# Patent

## Title
Device and method for determining a dialysis fluid flow rate for extracorporeal blood treatment

## Abstract

The present invention relates to a device and to a method for determining the dialysis fluid flow rate for an extracorporeal blood treatment device. The dialysis fluid flow rate Qd is determined in accordance with the blood flow rate Qb or the blood flow rate Qb is determined in accordance with the dialysis fluid flow rate Qd, wherein by increasing about a specific value, the increase of a variable characterising the efficiency of the blood treatment, in particular clearance K, does not exceed the specific value. The present invention also relates to a blood treatment device comprising a device for determining the dialysis fluid flow rate or blood flow rate and to a method for operating an extracorporeal blood treatment device. As a result, an optimal dialysis fluid flow rate and/or blood flow rate calculates the requirement in accordance with a high efficiency of the dialysis treatment and in accordance with a reduced consumption of the dialysis liquid.

## Background
CROSS REFERENCE TO RELATED APPLICATIONS
This is a 371 national phase application of PCT/EP2007/008297 filed Sep. 25, 2007, claiming priority to German Patent Application No. 10 2006 045 437.5 filed Sep. 26, 2006.
FIELD OF INVENTION
The present invention relates to a system and method for presetting a dialysis-fluid flow rate or blood flow rate for an extracorporeal blood-treating apparatus which has a dialyser which is divided by a semi-permeable membrane into a blood chamber through which blood flows at a preset blood flow rate and a dialysis-fluid chamber through which dialysis fluid flows at a preset dialysis-fluid flow rate. The present invention also relates to a blood-treating apparatus having an arrangement for presetting a dialysis-fluid flow rate or blood flow rate and to a method of operating an extracorporeal blood-treating apparatus.
BACKGROUND OF THE INVENTION
In processes used in blood cleansing therapy such as hemodialysis, hemofiltration and hemodiafiltration, blood from a patient is conveyed through an extracorporeal blood circuit in which there is a dialyser or filter, which is divided by a semi-permeable membrane into a blood chamber and a dialysis-fluid chamber or filtrate chamber. In hemodiafiltration, both hemodialysis and hemofiltration are performed. The present invention relates to all processes used in blood cleansing therapy in which blood flows through the blood chamber of a dialyser and dialysis fluids flows through the dialysis-fluid chamber.
There are various known physical and/or chemical metrics by means of which the performance of the dialyser and/or the effectiveness of a dialysis treatment can be specified. One known metric for the performance of a dialyser is the clearance K. The clearance K of a substance is that proportion of the total flow through the dialyser which is totally cleared of the substance concerned. For the effectiveness of a dialysis treatment, what is of crucial significance is what is termed the dialysis dose (Kt)/V, which is defined as the quotient of the product of clearance K for urea multiplied by effective treatment time t, divided by the volume V of the patient's body through which urea is distributed.
U.S. Pat. No. 5,100,554 describes a method of determining clearance in which dialyser electrolyte transfer is measured at each of two different dialysate input concentrations. It is known from U.S. Pat. No. 5,100,554 that the effectiveness of dialysis treatment is dependent on the blood flow and the dialysis-fluid flow.
DE 695 31 137 T2 (WO 95/32010) describes a method and arrangement for optimising the effectiveness of a dialysis treatment, in which a metric characteristic of the effectiveness of the dialysis treatment is measured during the treatment and a parameter of the dialysis treatment is determined on the basis of the metric to allow optimum effectiveness to be obtained for the dialysis treatment. It can be deduced in detail from the publication that a processor increases the selected parameters, for example the blood flow rate, in a stepwise manner in defined increments, a urea sensor continuously measuring a characteristic variable, in that a sample of the draining-off dialysate is taken. By comparing the currently measured concentration with the preceding concentration, it is ascertained whether the current concentration is smaller or greater than the preceding concentration. If the current concentration is smaller than the preceding concentration, it is concluded that the preceding concentration represents the optimum value. As a result, the maximum value of the concentration is intended to be determined.
In the past, known pieces of dialysis apparatus have been operated with a constant flow of dialysis fluid which could not be altered by the user. More recent pieces of apparatus on the other hand allow different dialysis-fluid flow rates, such for example as 300, 500 and 800 ml/min, to be set manually. To achieve a high clearance, quite high dialysis-fluid flows at quite high blood flows are required.
When a given dialysis-fluid flow is being set, although high clearance can be obtained with a high dialysis-fluid flow, the costs of supplying fresh dialysis fluid and of disposing used dialysis fluid go up. What is therefore desired in practice is relatively high clearance for a relatively low consumption of dialysis fluid.
It is known that, if the widely employed dialysers are used at a ratio of blood flow to dialysis-fluid flow of 1:2, only a slight reduction in clearance occurs in comparison with a non-variable dialysis-fluid flow of 500 ml/min (J. E. Siegdell, B. Tersteegen, Artificial Organs, 10(3), pages 219-225, 1986).
U.S. Pat. No. 5,092,836 therefore proposes controlling dialysis-fluid flow as a function of blood flow in accordance with preset criteria. In particular, what is proposed is for a dialysis-fluid flow to be set that is obtained by multiplying the blood flow by a constant factor. As well as a linear relationship between blood flow and dialysis-fluid flow, what is also proposed is a numerical data matrix, which, for each blood flow of a given dialyser, gives that dialysis-fluid flow at which a given percentage is achieved of the maximum clearance that would have to exist if the dialysis-fluid flow were assumed to be infinitely high. In practice, the percentage may be, for example, 95%.
