ADMINISTRATION SYSTEMS AND METHODS FOR THEIR USE

Description

TECHNICAL AREA

[0001] The present invention relates to the field of delivery systems for administering fluid medications by means of a delivery device, in particular an infusion pump or an injection device. Specifically, the present invention also relates to wireless communication within the delivery systems and software functions within the delivery systems. BACKGROUND OF THE INVENTION

[0002] Devices for administering fluid medications are well known to those skilled in the art from international patent class A61M5.

[0003] Due to rising healthcare costs in developed countries, the self-administration of liquid medications, even those requiring injection or infusion, is becoming increasingly important. Since patients are in most cases not medical professionals, there is a risk of misuse or incorrect administration of the wrong medication.

[0004] A typical example is the self-administration of insulin in diabetic patients. Insulin is administered via syringes, injection pens, or infusion pumps. Many different insulins are available in varying concentrations and with different action profiles. A common primary packaging for liquid insulins is the cartridge, available in either 3 ml or 1.6 ml sizes. Alternatively, there are pre-filled, disposable pens that already contain the appropriate insulin cartridge.

[0005] On the one hand, there is a risk that diabetic patients may administer the wrong form, with potentially serious consequences. For example, if the same number of units of very fast-acting insulin (Novo Nordisk Fiasp) is administered instead of the daily dose of slow-acting insulin (Sanofi Lantus), this can lead to hypoglycemia and a subsequent collapse of the diabetic patient.

[0006] On the other hand, patients should not be patronized and should be able to decide for themselves when to administer which medication. The potential negative consequence of patronizing treatment is decreased patient adherence to a specific therapy.

[0007] Furthermore, in the case of infusion pumps, especially insulin pumps, these are tested and approved for specific insulin products. This poses a risk of inaccurate dosing if a supposedly identical product is used in a supposedly identical-sized cartridge.

[0008] There is a need to further increase the safety of administering fluid medications without creating a paternalistic effect on patients that would be detrimental to therapy adherence.

[0009] In this context, the term fluid "product," fluid "medicine," or fluid "medicinal substance" encompasses any flowable medical formulation suitable for controlled administration via a cannula or hollow needle into subcutaneous or intramuscular tissue, for example, a liquid, solution, gel, or fine suspension containing one or more active medicinal substances. A medicinal product can therefore be a composition with a single active substance or a premixed or co-formulated composition with multiple active substances from a single container. The term specifically includes drugs such as peptides (e.g.,Insulins, insulin-containing medications, GLP-1-containing and derived or analogous preparations, proteins and hormones, biologically derived or active substances, hormone- or gene-based active substances, nutritional formulations, enzymes, and other substances in both solid (suspended) and liquid form. The term also includes polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies, as well as suitable base, excipient, and carrier substances.

[0010] US2018 / 0015218 A1 discloses methods for pairing a portable device with a medical device.

[0011] EP 3660856 A1 discloses methods that support the use of drug delivery devices, so-called augmented reality methods. In this process, at least one marker (of the drug delivery device or its packaging) is photographed using the camera of a mobile device. The image data is then sent to a provider, who in turn sends back data that supports the use of the drug delivery device.

[0012] US patent 2019 / 0378603 A1 discloses, on the one hand, automatic pairing between a computer-like device with a camera and a medical device. The document further discloses that, in some embodiments, the functioning of the delivery device can be bound to the computer-like device. PRESENTATION OF THE INVENTION

[0013] It is an object of the invention to provide administration systems consisting at least of a mobile communication device and an administration device, as well as associated methods, which offer the user increased safety when using the system.

[0014] The task is solved by the systems and methods defined in the independent claims. Advantageous further developments result from the dependent claims, as well as the description and drawings.

[0015] In one embodiment of the invention, a delivery system according to the invention for administering a fluid drug comprises at least one delivery device and a mobile communication device. The two devices can communicate wirelessly and bidirectionally with each other.

[0016] The communication device, which could be a smartphone such as an iPhone, has software, or more specifically a software application, installed that includes several functions for communicating with and / or controlling the delivery device. The communication device has several communication interfaces that can be used by the software. These could include, for example, interfaces for cellular networks, Wi-Fi, Bluetooth, NFC, ZigBee, Z-Wave, and / or similar technologies. The communication device also includes a camera that can be addressed and controlled by the software.The communication device also includes typical additional elements such as a user interface in the form of a screen and other controls, buttons, or a touch-sensitive screen, memory for storing data, as well as an electronic control system with at least one processor, an operating system, and other optional elements such as sensors.

