Infusion system with liquid balancing function

Abstract

The invention relates to a system (1) for performing a medical infusion operation for infusing a medical fluid into a patient, comprising at least one infusion device (2), a monitoring device (3) for monitoring the amount of fluid entries received by the patient, an alarm device (4) and a control device (5), configured to communicate with the at least one infusion device (2), the monitoring device (3) and the alarm device (4). The control device (5) is configured to control the alarm device (4) to give out an alarm signal if the amount of fluid entries monitored by the monitoring device (3) reaches or exceeds a predefined threshold value.

Description

[0001] Infusion system with liquid balancing function

[0002] Description

[0003] The invention relates to a system, also called infusion system, for performing a medical infusion operation for infusing a medical fluid into a patient.

[0004] Such systems comprise one or more infusion devices, such as volumetric pumps or syringe pumps serving to administer a medical fluid, for example a medication or nutrients, to a patient. The medical fluid may be administered orally or intravenously by the infusion device(s).

[0005] In some cases, for example when the patient is a child or baby or suffers from dehydration, it is very important to ensure that the patient ingests fluid in a sufficient amount as fluid deficiencies may rapidly provoke a severe medical condition.

[0006] It is an object of the instant invention to provide a system which enables a user (nurse, care giver, medical staff) to properly manage the patient’s liquid balance.

[0007] This object is achieved by the system comprising the features of claim 1.

[0008] Accordingly, the system comprises at least one infusion device for infusing a medical fluid (liquid) into a patient. The infusion device may be any of a variety of infusion devices, such as a large volume or general purpose infusion pump (i.e. one configured to dispense from a bag instead of a syringe), a patient-controlled analgesia (PCA) pump, an elastomeric pump, a syringe pump, an enteral or parenteral feeding pump, an insulin pump, an ambulatory pump, etc.

[0009] The system further comprises a monitoring device for monitoring the amount of fluid entries received by the patient. These entries may comprise any fluid administered by the one or more infusion device(s) as well as any fluid taken orally and independently from the at least one infusion device, such as water, beverages etc. In addition, the system comprises an alarm device for giving out an alarm signal. The alarm signal may be an audio signal and / or an optical signal. A control device is provided that is configured to communicate with the at least one infusion device, the monitoring device and the alarm device. The control device thus enables the at least one infusion device, the monitoring device and the alarm device to communicate with one another.

[0010] According to the invention the control device is configured to control the alarm device to give out an alarm signal if the (cumulative) amount of fluid entries monitored by the monitoring device reaches or passes (exceed or fall below) a predefined threshold value or is outside a predefined range. The threshold value may be a minimum threshold value and / or a maximum threshold value. The alarm signal enables the user to react rapidly and to take appropriate measures. For example, the user might stop the operation of the at least one infusion device to avoid that fluid is needlessly administered to the patient. Also, with detection of the fluid entries passing a minimum threshold value, the user might start the operation of the at least one infusion device to avoid dehydration of the patient. The threshold value(s) may be linked to a certain time period. For example, it may be defined that within a time period of 24 h a cumulative amount of fluid entries should not exceed a maximum threshold value of 3.5 liter or fall below a minimum threshold value of 0.5 liter. In case a different time period is chosen the thresholds are adapted accordingly.

[0011] In one embodiment the threshold value(s) may be configured via a central control station of the infusion system or via the control device. Preferably the threshold value(s) is adjusted for each patient or group of patients (e.g. adults, infants,...)

[0012] In one embodiment the monitoring device is configured to monitor additionally the amount of fluid exits (urine, dialysis...) that are released by the patient.

[0013] Furthermore, the control device may be configured to control the alarm device to give out an alarm signal if the (cumulative) amount of fluid exits monitored by the monitoring device reaches or passes (exceeds or falls below) a predefined threshold value or is outside a predefined range. The threshold value may be a minimum value and / or a maximum threshold value. The alarm signal enables the user to react rapidly and to take appropriate measures. Like for the threshold value for the (cumulative) amount of fluid entries, also the threshold value for the (cumulative) amount of fluid exits may be linked to a certain time period.

[0014] The monitoring device may be configured to determine a liquid balance (or fluid balance) which is the difference between the cumulative amount of fluid entries received by the patient and the cumulative amount of fluid exits released by the patient. In this respect, the control device may be configured to control the alarm device to give out an alarm signal if the liquid balance determined by the monitoring device reaches or passes (exceeds or falls below) a predefined threshold value or is outside a predefined range. The alarm signal(s) of the alarm device may be an audio signal and / or an optical signal.

