferred to that applied by this means, a sterile substitute is added to the patient's blood before entering the dialyzer. The excess water is again removed from the patient's blood by ultrafiltration in the dialyzer. Substitute ingredients in the blood, such as glucose, sodium, potassium, magnesium, calcium and bicarbonate, pass through the dialyzer from the blood side to the dialysate side and are at least indirectly detectable, for example, electrolytes by means of conductivity measuring cells.
    [039] Thus, the invention also allows a control of the flow of dialysate through a variation of a blood property and detection of a change in the blood property on the blood side or on the dialysate side.
    [040] The easiest method for determining the amplitude ratio of the electrical conductivity values of the dialysate before (LFd, in) and after the dialyzer (LF d, out) is to compare the amplitude values or the values of a peak to the another of the electrical conductivity of the dialysate when entering the dialyzer (LFd, in) and at the exit of the dialyzer (LF d, out) with each other. However, this approach has the disadvantage that noise and / or disturbances directly lead to measurement errors that, in turn, reduce the accuracy of the determined amplitude ratio. Therefore, on the C2 curve of the illustration according to Figure 1, the disturbances in the value of the electrical conductivity of the dialysate at the outlet of the dialyzer are about 10 percent. Thus, it is necessary to average the corresponding number of T / 2 half periods to increase accuracy.
    [041] Thus, it is more favorable to work with an average of the signals by comparing the absolute values of the areas under the conductivity curves:

    [042] In this way, all measurement values of time t are considered, whereby the statistical error is reduced to the maximum. However, this requires the determination of the mean values of the electrical conductivity of the dialysate when entering the dialyzer and at the exit of the dialyzer from receding half waves that, on the one hand, extend the entire averaging period and, on the other hand, can lead to systematic measurement errors, such as trends. Another option would be, first, to store all the measured values and to carry out the calculation later. This, however, requires a high storage capacity.
    [043] Therefore, it is favorable to work with the standard deviations of the signals or the effective values of the alternating components by comparing the variances of the electrical conductivity curves of the dialysate:

    [044] In practice, therefore, only the values LF d, in / LFd, out and LF2d, in / LF2d, out need to be summarized in full half waves.
    [045] The methods described above for determining the amplitude ratio of the electrical conductivity values of the dialysate before and after the dialysate can be applied to the values of other properties of the dialysate or blood in a similar way.
    [046] The dialysate flow can be generated and changed, for example, by means such as pumps and / or valves.
    [047] For determining the control factor from the dialysate or blood property values before and after the dialyzer, as well as for determining the derivation of the dialysate flow control factor, programmable microprocessors can be used, for example. example, which can also be used within a control unit to control the flow of dialysate and the associated generation of commands for pumps and / or valves. The control means of preference contains a storage to store the requirements for the limit value or the limit range and for a program that can execute the method according to the invention. In addition, it can also be established that the requirements for the threshold value or the threshold range at the beginning or during the execution of the program can be changed, so that instead of a default value of, for example, 20 percent of the value of the control factor for changing the dialysate flow of 100 mL / min, also a value of, for example, 5 percent of the control factor for changing the dialysate flow of 100mL / min can be adjusted. It can also be predicted that the tolerance range of a limit, that is, the upper limit and / or the lower limit of the limit, can be changed at the beginning or during the execution of the program.
    [048] It can be concluded that, due to the invention, the flow of dialysate in a dialysate device in relation to the effectiveness of the dialyzer and, thus, also the blood treatment is optimized regardless of the knowledge of the type of dialyzer used, the flow of blood or certain parameters of the patient. An excess increase in the flow of dialysate does not lead to a significant increase in the effectiveness of the dialyzer.
    权利要求:
    Claims (4)
    [0001]
    1. Device to control the flow of dialysate, CHARACTERIZED by the fact that it comprises a dialyzer with a blood chamber for infusion with blood and a dialysis chamber separated from the blood chamber by a semipermeable membrane for perfusion with a dialysate, a generator for perfuse the flow of dialysate through the dialysis chamber, a unit for determination configured to determine a change in the value of a control factor that is a measure for the exchange of substances in the dialyzer, based on a modulation in the values of a property of the dialysate determined before and after the dialyser, respectively, and a control facility configured to control the flow of dialysate through the dialysis chamber of the dialyser, if a dialysate property is modulated during treatment and if a change in the control factor value continuously at any time during treatment caused by a modulation of a dialysate property In a limit interval, the control facility instructs the generator to increase the flow of dialysate if a change in the value of the control factor exceeds the limit interval, and to reduce the flow of dialysate if the change in the value of the control factor becomes below the limit range.
    [0002]
    2. Device, according to claim 1, CHARACTERIZED by the fact that the device still has means to continuously modulate the property of the dialysate.
    [0003]
    3. Device, according to claim 1, CHARACTERIZED by the fact that the property of the dialysate is the concentration of electrolytes or the temperature.
    [0004]
    4. Device for the treatment of extracorporeal blood, CHARACTERIZED by the fact that it comprises a device as defined in claims 1 to 3.
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    法律状态:
    2018-12-11| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2019-10-15| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2020-09-29| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2021-01-05| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-09| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 31/08/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161529965P| true| 2011-09-01|2011-09-01|
    DE102011053200A|DE102011053200A1|2011-09-01|2011-09-01|Dialysate flow control|
    US61/529,965|2011-09-01|
    GB102011053200.5|2011-09-01|
    PCT/EP2012/066978|WO2013030350A1|2011-09-01|2012-08-31|Dialysate flow control|
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