Electronic Module and Autoinjector

Abstract

An electronics module (27) integrated with or connectable to the automatic injection device (1), the electronics module (27) configured to detect and monitor a dose administration process, or a parameter related to the dose administration process, using the automatic injection device (1), and to provide feedback to a user of the automatic injection device (1) regarding the executed dose administration process, or a parameter related to the dose administration process.

Description

[Technical field]

[0001] The present invention relates to an electronic module connectable to an autoinjector and to an autoinjector for administering medicines comprising such an electronic module.

[0002] Autoinjectors are well known and widely used by patients to self-administer drug injections. However, it has been found that there is a need for highly efficient and reliable monitoring of the drug administration process. Such monitoring is not only important for the patients themselves, but is also particularly important during clinical trials to reliably monitor the injection behavior of study subjects.

[0003] It is therefore an object of the present invention to provide an electronic module configured to provide highly functional and reliable drug monitoring of the drug administration process using an automatic injection device, and an automatic injection device equipped with such monitoring configuration.

[0004] This object is solved by the subject matter of independent claim 1. Preferred developments of such an arrangement are given in the dependent claims.

[0005] The electronic module according to the invention is configured to detect and monitor a dose administration process and / or parameters related to the dose administration process using the autoinjector and to provide feedback to a user of the autoinjector regarding the performed dose administration process and / or parameters related to the dose administration process. The electronic module is either non-removably integrated with the autoinjector or connectable to a corresponding autoinjector for self-administered drug injection.

[0006] The detection and monitoring of the dose administration process and / or at least one of the parameters related to the dose administration process allows for a highly functional and reliable monitoring of the drug administration process. Providing feedback to the user can include feedback information related to the completion and / or success of the administration process. This information can be provided to the user directly during the administration process to guide the user and / or immediately after the end of the drug administration process to inform the user of the success of the administration process. Moreover, the feedback information can be provided in the form of a signal forwarded to the user's portable device and / or to a server for storing the information for later evaluation. The electronic module thereby allows for a highly flexible and reliable monitoring of the drug administration process and thereby of the administration process with the automatic injection device.

[0007] Preferably, the autoinjector comprises a housing, a cartridge or syringe filled with a medicament to be delivered and disposed within the housing, a plunger disposed within the cartridge or syringe, and a driver disposed within the housing and coupled to the plunger. The driver comprises a drive chassis with a plunger rod and a locked drive spring acting between the housing and the drive chassis and thereby the plunger rod to generate a force required to move the plunger to deliver the medicament. Moreover, the autoinjector comprises a needle guard provided axially movably within the housing and configured to release the locked drive spring of the driver to deliver the medicament upon axial movement of the needle guard.

[0008] The above structural arrangement for an autoinjector is very simple, and thus cost effective, whilst still being extremely reliable and safe in use.

[0009] Preferably, the electronic module comprises a detection unit and a notification unit. The detection unit is configured to monitor, in other words, watch, one or more moving parts of the autoinjector and to generate information regarding the administration process of the autoinjector and / or parameters related to the administration process based on an operating state of at least one component of the autoinjector. The notification unit is configured to generate and output a notification signal including or indicating the generated information regarding the administration process and / or parameters related to the administration process.

[0010] Such an arrangement has proven very convenient for implementing monitoring or detection, respectively, and notification in the electronic module.

[0011] Further preferably, the detection unit comprises a photoreflector sensor configured to monitor the movement of at least one component of the autoinjector, in particular a drive chassis of the autoinjector, during the administration process.

[0012] Photoreflector sensors are a very reliable and inexpensive option for implementing sensing functionality.

[0013] In such a configuration, the drive chassis preferably includes at least one optical pattern that is monitored by a photoreflector sensor to monitor the delivery movement of the plunger rod.

[0014] This implementation of motion detection has proven to be very reliable and cost effective.

[0015] Alternatively, the detection unit preferably comprises a time-of-flight sensor configured to monitor the movement of at least one component of the automatic injection device, in particular a plunger rod of the automatic injection device, optionally the plunger rod being part of a drive chassis of the automatic injection device during said administration process.

[0016] Such an arrangement is also a very cost-effective yet extremely reliable option for implementing detection functionality.

[0017] In such a configuration, the time-of-flight sensor is preferably an optical time-of-flight sensor and the plunger rod includes a reflective surface that is monitored by the optical time-of-flight sensor to monitor the delivery movement of the plunger rod.

[0018] This particular implementation has proven to be particularly reliable and cost effective.

[0019] Further alternatively, the detection unit comprises a directional microphone, in particular a microelectromechanical system microphone, configured to detect a signal sound generated by at least one component of the automatic injection device, in particular a drive chassis of the automatic injection device, during the administration process.

[0020] Such an arrangement is yet a very cost-effective, yet extremely reliable option for implementing detection functionality.

[0021] In such a configuration, the drive chassis preferably comprises at least one acoustically active section, in particular a clicker protrusion, which generates an acoustic signal upon movement of the drive chassis in the proximal direction, thereby enabling a directional microphone to monitor movement of the plunger rod via the generated acoustic signal.

[0022] This particular implementation has proven to be particularly cost effective.

[0023] Further alternatively, the detection unit preferably comprises at least one frangible circuit element configured to be destroyed when at least one component of the automatic injection device, in particular a drive chassis of the automatic injection device, reaches a particular position during the administration process, in order to monitor the administration process.

[0024] Such an arrangement is yet a very cost-effective, yet extremely reliable option for implementing detection functionality.

[0025] Preferably, the notification unit comprises an active wireless communicator configured to actively transmit information wirelessly to a user device such as a smart phone or the like.

[0026] Providing a notification unit that communicates wirelessly allows for a highly flexible, connected configuration to be implemented.

[0027] In such a configuration, the active wireless communication may be based on the "cellular" communication technology SigFox.

[0028] This communication technology has been found to be particularly suitable for implementing active wireless communication of electronic modules: in particular, such "cellular" communication technologies allow electronic modules to transmit data directly to a remote server without the need for a local intermediate device to relay the information.

[0029] Alternatively, the active wireless communication may be based on the “cellular” communication technology NB-IoT.

[0030] This communication technology has been found to be a suitable alternative to "cellular" communication technology and thus particularly suitable for implementing active wireless communication of the electronic module as well, although other "cellular" communication technologies may also be used in the electronic module.

[0031] Further alternatively, the active wireless communication may be based on Bluetooth.

[0032] Bluetooth-based systems are well known and less expensive than the two above-discussed "cellular" communication technologies.

[0033] As an alternative to the active wireless communicator described above, the notification unit may comprise a passive wireless communicator configured to passively transmit information wirelessly to a user device such as a smartphone.

[0034] Such passive wireless communicators have the advantage over active wireless communicators in that, in principle, they do not require a separate power source in order to be operated, which makes it possible to reduce the size and cost of the electronic modules.

[0035] In such a configuration, the passive wireless communication is preferably based on NFC (Near Field Communication), in particular using an RFID chip and an antenna.

[0036] This particular implementation for the passive wireless communicator has proven to be an extremely robust and reliable option for implementing passive wireless communications in electronic modules.

[0037] Preferably, the notification unit comprises an optical notifier configured to display the information directly to a user of the autoinjector.

[0038] Such optical notifiers allow for providing feedback to a user of the autoinjector directly without the need for any additional electronic devices. This direct optical feedback can be given not only after completion of the drug administration process, but also during the administration process to guide the user.

[0039] In such a configuration, the optical notifier may include at least one, and in particular several, notification LEDs.

[0040] Notification LEDs have proven to be a very cheap and suitable option for implementing optical notifiers.

[0041] In configurations with an active wireless communicator and / or optical notifier, the electronic module preferably comprises a microcontroller and a battery configured to receive information regarding the administration process from the detection unit, to process the received information, and to control the operation of the notifying unit to output user feedback based on the processed information.

[0042] Such an arrangement is believed to be highly reliable yet simple and therefore cheap to implement.

[0043] Further preferably, the electronic module preferably comprises a wake switch, in particular of a mechanical type, coupled to the microcontroller and configured to switch the operating state of the microcontroller between an on state and an off state.

[0044] The provision of such a wake switch makes it possible to increase the operational life of the electronic module since the electronic components of the electronic module are turned off unless the electronic module or the autoinjector, respectively, are in use, thereby minimizing drain on the provided power source during non-use of the autoinjector, and thereby of the electronic module.

[0045] In such a configuration, the wake switch is preferably configured not to be operated by a user of the automatic injection device, but rather to be operated automatically during use of the automatic injection device, in particular either by the needle guard or by a drive chassis carrying the plunger rod.

[0046] This implementation allows, on the one hand, reliable prevention of accidental activation of the components of the electronic module and thus of accidental depletion of the power supply, and, on the other hand, it ensures that the user does not forget to activate the electronic module in time to check the drug administration process.