[0015] The monitoring device may be configured to store (in a memory) the liquid balance values determined at different points in time. In addition, the monitoring device may be configured to store (in the memory) the corresponding cumulative amount of fluid entries received by the patient and the cumulative amount of fluid exits. The monitoring device may be configured to provide the stored liquid balance values (and the corresponding cumulative amount of fluid entries and the cumulative amount of fluid exits) to the control device.

[0016] In one embodiment the system further comprises a display device which is constituted to display information to the user. The information relates for example to the patient. Said information may comprise the liquid balance of the patient. In particular, the displayed liquid balance is the liquid balance determined by the monitoring device. The monitoring device may thus be configured to provide data representing the liquid balance to the display device (via the control device). The user can thus be informed of the liquid balance of the patient.

[0017] It may provided that the display device is configured to communicate with the control device. The control device is thus the device where all other devices (display device, infusion device, monitoring device, alarm device) run together enabling all other devices to communicate with one another via the control device.

[0018] The display device may be configured to display the optical alarm signal.

[0019] In one embodiment the liquid balance is displayed graphically by the display device showing the evolution of the liquid balance over time. The evolution of the liquid balance may be considered and displayed for a specific time period (in the past). This time period may be for example 4 hours, 8 hours, 12 hours or 24 hours, for example the last 4 hours, 8 hours, 12 hours or 24 hours. The monitoring device may thus be configured to provide the liquid balance for said specific period of time in a format adapted for graphical representation. In particular, the display device may be configured to display the liquid balance over time on a linear scale or a logarithmic time scale. The monitoring device may thus be configured to provide the liquid balance over time on a logarithmic time scale (in a format adapted for graphical representation). The logarithmic time scale allows a user to view the most recent section of the time scale in more detail while the elder section of the time scale is more condensed. In addition, the display device may display a predefined threshold value, for example a maximum threshold value for the liquid balance, and / or the predefined liquid balance range. The user may thus rapidly compare the real liquid balance (determined by the monitoring device) with the target value I range and initiate appropriate actions if required. The evolution of the liquid balance in the past is an indicator for the user how to manage the patient’s liquid balance at that moment. Displaying the evolution of the liquid balance thus supports the user in managing the patient’s liquid balance.

[0020] For example, is the evolution of the liquid balance over time displayed in a coordinate system with the x-axis representing the time and the value of the liquid balance at the y- axis. The 0-line of the liquid balance is displayed and as further information, maximum threshold value and the minimum threshold value for the liquid balance may be displayed as dotted lines. In between these dotted lines is the predefined liquid balance range. Thus, a user can easily and quickly recognize if the evolution of the liquid balance approaches an upper or lower limit and if necessary prepare corresponding measures to prevent passing the threshold.

[0021] In addition or alternatively, the display device may be configured to display an instantaneous value of the liquid balance numerically. Also, the display device may be configured to display a value of the liquid balance for a specific moment in time numerically. The monitoring device may thus be configured to provide an (instantaneous) value of the liquid balance in a format adapted for numerical representation.

[0022] In one embodiment the control device comprises an input device for entering control commands and / or information. The input device may for example be constituted by a touch- sensitive screen and / or one or multiple buttons or knobs. The input device and the display device may form a single device constituted by a touch-sensitive screen. The input device may be configured to enable a user to enter control commands to select or change the information to be displayed by the display device. For example, the time period (over which the evolution of the liquid balance is displayed by the display device and / or the corresponding amounts of fluid entries / exits) may be modifiable via the input device. It may be provided that the user selects one of several predefined time periods or defines any appropriate time period by setting a start time and an end time. The input device may be configured to enable a user to enter control commands relating to the operation of the infusion device (for example to start an infusion process, to end an infusion process and / or to influence the operation of the infusion device).

[0023] In one embodiment the user has the possibility to select one of several predefined time periods via the input device. Exemplarily the user may choose between 4 hours, 8 hours, 12 hours and 24 hours. The selected time period may be the time period directly preceding the actual moment in time. Alternatively, the user may have the possibility to select the start or the end of the time period (via the input device). According to another alternative or in addition the user may select (via the input device) the start and the end of a time period or time frame to be shown instead of the whole predefined time period. For example, the time period of 24 hours has been selected and a time frame to be shown starts at 7 a.m. and ends at 7 p.m. The selected time period is highlighted and in addition the start and the end of the shown time frame are displayed.

