WO2011091998A1

WO2011091998A1 - Medical device

Info

Publication number: WO2011091998A1
Application number: PCT/EP2011/000331
Authority: WO
Inventors: Ulrich Wernicke
Original assignee: Fresenius Medical Care Deutschland Gmbh
Priority date: 2010-01-26
Filing date: 2011-01-26
Publication date: 2011-08-04
Also published as: DE102010005746A1

Abstract

The invention relates to a medical device, in particular a dialysis machine, having a control system and having a signal generator which can be actuated by the control system using an electric control signal, and having a monitoring unit for monitoring the proper functioning of the signal generator. The invention provides for the monitoring unit to monitor the proper functioning of the signal generator by using a phase shift of the control signal on the signal generator.

Description

Medical device

The present invention relates to a medical device, in particular a dialysis machine, with a controller and with a signal generator, which can be controlled by the controller with an electrical control signal. Furthermore, the medical device has a monitoring unit for monitoring the proper functioning of the signal generator.

Medical devices such. B. Dialysis machines often have signalers, via which the operating personnel e.g. can be signaled via an alarm signal that intervention could be necessary. In particular, the signal transmitter may be an alarm sounder via which an audible alarm can be output. If the control of the medical device therefore detects an alarm situation, it generates an electrical control signal, which is converted by the signal generator into an alarm signal.

Since a signal generator is a highly safety-relevant arrangement, monitoring units are known which perform the proper Monitor the functioning of the signaling device. This prevents that an alarm condition of the device remains undetected for too long because the signal generator is not working properly.

A monitoring unit is known from EP 1 704 882 B1, which measures the loudspeaker current and the frequency of the loudspeaker signals of an alarm sound loudspeaker. In this case, a supervisor is provided which monitors the signal generation and the correctness of the relevant alarm signal on the basis of these data. With this monitoring unit, however, certain errors of the signal transmitter such. do not detect a short circuit or a partial short circuit.

The object of the present invention is therefore to provide a medical device with a monitoring unit, which allows better monitoring of the proper functioning of a signal generator.

This object is achieved by a medical device according to claim 1. The medical device includes a controller and a signal generator, which can be controlled by the controller with an electrical control signal. Furthermore, the medical device comprises a monitoring unit for monitoring the proper functioning of the signal generator. According to the invention it is provided that the monitoring unit monitors the proper functioning of the signal generator based on a phase shift of the control signal at the signal generator.

On the basis of the phase shift not only an interruption of the signal transmission, but also errors such. B. a short circuit in the signal generator can be reliably detected. The present invention thus makes it possible to recognize an error of the signal transmitter even more reliable.

The monitoring unit according to the invention thus monitors the proper functioning of the signal due to the phase shift of the control signal. encoder and generates a Införmationssignal if it detects an improper functioning of the signal generator. As a result, the controller is informed about the missing or possibly limited signal function and can initiate appropriate measures.

Advantageously, the monitoring of the proper functioning of the signal generator is based on a phase shift between a current signal and a voltage signal at the signal generator. The invention makes use of the fact that the signal generator does not represent an ohmic resistance and therefore generates a phase shift between current and voltage when properly functioning, which is now used to monitor the function of the signal generator from the monitoring unit.

Further advantageously, a current signal according to the invention, the phase of which corresponds to the phase of a current flowing through the signal generator due to the control signal, enters the monitoring unit. This current signal is advantageously one of the two signals, based on which a phase shift is determined.

Advantageously, the current signal is generated based on the voltage drop across a measuring resistor in the signal line to the signal generator. In particular, the voltage drop across a measuring resistor in the ground line of the signal generator is measured.

Further advantageously, a voltage signal, the phase of which corresponds to the phase of a voltage drop across the signal generator due to the control signal, enters the monitoring unit. It can be z. B. the original signal, which was generated to control the signal generator, are used.

Advantageously, the monitoring unit determines the phase shift by comparing the current signal and the voltage signal. As a result, it can be determined whether there is a phase shift at the signal transmitter is present. Since conventional signal generators generate such a phase shift, the proper functioning of the signal generator can be monitored on the basis of the determined phase shift.

Advantageously, the signal generator according to the invention comprises a coil and / or a capacitor. These elements generate a phase shift, which can be used for monitoring.

Further advantageously, the signal generator according to the invention is an acoustic signal generator, in particular a loudspeaker. The speaker can be z. B. based on a coil or on a piezoelectric element. Such an acoustic signal generator generates a certain phase shift, which is used by the monitoring unit according to the invention for monitoring the proper functioning.

Further advantageously, the control signal for driving the signal generator based on a periodic electrical signal. In particular, according to the invention, this is an alternating voltage signal with which the signal generator is activated.

The control signal according to the invention is advantageously generated by a signal generator, in particular by a signal tone generator. The control signal is advantageously converted by the signal generator into an acoustic signal. The control signal advantageously has a frequency between 100 and 5000 Hz. The control signal thus corresponds to a corresponding alarm tone. The control signal may also be any audio signal, in particular: human speech, sounds or music.

Advantageously, the monitoring unit detects an error of the signal generator when the phase shift is outside a predetermined range. Advantageously, one or more limit values are stored in the monitoring unit, which ensure proper functioning. correspond to the signal generator. If the determined phase shift is not within this predetermined range, then the monitoring unit detects an error of the signal generator and generates a corresponding information signal to the controller of the medical device.

Advantageously, the monitoring unit detects an error of the signal transmitter, in particular, when the phase shift is equal to zero. Such a phase angle of zero is z. B. then, if there is a short circuit or an interruption of the signal line.

On the other hand, other errors can be reflected in a phase angle deviating from the normal phase angle. For example, a partial turn short in the buzzer may lead to a change in the phase angle, which is now detected by the monitoring unit according to the invention.

If any sound signals, the spectral composition of which can be variable, used as a test signal, the monitoring unit can perform a spectral analysis of the signals, in particular a frequency filtering and / or a Fourier analysis. By evaluating the phase shift and / or the amplitudes of the spectral components of the control signal at the signal generator, the monitoring unit can monitor the proper functioning of a signal generator.

The present invention further comprises a monitoring unit for a medical device, as set forth above. In particular, the monitoring unit monitors the proper functioning of a signal generator based on a phase shift of a control signal at the signal generator.

