CN118984722A

CN118984722A - Electronic modules and auto-injectors

Info

Publication number: CN118984722A
Application number: CN202380033308.3A
Authority: CN
Inventors: D·卡特莫尔; A·奥黑尔; M·琼斯; W·马什
Original assignee: Medmis Switzerland Ag
Current assignee: Medmis Switzerland Ag
Priority date: 2022-04-14
Filing date: 2023-03-21
Publication date: 2024-11-19
Also published as: EP4456956A1; KR20250006020A; WO2023198412A1; IL315773A

Abstract

An electronic module (27) is integrated with or connectable to an autoinjector (1), wherein the electronic module (27) is configured to detect and monitor a dosage administration process or parameters related thereto using the autoinjector (1), and to provide feedback to a user of the autoinjector (1) regarding the dosage administration process being performed or parameters related thereto.

Description

Electronic module and automatic injector

Technical Field

The present invention relates to an electronic module connectable to an automatic injector, and to an automatic injector for medication administration using such an electronic module.

Background

Autoinjectors are well known and are widely used by patients for self-administered drug injections. However, it has been found that there is a need for a highly functional and reliable supervision of the drug administration process. Such supervision may be relevant not only to the patient himself, but also in particular to reliably monitoring the injection behaviour of the test subject during the clinical test.

It is therefore an object of the present invention to provide an electronic module and an auto-injector having such a supervision configuration, which electronic module is configured to utilize the auto-injector to provide a highly functional and reliable medication supervision of a medication administration process.

Disclosure of Invention

This object is solved by the subject matter of independent claim 1. Preferred developments of this configuration are given in the dependent claims.

The electronic module according to the invention is configured to detect and monitor a dosing process and/or parameters related thereto with an automatic injector and to provide feedback to a user of the automatic injector regarding the performed dosing process and/or parameters related thereto. The electronic module is either non-releasably integrated with the auto-injector or connectable to a corresponding auto-injector for self-administered drug injection.

Detection and monitoring of the dosing process and/or at least the parameters related thereto allows for a very functional and reliable supervision of the drug administration process. Providing feedback to the user may include feedback information related to completion and/or success of the administration process. This information may be provided directly to the user during the administration process to guide the user and/or provided to the user immediately after the end of the administration process to inform the user that the administration process was successful. Furthermore, the feedback information may be provided in the form of a signal that is forwarded to the user's portable device and/or to a server for storing the information for later evaluation. Thus, the electronic module allows for a high degree of flexibility and reliability in supervising the medication administration process and thus the administration process with an automatic injector.

Preferably, the automatic injector includes a housing, a cartridge or syringe filled with a medicament to be dispensed and positioned within the housing, a plunger positioned within the cartridge or syringe, and a driver positioned within the housing and coupled to the plunger. The driver comprises a drive chassis with a plunger rod and a locking drive spring, wherein the locking drive spring acts between the housing and the drive chassis and thus between the housing and the plunger rod for generating the force required to move the plunger to dispense the medicament. In addition, the auto-injector includes a needle guard disposed for axial movement within the housing and configured to release a locked drive spring of the driver upon axial movement of the needle guard to dispense the medicament.

The above-described structural configuration for an automatic injector is very simple and therefore inexpensive, while still being highly reliable and safe in use.

Preferably, the electronic module comprises a detection unit and a notification unit. The detection unit is configured to monitor (i.e. supervise) one or more moving parts of the auto-injector and to generate information about the administration process of the auto-injector and/or parameters related thereto based on the operational state of at least one component of the auto-injector. The notification unit is configured to generate and output a notification signal comprising or indicative of the generated information about the administration process and/or parameters related thereto.

This construction has been found to be very advantageous for implementing supervision or detection and notification, respectively, in an electronic module.

It is further preferred that the detection unit comprises a light reflector sensor configured to monitor the movement of at least one component of the auto-injector, in particular the movement of the drive chassis of the auto-injector, during the application process.

Light reflector sensors depict a very reliable and inexpensive option for implementing detection functions.

In this configuration, the drive chassis preferably includes at least one optical pattern that is monitored by the light reflector sensor for monitoring the dispensing movement of the plunger rod.

Such motion detection is found to be very reliable and inexpensive to implement.

Alternatively, the detection unit preferably comprises a time-of-flight sensor configured to monitor the movement of at least one component of the auto-injector, in particular the movement of a plunger rod of the auto-injector during the administration process, optionally wherein the plunger rod is part of a drive chassis of the auto-injector.

This construction is also a very cost-effective but highly reliable option for implementing the detection function.

In this 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 for monitoring the dispensing movement of the plunger rod.

This particular implementation was found to be of particular reliability and low cost.

Further alternatively, the detection unit comprises a directional microphone, in particular a microelectromechanical system microphone, configured to detect signal sounds generated by at least one component of the auto-injector, in particular a drive chassis of the auto-injector, during the application process.

This configuration is yet another very cost-effective but highly reliable option for implementing the detection function.

In this configuration, the drive chassis preferably comprises at least one acoustically active section, in particular a click protrusion, which generates an acoustic signal when the drive chassis is moved in the proximal direction, such that the directional microphone can monitor the movement of the plunger rod via the generated acoustic signal.

This particular implementation was found to be particularly cost effective.

Further alternatively, the detection unit preferably comprises at least one frangible circuit element configured to be broken when at least one component of the auto-injector, in particular the drive chassis of the auto-injector, reaches a specific position during the administration process, to monitor the administration process.

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

Providing a wireless communication notification unit allows for a highly flexible and connected construction to be implemented.

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

Such communication techniques are found to be particularly suitable for implementing active wireless communication of electronic modules. In particular, such "cellular" communication techniques allow the electronic module to transmit data directly to a remote server without the need for local intermediary devices to relay the information.

Alternatively, the active wireless communication may be based on a "cellular" communication technology NB-IoT.

This communication technology depicts a suitable alternative to "cellular" communication technology and is therefore also found to be particularly suitable for implementing active wireless communication of electronic modules. However, other "cellular" communication technologies may also be used in the electronic module.

Further alternatively, the active wireless communication may be based on bluetooth.

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

As an alternative to the active wireless communication device described above, the notification unit may comprise a passive wireless communication device configured to passively wirelessly transmit information to a user device, such as a smart phone or the like.

Such passive wireless communication devices have in principle the advantage over active wireless communication devices that they do not require a separate power supply to operate. This allows to reduce the size and the cost of the electronic module.

In this configuration, the passive wireless communication is preferably based on NFC (near field communication), in particular with an RFID chip and an antenna.

This particular implementation of passive wireless communication means has been found to be a highly robust and reliable option for implementing passive wireless communication in electronic modules.

Preferably, the notification unit comprises an optical notifier configured to display information directly to a user of the automatic injector.

Such an optical notifier allows to provide feedback directly to the user of the auto-injector without any further electronic means. Such direct optical feedback may be given not only after the administration process is completed, but also during the administration process to guide the user.

In this configuration, the optical notifier may comprise at least one, in particular several notification LEDs.

Notification LEDs have been found to be a very inexpensive and suitable option for implementing optical notifiers.

In constructions with active wireless communication devices and/or optical annunciators, the electronic module preferably includes a microcontroller and a battery. The microcontroller is configured to receive information about the application process from the detection unit, process the received information, and control operation of the notification unit to output user feedback based on the processed information.

This construction is considered very reliable, but is still simple and therefore inexpensive to implement.

Further preferably, the electronic module preferably comprises a wake-up switch, in particular a mechanical wake-up switch. The wake-up switch is coupled to the microcontroller and is configured to switch an operational state of the microcontroller between an ON (ON) state and an OFF (OFF) state.

This wake-up switch arrangement allows for an increased operational lifetime of the electronic module, since the electronic components of the electronic module are turned off as long as the electronic module or the auto-injector, respectively, is not in use. Thus, the consumption of the power supplied during non-use of the auto-injector and electronics is minimized.

