Infusion pump and method for operating same

Abstract

Infusion pumps (10) for supplying a patient (2) with at least one medicament are known. An infusion pump (10) is proposed which has an electrically operated pump actuator (24) and preferably a plurality of valve actuators (22A). The infusion pump (10) has, on the base unit (20), a control device (30) for controlling at least the pump actuator (24) and the valve actuators (22A), the control device (30) being connected to at least one first data interface (32A) for connection to the at least one medicament store (110) and to a second data interface (32B) for connection to the patient. The control device (30) is designed to acquire patient-related and medicament-related data via the data interfaces (32A, 32B) and to control at least the pump actuator (24) in dependence on the data acquired via the data interfaces (32A, 32B).

Description

[0001] Infusion pump and method for its operation

[0002] FIELD OF APPLICATION AND STATE OF THE ART

[0003] The invention relates to an infusion pump for supplying a patient with medication in liquid form.

[0004] Conventional infusion pumps have a peristaltic-type pumping device. Medication reservoirs are connected to one of the pumping device's inlets. These reservoirs are each equipped with a manually opened and closed valve. During the infusion treatment, the fluid from the reservoirs is sequentially delivered to the patient via an access device such as a venous catheter.

[0005] Infusion treatment is usually performed under supervision and with manual intervention to change the valve position of the medication reservoirs.

[0006] Configuring an infusion system, including the infusion pump, the patient access device connected to the infusion pump's output side, and the medication reservoir connected to the infusion pump's input side, as well as the manual handling of the infusion treatment and the associated monitoring and documentation of the infusion treatment, represents a significant effort. Furthermore, there is a risk of errors. It requires precise and complex verification that the connected medications are the correct ones and that the respective infusion parameters of the individual medications are correctly specified and adhered to according to a treatment plan.

[0007] TASK AND SOLUTION

[0008] The object of the invention is to provide an infusion pump and a corresponding operating method that reduces personnel costs and / or the risk of treatment errors during infusion treatment.

[0009] For this purpose, the invention primarily proposes an infusion pump for supplying a patient with medication in liquid form, which is specially designed for data communication with patient-specific and medication-specific counterparts. An infusion pump according to the invention comprises, in a conventional manner, a base unit and a line unit to be coupled thereto.

[0010] The line unit comprises all fluid lines and fluid-conducting surfaces, which are at least partially designed to be flexible in shape. The line unit has at least one fluid inlet for connecting at least one medication reservoir and at least one outlet for connecting the patient. The number of fluid inlets is preferably two or more, in particular five or more. Multiple medication reservoirs and, if necessary, an additional reservoir for rinsing fluid can be connected via these.

[0011] The fluid outlets and fluid inlets are each designed in the form of a connector, in particular in the form of a Luer connector according to the ISO 80369 family of standards. They are used for connection to a corresponding mating connector of a hose line.

[0012] The base unit of the infusion pump is provided with at least one electrically operated pump actuator, which acts externally on the line unit, thus forming a peristaltic pump. This is preferably a slide-valve peristaltic pump, which ensures a particularly uniform flow. The pump actuator causes fluid to be pumped from a fluid inlet, and thus from the medication reservoir, to the fluid outlet, and thus to the patient.

[0013] In addition to the pump actuator, the base unit preferably has at least one electrically controllable valve actuator as part of a valve device, by means of which a fluid inlet can be isolated so that fluid can no longer flow from this fluid inlet to the pump device and the fluid outlet. Preferably, a valve actuator is assigned to each fluid inlet in order to selectively allow flow to the pump device from only one fluid inlet at a time. A valve device can also be assigned to the fluid outlet.

[0014] The base unit also supports a control unit. This control unit controls at least the pump actuator and preferably also the valve actuators. The control unit has data interfaces, namely a first data interface by means of which the control unit is coupled to the at least one medication storage device for data exchange, and a second data interface by means of which the control unit is coupled to the patient or a counterpart directly assigned to the patient for data exchange. The control unit is designed to acquire patient-related and medication-related data via the data interfaces. This data is used by the control unit when controlling the pump actuator and preferably the valve actuators.

[0015] In particular, the infusion pump can be designed so that patient-related and medication-related data are recorded and evaluated simultaneously and continuously. However, a procedure in which the respective data are recorded at intervals, for example, every five or ten seconds, is also conceivable.

[0016] An infusion pump according to the invention therefore offers significant advantages in handling. Because the infusion pump can itself detect which external components it is coupled to via the data interfaces, the effort required to prepare the infusion treatment can be reduced and the risk of incorrect treatment can be further reduced. The initiation of the infusion treatment can be automatically interrupted by the control unit if the recorded data indicates an error in the preparation of the treatment, for example, an incorrectly connected medication storage device or the use of the wrong therapy plan for a patient. The data interfaces also allow the progress of the infusion treatment to be monitored during the ongoing infusion treatment and, if necessary, to interrupt or adjust the infusion treatment if this appears necessary based on the recorded data.

[0017] The data exchange with the patient and with the medication reservoir preferably takes place at least partially along the fluid paths formed by the fluid inlets and the fluid outlet. It is therefore considered advantageous for the at least one connector to have a connecting device for establishing a data connection with an opposing mating connector on the fluid line of the medication reservoir or the patient.

[0018] Such a connecting device can be formed by galvanically coupled contact surfaces on the connectors. However, it is particularly valuable if the connectors are provided with a coil for inductive data transmission, particularly a coil with a cylindrical or conical basic shape.

[0019] By coupling the corresponding connectors, not only a fluid connection is created, but simultaneously a connection via which data and / or electrical energy can be transmitted. In particular, it is preferably provided that at least two connectors are provided, each forming a fluid inlet, each of which has a connecting device for establishing a data connection with an opposing mating connector.

[0020] Preferably, more than two connectors forming a fluid inlet are provided, for example, three, four, five, six, seven, eight, nine, or ten. In particular, each connector forming a fluid inlet is preferably assigned a connecting device for establishing a data connection with an opposing mating connector.

[0021] The plurality of fluid inlets and the at least one fluid outlet form a line topology, wherein a connecting device for establishing a data connection is preferably provided on each branch of this line topology.