The present invention further comprises a method for monitoring the proper functioning of a signal generator of a medical device, wherein the medical device has a controller and a signal generator, which is connected by the controller with an electrical control signal. is controlled. According to the invention, it is provided that the proper functioning of the signal generator is monitored on the basis of the phase shift of the control signal at the signal generator.

As already described above with regard to the corresponding monitoring unit, the proper functioning of the signal generator during operation can be monitored. In particular, the controller according to the invention thereby recognizes whether the signal generator, if it is actuated via the control signal, actually functions properly and emits a corresponding signal.

The method according to the invention is advantageously a method for operating a medical device, as has been described above.

The present invention can be used in any medical devices. The present invention is particularly advantageously used in a dialysis machine.

In particular, the signal generator is an alarm sounder which serves the acoustic warning of users. The alarm sounder is controlled via an alarm sound signal, which is generated by a corresponding signal generator. According to the invention, the phase shift is now used on the alarm sounder to monitor its proper functioning.

The present invention will now be described in more detail with reference to embodiments and drawings. Showing:

1 shows three diagrams which show typical courses of an automatic peritoneal dialysis treatment, 2 shows a schematic representation of a peritoneal dialysis system,

3 is a schematic representation of the division of the peritoneal dialysis system into a dialysis machine and a fluid system;

4 shows a first embodiment of a cassette,

5 shows a second embodiment of a cassette,

6 is a perspective view of a first embodiment of a

Dialysis machine,

7 shows a flowchart of a first embodiment of a peritoneal dialysis system,

8 is a perspective view of a second embodiment of a

Dialysis machine,

9 is a flowchart of a second embodiment of a peritoneal dialysis system,

Fig. 10: the coupling of the cassette in the second embodiment of a

peritoneal dialysis

11 shows a first embodiment of a pump actuator,

12: the coupling of a pumping area of the cassette to a pump actuator,

3 is a schematic diagram of the structure of an embodiment of a

Control, 14 shows an embodiment of a control of a medical device with a monitoring unit according to the invention and

Fig. 15 is a diagram showing the monitoring of the orderly

Operation of a signal generator based on the phase shift of a control signal at the signal generator.

In the following, the function of a dialysis machine, in which the present invention is used, will first be described generally. The dialysis machine in the exemplary embodiment is a peritoneal dialysis machine. However, the components described below may also be used in a similar or similar manner for a hemodialysis machine.

Peritoneal dialysis is a variant of artificial blood washing in which the patient's well-perfused peritoneal membrane is used as the body's own filter membrane. For this purpose, dialysate is introduced into the abdominal cavity via a catheter. According to the principle of osmosis, urinary components of the blood diffuse through the peritoneum into the dialysate in the abdominal cavity. After a certain residence time, the dialysate with the urinary components is discharged from the abdominal cavity again.

In automatic peritoneal dialysis, a dialysis machine controls and monitors the introduction of the fresh dialysate into the abdominal cavity and the discharge of the spent dialysate. Such a dialysis machine, also called a cycler, usually fills and empties the abdominal cavity several times overnight, ie. while the patient is sleeping.

FIGS. 1a to 1c show three different process sequences, as they are carried out by a dialysis machine. One or more of these procedures is usually stored in the control of the dialysis machine. It is usually possible to adapt the stored procedures to the patient. In FIGS. 1a to 1c, in each case the amount of dialysate V present in the abdominal cavity of the patient is recorded over the time t. FIG. 1a shows the course of a normal automatic peritoneal dialysis treatment overnight. At the beginning of the treatment, an initial outlet 5 initially takes place, through which dialysis, which had been left in the abdominal cavity of the patient throughout the day, is removed. Thereafter, several treatment cycles 1, in Figure 1a three consecutive treatment cycles 1. Each treatment cycle consists of an enema phase 2, a dwell phase 3 and a phase-out phase 4. During the enema phase 2 while a certain volume of fresh dialysis fluid is admitted into the abdominal cavity of the patient , Depending on the patient, the maximum permissible dialysate amount is between approximately 1.5 and 3 l. The fresh dialysate now remains in the abdominal cavity for a certain residence time 3. Typically, the dwell time lasts several hours. Then the now used dialysate is let out in the phase out 4 again from the abdominal cavity. Then a new treatment cycle starts. The treatment is completed with a final inlet 6, through which a certain amount of fresh dialysate is introduced into the abdominal cavity of the patient. This then remains throughout the day in the abdominal cavity of the patient.

The individual treatment cycles 1, which take place overnight, are automatically controlled by the control of the dialysis machine. The initial spout and the last enema can also be controlled automatically by the dialysis machine. Alternatively, they are manually activated by an operator or the patient.

FIG. 1 b shows a so-called tidal treatment. This also starts with an initial run 5 and ends with a last run 6. Furthermore, a basic cycle 7 is provided, which is divided into several Tidaizyklen 8. Initially, a base run-in phase 2 'is provided. After the dwell phase 3, however, not the complete dialysate volume is removed from the abdominal cavity, but only a certain subset of the dialysate present in the abdominal cavity. This is then replaced by a corresponding volume of fresh dialysate. After a renewed dwell cycle, a further tidal withdrawal can take place in which not all the dialysate located in the abdomen is removed. At the end of the basic cycle 7 there is a base outlet phase 4 ', in which now the entire dialysate is removed. In FIG. 1b, only one basic cycle 1 is shown. Alternatively, however, several base cycles may be provided.

FIG. 1c shows the course of a peritoneal dialysis treatment with a so-called PD-plus treatment. This is done during the night 9, a conventional peritoneal dialysis treatment, which z. B. according to the figures 1a or 1b can be performed. Furthermore, however, an additional PD-plus treatment is provided during the day, in which the spent dialysate is removed in an outflow phase 5 'and is replaced in a run-in phase 6' by fresh dialysate. PD Plus treatment combines a normal nocturnal peritoneal dialysis treatment with one or more additional cycles during the day. As usual, the course of the nocturnal treatment is carried out automatically by the dialysis machine. The treatment cycles during the day are also performed and monitored by the machine.