[0017] The delivery device comprises a replaceable reservoir containing the medication and a dispensing mechanism. To administer the medication, the dispensing mechanism is used to release the medication from the reservoir. When the reservoir is empty, it can be replaced with a new, full one. Furthermore, the delivery device features an electronic control unit and a communication device connected to the control unit for wireless communication with the communication system. The possible technologies used in this process have already been mentioned.

[0018] The reservoir can be a wide variety of primary packaging forms for fluid medications known to those skilled in the art; examples include, but are not limited to, bags, bottles, cartridges, cartridges, syringes, or syringe-like reservoirs. According to the invention, information is arranged on an outer surface of the reservoir or its packaging.

[0019] This information can be read and evaluated by the software using the camera. According to the invention, this information can be used to activate, deactivate, or keep deactivated functions implemented in the software. These functions can serve for communication or control of the delivery device.

[0020] Reading the information with the camera is advantageous when changing the reservoir. Alternatively, if there are multiple reservoirs in one package, the reading can also take place when a new package is opened. Another alternative is to time-controlled information reading, so that the information is read after a specific period when changing the reservoir, for example, after one week or one month.

[0021] The information is advantageously designed to be easily machine-readable, for example as a barcode, Data Matrix code, QR code, machine-readable font, or machine-readable pattern.

[0022] The information can include various elements, the following are mentioned here as examples and are not exhaustive: a unique product identifier, a batch number or lot number, a serial number, an expiry date, a manufacturing or production date, a manufacturer identifier.

[0023] In advantageous embodiments of the invention, the delivery device can be an infusion pump, in particular an insulin pump, a patch pump, or an injection device. In this description, the term "injection device" refers to a device in which the injection needle is removed from the tissue after a controlled amount of the medicinal substance has been delivered. Thus, with an injection device, the injection needle does not remain in the tissue for an extended period of hours. This contrasts with an infusion pump or a patch pump, where the infusion cannula can remain in the tissue for up to several days or even a week.With a classic infusion pump, the infusion cannula is part of an external infusion set, while with a patch pump, the infusion cannula is part of a short infusion line, which is often located inside the patch pump and where only the cannula protrudes from the housing into the tissue.

[0024] In further embodiments of the inventions, the information is presented as a standardized DataMatrix code or barcode, in particular according to ISO / IEC 15418 and / or ISO / IEC 16022. Advantageously, these are GS1 application identifiers ( https: / / www.gs1.org / These designs are also advantageous because they comply with the European Union's Falsified Medicines Directive 2011 / 62 / EU or analogous requirements from US authorities such as the FDA, or other official bodies.

[0025] In an advantageous embodiment, a DataMatrix code according to the invention, in particular a GS1 DataMatrix code, comprises a national or international article number (in particular a so-called NTIN or a GTIN), an expiry date, a batch or lot number, and optionally a serial number. NTIN is understood to mean 'National Trade Item Number' and GTIN to mean 'Global Trade Item Number'.

[0026] According to the invention, methods for releasing the aforementioned functions of the software are also included.

[0027] In one embodiment of the method according to the invention, the information is captured by the camera, particularly when changing the reservoir. The image information captured by the camera is temporarily stored in the communication device. Subsequently, the information can be extracted from the image data using the processor and stored for further use by the software. In a further step, parts of the information or all of the information can be sent to a remote server via one of the communication devices of the communication unit, in particular via mobile network or WLAN. The term "server" is to be interpreted broadly in the context of this document.A server can be a virtual instance of a server farm or a private or public cloud service, or it can be a virtual instance of a single server, or directly one or more servers, with further possibilities obvious to the expert. In addition to the typical elements that characterize a server computer, the server includes a database that allows for the verification of information received by the server. The database contains information about the activatable functions as well as reference information that can link the received information to these functions. The verification process checks whether and / or which activatable functions are compatible with the received information. After the server has performed a verification, a response containing the result of the verification is generated on the server and sent to the communication device.The software then evaluates the response. As a result, either none of the available functions, some of the available functions, or all of the available functions are enabled. Alternatively, one or more available functions can be disabled. This ensures that only those available functions relevant to the information are activated.