SUMMARY OF THE INVENTION
One object of the present invention is to specify a system and method for presetting an optimum dialysis-fluid flow rate or blood flow rate for an extracorporeal blood-treating apparatus in which account is taken of the demand for high effectiveness on the part of the dialysis treatment and of the demand for low consumption of the dialysis fluid. A further object of the present invention is to provide a blood-treating apparatus with which a dialysis treatment of relatively high effectiveness can be performed at a relatively low dialysis-fluid flow. It is also an object of the present invention to specify a method of operating a blood-treating apparatus to enable a dialysis treatment of relatively high effectiveness to be performed with a reasonable consumption of dialysis fluid.
In the system according to the present invention and the method according to the present invention for presetting a dialysis-fluid flow rate or blood flow rate for an extracorporeal blood-treating apparatus, that dialysis-fluid flow rate Qd is determined, for a preset blood flow rate, which, if it were increased by a given amount, would result in a metric characteristic of the effectiveness of the blood treatment increasing by not less than a given amount. Alternatively, that blood flow rate Qb may also determined, for a preset dialysis-fluid flow rate, which, if it were increased by a given amount, would result in a metric characteristic of the effectiveness of the blood treatment increasing by not less than a given amount.
The system according to the present invention and the method according to the present invention assume in this case that, although, as from an optimum value for the dialysis-fluid flow rate at a preset blood flow rate, or for the blood flow rate at a preset dialysis-fluid flow rate, an increase in the effectiveness of the dialysis treatment can still by achieved by a further increase in the dialysis-fluid flow rate and the blood flow rate in the respective cases, the additional dialysis fluid and the further increase in the blood flow which is required in the respective cases for such treatment of greater effectiveness does not bear an economical relationship to the increase in effectiveness which it gives. What is therefore aimed for as a target criterion is that operating point at which the consumption of additional dialysis fluid which would be needed to increase clearance by a given amount does not exceed a given amount, i.e. it is determined how many ml/min of dialysis fluid one is prepared to consume to achieve a further ml/min of clearance. Alternatively, what is aimed for is that operating point at which a further increase in the blood flow rate which would be necessary to increase clearance by a given amount does not exceed a given amount.
Different modes of treatment in which the effectiveness of the blood treatment differs can be preset, in which case that dialysis-fluid flow rate Qd or blood flow rate Qb is determined for the given mode of treatment which, if it were increased by a given amount, would result in the metric characteristic of the effectiveness of the blood treatment increasing by not less than an amount that is assigned to the given mode of treatment.
In practice, a ratio of 10:1 for the quotient Qd/K of dialysis-fluid flow rate Qd divided by clearance K, has proved satisfactory. Basically, however, a ratio covering a range from 5:1 to 20:1 is also acceptable.
The optimum dialysis-fluid flow rate Qdopt or blood flow rate Qbopt is dependent not only on the blood flow rate and dialysis-fluid flow rate respectively but also on the dialyser that is used for the dialysis treatment. The system according to the present invention and the method according to the present invention therefore make provision for the optimum dialysis-fluid flow rate or blood flow rate, as the case may be, to be determined as a function of a metric characteristic of the dialyser, and in particular the mass transfer coefficient k0A of the dialyser.
The optimum dialysis-fluid flow rate Qdopt as a function of the blood flow rate Qb and of a metric characteristic of the dialyser, and particularly the mass transfer coefficient k0A, can be stored in a memory of the dialysis apparatus as a three-dimensional family of characteristics. However, for reasons of storage space, the family of characteristics is preferably defined by a suitable mathematical equation from which the optimum dialysis-fluid flow rate can be calculated for preset blood flow rates and mass transfer coefficients. The three-dimensional family of characteristics is preferably approximated by a higher-order polynomial, and particularly a third-order polynomial in two or more variables including all the cross-terms. The same is true, mutatis mutandis, of the alternative of an optimum blood flow rate as a function of the dialysis-fluid flow rate.
For the calculation of the optimum dialysis-fluid flow rate or blood flow rate, the system according to the present invention preferably has a calculating unit by which the optimum dialysis-fluid flow rate is calculated as a function of the blood flow rate, or vice versa, for a given dialyser or for different dialysers having different mass transfer coefficients.
The system according to the present invention and the method according to the present invention for presetting a dialysis-fluid flow rate or a blood flow rate may be used to make a suggestion to the treating physician for the setting of an optimum dialysis-fluid flow rate or blood flow rate. The system according to the present invention may be part of a blood-treating apparatus in this case or may form a separate unit. The blood-treating apparatus will however preferably already have the system according to the present invention for presetting the optimum dialysis-fluid flow rate or blood flow rate. It is also preferable for the preset dialysis-fluid flow rate or blood flow rate not just to be suggested to the treating physician but also to be set automatically for the blood treatment.