FIG. 2 schematically shows the structure of a typical peritoneal dialysis system. The peritoneal dialysis system comprises a container 10 with fresh dialysate and an outlet 20 for used dialysate. Furthermore, a connector 30 is provided, which can be connected to a catheter of the patient to either introduce fresh dialysate into the abdominal cavity of the patient or remove used dialysate from the abdominal cavity. The fresh dialysate container 10, the used dialysate outflow 20 and the patient connector 30 are connected to each other via fluid paths 100 and together with them form the fluid system of the peritoneal dialysis system. To perform the peritoneal dialysis treatment, a dialysis machine 40, also called a cycler, is provided. The dialysis machine 40 comprises the following main components:

A pump 50, which is used to transport the liquids. The pump 50 thereby conveys the fresh dialysate from the container 10 to the Konnek- tor 30. Furthermore, the pump 50 can transport the spent dialysate from the connector 30 to the drain 20.

Valves 70, which are used to control the fluid flows. The valves 70 open and close the fluid paths 100 so as to establish the appropriate fluid connections between the container 10, the connector 30, and the drain 20.

A heater 60, which brings the fresh dialysate to a temperature of about 37 ° C before it is supplied to the patient. Since in peritoneal dialysis relatively large amounts of dialysate are introduced directly into the abdominal cavity of the patient, the heater 60 is necessary in order not to overcool the patient and to avoid an unpleasant feeling due to cold dialysate.

Sensors 80, over which the proper course of treatment can be monitored and / or controlled. In particular, temperature sensors can be used. Furthermore, optionally pressure sensors can be used.

All components of the dialysis machine 40 are controlled by a controller 90. The controller 90 controls in particular the pump 50, the heater 60 and the valves 70 based on the data of the sensors 80. The controller 90 thereby ensures the automatic course of peritoneal dialysis. As an important component, the controller 90 comprises a balance 95, which accounts for the quantities of liquid added and withdrawn from the patient. Balancing prevents too much liquid from being added to the patient or too much fluid being removed.

The balancing 95 can be carried out solely on the basis of the control data and / or the sensor data for the pump 50. Alternatively, the balancing can also take place via separately provided balancing chambers. It is also possible to use a balance for balancing. Such a balance weighs, for example, the weight of the container 10 with fresh dialysate and / or a container 20 with used dialysate.

Since dialysate is administered directly to the patient's peritoneal cavity in peritoneal dialysis, extreme sterility must be ensured. Therefore, the fluid paths or the fluid system, which comes into contact with the fresh and / or the used dialysate, usually carried out as a disposable part. In particular, the fluid paths or the fluid system are designed as plastic parts. These can be delivered in a sterile outer packaging and unpacked just before treatment.

In order nevertheless to enable control of the peritoneal dialysis by the dialysis machine 40, the fluid system must be coupled to the dialysis machine 40. FIG. 3 shows schematically how individual elements of the dialysis machine 40 are coupled to corresponding regions of the fluid system.

The dialysis machine 40 in this case has a heating element 61. This must be coupled to a corresponding heating area 62 of the fluid system. The coupling thereby enables the transfer of heat energy from the heating element 61 to the dialysate located in the heating region 62.

The dialysis machine 40 also has one or more pump actuators 51, which are coupled to a pumping area 52 of the fluid system. The pump actuators 51 generate a pumping force which is transferred to the pump region 52. will wear. As a result, the liquid located in the pump region 52 can be moved along the fluid paths.

Furthermore, the dialysis machine has one or more valve actuators 71. These generate a closing movement, which is transmitted to corresponding valve regions 72 of the fluid paths. As a result, the valve regions 72 of the fluid paths can be closed or opened accordingly.

Furthermore, the dialysis machine has one or more sensors 81. These are coupled to a corresponding sensor area 82 of the fluid system. As a result, the sensors 81 can measure certain properties of the dialysate. In particular, this can be used to measure the temperature of the dialysate. Furthermore, it can be provided that the pressure in the fluid system is determined.

Of course, the dialysis machine may also have additional actuators and / or sensors which do not have to be coupled to the fluid paths.

The individual components of a peritoneal dialysis system will now be described in greater detail below on the basis of exemplary embodiments.

1. fluid system

1.1 Dialysate container

Fresh dialysate is usually provided in plastic bags. Such plastic bags usually have two layers of plastic film, which are welded together in an edge region and thus form a container which is filled with fresh dialysate. To this container, a hose member is usually welded, through which the dialysate can be removed from the bag. On the hose element is usually a Konnek- arranged via which the dialysate container can be connected to the other fluid paths. Furthermore, the bag usually has on the opposite side of the hose on a recess or eyelet over which the bag can be hung on a hook. This can ensure that the dialysate flows easily out of the bag.

The dialysate usually consists of a buffer, an osmoticum and electrolytes. As a buffer can be z. B. bicarbonate can be used. The osmoticum is usually glucose. Alternatively, glucose polymers or glucose polymer derivatives can also be used. The electrolytes usually include calcium and sodium.

The dialysate can be heat sterilized. This is advantageously done after the dialysate has been filled into the bag. As a result, both the dialysate and the bag are heat sterilized. The filled bag is usually initially packed in an outer packaging, whereupon the entire system is sterilized.

Since the finished dialysate solution, depending on the ingredients often can not be heat sterilized or can not be stored for long, it can be provided to store individual components of the dialysate separately and merge shortly before treatment. A first individual solution usually comprises the buffer, while a second individual solution comprises glucose and electrolytes. Optionally, more than two individual solutions and thus more than two areas may be provided in a bag. In this case, a multi-chamber bag, in particular a double-chamber bag may be provided, which has a plurality of separate areas for storing the individual solutions. These areas are separated by a connecting element, which can be mechanically opened to mix the individual liquids together. In particular, it is possible to provide a so-called peel seam between the two regions of the bag, which opens when at least one of the regions of the bag is used when applying a specific pressure. Since relatively large amounts of dialysate are consumed during a nightly peritoneal dialysis treatment, several dialysate containers are usually used in parallel. These are connected to the fluid paths via corresponding connectors and can be used to fill the patient by means of a corresponding circuit of the valves.

1.2 outflow

To dispose of the used dialysis fluid, this can either be discharged immediately into the sewer or first collected in a drain tank. As a drain tank while a bag is usually also used. This is empty before the start of treatment and can thus absorb the used dialysate. The bag can then be disposed of appropriately after completion of the treatment.

1.3 cassette

As already described above, the fluid system has a plurality of regions in which the dialysis machine has to act on the fluid system. For this purpose, the fluid system must be coupled to the dialysis machine.