[0024] In one embodiment the input device is configured to enable a user to enter values of amounts of fluid entries and / or fluid exits. The values entered are transmitted from the input device to the monitoring device. The values of amounts of fluid entries entered by the input device may in particular comprise any fluid taken orally (without using the at least one infusion device). With respect to the fluid administered by the at least one infusion device, the at least one infusion device may be configured to transmit the values of amounts of administered fluid to the monitoring device (via the control device). Alternatively, also these values may be entered by a user using the input device. Ideally, entered values are time stamped in order for the input device to take an appropriate time basis for the balance. According to one embodiment a user is enabled to assign different time stamps for the entered values. The idea behind it is to enable the system to (re-)adapted the display of the evolution of liquid balance over time based on the entered values.

[0025] In one embodiment the liquid balance values are determined periodically after a given time span has passed and I or after entering a value for an amount of liquid entry and / or liquid exit by a user. The values of amounts of fluid entries and / or fluid exits may be transmitted from the input device to the monitoring device and from the monitoring device to the display device. With respect to the fluid administered by the at least one infusion device, the at least one infusion device may be configured to transmit the values of amounts of administered fluid to the monitoring device (via the control device), the monitoring device transmitting said values to the display device. The display device may thus display the values of amounts of fluid entries and / or fluid exits, for example numerically. In addition to the amount, the nature of fluid entries (isotonic fluid infusion, orally taken beverage etc.) and / or of fluid exits (urine, vomiting etc.) may be entered by a user via the input device and transmitted to the display device for display (via the monitoring device or not).

[0026] In one embodiment the control device is configured to control the at least one infusion device in dependence of the liquid balance determined by the monitoring device and / or in dependence of the fluid exit(s) monitored by the monitoring device and / or in dependence of the fluid entry(s) monitored by the monitoring device. If the monitoring device determines that the liquid balance is too low / high (reaches or exceeds (passes) a predefined threshold value or is outside a predefined range) the control device may control the infusion device to adapt the amount of liquid to be administered by the infusion device accordingly. If a considerable amount of fluid exit is monitored by the monitoring device, the control device may control the at least one infusion device to administer a specific amount of fluid to the patient to balance the fluid exit. The liquid administered by the infusion device may for example be an isotonic fluid (saline, Ringer’s solution) within a rehydration therapy or fluid replacement therapy. If no fluid exit is monitored by the monitoring device over a predefined time period, the control device may control the at least one infusion device to stop administration of fluid to the patient to balance the lack of fluid exit, or simply display / sounds an alarm without stopping the infusion.

[0027] In one embodiment the system further comprises at least one organization device for mechanically holding the at least one infusion device, the monitoring device, the alarm device, the control device and if present the display device. The organization device may be a rack. The organization device may be constituted to mechanically hold multiple infusion devices, for example in vertical stacks. In addition, the organization device may be constituted to provide an electric power supply to the infusion device(s) as well as a communication link for the infusion device(s) to communicate between each other and with external devices, for example via a hospital communication network. Alternatively, the system including one infusion device, the monitoring device, the alarm device and the control device may be used also as a stand-alone device independent from other (infusion) devices.

[0028] The idea underlying the invention shall subsequently be described in more detail with regard to the embodiments shown in the figures. Herein,

[0029] Fig. 1 shows schematically a system for performing a medical infusion operation for infusing a medical fluid into a patient according to one embodiment;

[0030] Fig.2 shows schematically a system for performing a medical infusion operation for infusing a medical fluid into a patient according to another embodiment;

[0031] Fig. 3 shows a screenshot of the information displayed by the display device; and

[0032] Fig. 4 shows another screenshot of the information displayed by the display device.

[0033] Figure 1 schematically shows a system 1 for performing a medical infusion operation for infusing a medical fluid into a patient. The system 1 comprises an infusion device 2, a monitoring device 3 and an alarm device 4. A control device 5 is provided that is configured to communicate with the infusion device 2, the monitoring device 3 and the alarm device 4.

[0034] In the embodiment of Figure 1 , the infusion device 2, the monitoring device 3, the alarm device 4 and the control device 5 are separate macro devices that are configured to communicate via a data link 6. The data link 6 connects the control device 5 on the one hand with the infusion device 2, the monitoring device 3 and the alarm device 4 on the other hand. The infusion device 2 is configured to deliver a medical fluid to the patient. The infusion device 2 is constituted for example as an infusion pump, such as a syringe pump or a volumetric pump. The monitoring device 3 is configured to monitor the amount of fluid entries received by the patient. The monitoring device 3 is configured to monitor the amount of fluid exits released by the patient and to determine a liquid balance which is the difference between the cumulative amount of fluid entries received by the patient and the cumulative amount of fluid exits released by the patient. The alarm device 4 is configured to give out an alarm signal if the alarm device 4 receives a corresponding control signal from the control device 5. Correspondingly, the control device 5 is configured to control the alarm device 4 to give out an alarm signal if the amount of fluid entries and or fluid exits monitored by the monitoring device 3 reaches or exceeds (passes) a predefined threshold value or is outside a predefined range.