[0028] In an advantageous embodiment of the method, those activatable functions are enabled that, according to the response, match the information, and in particular are compatible. In an advantageous embodiment, the server's response contains a list of the compatible activatable functions. Alternatively, such a list can also contain the incompatible activatable functions, and those activatable functions not on the list are enabled accordingly. To keep the data volume in the response as small as possible, the list can also be compressed or encoded, in particular, the list can be encoded using a hash function. Other variants of data volume optimization are obvious to those skilled in the art and do not deviate from the inventive concept.

[0029] In an alternative embodiment of the method, which is a modification of the method described above and / or its further developments, the information is not verified on a remote server, but rather on the communication device itself. In this alternative embodiment, the database is stored locally on the communication device. In an advantageous further development of this method, the database is updated at regular or irregular intervals via one of the communication devices' communication interfaces.

[0030] In another alternative embodiment of the method, which is a modification of the alternative embodiment of the method, the verification of the information takes place at least partially on the delivery device.

[0031] In an advantageous and inventive further development of the embodiments described above, the review may reveal that one of the activatable functions does not fit the information, in particular is not compatible, whereby in these further developments none of the activatable functions are then activated.

[0032] In a further advantageous development, the communication device also includes a real-time clock and an associated calendar; if the information, as described above, includes an expiry date and / or a manufacturing date, the check can further include verifying the date and the result can influence the activation of the activatable functions.

[0033] If it is determined that the expiration date has already been reached or exceeded (the medication is considered expired), the software can issue a message to the user interface, warning the user against using the medication and thus improving system safety. The expiration date can also be determined from the manufacturing date and a known maximum permissible storage period.

[0034] As a further safety enhancement, if medication has expired, the software can be used to send a control command to the delivery device, temporarily stopping or blocking the administration of the medication. This is not intended to completely prevent the use of expired medication. The user can manually unlock the delivery device, knowing that they are using expired medication.

[0035] The available functions can encompass a wide range of software features. To ensure safe use of the delivery system, the user should only use medications with valid information. This is further explained in the figure description below. The range of functions may include one or more of the following, although this list is not exhaustive: Remote control function, in which the software sends control commands to the delivery device, allowing the communication device to act as a remote control: Bolus programming and command (i.e., the delivery of a single dose of medication), which can be an immediate bolus (delivered in a single dispensing), a delayed bolus (delivered in several dispensings over a predetermined period), or a combination bolus (a combination of an immediate and a delayed bolus). The bolus is programmed in the software with regard to the delivery parameters and then sent to the delivery device. The delivery device receives the command and executes it.• Starting, stopping, and pausing medication delivery • Temporarily reducing medication delivery • Changing operating parameters on the delivery device (such as maximum daily dose or maximum dose size) • Convenience functions in software, such as a bolus calculator that calculates a bolus recommendation based on input values ​​• Automatic dose adjustment algorithms, for example, if the delivery system is a diabetes management system with a continuous glucose monitor, a communication device, and an insulin delivery device, where the communication device acts as a closed-loop controller. In this case, the communication device receives data from the continuous glucose monitor and automatically adjusts the insulin delivery rate based on dose and blood glucose data.

[0036] An alternative embodiment of the delivery system is described below. It is important to note that the methods described above can also be applied to this embodiment. The following section focuses primarily on the differences from the first described embodiment of the system; otherwise, the disclosure applies analogously to this alternative embodiment.

[0037] In this alternative embodiment of the system, the delivery device consists of an injection device and an add-on module. The injection device and add-on are operatively, and in particular mechanically, detachably connected during use. Importantly, the add-on can be used with multiple or even different injection devices in a staggered manner. The injection device contains a medication reservoir, which can be dispensed via a dispensing mechanism. The injection device can be an injection pen, a so-called patch injector, or an autoinjector. Preferably, the injection device is a disposable device that is emptied after one or more doses and can then be disposed of properly.Before first use, the add-on is connected to the injection device and disconnected again after the last use, making the add-on ready for a new injection device.