To simplify the coupling of the fluid paths to the dialysis machine and the action of the corresponding elements of the dialysis machine on the fluid paths, cassettes are used. In such a cassette, a plurality of regions in which the dialysis machine acts on the fluid paths are arranged together. For this purpose, a cassette usually has a hard plastic part, in which chambers open to one side are introduced as fluid paths. These chambers are covered by a flexible plastic film, which ensures the connection to the dialysis machine. The flexible plastic film is usually welded in an edge region with the hard part. The cassette is pressed with a coupling surface of the dialysis machine, so that the actuators and / or sensors the dialysis machine come into contact with corresponding areas of the cassette.

The cassette also has connections for connecting the dialysate container 10, the connector 30 and the drain 20.

A cassette usually comprises at least one pumping area and one or more valve areas. The liquid transport through the fluid system can thus be controlled via the cassette. Furthermore, the cassette can have sensor areas which enable a simple coupling of sensors of the dialysis machine to the fluid system. Optionally, the cassette may further comprise one or more heating areas, which can be coupled to corresponding heating elements of the dialysis machine.

FIGS. 4a and 4b show a first exemplary embodiment of a cassette. This has a hard part 101 made of plastic, in which the fluid paths and coupling regions are introduced as corresponding recesses, chambers and channels. The hard part can be z. B. be manufactured as an injection molded part or as a deep-drawn part. The coupling plane of the hard part 101 is covered by a flexible film 102, which is welded in an edge region with the hard part. By pressing the cassette with a coupling surface of the dialysis machine, the flexible film 102 is pressed with the hard part. By compressing the flexible film with the web portions of the hard part, the fluid paths inside the cartridge are fluid-tightly separated from each other.

The cartridge has ports for connecting the cartridge to the remaining fluid paths. On the one hand, a connection 21 for connection to the outflow 20 and a connection 31 for connection to the connector 30 are provided. At these connections corresponding hose elements may be provided, which are not shown in Figure 4a. Furthermore, the cassette has a plurality of connections 11 for connecting dialysate containers 10. The terminals 11 are in the first exemplary embodiment designed as connectors to which corresponding connector elements can be connected.

The ports are each in communication with fluid paths within the cartridge. In these fluid paths valve areas are provided. In these valve regions, the flexible film 102 can be pressed into the hard part 101 via machine-side valve actuators in such a way that the corresponding fluid path is blocked. The cassette initially has, for each connection, a corresponding valve via which this connection can be opened or closed. The connection 21 for the outflow 20 is assigned the valve V10, the connection 31 for the patient connector 30 the valve V6. The terminals 11 for the dialysate 10, the valves V11 assigned to V16.

Furthermore, pump chambers 53 and 53 'are provided in the cassette, which can be actuated by corresponding pump actuators of the dialysis machine. The pump chambers 53 and 53 'are concave recesses in the hard part 101, which are covered by the flexible film 102. By pump actuators of the dialysis machine, the film can now be pressed into the pump chambers 53 and 53 'and pulled out of these pump chambers again. In this way, in conjunction with the valves V1 to V4, which switch the approaches and sequences of the pump chambers 53 and 53 'and have been designated in FIG. 4a by the reference numeral 73, a pumping current is generated by the cassette. The pump chambers are connected via corresponding valve circuits with all ports of the cassette.

Furthermore, a heating area 62 is integrated in the cassette. In this area, the cassette is brought into contact with heating elements of the dialysis machine, which heat the dialysate flowing through this area of the cassette. The heating area 62 has a channel for the dialysate, which extends in a spiral over the heating area 62. The channel is formed by webs 64 of the hard part, which are covered by the flexible film 102. The heating area 62 is provided on both sides of the cassette. For this purpose, a flexible film on the hard part is arranged on the bottom 63 of the cassette in the heating area. The flexible film is also welded in an edge region with the hard part. On the bottom, a channel is also arranged, through which the dialysate flows. The channels on the bottom and the top are formed by a middle plate of the hard part, which separates the top from the bottom, and on which are provided downwardly and upwardly webs which form the channel walls. In this case, the dialysate initially flows spirally on the top to the opening 65 through the middle plate, from where the dialysate flows back on the bottom through the corresponding channel. Due to the provided on the top and bottom heating area, the heating surface, which is available for heating the liquid available to be increased accordingly. Of course, however, an embodiment of the cassette is possible in which only one side of the cassette, a heating area is arranged.

Furthermore, embodiments of the cassette are possible in which a heating element is integrated in the cassette. In particular, an electric heating element such as e.g. Heizwendel be poured into the hard part of the cassette. This can be dispensed with a machine-side heating element and the flow heater can be integrated into the cassette. In this case, electrical contacts for connecting the electrical heating element are arranged on the cassette.

The cassette also has sensor areas 83 and 84, by which temperature sensors of the dialysis machine can be coupled to the cassette. The temperature sensors lie on the flexible film 102 and can thus measure the temperature of the liquid flowing through the underlying channel. In this case, two temperature sensors 84 are provided at the entrance of the heating area. At the patient-side outlet, a temperature sensor 83 is provided, via which the temperature of the dialysate pumped to the patient can be measured. FIG. 5 shows a second exemplary embodiment of a cassette. The cassette corresponds in its embodiment substantially to the first embodiment, but does not include a heating area. When using this cassette, the heating is therefore not as shown in the first embodiment via a built-in cartridge heating, but eg via a heating bag, which is placed on a hot plate of the dialysis machine.

The second exemplary embodiment of a cassette shown in FIG. 5 in turn has fluid paths which can be opened and closed via valve regions, which are also numbered here from V1 to V16. Furthermore, the cassette has connections for connection to other components of the fluid system. In this case, the connection 21 for connection to the drain 20, as well as the connection 31 for connection to the connector 30 to the patient is again provided. Furthermore, connections 11 are provided for connecting dialysate containers 10.

In contrast to the first exemplary embodiment, the cassette shown in the second exemplary embodiment has a further connection 66 for connecting a heating bag. For heating the liquid from the dialysate containers 10, the liquid can be pumped via the connection 66 into a heating bag. This heating bag rests on a heating element, so that the liquid in the heating bag can be heated. The fluid is then pumped from the bag to the patient.

The pumping chamber 53 and 53 'and the valves V1 to V4 correspond in construction and function to the corresponding components in the first embodiment.

