MODULAR BLOOD TREATMENT DEVICE

Description

Technical field

[0001] The present invention relates to a modular blood treatment device according to claim 1, in particular to a modular dialysis device, preferably a modular hemodiafiltration device, comprising several modules configured to be detachably coupled to one another for the purpose of performing blood treatment on a patient, in particular mechanically, electrically, electronically, fluid-mechanically and / or hydraulically, comprising a main control unit configured to control the coupled modules for the purpose of performing the blood treatment, sensors and actuators. State of the art

[0002] US Patent 2011 / 0189048A1 discloses a blood treatment device in the form of a modular dialysis system comprising a user interface module, a water treatment module, and a dialysis module. According to US Patent 2011 / 0189048A1, a conventional dialysis system is modularized to facilitate its transport and thus simplify the performance of dialysis treatments at home, away from dialysis centers. When assembled, the dialysis system, according to US Patent 2011 / 0189048A1, is equivalent to a conventional dialysis system, but its handling and safety are adapted for use by trained personnel.

[0003] US 2013 / 0334138A1 discloses a blood treatment system comprising a peritoneal dialysis unit and a blood pump unit. For peritoneal dialysis, only the peritoneal dialysis unit is required. For hemodialysis, the blood pump unit is connected to the peritoneal dialysis unit. The peritoneal dialysis unit has a master controller, which is connected to a delegate controller in the blood pump unit, to control both units.

[0004] US 2016 / 0 101 225 A1 discloses a modular hemodialysis system with three different types of modules: a water module, a dialysate module, and a therapy module. The water module may include a pretreatment subsystem and an activated carbon filter as subsystems. The dialysate module may include a dialysate subsystem and an ultrafiltrate subsystem as subsystems. The therapy module may include a dialysis filter, a blood treatment subsystem, and an electrical or software subsystem as subsystems. A mechanical subsystem of the hemodialysis system according to US 2016 / 0 101 225 A1 has components that are distributed among the three modules (water, dialysate, therapy). A main control unit ("controller") of the therapy module controls the water and dialysate modules.

[0005] EP 0 997 157 A2 discloses a blood treatment device comprising a "blood system" and a "hydraulic system". The control units of the blood treatment device are interconnected via two buses. The control units according to EP 0 997 157 A2 do not themselves have any actuators or sensors.

[0006] The purpose of the present disclosure is therefore to provide a modular blood treatment device that enables improved safety.

[0007] This problem is solved by features of claim 1. Advantageous further developments are the subject of the dependent claims. Summary of Revelation

[0008] A modular blood treatment device as disclosed comprises several modules, a main control unit, sensors, and actuators. The modules are designed to be detachably coupled together to perform blood treatment on a patient.

[0009] "Coupled" means in particular that a mechanical, electrical, electronic, fluid-mechanical and / or hydraulic connection exists.

[0010] "Detachable" means in particular that the coupled modules can be separated or decoupled from each other without damage, preferably without tools.

[0011] Generally, a blood treatment device has a blood circulation system. Preferably, a blood treatment device has at least one additional fluid circulation system, for example, a dialysis fluid circulation system. During patient treatment, the blood circulation system is connected to the patient via ports. Within the scope of this disclosure, the term "fluid system" may be used when referring to the blood circulation system and / or the at least one additional fluid circulation system.

[0012] The main control unit is designed to control the interconnected modules for carrying out the blood treatment.

[0013] The sensors can be designed, for example, to measure pressure, temperature and / or conductivity of the blood in the bloodstream or the fluid in the fluid circuit, and / or to detect blood and / or air in the bloodstream and / or the fluid circuit.

[0014] Actuators can be designed, for example, as valves or pumps in the blood or fluid circuit. A heating element or heating rod can also constitute an actuator.

[0015] At least two of the modules are designed as self-control modules. Each of the at least two self-control modules has at least the following components: at least one actuator and at least one module control unit. In particular, the self-control modules can each also have at least one sensor. These components of a respective self-control module are interconnected in such a way that data can be exchanged between the components. The self-control modules can have lines for the blood circulation and / or at least one fluid circulation. However, it is also possible that the blood treatment device according to the disclosure is designed such that the at least one actuator (and in particular, possibly also a sensor) of one of the self-control modules has access to lines of other modules of the blood treatment device, so that the corresponding self-control module does not need to have its own lines.

[0016] Each module control unit is configured to control at least one actuator of the same self-control module, in particular based on data from at least one sensor of the same self-control module. Furthermore, each module control unit is configured to detect a predetermined change of state in the self-control module belonging to it. The predetermined change of state could be, for example, an interruption or fault in the connection between one of the module control units and the at least one actuator of the same self-control module, or an interruption or fault in the connection between one of the module control units and the at least one sensor of the same self-control module.

[0017] The module control units are designed in such a way that, upon detection of a predetermined change of state, they can send a corresponding module state change message directly to at least one other module control unit, and can accordingly receive a module state change message directly from at least one other module control unit.

[0018] "Direct" means that at least two module control units are configured to send and receive module state change messages to each other without intervening with the main control unit or involving it in the sending and receiving of a module state change message. In other words, module control units are configured to communicate directly with each other.

[0019] The at least two module control units are designed such that, upon receiving a module state change message from at least one other module control unit, they instruct at least one actuator of the same self-control module, i.e., at least one actuator of the self-control module whose module control unit received the module state change message, to execute a predetermined action.

[0020] The "predetermined action" can be implemented in the form of a predetermined single process or in the form of a sequence of several processes (in the form of a program or a routine).

[0021] The design as disclosed advantageously creates a modular blood treatment device that can quickly react to certain changes in the state of individual modules.

