WO2025157881A1

WO2025157881A1 - System for performing a medical treatment

Info

Publication number: WO2025157881A1
Application number: PCT/EP2025/051595
Authority: WO
Inventors: Laurine MONTI; Xavier BARRENECHE
Original assignee: Fresenius Vial SAS
Current assignee: Fresenius Vial SAS
Priority date: 2024-01-24
Filing date: 2025-01-23
Publication date: 2025-07-31
Anticipated expiration: 2026-07-24

Abstract

The invention relates to a system for setting up a medical treatment on a patient. The system comprises at least one patient device for delivering a drug to the patient, and a computing device with a user interface and a control unit, wherein the control unit is configured to control the at least one patient device. A protocol library is stored on a memory of the computing device or accessible by the computing device. The protocol library comprises a plurality of protocols, each protocol being associated to one medical indication or medical event. The protocol library comprises data for drug delivery including name and concentration of at least one drug. The user interface is configured to display the plurality of protocols or the associated medical indication or medical event and the data for drug delivery to a user.

Description

System for performing a medical treatment

Description

The invention relates to a system for performing a medical treatment on a patient according to the preamble of claim 1.

A system of this kind comprises at least one patient device for delivering a drug to the patient, and a computing device with a user interface and a control unit, wherein the control unit is configured to control the at least one patient device.

Patient devices for delivering a drug (or medicament) to a patient are used by medical staff, like nurses or physicians, that attend to a patient having a specific disease or experiencing a specific medical event.

Choosing the appropriate drug and administration parameters may take a long time and may be subject to errors, in particular if the medical staff is pressed for time as the patient is in a critical situation.

It is an object of the present invention to provide a system for performing a medical treatment on a patient which allows a time efficient use and limits the risk of errors by the medical staff.

This object is achieved by the system for performing a medical treatment on a patient comprising the features of claim 1. Accordingly, the system for performing a medical treatment on a patient comprises at least one patient device for delivering a drug (or medicament) to the patient, and a computing device with a user interface and a control unit. The control unit is configured to control the at least one patient device. The user interface may be provided to allow an exchange of information between the at least one patient device and a user.

The computing device has a memory and stored thereon a protocol library. Alternatively, the computing device is configured to access said protocol library. In this alternative the protocol library may be stored on a memory of a separate computing device associated (via a data link) with the computing device of the system.

The protocol library comprises a plurality of protocols, each protocol being associated to one medical indication or medical event and comprising data for drug delivery. The data for drug delivery include name and concentration of at least one drug. The user interface is configured to display the plurality of protocols or the associated medical indication or medical event. The plurality of protocols or the associated medical indication or medical event may be indexed by an identifier such as a name, abbreviation or reference sign. Displaying the plurality of protocols or the associated medical indication or medical event may thus be realized by displaying the corresponding identifier. The user interface is configured to display in addition the data for drug delivery (name and concentration of at least one drug) to the user.

The user is thus informed by the system about the name and concentration of the drug(s) to be administered to the patient if a specific protocol has to be applied or for a specific medical indication or medical event. Preparing the patient device or conducting the medical treatment will thus be simplified for the user resulting in a reduction of the time spent and of the risk for errors.

The protocols are typically created and managed by an authorised user, as an hospital biomed engineer or a qualified practioner, so that each protocol is validated only by authorized person. The protocols may be created in a hospital’s computer away from the computing devices, in a given software environment and then uploaded, via an internal local server, to the computing device. Therefore, several computing devices of a given hospital or ward or service, can be updated with the corresponding protocols library. Alternatively, the update can either be performed by a wired connection or a wireless connection. In one embodiment, the user interface is configured to allow the user to select one of the protocols or the associated medical indication or medical event. The user interface may be configured to first display a list or an overview of the protocols. The plurality of protocols or the associated medical indication or medical event may be displayed by displaying their names, abbreviations or reference signs (for example without displaying the data for drug delivery). The user interface may be configured to, upon selection of one protocol, medical indication or medical event by the user, display the data for drug delivery of the selected protocol, such as name and concentration of the drug to be administered to the patient. The user has then the possibility to prepare the required drug in the required concentration. In addition, the user interface may be configured to display a list or an overview of the patient devices of the system and to allow the user to select one patient device to be used for delivering the drug provided by the protocol.