In contrast to the first exemplary embodiment, the cassette in the second exemplary embodiment has no sensor area for connecting a temperature sensor. This is rather arranged in the region of the heating elements. However, the cassette has metering areas 85 and 86 for measuring the pressure in the pumping chambers 53 and 53 '. The measuring ranges 85 and 86 are chambers, wel surface are in fluid communication with the pumping chambers and are also covered by the flexible foil. Device-side pressure sensors, which measure the pressure in the measuring chambers 85 and 86 and thus in the pumping chambers 53 and 53 ', can be coupled to the measuring ranges.

The connection of the terminals 11, 21, 31 and 66 of the cassette with the other components of the fluid system takes place in the second embodiment via hose connections. If necessary, connectors are arranged at these hose connections.

1.3 hoses

The connection between the individual containers of the system, the cassette and the patient connector is usually via hose connections. Since it is in each case disposable, the hoses are usually at least on one side already firmly connected to another element. For example, hoses may already be provided at one or more of the ports of the cartridge. Also, hoses may already be tightly connected to bags.

1.4 connections

The fluid system is usually divided into several parts and each packaged sterile. These parts must first be connected together for treatment. In particular, the cassette and the dialysate bag (s) are usually packed separately from one another.

The connections between the individual elements of the fluid system usually takes place via connectors. The connectors are designed so that they allow a sterile connection between the individual components. This is done z. B. on appropriate protective films, which are opened automatically when closing the Konnc- sector. The connection of the individual components can be done manually by an operator or the patient himself. Alternatively it can be provided that the connection of the individual components takes place through the dialysis machine.

For this purpose, z. B. the corresponding connectors are inserted into a connector receptacle of the dialysis machine and automatically merged by the dialysis machine.

Furthermore, an electronic controller may be provided which monitors that the correct components of the system are interconnected. For this purpose, at the connectors identification means such. As barcodes or RFIDs are provided which identify the components. The dialysis machine comprises an identification means detection unit such. B. a bar code reader or an RFID detection unit which detects the identification means on the connectors. This allows the peritoneal dialysis control to know if the correct connectors have been inserted.

Such a check of the correct composition of the fluid system can be combined in particular with an automatic connection of the connectors. The system first checks whether the correct connectors have been inserted in the connector recordings. The connection between the connectors is made by the dialysis machine only when the correct connectors have been inserted. Otherwise, the dialysis machine alerts the user that the wrong connectors have been inserted.

2. The dialysis machine

The individual components of a dialysis machine will now be described in more detail below with reference to two exemplary embodiments. FIG. 6 shows a first exemplary embodiment of a dialysis machine in which the first exemplary embodiment of a cassette is used. The peritoneal dialysis system resulting from the first exemplary embodiment of a dialysis machine and the first exemplary embodiment of a cassette is shown in FIG.

FIG. 8 shows a second exemplary embodiment of a dialysis machine in which the second exemplary embodiment of a cassette is used. The dialysis system resulting from the combination of the second embodiment of a dialysis machine and the second embodiment of a cassette is then shown in FIG.

The two embodiments differ on the one hand in the design of the heater, in the coupling between the dialysis machine and the cassette and in the configuration of the actuators and sensors.

2.1 heating

The fresh dialysate must be brought to body temperature before being delivered to the abdomen of the patient. For this purpose, the dialysis machine has a corresponding heating.

The heating is usually carried out electrically via one or more heating elements. The heating elements may be z. B. act to ceramic heating elements. In such ceramic heating elements, a resistance path is applied to a ceramic carrier. By applying a voltage to the resistor track, it is heated, which also heats the ceramic carrier material. The ceramic heating element is usually arranged on a heating plate. This can be made for example of aluminum. In turn, the fluid paths are coupled to the heating plate, so that the dialysate located in the fluid paths can be heated. For heating the liquid two different configurations are available. On the one hand, a larger amount of dialysate can first be heated, which is pumped to the patient only after the warm-up phase. This is usually done via a heating bag, which rests on a hot plate of the dialysis machine.

The heating bag may be the dialysate bag in which the dialysate is made available. Usually, however, a separate heating bag is used, in which the dialysate is pumped in for heating. If the dialysate is heated in the heating bag, it is pumped from there to the patient.

Such a concept is realized in the second exemplary embodiment of a dialysis machine shown in FIGS. 8 and 9. In this case, a heating bag 67 is provided, which rests on a heating plate 68. The heating plate 68 is arranged on top of the peritoneal dialysis machine, so that it is easily accessible. The heating bag 67 is connected via a line 66 'to the cassette. The cassette in this case has the valves V5, V9 and V15, via which the heating bag 67 can be connected to the other components of the fluid system. Thus, fresh dialysate can be pumped from the dialysate containers 10 via the pumping chambers to the heating bag 67. Thus, at the beginning of a treatment, the heating bag 67 is first filled with cold dialysate. The dialysate in the heating bag 67 is then heated to body temperature via the heating plate 68. Thereafter, the dialysate is pumped via the pumping chambers to the patient. Thereafter, the heating bag 67 can be refilled so that the amount of dialysate required for the next treatment cycle can be heated.

Advantageously, a temperature sensor 88 is provided in the region of the heating plate 68, which is in contact with the heating bag 67 and thus can measure the temperature of the dialysate in the heating bag 67. Furthermore, a temperature sensor may be provided on the heating plate or on the heating element, which regulates the temperature. temperature of the heating element or heating plate. An appropriate control now ensures that the heating plate is not too hot for the material of the bag.

The heating bag 67 can also take over functions in the accounting of the fluid streams. Thus, the heating plate 68 may be part of a balance 87, via which the weight of the heating bag 67 can be determined. In this way, the amount of liquid which is supplied to the patient after heating, can be determined.

Alternatively to the heating of the dialysate shown in the second embodiment via a heating bag, the dialysate can also be heated while it is pumped to the patient. The heater thus operates in the form of a continuous flow heater which heats the dialysate moved by the fluid system as it is pumped through the fluid paths.

In this concept, a dialysate channel is provided, which is coupled to a heating element of the dialysis machine. As the dialysate flows through the dialysate channel, it absorbs heat from the heating element of the dialysis machine.

Such a concept is implemented in the first embodiment of a dialysis machine shown in FIGS. 6 and 7. The heating area is integrated in the cassette, as already shown above. When the cassette is coupled to the dialysis machine, the heating area of the cassette comes into thermal contact with heating elements of the dialysis machine.

