巴西专利BR112013019662B1 METHOD AND DEVICE FOR CONTROL OF AN EXTRACORPOREAL BLOOD TREATMENT DEVICE

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专利摘要:
Method and device for controlling an extracorporeal blood treatment device The invention relates to a method and device for controlling an extracorporeal blood treatment device, which can be operated in particular as a device and hemodialysis, a hemofiltration device or a hemodiafiltration device. for the control of pumps, the method according to the invention and the device according to the invention provide a condition, in addition to balancing fluids as a function of the weights of the containers, for measuring weight reduction or weight gain and at least one of the containers in the time interval in which the pump designated for the respective container performs a pre-established number of revolutions or pulsations of the pump. for example, the change in the weight of the container to half or a revolution of the pump can be determined. the release rate of the respective pump is defined based on the weight reduction or the weight gain measured in the defined time interval. the definition of the reduction or increase in weight per unit of time allows the precise determination of the actual release rate of one or more pumps. the actual release rates for all pumps are preferably monitored.
公开号:BR112013019662B1
申请号:R112013019662-9
申请日:2012-01-24
公开日:2020-12-15
发明作者:Lars BREUEL；Thomas Lindner；Josef Beden；Martin Herklotz；Georg Verch
申请人:Fresenius Medical Care Deutschland Gmbh；
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专利说明:

The invention relates to a method and device for controlling an extracorporeal blood treatment device, which can be operated in particular as a hemodialysis device, a hemofiltration device or a hemodiafiltration device. In addition, the invention relates to an extracorporeal blood treatment apparatus provided with a control device.
In a hemodialysis treatment, the blood to be treated flows through the first chamber of a dialyser separated by a semipermeable membrane to access the first chamber and a second chamber, while the dialysis fluid flows through the second chamber of the dialyzer. Hemodialysis treatment requires a balance between fresh and used dialysis fluid to control the amount of fluid administered and removed from the patient. In hemodialysis, great demands are made on fluid balance.
In the case of acute dialysis for use in intensive care units, cardiopulmonary bypass devices are used in which the fluids needed for blood treatment are made available in containers, especially bags. In the case of hemodiafiltration devices known for acute dialysis, dialysis fluid and substitutes are available in bags, while the filtrate is collected in a bag. To drive the fluids, peristaltic pumps are used, on whose release precision great demands are made so that the flow rate of the dialysis fluid, the substitute and the filtrate can be precisely adjusted.
The balance of fluids occurring in the case of blood treatment devices intended for use in intensive care units by the fact that the weight of the bags filled with fluids is monitored. The known blood treatment devices include scales for this purpose. The flow rates for dialysis fluid (dialysate), substitute and filtrate are pre-selected for blood treatment, the flow rates being adjusted with peristaltic pumps. However, as the actual release rates for peristaltic pumps, especially roller pumps, differ in practice from the predetermined release rates in the driving circuit, incorrect balance can occur. The exact balance is achieved by the fact that the deliberation rate of one or more pumps is altered in a way that the difference between the weight reduction per unit time of the dialysate bag and the replacement bag and the weight increase per unit time of the filtrate bag corresponds to a pre- established. If no fluid is to be removed from the patient, the pumps are adjusted so that the sum of the weight reduction of the dialysate and the substitute corresponds exactly to the increase in weight of the filtrate. Otherwise, a specific amount of fluid is administered to the patient or removed from the patient (ultrafiltration).
In balancing, it should be taken into account that additional fluids, such as heparin or citrate and calcium, are administered to the patient for anticoagulation purposes. The administration of additional fluids must be considered by a manual adjustment carried out by the operator or automatically with the flow of the filtrate. However, for the sake of simplicity, this will not be appreciated in more detail in the description below.
Only the determination of the sum of the weight of the dialysate bag and the substitute bag, on the one hand, and the weight of the filtrate bag, on the other hand, is in principle required for balance. Consequently, blood treatment devices are known which comprise only two scales. However, blood treatment devices with three scales are also known, in which the dialysate bag and the substitute bag are weighed with separate scales, so that the weight of each bag can be determined individually.
The control unit of the blood treatment devices provides a specific control range for the flow rates of the pumps, which in practice can be an amount, for example, of ± 20% of the pre-set adjusted flow. If an incorrect balance occurs, the incorrect balance can be compensated for by changing the flow rate of one or more pumps within the control range. For example, in the event that the actual release rate of the dialysate pump is less than the established release rate adopted in the driving circuit, the release rate of the dialysate pump can be increased proportionally. To compensate for the incorrect balance, however, the necessary increase in the dialysate pump release rate must be within the control range, that is, for example, within the ± 20 control range of the pre-established flow rate. , to compensate for the incorrect balance. The control cycle rises, for example, to 1 second.
The known scales for weighing the bags are precision scales, which have to be checked regularly. The known blood treatment devices therefore provide cyclical tests of the scales that are performed automatically. Cyclic equilibrium tests are intended to avoid not only incorrect balancing due to errors with the scales, but also incorrect balance caused by overflows in the pipe system, which are revealed in the balance tests by an unacceptable oscillation of the measured values.