[0022] In the simplest case, the cable unit can consist of a hose structure with one outlet and two or more inlets, with connectors located at the ends of the hoses. Data cables can be routed along the hose structure.

[0023] However, a line unit that has a rigid support part to which the fluid line is provided or attached is considered particularly advantageous. This rigid support part is coupled as a whole to the base unit, in particular without tools using a coupling device in the form of a snap connector. By attaching the support part to the base unit, the fluid lines are brought into the area of ​​the pump actuator and, if applicable, the valve actuators, so that after coupling, the fluid flow through the line unit can be controlled by the actuators on the base unit.

[0024] The fluid lines of the line unit can also be formed by a hose structure when using a support member of the type already described, in particular by uniform hose bodies with at least two ends, with the connecting pieces provided at the ends. However, the hose structure can be clamped to the support member by snap connectors. Alternatively, a design is also possible in which the fluid lines are formed, at least in sections, directly by surfaces of the support member. These surfaces are thus in fluid contact.

[0025] The supporting part is preferably made of a rigid plastic. Polycarbonate (PC), polyvinyl chloride (PVC), polyethylene (PE), and polypropylene (PP) are particularly suitable, but other plastics can also be used. The fluid lines of the line section are made, at least in sections, of a deformable plastic so that the pump actuator and, if applicable, the valve actuators can reduce the line cross-section via valve orifices or the like. Thermoplastic polyurethanes (TPU) and thermoplastic elastomers (TPE) are preferred materials for the deformable parts of the fluid lines. Polyvinyl chloride (PVC) can also be used for this purpose. Silicone is also a well-suited material for the deformable parts of the fluid lines.

[0026] The aforementioned connectors for connecting a patient-side tube and the medication reservoir-side connectors are preferably provided at the free ends of the tube body in the case of a design with a tube body. In particular, in such a design, the connectors are preferably not stationary relative to one another and, if applicable, to the support member, but rather are movable via inlet tube sections or an outlet tube section. Preferably, at least one connector forming a fluid inlet is provided on an inlet tube section, wherein a data line connected to the first data interface is preferably guided at least partially along the inlet tube section.Likewise, the connector forming the fluid outlet is preferably provided on an outlet hose section on the outlet side, wherein a data line connected to the second data interface is preferably routed at least partially along the outlet hose section. If such a design is provided in which data lines are routed along a hose section, the data line can be attached to the outside of the hose section or integrated into the wall of the hose section as an integral component.

[0027] Preferably, hose sections that are arranged in the area of ​​the pump actuator or the valve actuator when the line unit is connected to the base unit are free of data lines, since the deformation of the line wall here could damage the data lines in the long term.

[0028] In an alternative design to the movable connecting pieces, it is provided that at least one connecting piece forming a fluid inlet or the fluid outlet is fixedly attached to the support part and is thus arranged fixedly to the base unit after the support part has been attached to the base unit. In particular, all fluid inlets and the fluid outlet are preferably formed by mutually fixed connecting pieces on the support part. The data lines provided on the line unit, which are in particular preferably led to the respective connecting pieces, are connected at their other end to the base unit and the control device provided there. It is preferably provided that for the purpose of data transmission, at least one connecting device is provided for detachable connection to a mating connecting device of the base unit.If the line unit is mechanically coupled to the base unit, the data connection of the connection device to the counterpart connection device is preferably also established.

[0029] Particularly preferably, the connection device and the counter-connection device have corresponding contact surfaces for galvanic coupling, with spring contacts preferably being provided on at least one side. Alternatively, non-galvanic connection types between the base unit and the line unit are also possible, such as, in particular, an inductive connection. However, galvanic coupling is preferred because it allows higher electrical power and reduces losses. A single connection device can be provided on the line unit and a single counter-connection device on the base unit, whereby both the data connections to the patient and to the medication storage devices can be routed via these.

[0030] Alternatively, a plurality of connection devices and counter-connection devices can also be provided, in particular one connection device and counter-connection device each for the data connection to the patient and for the data connections to the medication storage devices and / or one connection device and counter-connection device each for each fluid inlet or for each fluid inlet and fluid outlet. Such a design with a plurality of connection devices and counter-connection devices can also be particularly advantageous because it has been shown that this can increase reliability and reduce the electrical control complexity during the energy and, in particular, information input and output. In addition, troubleshooting is facilitated, and separate evaluation and / or display of the connection devices detected as correctly or incorrectly connected is possible for each connection device.

[0031] The connection devices and the counter-connection devices are preferably arranged on the components of the infusion pump in such a way that they are aligned congruently when the base unit and the line unit are joined. In particular, the connection devices and the counter-connection devices are also correspondingly coordinated with the mechanical coupling components by means of which the base unit and the line unit are connected.

[0032] As already mentioned at the beginning, the base unit preferably has not only a pump actuator, but also at least one electrically controllable valve actuator, by means of which a valve device can be opened and closed. Such valve devices preferably allow all fluid inlets to be separated from the fluid outlet separately. Preferably, at least three fluid inlets and correspondingly at least three valve devices are provided. A valve device can also be assigned to the fluid outlet, so that the fluid outlet is closed, particularly before the line unit is separated from the base unit.

[0033] The infusion pump preferably has a common pump housing, within which and / or on the front of which at least one pump actuator and at least one valve device, and in particular the valve actuators, are arranged. The line unit can be attached to the front of the housing to enable the pumping of the fluid by means of the pump device and the opening and closing of the valve devices.

[0034] The valve devices can be designed as bistable valve devices, so that the respective valve device can remain in a closed state and an open state without power supply.

[0035] In contrast, however, a configuration of the at least one valve device as a monostable valve device is usually preferred. Such a monostable valve device has a return spring that counteracts the valve actuator, so that the valve device assumes a closed state without a power supply. If the infusion pump no longer supplies power to the valve actuators due to a defect, the corresponding valve device is closed accordingly.

[0036] Preferably, the line unit has a plurality of fluid inlets, for example, five fluid inlets, with a valve device being assigned to each of the plurality of fluid inlets, and preferably to all fluid inlets. In infusion therapy, unlike, for example, dialysis, mixing of medical infusion fluids before entering the patient's body is undesirable. Therefore, the infusion pump according to the invention is preferably designed to prevent the simultaneous opening of two valve devices.