The heating elements can also be designed as ceramic heating elements and are in contact with hot plates, which are then coupled to the heating of the cassette. As already described with regard to the cassette, in each case a heating plate is in contact with both the upper side and the lower side of the heating area, which heating element heats the dialysate flowing through the heating area. At the inlet and at the outlet of the heating area, temperature sensor areas are respectively provided in the cassette, which come into contact with the coupling of the cassette with temperature sensors of peritoneal dialysis. As a result of the temperature sensors T1 to T3, the temperature of the dialysate flowing into the heating area and the temperature of the dialysate flowing out of the heating area can be determined. Furthermore, temperature sensors T4 and T5 are provided, which determine the temperature of the heating elements and / or the heating plates.

The use of at least two heating elements makes it possible in each case to connect the heating elements in such a way that they deliver substantially the same power at a supply voltage of 220 V as with a supply voltage of 110 V. For this, the two heating elements at 110 V in a parallel circuit while operating at a supply voltage of 220V in a serial circuit. Such an adaptation of the interconnection of the heating elements to the supply voltage can be implemented independently of whether the heating takes place according to the first or the second embodiment.

2.2 Coupling of the cassette

In order to enable a coupling of the actuators and / or sensors of the dialysis machine to the corresponding regions of the cassette, the dialysis machine has a cassette holder with a coupling surface on which the cassette can be coupled. At the coupling surface, the corresponding actuators, sensors and / or heating elements of the dialysis machine are arranged. The cassette is pressed with this coupling surface so that the corresponding actuators, sensors and / or heating elements come into contact with the corresponding areas on the cassette.

In this case, a mat made of a flexible material is advantageously provided on the coupling surface of the dialysis machine, in particular a silicone mat. These ensures that the flexible film of the cassette is pressed against the land areas of the cassette, thus separating the fluid paths within the cassette.

Advantageously, a circumferential edge of the coupling surface is further provided, which is pressed with the edge region of the cassette. Advantageously, the compression takes place airtight, so that between the coupling surface and the cassette, a negative pressure can be established.

Optionally, a vacuum system may be provided which can pump air from the space between coupling surface and cassette. This allows a particularly good coupling of the actuators, sensors and / or heating elements of the peritoneal dialysis machine with the corresponding areas of the cassette. In addition, the vacuum system allows a leak test of the cassette. For this purpose, a corresponding vacuum is applied after coupling and checks whether this vacuum is maintained.

The pressing of the cassette takes place z. B. pneumatically. For this purpose, usually an air cushion is provided, which is filled with compressed air and thus presses the cassette to the coupling surface.

The cassette holder usually has a coupling surface opposite the receiving surface, in which the hard part of the cassette is inserted. The receiving surface advantageously has corresponding depressions for this purpose. The receiving surface with the inserted cassette can then be pressed by a pneumatic pressure device to the coupling surface.

The insertion of the cassette can be done in different ways. In the first exemplary embodiment of a dialysis machine, which is shown in FIG. 6, a drawer 111 is provided for this purpose, which can be extended out of the dialysis machine. The cassette is inserted in this drawer. The cassette is then inserted into the dialysis machine together with the drawer. Thereupon, the pressing of the cassette with the coupling surface, which in Interior of the device is arranged. In this case, the cassette and the coupling surface are first moved together mechanically and then pressed together pneumatically.

The coupling of a cassette 110 according to the second embodiment is shown in more detail in FIG. The coupling surface 130 is freely accessible by opening a door 140, so that the cassette can be arranged in the correct position on the coupling surface 130. The coupling surface 130 is inclined backwards to the vertical, which allows easier coupling. Now, the door 140 can be closed so that a receiving surface on the door comes into contact with the back of the cassette. The pressing is now carried out by an air cushion arranged on the door. In addition, a vacuum is applied between the coupling surface and the cassette 110.

The first exemplary embodiment of a dialysis machine also has a device for automatic connection. For this purpose, a connector receptacle 112 is provided, in which the connectors of the dialysate 10 are inserted. The connector receptacle 112 then moves into the device where a bar code reader is provided which reads the bar codes applied to the connectors. This allows the device to check if the correct bags have been inserted. When the correct bags are detected, the connector receptacle 112 retracts completely and thus connects the connectors of the bags to the connectors 11 of the cassette, which are designed as connectors.

In the second embodiment, however, has been dispensed with such an automatic Konnektierung. Therefore, tube sections are arranged at the terminals 11 of the cassette, which must be connected manually via connectors with the corresponding bags.

2.3 pump actuators The pumping of the liquid through the fluid system is in the embodiments by a diaphragm pump, which is formed by the pumping chambers 53 and 53 'together with the flexible film of the cassette. If the flexible film is pressed into the pumping chamber by a corresponding pump actuator, liquid is pumped out of the pumping chamber into the opened areas of the fluid paths of the cassette. Conversely, by pulling the film out of the pumping chamber, fluid is drawn out of the fluid paths into the pumping chamber.

The pumping stroke is carried out by moving a pump actuator into the pumping chamber. For the suction stroke of the pump actuator is moved away from the pumping chamber again. Due to the airtight compression of cassette and coupling surface creates a negative pressure, through which the flexible film of the cassette follows the pump actuator and is pulled out of the pumping chamber again.

In order to enable a good coupling of the pump actuator to the flexible film of the cassette, in addition, a vacuum system may be provided. In particular, the force with which the flexible film is moved away from the pumping chamber during a suction stroke can be adjusted by setting a corresponding vacuum between the coupling surface and the cassette.

As a result, the suction power of the pump can be set very fine. In contrast, the pumping force is set by the thrust of the actuator.

The balance of the liquid streams can be done by counting the suction and pump strokes, since the diaphragm pump has a high accuracy of the pumped with each stroke amount of liquid.

2.3.1. Hydraulic drive

The structure of a first embodiment of a pump actuator is shown in FIG. The pump actuator is moved hydraulically. For this purpose, a membrane 59 is provided, which applies to the flexible film of the cassette. The membrane 59 can be z. B. be made of silicone. Behind the membrane 59, a chamber 54 is provided, which can be filled with hydraulic fluid. By applying an overpressure in the chamber 54, the membrane 59 and with this the flexible film is pressed into the pumping chamber 53 of the cassette. By applying a negative pressure to the chamber 54, however, the membrane 59 is drawn into the chamber 54. Due to the negative pressure between the flexible film and the membrane, the flexible film follows this movement, so that the volume of the pumping chamber 53 increases. The pumping operation with the pumping stroke and the intake stroke is shown schematically in FIG. 12b.