[0022] According to one aspect of the disclosure, the predetermined action directed by at least one of the module control units may be switching the at least one sensor and / or the at least one actuator of the same self-control module to a zero position and / or enabling a bypass line of the same self-control module for a fluid system, that is, for the blood circuit and / or the at least one further fluid circuit, of the blood treatment device.

[0023] If the actuator is a pump, the zero position can correspond to the pump being switched off. If the actuator is a valve, the zero position can correspond to the valve being closed. The zero position of at least one sensor can correspond to the sensor being switched off.

[0024] Preferably, the bypass line is a component of the self-control module whose module control unit instructs the predetermined action. However, it is also possible for the bypass line to be a component of a different module.

[0025] "Activating a bypass line" means, in particular, that a line through which blood and / or another fluid, such as dialysis fluid, flows during normal operation is blocked, and the blood and / or other fluid is routed exclusively through the bypass line. However, it is also within the scope of the disclosure to only partially block the line used during normal operation and route only a portion of the blood and / or other fluid through the bypass line.

[0026] If a sensor and / or actuator is switched to a zero position and / or a bypass line is activated as a predetermined action, it is advantageously possible to quickly put other modules into a standby state when a control module undergoes a predetermined module state change, without having to shut down the entire blood treatment device.

[0027] According to one aspect of the disclosure, at least one of the self-control modules can have a monitoring sensor as a further component in addition to the at least one sensor. The module control unit of the self-control module with the monitoring sensor can have an execution unit and a monitoring unit. The at least one sensor of the self-control module can be connected to the execution unit, and the monitoring sensor can be connected to the monitoring unit. The module control unit can be configured to detect the predetermined module state change of the associated self-control module by comparing data from the execution unit and the monitoring unit.

[0028] In Under normal operating conditions, the monitoring computer, based on the monitoring sensor, arrives at the same results or data as the execution computer, based on the sensor. If a predetermined module state change occurs, the data from the execution computer and the monitoring computer will diverge, allowing the predetermined module state change to be detected.

[0029] As described above, a fault or interruption in the connection between a module control unit and the corresponding actuator or sensor can be interpreted as a predetermined module state change of the self-control module. If a monitoring sensor and a monitoring unit are provided, it is advantageously possible to specify the extent of the fault and to select one action from several possible actions, or a sequence of actions from several possible sequences, as the predetermined action according to the extent of the fault. Thus, it is possible to have one self-control module react appropriately to a module state change of another self-control module.

[0030] According to one aspect of the disclosure, a self-control module equipped with a monitoring unit can be configured such that the monitoring unit is connected not only to the corresponding monitoring sensor but also to the at least one sensor. Thus, it is possible for the monitoring computer to perform the same calculations as the execution computer, on the one hand based on the monitoring sensor and on the other hand based on the at least one sensor. Therefore, by comparing these two calculations of the monitoring computer with the corresponding calculation of the execution computer, the module control unit and the module control unit's monitoring computer, respectively, can determine whether the at least one sensor or the execution computer is functioning correctly.

[0031] According to one aspect of the disclosure, the design of the at least one sensor and the design of the monitoring sensor of the self-control module may differ, and / or the design of a microprocessor of the execution unit and the design of a microprocessor of the monitoring unit may differ. Different designs make it possible to detect not only random but also systematic failures or impairments.

[0032] According to one aspect of the disclosure, at least one of the self-control modules can store calibration data for at least some of the components of that same self-control module. In particular, at least one calibration curve, especially coefficients of a calibration curve, for example a polynomial, can be stored as calibration data. Storing calibration data in the self-control module can advantageously simplify the calibration of the self-control module. In particular, the calibration of the individual self-control module or its components (actuator; sensor) can be enabled or simplified independently of the blood treatment device.

[0033] According to one aspect of the disclosure, at least one of the self-control modules can store at least a threshold value for at least some of the components of the same self-control module, and the module control unit of the same self-control module can be configured to detect the predetermined module state change of the associated self-control module by comparing data from at least one of the components of the same self-control module with the at least one threshold value. By using threshold values, rapid detection of the predetermined module state change can advantageously be enabled.

[0034] According to one aspect of the disclosure, the main control unit can be configured as a separate module in the form of a main control module, and the blood treatment device can have multiple modules necessary for performing blood treatment on one patient, thus making the blood treatment device suitable for the simultaneous treatment of several patients. Accordingly, the main control module can be configured to control the simultaneous blood treatment of multiple patients. Providing a main control module can advantageously simplify the simultaneous treatment of multiple patients and reduce the costs associated with such treatment.

[0035] According to one aspect of the disclosure, the blood treatment device can include an operating and display module configured to display data from at least individual modules of the treatment device, receive commands from a user, and forward the commands to the main control unit and / or directly to at least individual modules of the treatment device. In particular, the operating and display module can itself be configured to include the main control unit. By providing a separate operating and display module, it is easily possible to adapt the human-machine interface to new standards, if necessary, without having to redesign the entire blood treatment device. In particular, an operating and display module can be configured such that it can be used for several treatment devices, especially simultaneously.