In this configuration, the wake-up switch is preferably configured not to be operated by the user of the auto-injector, but to be operated automatically during use of the auto-injector, in particular either by the needle guard or by the drive chassis with the plunger rod.

Such an embodiment allows on the one hand to reliably prevent accidental actuation of the components of the electronic module and thus to prevent accidental exhaustion of the power supply. On the other hand, it is ensured that the user does not miss activating the electronic module in time to check the application process.

Preferably, the electronic module is provided as an integral part of the auto-injector, which is non-releasably coupled to other parts of the auto-injector.

This embodiment results in a very reliable supervision of the administration process without the need to manipulate the automatic injector and the electronic module as two separate but interacting devices. Thus, the handling is greatly simplified.

In this configuration, the components of the electronics module are preferably positioned within the housing of the auto-injector.

This allows a very compact and robust overall construction to be implemented.

In particular, the electronic module is positioned side by side with the components of the auto-injector.

This configuration allows preventing an increase in the length of the automatic injector compared to an automatic injector not provided with an electronic module.

Alternatively, the electronic module may be provided as a separate add-on module configured to be releasably coupled to the auto-injector.

Thus, it would be possible to use a single electronic module with various auto-injectors, one after the other, without the need to dispose of the electronic module. This allows not only a very environmentally friendly but also a relatively inexpensive supervision of various administration procedures with various automatic injectors.

In this configuration, the electronic module preferably includes a sealing membrane positioned between the electronic module and the automatic injector in a state in which the electronic module is coupled to the automatic injector.

Such a sealing membrane allows to prevent intrusion of dust or water from the environment of the auto-injector into the connection between the electronic module and the auto-injector and thus to prevent possible problems associated with such contamination.

In particular, the sealing film is made of a material that is transparent to specific light, in particular IR light, so that the optical time-of-flight sensor can be used to monitor the application process through the sealing film.

It has been found that the use of such an optical time of flight with an add-on the electronic module will depict a very reliable and cost-effective implementation, while the transparent sealing film ensures the operability of the electronic module.

Preferably, such an additional electronic module comprises an attachment switch configured to detect attachment of the electronic module to the auto-injector.

The electronic module is thus configured to automatically detect the connection with the respective automatic injector, which substantially simplifies the handling.

In particular, an auto-injector provided for use with such an additional electronic module is provided with an NFC tag containing information about the medicament stored within the auto-injector.

Such an embodiment allows for automatic readout of information about the medicament stored in the automatic injector and thus allows for an increased functionality of the electronic module.

In this case, the electronic module preferably comprises an NFC reader configured to automatically read the information stored within the NFC tag.

Thus, information about the medicament stored in the automatic injector may be automatically read by the electronic module.

Preferably, at least one component of the auto-injector includes a bar code or QR code containing information about the medication within the auto-injector and configured to be read by a user device (e.g., a smartphone).

Such a bar code or QR code is a very simple but efficient way of providing information about the auto-injector to the user device.

Preferably, the additional electronic module comprises a mechanical coding feature that allows only the electronic module to be attached to an automatic injector provided with a matching mechanical coding feature.

Thus, dedicating an electronic module to a specific auto-injector is implemented in a very cost-effective but reliable manner.

Preferably, the electronic module is configured to be positioned or located at the distal end of the auto-injector axially behind other components of the auto-injector.

Thus, the electronics module does not increase the width of the auto-injector. Thus, the handling of the auto-injector is less affected by the setting of the electronic module.

Preferably, the auto-injector is a single use fixed dose auto-injector.

Such an automatic injector is very simple in construction and therefore very inexpensive.

Alternatively, the auto-injector is a single use variable dose auto-injector.

Such auto-injectors are more flexible in use than fixed dose auto-injectors.

Further alternatively, the auto-injector is a multi-use fixed dose auto-injector.

Such auto-injectors are very simple in construction, but are more environmentally friendly with a multiple use configuration than single use auto-injectors.

Finally, the auto-injector may be a multi-use variable dose auto-injector.

This embodiment provides maximum flexibility and environmental friendliness.

Preferably, the electronic module is configured to detect and monitor a dose administration procedure with the auto-injector or a parameter related thereto based on a state of motion of one or more moving parts of the auto-injector or based on a position of one or more moving parts of the auto-injector.

Such an embodiment was found to produce very reliable results for supervision of the administration process.

Alternatively, the electronic module is configured to detect and monitor a dose administration process utilizing the auto-injector or parameters related thereto based on both the motion state and the position of one or more moving parts of the auto-injector.

The combined movement and position detection yields the most reliable results for supervising the administration process.

In this configuration, the electronics module is preferably configured to detect and monitor the dosing process with the auto-injector or parameters related thereto based on the movement status and position of a single moving part of the auto-injector, in particular the drive chassis with the plunger rod.

The monitoring of the individual moving parts is relatively simple and therefore inexpensive, while also allowing a reliable supervision of the application process. The drive chassis with the plunger rod is a component identified as depicting the best option for a single part such as an auto-injector, as its movement is directly related to the administration process.

Preferably, the electronic module is configured to wait a certain period of time after determining that any one of the monitored parameters has not changed any further, and then finally to determine the end of the dosing process.

This time delay was found to be a simple option for ensuring that the application process was completed.

In particular, the specific period of time is 1, 2, 3, 5 or 10 seconds.

It has been found that said values for a specific period of time are particularly suitable.

Preferably, wherein the outer contour of the auto-injector is flush with the electronics module along the longitudinal axis of the auto-injector.

It has been found that such a flush outer contour will result in improved handling of the entire system.

Drawings

Exemplary embodiments and functions of the present invention are described below with reference to the attached drawing figures, in which:

FIG. 1 shows a cross-sectional view of an autoinjector having a basic injection configuration of an exemplary single-use fixed dose autoinjector for use with the electronic module of the present invention;

FIG. 2A shows a cross-sectional view of the auto-injector of FIG. 1 as delivered to a user;

FIG. 2B shows a cross-sectional view of the auto-injector of FIG. 1 immediately prior to drug delivery;

FIG. 2C shows a cross-sectional view of the auto-injector of FIG. 1 after completion of the administration process;

Fig. 3 shows a cross-sectional view of a first exemplary embodiment of an automatic injector with an electronic module according to the present invention;

FIG. 4 shows an enlarged and turned cross-sectional view of the auto-injector of FIG. 3;

Fig. 5A shows more detail of the auto-injector of fig. 3 and 4 prior to dispensing of a medicament;

fig. 5B shows more detail of the auto-injector of fig. 3 and 4 during dispensing of a medicament;

fig. 6 shows a schematic diagram depicting the function of the wake-up switch of the auto-injector of fig. 3-5B;

Fig. 7 shows a cross-sectional view of a second exemplary embodiment of an auto-injector with an electronic module according to the present invention;

FIG. 8 shows an enlarged and turned cross-sectional view of the auto-injector of FIG. 7;

Fig. 9 shows a cross-sectional view of a third exemplary embodiment of an auto-injector with an electronic module according to the present invention;

FIG. 10A illustrates a cross-sectional view of another exemplary embodiment of an automatic injector according to the present invention configured to be coupled to an additional electronics module;

FIG. 10B illustrates a cross-sectional view of the auto-injector of FIG. 10A coupled with an exemplary additional electronic module in accordance with the present invention;

FIG. 11 shows an enlarged and turned view of the electronic module of FIG. 10B;

FIG. 12 symbolically illustrates two exemplary wireless drug identification configurations according to the present invention;

FIG. 13 symbolically illustrates another exemplary wireless drug identification configuration in accordance with the present invention; and

Fig. 14 illustrates an exemplary embodiment of a mechanical medication identification configuration.

Detailed Description

In the present disclosure, the term "distal portion/end" refers to such portion/end of the device, or such portion/end of a component or member thereof: i.e. depending on the purpose of the device, it is located furthest from the delivery/injection site of the patient. Accordingly, the term "proximal portion/end" refers to such portion/end of the device, or such portion/end of a component thereof: i.e. it is located closest to the delivery/injection site of the patient, depending on the use of the device.