[0047] Preferably, the electronics module is provided as an integral component of the autoinjector, non-removably coupled to other components of the autoinjector.

[0048] Such an implementation provides highly reliable monitoring of the administration process without the need to treat the autoinjector and the electronic module as two separate but interacting devices, which substantially simplifies handling.

[0049] In such a configuration, the components of the electronic module are preferably located within the housing of the autoinjector.

[0050] This makes it possible to implement a very compact and robust overall configuration.

[0051] In particular, the electronic module is positioned adjacent to the components of the autoinjector.

[0052] Such a configuration makes it possible to avoid an increase in the length of the autoinjector compared to an autoinjector that is not provided with an electronic module.

[0053] Alternatively, the electronics module may be provided as a separate add-on module configured to be removably coupled to the autoinjector.

[0054] This allows one single electronic module to be used with different autoinjectors one after the other without the need to install the electronic modules, which allows a very environmentally friendly but also relatively cheap monitoring of different administration processes with different autoinjectors.

[0055] In such a configuration, the electronic module preferably includes a sealing membrane that is disposed between the electronic module and the autoinjector when the electronic module is coupled to the autoinjector.

[0056] Such a sealing membrane makes it possible to prevent the ingress of dust or water from the autoinjector environment into the connection between the electronic module and the autoinjector, and thus possible problems related to such contamination.

[0057] In particular, the sealing membrane is made from a material that is transparent to certain light, in particular IR light, so that an optical time-of-flight sensor can be used to monitor the administration process through the sealing membrane.

[0058] The use of such an optical time-of-flight sensor together with an add-on electronic module has proven to be a very reliable and cost-effective implementation, while a transparent sealing membrane ensures operability of the electronic module.

[0059] Preferably, such an add-on electronic module comprises an attachment switch configured to detect attachment of the electronic module to the autoinjector.

[0060] Thereby, the electronic module is configured to automatically detect the connection to a corresponding autoinjector, which significantly simplifies handling.

[0061] In particular, autoinjectors provided for use with such add-on electronic modules are provided with an NFC tag that contains information about the medication contained within the autoinjector.

[0062] Such an implementation allows for automatic readout of information regarding the medication contained within the automatic injection device, thereby allowing for increased functionality of the electronic module.

[0063] In such a case, the electronic module preferably comprises an NFC reader configured to automatically read the information stored in the NFC tag.

[0064] Thereby, information regarding the medication contained within the automatic injection device can be automatically read out by the electronic module.

[0065] Preferably, at least one component of the autoinjector comprises a barcode or QR code containing information about the medication within the autoinjector and configured to be read by a user device, such as a smartphone.

[0066] Such a bar code or QR code is a very simple yet effective way to provide information about the autoinjector to a user device.

[0067] Preferably, the add-on electronic module is provided with mechanical coding features which only allow attachment of the electronic module to autoinjectors which have been provided with matching mechanical coding features.

[0068] This allows the dedication of an electronic module to a particular autoinjector to be implemented in a very cost-effective, yet reliable manner.

[0069] Preferably, the electronics module is configured to be located or is located at the distal end of the autoinjector, axially behind the other components of the autoinjector.

[0070] Thereby, the width of the autoinjector is not increased by the electronic module, and therefore handling of the autoinjector is not significantly affected by the provision of the electronic module.

[0071] Preferably, the autoinjector is a single-use fixed-dose autoinjector.

[0072] Such autoinjectors are very simple in construction and therefore very cheap.

[0073] Preferably, the autoinjector is a single-use variable dose autoinjector.

[0074] Such an autoinjector is a dose autoinjector that is more flexible during use and then fixed thereafter.

[0075] Further alternatively, the autoinjector is a multi-use fixed dose autoinjector.

[0076] Such autoinjectors are structurally very simple, yet have a multi-use configuration that is more environmentally friendly than single-use autoinjectors.

[0077] Finally, the autoinjector can be a multi-use variable dose autoinjector.

[0078] Such an implementation offers maximum flexibility and environmental friendliness.

[0079] Preferably, the electronic module is configured to detect and monitor the dose administration process using the automatic injection device and / or parameters related to the dose administration process based on the movement status of one or more moving parts of the automatic injection device or based on the position of one or more moving parts of the automatic injection device.

[0080] Such an implementation has been found to provide very reliable results for monitoring the administration process.

[0081] Alternatively, the electronic module is configured to detect and monitor a dose administration process using the automatic injection device, or a parameter related to the dose administration process, based on both the movement status and position of one or more moving parts of the automatic injection device.

[0082] Combined movement and position detection results in the most reliable monitoring of the administration process.

[0083] In such a configuration, the electronic module is preferably configured to detect and monitor the dose administration process using the automatic injection device, or parameters related to the dose administration process, based on the movement status and position of one single moving part of the automatic injection device, in particular the drive chassis with the plunger rod.

[0084] The monitoring of one single moving part is rather simple, and thus cost-effective, whilst still allowing reliable monitoring of the administration process. A drive chassis with a plunger rod is the component identified to be the best option for such a single part of the autoinjector, as the movement of the drive chassis is directly connected to the administration process.

[0085] Preferably, the electronic module is configured to wait a certain period of time after no further changes in any one of the monitored parameters are determined before making a final decision to terminate the dose administration process.

[0086] Such a time delay has been found to be a simple option to ensure that the administration process is completed.

[0087] In particular, the particular time period is 1 second, 2 seconds, 3 seconds, 5 seconds or 10 seconds.

[0088] The above values ​​for the particular time periods have been found to be particularly suitable.

[0089] Preferably, the outer contour of the autoinjector together with the electronic module are flush when viewed along the longitudinal axis of the autoinjector.

[0090] Such a flush outer contour has been found to result in improved handling of the overall system.

[0091] Exemplary embodiments and features of the present invention are described below in conjunction with the accompanying drawings. [Brief description of the drawings]

[0092] [Figure 1] 1 is a cross-sectional view of an exemplary single-use fixed-dose autoinjector with a basic injection configuration to be used with the electronic module of the present invention; [Figure 2A] 2 is a cross-sectional view of the autoinjector of FIG. 1 as it is delivered to a user. [Figure 2B] 2 is a cross-sectional view of the autoinjector of FIG. 1 immediately prior to drug delivery. [Figure 2C] 2 is a cross-sectional view of the autoinjector of FIG. 1 after completion of the administration process. [Diagram 3] 1 is a cross-sectional view of a first exemplary embodiment of an autoinjector with an electronic module according to the present invention. [Figure 4] FIG. 4 is an enlarged, rotated cross-sectional view of the autoinjector of FIG. 3. [Figure 5A] FIG. 5 shows further details of the autoinjector of FIGS. 3 and 4 prior to drug delivery. [Figure 5B] FIG. 5 shows further details of the autoinjector of FIGS. 3 and 4 during drug delivery. [Figure 6] FIG. 5C is a diagram illustrating the function of a wake switch of the autoinjector of FIGS. 3 to 5B. [Figure 7] 2 is a cross-sectional view of a second exemplary embodiment of an automatic injection device with an electronic module according to the present invention. [Figure 8] FIG. 8 is an enlarged, rotated cross-sectional view of the autoinjector of FIG. 7. [Figure 9] 11 is a cross-sectional view of a third exemplary embodiment of an automatic injection device with an electronic module according to the present invention. [Figure 10A] 1 is a cross-sectional view of a further exemplary embodiment of an autoinjector configured to interface with an add-on electronic module according to the present invention. [Figure 10B]10B is a cross-sectional view of the autoinjector of FIG. 10A coupled with an exemplary add-on electronic module in accordance with the present invention. [Figure 11] FIG. 10C is an enlarged and rotated view of the electronic module of FIG. 10B. [Figure 12] 1A-1C are symbolic diagrams illustrating two exemplary wireless medication identification information configurations in accordance with the present invention. [Figure 13] FIG. 13 is a symbolic diagram illustrating a further exemplary wireless medication identification information configuration in accordance with the present invention. [Figure 14] FIG. 1 illustrates an exemplary embodiment of a mechanical medication identification information configuration. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0093] In this disclosure, the term "distal portion / end" refers to the portion / end of the device, or the portion / end of a component or member of the device, that is located furthest from the delivery / injection site on the patient upon use of the device. Correspondingly, the term "proximal portion / end" refers to the portion / end of the device, or the portion / end of a member of the device, that is located closest to the delivery / injection site on the patient upon use of the device.

[0094] The present disclosure of administration process monitoring is applicable to several autoinjector devices. One possible autoinjector device is a pen-type autoinjector with a basic injection configuration as shown in FIG.

[0095] FIG. 1 shows an exemplary embodiment of an autoinjector 1 adapted to be supplemented by or used in conjunction with an electronic module 27 according to the present invention.