[0036] According to one aspect of the disclosure, the blood treatment device can include a calibration module comprising at least one reference measuring device configured to enable alignment with at least one of the sensors. A calibration module advantageously simplifies the calibration of individual modules. In particular, such calibration can be performed in a state where the module to be calibrated is not connected to any other module, or not to all modules necessary for blood treatment (for example, before assembly, or when replacing a module). The calibration module helps to minimize the maintenance effort (maintenance time and / or costs) of the blood treatment device according to the disclosure. The calibration module is specifically designed such that it is not part of the blood treatment device during treatment. Brief description of the drawings

[0037] The blood treatment device according to the disclosure is described in more detail below with reference to preferred embodiments and the accompanying drawings. These show: Fig. 1 a schematic view of a blood treatment device as disclosed, a power supply, a water supply and disposal system, a central concentrate supply and a patient; Fig. 2 a schematic detail view of a self-control module according to the revelation in the form of a water treatment module; Fig. 3 a schematic detail view of a self-control module as disclosed, in the form of a dialysis fluid preparation module; Fig. 4 a schematic detail view of an accounting module; Fig. 5 a schematic detail view of a self-control module according to the disclosure in the form of a dialysis fluid connection module; Fig. 6 a schematic detail view of a self-regulating module according to revelation in the form of a hemodiafiltration module and Fig. 7 a schematic detail view of a self-regulating module according to revelation in the form of a blood connection module and a dialyzer. Detailed description of preferred embodiments

[0038] Fig. 1 shows a schematic view of a blood treatment device 2 according to the disclosure, a power supply 4, a water supply and disposal system 6, a central concentrate supply 8 and a patient 10.

[0039] The blood treatment device 2 comprises a water treatment module 12, a dialysis fluid treatment module 14, a balancing module 16, a dialysis fluid connection module 18, a hemodiafiltration module 20, a blood connection module 22, a dialyzer 24 and a main control module 26.

[0040] The water treatment module 12 has interfaces (connections or ports, not shown) to which a fresh water line and a wastewater line can be connected for connection to the water supply and wastewater system 6, so that the water treatment module 12 can receive a fresh water stream 28 and discharge a wastewater stream 30. Furthermore, the water treatment module 12 has interfaces (not shown) through which treated water can be delivered to the dialysate treatment module 14 in a main stream 32 and a secondary stream 34. The water treatment module 12 can also receive a dialysate stream 36 from the balancing module 16 via an interface (not shown).

[0041] The dialysis fluid preparation module 14 has interfaces (not shown) through which the main stream 32 and the side stream 34 of the water treated by the water treatment module 12 can be received. Furthermore, the dialysis fluid preparation module 14 has interfaces (not shown) through which it can receive a basic concentrate stream 38 and an acidic concentrate stream 40 from corresponding canisters or cartridges (not shown). The dialysis fluid preparation module 14 can receive an acidic concentrate stream 42 from the central concentrate supply 8 via at least one interface (not shown). The dialysis fluid preparation module 14 can deliver a dialysis fluid stream 44 to the balancing module 16 via an interface (not shown).

[0042] The balancing module 16 has an interface (not shown) through which the dialysate flow 44 can be received from the dialysate processing module 14. The balancing module 16 can also deliver a dialysate flow 48 to the hemodiafiltration module 20 via an interface (not shown). Furthermore, the balancing module 16 has interfaces (not shown) through which a dialysate flow 50 can be received from the dialysate connection module 18 and the dialysate flow 36 can be delivered to the water treatment module 12.

[0043] The dialyzer connection module 18 has an interface (not shown) through which a dialyzer flow 52 can be delivered to the dialyzer 24. Furthermore, the dialyzer connection module 18 has an interface (not shown) through which a dialyzer flow 54 can be received from the hemodiafiltration module 20. Via interfaces (not shown), the dialyzer connection module 18 can receive a dialysate flow 56 from the dialyzer 24 and deliver the dialysate flow 50 to the balancing module 16. Furthermore, the dialyzer connection module 18 has an interface (not shown) through which a flow 58 of excess substitute can be received from the hemodiafiltration module 20.

[0044] The hemodiafiltration module 20 has interfaces (not shown) through which the dialysis fluid flow 48 can be received by the balancing module 16, the dialysis fluid flow 54 can be delivered to the dialysis fluid connection module 18, and a substitute flow 60 can be delivered to the blood connection module 22. Furthermore, the hemodiafiltration module 20 has an interface (not shown) through which the flow 58 of excess substitute can be delivered to the dialysis fluid connection module 18.

[0045] The blood connection module 22 has interfaces (not shown) through which a stream of untreated blood (arterial blood) can be received from patient 10 and a stream of untreated blood (arterial blood) can be delivered to the dialyzer 24. The blood connection module 22 can also receive a stream of treated blood (venous blood) from the dialyzer 24 and deliver a stream of treated blood (venous blood) to patient 10 via interfaces (not shown). Furthermore, the blood connection module 22 has an interface (not shown) through which the substitution flow (venous blood) from the hemodiafiltration module 20 can be received.

[0046] The dialyzer 24 has interfaces through which the dialyzer fluid flow 52 can be received by the dialyzer fluid connection module 18 and the dialysate flow 56 can be delivered to the dialyzer fluid connection module 18. Furthermore, the dialyzer 24 has interfaces through which the flow 66 of untreated blood can be received by the blood connection module 22 and the flow 68 of treated blood can be delivered to the blood connection module 22.

[0047] The main control module 26 can be connected to the power supply 4 via an electrical line 72. The blood treatment device 2 has lines 74 by means of which the main control module 26 can supply modules 12 to 22 with electrical current or power. The lines 74 are also configured to allow the exchange of data (commands from the main control module 26 to one of the modules 12 to 22, feedback from one of the modules 12 to 22 to the main control module 26) between the main control module 26 and the modules 12 to 22. The main control module 26 is also configured as an operating and display module as disclosed and has a touch-sensitive screen 76 and input keys 78. Alternatively, the main control module 26 can also be configured without an integrated screen and / or without integrated input keys.In particular, the main control module 26 can be configured such that a separate screen and / or a separate keyboard can be connected. Specifically, the screen 76 and / or the input keys 78 can be configured in an operating and display module separate from the main control module 26.

[0048] Im The following describes the individual modules 12 to 22 in a state during blood treatment in which the modules 12 to 26 are connected to each other to form the blood treatment device 2, and the blood treatment device 2 is connected to the power supply 4, the water supply and disposal 6, the central concentrate supply 8 and the patient 10.