[0035] The control device 5 comprises an input device 51 configured to enable a user to enter control commands and / or information. The control commands may comprise control commands relating to the operation of the infusion device 2. The information may comprise patient information (such as the patient’s weight, size, age and / or gender), data representing an amount of fluid entries, data representing an amount of fluid exits, a threshold value or range for the fluid entries and / or a threshold value or range for the liquid balance.

[0036] The system of Figure 2 exemplarily comprises four infusion devices 2. The number of infusion devices in Figure 2 is exemplarily and may be greater than four, for example 24. In the embodiment of Figure 2, the infusion devices 2 are designed as infusion pumps. The infusion devices 2 are vertically arranged in an organization device 7. The organization device 7 is designed as a rack. The rack serves to arrange the infusion devices 2 in an organized fashion for example at the bedside of the patient. The rack herein provides a power supply for the infusion devices 2, ensures a secure and reliable fixation of the infusion devices 2, and provides a communication of the infusion devices 2 with the control device 5. This organization device 7 provides typically electrical power to the infusion devices 2 (infusion pumps) and embeds the infusion devices 2 into a hospital environment including a hospital communication network and a hospital management system. Each infusion pump is provided for delivering a specific medical fluid to a patient.

[0037] The system 1 further comprises a display device 8. The display device 8 may be designed as a touch screen. The display device 8 is configured to communicate with the control device 5. The display device 8 is configured to display information to the user. The information comprise the amount of fluid entries monitored by the monitoring device 3, the amount of fluid exits monitored by the monitoring device 3 and / or the liquid balance determined by the monitoring device 3. In the embodiment of Figure 2 the display device 8, the control device 5, the monitoring device 3 and the alarm device 4 form a single macro device, the display device 8 and the input device 51 (of the control device 5) being designed as a touch screen.

[0038] Figure 3 shows an exemplary screenshot of the information displayed by the display device 8. The display is exemplarily divided into an upper section 81 and a lower section 82. The upper section 81 displays a list of amounts of fluid entries (entitled cumulative entries) on the left and a list of amounts of fluid exits (entitled cumulative exits) on the right. With respect to the fluid entries, additional information is indicated which may inform about the way of administration. For example, the information specifies that part of the fluid entries has been administered as an infusion (by the infusion device 2). It is conceivable that the nature of the fluid entries (name of medical fluid, beverage etc.) is displayed too. In the example of Figure 3, two fluid entries (an infusion volume of 850 ml and an additional volume of 50 ml) and one fluid exit (an exit volume of 800 ml) are displayed. In the upper section 81 additionally the liquid balance at the actual moment in time which is the difference between the cumulative amount of fluid entries received by the patient and the cumulative amount of fluid exits released by the patient is displayed (+ 100 ml). The liquid balance is displayed numerically.

[0039] Additionally, the upper section 81 displays the time period over which the fluid entries and fluid exits are considered. The user has the possibility to select one of several predefined time periods (via the input device 51). Exemplarily the user may choose between 4 hours, 8 hours, 12 hours and 24 hours. The selected time period may be the time period directly preceding the actual moment in time. Alternatively, the user may have the possibility to select the start or the end of the time period (via the input device 51). According to another alternative the user selects (via the input device 51) the start and the end of a time period or time frame to be shown instead of a predefined time period. In Figure 3, the time period of 24 hours has been selected and the time frame to be shown exemplarily starts at 7 a.m. and ends at 7 p.m. The selected time period is highlighted and the start and the end of the shown time frame are displayed.

[0040] In the lower section 82 of the display the liquid balance is displayed graphically. In particular, in a coordinate system with the ordinate representing the liquid balance and the abscissa representing the time, the graph shows the evolution of the liquid balance over time in the selected time period (here from 7 a.m. to 7 p.m.). The time scale (abscissa) is a logarithmic time scale. The logarithmic time scale allows a user to view the most recent section of the time scale in more detail while the elder section of the time scale is more condensed. Using the input device, the user has the possibility to select a specific point of the graph. The control device 5 and the monitoring device 3 are configured to provide additional information in regard of the selected point, the additional information being displayed by the display device 8. The additional information comprises the cumulative amount of fluid entries at that point, the cumulative amount of fluid exits at that point and the liquid balance at that point. A horizontal dashed line indicates the zero line, where the liquid balance is zero. The zero line helps the user to easily identify in the graph whether the liquid balance is positive or negative.