[0037] There are several options for this.

[0038] The infusion pump can have valve devices that are mechanically coupled so that only one of the valve devices can be open at a time. As soon as one valve device is open, a second one is mechanically prevented from opening, in particular by the opening of the first valve device being accompanied by a displacement of a stop that prevents the opening of a second one when the first valve device is open.

[0039] The at least two valve devices can also be electronically coupled, so that only one of the at least two valve devices can be open at any one time. A corresponding circuit can be configured such that a power supply circuit can always be switched via relays, transistors, or the like with a view to opening exactly one valve device. Opening another valve device requires switching via the relay or transistor, so that the first valve device is necessarily closed.

[0040] Another possibility is for an infusion pump control unit and a control program running on it to ensure that only one valve is open at a time. This can be most easily implemented by ensuring that the routine for opening one valve always closes all other valves first.

[0041] The mechanical solution, the electronic solution, or the solution via the control unit can each be designed in such a way that they specify an opening sequence from which no deviation is permitted. In particular, a sequence can be specified according to which, after each medical infusion fluid has been administered to the patient, the valve device for the flushing fluid must first be opened to clear the lines of the previous medical infusion fluid before another medical infusion fluid is administered.

[0042] It is provided that an infusion pump according to the invention communicates via the first and second data interfaces with at least one medication-related counterpart and one patient-related counterpart. In the case of the patient-related counterpart, this can be, in particular, an integrated circuit and / or a memory on a patient's catheter, with which the control unit communicates via the second data interface. In the case of the medication-related counterpart, this can be, in particular, an integrated circuit and / or a memory on the medication reservoir, with which the control unit communicates via the first data interface.

[0043] The communication can, in particular, serve the purpose of reading control data for operating the pump actuator and / or the valve actuators into the control unit. In particular, it can be provided that a therapy plan is read in via one of the data interfaces. This plan contains information about which patient is to receive which medication and in which order. Activation of the pump actuator and switching of the valve actuators then take place according to this therapy plan. The control unit is preferably designed, in particular, to read the therapy plan from a connected medication storage device.

[0044] Furthermore, data communication can serve the purpose of reading unique identifiers via the data interfaces. Such a unique identifier can then be used to select the appropriate treatment plan. This can, for example, already be stored in the infusion pump or be read from an external server based on the unique identifier, in particular a patient identifier or a therapy identifier read from the patient. Furthermore, reading unique identifiers, in particular medication-related identifiers, serves to verify the validity of the respective identifiers within the framework of a previously provided treatment plan.In addition, the control unit can be designed to check, when connecting a medication storage device via the first data interface, whether the respective medication storage device, whose identifier was previously read in, has been connected to the connection piece provided for this purpose.

[0045] Preferably, the verification of validity, in particular the validity of medication memory identifiers read in via the second data interface, is accompanied by a verification of the authenticity of the medication memory. This can be done by verifying a digital and preferably cryptographic authentication read in this way.

[0046] Verifying the validity of the medication storage device can also include verifying the manufacturing date. In particular, the expiration date of the individual medication preparation can be verified, as used, for example, in personalized chemotherapy. In addition to transmitting identifiers or a treatment plan, the data interfaces can also be used to transmit sensor data. Preferably, a medication storage device is equipped with appropriate sensors, and the control unit is configured to read data from these sensors via the first data interface, in particular the temperature or optical properties or the concentration of the liquid.

[0047] The patient side, in particular a catheter provided on the patient side that is connected to the control unit via the second data interface, can also be equipped with sensors whose data is transmitted via the second data interface. In particular, the sensors can include a temperature sensor, a blood pressure sensor, a blood oxygen sensor, and / or a sensor for measuring cardiac currents or tissue impedance, the data from which is read by the control unit. The sensors serve the purpose of monitoring the patient's vital data. In particular, this allows any possible changes in the vital data in response to the infusion therapy and its sub-phases to be detected and, if necessary, documented.

[0048] The control unit can be configured to control the pump actuator and / or a valve actuator depending on the sensor data. In particular, the control unit can interrupt the infusion treatment by stopping the pump actuator or closing valve devices if sensor data from the patient or medication storage device fall outside a defined value range.

[0049] Furthermore, the control unit is preferably designed to generate a warning signal, particularly in visual or acoustic form, when data read via the data interfaces represents a situation that deviates from the target parameters, for example, if an incorrect medication storage device is connected or sensors provide critical data. The warning signal can be perceived as a visual or acoustic warning signal directly on the infusion pump. However, it can also or additionally be a true message sent over a network.

[0050] The control unit is preferably designed to maintain a log of the infusion pump's activity, i.e., to store corresponding data in its own memory or to transmit it for storage via a network interface or one of the data interfaces. In particular, it is considered advantageous if some or all of the following data is logged: connection of a patient to the infusion pump; connection of a medication storage device to the infusion pump, preferably including storage of data on the type of medication and / or comprising a unique batch identification; input values ​​from at least one sensor associated with a medication storage device or the patient.

[0051] In addition to the data interfaces, the control unit of the infusion pump preferably has a network interface via which it is connected to an external network. This network interface can be used, in particular, to read in the patient-specific treatment plan and / or data from a patient file, which can then be used to perform a validity check with regard to connected medication storage devices. The control unit can also be designed, in particular, to send a log of the infusion pump's activity via the network interface.

[0052] The infusion pump preferably has a display device, in particular in the form of a display permanently integrated into the infusion pump, preferably a touch display. This display device can primarily serve the purpose of displaying essential information during the preparation of the infusion pump, such as data on the counterparts connected via the first and second data interfaces on the patient side and on the medication storage side. In a design in which the control unit is configured to read sensor data, the display device can also serve the purpose of displaying this sensor data. Furthermore, the display device can serve the purpose of presenting information on a currently ongoing infusion treatment in a form suitable for medical personnel or the patient.In particular, it can show how far the infusion treatment has progressed and which medication is currently being administered.