[0096] The autoinjector 1 comprises a housing 3 formed from an outer body 3a and an inner body 3b. A cartridge or syringe 5 filled with a medicament to be administered is disposed in the housing 3. A plunger 7 for expelling the medicament from the cartridge or syringe 5 is disposed in the cartridge or syringe 5. Furthermore, a driver 9 is disposed in the housing 3 and coupled to the plunger 7. Said driver 9 comprises a drive chassis 10 with a plunger rod 11 and a locked drive spring 13, which acts between the housing 3 and the drive chassis 10 with the plunger rod 11 to generate the force required to move the plunger 7 through the cartridge or syringe 5 to expel the medicament. Moreover, the illustrated autoinjector 1 comprises a needle guard 15 movable against the force of a needle guard spring 16 into the housing 3 from a proximal end of the autoinjector 1 in a distal direction. The needle guard 15 is coupled to the drive chassis 10 in such a manner that distal movement of the needle guard 15 releases the locked drive spring 13, resulting in proximal movement of the plunger rod 11 and thereby the ejection movement of the plunger 7 along the cartridge or syringe 5.

[0097] For safety, the autoinjector 1 further includes a cap 17 with a rigid needle shield 19 connected to the proximal end of the autoinjector 1. This cap 17 not only shields the needle 22, but also prevents distal movement of the needle guard 15.

[0098] In the following, the basic function of the illustrated autoinjector 1 will be explained with reference to Figures 2A to 2C.

[0099] As seen in Figure 2A, in the supply state of the autoinjector 1, a cap 17 is placed on the proximal end of the autoinjector 1. A rigid needle shield 19 of the cap 17 surrounds a needle assembly 21 with a needle 22 of the cartridge or syringe 5. The drive chassis 10 with the plunger rod 11 and the drive spring 13 are in an initial state in which the drive spring is loaded and locked via a locking element 23 engaged with the housing 3. The autoinjector 1 is thus in a pre-filled and pre-loaded condition.

[0100] For drug administration, the cap 17 together with the needle shield 19 are removed from the proximal end of the autoinjector 1. The autoinjector 1 is then pressed against the injection side (not shown) with the needle guard 15 at its proximal end. This causes the needle guard 15 to move distally with respect to the housing 3 and the needle 22 of the needle assembly 21 to enter the injection site. Near the distal end position of the needle guard 15, the needle guard 15 separates the locking element 23 of the drive chassis 10 from the housing 3, thereby releasing the drive spring 13. Exactly this situation is illustrated in FIG. 2B.

[0101] The released drive spring 13 pushes the drive chassis 10 with the plunger rod 11 in a proximal direction, which results in a corresponding movement of the plunger 7 and thus the delivery of the medicament from the cartridge or syringe 5 through the needle 22 into the injection site. After this delivery, the autoinjector 1 is removed from the injection site. This results in the needle guard spring 16 pushing the needle guard 15 in a proximal direction so that the needle guard 15 surrounds the needle 22. In this expanded state, the acoustically active section 25 of the drive chassis 10 engages with the end 26 of the dose click protrusion of the housing 3 to generate an end of the dose click and lock the movement of the driver 9 components relative to the housing 3. Moreover, the locking element 23 of the drive chassis 10 engages with the needle guard 15 to prevent further distal movement of the needle guard 15 relative to the housing. This final locked state is illustrated in FIG. 2C.

[0102] In this connection, it is noted that the drive chassis 10 is arranged linearly movably within the housing 3. The drive chassis 10 comprises a delivery rim forming a plunger rod 11 and a trigger rim in whose interior a drive spring 13 is arranged. The plunger rod 11 is arranged at the proximal end of said delivery rim and a locking element 23 is arranged extending proximally from said trigger rim. The trigger rim and the delivery rim are respectively arranged parallel to each other, at least essentially parallel to each other, and are connected to each other and preferably integrally formed in one piece at the respective distal ends of the delivery rim and the trigger rim. This shape of the drive chassis 10 allows a particularly compact design of the automatic injection device 1.

[0103] In the following, a first exemplary embodiment of an autoinjector with an integrated electronic module according to the present invention will be described with reference to FIGS.

[0104] The basic injection configuration of the autoinjector 1 illustrated here is in principle the same as that of the autoinjector 1 described with reference to Figures 1 to 2C.

[0105] The above-described autoinjector 1 is merely supplemented with an exemplary electronic module 27 according to the present invention. Said electronic module 27 is arranged within the housing 3, in particular within the outer body 3a of the housing 3, next to the above-described components of the autoinjector 1.

[0106] The electronic module 27 comprises a printed circuit board arrangement (PCBA) 28 containing a detection unit with a photoreflector sensor 29 and a microcontroller 31, as well as a power source 33 in the form of a battery, in particular a standard AAA size battery (preferably either alkaline or LiMnO2). The microcontroller 31 is coupled to an active wireless communicator 35 in the form of a NB-IoT module of a notification unit of the electronic module 27. Moreover, a wake switch 37 (explained in more detail later) is provided at the proximal end of the housing 3 and coupled to the microcontroller 31. Finally, an optical notifier in the form of a notification LED (not shown) is also connected to the microcontroller 31. The drive chassis 10 is provided with an optical pattern 12 in the form of a printed coded track with sections of different reflectivity, in particular printed. This is illustrated in Figures 5A and 5B, where Figure 5A shows the relative position between the optical pattern 12 and the photoreflector sensor 29 just before the release of the drive spring 13, and Figure 5B shows the relative position between the optical pattern 12 and the photoreflector sensor 29 at a particular point in time during the delivery movement of the drive chassis 10 with the plunger rod 11.

[0107] The photoreflector sensor 29 is arranged such that an area of ​​the drive chassis 10 with the optical pattern 12 passes through the photoreflector sensor 29 during the delivery movement of the drive chassis 10 with the plunger rod 11 in the proximal direction. The photoreflector sensor 29 is thereby configured to monitor the delivery movement of the plunger rod 11 relative to the housing 3. To this end, the photoreflector sensor 29 is non-movably coupled to the housing 3. The microcontroller 31 is configured to receive varying brightness information corresponding to the movement of the drive chassis 10 relative to the photoreflector sensor 29 and to process the received information. In particular, the microcontroller 31 is configured to determine both the current position of the drive chassis 10 with the plunger rod 11 in the housing 2 and the current movement status of the drive chassis 10 with the plunger rod 11 in order to evaluate the current status of the administration process. However, the microcontroller 31 may, if desired, be configured to determine only one of the current position of the drive chassis 10 with the plunger rod 11 within the housing 2 and the current movement status of the drive chassis 10 with the plunger rod 11 in order to assess the current state of the dosing process. The microcontroller 31 is further configured to control the operation of various notification units of the electronic module 27, here in particular of the NB-IoT module 35 and of the notification LEDs, in order to output user feedback based on the processed information.

[0108] In particular, the notification LEDs are illuminated and turned off in a specific pattern to inform the user of the autoinjector 1 of the status of the administration process. At the same time, the NB-IoT module 35 wirelessly transmits electronic information regarding the administration process to an external server, where this information is stored.

[0109] To extend the service life of the electronic module 27, the microcontroller 31 is configured to be in an inactive sleep state until the wake switch 37 is activated. To this end, the wake switch 37 is positioned in such a manner that the wake switch 37 is activated only through distal movement of the needle guard 15 immediately prior to the release of the drive spring 13, as seen in FIG. 4. The wake switch 37 is a mechanical wake switch 37 due to the minimal energy consumption of such a mechanical switch compared to an accelerometer or similar component.

[0110] The microcontroller 31 is configured to not only signal the activation of the wake switch 37, but also the deactivation of the wake switch 37 upon proximal movement of the needle guard 15 and the associated release of the wake switch 37. In particular, the microcontroller 31 is configured to determine the time period during which the wake switch 37 is activated and to compare this time period with a predetermined time period expected to be required for the entire dosing process. Thus, the microcontroller 31 is configured to detect and monitor the dose administration process not only based on the movement of the drive chassis 10 with the plunger rod 11, but also based on the movement of the needle guard 15.

[0111] 6, the entire dosing process requires at least a certain predefined injection time, plus an additional dwell time from full activation of the wake switch 37 (see figure above). If the wake switch 37 is deactivated before the expiration of this predefined time period by removal of the autoinjector 1 from the injection site, and thereby by proximal movement of the needle guard 15, the microcontroller 31 determines an incomplete dosing process, but the drive chassis 10 with the plunger rod 11 completes all of its delivery movements.

[0112] In other words, using the needle guard 15 to activate the wake switch 37 provides the benefit of making it possible to detect premature removal of the automatic injection device 1 from the injection site before dose delivery is completed.