For a cyclical test of the scales, the pumps must be stopped to allow the scales to be checked. One attempt, therefore, is to keep the number of cyclical tests as much as possible. The interval between successive balance tests must be selected so that the incorrect balance that remains undetected cannot be greater than a specific value, for example, 500 mL. To remain undetected in the meantime, an error of balance or an overflow in the pipe system must be so small that the balance error or overflow can be compensated for by the permitted control range of, for example, ± 20% of the adjusted set flow , so that a shift in balance cannot occur. The time interval between equilibrium tests is therefore dependent on the flow rate and the permitted control range. The time intervals between cyclic balance tests are therefore also fixed in order to avoid the limiting value for incorrect balance between two exceeded cyclic balance tests. The smaller the permitted control range, therefore, the greater the interval between cyclic equilibrium tests that can be selected.
The underlying problem of the invention is to provide a method for controlling an extracorporeal blood treatment device, which allows exact fluid balance and an extension of the testing intervals on the scales, especially when only the sum of the weight of the two fluids is measured for balancing fluids. In addition, the underlying problem of the invention is to make available a device for controlling an extracorporeal blood treatment device, which enables precise balancing with extended intervals for balance tests. One problem of the invention is also to make an extracorporeal blood treatment device available. equipped with this control device.
According to the invention, the solution of these problems arises with the characteristics of claims 1, 10 and 19. Advantageous embodiments of the invention are the subject of the subclaims.
The basic principle of the method according to the invention and the device according to the invention lies in combining balance based on the weights of the fluid containers and determining the precise release rates of the pumps used to drive the fluids. An accurate knowledge of the release rates allows a smaller range of control of the pumps used for balancing and, therefore, allows deviations in the balancing due to errors with the scales, overflows in the system etc. that are detected early. An additional advantage lies in increasing the efficiency of the treatment due to the extension of the intervals for the tests with the scales. The advantages of a smaller control range are especially noticeable when only the sum of the weight of two containers filled with fluid is evaluated - for example, only the sum of the weight of the dialysate bag and the substitute bag is measured. In the case of an excessively larger control range, there is then a risk of an excessively larger proportion of the amount of unreleased substituent, for example, by the substitute pump assumed by the dialysate pump, as a result of how accurate the fluid balance can be. guaranteed, but the efficiency of blood treatment is, however, adversely affected in general. This is critical, especially since this error cannot be observed when measuring the sum of the weight of the dialysate bag and the substitute bag.
The method according to the invention and the device according to the invention are intended for an extracorporeal blood treatment apparatus, with which different types of treatment, such as hemodialysis, hemofiltration or hemodiafiltration, can be performed. The extracorporeal blood treatment apparatus comprises an exchange unit, which can be a dialyzer or a filter. In addition, the blood treatment apparatus comprises three pumps for conducting fluids, that is, dialysate, substitute and filtrate, from a container and respectively to a container. The dialysate and the substitute are conducted in each case of a container and the filtrate is taken to a container. The container can be a bag, in which fluid is made available or collected. In addition, the blood treatment apparatus comprises means for determining the sum of the weight of the two containers and resources for determining the weight of a container. The means for determining the weight of the containers are preferably scales. The means for determining the sum of the weight of the two containers preferably comprises only one scale. However, two scales can also be used, the sum of the weight measured with each scale being calculated.
An alternative embodiment provides a condition so that the first and third pumps, i.e., the dialysate pump and the substitute pump, can also release fluid from a common container. This alternative modality requires, however, that the dialysate and the substitute be the same fluid.
For the control of pumps, the method according to the invention and the device according to the invention provide a condition, in addition to balancing fluids as a function of the weights of the containers, for the measurement of weight reduction or weight gain of at least one of the containers in the time interval in which the pump related to the given container performs a pre-established number of revolutions or pulsations of the pump. If this involves roller pumps, a specific number of revolutions is pre-established. Otherwise, a specific number of pump pulsations is adopted. For example, the change in the weight of the container can be determined by half or one revolution of the pump.
The release rate of the respective pump is determined from the weight reduction or the weight gain measured in the specific time interval. Determining the weight reduction or weight gain per unit of time allows for the precise determination of the actual release rate of one or more pumps. The actual release rates of the dialysate pump, the substitute pump and the filtrate pump are preferably monitored.
The control is basically governed by the pre-set release rate of the pumps, which can be the rate of the dialysate, the rate of the filtrate or the rate of the substituent, which is assumed to be known. This release rate adopted in the conduction circuit, which must be adjusted according to a pre-established number of revolutions per unit time of the pump, is compared with the actual release rate of the pump, that is, the actual release rate .