The present disclosure of administration process supervision is applicable to many auto-injectors. One possible auto-injector is a pen-designed auto-injector having a basic injection configuration as shown in fig. 1.

Fig. 1 shows an exemplary embodiment of an automatic injector 1, which automatic injector 1 is configured to be supplemented by an electronic module 27 according to the present invention or to be used with an electronic module 27.

The automatic injector 1 comprises a housing 3 formed by an outer body 3a and an inner body 3 b. A cartridge or syringe 5 filled with the drug to be administered is positioned within the housing 3. A plunger 7 for dispensing medicament from the cartridge or syringe 5 is positioned within the cartridge or syringe 5. Further, a driver 9 is positioned within the housing 3 and coupled to the plunger 7. The driver 9 comprises a drive chassis 10 with a plunger rod 11 and a locking drive spring 13, the drive spring 13 acting between the housing 3 and the drive chassis 10 with the plunger rod 11 for generating the force required to move the plunger 7 through the cartridge or syringe 5 for dispensing the medicament. Furthermore, the shown auto-injector 1 comprises a needle guard 15, which needle guard 15 is movable in distal direction from the proximal end of the auto-injector 1 into the housing 3 against the force of a needle guard spring 16. The needle guard 15 is coupled to the drive chassis 10 in such a way that distal movement of the needle guard 15 releases the locked drive spring 13 resulting in proximal movement of the plunger rod 11 and thus dispensing movement of the plunger 7 along the cartridge or syringe 5.

For safety purposes, the auto-injector 1 further comprises a cap 17, which cap 17 has a rigid needle shield 19 connected to the proximal end of the auto-injector 1. The cap 17 not only protects the needle 22, but also prevents distal movement of the needle guard 15.

Hereinafter, the basic functions of the illustrated automatic injector 1 will be described with reference to fig. 2A to 2C.

As shown in fig. 2A, in the delivery state of the auto-injector 1, the cap 17 is positioned on the proximal end of the auto-injector 1. The rigid needle shield 19 of the cap 17 encloses 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, wherein the drive spring is loaded and locked via the locking element 23 engaged with the housing 3. Thus, the automatic injector 1 is in a pre-filled and pre-loaded state.

For drug administration, the cap 17 is removed from the proximal end of the auto-injector 1 along with the needle shield 19. The automatic injector 1 is then pressed at its proximal end against an injection site (not shown) with a needle guard 15. This results in distal movement of the needle guard 15 relative to the housing 3 while the needle 22 of the needle assembly 21 penetrates the injection site. Near the distal position of the needle guard 15, the needle guard 15 disengages the locking element 23 of the drive chassis 10 from the housing 3 and thus releases the drive spring 13. This situation is illustrated exactly in fig. 2B.

The released drive spring 13 pushes the drive chassis 10 with the plunger rod 11 in the proximal direction, which results in a corresponding movement of the plunger 7 and thus in the dispensing of medicament from the cartridge or syringe 5 through the needle 22 into the injection site. After this dispensing, the automatic injector 1 is removed from the injection site. This causes the needle guard spring 16 to push the needle guard 15 in a proximal direction such that the needle guard 15 encloses the needle 22. In this extended state, the acoustically active section 25 of the drive chassis 10 engages with the end of the dose click projection 26 of the housing 3, thereby generating an end-of-dose click and locking the movement of the components of the driver 9 relative to the housing 3. Furthermore, the locking element 23 of the drive chassis 10 engages with the needle guard 15, preventing further distal movement of the needle guard 15 relative to the housing. This final locked state is illustrated in fig. 2C.

In this respect, it should be noted that the drive chassis 10 is arranged to be linearly movable within the housing 3. The drive chassis 10 comprises a dispensing branch and a trigger branch forming a plunger rod 11, within which a drive spring 13 is arranged. The plunger rod 11 is arranged at the proximal end of the dispensing branch and the locking element 23 is arranged to extend proximally from the trigger branch. The trigger branch and the dispensing branch are arranged parallel to each other, at least substantially parallel to each other, and are connected to each other at respective distal ends of the dispensing branch and the trigger branch, respectively, preferably integrally formed as one piece. This shape of the drive chassis 10 enables a particularly compact design of the autoinjector 1.

Hereinafter, a first exemplary embodiment of an automatic injector with an integrated electronic module according to the present invention will be described with reference to fig. 3 to 6.

The basic injection configuration of the autoinjector 1 illustrated here is in principle identical to the configuration of one of the autoinjectors 1 described with reference to fig. 1 to 2C.

The above-described autoinjector 1 is only supplemented with an exemplary electronic module 27 according to the present invention. The electronic module 27 is positioned alongside the above-mentioned components of the automatic injector 1 within the housing 3, in particular within the outer body 3a of the housing 3.

The electronic module 27 comprises a Printed Circuit Board Arrangement (PCBA) 28, which printed circuit board arrangement 28 comprises a detection unit with a light reflector sensor 29 and a microcontroller 31, and a power supply 33 in the form of a battery, in particular a standard AAA size battery, preferably an alkaline battery or LiMnO ₂ battery. The microcontroller 31 is coupled to an active wireless communication device 35 in the form of an NB-IoT module of the notification unit of the electronic module 27. Furthermore, a wake-up switch 37 (described in more detail later) is provided in the proximal end of the housing 3 and is coupled to the microcontroller 31. Finally, an optical notifier (not shown) in the form of a notification LED is also connected to the microcontroller 31. The drive chassis 10 is provided with, in particular printed with, an optical pattern 12 in the form of a printed encoded track with sections having different reflectivities. This is illustrated in fig. 5A and 5B, where fig. 5A shows the relative positioning between the optical pattern 12 and the light reflector sensor 29 immediately before releasing the drive spring 13, and fig. 5B shows the relative positioning between the optical pattern 12 and the light reflector sensor 29 at a specific point in time during the dispensing movement of the drive chassis 10 with plunger rod 11.

The light reflector sensor 29 is positioned such that during a dispensing movement of the drive chassis 10 with the plunger 11 in the proximal direction, the area of the drive chassis 10 with the optical pattern 12 passes the light reflector sensor 29. Thus, the light reflector sensor 29 is configured to monitor the dispensing movement of the plunger rod 11 relative to the housing 3. For this purpose, the light reflector sensor 29 is immovably coupled to the housing 3. The microcontroller 31 is configured to receive luminance information corresponding to changes in the motion of the drive chassis 10 relative to the photo reflector 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 within the housing 2 and the current state of motion of the drive chassis 10 with the plunger rod 11 for evaluating the current state of the administration process. However, if desired, the microcontroller 31 may also 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 state of motion of the drive chassis 10 with the plunger rod 11 for evaluating the current state of the administration process. The microcontroller 31 is also configured to control the operation of the various notification units of the electronic module 27, here in particular the NB-IoT module 35 and the notification LEDs, to output user feedback based on the processed information.

In particular, the notification LED is illuminated and turned off in a particular pattern to notify the user of the automatic injector 1 of the status of the administration process. At the same time, NB-IoT module 35 wirelessly transmits electronic information about the application process to an external server where the information is stored.

To extend the useful life of the electronics module 27, the microcontroller 31 is configured to be in an inactive sleep state until the wake-up switch 37 is activated. For this purpose, the wake-up switch 37 is positioned in such a way that it is activated by the distal movement of the needle guard 15 just before the release of the drive spring 13, as shown in fig. 4. The wake-up switch 37 is a mechanical wake-up switch 37, because such a mechanical switch has a minimum energy consumption compared to an accelerometer or similar component.

The microcontroller 31 is not only configured to notice the activation of the wake-up switch 37, but also to notice the deactivation of the wake-up switch 37 upon a proximal movement of the needle protection device 15 and a release of the wake-up switch 37 associated therewith. In particular, the microcontroller 31 is configured to determine the period during which the wake-up switch 37 is activated and to compare this period with an expected predetermined period of time required for a complete administration procedure. Thus, the microcontroller 31 is configured to detect and monitor the dosing 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.

