# Patent

## Title
Dialysis machine for actuating a method for detecting a liquid level in a container in a circuit

## Abstract

A container of a dialysis machine has a determined shape and a known volume occupied in part by a volume of a mass of blood; a remaining part is occupied by a volume of a mass of gas. A disturbance is induced in a combined mass of the liquid and the gas in the container and an entity of the disturbance is measured. Measurements of pressure in the container before and after the disturbance are taken, the volume of gas is calculated using a function correlated to a gas law, and the volume and level of the liquid in the container are derived after the volume occupied by the gas is calculated.

## Background
This is a divisional of U.S. patent application Ser. No. 10/443,996, filed May 23, 2003.


BACKGROUND OF THE INVENTION
The invention relates to a method for detecting a liquid level in a container of a circuit.
In particular, the invention relates to a method for detecting a level of blood in a container of a circuit of a dialysis machine, to which the present application will make specific reference without in any way limiting the scope of the invention.
A known-type dialysis machine comprises a first blood circulation circuit and a second circulation circuit for the dialysate liquid. The first circuit and the second circuit are connected to a filter for conveying, respectively, the blood and dialysate liquid through the filter, which is provided with a semi-permeable membrane separating the blood from the dialysate liquid. The first circuit is provided with a container, known as a drip chamber, into which the blood is supplied from a first tract of the first circuit, and drips and collects on the bottom of the container, thence to enter a second tract of the first circuit. The container has the function of preventing air from becoming trapped in the blood in the form of bubbles, which might cause embolisms once the treated blood was returned to the cardio-vascular system of the patient. To guarantee the safest possible treatment the blood level in the container must be maintained within an optimum range of values, below which the possibility of creating air bubbles in the blood returning to the patient exists, and above which the pressure increases to unacceptable values which are dangerous for the patient.
To solve this problem, the prior art teaches blood level detection devices, comprising an optical emitter arranged on one side of the container and an optical reader arranged on another side of the container at an optimal level. This sensor device detects only if the level of blood is above or below the optimal level and is therefore unable to provide an accurate level reading. To obtain a more accurate blood level reading, the above-described sensor device has been modified to include two optical emitters and two optical readers suitably arranged, which provide an acceptability interval parameter of the blood level.
Still more accurate readings can be achieved with a plurality of optical emitters and a plurality of optical readers, which define a plurality of intervals and detect the interval which the blood level is at.
The above-described sensor devices are based on the principle of emission and reception of a signal and become progressively more complicated as the need for more accurate blood level readings increases, since the number of emitters and readers increases together with the need for accuracy.
SUMMARY OF THE INVENTION
The main aim of the present invention is to provide a level sensor method in a container of a circuit, which method is without the drawbacks inherent in the prior art and which, in particular, provides a high degree of accuracy and requires the use of simple and economical equipment.
The present invention provides a method for detecting a level of liquid in a container connected to a circuit, the container being of a determined shape and having a known volume occupied in part by a volume of a mass of liquid and, in a remaining part, by a volume of a mass of gas, the method being characterised in that it determines the volume of the mass of gas in order to calculate the volume of the liquid and the level thereof.
The present invention also relates to a dialysis machine.
The present invention provides a dialysis machine for actuating the method characterized in that it comprises a pressure sensor for detecting the pressure of the mass of gas in the container.



BRIEF DESCRIPTION OF THE DRAWINGS
The present invention will now be described with reference to the accompanying figures of the drawings, which illustrate a non-limiting embodiment thereof, and in which:
FIG. 1 is a schematic side elevation, with some parts removed for reasons of clarity and other parts shown in section, of a dialysis machine and a circuit associated to the dialysis machine, and
FIG. 2 is a schematic side elevation, with some parts removed for reasons of clarity and other parts shown in section, of a variant of the machine of FIG. 1.