The difference between the release rate at a fixed point and the actual release rate is taken into account in the next pump driving circuit. In practice, this can be done by the fact that, in the control of the pumps, it is considered an adjustment or correction factor, which results from the ratio between the release rate at a fixed point and the actual release rate, referred to below as the basic correction factor. If this basic correction factor is dependent on the release rate at a fixed point, the basic correction factor can be determined by an arbitrary number of release rates at a fixed point and considered in the pump driving circuit.
With the method according to the invention and the device according to the invention, therefore, systematic deviations from flow rates can readily be considered in the driving circuit regardless of actual control, said deviations resulting from deviations related to components - for example example, due to tolerances of the geometric dimensions of the pumps, etc. and tolerances in the respective tubular lines. A much smaller control range can be set for the pumps, because systematic deviations no longer have to be compensated for by pump regulation. A much smaller control range, in turn, means less risk of an excessively large proportion of the release volume of one pump being driven by another pump and allows for an extension of the intervals between tests on the scales. In general, blood treatment therefore becomes more efficient. A brief departure from the limited tolerance range in pump control can be allowed so that abnormal balance functions, for example, are better compensated.
A preferred embodiment of the invention provides the determination of the basic correction factor for all pumps. In principle, however, it is also possible to determine the basic correction factor for only one pump or two pumps. The systematic error of the two other pumps or the other pump, however, cannot then be detected and the control range cannot, therefore, be reduced to the last. The setting of a particularly small control range for all pumps involved in balancing, however, is only possible when the basic correction factor for all these pumps is defined.
In the preferred mode, in which the control of two pumps is done by determining the change in the weight of only one scale, the pump designated for the same scale is interrupted during the determination of the basic correction factor of a pump. The change in the weight of the container can therefore be designated exclusively for the conductive pump.
In the case of hemodiafiltration, the dialysate is fed to the second chamber of the exchange unit from a dialysate bag and the filtrate is transported from the second chamber of the exchange unit to a filtrate bag. Substituent is fed from a substitute bag into the extracorporeal blood circuit. The dialysate is conducted by the first pump, the filtrate by the second pump and the substitute by the third pump. For the purpose of fluid balancing, the pumps are controlled so that the difference between the weight reduction per unit time of the sum of the weights of the dialysate container and the substitute container and the weight increase per unit time of the container filtrate corresponds to a pre-established value. If the pre-established value is 0, fluid is not administered or removed from the patient.
A preferred embodiment provides a condition so that, in determining the basic correction factor for a pump, the amount of deviation from the release volume from the set point of that pump from the actual release volume as the pre-established number of revolutions or pump pulsations are compared with the pre-established limit value for a maximum deviation. If the amount of the deviation is greater than the pre-established limit value, it is concluded that there is an error and an error signal is generated. If an error signal is generated, the measurement can be repeated. If the amount of the deviation is not calculated, it is possible to differentiate between a positive upward deviation and a negative downward deviation from a basic value. For example, ± 0.3 g per ^ pump revolution can be pre-set for a maximum deviation from the set value from the actual value in practice. An upper and lower absolute limit value can also be set to compare the deviation of the established release quantity from the established release quantity.
In principle, it is sufficient to perform only a single measurement of weight reduction or weight gain per unit of time, that is, by revolutions or pulsations of the pump. Greater precision can, however, be achieved by making a plurality of measurements and obtaining an average value.
It is advantageous that the components required for the method according to the invention and for the device according to the invention are in any case present in the known blood treatment apparatus. The measurement of weight reduction or weight gain per unit of time with the scales in any case present for balancing, therefore, does not require any additional expense with the equipment. The control of individual components can be done by the central control and computing unit, which is present in each blood treatment device. The central control and computing unit of the blood treatment device can also perform the necessary computational operations. The device according to the invention, therefore, is preferably a component part of the extracorporeal blood treatment apparatus. However, it can also be a separate assembly.
An example of the modality of the invention is explained in detail below by reference to the drawings, which show in a very simplified schematic representation the main components of two alternative modalities of an extracorporeal blood treatment device, in which the balancing of fluids is carried out by means of scales.The corresponding parts in relation to each other are provided with the same reference numbers in Figures 1 and 2.
The cardiopulmonary bypass device is in particular intended for intensive care units, with which hemodialysis, hemofiltration or hemodiafiltration can be performed.
The blood treatment apparatus comprises an exchange unit 1, which is divided by a semipermeable membrane 2 for access to a first chamber 3 and a second chamber 4. The exchange unit is referred to below as dialyzer 1. Blood flows through the first chamber 3 of the dialyser 1. The blood is conducted through a blood supply line 5 of the patient by means of a blood pump 6 to the first chamber 3 of the dialyser 1 and flows back to the patient via a blood discharge line 7 of the first chamber 3 of the dialyzer 1 (Figure 1).