For operating the pump hydraulics, a hydraulic pump 58 is provided. This has a cylinder in which a piston can be moved via a motor 57 back and forth. As a result, the hydraulic fluid is pressed into the chamber 54 via a corresponding connecting line or sucked out of it again. At the hydraulic pump 58, a displacement sensor 56 is provided, via which the movement of the piston can be accommodated. In this way, it can be determined how much hydraulic fluid is forced into the chamber 54 or how much hydraulic fluid has been removed therefrom. Furthermore, pressure sensors 55 are provided on the hydraulics which measure the pressure in the hydraulic system. These allow, on the one hand, a functional check of the hydraulics, since the data of the pressure sensors can be compared with those of the displacement transducer 56 and, as a result, the tightness of the hydraulic system can be checked.

In addition, the pressure sensors allow a determination of the pressure in the pump chamber 53 of the cassette. If the hydraulic pump 58 is not moved, so sets a pressure equilibrium between the chamber 54 and the pumping chamber 53 a. The pressure of the hydraulic fluid thus corresponds to the pressure in the pump chamber 53.

FIG. 12 a shows the coupling process of the pump actuator to the pump chamber 53. To prepare the Ankoppeins while the chamber 54 acted upon by hydraulic fluid, that the diaphragm 59 bulges outwards. Then the coupling surface and cassette are moved towards each other, so that the membrane 59 pushes the flexible film of the cassette into the pumping chamber 53. After pressing the coupling surface and the cassette, the space between the membrane and the flexible film is hermetically sealed to the outside, so that the flexible film follows the movement of the membrane. This is shown in FIG. 12b.

The pump actuator shown in FIG. 11 is implemented in the first exemplary embodiment of a dialysis machine, as can also be seen from FIG. In each case, a corresponding pump actuator is provided for each of the two pumping chambers 53 and 53 '.

2.3.2 Electromechanical drive

Alternatively, the pump actuator can also be operated by an electric motor. For this purpose, a correspondingly shaped punch is provided, which is pressed by an electric motor, in particular via a stepping motor against the flexible film or moved away from it and thus generates the pumping or suction stroke. Such pump actuators 151 and 152 are shown in the embodiment in FIG. Advantageously, a vacuum system is provided, which ensures that the flexible film follows the stamp during the suction movement.

2.4 Valve actuators

As a valve actuator, a valve tappet may be provided, which pushes the flexible film of the cassette into a corresponding chamber of the hard part and thus closes the fluid idkanal in this area. The valve actuator can be actuated pneumatically. The plunger can be biased by a spring so that it either opens without pressure or closes without pressure. Alternatively, the valve actuator may be implemented via a flexible membrane which is hydraulically or pneumatically moved. The flexible membrane is thereby moved by applying pressure against the cassette and thus presses a corresponding valve region of the flexible film into a fluid channel in order to close it.

Valve actuators 71, which are coupled to the valve areas V1 to V16 of the cassette, can be seen in FIG. 10 on the coupling surface.

2.5 sensors

The dialysis machine has sensors via which the machine can be controlled or its proper functioning can be monitored.

On the one hand, one or more temperature sensors are provided, via which the temperature of the dialysate and / or the heating elements can be measured. In the first exemplary embodiment, the temperature sensors are arranged on the coupling surface to the cassette and can thus measure the temperature of the dialysate flowing through the cassette. In the second embodiment, however, a temperature sensor 88 is provided on the heating plate 68, which measures the temperature of the dialysate located in the bag 67. Furthermore, temperature sensors may be provided on the heating element (s).

Furthermore, one or more pressure sensors may be provided to determine the pressure in the pumping chambers. In this way it can be prevented that the dialyzate is pumped to the patient at too high a pressure or the suction pressure becomes too high when aspirating dialysate from the patient.

In the first embodiment, the pressure measurement takes place via pressure sensors in the hydraulics of the pump actuators, as has been shown above. In the second embodiment, however, pressure sensors 85 'and 86' are provided in the coupling surface, which the pressure in corresponding pressure measuring ranges of Measure the cassette directly. The coupling of these pressure sensors to the cassette is advantageously ensured by a vacuum system.

2.6 input / output unit

The dialysis machine further comprises an input / output unit for communicating with an operator. For the output of information while a corresponding display is provided which z. B. by light emitting diodes, LCD displays or a screen can be implemented. For input of commands corresponding input elements are provided. This z. B. push buttons and switches can be provided.

In both embodiments, a touch screen 120 is provided, which allows an interactive menu navigation. Furthermore, display elements 121 and 122 are provided, which represent states of the dialysis machine compact.

The first embodiment further comprises a card reader 125, via which a patient card can be read. Data for the treatment of the respective patient can be stored on the patient card. As a result, the treatment process for the respective patient can be determined individually.

Peritoneal dialysis also has an acoustic signal unit via which acoustic signals can be emitted. In particular, an acoustic warning signal can be output when a fault condition is registered. In this case, a loudspeaker is advantageously provided, via which the acoustic signals can be generated.

2.7 Control

The peritoneal dialysis also has a control, by which all components are controlled and monitored. The control ensures the automatic processing of the treatment. FIG. 13 now shows the basic structure of an embodiment of such a controller.

Communication with the operator as well as with external sources of information takes place via an interface computer 150. This communicates with a patient card reader 200, an input and output unit 210, which serves to communicate with the patient, as well as with a modem 220. Via the modem 220 can z. B. an updated software can be installed.

The interface computer 150 is connected via an internal bus with an action computer 160 and a protection computer 170 in connection. The action computer 160 and the protection computer 170 generate a redundancy of the system. The action computer 160 receives signals from the sensors of the system and calculates the control signals for the actuators 180. The protection computer 170 also receives signals from the sensors 80 and checks whether the commands issued by the action computer 160 are correct. If the protection computer 170 detects an error, it initiates a corresponding emergency procedure. In particular, the protective computer 170 can thereby trigger an alarm signal. Furthermore, the protection computer 170 may close the access to the patient. For this purpose, a special valve is arranged on the patient-side output of the cassette, to which only the protection computer 170 has access. This safety valve is closed in the depressurized state so that it closes automatically in the event of failure of the pneumatics.