For example, as shown in fig. 6, the complete administration process will require at least a specific predetermined injection time and a further dwell time from full activation of the wake-up switch 37 (see schematic above). If the wake-up switch 37 is deactivated by removing the auto-injector 1 from the injection site and thus by a proximal movement of the needle guard 15 before the expiration of the predetermined period of time, the microcontroller 31 determines that the administration process is not complete, even though the drive chassis 10 with the plunger rod 11 has completed its entire dispensing movement.

In other words, using the needle guard 15 to actuate the wake-up switch 37 provides the benefit of being able to detect premature removal of the automatic injector 1 from the injection site before dose delivery has been completed.

In other words, during normal operation, the wake-up switch 37 is actuated before the movement of the plunger rod 11 starts, and the wake-up switch 37 is not released until after the movement of the plunger rod 11 has stopped. When the auto-injector 1 is lifted away from the injection site, the needle guard spring 16 will displace the needle guard 15 proximally into its extended position. The wake-up switch 37 will register a change of state, as the needle protection device 15 will no longer interfere with the wake-up switch 37. Thus, if the movement of the plunger rod 11 continues after the wake-up switch 37 is released, this indicates a premature removal of the automatic injector 1. In this case, the event may be recorded as an error within the microcontroller 31 to be transmitted together with the dispensing time and the medication information. This information may then be used to mitigate future premature removal through user training or other intervention.

This function is particularly relevant when the microcontroller 31 is provided with further information about the auto-injector 1, such as the two time periods described above. In the present configuration, in which the electronic module 27 is integrated into the automatic injector 1, this information, as well as other information such as the particular medication within the cartridge or syringe 5, may be stored directly in a memory connected to the microcontroller 27.

As indicated above, complete administration of the drug may require a specific residence time. Thus, if for example an optical notifier LED is used to guide the user through the application process, the microcontroller 31 of the electronic module 27 may wait a certain period of time after the monitored component, here the drive chassis 10 with the plunger rod 11, is no longer moving, and accordingly after the monitored parameter is no longer changing, and then instruct the end of the dispensing process. It has been found that a suitable period of time is between 1 and 10 seconds, depending on the drug used and the structural configuration of the auto-injector 1 itself.

In principle, there are various aspects of the dosing process that can be detected and monitored by the electronic module 27. In particular, the start of dose dispensing and the successful completion of dose dispensing may be determined. Furthermore, the electronic module 27 may be configured to determine the termination of the dispensing process, e.g. to determine that no dispensing movement or no change in the monitored parameter has occurred, but that the dispensing of the dose has ended successfully, for example, within a certain time period, e.g. from 1 to 10 seconds, after the start of the dispensing of the dose has been determined. Furthermore, a specific progress of the application process can be monitored, in this embodiment in particular based on the movement characteristics of the drive chassis 10 with the plunger rod 11 relative to the light reflector sensor 29 and thus relative to the housing 3.

To this end, the light reflector sensor 29 comprises an LED for illumination and a phototransistor for detecting light reflected from the optical pattern 12 on the drive chassis 10. The optical pattern 12 is formed by regions of relatively high reflectivity and relatively low reflectivity positioned within the field of view of the light reflector sensor 29 such that axial movement of the drive chassis 10 with plunger 11 results in a change in the intensity of reflected light as determined by the phototransistor. This signal is transmitted to the microcontroller 31.

Such a sensing system provides a relative measurement of the distance traveled by the drive chassis 10 with the plunger rod 11 and allows the microcontroller 31 to determine that the plunger rod 11 has translated far enough for complete drug delivery. Furthermore, the microcontroller 31 may determine when the movement of the drive chassis 10 with the plunger rod 11 has stopped. At the end of the dispensing, the final axial position of the plunger rod 11 relative to the housing 3 is subject to large tolerance variations, mainly because the end stop is defined by the plunger 7 at the proximal end of the cartridge or syringe 5. Thus, if a mechanical switch is used to detect the end of dispense, the combined tolerance effects of device tolerance plus switch point variation and PCB mounting tolerance mean that such an alternative system would be too inaccurate. By detecting both the axial position of the drive chassis 10 with the plunger rod 11 and whether it has stopped moving allows the microcontroller 31 to more reliably identify the end of a dispensing operation, even with relatively large mechanical and electronic detection mechanism tolerances.

If the end of the dispensing is determined by detecting only the axial position of the drive chassis 10 with the plunger rod 11, the point at which the end of dispensing feedback is triggered must nominally be arranged to occur before the plunger rod 11 stops moving. This ensures that the end of dispense feedback is triggered even when the plunger rod 11 does not reach its nominal axial displacement due to component and system tolerances. By also monitoring the continuous 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 dispensing process can be determined only if the drive chassis 10 with the plunger rod 11 has been advanced far enough and has also stopped moving. This improves the accuracy of the timing of the end of the dispensing process and ensures that it is more closely aligned with the exact moment when the dose delivery is completed.

Here, the optical pattern 12 is a printed pattern on the drive chassis 10, as minimal changes to the original auto-injector mechanism (see fig. 1-2C) are preferred. Functionally, however, the optical pattern 12 may also be formed by molding features/grooves, laser surface markings, separate components, or other similar techniques. In addition, other sensing techniques (such as coded magnets or capacitive sensors) may be employed to provide similar feedback on the motion of the plunger rod 11.

In this embodiment, it is determined that the dose administration process is successfully completed when the drive chassis 10 with the plunger rod 11 has reached a full proximal displacement and has stopped moving. The microcontroller 31 is configured to identify a stall (due to either a mechanism or PFS failure) in which the plunger rod 11 completely stops moving or moves so slowly that it cannot achieve full proximal displacement within a predetermined time period. This will be recorded as an error event.

After allocation is complete, the system attempts to transmit data to a remote system ("cloud") using NB-IoT or similar network. Optionally, the data transfer may not start until the wake-up switch 37 has also been released, which indicates that the needle protection device 15 has been extended when the auto-injector 1 is removed from the injection site. The data transmitted may include variables related to the dose administration process such as time since waking, time since completing self-dispensing, time since error status and displacement of the drive chassis 10 with plunger rod 11, device status flags such as stall detected, premature removal, low battery, etc., and specific information of the medicament such as type, concentration, lot and expiration date along with data available to associate the device with the patient for which it was prescribed.

One or more notification LEDs visible to the user through a cutout, transparent window, or thin area in the housing 3 provide visual feedback to the user during use of the automatic injector 1. In particular, different LED flashing patterns and/or colors may be used to indicate to the user the status of the automatic injector 1. Examples of states are whether the wake-up switch 37 is activated, whether a dispense is in progress, whether a dose has been successfully delivered, whether an error condition has been detected, whether a data transfer is in progress, and whether data has been successfully transferred.

Hereinafter, a second exemplary embodiment of the automatic injector 1 with the corresponding electronic module 27 will be described with reference to fig. 7 and 8.

Here, the electronic module 27 is provided as an integrated module which is arranged in the distal end of the housing 3 behind the other components of the automatic injector 1. The outer body 3a of the housing 3 is increased in length to accommodate the power supply 33 and other electronics mounted in series with the injection mechanism to facilitate the connection feature.

No changes to the core principles and most parts of the injection mechanism of the automatic injector 1 as shown in fig. 1 to 2C are required.

The electronic module 27 in this embodiment basically comprises a PCBA28 with a microcontroller 31, an active wireless communication device 35 in the form of a SigFox module, a time-of-flight sensor 39, a wake-up switch 37, a notification LED (not shown) and a power supply 33.

Because of the reduced space, the power supply 33 is a relatively compact coin cell (high drain CR 2032) that has been specifically developed to meet the requirements of SigFox communications technologies. The present battery unit 33 is mounted using a proprietary coin cell holder. As a result, this integrated option requires relatively minor changes to the overall structure of the automatic injector 1, particularly an increase of about 27mm in length and about 1.6mm in width.

