Abstract:
The invention relates to the monitoring of the fluid flow in an apparatus for extracorporeal blood treatment. The device according to the invention and the method according to the invention are based on the fact that, in order to monitor the fluid flow, the change in weight of a collection container is monitored, in which a rinsing fluid is collected during a filling or rinsing phase. The monitoring of the fluid flow according to the invention permits continuous monitoring of the fluid flow both in a treatment mode, in which the blood treatment is carried out, as well as in a filling or rinsing mode, in which the fluid system is filled or rinsed with a fluid.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application claims priority to, and the benefit of, co-pending U.S. Provisional Application 61/477,655 filed on Apr. 21, 2011. The contents of this provisional application is incorporated herein by reference in its entirety. The present application also claims priority to, and the benefit of, German Patent Application DE 10 2011 018 601.8 filed on Apr. 21, 2011. The contents of this foreign application is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The invention relates to an apparatus for extracorporeal blood treatment, which comprises a unit for obtaining one or more blood constituents and a treatment unit for treating the obtained blood constituent or constituents. Moreover, the invention relates to a method for monitoring the fluid flow in such an extracorporeal blood treatment apparatus. 
       BACKGROUND OF THE INVENTION 
       [0003]    As therapeutic apheresis, a blood purification procedure is known, wherein blood or blood plasma in an extracorporeal circuit is freed from pathogenic substances. A distinction is made between non-selective plasmapheresis, wherein the plasma is separated from the blood and completely substituted, and selective plasmapheresis, wherein plasma is freed from pathogenic substances by filtration or adsorption. Diseases that are treated with therapeutic apheresis are for example autoimmune diseases. The known extracorporeal blood treatment apparatuses can be used for therapeutic apheresis. 
         [0004]    The known extracorporeal blood treatment apparatuses for apheresis comprise a unit for obtaining plasma, in particular a plasma filter, and a treatment unit for treating the obtained plasma, in particular a purification unit comprising one or more filters or adsorbers. 
         [0005]    The plasma filter is located in the extracorporeal blood circuit of the blood treatment apparatus. A blood supply line leads from the patient to the inlet of the plasma filter and a blood return line leads from the outlet of the plasma filter to the patient, so that blood removed from the patient can be conveyed through the plasma filter. The plasma obtained in the plasma filter is then conveyed through the purification unit and the purified plasma is again fed to the patient&#39;s blood in the extracorporeal blood circuit. 
         [0006]    Blood and plasma are conveyed by means of pumps in hose lines, which are filled and rinsed with fluid before the start of the blood treatment. The rinsing solution is collected in a collection container, in particular a bag. In order to avoid contamination by germs, the collection bag remains on the hose line system during the whole treatment, which can last for three to five hours. 
         [0007]    In the known blood treatment apparatuses for therapeutic apheresis, the line leading away from the purification unit branches into a first line segment leading to the blood return line and a second line segment leading to the collection container. During the treatment mode, the purified plasma flows through the first line segment to the blood return line, while the second line segment is closed. In the filling and rinsing mode, on the other hand, the rinsing solution is conveyed through the second line segment into the collection bag. The fluid flow is changed over by means of a change-over clamp, into which both line segments of the line leading away from the purification unit are placed. 
         [0008]    In the treatment mode, it must be ensured that the purified plasma does not get into the collection bag, whereas in the filling and rinsing mode it must be ensured that the rinsing solution is collected in the collection bag. Monitoring of the correct function of the change-over clamp is therefore required. 
         [0009]    Devices for therapeutic apheresis are known, wherein a pressure and clamp test is carried out in order to establish whether the hose line is properly placed in the change-over clamp. Change-over clamps are known which comprise a safety clip, which opens when the hose line is removed or slides out. An alarm is emitted when the safety clip opens. 
