ADMINISTRATION SYSTEMS AND METHODS FOR USING SAME

Abstract

The invention relates to administration systems and to methods which can improve the safety of administration systems, more particularly the safety of an infusion system, in which system it is checked, when the medication container is exchanged, whether the new container is appropriate for the system. A system of this type consists of an administration device (1), a mobile communication device (3) and servers (5). When a reservoir (2) or the administration device (1) is replaced, an image of information (2a) is captured by means of a camera (3a) of the communication device (3). As a result of evaluation of the information (2a) by means of a software application, functions of the administration device (1) are activated or not.

Claims

1. An administration system for administering a fluid medicament, comprising an administration device configured as an infusion pump or an injection device, and a mobile communication device, wherein the administration device and the mobile communication device are capable of communicating wirelessly with one another bi-directionally, the mobile communication device comprising: an electronic controller comprising a processor and a memory; a first communication module communicatively coupled to the processor and the memory and configured to wirelessly communicate with the administration device; a second communication module communicatively coupled to the processor and the memory and configured to wirelessly communicate with remote servers; a software application, which is stored and can be executed in the memory of the mobile communication device and implements multiple functions for communication with the administration device and for control of the administration device; a camera communicatively coupled to the processor and the memory, wherein the software application is configured to acquire information from and control the camera; and a user interface configured to receive user input for controlling the software application, the administration device comprising: an exchangeable reservoir for the fluid medicament to be administered, wherein machine-readable information is arranged on an outer surface or a package of the reservoir; an electronic controller and a wireless communication module comprising a processor and memory configured to be communicatively coupled to the electronic controller of the mobile communication device and configured for wireless and bi-directional communication with the mobile communication device; a dispensing apparatus controllable by the electronic controller of the mobile communication device and with which fluid medicament can be administered from the reservoir in individual doses, quasi-continuously or continuously via an infusion set or an injection needle; and a housing, which at least partially encloses the exchangeable reservoir, the electronic controller and wireless communication module, and the dispensing apparatus, wherein during exchange of the exchangeable reservoir, in which a used reservoir is removed and a new exchangeable reservoir is inserted, the machine-readable information on the outer surface of the new reservoir or the package thereof can be read with the camera of the mobile communication device, and wherein one or more of the multiple functions of the software application for the communication with the administration device and for the control of the administration device can be enabled or disabled by reading and evaluating the machine-readable information.

2. The administration system according to claim 1, wherein the machine-readable information comprises at least one or more of: a unique product identifier, a batch number, a serial number, an expiration date, a date of manufacture, or a manufacturer identifier.

3. The administration system according to claim 1, wherein the administration device is an insulin pump.

4. The administration system according to claim 1, wherein the machine-readable information is in the form of a data matrix code according to ISO/IEC 15418:2016.

5. The administration system according to claim 4, wherein the machine-readable information in the data matrix code contains the following information: a national or global item number, as NTIN or GTIN, an expiration date, a batch number, and optionally a serial number.

6. The administration system according to claim 1, wherein upon reading the machine-readable information using the camera, the one or more of the multiple functions of the software application can be enabled or disabled by: generating image information, and temporarily storing the image information in the memory of the mobile communication device; extracting the machine-readable information from the generated image information using the processor and temporarily storing the extracted information in the memory of the mobile communication device; transmitting at least a portion of the extracted information via the second communication module to a database of a remote server for comparing the transmitted extracted information against a list of activatable functions; using the transmitted extracted information to determine whether one or more activatable functions in the list of activatable functions are compatible with the transmitted extracted information; generating a response at the remote server based on the determination, and sending the response from the server to the mobile communication device via the second communication module; and enabling or disabling the one or more of the multiple functions of the software application on the mobile communication device based on the received response.

7. The administration system according to claim 6, wherein the generated response comprises a list of activatable functions compatible with the transmitted extracted information, and only the one or more of the multiple functions of the software application corresponding to a compatible activatable function from the list are enabled in the software application.

8. The administration system according to claim 6, wherein, if the server determines one or more of the activatable functions is not compatible with the transmitted extracted information, none of the one or more of the multiple functions are enabled.