Given the integrated nature of the auto-injector 1, the medication information may be directly encoded into the memory of the microcontroller 31 during manufacture and/or assembly. This avoids the need for the electronic module 27 to have the ability to identify different medicaments assembled into the automatic injector 1 and allows this information to be transmitted when the dose administration process is complete.

Hereinafter, the function of the present automatic injector 1 will be roughly described.

Prior to dispensing, the distal end of plunger rod 11 interacts with wake-up switch 37, maintaining wake-up switch 37 in a depressed state. When the wake-up switch 37 remains depressed, the electronics module 27 remains in a very low power deep sleep state, thereby maximizing the battery life of the auto-injector 1.

When dispensing begins, plunger rod 11 moves proximally, releasing wake-up switch 37. This signal activates the electronic module 27 to bring the microcontroller 31 out of the deep sleep state. To achieve the long storage times required for these types of devices, the wake-up switch 37 is a mechanical detection switch, and in this case is expected to be normally closed (so that when the switch is released, the circuit is completed). Thus, under storage conditions, the circuit remains open, so this does not draw a quiescent current and allows the microcontroller 31 to remain in a very low energy state until dose dispensing begins. 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 shelf life of the auto-injector 1 prior to drug dispensing.

During dose dispensing, the plunger rod 11 continues to translate axially in the proximal direction until the end of dose is reached. Preferably, in addition to simply starting the dose administration process, dose completion is also detected to provide a positive confirmation that the dose was delivered in its entirety successfully. If the dosing process is not completed successfully, for example due to a institutional arrest or another adverse event, this may be identified and feedback may be provided to the user or healthcare professional.

Many different non-contact methods for detecting the end of the application process are possible. In the present embodiment, a time-of-flight sensor 39 is used. The current time-of-flight sensor 39 is an optical time-of-flight sensor 39 that emits pulses of infrared light and detects the time it takes for the pulses to reflect back to the adjacent detector of the sensor 39. The time taken is used to calculate the distance between the sensor 39 and the target.

In this embodiment, the time of flight sensor 39 is positioned to be aimed at the distal reflecting surface 11a of the plunger rod 11. During dispensing, the distance between the time-of-flight sensor 39 and the plunger rod 11 increases until the plunger rod 11 stops moving when the dispensing of the dose is completed. Once the time-of-flight sensor 39 detects that the plunger rod 11 is stationary and that it has translated axially far enough to achieve both full dispensing, the microcontroller 31 records the completion of the dose dispensing process.

The sensing system provides a relative measurement of the distance traveled by the plunger rod 11 and allows the microcontroller 31 to determine when the plunger rod 11 has translated far enough and when the movement of the plunger rod 11 has stopped.

Alternatively, a directional microphone 39, in particular a MEMS (micro-electromechanical system) microphone system activated by releasing the wake-up switch 37, may also be used instead of the time-of-flight sensor 39.

As the plunger rod 11 approaches the end of the dispensing, a characteristic audible click is produced by the interaction of the resilient feature 25 of or on the drive chassis 10 with at least one corresponding feature 26 of the housing 3. Such resilient features 25 serve as acoustically active sections 25 of the drive chassis 10 and are provided in particular in the form of click lugs. It is expected that this will produce a sound of a particular frequency and amplitude that can be distinguished from other background noise via signal processing either by the microcontroller 31 or by a separate dedicated microprocessor.

To improve the robustness of the system, a plurality of different 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 dispensing, the MEMS microphone system may also be used to identify when the needle guard 15 is advanced (if this is accompanied by another discernible sound). This can be used to inform the correct sequence of operation in a manner similar to that described above in which wake-up switch 27 is used for early removal detection. This has the benefit of avoiding the addition of significant tolerances associated with the measurement.

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

The data transmission to the user and/or other devices is in principle the same as described for the first embodiment. The only difference is that SigFox networks are limited in their ability to provide positive acknowledgements that the transmitted information has been successfully received by the remote system, as compared to NB-IoT networks. As a result, sigFox-based electronics module 27 may be configured to repeat the attempt at data transmission a predetermined number of iterations after allocation, or until power supply 33 is exhausted, to maximize the likelihood of successful upload of data.

Hereinafter, another exemplary embodiment of the automatic injector 1 with the electronic module 27 according to the present invention will be described with reference to fig. 9.

This embodiment requires only minor changes to the core mechanism of the automatic injector 1 described with reference to fig. 1 to 2C. Here, detection or monitoring of the drug administration process and notification to the user is achieved by an integrated NFC connection system 41.

In contrast to the "cellular" communication integration system described above, the NFC integration option does not include a power supply 33. For NFC systems utilizing RFID (radio frequency identification) technology, the circuitry integrated into the auto-injector 1 serves as a passive wireless communication device and may not require a built-in power supply 33. When bringing a smart phone with NFC capability into close contact with an integrated NFC auto-injector 1, for example, the magnetic field generated by the smart phone may be used to power a passive NFC tag built into the auto-injector 1.

The illustrated integrated NFC option uses an NFC circuit arranged with a frangible circuit element 43, the frangible circuit element 43 being in particular in the form of a wire loop which is broken by driving the chassis 10 at the end of the dispensing process. Before use, when the smartphone is brought into close contact with the integrated NFC auto-injector 1, the RFID chip 45 is energized via the antenna 47 and acts as a transponder, providing a specific response to the smartphone to indicate that the auto-injector 1 has not been used.

The automatic injector 1 may then be activated by the user to dispense a dose without any modification to the user steps or specific instructions related to the connection system. As the drive chassis 10 with plunger rod 11 advances proximally during the application process, it interacts with the frangible line 43 connected to the RFID chip 45, breaking it when the end of the dispensing process is reached. The disconnection of the wire 43 alters the signal emitted by the RFID chip 45 when activated by the smartphone after use so that it can confirm that the automatic injector 1 has been used.

Preferably, the frangible circuit member 43 is arranged such that it is broken as close as possible to the end of the dispensing stroke of the drive chassis 10 with plunger rod 11. In this way, the change of state indicated by the disconnection of the element 43 can be used to provide a positive confirmation that the dose was delivered fully successfully.

If the administration process is not successfully completed and the drive chassis 10 with plunger rod 11 is not fully translated proximally due to a mechanism stall or other adverse event, the frangible circuit 43 will not be broken and the automatic injector 1 will not report dose completion.

The medication and/or device information may be programmed into a portion of the RFID circuit that is not affected by the opening of the frangible circuit member 43 so that this can be read both before and after use of the auto-injector.

Hereinafter, another exemplary automatic injector 1 having an electronic module 27 according to the present invention will be described with reference to fig. 10A, 10B and 11.

Here, the electronic module 27 is provided as a separate additional module that is releasably coupled to the distal end of the automatic injector 1. This additional configuration provides the opportunity to reuse the electronic module 27 for multiple doses with a plurality of different auto-injectors 1.

Only minor modifications to the housing 3 allow the design of the autoinjector 1 to be used with or without additional connection modules.

The connected electronic module 27 of the present embodiment basically includes a PCBA 28 with a microcontroller 31, a distribution sensor 29 or 39, a wake-up switch 37, an attachment switch 49, a user notification LED (not shown) and a power supply 33. Further, a bluetooth-based active wireless communication architecture is provided. The lower peak current involved in bluetooth transmissions allows for the use of smaller coin cells than the integrated "cellular" option described above. This allows a very compact add-on module 27. Such an electronic module 27 may be accommodated within the width and depth of the existing housing 3 of the embodiment described with reference to fig. 1 to 2C and have a length of approximately 18 mm.