For blood treatment, dialysis fluid (dialysate) is provided in a first container 8, which is preferably a pouch. The dialysate is guided from the dialysate bag 8 to a second chamber 4 of the dialyser 1 by a dialysate line 9, to which a dialysate pump 10 is incorporated. From the second chamber 4 of the dialyzer 1, the filtrate is conducted through a filtrate line 11, to which a filtrate pump 12 is incorporated, into a filtrate container 13, particularly a filtrate bag. For dialysis treatment, substituent is provided in a container of the substituent 14, in particular in a bag of the substituent. From the substituent bag 14, the substituent is administered by a line of substituent 15, to which a pump of substituent 16 is incorporated, into the extracorporeal blood circuit upstream of the first chamber 3 of the dialyzer (pre-dilution) or downstream the first chamber 3 of the dialyzer 1 (post-dilution).
The dialysate line 9, the filtrate line 11 and the substitute line 15, which are connected respectively to the dialysate bag 8, the filtrate bag 13 and the substitute bag 14, are tubular lines of a tubule system intended for single use (disposable). The dialysate pump 10, filtrate pump 12 and substitute pump 16 are peristaltic pumps, in particular roller pumps, into which the tubular lines are inserted. Roller pumps preferably comprise a stepper motor, the number of steps (revolutions) of which determines the amount of pump release. With each complete revolution or half revolution, each pump has a specific theoretical release amount, in which the inserted tubular line also has an influence. The fixed release rate of the pump indicated by the manufacturer may, however, deviate from the actual release rate . Balancing of fluids during the total treatment period is therefore not guaranteed without compensating for this deviation. Another motor can also be used in place of the stepper motor. For example, a brushed motor or a brushless motor equipped with a standard timing generator can be used.
A balancing system is provided for precise balancing of fluids, said balancing system comprising a first scale 17 and a second scale 18. The first scale 17 is used for weighing the distillate bag 8 and the substitute bag 14, while the filtrate bag 13 is weighed with the second scale 18. Scales 17, 18 can be designed differently. For example, the bags can be placed on the scales or hung on the scales. The first scale 17 weighs the sum of the weight of the dialysate bag and the substitute bag 8, 14, while the second scale weighs only the weight of the filtrate bag 13. Containers 8 and 14 may also not be placed together on the scale 14 , but on two separate scales.
To control the dialysate pump, the filtrate pump and the substitute pump 10, 12, 16, the control device according to the invention comprises a control unit 19, which can be a component part of the control and computing unit 20 of the extracorporeal blood treatment device. The control and computing unit 20 comprises a CPU for performing the calculations and the control.
The control unit 19 is connected by measuring lines 17 ', 18' with the first scale 17 and the second scale 18. Through the control lines 10 ', 12' and 16 ', the control unit 19 is connected with the dialysate pump 10, the filtrate pump 12 and the substituent pump 16.
To carry out the blood treatment, a specific release rate is first pre-established for the dialysate pump 10, the filtrate pump 12 and the substituent pump 16 by means of an inlet unit which is not shown. To adjust the release rates, the control unit 19 pre-establishes a specific number of steps (revolutions) per unit time for the stepper motors of the pumps. It is assumed that the desired release rate is also exactly fixed, although this is not the case in practice.
For example, a dialysate rate of 2000 ml / h, a substituent rate of 900 ml / h and a final ultrafiltration rate of 100 ml / h are adopted. A filtrate rate of 3000 ml / h (50 ml / min. ) results from this. Since actual pump release rates deviate from set release rates, pre-established final ultrafiltration is not achieved in practice. This can lead to incorrect balancing.
For fluid balancing, the control unit 19 regulates the release rates of the dialysate pump 10, the filtrate pump 12 and the substituent pump 16. The release rate of one or more pumps is therefore increased or reduced selectively to compensate for the error. The adjustment of the release rates takes place within a pre-established control range. The release rate of one or more pumps must not be increased or reduced by an amount that is greater than a specific limit value. This limit value can be a percentage of the fixed release rate, such as ± 20%.
On the assumption that fluid should not be administered or withdrawn from the patient, that is, the final ultrafiltration rate is 0, the control unit 19 regulates the pumps so that the sum of the weight reduction of the dialysate bag and the substituent 8, 14 in a specific time unit, such as per minute or hour, corresponds to the increase in weight of the filtrate bag 13. In the case that fluid must be withdrawn from the patient, the control unit regulates the pumps so that the amount of the difference between the weight reduction of the sum of the dialysate bag and the substitute 8, 14 and the weight increase in the weight of the filtrate bag 13 corresponds to the final ultrafiltration rate.
In the case of the above modality example, a filtration rate of 3000 mL / h (50 mL / min.) Is adjusted to achieve the final ultrafiltration rate of 100 mL / h. With an assumed control range for the filtrate pump of ± 20%, the filtrate rate can be increased or decreased by a maximum of ± 10 mL / min. related to the fixed value, in order to compensate for the error.
To avoid incorrect balancing, it is necessary to test scales 17, 18 at specific time intervals. The time intervals between tests are controlled according to the volume that can be administered or removed from the patient not detected by the actual balance (incorrect balance). If it is assumed that a pump is driven in the middle of the control range before an overflow, for example, the incorrect equilibrium rate in the presumed case would correspond to ± 20% = 10 mL / min. of the fixed release rate. If, for example, the incorrect balance between two balance tests is not greater than 500 mL, in the present example of modality it is necessary to carry out a balance test every 50 min. (500 mL / 10 mL / min. = 50 min.)