[0049] Fig. 2 Figure 1 shows a schematic detail view of the water treatment module 12. For blood treatment, water must first be degassed and tempered. The water treatment module 12 includes a supply tank 80 (water tank). The fresh water flow 28 from the water supply and drainage system 6 can be directed into the supply tank 80 via a valve 82 and a pressure reducing valve (not shown). Two level sensors (not shown) determine the fill level 84. A pump 86 is used for degassing, circulating the water in the supply tank 80 and creating a vacuum monitored by a pressure sensor 88, which allows dissolved gases to escape via a degassing chamber 90. The supply tank 80 also contains a heat exchanger 92 for energy recovery from the dialysate flow 36.The warm dialysate flows from the dialyzer 24 through the dialyzing fluid module 18 and the balancing module 16 into the heat exchanger 92, where it releases heat, and then as wastewater into the drain. A heating element 94 located in the supply tank 80 and a temperature sensor 96 are also used to heat the water. The temperature of the treated water can be measured with the temperature sensor 96, which then directs it to the main stream 32 and the bypass stream 34. Valves 100 and 102 can be used to shut off the main stream 32 and the bypass stream 34 of treated water.

[0050] Valves 82, 100, and 102, pump 86, and heating element 94 are actuators as disclosed. Pressure sensor 88 and temperature sensor 96 are sensors as disclosed. The water treatment module 12 has a module control unit 106, which is connected via lines (not shown) to valves 82, 100, and 102, pump 86, pressure sensor 88, heating element 94, and temperature sensor 96. Furthermore, the module control unit 106 is connected to the main control module 26 via one of the lines 74. The water treatment module 12 is designed as a self-regulating module as disclosed. The module control unit 106 controls the pump 86 based on the vacuum measured by pressure sensor 88 in order to achieve a predetermined target vacuum. It also controls the...The module control unit 106 regulates the heating element 94 on the basis of the temperatures measured by the temperature sensor 96 in order to achieve a predetermined target temperature.

[0051] During blood treatment, the main control module 26 of the module control unit 106 of the water treatment module 12 specifies the predetermined target negative pressure and target temperature. The main control module 26 has no direct access to the pump 86 and the heating element 94 and, for example, does not issue instructions regarding the speed of the pump 86 or the heat output of the heating element 94.

[0052] Fig. 3 Figure 14 shows a schematic detail view of the dialysis fluid preparation module. To prepare the dialysis fluid, a basic component (for example, sodium bicarbonate) is first added to the main stream 32 of the treated water in a mixing chamber 108. The basic component can be supplied either from a concentrate canister (not shown) (see basic concentrate stream 38) containing the basic component in a dissolved state (for example, dissolved sodium bicarbonate), or from a cartridge 110 containing the basic component in a powdered state (for example, powdered sodium bicarbonate).To facilitate the mixing of the powdered basic component with the main stream 32 of the treated water, the side stream 34 of the treated water is first mixed with the powdered basic component before the mixture of the side stream 34 of the treated water and the basic component is mixed with the main stream 32 of the treated water in the mixing chamber 108. Regardless of whether the basic component is supplied from the cartridge 110 or from the concentrate canister (not shown), the basic component is pumped to the mixing chamber 108 by a pump 111 located upstream of the mixing chamber 108. The water mixed with the basic component is then directed into a mixing chamber 112, in which an acidic component is added. The acidic component can be supplied from various sources.Firstly, the acidic component can be supplied from a concentrate canister (not shown), and secondly, the central concentrate supply 8 can supply the dialysis fluid preparation module 14 with the acidic component. Multiple lines can be provided for connection to the central concentrate supply 8 to allow for the supply of concentrates with different compositions as needed. Regardless of the supply source, the acidic component is pumped to the mixing chamber 112 via a pump 113 located upstream of the mixing chamber 112.

[0053] Conductivity sensors 114 and 116 are used to determine the composition of the dialysis fluid. Conductivity sensor 114 measures the conductivity after the addition of the basic component (sodium bicarbonate) to the degassed and heated water. Conductivity sensor 116 determines the total conductivity after the addition of the acidic component. Since an incorrectly composed dialysis fluid can potentially harm patient 10, the dialysis fluid preparation module 14 includes an additional conductivity sensor 118, which also determines the total conductivity. Conductivity sensor 118 serves as a monitoring sensor for conductivity sensor 116, as disclosed.

[0054] The dialysis fluid preparation module 14 has a valve 120 for controlling the inflow of the main stream 32 of the treated water, a valve 122 for controlling the inflow of the side stream 34 of the treated water, a valve 124 for controlling the inflow of the basic concentrate stream 38, a valve 126 for controlling the inflow of the acidic concentrate stream 40, a valve 128 for controlling the inflow of the acidic concentrate stream 42 from the central concentrate supply 8, and a valve 130 for controlling the outflow of the dialysis fluid stream 44. A temperature sensor 132 is connected upstream of the conductivity sensor 114. A temperature sensor 133 is connected upstream of the conductivity sensors 116 and 118, and a temperature sensor 134 is connected downstream. The temperature sensor 134 represents a monitoring sensor as disclosed with respect to the temperature sensor 133.

[0055] Instead of the valve 100 in the water treatment module 12 and the redundant valve 120 in the dialysis fluid treatment module 14 in the main stream 32 of the treated water, it is alternatively possible to provide only one corresponding valve in one of the two modules 12 or 14. Alternatively, instead of the valve 102 in the water treatment module 12 and the redundant valve 122 in the dialysis fluid treatment module 14 in the side stream 34 of the treated water, it is alternatively possible to provide only one corresponding valve in one of the two modules 12 or 14.

