Injection device

Abstract

An injection device includes a main housing, a drive mechanism for providing a motive force to deliver a medicament, and a shield attached to a proximal end of the main housing, the shield coupled to the drive mechanism such that inward movement of the shield causes release of the drive mechanism to provide the motive force, and the protective cover is biased towards the extending position. The injection device further includes: a plurality of sensors, including an in-use sensor coupled between the main housing and the shield; and a monitoring and reporting unit electrically coupled to the sensor for monitoring use. In the lower power mode, the sensor in use is monitored while other sensors and components are inoperable, and in the higher power mode, other sensors and components are operable. When the sensor in use detects inward movement of the shroud, the monitoring and reporting unit switches from the lower power mode to the higher power mode.

Description

Technical Field

[0001] The present invention relates to an injection device for drug delivery and is provided with electronic monitoring operable in a low-power mode. Background Art

[0002] Injection devices are commonly used to deliver many different types of drugs. In most injection devices, the force for delivering the injection is provided by a strong helical spring, either compressed and released to provide the delivery force or expanded and contracted to provide the force. In some cases, prior to drug delivery, the same or a different spring mechanism provides the needle insertion force to penetrate the skin of the user with the syringe or cartridge tip.

[0003] Of course, most importantly, the drug delivery protocol is precisely followed, for example, in terms of the drug delivered per injection and the injection timing. This has traditionally relied on careful use by the patient or their medical staff or caregiver. Especially for self-injection, in cases where the user may be elderly or otherwise infirm, it may be difficult to follow the set protocol and injections may be missed or too many injections may be performed, or the wrong dose may be delivered, which can lead to serious consequences.

[0004] With the widespread use of smart phones and other wirelessly connected personal devices, there is growing interest in the use of auto-injectors equipped with electronic monitoring devices and wireless connectivity, such as would allow for the automatic monitoring of injections and reporting to the user device, and possibly further reporting to some central monitoring service or medical practice. While such electronic monitoring and reporting functions can be used in conjunction with an electrical / electronic drive device for injection delivery (and needle insertion), it is at least currently considered preferable to continue to use a mechanical drug delivery mechanism to ensure reliability and allow for injections in the event that power (e.g., from a rechargeable battery) is unavailable.

[0005] WO2019086718 describes an embodiment of a mechanically powered self-injector with electronic monitoring. Detection relies on the use of microswitches, but it is suggested that other means for detection could be used.

[0006] While relatively low-power monitoring and wireless reporting functions can be implemented within an injection device, power consumption remains a challenge, especially in cases where the device is expected to have a lifespan of several years without the need for recharging or battery replacement; similarly, ease of operation is crucial for elderly and infirm users. Summary of the Invention

[0007] According to a first aspect of the present invention, there is provided an injection device for delivering a dose of medicament from a medicament-containing syringe or cartridge having a needle attached thereto into a patient. The injection device comprises: a main housing for receiving the syringe or cartridge; a drive mechanism substantially located within the main housing for providing motive power to deliver the medicament from the syringe or cartridge into the patient; and a shield defining an opening therethrough, the shield being attached to the proximal end of the main housing and being movable relative to the housing between an extended position and a retracted position, in the extended position, the needle tip is substantially shielded by the shield, in the retracted position, the needle tip extends through the opening in the shield, the shield being coupled to the drive mechanism such that movement of the shield from the extended position to the retracted position causes or permits release of the drive mechanism to provide the motive power, and the shield is biased towards the extended position. The injection device further comprises: a plurality of sensors including a sensor-in-use, the sensor-in-use being coupled between the main housing and the shield to detect movement of the shield between the extended position and the retracted position; and an electric monitoring and reporting unit substantially housed within the main housing and electrically coupled to the plurality of sensors for monitoring the use of the injection device including successful medicament delivery, and for reporting the use to an external device via a wireless interface of the unit, the unit being operable in at least one of a lower power mode and a higher power mode. In the lower power mode, at least the sensor-in-use is monitored by the unit, while other sensors and components are inoperable or otherwise consume no power, and in the higher power mode, other sensors and components are operable, and wherein detection of movement of the shield from the extended position to the retracted position by the sensor-in-use causes the monitoring and reporting unit to switch from the lower power mode to the higher power mode.