9. The administration system according to claim 6, wherein the mobile communication device further comprises a clock capable of rendering a current time, and a calendar capable of rendering a current date, and wherein the extracted information comprises at least one expiration date, and wherein the one or more of the multiple functions of the software application can be enabled or disabled by: comparing the expiration date to the current date; and enabling none of the one or more of the multiple functions to be enabled if the comparison reveals that the expiration date has already been reached or exceeded.

10. The administration system according to claim 9, wherein, if the comparison reveals that the expiration date has already been reached or exceeded, the software application outputs a message on the user interface, which makes the user aware that the expiration date has been reached and the one or more of the multiple functions to be enabled are therefore not enabled.

11. The administration system according to claim 9, wherein the administration device further comprises a user interface for controlling the administration device, and wherein, if the comparison reveals that the expiration date has already been reached or exceeded, the software application sends a deactivation command via the first communication module to the administration device, by means of which the administration device is temporarily deactivated, and the user must manually reactivate the administration device via the user interface of the administration device.

12. The administration system according to claim 1, wherein upon reading the machine-readable information using the camera, the one or more of the multiple functions of the software application can be enabled or disabled by: generating image information, and temporarily storing the image information in the memory of the mobile communication device; extracting the machine-readable information from the generated image information using the processor and temporarily storing the extracted information in the memory of the mobile communication device; using at least some of the extracted information in a comparison against stored data in a local database of the mobile communication device to determine whether activatable functions in the stored data are compatible with the transmitted extracted information; and enabling or disabling the one or more of the multiple functions of the software application on the mobile communication device based on the comparison.

13. The administration system according to claim 1, wherein upon reading the machine-readable information using the camera, the one or more of the multiple functions of the software application can be enabled or disabled by: using the mobile communication device to generate image information and temporarily store the image information in the memory of the mobile communication device; using the mobile communication device to extract the machine-readable information from the generated image information using the processor and temporarily store the extracted information in the memory of the mobile communication device; using the second communication module to transmit at least a portion of the extracted information to and receive a response from a remote server, the response based on the transmitted extracted information and comprising information regarding the activatable functions; and using the mobile communication device to enable or disable the one or more of the multiple functions of the software application on the mobile communication device based on the received response.

14. The administration system according to claim 1, wherein the multiple functions comprise one or more of: a. a remote-control function, by means of which a bolus command can be sent to the administration device via the software application, wherein bolus size and the time profile 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 via the software application, with which command ongoing medicament administrations are stopped, c. a remote-control function, by means of which a command can be sent to the administration device via the software application, with which command interrupted medicament administrations are restarted, d. a remote-control function, by means of which a command can be sent to the administration device via the software application, with which command medicament administrations are started, or e. a remote-control function, by means of which a command can be sent to the administration device via the software application, with which command any medicament administrations are temporarily reduced.

15. The administration system according to claim 1, wherein the administration device is an infusion pump, wherein the software application is configured cause the camera to acquire image information regarding an appearance and a shape of the infusion pump , wherein the image information can be processed either on the communication device or on the remote servers, and a result of the processing the image information influences the ability of the multiple functions of the software application to be enabled or disabled by reading and evaluating the machine-readable information.

16. An administration system for administering a fluid medicament, comprising an add-on with an exchangeable injection device and a mobile communication device, wherein the add-on and the mobile communication device are capable of communicating wirelessly with one another bi-directionally, the mobile communication device comprising: an electronic controller comprising a processor and a memory; a first communication module communicatively coupled to the processor and the memory and configured to wireless communication with the add-on; a second communication module communicatively coupled to the processor and the memory and configured to wirelessly communicate with remote servers; a software application, which is stored and can be executed in the memory of the mobile communication device and implements multiple functions for communication with the add-on; a camera communicatively coupled to the processor and the memory, wherein the software application is configured to acquire information from and control the camera; and a user interface configured to receive user input for interacting with the software application, wherein the exchangeable injection device is connectable in a mechanically detachable manner to the add-on, the exchangeable injection device comprising: a reservoir with the fluid medicament, which can be emptied for administration thereof; a housing comprising an outer surface, wherein machine-readable information is arranged on the outer surface or a package of the injection device; and a dispensing apparatus, with which fluid medicament can be administered from the reservoir in individual doses via an administration line; the add-on comprising: an electronic controller and a wireless communication module configured to be communicatively coupled to the electronic controller of the mobile communication device, for wireless and bi-directional communication with the mobile communication device; at least one sensor, which is communicatively coupled to the electronic controller and wireless communication module and with which at least one state of the injection device can be detected when the injection device and the add-on are connected to one another; wherein the electronic controller and wireless communication module is configured to send the at least one detected state to the mobile communication device and an add-on housing which at least partially encloses the exchangeable injection device and the electronic controller and wireless communication module, wherein the add-on housing at least partially encloses the housing of the injection device when the add-on and the injection device are connected to one another, wherein during exchange of the injection device, in which a used injection device is removed and a new injection device is inserted, the machine-readable information on the new injection device or the package thereof can be read with the camera of the mobile communication device, and wherein one or more of the multiple functions of the software application for the communication with the add-on can be enabled or disabled by reading and evaluating the machine-readable information.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0056] Preferred embodiments of the invention are described below in connection with the appended figures. These exemplary embodiments are intended to show basic possibilities of the invention and are in no way to be interpreted as limiting.