[0113] In other words, during normal operation, the wake switch 37 is actuated before the movement of the plunger rod 11 begins, and the wake switch 37 is not released until the movement of the plunger rod 11 stops. When the autoinjector 1 is lifted away from the injection site, the needle guard spring 16 displaces the needle guard 15 proximally to its extended position. The wake switch 37 registers a change of state since the needle guard 15 is no longer interfering with the wake switch 37. Therefore, if the movement of the plunger rod 11 continues after the wake switch 37 is released, this indicates premature removal of the autoinjector 1. In this case, the event may be logged as an error within the microcontroller 31 and transmitted along with the delivery time and drug information. This information may then be used to mitigate future premature removals, either through user training or other interventions.

[0114] Such functionality is particularly appropriate when the microcontroller 31 is provided with further information regarding the autoinjector 1, such as the two above-mentioned time periods. In the present configuration where the electronic module 27 is integrated into the autoinjector 1, these and other information, such as the particular medication in the cartridge or syringe 5, may be stored directly in a memory connected to the microcontroller 27.

[0115] As indicated above, the entire administration of the drug may require a certain dwell time, so that, for example, if an optical notifier LED is used to guide the user through the administration process, the microcontroller 31 of the electronic module 27 may wait a certain time period after the monitored component, here the drive chassis 10 with the plunger rod 11, has not moved any further and after the monitored parameter has not changed any further, before indicating the end of the delivery process. A suitable time period has been found to be between 1 and 10 seconds, depending on the drug used and the structural configuration of the automatic injection device 1 itself.

[0116] In principle, there are various aspects of the dose administration process that can be detected and monitored by the electronic module 27. In particular, the start of dose delivery and the normal completion of dose delivery can be determined. Moreover, the electronic module 27 can be configured to determine the termination of the delivery process after no delivery movement or change in the monitored parameter has been determined for a certain time, for example from 1 to 10 seconds, after the start of dose delivery has been determined but the normal end of dose delivery has not yet been determined. Also, the specific progress of the administration process can be monitored, in this embodiment, in particular based on the movement characteristics of the drive chassis 10 with the plunger rod 11 with respect to the photoreflector sensor 29 and thereby with respect to the housing 3.

[0117] For this purpose, the photoreflector sensor 29 comprises an LED for illumination and a phototransistor for detecting light reflected from an optical pattern 12 on the drive chassis 10. The optical pattern 12 is formed of more reflective and less reflective areas arranged with respect to the photoreflector sensor 29 such that an axial movement of the drive chassis 10 with the plunger rod 11 results in a change in the intensity of the reflected light which is determined by the phototransistor. This signal is transmitted to the microcontroller 31.

[0118] Such a sensing system provides a relative measure of the distance traveled by the drive chassis 10 with the plunger rod 11, allowing the microcontroller 31 to determine when the plunger rod 11 has been translated far enough for full drug delivery. Moreover, the microcontroller 31 can determine when the movement of the drive chassis 10 with the plunger rod 11 has stopped. The final axial position of the plunger rod 11 relative to the housing 3 at the end of delivery is subject to large tolerance variations, primarily because this end stop is defined by the plunger 7 at the proximal end of the cartridge or syringe 5. As a result, if a mechanical switch is used to detect the end of delivery, the combined tolerance effects of device tolerances and PCB mounting tolerances coupled with switch point variations mean that such an alternative system is too inaccurate. By detecting both the axial position of the drive chassis 10 with the plunger rod 11 and whether the drive chassis 10 has stopped moving, the movement allows the microcontroller 31 to more reliably identify the end of the delivery operation, even with relatively large mechanical and electronic detection mechanism tolerances.

[0119] If the end of delivery is determined solely through detecting the axial position of the drive chassis 10 with the plunger rod 11, the point at which the end of delivery feedback is triggered must be arranged to occur nominally before the plunger rod 11 stops moving. This ensures that the end of delivery feedback is still triggered even when the plunger rod 11 does not reach its nominal axial displacement due to component and system tolerances. By also monitoring the continuing movement of the drive chassis 10 with the plunger rod 11, this information can be combined with the relative displacement of the plunger rod 11, and the end of the delivery process can be determined only when the drive chassis 10 with the plunger rod 11 has advanced far enough and stopped moving. This improves the accuracy of the timing of the end of the delivery process and ensures that it more closely aligns with the exact moment when the dose delivery is completed.

[0120] Here, optical pattern 12 is a printed pattern on drive chassis 10, as minimal modifications to the original autoinjector mechanism (see FIGS. 1-2C) are preferred. However, functionally, this optical pattern 12 may be formed by molded-in features / recesses, laser surface marking, separate components or other similar techniques. Additionally, other sensing technologies, such as coded magnets or capacitance sensors, may be employed to provide similar feedback of plunger rod 11 movement.

[0121] In this embodiment, successful completion of the dose delivery process is determined when the drive chassis 10 with the plunger rod 11 reaches full proximal displacement and stops moving. The microcontroller 31 is configured to identify stalls (either due to a mechanism or PFS failure) where the plunger rod 11 has either stopped moving completely or is moving so slowly that the plunger rod 11 does not achieve full proximal displacement within a pre-determined time limit. This is recorded as an error event.

[0122] Once delivery is complete, the system attempts to transmit data to a remote system (the "Cloud") using an NB-IoT or similar network. Optionally, data transmission may not start until the wake switch 37 has also been released, indicating that the needle guard 15 has extended as the autoinjector 1 has been removed from the injection site. The data transmitted may include device status flags such as time since wake, time since delivery completion, time since an error condition and variables related to the dose administration process such as displacement of the drive chassis 10 with the plunger rod 11, detection of stall, premature removal, low battery, etc., along with drug specific information such as type, concentration, batch and expiration date, along with data that may be used to link the device to the patient for whom it was prescribed.

[0123] A transparent window or thinned area in the housing 3 of one or more notification LEDs, visible to the user through the cutout, provides visual feedback to the user during use of the autoinjector 1. In particular, different LED blinking patterns and / or colors may be used to indicate to the user the status of the autoinjector 1. Examples of status are whether the wake switch 37 has been activated, whether a delivery is in progress, whether a dose was delivered successfully, whether an error condition has been detected, whether a data transmission is in progress, and whether data was transmitted successfully.

[0124] In the following, a second exemplary embodiment of an automatic injection device 1 with a corresponding electronic module 27 is described with reference to FIGS.

[0125] Here, electronic module 27 is provided as an integrated module provided within the distal end of housing 3 behind the other components of autoinjector 1. The outer body 3a of housing 3 is increased in length to accommodate a power source 33 and other electronic circuitry mounted in series with the injection mechanism to facilitate connection features.

[0126] No modifications are required to the core principles and most of the components of the injection mechanism of the autoinjector 1 illustrated in Figures 1-2C.

[0127] The electronic module 27 in this embodiment essentially comprises a PCBA 28 with a microcontroller 31, an active wireless communicator 35 in the form of a SigFox module, a time-of-flight sensor 39, a wake switch 37, a notification LED (not shown) and a power supply 33.

[0128] Due to the reduced space, the power source 33 is a relatively compact coin cell (high drain CR2032) developed specifically to meet the requirements of SigFox communication technology. The battery 33 is mounted using a proprietary coin cell holder. As a result, this integration option requires relatively minor modifications to the overall configuration of the autoinjector 1, specifically adding approximately 27 mm to the length and 1.6 mm to the width.

[0129] Given the integrated nature of this autoinjector 1, medication information may be coded directly into the memory of the microcontroller 31 during manufacture and / or assembly. This avoids the need for the electronics module 27 to have the ability to distinguish between different medications incorporated into the autoinjector 1 and allows this information to be transmitted once the dose administration process is complete.

[0130] In the following, the functioning of the automatic injection device 1 is explained in brief.

[0131] Prior to delivery, the distal end of plunger rod 11 interacts with wake switch 37 to hold wake switch 37 in a depressed state. While this wake switch 37 remains depressed, electronic module 27 remains in an ultra-low power deep sleep state, maximizing battery life of autoinjector 1.

[0132] When delivery begins, the plunger rod 11 moves proximally and releases the wake switch 37. This signal triggers the electronic module 27 to wake the microcontroller 31 from the deep sleep state. To achieve the long storage times required for these types of devices, the wake switch 37 is expected to be a mechanical detection switch, in this case of the normally closed type (where the circuit is completed when the switch is released). Therefore, in storage conditions, the circuit remains open, which therefore draws no quiescent current and allows the microcontroller 31 to remain in a very low energy state until dose delivery starts. Other active sensing options, such as accelerometers, draw current themselves and require the microcontroller 31 to be in a higher power monitoring state throughout the storage period of the autoinjector 1 prior to drug delivery.