[0008] The housing may include a first main housing portion and a second main housing portion, the first main housing portion and the second main housing portion being movable relative to each other between an open position and a closed position, in the open position, the syringe or cartridge can be inserted into a receiving slot defined within the first main housing portion, in the closed position, the inserted syringe or cartridge is firmly held within the receiving slot and within the housing, wherein, the shield includes a first shield portion and a second shield portion, the first shield portion being coupled to the first main housing portion, the second shield portion being coupled to the second main housing portion such that when the main housing portions are in the closed position, the shield portions are joined together to form a substantially integral shield. The shield is also coupled to the drive mechanism via the first shield portion and the first main housing portion, while the sensor-in-use is coupled between the second shield portion and the second main housing portion.

[0009] Movement of the shield from the retracted position to the extended position detected by the sensor in use may cause the monitoring and reporting unit to switch from the higher power mode to the lower power mode.

[0010] The monitoring and reporting unit may include a processor, and in the lower power mode and the higher power mode, the processor is configured to detect an interrupt signal at one or more inputs coupled to the sensor in use.

[0011] The sensor in use may include a microswitch. The other sensors may at least include a sensor for detecting the start of drug delivery and a sensor for detecting the end of drug delivery.

[0012] According to a second aspect of the present invention, there is provided an injection device for delivering a dose of drug from a syringe or cartridge containing the drug with a needle fixed thereto into a patient's body. The injection device includes: a main housing for receiving the syringe or cartridge; a drive mechanism substantially located within the main housing for providing motive power to deliver the drug from the syringe or cartridge into the patient's body; a trigger coupled to the drive mechanism such that movement of the trigger relative to the main housing from a first position to a second position causes or permits release of the drive mechanism to provide the motive power; and a plurality of sensors including a sensor in use, the sensor in use being coupled between the main housing and the trigger to detect movement of the trigger from the first position to the second position. The injection device further includes an electric monitoring and reporting unit substantially housed within the main housing and electrically coupled to the plurality of sensors for monitoring the use of the injection device including successful drug delivery and for reporting the use to an external device via a wireless interface of the unit, the unit being capable of operating in at least one of a lower power mode and a higher power mode. In the lower power mode, at least the trigger is monitored by the unit while the other sensors and components are inoperable or otherwise do not consume power, and in the higher power mode, the other sensors and components are operable, and wherein detection of movement of the trigger from the first position to the second position by the sensor in use causes the monitoring and reporting unit to switch from the lower power mode to the higher power mode. Description of the Drawings

[0013] Figure 1A -C shows the auto-injector in the (A) closed, (B) partially open, and (C) open states;

[0014] Figure 2 A safety syringe is shown;

[0015] Figure 3 shows the Figure 1A capped end of the auto-injector of -C;

[0016] Figure 4A and 4B shows the Figure 1A partial cross-sectional view of the auto-injector of -C; and

[0017] Figure 5 shows the Figure 1C features of the auto-injectors of FIGS. 1 to 4 within detail A. DETAILED DESCRIPTION

[0018] As described above, it is desirable to minimize the power consumption of an injection device utilizing electronic components including sensors, for example to extend the life of a non-rechargeable device or to maximize the interval between charges in the case of a rechargeable device. This can be achieved at least in part by providing one or more sensors for detecting an injection initiation step, the detection being used to change the power operation mode of the device from a low power or "sleep" mode to a higher power mode in which additional sensors and / or monitoring functions are switched on.

[0019] The terms "forward" or "front" are used herein to refer to the needle side or injection site end of the auto-injector, while the term "rear" refers to the end of the auto-injector remote from the needle or injection site.

[0020] Figure 1A -C shows an embodiment of the auto-injector 100 in: A) a closed state; B) a partially open state; and C) a fully open state.