[0057] FIG. 1 shows an exemplary system according to the invention

[0058] FIG. 2a shows a second exemplary system according to the invention

[0059] FIG. 2b shows add-on and injection device in an assembled state

[0060] FIG. 3 shows a further example of an administration device according to the invention, which can alternatively be embedded in the system according to the invention of FIG. 1

DETAILED DESCRIPTION

[0061] A first administration system according to the invention is shown in FIG. 1. The administration device 1, which can in particular be an infusion pump, specifically an insulin pump 1, is shown schematically. Such pumps are well-known to the person skilled in the art in the form of the mylife Ypsopump from Ypsomed or the 670 G from Medtronic and therefore do not require a more detailed description. It is important that the administration device 1 can communicate bi-directionally with a mobile communication device 3, in particular a smartphone 3, via a radio link 6, specifically a Bluetooth link 6. The exchangeable reservoir 2 can be inserted into the administration device 1. As shown, the reservoir 2 can be in the form of a carpule, but other forms are possible, as mentioned. In this example, the information according to the invention is arranged in the form of a GS 1 data matrix code 2a on the outer surface 2b of the carpule 2. In this case, the data matrix code 2 can be printed directly onto the outer wall 2b, or be attached, in particular glued, to the outer wall 2b in the form of or as part of a label. Alternatively, it can enclose the circumference of the outer wall and be shrunk onto it, for example.

[0062] As usual in the case of smartphones, the smartphone 3 comprises one or more cameras on the front and/or rear side (symbolically reference sign 3a). An operating system, such as iOS or Android, is installed on the smartphone 3 and 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 administration device 1, and a WLAN and a mobile radio module in order to connect to a remote server 5 via the Internet and/or via mobile radio (both shown symbolically as a mobile radio tower 4). As mentioned, the server 5 can be designed in different variants. In the variant shown, it is part of a cloud service 8 and can be configured as a virtual server instance. Associated with the server is a database 5a, which either runs directly on the server 5 or can run on another server instance of the cloud 8.

[0063] Camera 3b of the smartphone 3 can be used to photograph the information of the reservoir when the reservoir is changed. In the present example, it is a standardized GS 1 data matrix code which contains various data relating to the medicament. The Global Trade Item Number (GTIN), which uniquely identifies the product (of course, alternative systems are possible, the identifier must simply be unique), a batch number, an expiration date and optionally a serial number and/or a manufacturer identifier. Further data could be added without any problems and would also be compliant with standards.

[0064] After being photographed, the data encoded in the data matrix code can be extracted from the photograph in the smartphone and evaluated. For this purpose, the operating systems iOS and Android provide functions which can be used by the software application. Alternatively, other, also separate, apps for data extraction can also be used, which transfer the extracted data to the software application after extraction.

[0065] The software application uses the data to check which functionality of the software application is compatible with the information present in the extracted data. The above-mentioned GTIN contained in the data uniquely identifies the product (can be checked at compendium.ch, for example); for example, the GTIN 7680553460037 clearly identifies Lantus from Sanofi in the concentration of 100 units/ml in 3 ml carpules (pack of 5). The same medicament in the same concentration in the same reservoir size but in the prefilled Solostar pen (pack of 5) has the GTIN 7680580440019. The fast-acting insulin Lispro from Eli Lilly in the same concentration also in 5×3 ml pack has the GTIN 7680535530369. While it is not likely that a carpule and a pen will be confused with one another, there is the risk of a patient using a Lispro (fast-acting insulin) instead of a Lantus carpule (slow-acting basal insulin).