[0038] In contrast to the first described embodiment of the system, in this alternative embodiment the information is preferably applied to an outer surface of the injection device. Alternatively, the information can also be arranged on packaging containing several identical injection devices, for example, on a package of insulin pens. Alternatively, if the reservoir is permanently attached to the injection device, that is, if the reservoir and injection device can only be separated destructively, the information can still be arranged on an outer surface of the reservoir. However, this requires that the information remains visible when the reservoir is attached to or installed in the injection device.

[0039] The add-on features an electronic control unit and a communication device connected to the control unit for wireless communication with the communication device. Furthermore, the add-on includes one or more sensors connected to the control unit. When connected to the injection device, this allows the add-on to detect various states of the injection device and, for example, transmit this information to the communication device via the communication device.

[0040] The add-on further comprises a housing that at least partially encloses the control unit, the at least one sensor, and the communication device. Preferably, the housing includes a receptacle through which the injection device can be mechanically connected to the add-on. For example, the housing may have an approximately cylindrical recess into which the end of an injection pen or an autoinjector can be inserted. As mentioned, the connection between the add-on and the injection device is preferably also mechanical, and suitable retaining elements may be provided on the injection device and / or the add-on to prevent unintentional separation. These may, in particular, be threaded elements or snap-fit ​​elements.

[0041] The methods according to the invention, as described above, function analogously or identically with this alternative embodiment of the system.

[0042] Once an injection device has reached the end of its service life, it is disconnected from the add-on and a new injection device is inserted. Before, during, or even after the replacement, the information belonging to the new injection device is captured by the camera and subsequently checked as described.

[0043] In a further modification of the first embodiment of the invention and the variants associated with it, another variant is described below (based on the description above). In this further variant, the delivery device is an infusion pump, in particular an insulin pump. In this further variant, the reservoir is preferably a commercially available cartridge on which the information is printed. In this further variant, the information is only captured by the camera when the reservoir is inserted into the infusion pump. To enable this, the infusion pump includes a window through which the reservoir and the information on the reservoir are visible. The camera then captures not only the information but also image information about the pump. This image information can, for example, include shape and / or color information of the infusion pump.Image recognition software, installed on the communication device or a server integrated into the system, can, for example, identify the type of insulin pump. The image information obtained from image recognition can then be used... together The information can be used according to the invention to activate, deactivate, or keep deactivated functions implemented in the software. These functions can serve for communication or control of the delivery device. It is also conceivable, and likewise according to the invention, that information and image information can be used to activate or deactivate separate functions. This further variant can be combined with the embodiments described above in any way accessible to a person skilled in the art, without departing from the inventive concept.

[0044] In an alternative version of this variant, the image information can also include codes or text arranged on the surface of the pump. For example, this could be the pump's serial number. FIGURES

[0045] In connection with the attached figures, preferred embodiments of the invention are described below. These are intended to illustrate fundamental possibilities of the invention and are in no way to be interpreted as limiting. Fig. 1 shows an example system according to the invention. Fig. 2a shows a second example system according to the invention. Fig. 2b shows the add-on and injection device in the assembled state. Fig. 3 shows a further example of an administration device according to the invention, which can alternatively be integrated into the system according to the invention. Figure 1 can be embedded FIGURE DESCRIPTION

[0046] A first delivery system according to the invention is in Figure 1The schematic diagram shows the delivery device 1, which can be, in particular, an infusion pump, specifically an insulin pump 1. Such pumps are well known to those skilled in the art, for example, the mylife Ypsopump from Ypsomed or the 670G from Medtronic, and therefore do not require a more detailed description. Importantly, the delivery device 1 can communicate bidirectionally with a mobile communication device 3, in particular a smartphone 3, via a radio connection 6, specifically a Bluetooth connection 6. The replaceable reservoir 2 can be inserted into the delivery device 1. As shown, the reservoir 2 can have the form of a cartridge; however, other forms are possible, as mentioned. In this example, the information according to the invention is arranged in the form of a GS 1 DataMatrix code 2a on the outer surface 2b of the cartridge 2.The DataMatrix code 2 can be printed directly onto the outer wall 2b, or affixed to the outer wall 2b in the form of or as part of a label, in particular by gluing. Alternatively, it can encircle the outer wall and, for example, be shrink-wrapped.