The mode of operation of the control unit 19 for controlling the extracorporeal blood treatment apparatus is described below using the example of hemodiafiltration.
The dialysate pump and the substitute pump 10, 16 release from a common equilibrium 17. The invention provides a reduction in the control range. In the present example of modality, the control range must correspond, for example, to only ± 8% of the fixed release rate.
Preferably before the blood treatment itself, the central computing and control unit 20 of the blood treatment apparatus generates a control signal to start determining the basic correction factor for the pumps 10, 12, 16 involved in the balancing. The determination of the basic correction factor can, however, be initiated during treatment or a pause in treatment. The determination of the basic correction factor is preferably carried out during treatment - for example, 10 min. after the start of treatment, when the dialysate pump 10, filtrate pump 12 and substitute pump 16 are in operation.
After the control signal is received, the control unit 19 stops the pump 16. The release rate of the filtrate pump 12 is then adopted by the control unit so that the final ultrafiltration rate is reset. For this purpose, the fixed release rate of the filtrate pump 12 is reduced by the flow of the interrupted pump 16.
The amount of dialysate driven by revolution or by pulse of the dialysate pump 10 is then determined, said amount being denoted below as the pulse volume of the dialysate pump. For this purpose, the reduction in the weight of the dialysate bag 8 is detected in the time interval in which the dialysate pump performed a specific number of revolutions or pulsations. The reduction in the volume of dialysate that corresponds to the reduction in weight in that time interval divided by the number of revolutions or pulsations performed corresponds to the pulse volume of the dialysate pump to be measured. The control unit 19 preferably performs a large number of successive measurements for half or for a total revolution of the pump, such as 20 measurements, and calculates the average value of the defined pulse volumes.
The control unit 19 then puts the pump of the substituent 16 back into operation and now for the pump of the dialysate 10. The control unit 19 now determines the pulse volume of the pump of the substituent 16, just as it was done with the dialysate pump 10. After determining the pulsation volume of the pump of the substituent 16, the dialysate pump 16 is put into operation again. When the pulsation volume of the pump of the substituent 16 is determined, the fixed release rate of the filtrate pump 12 is also reduced again by the control unit 19 by means of the flow of the pump 10 which is again interrupted, so that the rate of desired final ultrafiltration is established.
It is also possible that the aforementioned stopped pumps are not interrupted to determine the correction factor for another pump, but only have their flow reduced to a minimum. Thus, the flow of the filtrate pump 12 can then be adjusted by the reduced flow.
The determination of the pulsation volume of the filtrate pump13 is carried out during the determination of the volume of purification of the dialysate pump of the replacement pump, 16. For this purpose, the increase in the weight of the filtrate bag 13 is detected in each case in successive measurements within the time interval in which the filtrate pump 12 performs a specific number of revolutions, with an average value of the defined pulse volumes being calculated.
After determining the pulsation volumes of the pumps 10,12,16, the pulse volume that has been adopted in the control so far and that corresponds to the value stipulated by the pump manufacturer is related to the actual pulsation volume defined for the pumps to determine a corresponding control factor, the basic correction factor. The "zero line" for driving the pump is then changed by the basic correction factor thus determined. The driving of the pump is then carried out with a "specific compensation". The sharing of systematic flow deviations resulting from the tolerances of the pumps and the accessory item (disposable) is then considered, so that a smaller control range, such as ± 8% of the fixed flow rate, can be pre-established in order to extend the time intervals between cyclic equilibrium tests.
The basic correction factor should not produce a compensation greater than the maximum possible error in the fixed release rate due to deviations related to components - for example, more than ± 15%. If the basic correction factor is, for example, between ± 15% and ± 20%, it is limited by the control unit 19 to ± 15%. If the defined compensation is greater than ± 20%, the determination of the pulse volume is not considered successful and can be repeated by the user. The control unit 19 generates an error signal in this case.
When determining the basic correction factor for pumps, pulse volumes identified as interrupted are not used to determine the basic correction factor. If an error is present, the measurement of weight reduction or weight gain can be extended by the number of interrupted pulse volumes. Even if, in this way, more than a specific number of pump revolutions are required to determine the basic correction factor, such as 25 pump revolutions, the calibration is considered successful and can be repeated by the user. The control unit 19 also generates an error signal in this case. To compensate for any long-term deviations that occur in the pulse volumes, the basic correction factor can still be corrected after completing the calibration using a separate algorithm.
The determination of pulse volumes does not need to be repeated during continuous treatment. Laboratory tests have shown that the pulsation volume of the pumps used, after an initial period of approximately 5 minutes, rarely exhibits any measurable oscillation in the next 70 hours. During the determination of the pulsation volumes, the flow rates of the pumps can be limited to a higher value, which can be, for example, at a maximum of 2000 mL / h, to increase the accuracy of the determination of the basic factor of correction.