A sealing membrane 51 is provided on the proximal end of the electronic add-on module 27 to prevent ingress of fluids and particles that might affect the function of the add-on module 27. The sealing membrane 51 is flexible so that the wake-up switch 37 and the attachment switch 49 can be operated by deflection of a locally thinned or curled region of the sealing membrane 51. In the case of an optical time-of-flight sensor 39, the sealing film 51 is also made at least in part of a material transparent to light of a specific wavelength, in particular to IR light, so as to permit the correct functioning of the sensor 39.

The bluetooth accessory module 27 may be attached to and detached from the distal end of the modified housing 3 via a detachable clip feature 53. The attachment module 27 detects the assembly with the auto-injector 1 via an attachment switch 49, which attachment switch 49 interacts with a local protrusion 55 on the distal face of the housing 3. When the attachment switch 49 remains released, indicating that the additional module 27 is not fitted to or is incorrectly fitted to the auto-injector 1, the additional module 27 will remain in a very low power state, thereby conserving battery life.

When the attachment switch 49 is pressed, this indicates that the electronic module 27 has been fitted to the auto-injector 1, and the electronic module 27 may be activated and enter a higher power state to check the medication identification, switch operating sequences and conduct a system health check (e.g. confirm battery voltage level). When assembled to the auto-injector 1, the wake-up switch 37 is also pressed via interaction with the distal surface of the plunger rod 11, which is accessible through an opening in the distal end of the housing 3. The height of the local protrusion 55 on the distal face of the housing 3 ensures that when the electronic module 27 is coupled to the auto-injector 1, the attachment switch 49 is pressed before the wake-up switch 37 and the attachment switch 49 is released after the wake-up switch 37 when the electronic module 27 is removed. The sequence of the switch state changes may be used to inform the electronic module 27 that it is properly assembled to the automatic injector 1.

Furthermore, a defined sequence or combination of switch press events and potentially specific timing between two or more switch state change events may be used to provide a means for a user to interact 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 accessible switches in a particular sequence and/or for a particular duration to activate a different module function in the uncoupled state of electronic module 27.

Similar to the wake-up switch 37 described above, in this variant, both the attachment switch 59 and the wake-up switch 37 are desirably of a mechanical type to minimize quiescent current consumption in storage.

Once the electronic module 27 has confirmed attachment to the auto-injector 1, it monitors the state of the wake-up switch 37 to indicate that dispensing has begun. The wake-up switch 37 and the end of dose detection (e.g. the time of flight sensor 39 aimed at the plunger rod 11 or the MEMS microphone and signal processing identifying the end of dose click) are functionally identical to the arrangement described above in relation to the second exemplary embodiment. Therefore, further functions of this embodiment will not be described in detail.

Another key aspect of the connected drug delivery system 1 is the ability to confirm the type and expiration date of the drug to be delivered, thereby providing an opportunity to alert or guide the user before an error is generated. In particular, given the additional electronic module 27, there is a possibility to assemble the electronic module 27 to an automatic injector 1 containing different drugs. For such an additional module 27, three possible solutions to solve this problem are given below with reference to fig. 12 to 14.

As shown in fig. 12, according to the first exemplary configuration, the NFC tag 57 is embedded in a tag on the housing 3 of the auto-injector 1. The NFC tag 57 contains information about the medicament stored within the auto-injector 1. The NFC tag 57 is then read independently by the smartphone 59, in particular before the application process. This data may be stored in the smartphone 59 and then potentially combined with the dose delivery data provided by the add-on module 27 after the drug administration process is completed. Alternatively, a bar code or QR code 61 is printed on the tag to be read by the camera of the smartphone 59. Thus, the user may be informed of specific information about the automatic injector 1 prior to use to guide the subsequent administration process.

Referring to fig. 13, an NFC reader 63 may be incorporated into the add-on electronic module 27 to automatically read the NFC tag 57 of the auto-injector 1, as described above. This avoids the need for an additional user step of independently reading the NFC tag 57 using the smartphone 59 and also more reliably couples the drug information with the dosing process. When the attachment switch 59 is pressed when the add-on module 27 is assembled to the auto-injector 1, the built-in NFC reader 63 is activated to detect drug information. This provides the opportunity to alert the user if an incorrect combination of the add-on module 27 and the auto-injector 1 has been connected, either by further bluetooth communication with the smartphone 59 or via a notification LED of the electronic module 27 itself. A positive acknowledgement may also be provided if the medication information indicates that the medication is acceptable. After completion of the medication administration process, the medication information previously read by the additional electronic module 27 may be combined with any dose event data and this information may be transmitted to the smartphone 59 via bluetooth, for example, as a single record.

Finally, mechanical coding features 65 may also be incorporated into the interface between the additional electronic module 27 and the housing 3 of the auto-injector 1 to lock or code certain modules 27 so that they can only be assembled to a particular auto-injector 1. An example of such a mechanical coding feature 65 is illustrated in fig. 14. For such an arrangement, it is believed to be unlikely that sufficient resolution can be achieved in the encoding system to achieve unique expiration date or lot identification, but drug specific encoding is believed to be viable.

Referring again to the wireless communication of the electronic module 27, communicating using the bluetooth protocol allows two-way communication and thus enables the smartphone 59 to confirm successful receipt of data to the additional electronic module 27, thereby preventing unnecessary retransmission of data that would reduce battery life.

With the additional electronic module 27 described, after use with one first automatic injector 1, the patient removes the additional electronic module 27 from the depleted automatic injector 1 and either immediately attaches it to a new automatic injector 1 or stores it separately waiting to be fitted to another automatic injector 1, whereby the administration process may be repeated.

It is pointed out the fact that the above-described auto-injector 1 is a single-use fixed dose auto-injector. Thus, depending on the internal structural configuration of the autoinjector 1, only a preset amount of one single dose can be dispensed with these autoinjectors 1.

However, the above-described drug administration process supervision is not limited to such a single-use fixed dose automatic injector 1. The above-described functionality may also be combined with a multiple use fixed dose automatic injector allowing for dispensing a plurality of preset doses, a single use variable dose automatic injector allowing for dispensing a user selectable amount of a single dose, and a multiple use variable dose automatic injector allowing for dispensing a user selectable amount of a plurality of doses, if desired.

Finally, it is noted that the automatic injector 1 and the electronic module 27 are configured in such a way that the outer surface of the entire product in the connected state appears to be flush along the longitudinal axis of the automatic injector 1 without any steps or protrusions, which allows a highly improved handling of the automatic injector 1 with the electronic module 27 by the user. This configuration is implemented in all of the illustrated embodiments. The cut-outs shown in fig. 12 and 13 depict only the window 67 in the housing 3, but do not show a true groove perpendicular to the longitudinal axis of the automatic injector 1.

The essential features relating to the invention are listed below with reference to certain aspects of the invention:

A first aspect of the invention relates to an electronic module (27) connectable to an automatic injector (1) or an automatic injector (1) having such an electronic module (27), wherein the electronic module (27) is configured to detect and monitor a dosing process and/or parameters related thereto with the automatic injector (1) and to provide feedback to a user of the automatic injector (1) about the performed dosing process and/or parameters related thereto.

A second aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the first aspect,

Wherein the automatic injector (1) comprises: a housing (3); a cartridge or syringe (5) filled with a medicament to be dispensed and positioned within the housing (3); a plunger (7) positioned within the cartridge or syringe (5); a driver (9) positioned within the housing (3) and coupled to the plunger (7), wherein the driver (9) comprises a drive chassis (10) with a plunger rod (11) and a locked drive spring (13), wherein the locked drive spring (13) acts between the housing (3) and the drive chassis (10) for generating the force required to move the plunger (7) to dispense the medicament; and a needle protection device (15) arranged axially movable within the housing (3) and configured to release the locked drive spring (13) of the driver (9) upon axial movement for dispensing the medicament.

A third aspect of the invention relates to the electronic module (27) or the auto-injector (1) of either of the first and second aspects,

Wherein the electronic module (27) comprises a detection unit and a notification unit,

Wherein the detection unit is configured to monitor (i.e. supervise) one or more moving parts of the automatic injector (1) and to generate information about or parameters related to the administration process of the automatic injector (1) based on the operational status of at least one component of the automatic injector (1);

Wherein the notification unit is configured to generate and output a notification signal comprising or indicative of the generated information about the administration process or parameters related thereto.