[0133] During dose delivery, the plunger rod 11 continues to translate axially in the proximal direction until the end of the dose is reached. It is preferable to detect dose completion in addition to simply starting the dose administration process to provide positive confirmation that the entire dose was delivered successfully. If the dose administration process is not completed successfully, for example due to a stalled mechanism or another adverse event, this can be identified and feedback can be provided to the user or health care professional.

[0134] Several different non-contact methods for detecting the end of the administration process are possible. In this embodiment, a time-of-flight sensor 39 is used. This is an optical time-of-flight sensor 39 that emits a pulse of infrared light and detects the time it takes for this pulse to be reflected to a detector adjacent to the sensor 39. The time taken is used to calculate the distance between the sensor 39 and the target.

[0135] In this embodiment, the time-of-flight sensor 39 is positioned to target the distal reflective surface 11a of the plunger rod 11. During delivery, the distance between the time-of-flight sensor 39 and the plunger rod 11 increases until dose delivery is complete and the plunger rod 11 stops moving. When the time-of-flight sensor 39 detects both that the plunger rod 11 is stationary and that the plunger rod 11 has translated axially far enough to achieve full delivery, the microcontroller 31 records the completion of the dose delivery process.

[0136] This sensing system provides a relative measure of the distance traveled by the plunger rod 11, allowing the microcontroller 31 to determine when the plunger rod 11 has translated sufficiently far and when the movement of the plunger rod 11 has stopped.

[0137] Alternatively, a directional microphone 39 , in particular a MEMS (micro-electromechanical systems) microphone system that is activated by the release of a wake switch 37 , may also be used in place of the time-of-flight sensor 39 .

[0138] When the plunger rod 11 approaches the end of delivery, a characteristic audible click sound is produced by a resilient feature 25 of or on the drive chassis 10 interacting with at least one corresponding feature 26 of the housing 3. Such a resilient feature 25 serves as an acoustically active section 25 of the drive chassis 10 and is in particular provided in the form of a clicker protrusion. This is expected to produce a sound of a particular frequency and amplitude that can be distinguished from other background noises via signal processing performed either by the microcontroller 31 or a separate dedicated microprocessor.

[0139] To improve the robustness of the system, multiple distinct clicks may be generated by the mechanism, all or some of which must be identified by the electronic module 27 before the end of the dose administration process is confirmed. In addition to detecting the end of dose delivery, the MEMS microphone system may also be used to identify when the needle guard 15 has been advanced, if this is accompanied by another identifiable sound. This may be used to signal the correct sequence of operations in a similar manner as the wake switch 27 is employed for the detection of premature removal described above. This has the benefit of avoiding the addition of significant measurement relationship tolerances.

[0140] Other possible non-contact methods of detecting the end of delivery (e.g., accelerometers, ultrasonic sensors, camera-based vision systems, etc.) are expected to be feasible within this configuration but have not been developed at this stage.

[0141] Data transmission to a user and / or other devices is in principle identical to that described in the first embodiment. The only difference is that, compared to NB-IoT networks, SigFox networks are limited in their ability to provide positive confirmation that the transmitted information has been successfully received by the remote system. As a result, the SigFox-based electronic module 27 may be configured to repeatedly attempt to transmit data following a send for a predetermined number of iterations or until the power source 33 is depleted, in order to maximize the chances of successfully uploading the data.

[0142] In the following, a further exemplary embodiment of an automatic injection device 1 with an electronic module 27 according to the invention will be described with reference to FIG.

[0143] This embodiment requires only minimal modifications to the core mechanics of the autoinjector 1 described with reference to Figures 1 to 2C, where detection or monitoring of the medication administration process and notification of the user is achieved by an integrated NFC connectivity system 41.

[0144] In contrast to the "cellular" communication integrated system described above, the NFC integrated option does not include a power source 33. In the case of an NFC system utilizing RFID (radio frequency identification) technology, the circuitry integrated into the autoinjector 1 acts as a passive wireless communicator and may not require an on-board power source 33. When an NFC-capable smartphone is brought into close contact with the integrated NFC autoinjector 1, for example, the magnetic field created by the smartphone may be used to provide power to a passive NFC tag incorporated into the autoinjector 1.

[0145] The illustrated integrated NFC option uses an NFC circuit arranged with a frangible circuit element 43, particularly in the form of a loop of wire, that is destroyed when the delivery process by the drive chassis 10 is completed. Prior to use, when a smartphone is brought into close contact with the integrated NFC autoinjector 1, the RFID chip 45 is excited via the antenna 47 and acts as a transponder providing a specific response to the smartphone to indicate that the autoinjector 1 has not yet been used.

[0146] The autoinjector 1 can then be activated by the user to deliver a dose without any user steps or modifications to the specific instructions pertaining to the connection system. As the drive chassis 10 with the plunger rod 11 advances proximally during the administration process, the drive chassis 10 interacts with the frangible loop of wire 43 connected to the RFID chip 45 to break the wire 43 when the end of the delivery process is reached. The breaking of the wire 43 alters the signal transmitted by the RFID chip 45 when energized by a smartphone after use such that it can be confirmed that the autoinjector 1 has been used.

[0147] It is preferable to arrange the frangible circuit element 43 so that it breaks as close as possible to the end of the delivery stroke of the drive chassis 10 with the plunger rod 11. In this way, the change of state indicated by the breaking of element 43 can be used to provide positive confirmation that the entire dose has been successfully delivered.

[0148] If the administration process is not completed normally due to a stalled mechanism or another adverse event and the drive chassis 10 with the plunger rod 11 does not translate proximally to its full extent, the fragile circuit element 43 is not destroyed and the automatic injection device 1 does not report dose completion.

[0149] Medication and / or device information may be programmed into a portion of the RFID circuit that is not susceptible to destruction of the fragile circuit element 43 so that it may be read both before and after use of the autoinjector.

[0150] In the following, a further exemplary autoinjector 1 with an electronic module 27 according to the invention will be described with reference to FIGS. 10A, 10B and 11. FIG.

[0151] Here, electronic module 27 is provided as a separate add-on module that is removably coupled to the distal end of autoinjector 1. Such an add-on configuration provides the opportunity to reuse electronic module 27 for multiple doses with multiple different autoinjectors 1.

[0152] Only minor modifications to the housing 3 allow the design of the autoinjector 1 to be used both with and without add-on modules.

[0153] The connected electronic module 27 of this embodiment essentially comprises a PCBA 28 with a microcontroller 31, a sending sensor 29 or 39, a wake switch 37, an attachment switch 49, a user notification LED (not shown) and a power supply 33. Moreover, an active wireless communication configuration based on Bluetooth is provided. The lower peak currents involved in Bluetooth transmission allow a smaller button cell battery to be used compared to the integrated "cellular" option described above. This allows for a very compact add-on module 27. Such an electronic module 27 can be accommodated within the width and depth of the existing housing 3 of the implementation described with reference to Figures 1 to 2C and has a length of approximately 18 mm.

[0154] A sealing membrane 51 is provided at the proximal end of the electronic add-on module 27 to prevent the ingress of fluids and particles that may affect the functioning of the add-on module 27. The sealing membrane 51 is flexible to allow the wake switch 37 and the attachment switch 49 to be operated by deflection of a locally thinned or folded area of ​​this sealing membrane 51. In the case where an optical time-of-flight sensor 39 is employed, the sealing membrane 51 is also made, at least in part, from a material that is transparent to certain wavelengths of light, in particular IR light, to enable correct functioning of the sensor 39.

[0155] The Bluetooth add-on module 27 may be attached and detached to the distal end of the modified housing 3 via a removable clip feature 53. The add-on module 27 detects attachment to the autoinjector 1 via an attachment switch 49 that interacts with a localized protrusion 55 on the distal end face of the housing 3. While the attachment switch 49 remains disengaged, indicating that the add-on module 27 is not or improperly attached to the autoinjector 1, the add-on module 27 remains in an ultra-low power state, preserving battery life.

[0156] When the attachment switch 49 is depressed, this indicates that the electronic module 27 has been attached to the autoinjector 1, and the electronic module 27 is activated and enters a higher power state, checks drug identification information, switches operational sequences, and performs system health checks (e.g., verifying battery voltage levels). When attached to the autoinjector 1, the wake switch 37 is also depressed via interaction with the distal surface of the plunger rod 11, which is accessible through an opening at the distal end of the housing 3. The height of the local protrusion 55 on the distal end face of the housing 3 ensures that the attachment switch 49 is depressed before the wake switch 37 when the electronic module 27 is coupled to the autoinjector 1, and is released after the wake switch 37 upon removal of the electronic module 27. The sequence of switch state changes can be used to signal the correct attachment of the electronic module 27 to the autoinjector 1.