It is intended to illustrate once again, based on the following example, that the interval between cyclic balance tests can be markedly increased when, after determining the pulsation volumes of the pumps, the permissible control range for the filtrate pump is reduced. For example: Method: CVVHDF Taxadodialysed: 2000 mL / h Taxadosubituituente: 900 mL / h Final taxadeultrafiltração: 100mL / h
To adjust the final ultrafiltration rate, a filtrate rate of 3000 mL / h = 50 mL / min. must be pre-established by the control unit. A filtrate control range of ± 8% = ± 4mL / min. is pre-established. As the pump is conducted precisely in the middle of the control range in the normal case, the incorrect equilibrium rate resulting, for example, from an overflow can correspond to only a unilateral control range of 8% = 4 mL / min. If 500 mL is allowed as the maximum incorrect balance, a cyclic balance test results which must be performed every 125 min. (500 ml / 4 ml / min. = 125). It appears that the interval between the balance tests is greater than in the case of a control range of ± 20%, with the result that the interval between tests is 50 min.
When the method according to the invention and the device according to the invention are used in hemodialysis, only the pulse volumes of the dialysate pump and the filtrate pump need to be determined, since the pump of the substituent is not operated for hemodialysis.
When the method according to the invention and the device according to the invention are used in hemofiltration (CVVH), only the pulsation volumes of the substituent pump and the filtrate pump need to be determined, since the dialysate pump it is not operated for hemofiltration.
Figure 2 shows an alternative modality of the extracorporeal blood treatment apparatus, which differs from the first example of modality only in that the two lines 9 and 15 of bags 8 and 14 comprise a common line segment A. For example, the two lines 9, 15 can be conducted together with a first Y connection fragment (not shown) to form the common segment in line A, which, for example, can be 50 cm long, and can be divided again with a second connection fragment in Y (also not shown). The composition of the dialysate and the substitute in bags 8 and 14 respectively is, in this case, identical. The two bags 8, 14 act as a single bag. Instead of the two bags 8, 14, dialysate and substitute can therefore be made available in a single bag, to which lines 9 and 15 are connected. This single container B, which replaces containers 8 and 14, is shown in broken lines in Figure 2 as an additional alternative embodiment.
The alternative modality with the two bags and the common line segment has the advantage of handling that the two bags 8 and 14 become empty simultaneously regardless of the different flow rates of the pumps510 and 16. When the fluid is available in just in a bag, the problem of simultaneous emptying does not exist at all.

权利要求:
Claims (19)
[0001]
1. A method for controlling an extracorporeal blood treatment device comprising: an exchange unit, which is divided by a semipermeable membrane to access a first chamber and a second chamber, in which the first chamber is part of an extracorporeal circuit and the second chamber is part of a fluid circuit, a first pump for conducting a fluid from a first container at a first release rate to a second chamber of the exchange unit; a second pump for conveying a fluid from the second chamber of the exchange unit at a second release rate to a second container; a third pump for conducting a third fluid at a third rate of releasing a third container or the first container into the blood extracorporeal circuit; a first weighing device; and a second weighing device, said method comprising: weighing the first container and the third container using the first weighing device or weighing the first container using the first weighing device and weighing the second container using the second weighing device; adjust the first, second and third pumps to balance the first, second and third fluids according to: (I) a sum of the weights of the first and third containers and the weight of the second container; or (II) the weight of the first container and the weight of the second container; characterized by the fact that the measurement of weight reduction or an increase in weight of at least one of the first, second or third containers in a time interval in which the first, second or third pump designated for the respective first, second or third container performs a pre-established number of revolutions or pulsations of the pump, determine a quantity of release of the respective first, second or third pump in the predetermined number of revolutions or pulsations of the pump from the weight reduction or the weight increase measured in the interval of time; compare the quantity of fixed release of the respective first, second or third pump in the pre-established number of revolutions or pulsations of the pump adopted in the driving circuit of the respective first, second or third pump with the measured release quantity of the respective first, second and third pump on the pre-established number of revolutions or pulsations of the pump, and base the conduction circuit of the first, second and third pumps on the deviation of the fixed release quantity adopted from the respective first, second or third pump on the predetermined number of revolutions or pulsations of the pump from the measured release quantity of the first, second or third pump at the predetermined number of revolutions or pulsations of the pump.
[0002]
2. Method according to claim 1, characterized in that it further comprises: controlling the first, second and third pumps for fluid balancing are controlled so that the difference between the weight reduction per unit time of the sum of the weights of the first and the third container and the weight gain per unit time of the second container corresponds to a pre-established value.