[0047] The smartphone 3, as is typical for smartphones, includes one or more cameras on the front and / or back (symbolically represented by reference numeral 3a). An operating system, such as iOS or Android, is installed on the smartphone 3, which allows the installation and execution of the software application according to the invention. The smartphone has at least one Bluetooth module for bidirectional communication with the delivery device 1, as well as a WLAN and a cellular module to connect to a remote server 5 via the internet and / or cellular network (both symbolically represented by cell tower 4). As mentioned, the server 5 can be configured in various ways. In the configuration shown, it is part of a cloud service 8 and can be configured as a virtual server instance. A database 5a is associated with the server, which either runs directly on the server 5 or can run on another server instance of the cloud 8.

[0048] Camera 3b of the smartphone 3 can be used during reservoir changes to photograph the reservoir's information. In this example, it is a standardized GS1 DataMatrix code containing various data about the medication. This includes the Global Trade Item Number (GTIN), which uniquely identifies the product (alternative systems are possible, but the identifier must be unique), a batch number, an expiration date, and optionally a serial number and / or a manufacturer's identifier. Additional data could easily be added and would also comply with the standard.

[0049] After taking a photograph, the data encoded in the DataMatrix code can be extracted and analyzed on a smartphone. The iOS and Android operating systems provide functions for this purpose, which can be used by the software application. Alternatively, other, even separate, apps can be used for data extraction, which then transfer the extracted data to the software application.

[0050] The software application uses the data to check which of its functionalities are compatible with the information contained in the extracted data. The GTIN mentioned above, which is included in the data, uniquely identifies the product (this can be verified, for example, at compendium.ch). Thus, GTIN 7680553460037 uniquely identifies Lantus by Sanofi at a concentration of 100 units / ml in 3 ml cartridges (pack of 5). The same medication, in the same concentration and reservoir size, but in the Solostar pre-filled pen (5-pack), has the GTIN 7680580440019. Rapid-acting insulin Lispro from Eli Lilly, in the same concentration, also in a 5x3ml pack, has the GTIN 7680535530369. While a mix-up between the cartridge and the pre-filled pen is not expected, there is a risk that a patient might use Lispro (rapid-acting insulin) instead of a Lantus cartridge (slow-acting basal insulin).

[0051] If the information is now read out with the smartphone 3 and the GTIN is isolated, the GTIN can be used to check whether the patient wants to insert the correct medication into the delivery device, in this case an insulin pump.

[0052] In this example, the smartphone's software application 3 sends the extracted GTIN and possibly other information to a remote server, via Wi-Fi / Internet or mobile network / Internet (7 and 4). Server 5 receives the GTIN and checks its database to determine if it is an approved product and, if so, which one. To continue with the Lantus / Lispro example, the insulin pump may be recommended and approved for Lispro from Eli Lilly, while Lantus from Sanofi is not. If the GTIN matches Lispro from Lilly in the correct concentration and packaging, the server can send a response via the Internet to the smartphone, which then, for example, unlocks the full functionality of the software application. Conversely, if an invalid GTIN or an insulin not approved for the insulin pump is detected, the server can also forward this information to the software application.The software application will then only enable very basic functionality. Advantageously, the software application displays a warning message on the smartphone screen, alerting the patient to the problem. As a further consequence, the software application can send a control signal to the delivery device, in this example, the insulin pump, and temporarily block it. If the patient still wishes to administer the medication despite the warning and temporary blockage, they should be able to do so. In this case, only limited functionality will be available in the app; for example, the remote control function can be deactivated. The patient can manually release the blockage on the pump itself.

[0053] It is important that patients can consciously bypass the system. For example, there might be a supply shortage of a specific approved medication, requiring the use of an alternative medication at short notice to treat an illness. Such situations must remain possible, but measures should be taken to prevent the inadvertent use of the wrong medication.

[0054] The first system according to the invention made of Figure 1 This can be varied without deviating from the inventive concept. For example, it is conceivable that the software application on the smartphone stores the product references (e.g., the GTIN) of all approved products in an internal database, and that this database is synchronized with the external server from time to time.

[0055] Another feature that can increase safety is the following: In addition to product identification, the batch number can also be checked against the server. For example, if a batch needs to be recalled and this information is stored on the server, the server can also indicate in its response that while the medication is correct, this particular batch should not be used. The software application can also display a corresponding message on the smartphone screen, especially along with instructions on what the patient should do with the medication (e.g., return it to the nearest pharmacy).