[0066] If the information is now read with the smartphone 3 and the GTIN is isolated, the GTIN can be used to check whether the patient wishes to use the correct medicament in the administration device, in this case an insulin pump.

[0067] In the example, the software application of the smartphone 3 sends the extracted GTIN and, if need be, further information, to a remote server, which takes place via WLAN/Internet or mobile radio/Internet 7 and 4. The server 5 receives the GTIN and checks via the database whether it is an approved product and if so, which one. Remaining with the example of Lantus/Lispro, it may be that the insulin pump for Lispro from Eli Lilly is recommended and approved, while Lantus from Sanofi is not approved. If the GTIN now corresponds to Lispro from Lilly in the correct concentration and the correct container, the server can accordingly send a response via the Internet to the smartphone, which, for example, then enables the entire functionality of the software application. Conversely, if an invalid GTIN or an insulin not approved for the insulin pump is determined, the server can also convey this to the software application. The software application will then only enable a very rudimentary functionality. The software application advantageously displays a warning message on the display of the smartphone, notifying the patient of the problem. In a further consequence, the software application can send a control signal to the administration device, i.e., the insulin pump of the example, and temporarily block the latter. If the patient still wishes to use the medicament despite all the warning and temporary blocking, it should be possible to do so. Only a limited functionality is then available to the patient in the app; for example, the remote-control functionality may be deactivated. The patient can manually release the block on the pump.

[0068] It is important that the patient can deliberately override the system. It may, for example, be that there is a supply shortage of a certain approved medicament and for a short time, an alternative medicament must be used to treat a disease. Something like this must still be possible, but a situation in which an incorrect medicament is inadvertently used should be prevented.

[0069] The first system according to the invention from FIG. 1 can be varied without deviating from the concept of the invention. 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 data storage, and the data storage is compared to the external server from time to time.

[0070] Another function which can increase safety is as follows: In addition to the product identifier, the batch number can also be compared to the server. If, for example, a batch has to be recalled and this information is stored on the server, then the server 5 can also store in its response that the medicament would be the correct one, but the batch should not be used. Advantageously, the software application can display a corresponding message on the display, e.g., user interface, of the smartphones 3, in particular together with instructions as to what the patient should do with the medicament (e.g., return it to the closest pharmacy).

[0071] As mentioned, it is advantageous if an expiration date is also stored in the information; the smartphone 3 can thus check, after the extraction of the information, via the internal clock and the calendar whether a medicament has already expired. If this is the case, various possibilities for consequences are again available: deactivation of functionality, message to patient via display, temporary blocking of the administration device.

[0072] A second system according to the invention is shown in FIGS. 2a and 2b. In this system, the administration device consists of two components, i.e., an add-on 11 and an injection device 10. The injection device shown is an autoinjector. The administration device consisting of the shown add-on and the autoinjector is described in detail in WO 2018064784 A1, which is hereby incorporated by reference into the present document in full.

[0073] The add-on 11 can be used multiple times, while the autoinjector 10 is designed for exactly one injection. The autoinjector 11 is thus exchanged after each administration. The add-on and the auto-injector are mechanically connected to one another for use. For this purpose, the autoinjector is inserted into the opening of the add-on 11. Advantageously, the autoinjector 10 is held in the add-on 11 via a mechanical snap mechanism.

[0074] The add-on 11 comprises an electronic controller and a wireless communication module or appliance connected thereto, in the present case Bluetooth. The electronic controller can communicate bi-directionally with the smartphone 3 via Bluetooth. The add-on further comprises sensors that serve to detect states in the autoinjector 10 when the add-on 11 and the autoinjector are assembled. With regard to details, reference is explicitly made to WO 2018064784 A1 cited above. The states may include, for example, the following states: “before injection,” “during injection,” “after injection.” The detected states can then be forwarded to the smartphone 3. These states can be logged in the software application and used further, for example in order to display meaningful information about the use of the medicament, such as instructions, to the patient on the display of the smartphone.