DETAILED DESCRIPTION
With reference to FIG. 1, 1 denotes in its entirety a dialysis machine comprising a blood circulation circuit 2, which during operation is connected up to the cardio-vascular system of a patient, in order to convey the patient's blood during a dialysis treatment. At the end of the treatment the circuit 2 is eliminated as it is disposable as special waste after one use only.
The dialysis machine 1 comprises a control unit 3 and a peristaltic pump 4 for circulating the blood in the circuit 2.
The circuit 2 comprises a container 5, a supply branch 6 for taking blood to the container 5 which is trained about a peristaltic pump 4, and a return branch 7 taking the blood from the container 5. The container 5 comprises an upper wall 8, through which the supply branch 6 is connected to the container 5, a lower wall, to which the return branch 7 is attached, and a lateral wall 10.
The machine 1 comprises a pressure sensor 11 arranged along the supply branch 6 directly upstream of the container 5, a temperature sensor 12 arranged along the lateral wall 10 of the container 5, and a pressure sensor 13 arranged along the return branch 7. Alternatively, the pressure sensor 13 can be substituted by a flow rate sensor 14, which is illustrated in a broken line in FIG. 1, and detects the flow rate Qout of blood exiting from the container 5. The pressure sensor 13 reads the pressure Pb at a predetermined point in the branch 7 and enables calculation of flow rate Qout by means of a constant H of known loss of head along the return branch 7 comprised between the container 5 and the pressure sensor 13. The pressure sensor 11, the temperature sensor 12, and the pressure sensor 13 are connected to the control unit 3, which is connected in turn to the peristaltic pump 4 for controlling and commanding the peristaltic pump 4 and for reading, at the same time, the flow rate of the blood Qin introduced into the container 5 by the peristaltic pump 4.
During operation, the blood removed from the patient is fed into the container 5 through the supply branch 6, where it drips and is collected on the bottom of the container 5 from which it is removed through the return branch 7.
The container 5 is hermetically sealed and is connected only to the supply branch 6 and the return branch 7. The container 5 exhibits a constant volume VC, which is in part occupied by a mass M of blood corresponding to a volume V of blood and a mass N of air which corresponds to a volume VA at a predetermined pressure P.
The pressure sensor 11 monitors the air pressure P (which corresponds to the blood pressure in the container 5) present in the upper part of the container 5 and transmits the values detected to the control unit 3, while the temperature sensor 14 monitors the temperature T of the air contained in the container 5 and transmits the read values to the control unit 3, which receives the measurements of the flow rate at inflow Qin and the flow rate at outflow QOUT.
Determination of the level of blood in the container 5 is done by means of a calculation of the volume V of blood, which is determined as the difference between the volume VC of the container 5 and the volume VA of the air, which volume VA is determined by means of a function correlated to a law relating to gases on the basis of the values transmitted to the control unit 3. As the calculation of the volume of air done using a gas law, such as Perfect Gas Law, (also known as Boyle-Mariotte's Law) namely PV=JRT, also requires measurement of the number J of moles of air present in the container 5, as well as two easily measurable amounts i.e. pressure P and temperature T, the method is based on the principle of disturbance of the overall mass contained in the container 5.
This in effect means inducing a change in the mass M of blood in the container 5, calculating the entity of the ensuing disturbance corresponding to the variation in the volume V of blood, which can be calculated from the integral of the balance of the blood inflowing flow rate Qin and the outflowing flow rate Qout and detecting the effects of the disturbance, which correspond to a change in the pressure P of the air, the temperature T remaining practically constant. With the disturbance caused to the mass M, the volume VA occupied by the air can be calculated and so can the volume V and level of the blood.
The present invention presupposes that the blood is a non-compressible liquid and that the measurement of the level will be more accurate according to how true the non-compressible aspect is. Tests have shown that blood at the machine working pressures in dialysis machines does in fact behave as a non-compressible liquid: there therefore exists a directly proportional relationship between the mass M of blood and the volume V of blood in the container 5.
In order to explain the invention in more detail, there follows an example relating to the calculation of the level following creation of a disturbance in the mass M of blood.
EXAMPLE 1
The container 5 contains, at a determined moment t0, a volume V of blood and the blood inflows at a flow rate Qin by means of the peristaltic pump 4, while outflowing blood from the container 5 occurs at a flow rate Qout. The overall volume of the container 5 is VC, thus the volume VA occupied by the air at t0 is VC−V, while the air pressure at t0 is equal to P0. The peristaltic pump 4 operation modes cause a variation in the inflow flow rate Qin and the outflow flow rate Qout and therefore cause a cyclic variation in the volume V of blood in the container 5. Thus, at a determined moment t1 the change in the blood volume is VD and the following expression of the relations results:

P0(VC−V)=JRT at moment t0 

P1(VC−V−VD)=JRT at moment t0 

in which the number J of moles of air remains constant, R is a constant, and the temperature T is considered to be constant. From the above expressions the following can be derived:

P0(VC−V)=P1(VC−V−VD)

in which 



  
    V
    D
  
  =
  
    
      ∫
      
        t
        0
      
      
        t
        1
      
    
    ⁢
    
      
        (
        
          
            Q
            in
          
          -
          
            Q
            out
          
        
        )
      
      ⁢
      
        
      
      ⁢
      
        d
        t
      
    
  




from which the volume V at moment t0 is derived as 



  V
  =
  
    
      V
      c
    
    -
    
      
        
          P
          1
        
        ·
        
          V
          D
        
      
      
        
          P
          1
        
        -
        
          P
          0
        
      
    
  




and the volume at t1 is V+VD.

The value of V can be derived from the inflow flow rate Qin and the outflow flow rate Qout i.e. the disturbance caused, and from the pressure P change, i.e. the effect of the disturbance. From the value of V the level of blood contained in the container can be determined. In this case, the circuit 2 must be equipped with the flow rate sensor 14 in order to detect the outflowing flow rate Qout from the container 5; and the control of the peristaltic pump 4 r.p.m. must provide the inflowing flow rate Qin Alternatively, on reading the outflowing flow rate Qout, the pressure Pb read at a determined point along the return branch 7 enables the outflow flow rate to be determined using the following equation:

Qout=H·(P−Pb),

in which H is the loss of head in the return branch 7 comprised between the container 5 and the pressure sensor 13.

The temperature T is monitored only for the purpose of determining if there occur any relevant changes in the temperature T and, therefore, for the purpose of evaluating whether the measurement taken is valid. However, it has generally been the case that the change in temperature T is not appreciable and the temperature sensor 12 can be left out. The function PV=JRT can be rewritten as PV=NK in which K is a constant that comprises the value of the temperature T and the constant R of the gas, while the number J of moles of air is related to the mass N of air.
In the variant of FIG. 2, the peristaltic pump 4 is left out and the machine 1 comprises a pump 15 connected to the upper wall 8 of the container 5 by a conduit 16 and controlled by the control unit 3. The pump 15 is a positive displacement pump supplying an air flow rate QA which varies according to the number of pump 15 revolutions per minute.
In this case, the function PV=NK is used to evidence the variation in the mass of gas determined by the pump 15. During operation, the pump 15 sends a determined mass DN of air into the container 5 to calculate the volume VA of air on the basis of the disturbance in the pressure P. To clarify this calculation process, a further example is now given.
EXAMPLE 2
The container 5 contains a determined volume V of blood which corresponds to a mass M of blood and both the blood supply and evacuation are interrupted. The volume occupied by the air is VA, which corresponds to a mass N of air. The overall volume of the container 5 is VC, therefore the volume occupied by the air is VC−V, while the pressure detected at a determined moment to is P0. The slight pressure variations P lead to establish that the temperature T can be considered constant.
In the above established state, at moment to the following is a valid expression:

P0(VC−V)=N0K  a)

The pump 15 induces a disturbance in the container 5, which is a variation in the mass N0 of air, by injecting a mass DN of air into the container 5, to bring the mass of air up to a level expressed by:

N1=N0+DN.  b)

The disturbance in the mass of air determines a variation in pressure P inside the container 5. Following the variation in mass, at moment t1 the following is a valid expression:

P1(VC−V)=N1K.  c)

Putting the three expressions together (a, b, c), unknowns N0, N1 and V are derived, while P0 and P1 are measured, VC is known from the geometry of the container 5 and DN is derived from the following equation: 



  DN
  =
  
    
      ∫
      
        t
        0
      
      
        t
        1
      
    
    ⁢
    
      
        Q
        A
      
      ⁢
      
        
      
      ⁢
      
        d
        t
      
    
  




in which QA is the flow rate of the pump 4.