[0056] As mentioned, it is advantageous if the information also includes an expiration date. This allows the smartphone to check whether a medication has expired using its internal clock and calendar after extracting the information. If so, several possible consequences arise: deactivation of functionality, notification to the patient via the display, or temporary blocking of the delivery device.

[0057] A second system according to the invention is described in the Figures 2a and 2b The delivery device in this system consists of two components: an add-on 11 and an injection device 10. The injection device shown is an autoinjector. The delivery device, consisting of the add-on and the autoinjector, is described in detail in WO 2018064784 A1, which is hereby incorporated in its entirety by reference into this document.

[0058] The add-on 11 is reusable, while the autoinjector 10 is designed for a single injection. The autoinjector 11 is therefore replaced after each administration. The add-on and autoinjector are mechanically connected for use. To do this, the autoinjector is inserted into the opening of the add-on 11. Advantageously, the autoinjector 10 is held in the add-on 11 by a mechanical snap mechanism.

[0059] Add-on 11 comprises an electronic control unit and an associated wireless communication device, in this case Bluetooth. The electronic control unit can communicate bidirectionally with the smartphone 3 via Bluetooth. The add-on also includes sensors that serve to detect states in the autoinjector 10 when add-on 11 and the autoinjector are assembled. For details, explicit reference is made to the above-cited WO 2018064784 A1. The states can include, for example, the following: 'before injection', 'during injection', 'after injection'. The detected states can then be transmitted to the smartphone 3. These states can be logged in the software application and used further, for example, to display useful information on the use of the medication, such as instructions, to the patient on the smartphone's screen.

[0060] The illustrated autoinjector 10 contains a reservoir with a fluid drug and a dispensing device which enables automatic injection and emptying of the reservoir after activation of the dispensing device.

[0061] As is typical for autoinjectors, a standard 1 ml pre-filled syringe serves as the reservoir. A 2.25 ml version is also available. Since these are widely used standard reservoir types, the identical Autoinjector 10 can be used for a wide variety of injectable medications, for example, for the treatment of rheumatoid arthritis or sexual dysfunction. It is therefore crucial to avoid any mix-ups.

[0062] Information, in this example in the form of a GS1 DataMatrix 10a code, is arranged on an outer surface of the autoinjector. As with the first system described, this GS1 DataMatrix 10a code contains a unique identification of the medication.

[0063] If the autoinjector 10 is now replaced on the add-on 11, the camera of the smartphone 3 can be used to read the GS 1 DataMatrix code 10a and check the information analogously to the first system described. If the check is successful, the software application can confirm the correct medication on the display and provide further instructions to the patient via the display, for example, showing how to correctly insert the autoinjector 10 into the add-on. After insertion, the software application can provide further instructions, confirmation, and logging based on the states reported by the add-on 11.

[0064] Other applications, such as checking the expiry date, are of course also possible in this system and are in accordance with the invention.

[0065] A third system according to the invention is a variant of the first system described according to the invention. Unless otherwise stated, the third system is identical to the first. Figure 3Therefore, to keep this document as concise as possible, only the delivery device, namely the insulin pump 20, of the system is shown. In a variation, delivery device 1 is an insulin pump 20, and reservoir 2 with Data Matrix code 2a is now reservoir 22 with Data Matrix code 22a. The pump also includes a touch display 23, an infusion set 24 (where only the infusion set adapter 24a and the tubing 24b are shown), and the control button 25. Pump 20 is a version of the Ypsopump, which is operated via touchscreen and control button. The Ypsopump is described in detail in WO2015 / 127965A1. WO2015 / 127965A1 is hereby incorporated in its entirety into this document by reference.

[0066] The insulin pump 20 comprises a housing 21 with a window 21a. The window 21a can be designed as a transparent area of ​​the housing 21. Alternatively, the housing 21 can include an opening at the location of the window 21a, into which a transparent piece of plastic or glass is inserted. The window 21a allows a view into the cartridge compartment 20a of the pump 20. Figure 3 Cartridge 22 is inserted into pump 20. Cartridge 22 with the Data Matrix code 22a is visible through window 21a.