[0157] Additionally, defined sequences or combinations of switch press events, and potentially specific timing between two or more switch state change events, may be used to provide a means of user interaction with the electronic module 27, such as initiating pairing with a smartphone or manual synchronization of stored data. The user may be instructed to press one or more of the available switches in a specific sequence and / or for a certain duration to activate different module functions in the unbound state of the electronic module 27.

[0158] Like the wake switch 37 described above, the attachment switch 59 and wake switch 37 in this variation are expected to be of the mechanical type to minimize static current drain during storage.

[0159] Once the electronic module 27 confirms attachment to the autoinjector 1, it monitors the state of the wake switch 37 for an indication that delivery has commenced. The wake switch 37 and dose completion detection (e.g., a time-of-flight sensor 39 targeting the plunger rod 11, or a MEMS microphone and signal processing to identify the end of the dose click) are functionally identical to the arrangement described above with respect to the second exemplary embodiment, such that further features of this embodiment will not be described again in detail.

[0160] A further key aspect of the connected medication delivery system 1 is the ability to verify the type and expiry date of the medication to be delivered, providing an opportunity to warn or guide the user before a mistake is made. In particular, in the case of an add-on electronic module 27, there is the possibility of attaching the electronic module 27 to an autoinjector 1 containing a different medication. Three possible solutions to address this concern in the case of such an add-on module 27 are presented below with reference to Figures 12-14.

[0161] As illustrated in FIG. 12, according to a first exemplary configuration, an NFC tag 57 is embedded in a label on the housing 3 of the autoinjector 1. This NFC tag 57 contains information about the medication contained within the autoinjector 1. The NFC tag 57 is then read independently by a smartphone 59, particularly prior to the administration process. This data can be stored in the smartphone 59 and then potentially combined with the dose delivery data provided by the add-on module 27 after completion of the medication administration process. Alternatively, a barcode or QR code 61 is printed on the label to be read by the camera of the smartphone 59. This allows the user to be informed of certain information of the autoinjector 1 prior to use in order to guide the subsequent administration process.

[0162] With reference to FIG. 13, an NFC reader 63 may be assembled to the add-on electronic module 27 to automatically read the NFC tag 57 of the autoinjector 1 described above. This avoids the need for an additional user step of independently reading the NFC tag 57 with the smartphone 59 and also more reliably couples the drug information with the dose administration process. When the attachment switch 59 is pressed upon attachment of the add-on module 27 to the autoinjector 1, the built-in NFC reader 63 is activated to detect the drug information. This provides an opportunity to alert the user, either through further Bluetooth communication to the smartphone 59 or via a notification LED on the electronic module 27 itself, if an incorrect combination of the add-on module 27 and the autoinjector 1 is connected. A positive confirmation may also be provided if the drug information indicates that the drug is acceptable. Following completion of the drug administration process, the drug information previously read by the add-on electronic module 27 may be combined with any dose event data and this information may be transmitted to the smartphone 59, for example, via Bluetooth, as a single record.

[0163] Finally, mechanical coding features 65 may also be incorporated into the interface between the add-on electronic modules 27 and the housing 3 of the autoinjector 1 to lock or code certain modules 27 so that they can only be incorporated into a particular autoinjector 1. An example of such a mechanical coding feature 65 is illustrated in Figure 14. With such an arrangement, it is unlikely that sufficient resolution could be achieved in the coding system to achieve unique expiration date or batch identification information, although drug-specific coding may be feasible.

[0164] Referring again to the wireless communication of the electronic module 27, the use of the Bluetooth protocol for communication allows for two-way communication, thus allowing the smartphone 59 to confirm successful receipt of data to the add-on electronic module 27, preventing unnecessary retransmission of data, which would reduce battery life.

[0165] In the case of the described add-on electronic module 27, following use with one first autoinjector 1, the patient either removes the add-on electronic module 27 from the now emptied autoinjector 1 and immediately attaches the add-on electronic module 27 to a new autoinjector 1, or stores the add-on electronic module 27 independently, awaiting attachment to another autoinjector 1 with which the administration process can be repeated.

[0166] It is noted that the autoinjectors 1 described above are single-use fixed-dose autoinjectors, and thus only one single dose of a pre-set amount depending on the internal structural configuration of the autoinjector 1 can be delivered using these autoinjectors 1.

[0167] However, the drug administration process monitoring described above is not limited to such single-use fixed dose autoinjectors 1. If desired, the functionality described above may be combined with multi-use fixed dose autoinjectors that allow for the delivery of multiple pre-set doses, single-use variable dose autoinjectors that allow for the delivery of a single dose in a user-selectable amount, and multi-use variable dose autoinjectors that allow for the delivery of multiple doses in user-selectable amounts.

[0168] Finally, it is noted that the discovery is that configuring the autoinjector 1 and electronic module 27 in such a manner that the exterior surface of the entire product in its connected state is flush, without steps or protrusions, when viewed along the longitudinal axis of the autoinjector 1, allows for greatly improved handling by a user of the autoinjector 1 with attached electronic module 27. Such a configuration is implemented in all illustrated embodiments. The cutouts illustrated in Figures 12 and 13 merely represent windows 67 in the housing 3 and are not actual recesses perpendicular to the longitudinal axis of the autoinjector 1.

[0169] Below, essential features relating to the present invention are listed with respect to specific embodiments of the invention.

[0170] A first aspect of the present invention refers to an electronic module (27) connectable to an automatic injection device (1), or to an automatic injection device (1) equipped with such an electronic module (27), wherein the electronic module (27) is configured to detect and monitor a dose administration process using the automatic injection device (1) and / or parameters related to the dose administration process, and to provide feedback to a user of the automatic injection device (1) regarding the performed dose administration process and / or parameters related to the dose administration process.

[0171] A second aspect of the present invention is The automatic injection device (1) comprises a housing (3), a cartridge or syringe (5) filled with a medicament to be delivered and disposed within the housing (3), a plunger (7) disposed within the cartridge or syringe (5), a driver (9) disposed within the housing (3) and coupled to the plunger (7), the driver (9) comprising a drive chassis (10) with a plunger rod (11) and a locked drive spring (13), the locked drive spring (13) acting between the housing (3) and the drive chassis (10) to generate a force required to move the plunger (7) to deliver the medicament, and a needle guard (15) provided axially movable within the housing (3) and configured to release the locked drive spring (13) of the driver (9) to deliver the medicament upon axial movement. 1 refers to a first embodiment of an electronic module (27) or autoinjector (1).

[0172] A third aspect of the present invention is an electronic module (27) comprising a detection unit and a notification unit; a detection unit configured to monitor, in other words, watch, one or more moving parts of the automatic injection device (1) and to generate information about the administration process of the automatic injection device (1) or about a parameter related to the administration process based on an operating state of at least one component of the automatic injection device (1); the notification unit is configured to generate and output a notification signal including or indicating the generated information regarding the administration process or a parameter related to the administration process; Refers to the electronic module (27) or autoinjector (1) of any one of the first and second embodiments.

[0173] A fourth aspect of the present invention is the detection unit comprises a photoreflector sensor (29) configured to monitor the movement of at least one component of the autoinjector (1), in particular the drive chassis (10) of the autoinjector (1), during the administration process; 1 refers to a third embodiment of an electronic module (27) or autoinjector (1).

[0174] A fifth aspect of the present invention is The drive chassis (10) includes at least one optical pattern (12) that is monitored by a photoreflector sensor (29) to monitor the delivery movement of the plunger rod (11); FIG. 10 refers to a fourth embodiment of an electronic module (27) or autoinjector (1).

[0175] A sixth aspect of the present invention is a method for producing a composition comprising the steps of: the detection unit comprises a time-of-flight sensor (39) configured to monitor the movement of at least one component of the autoinjector (1), in particular the plunger rod (11) of the autoinjector (1), during the administration process; 1 refers to a third embodiment of an electronic module (27) or autoinjector (1).

[0176] A seventh aspect of the present invention is the time-of-flight sensor (39) is an optical time-of-flight sensor, and the plunger rod (11) comprises a reflective surface that is monitored by the optical time-of-flight sensor (39) to monitor the delivery movement of the plunger rod (11); FIG. 13 refers to an electronic module (27) or autoinjector (1) of a sixth embodiment.

[0177] An eighth aspect of the present invention is a method for producing a composition comprising the steps of: the detection unit comprises a directional microphone (39), in particular a Microelectromechanical System (MEMS) microphone, configured to detect a signal sound generated by at least one component of the autoinjector (1), in particular a drive chassis (10) of the autoinjector (1), during the administration process; 1 refers to a third embodiment of an electronic module (27) or autoinjector (1).

[0178] A ninth aspect of the present invention is a method for producing a composition comprising the steps of: the drive chassis (10) comprises at least one acoustically active section (25), in particular a clicker protrusion, which generates an acoustic signal upon movement of the drive chassis (10) in the proximal direction, whereby a directional microphone (39) can monitor the movement of the plunger rod (11) via the generated acoustic signal; 1 refers to an electronic module (27) or autoinjector (1) of an eighth embodiment.