[0021] The auto-injector 100 includes a housing 102, the housing 102 including a body 104 and a cap 106, the body 104 and the cap 106 being hingedly connected to allow opening and closing of the housing. The auto-injector also includes a plurality of component parts housed within the housing. A syringe such as Figure 2 syringe 200 (not shown in Figure 1A -C) can be received within the housing in a slot 112 defined in the body. The cap 106 of the auto-injector 100 includes a through-hole 126, the through-hole 126 being positioned such that once firing is complete, the surface of the plunger driver 116 (the operation of which is described below) is visible. This surface is distinctly colored compared to other parts visible through the through-hole before and during drug delivery, thereby providing a visual indication to the user of the completion of drug delivery.

[0022] As Figure 1A and 1BAs most clearly shown, the self-injector 100 also includes a protective cover 108 formed by a lower portion 108a and an upper portion 108b. The lower and upper portions are respectively coupled to the body 104 and the cap 106 such that when the housing 102 is opened, the portions 108a, 108b separate to allow insertion of the syringe 200, and when the housing is closed, the portions 108a, 108b are joined together to form an integral protective cover 108. The protective cover 108 defines an aperture through which the needle 210 of the syringe 200 extends at least partially when the syringe is received in the self-injector 100. The lower portion 108a and the upper portion 108b respectively include slidable connections to the body 104 and the cap 106 to allow movement between an extended position and a retracted position, in which the end of the syringe needle is substantially covered by the protective cover and in which the end of the syringe needle is exposed. The protective cover portions are individually biased towards the extended position such that the needle of the syringe in the self-injector remains substantially covered prior to injection.

[0023] As Figure 1C shown, the self-injector 100 includes a removable cap 110 which is normally in place prior to performing an injection. For ease of understanding, the cap is omitted from Figure 1A and 1B for clarity. In the illustrated configuration, the cap slidably mates over the lower protective cover portion 108b and further abuts against the front end of the body 104. The cap 110 prevents the user from accessing the protective cover and thus prevents accidental firing while the cap is in place.

[0024] Figure 2 Shown is a safety syringe 200 suitable for use with the self-injector 100. Such a syringe 200 is described in detail in WO2019086718. It suffices here to note that the syringe includes a syringe body 202 for containing a drug, a syringe plunger 204 engaged with a stopper 206 within the syringe body, a needle shield 208 coupled to a safety plunger 209, and a needle 210. The coupling between the syringe plunger and the safety plunger / needle shield causes the needle shield 208 to deploy around the needle of the syringe so as to substantially cover the needle after delivery of the drug from the syringe body. This coupling is described in detail in WO2019 / 086718.

[0025] Generally, syringes (including safety syringes) are typically provided with a protective rigid needle shield (RNS) which needs to be removed before the syringe can be used (the RNS is not shown in Figure 2 for clarity). To this end, the cap 110 also operates as an RNS remover 300 in a known manner. Figure 3A top view of the end of the self-injector with the cap in place is shown. The self-injector 100 is in an open state such that the end of the RNS remover and the syringe 200 with the attached RNS 212 are visible. The RNS remover includes a sidewall 302 extending away from the cap, and the sidewall 302 defines a channel 304 for receiving the RNS when the cap is assembled to the self-injector. The front end of the sidewall terminates at a gripping member 306. The gripping member is configured to allow the RNS 212 to be easily inserted into the channel while preventing its subsequent withdrawal. Thus, when the cap is removed, the RNS can be removed from the syringe.

[0026] In Figure 3 In the configuration shown, the gripping member 306 includes a protrusion 308 extending inwardly into the channel 304, and the protrusion 308 is angled away from the front end of the sidewall 302. When the syringe 200 with the RNS is inserted into the slot 112 of the body 104, the protrusion 308 can bend outwardly, and when the protrusion 308 engages the RNS 212, the protrusion 308 prevents any return movement.