The protocol may comprise in addition to name and concentration of the drug further data for drug delivery. For example, the protocol comprises one or more of drug volume, loading dose, bolus, administration rate, temporal profile of the administration rate, combination of two or more drugs, time delay for starting drug delivery, parameters of the end of drug delivery or any other parameters comprising delivery settings. For example, if the protocol provides that a combination of two or more drugs has to be administered, the protocol may comprise a temporal sequence of administration (simultaneously, with a temporal overlap, separately one after the other, time interval between two drugs) of the drugs. The data of the protocol may be in a format that is readable by the at least one patient device and that the at least one patient device uses in its operation. Alternatively or additionally, these data may be in a format adapted to be displayed to the user.

In one embodiment, the at least one patient device is controlled by the control unit using the protocol selected by the user. Here, all data of the protocol relevant for operating the at least one patient device are in the format that is readable by the at least one patient device. In addition, said data may be in the format adapted to be displayed to the user, for example for information purposes.

In one embodiment, the protocol comprises information and/or instructions that guide the user through the protocol to be displayed to the user. The information may advise the user about the target patient population, about any pertinent clinical warning, whether the parameters (such as concentration, administration rate) are fixed or within a range (allowing minimum, default and maximum values). Said instructions may be procedural steps to be followed by the user, for example until the start of drug delivery. These steps may be displayed at once (in a list) or one after the other.

It may be provided that the user interface is configured to allow a user to enter validation data for validating a specific status, parameter or step that has been accomplished. After entering said validation data further information and/or instructions may be displayed to the user. For example, when the user validates that a procedural step has been accomplished, the user interface may display the next procedural step to be followed and/or information which are relevant when said step has been accomplished.

Alternatively, it may be provided that the user interface is configured to allow a user to modify settings or parameters of a protocol, for example the administration rate or the time delay for starting drug delivery or other. The modifications can only be applied in respect to a DERS (Dose Error Reduction System) as known in the state of the art.

In this example, the settings modification may happen temporarily as it is only applied for a given and unique situation under the control of the user facing a specific event. The modification is then not applied to (not memorised in) the computer device but rather temporarily memorised in, typically, a volatile memory. In consequences, the protocol database is not affected by a local deviation occurring in given circumstances.

In one embodiment, the user interface is configured to allow a user to enter information in relation to the patient. The information in relation to the patient may comprise the patient’s weight, size, age and/or gender. The patient information may have an influence on the protocols displayed to the user. For example, the protocol library may comprise different groups of protocols wherein each group is associated to a specific target patient population (characterized by weight, size, age and/or gender for example). In dependence of the patient information entered by the user, the user interface may display protocols only of that group of protocols that is associated to the target patient population matching the patient information.

It may be provided that the user interface of the computing device is configured to allow a user to enter control commands or validation data relating to the activation or operation of the at least one patient device. For example, it may be provided that the control command actively starts the operation of the patient device. Instead of said control command, validation data may be entered to validate at the end of the protocol that all procedural steps have been accomplished whereby the activation of the patient device is triggered. It may be provided that the at least one patient device also comprises a user interface that is configured to allow a user to enter control commands or validation data relating to the activation or operation of the patient device for actively starting the operation of the patient device or triggering the activation of the patient device.

In one embodiment, the patient device comprises an infusion device for infusing the drug into the 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. It may be provided that the protocol comprises data relating to the type of infusion device. It may be provided that the protocol comprises data relating to the moment of installation of the infusion device (filled with the at least one drug) on the patient device.

In one embodiment, the system further comprises at least one organization device for mechanically holding the at least one patient device and the computing device. The organization device may be a rack. The organization device may be constituted to hold multiple patient devices, for example in vertical stacks. In addition, the organization device may be constituted to provide an electric power supply to the patient devices as well as a communication link for the patient devices to communicate between each other and with external devices, for example via a hospital communication network. Alternatively, the system including the patient device and the computing device may be used also as a stand-alone device independent from other devices.

A device following the invention particularly brings efficiency in urgent situations which allows reducing human errors when programming the infusion devices but also reducing the time before a global, sometimes complex but always vital, therapy is actually applied to a patient. Namely, the invention will provide a solution to the user with a general guide and ready-to-use protocols involving several drugs, solution which is in contrast with the current known infusion devices.

The idea underlying the invention shall subsequently be described in more detail with reference to the embodiments shown in the figures. Herein:

Fig. 1 shows schematically a system for performing a medical treatment on a patient according to one embodiment; Fig.2 shows a system for performing a medical treatment on a patient according to another embodiment;

Fig. 3-6 show screenshots of the user interface at different stages of a procedure of preparing the administration of one or more drugs to a patient for a medical treatment; and

Fig. 7 shows a system for performing a medical treatment on a patient according to another embodiment.