Once V has been determined, as the geometry of the container 5 is known, the level of blood in the container can be deduced. In this case the control unit 3 receives the values of the pressure P0 before the disturbance, the values of flow rate QA of the peristaltic pump 4 for determining the entity of the disturbance, and the values P1 after the disturbance. The start of the disturbance enables a relatively easy measurement to be made, namely the flow rate of air QA to obviate the measurement of the mass N0 contained in the container 5. The flow rate of air QA in terms of mass can be derived from the measurement of the flow rate QA in terms of volume, the compression ratio of the pump 4 and the fact that the air is taken in at room temperature.
In examples 1 and 2, reference has been made to Perfect Gas Law, though the method of the present invention is valid for determining the level even when other gas laws are used that relate the volume VA, the pressure P, the mass N and the temperature T and other properties that can be considered constant.
Tests carried out by the applicant have demonstrated that the reading of the pressure P before and after the disturbance is vital in calculating the volume of air VA and, therefore, the level, while monitoring the temperature T is not necessary for the calculation of the level, as it is supposed that variations in mass M and N induce isothermal transformation. The reading of the temperature can be considered constant and, therefore, provides an evaluation parameter regarding the reliability of the measurement.

## Claims

1. A dialysis machine comprising:
a pump for circulating blood through a circuit comprising a container in which a gas space is created above a liquid level;
a pressure sensor for detecting a pressure in said container; and
a control unit connected to the pump and to the pressure sensor and designed to determine the liquid level in the container from pressure values detected by the pressure sensor before and after a variation induced in at least one of a mass of the gas and a mass of the liquid in the container.

2. The machine of claim 1, wherein said pump is a peristaltic pump able to induce said variation of liquid mass in the container.

3. The machine of claim 1, comprising a conduit for channeling the gas to the container and a pump for supplying the gas.

4. The machine of claim 1, comprising a temperature sensor for detecting the temperature of the gas in the container.

5. The machine of claim 1, wherein the control unit is designed to calculate a volume of the gas in the container on the basis of a gas law which interrelates mass, volume, temperature and pressure of the gas, and to determine the liquid level from said gas volume.

6. The machine of claim 1, wherein the control unit is designed to calculate a liquid volume variation equal to an integral of the difference between a liquid flow rate in inflow to the container and a liquid flow rate in outflow from the container between an initial moment and a final moment.

7. The machine of claim 6, comprising sensors for measuring the liquid flow rate in inflow to the container and the liquid flow rate in outflow from the container.

8. The machine of claim 6, further comprising:
sensors for measuring the liquid flow rate in inflow to the container and the blood pressure at a point of a circuit downstream of the container;
wherein the control unit is designed to calculate the liquid flow rate in outflow from the container as a function of a known loss of head in a tract of the circuit situated between the container and said point of the circuit.

9. A dialysis machine for actuating a method for determining a liquid level in a container connected to a circuit, the container having a known volume occupied in part by a volume of a liquid and in part by a volume of a gas, the circuit comprising a supply branch taking the liquid to the container and a return branch evacuating the liquid from the container, the method determining the volume of the gas in order to calculate the volume of the liquid and the liquid level in the container, the dialysis machine comprising:
a pressure sensor for detecting a pressure of the gas in the container; and
a peristaltic pump for circulating the liquid through the circuit.

10. The machine of claim 9, comprising a conduit for channeling the gas to the container and a pump for supplying the gas.

11. The machine of claim 9, comprising a temperature sensor for detecting the temperature of the gas in the container.

12. The machine of claim 9, comprising a control unit designed to calculate the volume of the gas in the container on the basis of a gas law which interrelates mass, volume, temperature and pressure of the gas.

13. The machine of claim 9, comprising a control unit designed to determine the liquid level in the container from pressure values detected by said pressure sensor before and after a disturbance induced in the liquid and/or gas contained in the container.

14. The machine of claim 13, wherein said disturbance is induced by said peristaltic pump.

15. The machine of claim 13, wherein said disturbance is of an entity which determines an isothermal transformation.

16. The machine of claim 13, wherein said disturbance comprises a variation of the mass of the liquid and/or the mass of the gas contained in the container.