[0053] It is particularly advantageous if the infusion pump with its display device is used for supplementary functions that do not directly serve the implementation of therapy using the infusion pump. Such functions include the use of the infusion pump as a feedback system. The infusion pump is therefore preferably designed to receive feedback from the patient, for example in the form of operation of control elements and / or from a touchscreen of the infusion pump. The patient can use this, for example, to enter their subjectively perceived current condition. If necessary, this can also be used to interrupt or adjust the infusion treatment in response to such feedback. The entered feedback can be sent via the described network interface, optionally supplemented by data on the currently ongoing infusion treatment and / or sensor data read in by the infusion pump.The presence of a display device, together with a camera integrated into the infusion pump, can also be used to conduct video calls. In particular, this allows the patient to contact medical staff.

[0054] The invention relates not only to the infusion pump itself, but also to an infusion arrangement which, in addition to the infusion pump, has at least one medication reservoir filled with a liquid medication. This is connected to the control unit of the infusion pump via the first data interface. The medication reservoir is provided with a counterpart in the form of at least one integrated circuit or an electronic memory, the data from which can be read by the control unit. Preferably, the medication reservoir has a connecting tube for connection to the infusion pump, at the end of which a counterpart connection piece for the fluid inlet connection piece of the infusion pump is provided. Just like the connection piece on the infusion pump, the counterpart connection piece also preferably has a connection device for establishing the data connection, in particular in the form of a coil.In addition to the integrated circuit and / or the memory, or alternatively, at least one sensor can also be provided on the medication reservoir, in particular a temperature sensor, a sensor for detecting the optical properties of the liquid, or a sensor for detecting the concentration of the liquid. The sensor data from this sensor can be read by the control unit via the first data interface.

[0055] Furthermore, the infusion arrangement preferably has a patient-side access device that is connected to the control unit of the infusion pump via the second data interface. Just like the medication reservoir, the access device, which in particular comprises a catheter, can have an integrated circuit and / or an electronic memory that the control unit of the infusion pump can access via the second data interface. Preferably, the access device is further assigned at least one sensor that can be read by the control unit via the second data interface. In particular, this is preferably a temperature sensor, a blood pressure sensor, an oxygen sensor for measuring the oxygen content in the patient's blood, or a sensor for measuring cardiac currents or for measuring tissue impedance.

[0056] The described infusion arrangement is preferably part of an infusion system according to the invention. Such an infusion system comprises, in addition to the infusion arrangement, a server connected to the control unit of the infusion pump via a network. The infusion system preferably comprises a plurality of infusion pumps, each connected to the same server. The server preferably has access to patient records and / or therapy plans via the network.

[0057] The control unit of the infusion pump is designed to transmit data to the server via the network or to retrieve data from there. In particular, the control unit can be designed to retrieve data relating to a therapy from the server, wherein the request directed to this is preferably created using data read in by the control unit via the first or second data interface, i.e. in particular an identifier that is uniquely assigned to the patient. Furthermore, the control unit can be designed to transmit status messages or the patient feedback described above to the server, preferably in real time. The above-mentioned logging of the infusion treatment can then be performed by the server instead of by the infusion pump itself.

[0058] Preferably, the infusion system with server and infusion pump is configured so that the server can trigger an interruption of an ongoing therapy, in particular a personalized cellular therapy. This can be used, for example, to allow the drug manufacturer to interrupt the therapy under certain conditions if medically necessary, particularly in response to a server-side evaluation of patient-related or drug-related data.

[0059] In addition to the infusion pump, the infusion arrangement and the infusion system, the invention also relates to a corresponding method for operating an infusion pump, which is preferably designed according to the above description.

[0060] The method provides that the infusion pump reads data from a medication storage device via the first data interface and / or reads data about the patient via the second data interface. The data is then processed, in particular to check the validity of the patient data and the medication storage device. During the check, the authenticity of a connected medication storage device or its compatibility with the therapy plan is checked, and / or whether the medication storage device is connected to the designated fluid inlet is checked. Data processing may further include reading therapy data via a network interface.

[0061] In response to this data processing, fluid delivery via the infusion pump is started, usually after manual approval by medical personnel, and / or at least one valve device is opened if the read data does not conflict with the infusion treatment. Otherwise, the infusion treatment is not started, in particular by deactivating or not activating the pump actuator or by a valve actuator closing a valve device of the infusion pump.

[0062] BRIEF DESCRIPTION OF THE DRAWINGS

[0063] Further advantages and aspects of the invention emerge from the claims and from the following description of preferred embodiments of the invention, which are explained below with reference to the figures.

[0064] Fig. 1 shows an infusion pump as part of an infusion system.

[0065] Fig. 2 and 3 show a base unit and a line unit of the infusion pump.

[0066] Fig. 4 and 5 show alternative designs of the infusion pump line unit.

[0067] Fig. 6 shows a connection device of the infusion pump.

[0068] Fig. 7 and 8 show the structure of the valve devices of the infusion pump.

[0069] DETAILED DESCRIPTION OF THE EMBODIMENTS

[0070] Fig. 1 shows an infusion pump 10 which is part of an infusion arrangement 100.

[0071] The infusion pump 10 serves the primary purpose of delivering fluid from the medication reservoirs 110 to a patient 2. Patient 2 is connected to a fluid outlet of the infusion pump 10 via an access device 120. The five medication reservoirs 110 shown in the example contain different medications, which are typically created specifically for patient 2. One of the medication reservoirs 110 can contain a flushing fluid to flush the fluid lines and the infusion pump 10 between different phases of medication delivery.

[0072] The access device 120 and the medication storage 110 are not only fluidically connected to the infusion pump 10, but also via data lines 65A-65F. A control unit 30 of the infusion pump 10 is connected via these data lines to counterparts on the patient side or the medication storage side. In the case of the patient, the access device 120 has a memory 122. A processor for processing the data can also be provided here. Furthermore, a sensor 124 or a plurality of sensors 124 are preferably provided on the side of the access device 120. These can be a directly integral part of the access device 120 or connected to the access device via additional lines.

[0073] Memory 122 preferably contains at least one identifier unique to the patient or the planned infusion therapy, for example, an ID number. However, additional useful data can also be stored here, for example, the therapy plan itself.