BRIEF DESCRIPTION OF THE DRAWINGS
An embodiment of the present invention is explained in detail below by reference to the drawings. In the drawings:
FIG. 1 is a highly simplified schematic view of the principal components of an apparatus according to the present invention for the extracorporeal treatment of blood, having a system according to the present invention for presetting an optimum dialysis-fluid flow rate.
FIG. 2 shows clearance K (ml/min) as a function of the dialysis-fluid flow rate Qd (ml/min) for a given dialyser for various blood flow rates Qb.
FIG. 3 shows the additional amount of dialysis fluid that is required to increase clearance by 1 ml/min at different dialysis-fluid flow rates Qd and blood flow rates Qb.
FIG. 4 shows a three-dimensional family of characteristics in which the optimum dialysis-fluid flow rate Qdopt is represented as a function of blood flow rate Qb and the mass transfer coefficient of the dialyser.
FIG. 5 shows dialysis-fluid flow rate Qd (ml/min) as a function of blood flow rate Qb (ml/min) in the case of the method according to the present invention, i.e. the system according to the present invention, in comparison with known methods.
FIG. 6 shows clearance K (ml/min) as a function of blood flow rate Qb (ml/min) in the case of the method according to the present invention, or in other words the system according to the present invention, in comparison with known methods.
FIG. 7 shows the difference between clearance Kopt in the case of the method according to the present invention, or in other words the system according to the present invention, and clearance K(A, B) in the case of known methods, as a function of the blood flow rate Qb (ml/min).
FIG. 8 shows the quotient of optimum dialysis-fluid flow rate Qdopt divided by blood flow rate Qb in accordance with the present invention as a function of blood flow rate Qb, in comparison with the known methods.
FIG. 9 shows the quotient of optimum dialysis-fluid flow rate Qdopt divided by blood flow rate Qb as a function of blood flow rate Qb, in comparison with known methods.