The protection computer 170 also communicates with the bar code reader 190, thus checking the connection of the correct dialysate bags.

Furthermore, a diagnostic system 230 is provided, via which errors of the system can be determined and remedied.

3. Implementation of the invention An embodiment of the present invention, which is used in a dialysis system shown above or in one of the dialysis machines shown above, will now be shown in the following. In this case, the embodiment of the present invention can be combined with single or multiple components as described above.

FIG. 14 shows an exemplary embodiment of the present invention as it can be used in a medical device. In particular, the exemplary embodiment is used in a dialysis machine, in particular in a peritoneal dialysis machine as described above. However, the present invention is not limited to dialysis machines, but can generally be used in medical devices.

The embodiment of the present invention comprises a controller 300, which controls a signal generator 320. For this purpose, the controller has a signal generator 310, which generates at its outputs 311 and 312 a control signal for driving the signal generator 320. The signal generator 320 is an acoustic signal transmitter, in the exemplary embodiment a loudspeaker based on a coil. The control signal is a periodic signal, in this case an alternating voltage signal, which is converted by the signal generator 320 into a corresponding acoustic signal.

To monitor the proper functioning of the signal generator 320, a monitoring unit 330 is provided according to the invention. This monitors the function of the signal generator based on the phase shift at the signal generator 320. The phase shift arises because the signal generator 320 is not an ohmic resistor. With proper functioning of the signal generator 320 thus occurs a phase shift not equal to zero. The monitoring unit 330 comprises a phase detector, which compares the phase of a current signal in the signal line with the phase of a voltage signal in the signal line. Since the signal generator 320 is a non-ohmic resistor, there is a phase shift between the current and the voltage signal, which is detected by the phase detector 330 and used for monitoring or checking the signal generator.

The current signal is generated by a measuring resistor 340, which is arranged in the signal line to the signal generator 320. Due to the serial arrangement of the measuring resistor 340 with the signal generator 320, the voltage drop across the measuring resistor 340 corresponds to the current through the signal generator. This current signal is applied as a voltage between the inputs b and c of the monitoring unit 330. As a voltage signal, the voltage signal generated by the signal generator 310 is used, which is applied between the inputs a and c of the monitoring unit 330. This voltage signal corresponds to the voltage which drops at the signal generator 320. Although the measuring resistor 340 changes the value of the voltage, not the phase, since it is an ohmic resistance.

If an alarm sound signal is now applied to the signal generator, the signal generator generates a phase shift between current and voltage. Such a phase shift P is shown in FIG. 15, in which the signals at the input a and at the input b of the monitoring unit 330 are shown over time. By means of this phase shift, the monitoring unit 330 can directly monitor the signal generator 320 and returns information to the system as to whether the alarm system is functioning correctly. For this purpose, the monitoring unit 330 has an output e, via which a corresponding information signal is returned to the controller 300.

The phase detector of the monitoring unit 330 generates z. B. a voltage which is proportional to the phase angle between the two inputs a and b. A properly functioning signal generator generates a Phase angle non-zero, while a short circuit or an interruption generate a phase angle of 0 °. Such an error can therefore be easily recognized. A partial winding short circuit in the signal generator can also be detected via the phase angle changed thereby or the changed measurement signal resulting therefrom. The controller is informed when a fault is detected by the malfunctioning audible warning function and can take appropriate action.

The embodiment of the present invention thus enables the direct monitoring of the function of an alarm sounder, in particular an acoustic alarm sounder. If a malfunction of the alarm sounder detected, the monitoring unit outputs a corresponding information signal to the controller, which initiates appropriate action. In particular, a corresponding visual indication of the missing functionality and / or the initiation of a safe state of the medical device can be provided here.

The monitoring is thus carried out during operation of the medical device. If appropriate, the system according to the invention can also have an inertial test function, which controls the function of the monitoring unit in an inertial manner. B. checked during commissioning of the medical device. For this purpose, z. B. a relay can be provided which short-circuits the signal line to the signal generator or completely opens.

The monitoring unit according to the invention can be used in particular for monitoring a signal generator of a dialysis machine, as described in more detail above. However, the present invention is not limited to dialysis machines, but can be generally used in medical devices.

Claims

claims

1. medical device, in particular dialysis machine, with a controller and with a signal generator, which can be controlled by the controller with an electrical control signal, and with a monitoring unit for monitoring the proper functioning of the signal generator,

characterized,

that the monitoring unit monitors the proper functioning of the signal generator based on a phase shift of the control signal at the signal generator.

2. Medical device according to claim 1, wherein the monitoring of the proper functioning of the signal generator based on a phase shift between a current signal and a voltage signal at the signal transmitter takes place.

3. Medical device according to claim 1 or 2, wherein a current signal whose phase corresponds to the phase of a current flowing through the signal generator due to the control signal, enters the monitoring unit.

4. Medical device according to claim 3, wherein the current signal is generated based on the voltage drop across a measuring resistor in the signal line to the signal generator.

5. Medical device according to one of claims 1 to 4, wherein a voltage signal whose phase corresponds to the phase of a falling due to the control signal to the signal generator voltage, enters the monitoring unit.

6. Medical device according to one of the preceding claims, wherein the signal generator is an acoustic signal generator, in particular a loudspeaker.

7. Medical device according to one of the preceding claims, wherein the signal transmitter has a coil and / or a capacitor.

8. Medical device according to one of the preceding claims, wherein the control signal is based on a periodic electrical signal, in particular on an AC signal.

9. Medical device according to one of the preceding claims, wherein the monitoring unit detects an error of the signal generator when the phase shift is outside a predetermined range.

10. Medical device according to one of the preceding claims, wherein the monitoring unit detects an error of the signal generator when the phase shift is equal to zero.

11. Monitoring unit for a medical device according to one of the preceding claims.

12. A method for monitoring the proper functioning of a signal generator of a medical device, in particular a dialysis machine, wherein the medical device has a controller and a signal generator, which is controlled by the controller with an electrical control signal,

characterized,

that the proper functioning of the signal generator is monitored by means of the phase shift of the control signal at the signal generator.

13. The method of claim 12 for operating a medical device according to one of the preceding claims.