[0067] In a modification of the first system described, the Data Matrix code 22a is now captured by the smartphone camera 3a only after the cartridge 22 has been inserted into the pump 20. This captures not only the Data Matrix code 22a, but also the entire pump 20. The further processing of the information from the Data Matrix code 22a proceeds analogously to the processing in the first system, with all possible variations as described above.

[0068] In addition, the processing of image information from pump 20 is now included. According to the invention, image recognition packages from Android (ML Kit or OpenCV) or iOS (AR Kit, Vision or OpenCV) on the smartphone 4, as known to those skilled in the art and readily available, or on the server 5, for example using OpenCV, TensorFlow, PyTorch or Amazon Image Recognition, can detect whether the pump used is an approved infusion pump, such as an insulin pump. Depending on the detected pump, functionality can be activated or deactivated according to the invention.

[0069] Other applications, such as checking the expiry date, are of course also possible in this system and are in accordance with the invention. REFERENCE MARK LIST

[0070] 1 Administration device 2 Reservoir 2a Data Matrix code (information) 3 Smartphone (mobile communication device) 3a Camera (symbolic) 3b Display (screen) 4 Mobile network / Internet 5 Server 5a Database 6 Bluetooth connection 7 Wi-Fi or mobile network connection 8 Cloud 10 Auto-injector (injection device) 10a Data Matrix code (information) 11 Add-on 11a Opening 20 Insulin pump 20a Cartridges 21 Housing 21a Window in housing 22 Reservoir (carpule) 22a Data Matrix code (information) 23 Touch-sensitive display 24 Infusion set 24a Infusion set adapter 24b Infusion line 25 Control button

Claims

1. Administration system for administering a fluid medicament, comprising at least an administration device (1), in particular an infusion pump or an injection device, and a mobile communication device (3), in particular a mobile telephone or a smart phone, which are able to communicate bidirectionally with one another wirelessly, the mobile communication device (3) comprising: a. an electronic controller with a processor and a memory, which enables the execution of software applications, b. a communication device connected to the processor and the memory, which serves for wireless communication (6) with the administration device (1), in particular a Bluetooth unit, c. a further communication device connected to the processor and the memory, which serves for communication (7) with remote servers (5), in particular a WLAN and / or a mobile radio unit, d. a software application which is stored in the memory of the mobile communication device (3) and can be executed and which implements a plurality of functions for communication with the administration device (1) as well as the control of the administration device, e. a camera (3a) which is connected to the processor and the memory and which can be addressed and controlled by the software application, f. a user interface (3b) which enables interaction between the mobile communication device (3) and a user, in particular a touch-sensitive screen and / or a combination of a screen and further operating elements, and wherein the user interface (3b) in particular also enables the interaction of the user and the software application, the administration device (1) comprising at least: g. an exchangeable reservoir (2) for the fluid medicament to be administered, wherein information (2a), in particular in the form of a Data Matrix code, QR code or barcode, is arranged on an outer surface (2b) or the packaging of the reservoir, h. an electronic controller and a wireless communication device connected to the electronic controller, in particular a Bluetooth unit, for wireless and bidirectional communication with the mobile communication device (3), i. a dispensing device which is controlled via the electronic controller and by means of which fluid medicament from the reservoir (2) can be administered in individual doses, quasi-continuously or continuously via an administration line, in particular an infusion set or an injection needle, j. a housing which at least partially encloses the exchangeable reservoir, controller, communication device and dispensing device, wherein k. when the reservoir (2) is exchanged, in which a used reservoir (2) is removed and a new reservoir (2) is inserted, the information (2a) on the new reservoir (2) or its packaging can be read out with the camera (3a) of the communication device (3), characterized in that l. a portion of the plurality of functions of the control of the administration device (1) of the software application are activatable or deactivatable by reading out and evaluating the information (2a).

2. Administration system according to the preceding claim, wherein the information (2a) comprises at least one or more of the following elements: a unique product identifier, a batch number, a serial number, an expiry date, a manufacturing date or a manufacturer identifier.

3. Administration system according to the preceding claims, wherein the administration device (1) is an insulin pump.

4. Administration system according to the preceding claims, wherein the form of the information (2a) is a DataMatrix code according to ISO / IEC 15418:2016.