DETAILED DESCRIPTION OF THE DRAWINGS
FIG. 1 shows an embodiment of a blood-treating apparatus according to the present invention which has a system according to the present invention for presetting an optimum dialysis-fluid flow rate. A blood-treating apparatus which has a system according to the present invention for presetting an optimum blood flow rate differs from the apparatus shown in FIG. 1 only in that what is determined in accordance with the criteria according to the present invention is not the dialysis-fluid flow rate Qd as a function of the blood flow rate, but the blood flow rate Qb as a function of the dialysis-fluid flow rate Qd, which, if it were increased by a given amount, would result in a metric characteristic of the effectiveness of the blood treatment increasing by not less than a given amount. Otherwise, both pieces of apparatus comprise the same components.
For greater clarity, it is only the essential components of the blood-treating apparatus which are shown in FIG. 1 because the individual components of a blood-treating apparatus for hemodialysis or hemodiafiltration will be generally familiar to the person skilled in the art.
The dialysis apparatus according to the present invention has a dialyser 1 which is divided by a semi-permeable membrane 2 into a blood chamber 3 and a dialysis-fluid chamber 4. From a patient, an arterial blood line 5, into which a blood pump 6 is connected, runs to an inlet of the blood chamber 3 of the dialyser, while a venous blood line 7 runs from an outlet of the blood chamber to the patient.
Fresh dialysis fluid is made available in a dialysis-fluid source 8. From the dialysis-fluid source 8, a dialysis-fluid inlet line 9 runs to an inlet of the dialysis-fluid chamber 4 of the dialyser 1, while a dialysis-fluid outlet line 10 runs from an outlet of the dialysis-fluid chamber to a discharge outlet 11. A dialysis-fluid pump 12 is connected into the dialysis-fluid outlet line 10.
The dialysis apparatus has a control unit 13 which is connected to the blood pump 6 and the dialysis-fluid pump 12 via control lines 14, 15, respectively. The control unit 13 produces control signals for operating the blood and dialysis-fluid pumps 6, 12 at a preset pumping rate so that a preset blood flow rate Qb is set in the blood line 5 and a preset dialysis-fluid flow rate Qd is set in the dialysis-fluid line.
For the input of various parameters for the dialysis, the dialysis apparatus has an input unit 16 which has for example an alphanumeric keyboard 16A. As well as various other variables, the blood flow rate Qb and a metric characteristic of the effectiveness of the dialyser 1 that is being used, and in particular the mass transfer coefficient k0A of the dialyser, may be entered with the input unit 16. Via a data line 17, the input unit 16 is connected to the control unit 13, by which the individual components of the dialysis apparatus, and in particular the blood and dialysis-fluid pumps, are operated in such a way that the dialysis treatment is performed with the preset dialysis parameters.
For a preset blood flow rate Qb, the dialysis apparatus presets an optimum dialysis-fluid flow rate Qd. For this purpose, the dialysis apparatus has an arrangement 18 for presetting the optimum dialysis-fluid flow rate Qdopt, the construction and operation of which will be described in detail in what follows.
It is assumed that the dialysis treatment will be performed with a given dialyser 1 which has a given effectiveness which can be specified by means of the mass transfer coefficient k0A of the dialyser. In the case of hemodialysis, clearance K is calculated from the blood flow rate Qb, the dialysis-fluid flow rate Qd and the mass transfer coefficient k0A of the dialyser 1 using the following equation:




  
    
      
        K
        =
        
          
            Q
            b
          
          ⁢
          
            
              
                e
                
                  k
                  ⁢
                  
                    
                  
                  ⁢
                  0
                  ⁢
                  
                    
                  
                  ⁢
                  
                    A
                    ⁡
                    
                      (
                      
                        
                          1
                          
                            Q
                            b
                          
                        
                        -
                        
                          1
                          
                            Q
                            d
                          
                        
                      
                      )
                    
                  
                
              
              -
              1
            
            
              
                e
                
                  k
                  ⁢
                  
                    
                  
                  ⁢
                  0
                  ⁢
                  
                    
                  
                  ⁢
                  
                    A
                    ⁡
                    
                      (
                      
                        
                          1
                          
                            Q
                            b
                          
                        
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                          1
                          
                            Q
                            d
                          
                        
                      
                      )
                    
                  
                
              
              -
              
                
                  Q
                  b
                
                
                  Q
                  d
                
              
            
          
        
      
    
    
      
        Equation
        ⁢
        
          
        
        ⁢
        
          (
          1
          )
        
      
    
  