[0074] The sensors are primarily used to monitor the vital functions of patient 2. These can be, for example, a temperature sensor, a blood pressure sensor, or a blood oxygen sensor. Sensors for measuring cardiac currents and tissue impedance can also be provided. Furthermore, they can also be sensors used to monitor the functionality of the infusion system. For example, sensors for monitoring the fluid flow can be provided here, for example, to check whether there is a fluidic interruption between the infusion pump and the access device.

[0075] In the case of the design of Fig. 1, a memory 112 and at least one sensor 124 are also provided on the side of the medication storage 110.

[0076] The memory 112 preferably contains a unique identifier that is unique to the specific medication storage device. In addition to or instead of this, information about the contained fluid can also be stored here, such as, in particular, its composition, an identifier of the patient for whom the fluid was created, or even the date of creation and / or an expiration date.

[0077] Furthermore, the reservoir 112 can also contain a therapy plan. This therapy plan can contain information about how the fluid contained in the respective medication reservoir itself is to be dispensed, as well as information about other medications with which the fluid is to be dispensed.

[0078] Sensor 114 serves to monitor medication reservoir 110 and, in particular, the liquid contained therein. Sensor 114 can be a temperature sensor, a sensor for detecting the optical properties of the liquid, or a sensor for detecting the concentration of the liquid. A sensor 114 for detecting the fill level of the medication reservoir may also be appropriate.

[0079] The control unit 30 is capable of reading and, if necessary, writing to the memories 112, 122 via the data lines 65A-65F. Alternatively, the control unit 30 can also exchange data with counterparts at the medication storage units 110 and the access device 120, whereby these counterparts grant access to the respective memories 112, 122 and sensors 114, 124.

[0080] Furthermore, it can be provided that the control unit 30 accesses an associated server 210 via a network 212 in order to receive data from there, for example, a therapy plan, or to send data to the server, for example, status data that enables the server-side creation of a therapy protocol. Alternatively, the therapy protocol can also be generated locally by the control unit 30 and at least initially stored in its memory.

[0081] The control unit 30 controls the supply of fluid from the medication reservoirs 110 to the patient 2. In a manner explained in more detail below, the control unit 30 is designed to control the fluid delivery via actuators, in particular to be able to selectively release and disconnect the medication reservoirs 110 and to deliver fluid from the released medication reservoir 110 to the access device 120.

[0082] The control unit 30 is designed to control fluid delivery according to a treatment plan specifically compiled for the patient. This treatment plan contains the necessary information regarding the order and quantity of medications to be delivered.

[0083] The therapy plan can be entered into the control unit in several ways. It can be entered directly on the infusion pump using the input devices there or read from a separate memory.

[0084] Within the scope of the present invention, however, the therapy plan is preferably read directly from the memory 122 on the patient side or from the memory 112 of one of the medication stores. Alternatively, the therapy plan can be obtained from the server 210 via the network 212 based on an identifier read from one of the stores or based on a manual selection on the infusion pump 10. The therapy plan contains information about the patient for which it was created and which medications are used in the therapy. The control unit 30 is capable of comparing these specifications with data read from the various medication stores 110 and from the access device 120.

[0085] In particular, it can be checked whether the connected medication storage devices 110 match those contained in the therapy plan and that all required medication storage devices 110 have been connected. It can also be checked whether the medication storage devices 110 are connected to the correct connectors of the infusion pump 10.

[0086] Furthermore, it can be checked whether the correct patient 2 or the access device 120 of the correct patient 2 is connected to the infusion pump.

[0087] If all requirements according to the therapy plan are met, the control unit 30 starts the therapy by opening a first medication reservoir 110 via a valve device in accordance with the therapy plan, while the others remain closed. By activating a pump device, the fluid is pumped from the opened medication reservoir 110 to the access device 120 and delivered to the patient.

[0088] As soon as the required amount of the first medication has been reached according to the therapy plan, the control unit closes the corresponding valve device and opens a valve device of a medication reservoir 110, which is filled with a rinsing fluid. After the fluid lines have been rinsed, the valve device of another medication reservoir 110 is opened, and the infusion therapy continues with the corresponding fluid.

[0089] During the infusion treatment, the control unit 30 monitors the sensors 114, 124. On the medication storage side, it can be monitored, in particular, whether the respective fluids are at the desired temperature. On the patient side, the patient's vital signs are primarily monitored.

[0090] If the data acquired by control unit 30 indicates a potentially critical situation, the control unit can take various measures. It can initially interrupt the therapy completely, in particular by deactivating the pumping device of infusion pump 10. It can also adjust the therapy instead. Furthermore, it can be provided that control unit 30 contacts server 210 or other external components regarding the detected situation, so that, for example, medical personnel can be informed.

[0091] A display device 34 of the infusion pump 10 allows not only medical personnel to operate the infusion pump 10. It can also be provided that the patient 2 themselves use the display device and associated controls to provide feedback. This allows the patient to directly call medical personnel or initiate a video call with a physician via the display device 34 if they deem this necessary.

[0092] Instead, the patient can also provide information about his or her condition on the screen within a dedicated dialog system. The control unit 30 can then, if necessary, take such data into account and decide whether the infusion treatment should be interrupted.

[0093] Preferably, the control unit 30 is configured to log the infusion treatment and store corresponding data, whereby the data can be stored either locally in the infusion pump 10 or via the network 212 on a server 210. In particular, the control unit 30 stores data on the respective therapy steps performed and the respective times of the steps, as well as data from the sensors 114, 124. In particular, this therapy protocol can be stored directly in the patient file of the respective patient 2.

[0094] Fig. 2 and 3 show a first embodiment of the infusion pump 10. The infusion pump 10 has two main components, namely a base unit 20, which is shown in Fig. 2, and a line unit 50, which is shown in Fig. 3.

[0095] The base unit 20 comprises exclusively components that do not directly carry fluid, in particular a housing, within which or on the front of which various actuators are provided, namely a pump actuator 40 and five input-side and one output-side valve actuator 22A as part of valve devices 22. These actuators are connected to the control unit 30 so that the control unit 30 can control the fluid delivery via them.