5. Administration system according to the preceding claim, wherein the information (2a) in the DataMatrix codes contains the following information: a. a national or global article number, as NTIN or GTIN, b. an expiry date, c. a batch number, and optionally d. a serial number.

6. An administration system according to any of claims 1 to 5, wherein the administration device (1) is an infusion pump (20), wherein by means of the camera (3a) of the communication device (3) not only the information (2a) can be read out, but also image information on the appearance and shape of the infusion pump (20), wherein the image information can be processed either on the communication device (3) or the remote servers (5), and the result of the processing has an influence on the activatability or deactivatability of the functions of the control of the administration device (1) of the software application by reading out and evaluating the information (2a).

7. Method for releasing functions in an administration system according to any of the preceding claims 1-5, wherein the functions to be released relate to activatable functions of the software application and wherein the method comprises at least the following steps: a. reading the information (2a) by the camera of the mobile communication device (3), generating image information and temporarily storing the image information in the memory, b. extracting the information (2a) from the generated image information by means of the processor and temporarily storing the extracted information (2a) in the memory, c. transmitting at least parts of the extracted information via the further communication device (7) to a remote server (5), which comprises a database (5a) for verifying the transmitted extracted information and contains a listing of activatable functions, d. verifying the transmitted extracted information in the database (5a), wherein it is verified whether the activatable functions are compatible with the transmitted extracted information, e. creating a response on the server (5) on the basis of the verification and sending the response from the server (5) to the mobile communication device (3) via the further communication device (7), and f. no, partial, or complete release of the activatable functions of the software application on the mobile communication device (3).

8. Method according to the preceding claim, wherein the response of the server (5) transmits a list with the functions compatible with the transmitted extracted information and only the compatible activatable functions are released in the software application.

9. Method for releasing functions in an administration system according to 1 to 5, wherein the functions to be released relate to activatable functions of the software application, wherein the memory of the mobile communication device (3) contains a local database which contains data for verifying the information and wherein the method comprises at least the following steps: a. reading the information (2a) by the camera (3a) of the mobile communication device (3) and generating image information and temporarily storing the image information in the memory, b. extracting the information (2a) from the generated image information by means of the processor and temporarily storing the extracted information (2a) in the memory, c. verifying at least parts of the extracted information in the local database, wherein it is verified whether the activatable functions are compatible with the transmitted extracted information, and d. no, partial, or complete release of the activatable functions of the software application on the basis of the verification.

10. Method according to claim 7 or 9, wherein if the verification of the transmitted extracted information on the server (5) or of the extracted information in the local database reveals that at least one activatable function is not compatible, none of the functions to be released is released.

11. Method according to any of the preceding claims 7 to 10, wherein the mobile communication device (3) further comprises a clock which can reproduce the current time and a calendar which can reproduce the current date and the extracted information comprises at least an expiry date and wherein the method further comprises the following steps: a. comparing the expiry date with the current date, b. releasing none of the functions to be released if the comparison reveals that the expiry date has already been reached or exceeded.

12. Method according to the preceding claim, wherein if the comparison reveals that the expiry date has already been reached or exceeded, the software application outputs a message on the user interface (3b) which draws the user's attention to the fact that the expiry date has been reached and therefore the functions to be released are not released.

13. Method according to any of claims 11 or 12, wherein the administration device (1) further has a user interface for controlling the administration device and wherein if the comparison reveals that the expiry date has already been reached or exceeded, the software application sends a control command to the administration device (1) via the communication device (6), by which the administration device (1) is temporarily deactivated, and a user must reactivate the administration device (1) manually via the user interface of the administration device (1).

14. System according to any of claims 1 or 5 or a method according to any of claims 7 to 13, characterized in that the activatable functions comprise one or more of the following functions: a. a remote control function by means of which a bolus command can be sent to the administration device (1) via the software application, wherein bolus size and the temporal course of the bolus delivery are programmable in the software application, b. a remote control function by means of which a command can be sent to the administration device (1) via the software application by which ongoing medicament administrations are stopped, c. a remote control function by means of which a command can be sent to the administration device (1) via the software application by which interrupted medicament administrations are started again, d. a remote control function by means of which a command can be sent to the administration device (1) via the software application by which medicament administrations are started, or e. a remote control function by means of which a command can be sent to the administration device (1) via the software application by which any medicament administrations are temporarily reduced.