FIG. 2 shows clearance K as a function of dialysis-fluid flow rate Qd for various blood flow rates Qb. It can be seen that a saturation of clearance K occurs at high dialysis-fluid flow rates Qd. Therefore, as from a certain blood flow rate, an increase in dialysis-fluid flow rate ceases to produce any appreciable gain in clearance. As a function of the blood flow rate Qb, the system according to the present invention presets an optimum dialysis-fluid flow rate Qdopt as an optimum operating point for the dialysis apparatus. The optimum operating points for different blood flow rates are indicated in FIG. 2 by circles, a ratio of additional dialysis fluid per ml/min of additional clearance of 10:1 having been selected for the operating points. If, starting from the given operating point, a further increase is made in the dialysis-fluid flow rate Qd, then an increase in the dialysis-fluid flow rate no longer involves an increase of more than a given amount in a metric characteristic of the dialysis treatment, and in particular in the clearance K. Hence, the optimum dialysis-fluid flow rate Qdopt is that dialysis-fluid flow rate which, when exceeded, results in the derivative of the function shown in FIG. 1, which defines the dependence on the dialysis-fluid flow rate Qd of the metric characteristic of the dialysis treatment, in particular the clearance K, being less than a given value. Consequently, what is considered is not the absolute value of clearance but the derivative. FIG. 3 shows how many ml/min of additional dialysis-fluid are required at different blood flow rates Qb from 100 ml/min to 600 ml/min to increase the clearance K by 1 ml/min.
Trials have shown that in practice a ratio of 10:1 gives an operating point at which relatively high effectiveness is obtained from the dialysis treatment for an acceptable consumption of dialysis fluid. This target criterion of 10:1 is indicated in FIG. 3 by a horizontal dashed line. The respective intersections with the curves for the different blood flow rates represent the various operating points. Because the derivative of the dialysis-fluid-flow-rate-dependent function described above cannot readily be actually calculated, the present invention makes provision for iterative approximate solutions.
In FIGS. 2 and 3, it can clearly be seen that at a blood flow rate Qb=100 ml/min the operating point is in the saturation range. However, at the operating point for Qb=600 ml/min it could be assumed that a further increase in the dialysis-fluid flow rate would still give a pertinent gain in clearance. However, an objection that has to be raised in this case is that, to the right of the operating point, the dialysis-fluid flow rate would have to be raised by more than 10 ml/min to obtain a gain in clearance of only 1 ml/min.
FIGS. 2 and 3 show clearance as a function of dialysis-fluid flow rate only for one specific type of dialyser which has a given mass transfer coefficient k0A. However, in practice different dialysers which differ in having different mass transfer coefficients can be used in pieces of dialysis apparatus. FIG. 4 shows a three-dimensional family of characteristics from which the optimum dialysis-fluid flow rate Qdopt can be determined as a function of the blood flow rate Qb for different dialysers, which are each distinguished by a given mass transfer coefficient k0A.
The family of characteristics shown in FIG. 4 could be stored in the form of a table in a memory of the arrangement 18 according to the present invention for presetting the optimum dialysis-fluid flow rate. However, for reasons of storage space, the present invention makes provision for the family of characteristics to be approximated by means of a suitable function. Various mathematical processes are known for this purpose.
In the embodiment described, the three-dimensional family of characteristics is approximated by a third-order polynomial in two axes using all the possible cross-terms. This gives the following modelling equation having 4×4=16 parameters a(i,j):

QDopt=α33·Qb3k0A3+α32·Qb3k0A2 . . . α30·Qb3k0A0 

+α23·Qb2k0A3+α22·Qb2k0A2 . . . α20·Qb2k0A0 

. . .

+α03·Qb0k0A3+α02·Qb0k0A2 . . . α00  Equation (2)