         [0010]    The monitoring of the weight of containers for making available and collecting fluids during an extracorporeal blood treatment is known, for example as described in WO 91/15253 and U.S. Pat. No. 7,686,778 B2. For example, balances are used for balancing fresh and used dialysing fluid, which is made available and/or collected in a bag. The monitoring of the level of bags is also known in order to detect when they become empty or overflow. 
         [0011]    The invention herein is to increase further the reliability of an extracorporeal blood treatment apparatus. 
       SUMMARY OF THE INVENTION 
       [0012]    The device according to the invention and the method according to the invention are based on the fact that, in order to monitor the fluid flow in the line leading away from the blood treatment unit, the change in weight of the collection container is monitored. It is possible to conclude that there is a defective state solely on the basis of the change in weight of the collection container. The monitoring of the fluid flow according to the invention can replace the known monitoring of the function of the change-over clamp. In order to increase the redundancy, however, both safety devices can also be provided. 
         [0013]    The monitoring device according to the invention comprises means for determining the weight of the collection container and an evaluation unit, which is constituted such that a change in the weight of the collection container can be ascertained in order to monitor the fluid flow. The means for determining the weight can be a conventional electronic balance, onto which a collection bag can be placed or on which the bag can be suspended. 
         [0014]    The monitoring of the fluid flow according to the invention permits continuous monitoring of the fluid flow both in a treatment mode, in which the blood treatment is carried out, as well as in a filling and rinsing mode, in which the fluid system is filled and rinsed with a fluid. 
         [0015]    The extracorporeal blood treatment apparatus provides a control unit for selecting the treatment mode or the filling or rinsing mode. In the treatment mode, one or more blood components, in particular blood plasma, are conveyed via the first segment of the line leading away from the blood treatment unit to the blood return line, while in the filling or rinsing mode, fluid, in particular a rinsing fluid, is conveyed by the second segment of the line leading away from the blood treatment unit into the collection container. The evaluation unit monitors the change in the weight of the collection container during the treatment mode or the filling or rinsing mode. 
         [0016]    In the case where the control unit selects the treatment mode, the evaluation unit generates a first control signal when an increase in weight is ascertained, preferably in a preset time interval. If an increase in weight is ascertained in the preset time interval, it can be concluded that one or more blood components, in particular blood plasma, have got into the collection container during the treatment mode. This can only be the case when there is a defective fluid flow through the line leading away from the blood treatment unit. Continuous monitoring of the plasma flow is therefore made possible by monitoring the increase in weight, it being ensured that plasma cannot flow away unintentionally into the surroundings, i.e. cannot be discarded into the collection bag during the blood treatment. 
         [0017]    In the case where the control unit selects the filling or rinsing mode, the evaluation unit generates a second signal when, after the lapse of a preset time interval after the start of the filling or rinsing mode, an increase in weight is not ascertained, preferably in a preset time interval. If an increase in weight in the preset time interval is not ascertained, it can be concluded that rinsing fluid is not getting into the collection container. A defective state is then again present. The preset time interval is fixed in such a way that the hose lines of the fluid system can be completely filled with rinsing fluid. This is because it is only with complete filling of the hose lines of the fluid system with fluid that an increase in weight of collection bag  13  can be expected. This is however the case after the lapse of the preset time interval. 
         [0018]    When the control unit generates the first or second control signal, an acoustic and/or optical alarm can be emitted. The blood treatment apparatus according to the invention provides an alarm unit for this. 
         [0019]    It is advantageous if the alarm unit generates a first alarm signal when the first control signal is generated and a second alarm signal when the second control signal is generated, in order that a distinction can be made between the two defective states during the treatment mode or the filling or rinsing mode. 