[0075] The autoinjector 10 shown contains a reservoir with a fluid medicament and a dispensing apparatus which enables automatic injection and emptying of the reservoir after activation of the dispensing apparatus.

[0076] As is usual with autoinjectors, a standard 1 ml prefilled syringe serves as a reservoir. Alternatively, a 2.25 ml variant would also be possible. Since these are widely used standard forms of reservoirs, the same autoinjector 10 can be used for very different medicaments to be injected, for example for the treatment of rheumatoid arthritis or sexual dysfunction. Accordingly, it is important that there is no confusion.

[0077] Information, in the present example in the form of a GS 1 data matrix code 10a, is arranged on an outer surface of the autoinjector. As in the first described system, this GS 1 data matrix code 10a contains a unique identification of the medicament.

[0078] If the autoinjector 10 on the add-on 11 is now exchanged, a camera of the smartphone 3 can be used to read the GS 1 data matrix code 10a and to check the information analogously to the first described system. If the result of the check is positive, the software application can confirm the correct medicament on the display and instruct the patient further via the display, for example show how the autoinjector 10 is correctly inserted into the add-on. After the insertion, the software application can, in response to the states reported by the add-on 11, further instruct, confirm and log.

[0079] Further applications, such as checking the expiration date, are of course also possible and according to the invention in this system.

[0080] A third system according to the invention is a variant of the first described system according to the invention. Unless mentioned here, the third system is the same as the first. In order to keep the present document as compact as possible, FIG. 3 therefore shows only the administration device, namely the insulin pump 20, of the system. In a modification, the administration device 1 is an insulin pump 20; the reservoir 2 with the data matrix code 2a is now the reservoir 22 with the data matrix code 22a. The pump further comprises a touch display 23, an infusion set 24 (wherein only the infusion set adapter 24a and the hose 24b are shown), as well as the operating button 25. The pump 20 is a design of the Ypsopump, which can be operated via the touchscreen and operating button. The Ypsopump is described in detail in WO2015/127965A1. WO2015/127965A1 is hereby incorporated by reference into the present document in full.

[0081] The insulin pump 20 comprises a housing 21 with a window 21a. The window 21a can be designed as a transparent region of the housing 21. Alternatively, at the location of the window 21a, the housing 21 can comprise an opening into which a transparent piece of plastic or glass is inserted. The window 21a allows a view into the carpule compartment 20a of the pump 20. In FIG. 3, the carpule 22 is inserted into the pump 20. The carpule 22 with the data matrix code 22a is visible through the window 21a.

[0082] In a modification to the first system described, the data matrix code 22a is now only acquired using the smartphone camera 3a after the carpule 22 has been inserted into the pump 20. In this case, not only the data matrix code 22a is acquired, 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 variants as described above.

[0083] The processing of the image information of the pump 20 is now added. According to the invention, via image recognition packages of Android (ML Kit or OpenCV) or iOS (AR Kit, Vision or OpenCV) on the smartphone 4, as are known and often available to the person skilled in the art, or on the server 5, for example by means of OpenCV, TensorFlow, PyTorch or Amazon Image Recognition, it is possible to detect whether the pump used is an approved infusion pump, for example the insulin pump. According to the invention, functionality can be activated or deactivated according to the recognized pump.

[0084] Further applications, such as checking the expiration date, are of course also possible and according to the invention in this system.

LIST OF REFERENCE SIGNS

[0085] 1 Administration device [0086] 2 Reservoir [0087] 2a Data matrix code (information) [0088] 3 Smartphone (mobile communication device) [0089] 3a Camera (symbolic) [0090] 3b Display (screen) [0091] 4 Mobile radio network/Internet [0092] 5 Server [0093] 5a Database [0094] 6 Bluetooth link [0095] 7 WLAN or mobile radio link [0096] 8 Cloud [0097] 10 Autoinjector (injection device) [0098] 10a Data matrix code (information) [0099] 11 Add-on [0100] 11 a Opening [0101] 20 Insulin pump [0102] 20a Carpules [0103] 21 Housing [0104] 21a Window in housing [0105] 22 Reservoir (carpule) [0106] 22a Data matrix code (information) [0107] 23 Touch-sensitive display (touch display) [0108] 24 Infusion set [0109] 24a Infusion set adapter [0110] 24b Infusion line [0111] 25 Operating button