The individual parameters in the above system of equations are determined by the least squares method, thus minimizing the sum of the squared differences between the raw data and the model. In practice, the match between the family of characteristics (surface) and the modelling equation is sufficiently good.
For the dialysis treatment to be performed, the treating physician presets a given blood flow rate Qb, which he enters from the keyboard 16A of the input unit 16, whereupon the control unit 13 sets the pumping rate (speed) of the blood pump 6 accordingly. From the input unit 16, the physician also enters details of which dialyser 1 is being used for the dialysis treatment, whereupon the mass transfer coefficient k0A belonging to the given type of dialyser, which is stored in a memory, is determined. It is however also possible for the particular mass transfer coefficient k0A of the dialyser that is being used to be entered directly.
The values of the preset blood flow rate Qb and the preset mass transfer coefficient k0A are received from the control unit 13 by the arrangement 18 via a data line 19. The arrangement 18 has a calculating unit 18A which calculates the optimum dialysis-fluid flow rate Qdopt on the basis of the third-order equation described above. To show the optimum dialysis-fluid flow rate Qdopt, the arrangement 18 has an indicating unit 18B, in the form of a screen or display for example.
The arrangement 18 also transmits the value calculated for the optimum dialysis-fluid flow rate Qdopt via the data line 19 to the control unit 16, which in turn sets the speed of the dialysis-fluid pump 12 in such a way that the dialysis fluid is pumped at the optimum dialysis-fluid flow rate Qdopt.
In a preferred embodiment, the input unit 16 makes provision for the input of different target criteria. What may be set as a target criterion in addition to the ratio of 10:1 described above is for example a ratio of 5:1, i.e. 5 ml/min of additional dialysis fluid for 1 ml/min of additional clearance and a ratio of 15:1 or 20:1.
As a function of the mode set (5:1, 10:1 and 15:1 or 20:1), the calculating unit 18A of the arrangement 18 then calculates the optimum dialysis-fluid flow rate Qdopt. The ratio of 5:1 represents in this case an economical mode in which, although dialysis fluid is to be saved, the accustomed clearance cannot be achieved, the ratio of 10:1 represents a normal mode and the ratio of 15:1 or 20:1 represents an intensive mode in which particularly high clearance is to be achieved but by using a larger amount of dialysis fluid.
In the event of allowance also being made for the ultrafiltrate flow in hemodialysis, what is obtained in place of equation (1) given above is the following equation (1′) for hemodialysis with allowance made for the ultrafiltration:




  
    
      
        K
        =
        
          
            
              
                1
                -
                
                  exp
                  ⁡
                  
                    [
                    
                      
                        
                          
                            k
                            0
                          
                          ⁢
                          A
                        
                        
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                          B
                        
                      
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              (
              
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                    Q
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              )
            
          
          +
          
            Q
            F
          
        
      
    
    
      
        Equation
        ⁢
        
          
        
        ⁢
        
          (
          
            1
            ′
          
          )
        
      
    
  




where

QB=blood flow

QD=dialysate flow

QF=filtrate flow, only ultrafiltration in the present case

k0A=mass transfer area coefficient.

In what follows, the more general case of hemodiafiltration will be described, in which not only hemodialysis but also hemofiltration takes place. In the case of hemodiafiltration, the relationship between the flow rates is defined by the following more general equation (1′′) for hemodiafiltration.




  
    
      
        
          K
          =
          
            
              Q
              Bi
            
            ·
            
              
                1
                -
                
                  
                    
                      
                        Q
                        Do
                      
                      
                        Q
                        Di
                      
                    
                    ·
                    
                      
                        Q
                        Bo
                      
                      
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                        Bi
                      
                    
                  
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                -
                
                  
                    
                      Q
                      Bo
                    
                    
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                      Di
                    
                  
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        ⁢
        where
        ⁢
        
          

        
        ⁢
        
          Z
          =
          
            
              
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                  -
                  
                    
                      Q
                      F
                    
                    
                      Q
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              A
            
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                  -
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                F
              
            
          
        
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                F
              
              
                
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        ⁢
        
          
        
        ⁢
        
          (
          
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where

    σ=reflection coefficient (0<σ<1), e.g. σ=0 for urea
    i=subscript for inflow
    o=subscript for outflow
    QF=total filtration rate=sum of ultrafiltration rate QUF and substitution rate QS 

QF=QUF+QS 

    QDi=flow which is present at the dialysate inlet of the dialyser; generally corresponds to the dialysate flow QD set on the machine
    QDo=flow which is present at the dialysate outlet of the dialyser

QDo=QDi+QF 

    QBi=flow which is present at the blood inlet of the dialyser

QBi=QB+f·QS 
    
        where f is a factor for pre-dilution or post-dilution; f=0 for post-dilution, f=1 for pre-dilution and f=between 0 and 1 for mixed dilution
    
    
    QBo=flow which is present at the blood outlet of the dialyser

QBo=QBi+QF 

    QB=blood flow which is present in the extra-corporeal blood circuit upstream of the point of arterial infusion; generally corresponds to the blood flow set by the user.