[0096] Furthermore, the base unit features the previously described display device 34, particularly configured as a touchscreen. A loudspeaker 36 is also integrated into the base unit.

[0097] The fluid is guided entirely within the line unit 50. The line unit 50 has a support part 62 made of a rigid plastic. A hose structure 52 is provided on this support part, forming the fluid line 64. This hose structure 52 is attached to the support part 62 by means of snap connectors 54. The hose structure has five inlet-side hose sections, each of which has a connector 66A-66E. The hose structure also has an outlet-side hose section, to which another connector 66F is attached. The connectors are each designed in the manner of a Luer connector in accordance with the ISO 80369 family of standards.

[0098] A connector corresponding to connectors 66A-66F is shown again in Fig. 6, connected to a mating connector 66'. The assignment is arbitrary here, because the right-side connector shown in Fig. 6 could also correspond to one or more of the connectors on the line unit.

[0099] As can be seen in Fig. 6, the connectors 66A-66F include coils 68 as a connecting device for transmitting data and / or electrical power across the connected connectors 66A-66F. The coils are shaped as cylindrical or conical coils, but could also be designed as planar coils.

[0100] The data lines 65A-65F connected to the connecting pieces 66A-66F and their coils 68 are guided in sections along the hose structure 52 and then guided to a common connection device 72 in the area of ​​the supporting part 62.

[0101] The line unit 50 has a coupling device 63 for mechanical coupling to the base unit 20. As intended, the line unit 50 of Fig. 3 is pressed from the front against the base unit 20, so that the coupling devices snap releasably together with a corresponding geometry on the side of the base unit.

[0102] In addition to this mechanical coupling, the fluid line 64 also reaches the area of ​​the pump actuator 24, allowing it to pump the fluid through the flexible wall of the fluid line 64 toward the fluid outlet. Valve orifices 22E are provided on each of the five inlet branches of the fluid line 64 and on the outlet side of the fluid line 64. These valve orifices 22E engage with the corresponding valve actuators 22A when the line unit 50 is placed on the base unit 20.

[0103] The valve devices 22 together with the valve orifice 22E are shown in Figs. 7 and 8.

[0104] The design shown in Fig. 7 is a bistable valve device. On the base unit 20 side, there is a receptacle into which the valve orifice 22E is inserted. Within this receptacle, a coupling extension 22D is provided, which engages with a groove in the valve orifice 22E, so that the valve actuator 22A, designed as a servomotor, displaces the coupling extension 22D and thus the valve orifice 22E relative to the fluid line via a spindle 22C. This allows the closed state to be achieved, which is shown on the right side of Fig. 7.

[0105] The design shown in Fig. 8 is a monostable valve device 22. The basic structure is similar to Fig. 7. The difference is that a return spring 22B is provided, which applies an upward force to the coupling extension 22D. The valve device therefore closes if no current is applied to the valve device 22. If the valve device 22 is energized, this activates an electromagnet, which represents the valve actuator 22A. This electromagnet pulls the coupling extension 22D and thus the valve orifice 22E downward, thereby opening the valve device 22.

[0106] The attachment of the line unit 50 to the base unit 20 also leads to the coupling of the connection device 72 on the line unit to the mating connection device 32 of the base unit 20. Thus, the connection pieces 66A-66F, which are part of the line unit 50, are connected to the control unit 30 so that the communication described above can take place with counterparts connected to the connection pieces 66A-66F.

[0107] Figures 4 and 5 show alternative designs of the line unit 50.

[0108] In both cases, in contrast to the design of Fig. 3, the connecting pieces 66A to 66F are not provided on hose sections that are movable relative to the support member 62. Instead, the connecting pieces 66A to 66F are each fixedly attached to the support member.

[0109] In the design of Fig. 5, it is additionally provided, in contrast to the designs of Figs. 3 and 4, that the fluid lines 64 are not formed by a hose structure 52 that is attached to the support member 62. Instead, the fluid lines 64 are formed directly by the support member 62. The fluid lines 64 are thus predominantly defined by rigid walls of the support member 62. Only in sections 64A, 64B are the fluid lines provided with a flexible wall, so that here the pump actuator 24 can exert a conveying effect on the fluid line 64 and the valve orifice 22E can selectively close the fluid line.