[0056] Pumps 111 and 113 and valves 120 to 130 are actuators as disclosed. Conductivity sensors 114 to 118 and temperature sensors 132, 133, and 134 are sensors as disclosed. The dialysis fluid preparation module 14 has a module control unit 135, which is connected via lines (not shown) to pumps 111 and 113, valves 120 to 130, conductivity sensors 114 to 118, and temperature sensors 132, 133, and 134. Furthermore, the module control unit 135 is connected to the main control module 26 via one of the lines 74. The dialysis fluid preparation module 14 is designed as a self-regulating module as disclosed. The module control unit 135 has an execution unit 136 which controls the pump 111 and the valves 120 to 124 on the basis of the conductivity measured by the conductivity sensor 114.The execution unit 136 of the module control unit 135 controls the pump 113 and the valves 126 and 128 based on the conductivity measured by the conductivity sensor 116 to achieve a predetermined target conductivity of the dialysis fluid.

[0057] During blood treatment, the main control module 26 specifies the predetermined target conductivity of the basic mixture and the target conductivity of the dialysate to the module control unit 135 of the dialysate preparation module 14. Optionally, the blood treatment device 2 can also be configured such that the main control module specifies target concentrations (for example, of bicarbonate and sodium) to the dialysate preparation module 14, and the module control unit 135 of the dialysate preparation module 14 then converts the target concentrations into the target conductivities.

[0058] The module control unit 135 of the dialysis fluid preparation module 14 also includes a monitoring unit 138, which is connected via lines (not shown) to the pumps 111 and 113, the valves 120 to 130, the conductivity sensors 114 to 118, and the temperature sensors 132 to 134, just like the execution unit 136. During blood treatment, the monitoring unit 138 performs the same calculation processes as the execution unit 136. The monitoring unit 138 is connected to the execution unit 136 via a line (not shown). Furthermore, the monitoring unit 138 is configured to compare the results of its own calculations with corresponding results from the execution unit 136, so that the module control unit 135 can register whether the calculations of the execution unit 136 and the monitoring unit 138 agree.

[0059] Fig. 4 Figure 16 shows a schematic detail view of the balancing module 16. In the balancing module 16, the dialysate flow 44 coming from the dialysate preparation module 14 is directed by a dialysate pump 140 through the dialysate-side sections of two balancing chambers 142 and 144 to a dialysate filter 146, from which the filtered dialysate is fed to the dialysate flow 48 to the hemodiafiltration module 20. The dialysate of the dialysate flow 50 coming from the dialysate connection module 18 is pumped by a dialysate pump 148 through the dialysate-side sections of the balancing chambers 142 and 144 to the dialysate flow 36.In order to remove a defined amount of fluid from patient 10, a portion of the dialysate from the dialysate flow 50 coming from the dialysate connection module 18 can be pumped via an ultrafiltrate pump 150 past the dialysate-side parts of the balance chambers 142 and 144 directly to the dialysate flow 36.

[0060] The dialysis fluid filter 146 is connected to the dialysate stream 36 via a valve 156 such that the portion of the dialysis fluid retained by the filter 146 from the dialysis fluid stream 44 can be fed into the dialysis fluid stream 36 by opening the valve 156. With the valve 156 open, the portion of the dialysis fluid retained by the filter 146 from the dialysis fluid stream 44 is introduced into the dialysis fluid stream 36 upstream of the parallel-connected pumps 148 and 150. During normal operation, the valve 156 is closed.

[0061] For the operation of the balance chambers 142 and 144, the balance module 16 has valves 152 and 154, which are switched in a known manner (see, for example, DE 10 2017 125 962 A1). Furthermore, the balance module 16 has a valve 158 by means of which the inflow to the dialysis fluid stream 48 can be controlled. A sensor (not shown) is provided for each balance chamber 142 and 144 for monitoring and / or detecting the membrane position.

[0062] The dialysis fluid pump 140, the valves 152, the dialysate pump 148, the ultrafiltrate pump 150, and the valves 154 and 158 are actuators as disclosed. The balancing module 16 has a module control unit 160, which is connected via lines (not shown) to the dialysis fluid pump 140, the valves 152, the dialysate pump 148, the ultrafiltrate pump 150, and the valves 154 and 158. Furthermore, the module control unit 160 is connected to the main control module 26 via one of the lines 74. The balancing module 16 is designed as a self-regulating module as disclosed. The module control unit 160 controls the dialysis fluid pump 140, the valves 152, the dialysate pump 148, the ultrafiltrate pump 150 and the valves 154 and 158 according to a flow rate of the dialysis fluid specified by the main control module 26 and according to an ultrafiltration volume.

[0063] Fig. 5 Figure 1 shows a schematic detail view of the dialysate connection module 18. In the dialysate connection module 18, the dialysate flow 56 coming from the dialyzer 24 is directed to the dialysate flow 50 leading to the balancing module 16. The dialysate flow 54 coming from the hemodiafiltration module 20 can be fed into the dialysate flow 52 leading to the dialyzer 24 and / or, via a bypass line 169, into the dialysate flow 50 leading to the balancing module 16 in the dialysate connection module 18. The excess substitute flow 58 coming from the hemodiafiltration module 20 can be fed into the dialysate flow 50 leading to the balancing module 16 in the dialysate connection module 18. The dialysate connection module 18 has valves 162, 163, and 164. The valve 162 allows the flow from the dialysis fluid stream 54 to the dialysate stream 50.The flow through bypass line 169 can be controlled. Valve 163 controls the inflow from dialysis fluid stream 54 to dialysis fluid stream 52. Valve 164 controls the inflow from dialysate stream 56 to dialysate stream 50. If valve 163 is fully closed and valve 162 is simultaneously fully opened, the dialysis fluid stream 54 can be completely fed into dialysate stream 50 via bypass line 169. Downstream of valve 164, a blood leak detector 165 and, optionally, a UV sensor 166, a temperature sensor 167, and / or a conductivity sensor 168 are arranged.