The differences of the method according to the present invention for presetting a given dialysis-fluid flow rate as compared with the known methods will be described below by reference to FIGS. 5 to 9. In FIGS. 5 to 9, a known method in which a constant dialysis-fluid flow rate Qd of 500 ml/min is set for blood flow rates Qb Up to 300 ml/min and a constant dialysis-fluid flow rate Qd of 800 ml/min is set for blood flow rates Qb greater than 300 ml/min is shown as “A.” A known method in which the dialysis-fluid flow rate is calculated by multiplying the blood flow rate Qb by a factor of 1.2 is shown as “B.” FIG. 5 shows dialysis-fluid flow rate Qd as a function of blood flow rate Qb for the method according to the present invention as compared with the known methods “A” and “B,” while FIG. 6 shows clearance K as a function of blood flow rate for the method according to the present invention and the known methods “A” and “B.”
FIG. 7 shows, as a function of the blood flow rate Qb, the difference between the clearance Kopt at the optimum dialysis-fluid flow rate Qdopt achieved with the method according to the present invention and the clearances KA and KB achieved with the known methods, to give a clearer picture of the differences between the method according to the present invention and the known methods with regard to the change in clearance. Compared with the known method “A,” a relatively large amount of dialysis fluid is saved with the method according to the present invention, even though clearance is reduced by only a relatively small amount. It is true that with method “B” more dialysis fluid is saved than with method “A,” but it also results in a larger reduction in clearance.
For the selected “target criteria” of 10:1 (FIG. 8) and 5:1 (FIG. 9), FIGS. 8 and 9 show the optimum dialysis-fluid flow rates Qdopt that are standardised in accordance with the present invention to the blood flow rate, for three different dialysers. It can be seen that, for the selected target criterion of 10:1, a factor of 1.5 is only plausible for different dialysers as a first approximation in the working range between Qb=200 and 400. The factor of 1.2 on the other hand is too low for the target criterion of 10:1. The position changes however if a target criterion of 5:1, i.e. 5 ml/min of dialysis fluid for 1 ml/min of clearance, is selected. It can be seen that a factor of 1.2 is a better approximation in this case. With the teaching according to the present invention, a compromise is successfully found between methods A and B, the user being given at the same time quantified operating points at which he has a direct overview of the effects which increases in flow rate have on the effectiveness of the treatment.

## Claims

1. A system for pre-setting a flow rate for an extracorporeal blood-treating apparatus comprising a dialyser divided into a blood chamber and a dialysis chamber by a semi-permeable membrane, wherein blood flows through the blood chamber and dialysis fluid flows through the dialysis chamber, said system comprising
a means for selecting an optimum flow rate, said means for selecting an optimum flow rate being selected from the group consisting of:
a means for selecting an optimum dialysis fluid flow rate Qdopt as a function of a pre-set blood flow rate Qb, wherein Qdopt for the pre-set blood flow rate Qb is a solution for Qdopt such that if Qdopt were increased by a first given amount, a metric characteristic of the effectiveness of the blood treatment would increase by approximately a second given amount; and
a means for selecting an optimum blood flow rate Qdopt as a function of a pre-set dialysis fluid flow rate Qd, wherein Qbopt for the pre-set dialysis fluid flow rate Qd is a solution for Qbopt such that if Qbopt were increased by a third given amount, a metric characteristic of the effectiveness of the blood treatment would increase by approximately a fourth given amount,
wherein the means for selecting Qdopt or the means for selecting Qbopt is a calculating unit configured such that Qdopt or Qbopt is calculated from a mathematical equation by an iterative approximate solution method.

2. The system of claim 1, wherein the metric characteristic of the effectiveness is a clearance K of the dialysis treatment.

3. The system of claim 2, configured such that Qbopt or Qdopt is selected as a function of a metric characteristic of the dialyser.

4. The system of claim 1, configured such that Qbopt or Qdopt is selected as a function of a metric characteristic of the dialyser.

5. The system of claim 4, wherein the metric characteristic of the dialyser is a mass transfer coefficient k0A of the dialyser.