         [0020]    In a particularly preferred embodiment of the invention, the amount of the change in the weight of the collection container in a preset time interval is determined in the filling or rinsing mode, again after the lapse of a preset time interval after the completed filling of the hose lines of the fluid system, and the amount of the change in weight in the preset time interval is compared with a preset threshold value in order to be able to ascertain not only whether the weight increases, but also to be able to ascertain the amount by which the weight increases. The filling of the fluid system, in particular of the plasma circuit, can thus be monitored. After the start of the filling or rinsing mode, it is also possible to monitor whether a continuous increase in weight is established in a preset time interval. Only when this is the case can it be concluded that the fluid system is air-free. 
         [0021]    If the increase in weight lies below a preset threshold value, it can be concluded that there is a defective state. For example, it can be concluded that the hose line is not seated properly in the single change-over clamp for changing over the fluid flow or in the two hose clamps. 
         [0022]    In a further particularly preferred embodiment, the weight of the collection container is ascertained at the start of the filling or rinsing mode and after completion of the filling or rinsing mode, in order to determine the conveyed volume of fluid in the fluid system, in particular of the plasma circuit. However, this again requires the complete filling of the hose lines of the fluid system with fluid. 
         [0023]    The monitoring of the fluid flow on the basis of the weight of the collection container can be used in all blood treatment apparatuses that comprise a unit for obtaining one or more blood constituents and a treatment unit for treating the obtained blood constituent or constituents, wherein the treated blood components are fed back to the blood. It is not important how the unit for obtaining the blood constituents and the treatment unit are constituted. The extracorporeal blood treatment apparatus is, in particular, an apparatus for apheresis, wherein the unit for obtaining one or more blood constituents is a unit for obtaining plasma, in particular a plasma filter, and the blood treatment unit is a unit for freeing the plasma of pathogenic components, for example a purification unit comprising one or more filters or adsorbers. 
         [0024]    The means for changing over the fluid flow preferably comprises a first hose clamp for pinching off the first line segment of the line leading away from the blood treatment unit, and a second hose clamp for pinching off the second line segment of the line leading away from the blood treatment unit. Both hose clamps can however also form a unit. For example, it may be a change-over clamp. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]      FIG. 1  shows, in a very simplified schematic representation, the main components of the extracorporeal blood treatment apparatus, which comprises a device for monitoring the fluid flow. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0026]    In one embodiment of the invention, the device for monitoring the fluid flow is a component of the extracorporeal blood treatment apparatus. It can however also be a separate assembly. In the present example of embodiment, the extracorporeal blood treatment apparatus is a device for therapeutic apheresis. 
         [0027]    The blood treatment apparatus comprises an extracorporeal blood circuit I, which comprises a unit  1  for obtaining one or more blood constituents. In one embodiment, this unit is a plasma filter  1 , which is divided by a semi-permeable membrane  1 A into a first chamber  2  and a second chamber  3 . A blood supply line  4  leads from the patient to inlet  2 A of first chamber  2  of plasma filter  1 . A blood return line  5  leads from outlet  2 B of first chamber  2  of plasma filter  1  back to the patient. 
         [0028]    A blood pump  6 , which is incorporated into blood supply line  4 , is used to convey the blood from the patient into plasma filter  1 . Heparin can be fed upstream of plasma filter  1  to the patient&#39;s blood by means of a heparin pump  7  represented solely by way of indication. A drip chamber  8  is incorporated into blood return line  5 . 
         [0029]    Apart from extracorporeal blood circuit I, the blood treatment apparatus comprises a secondary circuit II, which will be referred to below as plasma circuit II. Plasma circuit II comprises a line  9 , which leads away from outlet  3 A of second chamber  3  of plasma filter  1  and leads to inlet  10 A of blood treatment unit  10 . In the present example of embodiment, blood treatment unit  10  represented solely by way of indication in the figure is a purification unit, which comprises one or more filters or adsorbers in order to purify the plasma obtained from the patient&#39;s blood in plasma filter  1 . The plasma is conveyed from plasma filter  1  to blood treatment unit  10  by means of a plasma pump  11 , which is incorporated into line  9 . 