[0064] Valves 162 to 164 are actuators as disclosed. The blood leak detector 165, the optional UV sensor 166, the optional temperature sensor 167, and / or the optional conductivity sensor 168 are sensors as disclosed. The dialysis fluid connection module 18 has a module control unit 170, which is connected via lines (not shown) to valves 162 to 164, the blood leak detector 165, and optionally to the UV sensor 166, the temperature sensor 167, and / or the conductivity sensor 168. Furthermore, the module control unit 170 is connected to the main control module 26 via one of the lines 74. The dialysis fluid connection module 18 is designed as a self-regulating module as disclosed.The dialysis fluid connection module 18 can control the valves 162 to 164 according to a setting from the main control module 26 and, for example, activate the bypass line 169 and interrupt the supply of dialysis fluid to the dialyzer 24 upon instruction. The module control unit 170 is also configured to activate the bypass line 169 and interrupt the supply of dialysis fluid to the dialyzer 24 if the blood leak detector 165, the optional UV sensor 166, the optional temperature sensor 167, and / or the optional conductivity sensor 168, individually or in combination, measure one or a predetermined number of values ​​that indicate a malfunction of the dialyzer 24 and / or a complication in the patient 10.The module control unit 170 detects the malfunction of the dialyzer 24 and / or the complication in the patient 10 by comparing the measured value and / or the predetermined quantity of measured values ​​with one or more corresponding reference values ​​stored in the module control unit 170 or in the main control module 26 and detecting a predetermined deviation from the reference value(s).

[0065] Fig. 6 Figure 1 shows a schematic detail view of the hemodiafiltration module 20. In the hemodiafiltration module 20, the dialysis fluid from the dialysis fluid stream 48 can be directed to a hemodiafiltration filter 172. From there, the filtered dialysis fluid can be discharged as substitute via a valve 178 to the substitute stream 60 and via a valve 176 to the excess substitute stream 58. The portion of the dialysis fluid from the dialysis fluid stream 48 retained by the hemodiafiltration filter 172 can be discharged via a valve 174 to the dialysis fluid stream 54.

[0066] Instead of the mutually redundant valves 164 of the dialysis fluid connection module 18 and 174 of the hemodiafiltration module 20, it is alternatively possible to provide only one of the two valves 164 and 174.

[0067] Valves 174 to 178 represent actuators as disclosed. The hemodiafiltration module 20 has a module control unit 180, which is connected to valves 174 to 178 via lines (not shown). Furthermore, the module control unit 180 is connected to the main control module 26 via one of the lines 74. The hemodiafiltration module 20 is designed as a self-regulating module as disclosed. The hemodiafiltration module 20 can control valves 174 to 178 according to a command from the main control module 26 and, for example, stop the supply of substitute to patient 10 upon instruction. To prevent the introduction of the substitute into the blood, valve 178 can be closed and valve 176 opened, so that the substitute is fed into the excess substitute stream 58 and flows to the dialysis fluid connection module 18, where it is fed into the dialysate stream 50.

[0068] Fig. 7 Figure 1 shows a schematic detail view of the blood connection module 22 and the dialyzer 24. The blood connection module 22 is designed to be connected to the patient 10 via (not shown) tubes. In the blood connection module 22, the untreated blood from stream 64 is fed to stream 66 of untreated blood via a valve or hose clamp 182, a hematocrit sensor 184, an arterial pressure sensor 186, and a blood pump 188. After passing through the dialyzer 24 according to a known design, the now-treated blood flows back to the blood connection module 22 in stream 68, where it flows via a venous pressure sensor 190, an air and blood detector 192, and a valve or hose clamp 194 into stream 70 of treated blood and thus to the patient 10. Furthermore, in the blood connection module 22, substitution fluid can be introduced from the substitution fluid stream 60 into the stream 70 of treated blood via a substitution fluid pump 196.To prevent blood clotting, the blood connection module 22 has an anticoagulation pump 198, by means of which an anticoagulant can be introduced into the blood downstream of the blood pump 188.

[0069] The valves or hose clamps 182 and 194, as well as the pumps 188, 190, 196, and 198, constitute actuators as disclosed. The sensors 184, 186, 190, and 192 constitute sensors as disclosed. The blood connection module 22 has a module control unit 200, which is connected via lines (not shown) to the valves 182 and 194, the pumps 188, 190, 196, and 198, and the sensors 184, 186, 190, and 192. Furthermore, the module control unit 200 is connected to the main control module 26 via one of the lines 74. The blood connection module 22 is designed as a self-regulating module as disclosed. The blood connection module 22 can control the valves 182 and 194 and / or the pumps 188, 190, 196 and 198 according to a specification from the main control module 26 and, for example, stop the supply of substitute to patient 10 or stop the withdrawal of blood on instruction.

[0070] According to the disclosure, the module control units 106, 135, 160, 170, 180 and 200 of modules 12 to 22 and the monitoring unit 138 of the dialysis fluid preparation module 14, as shown in Fig. 1 As indicated, they are connected to each other via lines 202. Since modules 12 to 22 are all configured as self-regulating modules, their module control units 106, 135, 160, 170, 180, and 200 can register predetermined state changes of the respective modules 12, 14, 16, 18, 20, and 22, and communicate with each other without involving the main control module 4 by means of disclosed module state change messages. The module control units 106, 135, 160, 170, 180, and 200 can also be configured to communicate with each other via the main control module 4.