6. The system of claim 5, further comprising
an input unit for presetting various modes of treatment in which the effectiveness of the blood treatment differs, configured such that for a first given mode of treatment and a second given mode of treatment:
a ratio of the first given amount to the second given amount for the first given mode of treatment differs from a ratio of the first given amount to the second given amount for a second given mode of treatment; or
a ratio of the third given amount to the fourth given amount for the first given mode of treatment differs from a ratio of the third given amount to the fourth given amount for the second given mode of treatment.

7. The system of claim 1, further comprising:
an input unit for presetting various modes of treatment in which the effectiveness of the blood treatment differs, configured such that for a first given mode of treatment and a second given mode of treatment:
a ratio of the first given amount to the second given amount for the first given mode of treatment differs from a ratio of the first given amount to the second given amount for the second given mode of treatment; or
a ratio of the third given amount to the fourth given amount for the first given mode of treatment differs from a ratio of the third given amount to the fourth given amount for the second given mode of treatment.

8. The system of claim 1, wherein the mathematical equation is a multi-order polynomial.

9. A blood-treating apparatus for the extracorporeal treatment of blood, comprising:
a dialyser divided by a semi-permeable membrane into a blood chamber and a dialysis chamber, wherein blood flows through the blood chamber at a pre-set blood flow rate Qb, or a dialysis fluid flows through the dialysis chamber a pre-set dialysis fluid rate Qd; and
the system for pre-setting a flow rate of claim 1.

10. The blood-treating apparatus of claim 9, further comprising:
a control unit for pre-setting Qd or Qb.

11. The blood-treating apparatus of claim 10, further comprising:
at least one of:
a dialysis-fluid pump for pumping the dialysis fluid, and
a blood pump for pumping blood,

wherein the control unit is configured to set the speed of the dialysis fluid pump at the pre-set dialysis flow rate Qd or to set the speed of the blood pump at the pre-set blood flow rate Qb.

12. A method for pre-setting a dialysis fluid flow rate or a blood flow rate for an extracorporeal blood-treating apparatus comprising a dialyser divided into a blood chamber and a dialysis chamber by a semi-permeable membrane, wherein the blood flows through the blood chamber and dialysis fluid flows through the dialysis chamber, the method comprising:
selecting an optimum dialysis fluid flow rate Qdopt as a function of a pre-set blood flow rate Qb at a pre-set blood flow rate Qb such that if Qdopt were increased by a first given amount, a metric characteristic of the effectiveness of the blood treatment would increase by approximately a second given amount; or
selecting an optimum blood flow rate Qbopt as a function of a pre-set dialysis fluid flow rate Qd at a pre-set dialysis fluid flow rate Qd such that if Qbopt were increased by a third given amount, a metric characteristic of the effectiveness of the blood treatment would increase by approximately a fourth given amount,
wherein Qdopt or Qbopt is calculated from a mathematical equation by an iterative approximate solution method.

13. The method of claim 12, wherein the metric characteristic of the effectiveness is a clearance K of the dialysis treatment.

14. The method of claim 12, further comprising selecting Qbopt or Qdopt as a function of a metric characteristic of the dialyser.

15. The method of claim 14, wherein the metric characteristic of the dialyser is a mass transfer coefficient k0A of the dialyser.

16. The method of claim 12, further comprising:
presetting at least two modes of treatment in which the effectiveness of the blood treatment differs, such that for a first given mode of treatment and a second given mode of treatment:
a ratio of the first given amount to the second given amount for the first given mode of treatment differs from a ratio of the first given amount to the second given amount for the second given mode of treatment; or
a ratio of the third given amount to the fourth given amount for the first given mode of treatment differs from a ratio of the third given amount to the fourth given amount for the second given mode of treatment.

17. The method of claim 12, wherein the mathematical equation is a multi-order polynomial.

18. A method comprising:
performing the method for pre-setting the dialysis fluid flow rate or the blood flow rate of claim 12; and
operating the extracorporeal blood-treating apparatus comprising a dialyser divided by a semi-permeable membrane into a blood chamber and a dialysis chamber, wherein blood flows through the blood chamber at the pre-set blood flow rate Qb, or a dialysis fluid flows through the dialysis chamber at the pre-set dialysis fluid rate Qd.