[0179] A tenth aspect of the present invention is a method for producing a composition comprising the steps of: the detection unit comprises at least one frangible circuit element (43) configured to be destroyed when at least one component of the autoinjector (1), in particular the drive chassis (10) of the autoinjector (1), reaches a specific position during the administration process, in order to monitor the administration process; 1 refers to a third embodiment of an electronic module (27) or autoinjector (1).

[0180] An eleventh aspect of the present invention is a method for producing a composition comprising the steps of: The notification unit includes an active wireless communicator (35) configured to actively transmit information wirelessly to a user device such as a smartphone (59), The electronic module (27) or autoinjector (1) of any one of the third to tenth aspects.

[0181] A twelfth aspect of the present invention is a method for producing a composition comprising the steps of: Active wireless communication is based on the "cellular" communication technology SigFox, The present invention refers to an electronic module (27) or autoinjector (1) of an eleventh embodiment.

[0182] A thirteenth aspect of the present invention is a method for producing a composition comprising the steps of: Active wireless communication is based on the "cellular" communication technology NB-IoT. The present invention refers to an electronic module (27) or autoinjector (1) of an eleventh embodiment.

[0183] A fourteenth aspect of the present invention is a method for producing a composition comprising the steps of: Active wireless communication is based on Bluetooth The present invention refers to an electronic module (27) or autoinjector (1) of an eleventh embodiment.

[0184] A fifteenth aspect of the present invention is a method for producing a composition comprising the steps of: The notification unit comprises a passive wireless communicator (41) configured to passively transmit information wirelessly to a user device such as a smartphone (59), The electronic module (27) or autoinjector (1) of any one of the third to tenth aspects.

[0185] A sixteenth aspect of the present invention is a method for producing a composition comprising the steps of: Passive wireless communication is based on NFC (Near Field Communication), in particular using an RFID chip (45) and an antenna (47), The present invention refers to an electronic module (27) or autoinjector (1) of a fifteenth embodiment.

[0186] A seventeenth aspect of the present invention is a method for producing a composition comprising the steps of: the notification unit comprises an optical notifier configured to display information directly to a user of the automatic injection device (1); The electronic module (27) or autoinjector (1) of any one of the third to sixteenth aspects.

[0187] An eighteenth aspect of the present invention is a method for producing a composition comprising the steps of: The optical notifier comprises at least one, in particular several, notification LEDs, 17. An electronic module (27) or autoinjector (1) according to a seventeenth embodiment.

[0188] A nineteenth aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) comprising a microcontroller (31) and a power supply (33); a microcontroller (31) configured to receive information relating to the dosing process from the detection unit, to process the received information, and to control the operation of the notification unit to output user feedback based on the processed information; The electronic module (27) or autoinjector (1) of any one of the third to fourteenth, seventeenth and eighteenth aspects.

[0189] A twentieth aspect of the present invention provides a method for producing a composition comprising the steps of: the electronic module (27) is equipped with a wake switch (37), in particular of the mechanical type, a wake switch (37) coupled to the microcontroller (31) and configured to switch an operational state of the microcontroller (31) between an on state and an off state; The electronic module (27) or autoinjector (1) of any one of the third to fourteenth and seventeenth to nineteenth aspects.

[0190] A twenty-first aspect of the present invention is a method for producing a composition comprising the steps of: the wake switch (37) is configured to be operated not by a user of the autoinjector (1) but automatically during use of the autoinjector (1), in particular by either the needle guard (15) or the drive chassis (10) with the plunger rod (11); The present invention refers to an electronic module (27) or autoinjector (1) of a twentieth embodiment.

[0191] A twenty-second aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) provided as an integral component of the autoinjector (1) that is non-detachably coupled to the components of the autoinjector (1); The electronic module (27) or autoinjector (1) of any one of the first to twenty-first aspects.

[0192] A twenty-third aspect of the present invention is a method for producing a composition comprising the steps of: The components of the electronic module (27) are disposed within the housing (3) of the automatic injection device (1). The twenty-second embodiment of the electronic module (27) or autoinjector (1) is shown.

[0193] A twenty-fourth aspect of the present invention is a method for producing a composition comprising the steps of: An electronic module (27) is arranged adjacent to the components of the automatic injection device (1), The electronic module (27) or autoinjector (1) of the twenty-second or twenty-third embodiment.

[0194] A twenty-fifth aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) provided as a separate add-on module configured to be removably coupled to the autoinjector (1); The electronic module (27) or autoinjector (1) of any one of the first to twenty-first aspects.

[0195] A twenty-sixth aspect of the present invention is a method for producing a composition comprising the steps of: the electronic module (27) includes a sealing membrane (51) disposed between the electronic module (27) and the autoinjector (1) when the electronic module (27) is coupled to the autoinjector (1); The twenty-fifth embodiment refers to an electronic module (27) or autoinjector (1).

[0196] A 27th aspect of the present invention is a method for producing a composition comprising the steps of: the sealing membrane (51) is made of a material that is transparent to certain light, in particular IR light, so that an optical time-of-flight sensor (39) can be used to monitor the administration process through the sealing membrane (51); The twenty-sixth embodiment refers to an electronic module (27) or autoinjector (1).

[0197] A 28th aspect of the present invention is a method for producing a composition comprising the steps of: the electronic module (27) includes an attachment switch (49) configured to detect attachment of the electronic module (27) to the autoinjector (1); The electronic module (27) or autoinjector (1) of any one of the twenty-fifth to twenty-seventh aspects.

[0198] A 29th aspect of the present invention is a method for producing a composition comprising the steps of: The autoinjector (1) is provided with an NFC tag (57) containing information about a medication stored within the autoinjector (1), The electronic module (27) or the autoinjector (1) of any one of the preceding twenty-fifth to twenty-eighth aspects.

[0199] A 30th aspect of the present invention is a method for producing a composition comprising the steps of: the electronic module (27) comprises an NFC reader (63) configured to automatically read information stored in the NFC tag (57); The electronic module (27) or the autoinjector (1) of the twenty-ninth aspect having the features of any one of the twenty-fifth to twenty-eighth aspects.

[0200] A thirty-first aspect of the present invention is a method for producing a composition comprising the steps of: At least one component of the autoinjector (1) includes a barcode or QR code (61) containing information about the medication in the autoinjector (1) and configured to be read by a user device, such as a smartphone (59); The electronic module (27) or autoinjector (1) of any one of the first to thirtieth embodiments.

[0201] A 32nd aspect of the present invention is a method for producing a composition comprising the steps of: the electronic module (27) is provided with a mechanical coding feature (65) that only allows attachment of the electronic module (27) to an automatic injection device (1) that is provided with a matching mechanical coding feature; The electronic module (27) or autoinjector (1) of any one of the first to thirty-first aspects having the features of any one of the twenty-fifth to twenty-eight and thirtieth aspects.

[0202] A thirty-third aspect of the present invention provides a method for producing a composition comprising the steps of: an electronic module (27) configured to be disposed at or at the distal end of the autoinjector (1) axially behind the components of the autoinjector (1); The electronic module (27) or the autoinjector (1) of any one of the aforementioned third to twenty-third and twenty-fifth to thirty-second aspects without the further features of the twenty-fourth aspect.

[0203] A thirty-fourth aspect of the present invention is a method for producing a composition comprising the steps of: The autoinjector (1) is a single-use fixed-dose autoinjector; The present invention refers to the electronic module (27) or autoinjector (1) of any one of the first to thirty-third aspects.

[0204] A 35th aspect of the present invention is a method for producing a composition comprising the steps of: The autoinjector (1) is a single-use variable dose autoinjector; The electronic module (27) or autoinjector (1) of any one of the first to thirty-third aspects described above.

[0205] A 36th aspect of the present invention is a method for producing a composition comprising the steps of: The autoinjector (1) is a multi-use fixed dose autoinjector; The electronic module (27) or autoinjector (1) of any one of the first to thirty-third aspects described above.

[0206] A 37th aspect of the present invention is a method for producing a composition comprising the steps of: The autoinjector (1) is a multi-use variable dose autoinjector; The electronic module (27) or autoinjector (1) of any one of the first to thirty-third aspects described above.

[0207] A 38th aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) configured to detect and monitor a dose administration process using the automatic injection device (1) and / or parameters related to the dose administration process based on a movement status of one or more moving parts of the automatic injection device (1) or based on a position of one or more moving parts of the automatic injection device (1); The present invention refers to an electronic module (27) or autoinjector (1) of any one of the first to thirty-seventh aspects.