[0071] For example, if one of the temperature sensors 132 and 133 of the dialysis fluid preparation module 14 registers that the temperature of the treated water deviates from a predetermined temperature (is higher / lower than the predetermined temperature), a corresponding module state change message is sent from the module control unit 135 of the dialysis fluid preparation module 14 to the module control unit 106 of the water treatment module 12, which then, as a predetermined action, controls the heating element 94 (that is, decreases / increases the power supplied to the heating element 94) in order to reach the predetermined temperature.

[0072] The module status change message from the module control unit 135 can be sent in parallel to the module control unit 106 of the water treatment module 12 and also to the module control unit 170 of the dialyzer connection module 18, which then, as a predetermined action, closes the valve 163, opens the valve 162, diverts the incorrectly tempered dialyzer fluid through the bypass line 169 and thus prevents the supply of the incorrectly tempered dialyzer fluid to the dialyzer 24.

[0073] In order for the respective module control units to register changes in state in the form of deviations of measurement data from predetermined values ​​or from predetermined tolerance ranges, corresponding predetermined values ​​ / tolerance ranges for the sensor(s) belonging to the respective self-control module are stored on the respective module control unit of those self-control modules which have at least one sensor.

[0074] To enable the module control units to perform appropriate predetermined actions upon receiving a module state change message, the state changes can be categorized. For example, a first category of state changes can be defined, requiring the immediate shutdown of the individual self-control modules of treatment device 2, while a second category can be defined, requiring only waiting for individual self-control modules to complete their changes. Each module control unit of each self-control module stores a predetermined action for each category, which is executed when a state change of the corresponding category occurs.

[0075] For example, if the monitoring unit 138 of the dialysis fluid preparation module 14 registers that the measured values ​​of the conductivity sensors 116 and 118 differ from each other, this means that the monitoring of the composition of the dialysis fluid, which is highly relevant for the survival of patient 10, is faulty. Due to the relevance of monitoring the composition, the treatment would have to be stopped, and this change of state of the dialysis fluid preparation module 14 would consequently trigger a module state change message of the first category, whereupon the dialysis fluid would immediately be diverted from the module control unit 170 of the dialysis fluid connection module 18 through the bypass line 169 and the substitute from the module control unit 180 of the hemodiafiltration module 20, before the entire blood treatment device 2 is subsequently shut down.The monitoring unit 138 of the dialysis fluid preparation module 14 is also designed to trigger a first-category module status change message if the temperature measured by temperature sensor 133 differs from the temperature measured by temperature sensor 134. Based on this first-category module status change message, the dialysis fluid would be diverted from the module control unit 170 of the dialysis fluid connection module 18 through the bypass line 169, and the substitute would be diverted from the module control unit 180 of the hemodiafiltration module 20, before the entire blood treatment device 2 is subsequently shut down or at least placed in a standby mode.

[0076] For example, if only one temperature measured by the temperature sensor 96 deviates from a predetermined value, the module control unit 106 of the water treatment module 12 can only issue a module status change message of the second category. Accordingly, although the dialysis fluid would initially be diverted through the bypass line 169 by the module control unit 170 of the dialysis fluid connection module 18 and the substitute would be diverted by the module control unit 180 of the hemodiafiltration module 20, since the temperature can be regulated by the heating element 94, there is no need to immediately shut down the blood treatment device 2.

[0077] The in the Figuren 1 bis 7 The embodiment of the blood treatment device according to the invention shown and described above represents only one possible implementation of the claimed invention.

[0078] The connection between the module control units and between each of them and the main control module does not need to be separate as described, but can be implemented via a bus to which both the main control module and the module control units of the blood treatment device are connected. Communication between the module control units can also be wireless. Reference symbol list

[0079] 2 Blood treatment device 4 Power supply 6 Water supply and disposal 8 Central concentrate supply 10 Patient 12 Water treatment module 14 Dialysis fluid treatment module 16 Balancing module 18 Dialysis fluid connection module 20 Hemodiafiltration module 22 Blood connection module 24 Dialyzer 26 Main control module 28 Fresh water flow 30 Wastewater flow 32 Main flow of treated water 34 By-flow of treated water 36, 50, 56 Dialysate flow 38 Alkaline concentrate flow from canister 40 Acidic concentrate flow from canister 42 Acidic concentrate flow from central concentrate supply 44, 48, 52, 54 Dialysis fluid flow 58 Flow of excess substitute 60 Substitute flow 64, 66 Flow of untreated blood 68, 70 Electrically treated blood 72 Electrical line 74 Lines for power and data transmission 76 Touch-sensitive screen 78 Enter key 80 Pre-fill tank 82, 100,102 Water treatment module valve 84 Supply tank level 86 Water treatment module pump 88 Water treatment module pressure sensor 90 Degassing chamber 92 Heat exchanger 94 Heating element 96 Water treatment module temperature sensor 106 Water treatment module control unit 108, 112 Mixing chamber 110 Cartridge 111, 113 Dialysis fluid preparation module pump 114, 116, 118 Conductivity sensor 120 to 130 Dialysis fluid preparation module valve 132, 133, 134 Dialysis fluid preparation module temperature sensor 135 Dialysis fluid preparation module control unit 136 Execution unit 138 Monitoring unit 140 Dialysis fluid pump 142, 144 Balancing chamber 146 Dialysis fluid filter 148 Dialysate pump 150 Ultrafiltrate pump 152 to 158 Valve of the balancing module 160 Module control unit of the balancing module 162, 163,164 Valve of the dialysis fluid connection module 165 Blood leak detector of the dialysis fluid connection module 166 UV sensor of the dialysis fluid connection module 167 Temperature sensor of the dialysis fluid connection module 168 Conductivity sensor of the dialysis fluid connection module 169 Bypass line 170 Module control unit of the dialysis fluid connection module 172 Hemodiafiltration filter 174, 176, 178 Valve of the hemodiafiltration module 180 Module control unit of the hemodiafiltration module 182, 194 Valve of the blood connection module 184 Hematocrit sensor of the blood connection module 186 Arterial pressure sensor of the blood connection module 188 Blood pump of the blood connection module 190 Venous pressure sensor of the blood connection module 192 Air and blood detector of the Blood connection module 196 Substitute pump of the blood connection module 200 Module control unit of the blood connection module 202 Line between module control units,