         [0030]    The purified plasma is fed back to the patient&#39;s blood. Leading away from outlet  10 B of blood treatment unit  10  is a line  12 , which branches into a first line segment  12 A and a second line segment  12 B. First line segment  12 A leads to blood return line  5 . In one embodiment, first line segment  12 A is connected to drip chamber  8  incorporated into blood return line  5 . Second line segment  12 B of line  12  leading away from blood treatment unit  10  leads to a container  13  for the collection of fluid, in particular a collection bag. 
         [0031]    Lines  4 ,  5  of extracorporeal blood circuit I and lines  9 ,  12  of plasma circuit II are hose lines of one or more hose line sets. 
         [0032]    Collection bag  13  serves to accommodate a rinsing fluid. For apheresis, bag  13  remains firmly connected to the hose set in order to reduce the risk of contamination by germs. 
         [0033]    During the apheresis, the fluid flow in hose line segment  12 B of hose line  12  leading to collection bag  13  is interrupted, so that the purified plasma cannot get into collection bag  13 . During the filling or rinsing mode, on the other hand, rinsing fluid is discarded through line segment  12 B of line  12  into collection bag  13 . Moreover, blood return line  5  can be connected to collection bag  13  in the filling and rinsing mode. The connection of blood return line  5  to collection bag  13  is indicated in the figure by a dashed line. When blood return line  5  is connected to collection bag  13 , the collection bag is filled in the filling and rinsing mode both via second line segment  12 B of line  12  leading away from blood treatment unit  10  as well as via blood return line  5 . 
         [0034]    The means for changing over fluid flow  14  are represented only schematically in the figure. In the present example of embodiment, they involve two hose clamps  14 A,  14 B which are operated alternately. Hose line segments  12 A and  12 B of hose line  12  must be inserted into hose clamps  14 A,  14 B before the filling or rinsing mode, i.e. before the blood treatment, in order to be able to pinch off respective line segments  12 A,  12 B. 
         [0035]    Moreover, the blood treatment apparatus comprises a central control unit  15 , which is connected via control lines  6 ′,  11 ′ to blood pump  6  and plasma pump  11 . 
         [0036]    Device  16  for monitoring the fluid flow comprises means  17  for weighing collection bag  13 , an evaluation unit  18  and an alarm unit  19 . Evaluation unit  18  is connected via a data line  18 ′ to central control unit  15  of the blood treatment apparatus, while alarm unit  19  is connected via a data line  19 ′ to evaluation unit  18 . Evaluation unit  18  can however also be a component of central control unit  15  of the blood treatment apparatus. Means  17  for weighing collection bag  13  are connected via a data line  17 ′ to evaluation unit  18 . Hose clamps  14 A,  14 B of means  14  for changing over the fluid flow can be manually operated hose clamps. In the present example of embodiment, the hose clamps are operated alternately via control lines  14 A′,  14 B′ by central control unit  15 . 
         [0037]    Central control unit  15  can select a treatment mode and a filling and rinsing mode. In the treatment mode, control unit  15  opens first hose clamp  14 A, which is used to pinch off first segment  12 A of line  12 , and closes second hose clamp  14 B, which is used to pinch off second segment  12 B of line  12 , so that plasma cannot get into collection bag  13 . In the filling and rinsing mode, on the other hand, control unit  15  opens second hose clamp  14 B, so that rinsing fluid can be discarded into collection bag  13 . 
         [0038]    Apart from the components described above, the blood treatment apparatus can also comprise further components, for example an anti-coagulation bag and an anti-coagulation pump or further hose clamps, in particular a venous clamp, which however are not represented in the figure. 
         [0039]    The mode of functioning of the monitoring device is described in detail below. 
         [0040]    It is assumed that central control unit  15  selects the treatment mode. In the treatment mode, it must be ensured that second hose clamp  14 B is closed. Moreover, it must be ensured that second segment  12 B of line  12  is inserted into second hose clamp  14 B. Otherwise, the hose clamp could not pinch off the line segment, so that plasma could get into collection bag  13 . 