A fourth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the third aspect,

Wherein the detection unit comprises a light reflector sensor (29) configured to monitor a movement of at least one component of the auto-injector (1), in particular a movement of a drive chassis (10) of the auto-injector (1), during an application process.

A fifth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the fourth aspect,

Wherein the drive chassis (10) comprises at least one optical pattern (12) which is monitored by a light reflector sensor (29) for monitoring the dispensing movement of the piston rod (11).

A sixth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the third aspect,

Wherein the detection unit comprises a time-of-flight sensor (39) configured to monitor a movement of at least one component of the auto-injector (1), in particular a movement of a plunger rod (11) of the auto-injector (1), during an administration procedure.

A seventh aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the sixth aspect,

Wherein the time of flight sensor (39) is an optical time of flight sensor and the plunger rod (11) comprises a reflective surface monitored by the optical time of flight sensor (39) for monitoring the dispensing movement of the plunger rod (11).

An eighth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the third aspect,

Wherein the detection unit comprises a directional microphone (39), in particular a microelectromechanical system (MEMS) microphone, configured to detect signal sounds generated by at least one component of the auto-injector (1), in particular a drive chassis (10) of the auto-injector (1), during an application process.

A ninth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the eighth aspect,

Wherein the drive chassis (10) comprises at least one acoustically active section (25), in particular a click protrusion, which generates an acoustic signal when the drive chassis (10) is moved in the proximal direction, such that the directional microphone (39) can monitor the movement of the plunger rod (11) via the generated acoustic signal.

A tenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the third aspect,

Wherein the detection unit comprises at least one frangible circuit element (43) configured to break when at least one component of the auto-injector (1), in particular a drive chassis (10) of the auto-injector (1), reaches a specific position during an administration process to monitor the administration process.

An eleventh aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any one of the third to tenth aspects,

Wherein the notification unit comprises an active wireless communication device (35) configured to actively transmit information wirelessly to a user device, such as a smart phone (59) or the like.

A twelfth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the eleventh aspect,

Wherein the active wireless communication is based on a "cellular" communication technology SigFox.

A thirteenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the eleventh aspect,

Wherein the active wireless communication is based on a "cellular" communication technology NB-IoT.

A fourteenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the eleventh aspect,

Wherein the active wireless communication is based on bluetooth.

A fifteenth aspect of the invention relates to the electronic module (27) or the automatic injector (1) of any one of the third to tenth aspects,

Wherein the notification unit comprises a passive wireless communication device (41), the passive wireless communication device (41) being configured to passively wirelessly transmit information to a user device, such as a smartphone (59) or the like.

A sixteenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the fifteenth aspect,

Wherein the passive wireless communication is based on NFC (near field communication), in particular with an RFID chip (45) and an antenna (47).

A seventeenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the third to sixteenth aspects,

Wherein the notification unit comprises an optical notifier configured to display information directly to a user of the automatic injector (1).

An eighteenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the seventeenth aspect,

Wherein the optical notifier comprises at least one, in particular several notification LEDs.

A nineteenth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the third to fourteenth, seventeenth and eighteenth aspects,

Wherein the electronic module (27) comprises a microcontroller (31) and a power supply (33),

Wherein the microcontroller (31) is configured to receive information about the application process from the detection unit, process the received information, and control operation of the notification unit to output user feedback based on the processed information.

A twentieth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any one of the third to fourteenth and seventeenth to nineteenth aspects,

Wherein the electronic module (27) comprises a wake-up switch (37), in particular a mechanical wake-up switch (37),

Wherein the wake-up switch (37) is coupled to the microcontroller (31) and is configured to switch an operational state of the microcontroller (31) between an ON (ON) state and an OFF (OFF) state.

A twenty-first aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the twentieth aspect,

Wherein the wake-up switch (37) is configured not to be operated by a user of the auto-injector (1) but to be operated automatically during use of the auto-injector (1), in particular either by the needle protection device (15) or by the drive chassis (10) with the plunger rod (11).

A twenty-second aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the preceding aspects,

Wherein the electronic module (27) is provided as an integral part of the auto-injector (1) which is non-releasably coupled to a part of the auto-injector (1).

A twenty-third aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the twenty-second aspect,

Wherein components of the electronic module (27) are positioned within the housing (3) of the auto-injector (1).

A twenty-fourth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the twenty-second or twenty-third aspect,

Wherein the electronic module (27) is positioned side by side with the components of the automatic injector (1).

A twenty-fifth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any one of the first to twenty-first aspects,

Wherein the electronic module (27) is provided as a separate additional module configured to be releasably coupled to the auto-injector (1).

A twenty-sixth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the twenty-fifth aspect,

Wherein the electronic module (27) comprises a sealing membrane (51), which sealing membrane (51) is positioned between the electronic module (27) and the automatic injector (1) in a state in which the electronic module (27) is coupled to the automatic injector (1).

A twenty-seventh aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the twenty-sixth aspect,

Wherein the sealing film (51) is made of a material transparent to specific light, in particular IR light, so that the optical time-of-flight sensor (39) can be used to monitor the application process through the sealing film (51).

A twenty-eighth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any one of the twenty-fifth to twenty-seventh aspects,

Wherein the electronic module (27) comprises an attachment switch (49) configured to detect attachment of the electronic module (27) to the auto-injector (1).

A twenty-ninth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the twenty-fifth to twenty-eighth aspects described above,

Wherein the autoinjector (1) is provided with an NFC tag (57) containing information about the medicament stored within the autoinjector (1).

A thirty-first aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of the twenty-ninth aspect, having the features of any one of the twenty-fifth to twenty-eighth aspects,

Wherein the electronic module (27) comprises an NFC reader (63) configured to automatically read information stored within the NFC tag (57).

A thirty-first aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the preceding aspects,

Wherein at least one component of the auto-injector (1) comprises a bar code or QR code (61) containing information about the medicament within the auto-injector (1) and configured to be read by a user device (59), such as a smartphone.

A thirty-second aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any of the preceding aspects, having the features of any of the twenty-fifth to twenty-eighth and thirty-first aspects,

Wherein the electronic module (27) comprises a mechanical coding feature (65) which allows only the electronic module (27) to be attached to an auto-injector (1) provided with a matching mechanical coding feature.

A thirty-third aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any one of the foregoing third to twenty-third aspects and twenty-fifth to thirty-second aspects, which does not have the further features of the twenty-fourth aspect,

Wherein the electronic module (27) is configured or positioned at the distal end of the auto-injector (1) axially behind a component of the auto-injector (1).

A thirty-fourth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the preceding aspects,

Wherein the auto-injector (1) is a single use fixed dose auto-injector.

A thirty-fifth aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any one of the preceding first to thirty-third aspects,

Wherein the auto-injector (1) is a single use variable dose auto-injector.

A thirty-sixth aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any one of the preceding first to thirty-third aspects,

Wherein the auto-injector (1) is a multiple use fixed dose auto-injector.

A thirty-seventh aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any one of the foregoing first to thirty-third aspects,

Wherein the auto-injector (1) is a multi-use variable dose auto-injector.

A thirty-eighth aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any one of the preceding aspects,

Wherein the electronic module (27) is configured to detect and monitor a dose administration procedure with the automatic injector (1) and/or parameters related thereto based on a state of motion of one or more moving parts of the automatic injector (1) or based on a position of one or more moving parts of the automatic injector (1).

A thirty-ninth aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of any one of the foregoing first to thirty-seventh aspects,

Wherein the electronic module (27) is configured to detect and monitor a dosing procedure with the automatic injector (1) and/or parameters related thereto based on a movement state and based on a position of one or more moving parts of the automatic injector (1).