Figure 1 schematically shows a system 1 for performing a medical treatment on a patient. The system comprises a patient device 2 and a computing device 3. In the embodiment of Figure 1, the patient device 2 and the computing device 3 are two separate macro devices that are configured to communicate via a data link 4. The patient device 2 is configured to deliver a drug to the patient. The computing device 3 comprises a memory 33 with a protocol library stored thereon, the protocol library comprising a plurality of protocols. The computing device 3 comprises a control unit 31 that is configured to control the patient device 2, in particular using one of the protocols of the protocol library. In addition, the computing device 3 comprises a user interface 32. The user interface 32 is configured for displaying information (such as identifiers for a plurality of protocols or medical indications associated with the protocols or medical events associated with the protocols, data for drug delivery and information or instructions that guide the user through one protocol) and for entering information (such as validation data, information in relation to the patient or control commands relating to the activation or operation of the patient device). The user interface 32 may be designed as a touch screen.

The system of Figure 2 exemplarily comprises four patient devices 2. The number of patient devices in Figure 2 is exemplarily and may be greater than four, for example 24. In the embodiment of Figure 2, the patient devices 2 are designed as infusion pumps. The patient devices 2 are vertically arranged in an organization device 4. The organization device 4 is designed as a rack. This organization device 4 provides typically electrical power to the patient devices 2 (infusion pumps) and allows data exchange between the patient devices 2 and the computing device 3. Each infusion pump is provided for delivering a specific drug to a patient.

For preparing the administration of one or more drugs to a patient for a medical treatment, the medical staff uses the user interface 32 of the system 1 and the patient device(s) 2 of the system 1. Figures 3 to 6 exemplarily show screenshots of the user interface 32 to illustrate the stages of the procedure of preparation using the system 1. Here, a system 1 is used where the computing device 3 and the patient devices 2 are separate macro devices.

First, the user interface 32 displays a plurality of protocols as shown in Figure 3. On the user interface 32 of Figure 3 one protocol is displayed with its identifier “cardiac resuscitation”. Further protocols are displayed that are each indexed by a number (2-12). The user has to select one (or more) of the protocols by entering validation data in respect of the desired protocol.

In the example shown in Figure 4, the protocol “cardiac resuscitation” has been selected. The selected protocol PS is visually highlighted and is easily distinguishable from the other protocols. In a lower region of the user interface 32 information in regard of the selected protocol are displayed for the user: “Protocol to be used only on adults. Drugs to be administered: Midazolam and Morphine”. The information relate to the target patient population and to the name of the drugs to be administered. In addition, concentration and administration rate of the drugs may be displayed. In addition to said information (target patient population and drug name), the plurality of protocols are displayed by the user interface 32. The information for the user and the plurality of protocols may be displayed in other regions of the user interface 32 than shown in Figure 4. The user has to confirm the selected protocol PS by entering validation data. For this purpose, the user interface 32 displays a confirmation button C.

Once the selected protocol PS has been confirmed, the user interface 32 displays the (first) drug to be administered and a specific concentration or concentration range of the drug. In the example of Figure 5, the first drug is Midazolam and the required concentration is 2 mg/ml. In addition to name and concentration of the (first) drug, the user interface displays an overview of all patient devices 2 of the system 1 including status information of the patient devices. In the example of Figure 5 the system comprises 16 patient devices 2 (syringe pumps and volumetric pumps). Two of the patient devices 2, namely number 2 and 3, are displayed to be in operation. The user interface 32 also displays the drug that is administered by the patient devices 2 in operation. Exemplarily the drugs are Noradrenaline and Insuline in Figure 5. Furthermore, the user interface 32 displays instructions for the user. Here the instructions are ’’Select the dilution and the pump position, then tap CONFIRM.”. In case that several concentrations are proposed, the user has to select one of the proposed concentrations. In the example of Figure 5 only one concentration is proposed and the user has to select the proposed concentration. The user has to select one of the patient devices 2 that are not in operation yet. The selection of the drug concentration and of the patient device is confirmed by the user with the confirmation button C displayed by the user interface 32. The user has to fill (now or later, but before activation of drug administration) the drug in the required concentration in a recipient (syringe) of the selected patient device.

In case of the protocol “cardiac resuscitation” a second drug (Morphine) has to be administered. The steps described with respect to Figure 5 are repeated for the second drug Morphine.

Figure 6 shows that two patient devices 2 for the drugs Midazolam and Morphine and the concentrations of these two drugs (2 mg/ml and 1 mg/ml, respectively) have been selected. The user interface also displays the administration rate of the drugs. In Figure 6 the administration rates are exemplarily 5 ml/h and 25 ml/h for Midazolam and Morphine, respectively. Finally, the user interface 32 displays further instructions for the user. Here the instructions are ’’Confirm infusion settings on the syringe pumps.”. By confirming the settings on the patient devices according to the instruction, the patient devices are activated and the administration of the drugs according to the protocol “cardiac resuscitation” starts. As an alternative, it may be provided that the computing device is configured to allow a user to finally confirm the protocol, for example once all settings have been confirmed at the patient devices. This final confirmation may activate the patient devices and start the administration of the drugs.