         [0041]    During the blood treatment, evaluation unit  18  continuously receives the signals of means  17  for weighing the weight of the collection bag, in order to ascertain whether the weight is increasing or remaining constant. If evaluation unit  18  detects an increase in weight, a first control signal is generated which is received by alarm unit  19 . The alarm unit then emits a first acoustic or optical alarm, which indicates that plasma is getting into the surroundings. The first control signal is also received by central control unit  15 , which can carry out an intervention into the machine control. For example, control unit  15  can interrupt the blood treatment. Evaluation unit  18  thus verifies whether the weight of collection container  13  is increasing during the blood treatment. As long as the weight does not increase, a correct operation is ensured. 
         [0042]    In the filling or rinsing mode, it must be ensured that second hose clamp  14 B is open, so that rinsing fluid is discarded into plasma bag  13  for the complete air-free filling of the entire plasma circuit II. When control unit  15  selects the filling and rinsing mode, evaluation unit  18  again monitors the weight of collection bag  13 . Evaluation unit  18  generates a second control signal when an increase in weight is not ascertained after the lapse of a preset time interval after the start of the filling and rinsing mode. In this case, second hose clamp  14 B is closed. The preset time interval is fixed in such a way that the fluid system can be completely filled with rinsing fluid. This is because, in practice, the hose lines of the fluid system are not completely filled with fluid before the filling and rinsing mode or at the start of the filling and rinsing phase, since air is present at least in parts of the fluid system. Only when the hose lines of the fluid system are completely filled with fluid can an increase in weight of collection bag  13  be expected. This is the case, however, after the lapse of the preset time interval. 
         [0043]    When the second control signal is generated, alarm unit  19  emits a second acoustic and/or optical alarm signal, which indicates a defective state. Control unit  15  also receives the second control signal, in order to be able to carry out an intervention into the machine control. For example, the control unit can interrupt the filling or rinsing mode. 
         [0044]    In the present example of embodiment, evaluation unit  18  monitors not only whether an increase in weight is present, but also monitors the amount of the increase in weight per unit of time. It determines the amount of the change in weight of collection bag  13  in a preset time interval and compares the amount of the change in weight in the preset time interval with a preset value. If the amount of the change in weight in the preset time interval is less than a preset threshold value, a third control signal is generated, which can trigger a third alarm and a further intervention into the machine control. It is thus possible to monitor the flow of the rinsing fluid into collection bag  13 . If, in the case of a defective state, the fluid flow falls below a setpoint value, the otherwise continuous increase in the specific weight of collection bag  13  declines, so that the amount of the change in weight falls below the preset value. In the case of the monitoring of the amount of the increase in weight per unit of time, the generation of the third control signal also does not take place until after the lapse of a preset time interval after the start of the filling or rinsing mode, which is fixed in such a way that complete filling of the fluid system is to be expected in this time interval. 
         [0045]    Apart from the monitoring of the increase in weight of the collection bag in a specific preset time interval of the filling or rinsing mode, evaluation unit  18  can in principle also provide for monitoring of the increase in weight during the whole filling and rinsing phase, although this requires that the fluid system is previously completely filled with fluid before the monitoring starts. For this purpose, the evaluation unit determines the weight of collection container  13  at the start of the filling or rinsing mode at a time at which the fluid system is completely filled with fluid, and after completion of the filling and rinsing mode. Evaluation unit  18  then ascertains the conveyed volume of fluid in plasma circuit II from the difference in weight of collection bag  13  before the start and after completion of the filling or rinsing mode. For the calculation of the required fluid volume, the specific weight of the rinsing fluid is stored in a memory of evaluation unit  18 . If the measured fluid volume deviates from the actual fluid volume of the hose system, evaluation unit  18  can again generate a signal which indicates a defective state and can generate an alarm.