[0041] The lower section 82 shows on the right (numerically) a threshold value of the liquid balance. Exemplarily, the threshold value is 300 ml. The threshold value is a maximum value of the liquid balance which shall not be exceeded for medical reasons.

[0042] Figure 4 shows an alternative screenshot of the information displayed by the display device 8. The screenshot of Figure 4 differs from that of Figure 3 in that additionally a warning is displayed: volume max. almost reached. Before reaching the threshold value the user is thus sensibilized to carefully observe the liquid balance. For this purpose, a liquid balance range may be defined in which a warning of this kind is displayed without giving out an alarm signal. Exemplarily, the warning is displayed on the top of the upper section 81. However, other locations are conceivable. In addition to the warning described above, the liquid balance threshold is displayed in a noticeable colour. Once the threshold is reached the alarm device gives out an alarm signal.

[0043] The location of the information displayed in the screenshots of Figures 3 and 4 are only exemplarily and may differ from the embodiments shown in Figures 3 and 4.

[0044] The idea underlying the invention is not limited to the embodiments described above, but may be implemented also in an entirely different fashion.

[0045] In particular, an infusion device of the kind described herein not necessarily is installed on an organization device in the shape of a rack, but may be used also as a stand-alone device independent from other devices.

[0046] An infusion device of the kind concerned herein may for example be an infusion pump such as a volumetric pump or a syringe pump. An infusion device however may in general also be a device used for controlling other infusion devices for performing an infusion operation.

Claims

Claims:1 . System (1) for performing a medical infusion operation for infusing a medical fluid into a patient, comprising:- at least one infusion device (2),- a monitoring device (3) for monitoring the amount of fluid entries received by the patient,- an alarm device (4) and- a control device (5), configured to communicate with the at least one infusion device (2), the monitoring device (3) and the alarm device (4), wherein the control device (5) is configured to control the alarm device (4) to give out an alarm signal if the (cumulative) amount of fluid entries monitored by the monitoring device (3) reaches or passes (exceeds, falls below) a predefined threshold value.

2. System (1) according to claim 1 , characterized in that the monitoring device (3) is configured to monitor the amount of fluid exits released by the patient and to determine a liquid balance which is the difference between the cumulative amount of fluid entries received by the patient and the cumulative amount of fluid exits released by the patient.

3. System (1) according to claim 2, characterized in that the system (1) further comprises a display (8) device which is configured to communicate with the control device (5) and which is constituted to display information in relation to the patient, wherein the information comprise the liquid balance of the patient.

4. System (1) according to claim 3, characterized in that the liquid balance is displayed graphically by the display device (8) showing the evolution of the liquid balance over time.

5. System (1) according to claim 4, characterized in that the evolution of the liquid balance is displayed for a specific time period, in particular 4 hours, 8 hours, 12 hours or 24 hours.

6. System (1) according to one of the claims 3 to 5, characterized in that the display device (8) is configured to display the liquid balance over time on a logarithmic time scale.

7. System (1) according to one of the claims 3 to 6, characterized in that the display device (8) is configured to display an instantaneous value of the liquid balance numerically.

8. System (1) according to one of the preceding claims, characterized in that the control device (5) comprises an input device (51) for entering control commands and / or information.

9. System (1) according to claim 8 when dependent on claim 5, characterized in that the time period is modifiable via the input device (51).

10. System (1) according to claim 8 or 9, characterized in that the input device (51) is configured for entering values of amounts of fluid entries and / or fluid exits.11 . System (1) according to one of the preceding claims, characterized in that the at least one infusion device (2) is configured to provide values of fluid entries to the monitoring device (3) via the control device (5), the values of fluid entries representing the amount of fluid administered to the patient by the at least one infusion device (2).

12. System (1) according to one of claims 2 to 11 , characterized in that the control device (5) is configured to control the alarm device (4) to give out an alarm signal if the liquid balance determined by the monitoring device (3) reaches or passes a predefined threshold value.

13. System (1) according to one of claims 2 to 12, characterized in that the control device (5) is configured to control the at least one infusion device (2) in dependence of the liquid balance determined by the monitoring device (3).

14. System (1) according to one of the preceding claims, characterized in that the system(1) further comprises at least one organization device (7) for mechanically holding the at least one infusion device (2), the monitoring device (3), the alarm device (4), the control device (5) and, if present, the display device (8).

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