In the embodiments described above, the computing device 3 and the patient devices 2 are separate macro devices. In the embodiment of Figure 7, the patient device 2 and the computing device 3 form a single macro device.

The system 1 for performing a medical treatment on a patient of Figure 7 exemplarily comprises two patient devices 2. However, the system may comprise only one or more than two patient devices 2. The patient devices 2 are each configured to deliver a drug to the patient. Each patient device 2 comprises a computing device 3. Each computing device 3 comprises a memory 33 with a protocol library stored thereon, the protocol library comprising a plurality of protocols. Each computing device 3 comprises a control unit 31 that is configured to control drug delivery by the respective patient device 2, in particular using one of the protocols of the protocol library. In addition, each computing device 3 comprises a user interface 32. Each user interface 32 is configured for displaying information (such as identifiers for a plurality of protocols or medical indications associated with the protocols or medical events associated with the protocols, data for drug delivery and information or instructions that guide the user through one protocol) and for entering information (such as validation data, information in relation to the patient or control commands relating to the activation or operation of the patient device). The user interfaces 32 may be designed as a touch screen.

According to a further embodiment, the system 1 for performing a medical treatment on a patient comprises two or more patient devices 2. A first patient device 2 comprises a computing device 3 with a memory 33 with the protocol library (explained with regard to Figure 7) stored thereon, a control unit 31 and a user interface 32. The other (second) patient device(s) 2 comprise(s) a computing device 3 with a control unit 31 and optionally a user interface 32. The computing device(s) 3 of the/each second patient device(s) is connected to the computing device 3 of the first patient device 2 so that the computing device 3 of the first patient device 2 serves to provide the protocol library for all patient devices 2 of the system 1 and optionally to control not only the first patient device 2 but also the second patient device(s) 2.

In consequences, a computing device 3 may apply to several patient devices 2, one patient device 2 being then configured to be in a master mode and the other patient devices 2 in relation sharing the same available protocols in a slave mode so that the user may find the same protocols when needed at each pump level. Having the computing devices 3 integrated on a patient device 2 is of particular interest for modularity reason so that a patient device 2 may be used in conjunction with a plurality of other patient devices 2 in different environments.

Claims

Claims:

1. System (1) for setting up a medical treatment on a patient, comprising:

- at least one patient device (2) for delivering a drug to the patient, and

- a computing device (3) with a user interface (32) and a control unit (31), wherein the control unit (31) is configured to control the at least one patient device (2), characterized in that a protocol library is stored on a memory of the computing device (3) or accessible by the computing device (3), the protocol library comprising a plurality of protocols, each protocol being associated to one medical indication or medical event and comprising data for drug delivery including name and concentration of at least one drug wherein the user interface (32) is configured to display the plurality of protocols or the associated medical indication or medical event and the data for drug delivery to a user.

2. System (1) according to claim 1, characterized in that the user interface (32) is configured to allow the user to select one of the protocols or the associated medical indication or medical event.

3. System (1) according to claim 2, characterized in that the at least one patient device (2) is controlled by the control unit (31) using the protocol selected by the user.

4. System (1) according to one of the preceding claims, characterized in that the protocol comprises one or more of drug volume, loading dose, bolus, administration rate, temporal profile of the administration rate, combination of two or more drugs, time delay for starting drug delivery, parameters of the end of drug delivery.

5. System (1) according to one of the preceding claims, characterized in that the protocol comprises information and/or instructions that guide the user through the protocol to be displayed to the user.

6. System (1) according to one of the preceding claims, characterized in that the user interface (32) is configured for entering validation data for validating a specific status or step that has been accomplished.

7. System (1) according to one of the preceding claims, characterized in that the user interface (32) is configured for entering information in relation to the patient.

8. System (1) according to claim 7, characterized in that the information in relation to the patient comprise the patient’s weight, size, age and/or gender.

9. System (1) according to one of the preceding claims, characterized in that the user interface (32) is configured for entering control commands relating to the activation or operation of the patient device.

10. System (1) according to one of the preceding claims, characterized in that the patient device (2) comprises an infusion device for infusing the drug into the patient.

11. System (1) according to one of the preceding claims, characterized in that the system (1) further comprises at least one organization device (4) for mechanically holding the at least one patient device (2) and the computing device (3).