Claims

Claims: Infusion pump (10) for supplying a patient (2) with at least one drug in liquid form, comprising the following features: a. the infusion pump (10) has a base unit (20), and b. the infusion pump (10) has a line unit (50) to be coupled to the base unit (20), which comprises a fluid line (64) that is at least partially flexible in shape, with at least one connection piece (66A-66E) forming a fluid inlet and with a connection piece (66F) forming a fluid outlet, and c.The infusion pump (10) has at least one electrically operated pump actuator (24) on the base unit (20), which is designed to act externally on the at least partially flexible fluid line (64) between the fluid inlet and the fluid outlet, thereby pumping the medication from at least one medication reservoir (110) connected to the at least one fluid inlet (66A-66E) to the fluid outlet and thus to the patient (2), and d. the infusion pump (10) has a control unit (30) on the base unit (20) for controlling at least the pump actuator (24), wherein the control unit (30) is connected to at least one data interface (32A) for connection with the at least one medication reservoir (110) and to a second data interface (32B) for connection with the patient, and e.The control unit (30) is configured to acquire patient-related and drug-related data via the data interfaces (32A, 32B) and to control at least the pump actuator (24) depending on the data acquired via the data interfaces (32A, 32B). Infusion pump (10) according to claim 1 with the following further feature: a. the control unit (30) is configured to check the accuracy and plausibility of the patient-related and drug-related data, in particular to check continuously. Infusion pump (10) according to claim 1 or 2 with the following further feature: a. the at least one connector (66A-66F) has a connection device (68) for establishing a data connection with a corresponding counterpart connector (66'), in particular in the form of a coil (68) for inductive data transmission. Infusion pump (10) according to claim 3 with the following further feature: a. at least two connectors (66A-66E) each forming a fluid inlet are provided, each having a connection device (68) for establishing a data connection with a corresponding counterpart connector (66'), preferably with one of the following additional features: b. three or more connectors (66A-66E) each forming a fluid inlet are provided, each having a connection device (68) for establishing a data connection with a corresponding counterpart connector (66'), and / or c.Each connection piece (66A-66E) forming a fluid inlet is associated with a connection device (68) for establishing a data connection with a corresponding counterpart connection piece (66'). Infusion pump (10) according to one of the preceding claims with the following further feature: a. The line unit (50) has a rigid support part (62) to which the fluid line (64) is provided or attached, preferably with at least one of the following additional features: b. the fluid line (64) is formed at least partially by a surface of the support part (62), or c. the fluid line (64) is formed by a uniform hose body with at least two ends, wherein the connection pieces (66A-66F) are provided at the ends, and / or. d. The support element (62) has a coupling device (63) for detachably attaching the support element (62) to the base unit (20), and / or e. the support element (62) is made at least predominantly of a rigid plastic, in particular of polycarbonate (PC), polyvinyl chloride (PVC), polyethylene (PE) and / or polypropylene (PP), and / or f. the fluid line is made at least partially of an elastically deformable plastic, preferably of a thermoplastic polyurethane (TPU), a thermoplastic elastomer (TPE), or a rubber, preferably silicone. Infusion pump (10) according to claim s with at least one of the following further features: a. at least one connection piece (66A-66E) forming a fluid inlet is fixedly provided on the support element (62), and / or b. the connection piece (66F) forming the fluid outlet is fixedly provided on the support element, preferably with the following additional feature: c.All connecting pieces (66A-66F) are fixedly mounted on the support part (62). Infusion pump (10) according to one of the preceding claims with the following further feature: a. at least one connecting piece (66A-66E) forming a fluid inlet is provided on an inlet hose section (64A-64E), wherein a data line (65A-E) connected to the first data interface (32A) is routed at least section by section along the inlet hose section (64A-64E). Infusion pump (10) according to one of the preceding claims with the following further feature: a. the connector (66F) forming the fluid outlet is provided on an outlet hose section (64F), wherein a data line (65F) connected to the second data interface (32B) is guided at least section by section along the outlet hose section (64F). Infusion pump (10) according to one of the preceding claims with the following further feature: a. the line unit (50) has at least one connection device (72) for the purpose of data transmission for detachable connection to a mating connection device (32) of the base unit (20), preferably with at least one of the following features: b. the connection device (72) and the mating connection device (32) have corresponding contact surfaces for galvanic coupling, and / or c. the connection device (72) is provided on the support part (62).Infusion pump (10) according to one of the preceding claims with the following further feature: a. a plurality of connection devices and counter-connection devices are provided, preferably with the following additional feature: b. each connection piece (66A-66E) forming a fluid inlet is assigned a connection device and a counter-connection device. Infusion pump (10) according to one of the preceding claims with the following further feature: a. the infusion pump (10) has at least one valve assembly (22) electrically controllable by means of a valve actuator (22A), which is configured to separate the at least one fluid inlet from the fluid outlet, preferably with at least one of the following additional features: b. the line unit (50) has a plurality of fluid inlets, preferably five fluid inlets, wherein, in particular preferably, a valve assembly (22) is assigned to each of the fluid inlets, and / or c. a valve assembly (22) is assigned to the fluid outlet, and / or d. the valve actuator (22A) is part of the base unit (20), and / or e. the at least one valve assembly (22) is configured as a bistable valve assembly (22), so that the valve assembly (22) can remain in a closed state and an open state without a current supply, or f.The at least one valve assembly (22) is designed as a monostable valve assembly (22) and has a return spring (22B) that opposes the valve actuator (22A), so that the valve assembly (22) assumes a closed state without power supply. Infusion pump (10) according to one of claim 11 with the following further features: a. the line unit (50) has a plurality of fluid inlets, wherein a valve assembly (22) is assigned to each plurality of fluid inlets and preferably to all fluid inlets, and b. the infusion pump is designed to prevent the simultaneous opening of two valve assemblies (22), in particular with at least one of the following further features:. c. The infusion pump has at least two valve assemblies (22) that are mechanically coupled, such that only one of the at least two valve assemblies (22) can be open at any given time; or d. The infusion pump has at least two valve assemblies (22) that are electronically coupled, such that only one of the at least two valve assemblies (22) can be open at any given time; or e. The infusion pump has at least two valve assemblies (22) that are controlled by a common control unit (30), wherein the control unit is configured to open at most one of the at least two valve assemblies (22) at any given time. Infusion pump (10) according to one of the preceding claims with the following further feature: a. The control unit (30) is configured to read a unique identifier via the first and / or the second data interface (32A, 32B).Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to read a patient-specific therapy plan from a connected drug storage device (110) via the first data interface (32A). Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to read a therapy plan in response to the connection of a drug storage device (110) and / or a patient (2) and, upon subsequent connection of another drug storage device (110), to check whether it is consistent with the therapy plan. An infusion pump (10) according to any of the preceding claims, comprising the following further feature: a. the control unit (30) is configured to check, upon connection of a medication storage device (110), whether the medication storage device (110) has been connected to the connection piece (66A-66E) provided for this purpose. An infusion pump (10) according to any of the preceding claims, comprising the following further feature: a. the control unit (30) is configured to check the authenticity of a connected medication storage device (110), in particular by verifying a digital and preferably cryptographic authentication transmitted via the first data interface (32A). An infusion pump (10) according to any of the preceding claims, comprising the following further feature: a. the control unit (30) is configured to check at least one date associated with the medication storage device (110), in particular a manufacturing date.Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to determine the type of medication in a medication storage device (110) via the first data interface (32A) and to compare it with a therapy plan. Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to read data from a sensor (114) assigned to a medication storage device (110) via the first data interface (32A) and / or to read data from a sensor (124) assigned to the patient (2) via the second data interface (32B). Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is designed to keep a log of the activity of the infusion pump (10), in particular logging one or more of the following events and / or data: - Connecting a patient (2) to the infusion pump (10), and / or - Connecting a drug storage device (110) to the infusion pump (10), preferably including data on the type of drug and / or comprising a unique batch identifier, and / or - Input values ​​from at least one sensor (114) assigned to a drug storage device (110), and / or - Input values ​​from at least one sensor (124) assigned to the patient. Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to be connected to an external network (212) and to receive data via this external network (212) - to read a patient-specific therapy plan and / or data from a patient file, and / or - to send a report on the activity of the infusion pump (10), and / or - to receive a termination signal and, in response to this termination signal, to terminate an ongoing therapeutic measure, in particular to stop the pump actuator (24). Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to prevent or interrupt the activation of the pump actuator (24) and / or the opening of a valve device (22) if data read in via the data interfaces (32A, 32B) represent a situation deviating from the target parameters. Infusion pump (10) according to one of the preceding claims with the following further feature: a. the control unit (30) is configured to generate a warning signal and, in particular, to emit it in visual or acoustic form if data read in via the data interfaces (32A, 32B) represent a situation deviating from the target parameters. Infusion pump (10) according to one of the preceding claims with at least one of the following further features: a.The infusion pump (10) has a common pump housing within which and / or on the front of which at least one pump actuator (24) and at least one valve assembly (22) are arranged, and / or b. in the area of ​​the valve assembly (22) or in the area of ​​the at least one pump actuator (24) the fluid line (64) is designed without data lines, and / or c. at least one connector (66A-66F) is designed as a Luer connector according to the ISO 80369 standard family, wherein preferably all connectors (66A-66F) are designed as Luer connectors according to the ISO 80369 standard family. Infusion pump (10) according to one of the preceding claims with the following further feature: a. the infusion pump (10) has a display device (34), preferably with at least one of the following additional features:. b. the control unit (30) is designed to display the following on this display device (34): - Input values ​​from at least one sensor (114) assigned to the drug storage (110), and / or - Input values ​​from at least one sensor (124) assigned to the patient (2), and / or - Information on an ongoing infusion treatment in a form suitable for medical personnel or the patient, and / or c. the control unit (30) is configured to display a video conference via the display device (34). Infusion pump (10) according to one of the preceding claims with the following further feature: a. the infusion pump (10) is configured to receive feedback from the patient, in particular with the following additional feature: b. the infusion pump (10) has input means, in particular in the form of a display device (34) configured as a touchscreen or in the form of separate control elements by means of which the patient can provide feedback, and / or c. the infusion pump (10) is configured to adjust or interrupt an ongoing infusion treatment depending on the feedback. Infusion arrangement (100) with the following features: a.The infusion arrangement (100) comprises an infusion pump (10) according to one of the preceding claims, and. b. The infusion arrangement (100) has at least one drug reservoir (110) filled with a liquid drug, which is connected to the at least one fluid inlet of the infusion pump (10), and c. the infusion arrangement (100) has at least one patient-side access device (120) for administering the liquid drug into the body of a patient, and d. the control unit of the infusion pump (10) is connected to the drug reservoir (110) and to the access device (120) via the first and second data interfaces. Infusion arrangement (100) according to claim 28 with the following further feature: a. the drug reservoir (110) is provided with an electronic memory (112) which can be read by the control unit (30) via the first data interface (32A). Infusion arrangement (100) according to claim 28 or 29 with the following further feature: a.The drug storage device (110) is provided with at least one sensor (114) which can be read by the control unit (30) via the first data interface (32A), preferably with the following additional feature: b. the at least one sensor (114) is a temperature sensor or a sensor for detecting optical properties of the liquid or a sensor for detecting the concentration of the liquid. Infusion arrangement (100) according to one of claims 27 to 30 with the following further feature: a. the access device (120) is provided with an electronic memory (122) which can be read by the control unit (30) via the second data interface (32B). Infusion arrangement (100) according to any one of claims 28 to 31 with the following further features: a. the access device (120) is provided with at least one sensor (124) which can be read by the control unit (30) via the second data interface (32B), preferably with the following additional feature: b. the at least one sensor (124) is a temperature sensor or a blood pressure sensor or an oxygen sensor or a sensor for measuring cardiac currents or a sensor for measuring tissue impedance. Infusion system (200) with the following features: a. the infusion system (200) comprises an infusion pump (10) according to any one of claims 1 to 27 or an infusion arrangement (100) according to any one of claims 28 to 32, and b. the infusion system (200) comprises at least one server (210) which is connected to the infusion pump (10) via a network (212), and c.The control unit (30) of the infusion pump (10) is configured to retrieve data from the server (210) and / or to store data on the server (210). Infusion system (200) according to claim 33 with the following further feature: a. the infusion pump (10) is configured to receive feedback from the patient and transmit it to the server (210). Infusion system (200) according to claim 34 with the following further feature: a. the server (210) is configured to store data in a patient record in response to the incoming feedback. Infusion system (200) according to claim 34 or 35 with the following further feature: a. the server (210) is configured to provide modified therapy data in response to incoming feedback and to forward it to the infusion pump (10) for therapy adjustment. Method for operating an infusion pump (10) according to any one of claims 1 to 26 with the following further features: a. data is read from the drug storage device (110) via the first data interface (32A), and b. data about the patient (2) is read via the second data interface (32A), and c. the data is processed jointly, and d.Depending on the result of the data processing, the fluid delivery via the infusion pump (10) is started or not started and / or at least one valve device (22) of the infusion pump (10) is closed or opened, preferably with at least one of the following further steps: e. during data processing, the authenticity of a connected drug storage device (110) is checked, and / or f. during data processing, it is checked whether a connected drug storage device (110) is connected to the correct connector (66A-66E), and / or g. during data processing, it is checked whether the therapy time is not after an expiry date assigned to the drug storage device (110), and / or h. during data processing, it is checked whether the drug storage device (110) is suitable for the therapy of the patient (2), and / or i. during data processing, a therapy plan is read in, preferably The therapy plan is read in via the first data interface (32A) or via the second data interface (32B), or the therapy plan is read in via an external network (212), whereby a unique identifier is used for this purpose, which was previously read in via the first data interface (32A) or via the second data interface (32B), the therapy plan is read in via an external network (212), whereby even after the initial reading of the therapy plan, it is continuously checked, so that changes to the therapy plan as well as an interruption of the therapy plan can be caused via the external network (212).

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