[0003]
3. Method according to claim 1, characterized by the fact that it additionally comprises: measuring the weight reduction of the first container in a time interval in which the first pump performs a pre-established number of revolutions or pulsations of the pump and determining the amount of release of the first pump in the pre-established number of revolutions or pulsations of the pump based on the measured weight reduction, measure the weight increase of the second container in a time interval in which the second pump performs a pre-established number of revolutions or pulsations of the pump and determine the amount of release of the second pump in the pre-established number of revolutions or pulsations of the pump based on the measured weight increase, measure the weight reduction of the third container in a time interval in which the third pump performs a pre-established number of revolutions or pulsations of the pump and determine the amount of release of the third pump in the pre-established number of pump revolutions or pulsations based on the measured weight reduction and compare the release quantities of the first, second and third pumps in the pre-established number of pump revolutions or pulsations adopted in the driving circuit of the first, second and third pumps with the release quantities of the first, second and third pumps measured in the pre-established number of revolutions or pulsations of the pump, and base the conduction circuit of the first, second and third pumps on the deviation of the adopted release quantities of the first, second and third third pumps in the pre-established number of revolutions or pulsations of the first, second and third pumps from the measured release quantities of the pumps in the pre-established number of revolutions or pulsations of the pump.
[0004]
Method according to claim 1, characterized in that the first weighing device comprises a first scale for the simultaneous weighing of the first and the third container and the second weighing device comprises a second scale for weighing the second container .
[0005]
5. Method according to claim 4, characterized by the fact that it additionally comprises: determining the weight reduction of the first container by stopping the third pump or by reducing the flow rate of the third pump in a time interval in which the first pump performs a pre-established number of revolutions or pulsations of the pump.
[0006]
6. Method according to claim 5, characterized in that it additionally comprises: determining the weight reduction of the third container by stopping or reducing the flow rate of the first pump in a time interval in which the third pump performs a number pre-set of pump revolutions or pulsations.
[0007]
7. Method according to claim 6, characterized by the fact that it further comprises: the increase or reduction of the pre-established fixed release rate of at least one of the first, second or third pumps within a control range predetermined by a specific quantity that is less than a pre-established limit value, so that the difference between the weight reduction per unit time of the sum of the weights of the first and third container and the weight increase per unit time of the second container, corresponds to a pre-established value.
[0008]
8. Method, according to claim 7, characterized by the fact that the pre-established limit value is a pre-established percentage of the pre-established fixed release rate of the respective first, second or third pump.
[0009]
9. Method, according to claim 8, characterized by the fact to further understand: to compare the deviation of the adopted release quantity of the respective first, second or third pump in the pre-established number of revolutions or pulsations of the pump from the measured release quantity of the first, second or third pump in the pre-established number of revolutions or pump pulsations with a pre-established limit value; generate a deer signal when the deviation is greater than the limit value.
[0010]
10. Device for controlling an extracorporeal blood treatment device, in which the extracorporeal blood treatment device comprises: an exchange unit, which is divided into a semipermeable membrane to access a first chamber and a second chamber, in which the first chamber is part of an extracorporeal blood circuit and the second chamber is part of a fluid circuit; a first pump for conducting a first fluid from a first container at a first release rate to the second chamber of the exchange unit; a second pump for conducting a second fluid from a second chamber of the exchange unit at a second release rate to a second container; a third pump for conducting a third fluid at a third release rate from a third container or first container into the extracorporeal blood circuit, a first weighing device configured to weigh the first container and the third container or configured to weigh the first container; a second weighing device configured to weigh the second container; in which the device for controlling the extracorporeal blood treatment device comprises: a control unit for controlling pump release rates, in which said control unit is configured to balance fluids as a function of: (I) a sum the weights of the first and third containers and the weight of the second container; or (II) the weight of the first container and the weight of the second container, characterized by the fact that the weight reduction or weight gain of at least one of the first, second or third containers is measured in the time interval in which the first, second or third pump designated for the respective first, second or third container performs a pre-established number of revolutions or pulsations of the pump; the amount of release of the respective first, second or third pumps in the pre-established number of revolutions or pulsations of the pump is defined based on the weight reduction or the weight increase measured in the time interval; the fixed release quantity of the first, second or third pumps in the pre-established number of revolutions or pulsations of the pump adopted in the conduction circuit of the respective first, second or third pump is compared with the measured release quantity of the first. Second or third pump in the pre-established number of revolutions or pulsations of the pump, and the conduction circuit of the first, second or third pumps is based on the deviation of the fixed release quantity adopted from the respective first, second or third pump in the pre- set of pump revolutions or pulsations from the measured release quantity of the first, second or third pump in the pre-established number of pump revolutions or pulsations.
[0011]
11. Device according to claim 10, characterized by the fact that the control unit is configured so that, to balance the fluids, the release rates of the first, second or third pumps are adjusted so that the difference between the weight reduction per unit time of the sum of the weights of the first and third container and the weight increase per unit time of the second container corresponds to a pre-established value.