Claims

1. A modular blood treatment device (2) comprising a plurality of modules (12, 14, 16, 18, 20, 22) configured to be detachably coupled together to perform blood treatment on a patient (10), a main control unit (26) configured to control the coupled modules (12, 14, 16, 18, 20, 22) to perform the blood treatment, sensors (88, 96; 114, 116, 132, 133, 165, 167, 168; 186, 190, 192), and actuators (82, 86, 94, 100, 102; 111, 113, 120-130; 140, 148, 150, 152-158; 162-164; 174-178; 182, 194, 196), wherein at least two of the modules (12, 14, 16, 18, 20, 22) are configured as self-control modules, each of which includes, as components, at least one of the actuators (82, 86, 94, 100, 102; 111, 113, 120-130; 140, 148, 150, 152-158; 162-164; 174-178; 182, 194, 196) and at least one module control unit (106, 135, 160, 170, 180, 200), and the module control units (106, 135, 160, 170, 180, 200) are configured to be able to control the at least one actuator (82, 86, 94, 100, 102; 111, 113, 120-130; 140, 148, 150, 152-158; 162-164; 174-178; 182, 194, 196) of the same self-control module, be able to detect a predetermined state change of the self-control module (12, 14, 16, 18, 20, 22) associated with the respective module control unit (106, 135, 160, 170, 180, 200), be able, upon detection of the predetermined state change, to send a corresponding module state change message directly to the at least one other module control unit (106, 135, 160, 170, 180, 200), and upon receiving a module state change message from the at least one other module control unit, to control the at least one actuator (82, 86, 94, 100, 102; 111, 113, 120-130; 140, 148, 150, 152-158; 162-164; 174-178; 182, 194, 196) of the same self-control module (12, 14, 16, 18, 20, 22) to perform a predetermined action.

2. The blood treatment device (2) according to claim 1, characterized in that the predetermined action commanded by at least one of the module control units (106, 135, 160, 170, 180, 200) is to activate the at least one actuator (82, 86, 94, 100, 102; 111, 113, 120-130; 140, 148, 150, 152-158; 162-164; 174-178; 182, 194, 196) of the same self-control module (12, 14, 16, 18, 20, 22) to a zero position and / or activating a bypass line (169) of the same self-control module for a fluid system of the blood treatment device (2).

3. The blood treatment device (2) according to claim 1 or 2, characterized in that at least one of the self-control modules (14) comprises at least one of the sensors (116, 118) and, in addition to said at least one sensor (116; 133), includes a monitoring sensor (118; 134) as a further component, the module control unit (135) of the self-control module (14) comprises, in conjunction with the monitoring sensor (118; 134) an execution unit (136) and a monitoring unit (138), the at least one sensor (116; 133) of the self-control module (14) is connected to the execution unit (136), the monitoring sensor (118; 134) is connected to the monitoring unit (138), and the module control unit (135) is configured to detect the predetermined module state change of the associated self-control module (14) by comparing data from the execution unit (136) and the monitoring unit (138).

4. The blood treatment device (2) according to claim 3, characterized in that the monitoring unit (138) is also connected to the at least one sensor (116).

5. The blood treatment device (2) according to claim 3 or 4, characterized in that the design of the at least one sensor (116) and the design of the monitoring sensor (118) of the self-control module (14) differ and / or the design of a microprocessor of the execution unit (136) and the design of a microprocessor of the monitoring unit (138) differ.

6. The blood treatment device (2) according to any one of claims 1 through 5, characterized in that at least one of the self-control modules (12, 14, 16, 18, 20, 22) stores calibration data for at least part of the components of the same self-control module (12, 14, 16, 18, 20, 22).

7. The blood treatment device (2) according to any one of claims 1 through 6, characterized in that at least one of the self-control modules (12, 14, 16, 18, 20, 22) stores at least one threshold value for at least part of the components of the same self-control module (12, 14, 16, 18, 20, 22) and the module control unit (106, 135, 160, 170, 180, 200) of the same self-control module (12, 14, 16, 18, 20, 22) is configured to detect the predetermined module state change of the associated self-control module (12, 14, 16, 18, 20, 22) by comparing data from at least one of the components of the same self-control module (12, 14, 16, 18, 20, 22) with the at least one threshold value.

8. The blood treatment device (2) according to any one of claims 1 through 7, characterized in that the main control unit is configured as a separate module in the form of a main control module (26), the blood treatment device (2) includes the modules (12, 14, 16, 18, 20, 22) necessary to perform blood treatment on a patient multiple times, such that the blood treatment device (2) is suitable for the simultaneous blood treatment of multiple patients, and the main control module (26) is configured to be able to control the simultaneous blood treatment of the multiple patients.

9. The blood treatment device (2) according to any one of claims 1 through 8, characterized by a control and display module configured to display data from at least individual modules (12, 14, 16, 18, 20, 22) of the treatment device (2), to receive commands from a user, and to forward the commands to the main control unit and / or directly to at least individual modules (12, 14, 16, 18, 20, 22) of the treatment device (2).

10. The blood treatment device (2) according to any one of claims 1 through 9, characterized by a calibration module including at least one reference measuring device configured to enable calibration with at least one of the sensors.