A fortieth aspect of the present invention relates to the electronic module (27) or the auto-injector (1) of the thirty-ninth aspect,

Wherein the electronic module (27) is configured to detect and monitor a dosing procedure with the automatic injector (1) and/or parameters related thereto based on a single moving part of the automatic injector (1), in particular the movement state and position of the drive chassis (10).

A fortieth aspect of the present invention is directed to the electronic module (27) or the auto-injector (1) of any one of the preceding aspects,

Wherein the microcontroller waits a specified period of time after no further changes in any of the monitored parameters have occurred, and then ultimately determines the end of the dosing process.

A forty-second aspect of the invention relates to the electronic module (27) or the auto-injector (1) of the forty-first aspect,

Wherein the specific time period is 1, 2, 3, 5 or 10 seconds.

Wherein the outer contour of the automatic injector (1) is flush with the electronic module (27) along the longitudinal axis of the automatic injector (1).

A forty-fourth aspect of the invention relates to the electronic module (27) or the auto-injector (1) of any of the preceding aspects,

Wherein the electronic module (27) is configured to monitor movement of a portion of the drive chassis (10) during an application process.

List of reference numerals

1 Automatic injector

3 Shell body

3A outer body

3B inner body

5 Cartridge/syringe

7 Plunger piston

9 Driver

10 Drive chassis

11 Plunger rod

11A reflecting surface

12 Optical pattern

13 Drive spring

15-Needle protection device

16 Needle protector spring

17 Cap

19-Needle shield

21 Needle assembly

22 Needle

23 Locking element

25 Elastic feature/acoustically active section

26 End of dose click projection

27 Electronic module

28PCBA

29 Light reflector sensor

31 Microcontroller

33 Power supply

35 Active wireless communication device

37 Wake-up switch

39 Time-of-flight sensor/directional microphone

41NFC connection system

43 Frangible circuit element

45RFID chip

47 Antenna

49-Attached switch

51 Sealing member

53 Clip features

55 Projection

57NFC tag

59 Smart phone

61 Bar code/QR code

63NFC reader

65 Mechanical coding features

67 Window

Claims

1. An electronic module (27) connectable to an automatic injector (1) or an automatic injector (1) having such an electronic module (27), wherein the electronic module (27) is configured to detect and monitor a dosing process and/or parameters related thereto with the automatic injector (1) and to provide feedback to a user of the automatic injector (1) about the performed dosing process and/or parameters related thereto.

2. Electronic module (27) or auto-injector (1) according to claim 1,

Wherein the electronic module (27) comprises a light reflector sensor (29) configured to monitor a movement of at least one component of the automatic injector (1), in particular of a drive chassis (10) of the automatic injector (1), during an application process,

Wherein in particular the drive chassis (10) comprises at least one optical pattern (12) monitored by the light reflector sensor (29) for monitoring the dispensing movement of the plunger rod (11).

3. Electronic module (27) or auto-injector (1) according to claim 1 or 2,

Wherein the electronic module (27) comprises a time-of-flight sensor (39) configured to monitor a movement of at least one component of the auto-injector (1), in particular a movement of a plunger rod (11) of the auto-injector (1), during an administration procedure, optionally wherein the plunger rod (11) is part of a drive chassis (10),

Wherein in particular the time of flight sensor (39) is an optical time of flight sensor and the plunger rod (11) comprises a reflective surface monitored by the optical time of flight sensor (39) for monitoring the dispensing movement of the plunger rod (11).

4. Electronic module (27) or auto-injector (1) according to claim 1 or 2,

Wherein the electronic module (27) comprises a directional microphone (39), in particular a microelectromechanical system (MEMS) microphone, which is configured to detect signal sounds generated by at least one component of the autoinjector (1), in particular a drive chassis (10) of the autoinjector (1), during an application process,

Wherein in particular the drive chassis (10) comprises at least one acoustically active section (25), in particular a click protrusion, which generates an acoustic signal when the drive chassis (10) is moved in the proximal direction, such that the directional microphone (39) can monitor the movement of the plunger rod (11) via the generated acoustic signal.

5. Electronic module (27) or auto-injector (1) according to claim 1 or 2,

Wherein the electronic module (27) comprises at least one frangible circuit element (43) configured to be broken when at least one component of the auto-injector (1), in particular a drive chassis (10) of the auto-injector (1), reaches a specific position during an administration process to monitor the administration process.

6. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the electronic module (27) comprises active wireless communication means (35) configured to actively transmit information wirelessly to a user device, such as a smart phone (59) or the like,

Wherein in particular the active wireless communication is based on a "cellular" communication technology SigFox, on a "cellular" communication technology NB-IoT or on bluetooth.

7. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the electronic module (27) comprises passive wireless communication means (41) configured to passively wirelessly transmit information to a user device, such as a smartphone (59) or the like,

Wherein in particular the passive wireless communication is based on NFC (near field communication), in particular with an RFID chip (45) and an antenna (47).

8. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the electronic module (27) comprises an optical notifier configured to display information directly to a user of the automatic injector (1),

Wherein in particular the optical notifier comprises at least one, in particular several notification LEDs.

9. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the microcontroller (31) is configured to receive information about the application process, process the received information, and control the output of user feedback based on the processed information.

10. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the wake-up switch (37) is coupled to the microcontroller (31) and is configured to switch an operating state of the microcontroller (31) between an on-state and an off-state,

Wherein in particular the wake-up switch (37) is configured not to be operated by a user of the auto-injector (1) but to be operated automatically during use of the auto-injector (1), in particular either by the needle protection device (15) or by the drive chassis (10) with the plunger rod (11).

11. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the electronic module (27) is provided as an integral part of the autoinjector (1) which is non-releasably coupled to a part of the autoinjector (1),

Wherein in particular the components of the electronic module (27) are positioned within the housing (3)/the housing (3) of the automatic injector (1),

Wherein preferably the electronic module (27) is positioned alongside the components of the automatic injector (1) or behind them in the distal end of the housing (3).

12. Electronic module (27) or auto-injector (1) according to any one of claims 1 to 10,

Wherein the electronic module (27) is provided as a separate add-on module configured to be releasably coupled to the automatic injector (1),

Wherein, in particular, the electronic module (27) comprises a sealing film (51) positioned between the electronic module (27) and the automatic injector (1) in a state in which the electronic module (27) is coupled to the automatic injector (1),

Wherein preferably the sealing film (51) is made of a material transparent to specific light, in particular IR light, so that an optical time-of-flight sensor (39) can be used to monitor the application process through the sealing film (51).

13. Electronic module (27) or auto-injector (1) according to claim 12,

Wherein the electronic module (27) comprises an attachment switch (49) configured to detect the attachment of the electronic module (27) to the automatic injector (1),

Wherein in particular the automatic injector (1) is provided with an NFC tag (57) containing information about the medicament stored within the automatic injector (1),

Wherein preferably the electronic module (27) comprises an NFC reader (63) configured to automatically read information stored within an NFC tag (57); and/or

Wherein at least one component of the automatic injector (1) comprises a bar code or QR code (61) containing information about the medicament within the automatic injector (1) and configured to be read by a user device such as a smartphone (59); and/or

Wherein the electronic module (27) comprises a mechanical coding feature (65) allowing only the electronic module (27) to be attached to an auto-injector (1) provided with a matching mechanical coding feature.

14. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the auto-injector (1) is preferably one of a single-use fixed dose auto-injector or a single-use variable dose auto-injector, a multi-use fixed dose auto-injector and a multi-use variable dose auto-injector.

15. Electronic module (27) or an automatic injector (1) according to any of the preceding claims,

Wherein the electronic module (27) is configured to detect and monitor a dosing procedure with the automatic injector (1) and/or parameters related thereto based on at least one, preferably both, of: the state of motion of one or more moving parts of the autoinjector (1) and the position of one or more moving parts of the autoinjector (1),

Wherein in particular the electronic module (27) is configured to detect and monitor a dosing procedure with the automatic injector (1) and/or parameters related thereto based on movement and/or position information of one single moving part of the automatic injector (1), in particular of its drive chassis (10).