[0208] A thirty-ninth aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) configured to detect and monitor a dose administration process using the automatic injection device (1) and / or parameters related to the dose administration process based on the movement status and based on the position of one or more moving parts of the automatic injection device (1); The electronic module (27) or autoinjector (1) of any one of the first to thirty-seventh aspects described above.

[0209] A 40th aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) configured to detect and monitor a dose administration process using the automatic injection device (1) and / or parameters related to the dose administration process based on the movement status and the position of one single moving part of the automatic injection device (1), in particular the drive chassis (10); The present invention refers to a thirty-ninth embodiment of an electronic module (27) or an automatic injection device (1).

[0210] A forty-first aspect of the present invention is a method for producing a composition comprising the steps of: the microcontroller waits a specified period of time after no further change in any one of the monitored parameters is determined before finally determining an end to the dose administration process; The electronic module (27) or autoinjector (1) of any one of the first to fortieth aspects.

[0211] A forty-second aspect of the present invention is a method for producing a composition comprising the steps of: The particular time period is 1 second, 2 seconds, 3 seconds, 5 seconds, or 10 seconds; The present invention refers to a forty-first embodiment of an electronic module (27) or an automatic injection device (1).

[0212] A forty-third aspect of the present invention provides a method for producing a composition comprising the steps of: the outer contour of the autoinjector (1) together with the electronic module (27) are flush when viewed along the longitudinal axis of the autoinjector (1); The electronic module (27) or autoinjector (1) of any one of the first to forty-second embodiments.

[0213] A forty-fourth aspect of the present invention is a method for producing a composition comprising the steps of: an electronic module (27) configured to monitor the movement of a portion of the drive chassis (10) during the dosing process; The electronic module (27) or autoinjector (1) of any one of the first to forty-third aspects.

[0214] Explanation of symbols 1 Automatic injection device 3. Housing 3a Outer body 3b Inner body 5 Cartridges / Syringes 7 Plunger 9 Drivers 10 Drive Chassis 11 Plunger rod 11a Reflective surface 12 Optical Pattern 13 Drive spring 15 Needle Guard 16 Needle guard spring 17 Cap 19 Needle Shield 21 Needle Assembly 22 Needle 23 Locking Elements 25 Elastic Features / Acoustically Active Sections 26 End of dose click protrusion 27 Electronic Module 28 PCBA 29 Photoreflector sensor 31 Microcontrollers 33 Power supply 35 Active Wireless Communicator 37 Wake Switch 39 Time-of-Flight Sensor / Directional Microphone 41 NFC connection system 43 Fragile Circuit Elements 45 RFID chips 47 Antenna 49 Attachment Switch 51 Sealing materials 53 Clip Feature 55 Protrusion 57 NFC Tags 59 Smartphone 61 Barcode / QR Code 63 NFC Reader 65 Mechanical Coding Features 67 Windows

Claims

1. An electronic module (27) connectable to an automatic injection device (1), or an automatic injection device (1) equipped with such an electronic module (27), wherein the electronic module (27) is configured to detect and monitor a dose administration process using the automatic injection device (1) and / or parameters related to the dose administration process, and to provide feedback to a user of the automatic injection device (1) regarding the performed dose administration process and / or parameters related to the dose administration process.

2. the electronic module (27) comprises a photoreflector sensor (29) configured to monitor the movement of at least one component of the autoinjector (1), in particular the drive chassis (10) of the autoinjector (1), during the administration process; In particular, the drive chassis (10) comprises at least one optical pattern (12) that is monitored by the photoreflector sensor (29) for monitoring the delivery movement of the plunger rod (11).

2. An electronic module (27) or an autoinjector (1) according to claim 1.

3. the electronic module (27) comprises a time-of-flight sensor (39) configured to monitor the movement of at least one component of the autoinjector (1), in particular a plunger rod (11) of the autoinjector (1), during the administration process, optionally the plunger rod (11) being part of a drive chassis (10); In particular, the time-of-flight sensor (39) is an optical time-of-flight sensor, and the plunger rod (11) comprises a reflective surface that is monitored by the optical time-of-flight sensor (39) for monitoring the delivery movement of the plunger rod (11). An electronic module (27) or an autoinjector (1) according to claim 1 or 2.

4. the electronic module (27) comprises a directional microphone (39), in particular a microelectromechanical system (MEMS) microphone, configured to detect a signal sound generated by at least one component of the autoinjector (1), in particular a drive chassis (10) of the autoinjector (1), during the administration process, In particular, the drive chassis (10) comprises at least one acoustically active section (25), in particular a clicker protrusion, which generates an acoustic signal upon movement of the drive chassis (10) in a proximal direction, whereby the directional microphone (39) can monitor the movement of the plunger rod (11) via the generated acoustic signal. An electronic module (27) or an autoinjector (1) according to claim 1 or 2.

5. said electronic module (27) comprises at least one frangible circuit element (43) adapted to be destroyed when at least one component of said autoinjector (1), in particular a drive chassis (10) of said autoinjector (1), reaches a certain position during said administration process, in order to monitor said administration process; An electronic module (27) or an autoinjector (1) according to claim 1 or 2.

6. the electronic module (27) comprises an active wireless communicator (35) configured to actively transmit information wirelessly to a user device, such as a smartphone (59); In particular, the active wireless communication is based on the "cellular" communication technology SigFox, on the "cellular" communication technology NB-IoT or on Bluetooth, An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 5.

7. the electronic module (27) comprising a passive wireless communicator (41) configured to passively transmit information wirelessly to a user device such as a smartphone (59); In particular, passive wireless communication is based on NFC (Near Field Communication), in particular using an RFID chip (45) and an antenna (47), An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 6.

8. the electronic module (27) comprises an optical notifier configured to display information directly to a user of the autoinjector (1); In particular, the optical notifier comprises at least one, in particular several, notification LEDs; An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 7.

9. said electronic module (27) comprising a microcontroller (31) and a power supply (33); the microcontroller (31) is configured to receive information about the dosing process, process the received information, and control an output of user feedback based on the processed information. An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 8.

10. said electronic module (27) comprises a wake switch (37), in particular of the mechanical type, the wake switch (37) is coupled to the microcontroller (31) and configured to switch an operational state of the microcontroller (31) between an on state and an off state; In particular, the wake switch (37) is configured not to be operated by a user of the autoinjector (1), but automatically during use of the autoinjector (1), in particular by either a needle guard (15) or a drive chassis (10) comprising a plunger rod (11). An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 9.

11. the electronic module (27) is provided as an integral component of the autoinjector (1) non-detachably connected to a component of the autoinjector (1); In particular, the components of the electronic module (27) are arranged within a housing (3) of the automatic injection device (1), Preferably, the electronic module (27) is arranged next to the components of the automatic injection device (1) or behind them at the distal end of the housing 3. An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 10.

12. the electronic module (27) being provided as a separate add-on module adapted to be removably coupled to the autoinjector (1); In particular, the electronic module (27) comprises a sealing membrane (51) arranged between the electronic module (27) and the autoinjector (1) when the electronic module (27) is connected to the autoinjector (1); Preferably, the sealing membrane (51) is made of a material that is transparent to certain light, in particular IR light, so that an optical time-of-flight sensor (39) can be used to monitor the administration process through the sealing membrane (51). An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 10.

13. the electronic module (27) comprising an attachment switch (49) configured to detect attachment of the electronic module (27) to the automatic injection device (1); In particular, the autoinjector (1) is provided with an NFC tag (57) containing information about a medication stored in the autoinjector (1), Preferably, said electronic module (27) comprises an NFC reader (63) configured to automatically read the information stored in said NFC tag (57), and / or At least one component of the autoinjector (1) comprises a barcode or QR code (61) containing information about the medication in the autoinjector (1) and configured to be read by a user device such as a smartphone (59); and / or the electronic module (27) is provided with a mechanical coding feature (65) that allows the attachment of the electronic module (27) only to an automatic injection device (1) that is provided with a matching mechanical coding feature; An electronic module (27) or an autoinjector (1) according to claim 12.

14. said autoinjector (1) is preferably a single-use fixed-dose autoinjector or one of a single-use variable-dose autoinjector, a multiple-use fixed-dose autoinjector and a multiple-use variable-dose autoinjector; An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 13.

15. the electronic module (27) is configured to detect and monitor the dose administration process using the automatic injection device (1) and / or parameters related to the dose administration process based on at least one of the movement status of one or more moving parts of the automatic injection device (1) and the position of one or more moving parts of the automatic injection device (1), preferably based on both, in particular, said electronic module (27) is adapted to detect and monitor the dose administration process using said automatic injection device (1) and / or parameters related to said dose administration process based on movement and / or position information of one single moving part of said automatic injection device (1), in particular a drive chassis (10) of said automatic injection device (1), An electronic module (27) or an autoinjector (1) according to any one of claims 1 to 14.

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