[0012]
12. Device, according to claim 10, characterized by the fact that the control unit is configured so that: the weight reduction of the first container is measured in the time interval in which the first pump performs a pre-established number pump revolutions or pulsations, and the quantity released from the first pump in the pre-established number of pump revolutions or pulsations is defined based on the measured weight reduction; the weight increase of the second container is measured in the time interval in which the second pump performs a pre-established number of revolutions or pulsations of the pump, and the quantity released from the second pump in the pre-established number of revolutions or pulsations of the pump is defined based on the measured weight gain; the weight reduction of the third container is measured in the time interval in which the third pump performs a pre-established number of revolutions or pulsations of the pump, and the quantity released from the third pump in the pre-established number of revolutions or pulsations of the pump is defined based on the measured weight reduction; and the release quantities of the first, second or third pumps in the pre-established number of revolutions or pulsations of the pump adopted in the conduction circuit of the first, second or third pumps are compared with the measured release quantities of the first, second or third pumps on the pre-established number of revolutions or pulsations of the pump, and the conduction circuit of the first, second or third pumps is based on the deviation of the release quantities adopted from the first, second or third pumps on the pre-established number of revolutions or pulsations of the pump of the measured release quantities of the first, second or third pumps in the pre-established number of revolutions or pulsations of the pump.
[0013]
13. Device according to claim 12, characterized in that the first weighing device comprises a first scale for the simultaneous weighing of the first and third container and the second weighing device comprises a second scale for weighing the second container .
[0014]
14. Device according to claim 13, characterized by the fact that the control unit is configured so that, to determine the weight reduction of the first container, the third pump is stopped or the flow rate of the third pump it is reduced in the time interval in which the first pump performs a pre-established number of revolutions or pulsations of the pump.
[0015]
15. Device according to claim 14, characterized by the fact that the control unit is configured so that, in order to determine the weight reduction of the third container, the first pump is stopped or the flow rate of the first pump it is reduced in the time interval in which the third pump performs a pre-established number of revolutions or pulsations of the pump.
[0016]
16. Device according to claim 10, characterized by the fact that the control unit is configured so that the pre-set fixed release rate of at least one of the pumps is increased or reduced within a pre-control range -established by a specific quantity that is less than a pre-established limit value, so that the difference between the weight reduction per unit time of the sum of the weights of the first and third container and the weight increase per unit time of the second container corresponds to a pre-established value.
[0017]
17. Device according to claim 16, characterized by the fact that the control unit is configured so that the pre-established limit value is a pre-established percentage of the pre-established fixed release rate of the respective first, second or third bomb.
[0018]
18.Device according to claim 16, characterized by the fact that the control unit is configured so that the deviation of the amount of release adopted from the respective first, second or third pump in the pre-established number of revolutions or pulsations of the pump from the measured release quantity of the first, second or third pump in the pre-established number of revolutions or pulsations of the pump is compared with a pre-established limit value, in which an error signal is generated when the deviation is greater than the limit value.
[0019]
19. Blood treatment apparatus comprising: a first pump for conducting a first fluid from a first container at a first release rate to the second chamber of the exchange unit; a second pump for conducting a second fluid from the second chamber of the exchange unit at a second release rate to a second container; a third pump for conducting a third fluid at a third rate of releasing a third container into the extracorporeal blood circuit; a first weighing device for determining the sum of the weights of the first d of the third container; a second weighing device for determining the weight of the second container, characterized by the fact that a control unit to control the release rates of the pumps, in which the said control unit is configured to balance the fluids according to the sum of the weights the first container and the third container or the weight of the first container and the weight of the second container; wherein a weight reduction or weight gain of at least one of the first, second or third containers is measured in the time interval in which the first, second or third pump assigned to the respective first, second or third container performs a pre-number -established of pump revolutions or pulsations; the amount of release of the respective first, second or third pump in the pre-established number of revolutions or pulsations of the pump is determined from the measured weight reduction or weight increase in the time interval; the amount of fixed release of the first, second and third pumps in the pre-established number of revolutions or pulsations of the pump adopted in the conduction circuit of the respective first, second or third pump is compared with the measured release quantity of the first, second or third pump in the pre-established number of revolutions or pulsations of the pump; and the driving circuit of the first, second and third pumps is based on the deviation of the fixed release quantity adopted from the respective first, second or third pump in the pre-established number of revolutions or pulsations of the pumped release quantity measured from the first, second or third pump in the pre-set of pump revolutions or pulsations.

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同族专利:

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法律状态:
2019-10-01| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2020-08-25| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2020-12-15| 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 24/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |

2021-03-23| B16C| Correction of notification of the grant [chapter 16.3 patent gazette]|Free format text: REF. RPI 2606 DE 15/12/2020 QUANTO A PRIORIDADE UNIONISTA. |

优先权:

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US61/348,275|2010-05-26|

US201161438275P| true| 2011-02-01|2011-02-01|

DE201110010067|DE102011010067A1|2011-02-01|2011-02-01|Method and device for controlling an extracorporeal blood treatment device|

DE102011010067.9|2011-02-01|

PCT/EP2012/000292|WO2012104026A1|2011-02-01|2012-01-24|Method and device for controlling an extracorporeal blood treatment device|

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