[0027] Figure 4A and 4B Partial cross-sectional views of the self-injector 100 during various stages of activation are shown to illustrate the presence and operation of additional internal components during the opening and closing strokes of the lid 106. In particular, it can be seen that the self-injector 100 includes: a shuttle 114 operable to move between a first forward position and a second rearward position along a shuttle guide 120 on the body 104 of the housing 102; a plunger driver 116 for driving the syringe plunger 204; and a biasing element 118 coupling the shuttle and the plunger driver 116. The shuttle and the plunger driver are slidably connected to the shuttle guide 120 to allow backward and forward movement within the housing 102. Different from the plunger driver, the shuttle is also fixedly connected to the lid 106 via two arm members 122. The plunger driver includes a rearmost member 117, herein referred to as the "pushing member", which is located behind the rear end of the plunger of the inserted syringe during use.

[0028] The biasing element 118 includes two tension springs on both sides of the device, but only one is visible in the drawings. Before any activation, these springs are under slight tension to hold the plunger driver 116 and the shuttle 114 together. Thus, it should be noted that in the context of the tension springs, activation refers to the process of further tensioning the tension springs to a state where firing can be initiated.

[0029] Each of the shuttle guide 120 and the plunger driver 116 includes a part of a latching device configured to cooperate to fix the plunger driver at the rear end of the self-injector 100. A suitable latching device is described in WO2022179832.

[0030] The self-injector 100 further includes a torsion spring 124 disposed at the hinge connection between the cap 106 and the body 104 of the self-injector 100. The torsion spring is coupled to both the cap and the body. In the illustrated embodiment, one end of the torsion spring is attached to the cap and the opposite end is attached to the body of the self-injector.

[0031] The activation of the self-injector during the cap opening stroke ( Figure 4A ), and the cap closing stroke ( Figure 4B ), is now described. WO2021058474 describes the operation of a similar self-injector, except that the biasing element described therein further includes a compression spring.

[0032] When the cap 106 is opened, the arm member 122 that couples the cap and the shuttle 114 causes the shuttle to move rearward from the first position to the second position. The shuttle remains in continuous engagement with the plunger driver 116 such that its rearward travel causes the same rearward travel of the plunger driver. Accordingly, the tension spring coupled between them remains unactivated (i.e., further extended) during cap opening. Near the end of the cap opening stroke, the latch device portion on the shuttle guide 120 and the plunger driver engage together such that they can cooperate to fix the plunger driver at the rear end of the self-injector 100.

[0033] The opening of the cap 106 also causes the end of the torsion spring 124 attached to the cap to rotate about its spring axis relative to the opposite end of the torsion spring. This primes the torsion spring on the cap opening for activation. When primed, the torsion spring produces a restoring force that tends to urge the cap to close.

[0034] When closing the cap 106, the plunger driver 116 is held at the rear of the self-injector by the latch device while the shuttle 114 freely moves forward along the shuttle guide 120 to the first position. Accordingly, during the cap closing stroke, the shuttle and the plunger driver separate and the tension spring coupled between them is activated (i.e., further tensioned).

[0035] As already noted above, the torsion spring 124 after being pre-primed urges the cap 106 to close. This helps to pre-prime the tension spring 118 during closing while requiring minimal force to pre-prime the torsion spring during opening. This is important for the user of the auto-injector, who would otherwise find it difficult to apply the necessary force to close the cap.

[0036] The firing of the self-injector is now described. The firing mechanism is described in more detail in WO2022179832.

[0037] To activate a loaded and pre - primed self - injector, the user pushes the front end of the self - injector 100 into contact with the injection site (e.g., the user's skin). This causes the shield parts 108a, 108b to move to the retracted position against their biasing means (e.g., respective springs). When the shields are retracted into the housing 102, the lower shield 108b allows or causes the release of the latch means and the pre - primed tension springs 118a, 118b. The restoring force of the tension springs acting on the plunger driver 116 drives the plunger driver, in particular the pushing member 117, to press the syringe plunger forward and force the drug out of the syringe needle into the injection site.

[0038] Now refer to Figure 4A , which shows an electronic module 127 located within the cap 106 of the housing 102. Components within the housing (including, for example, a processor and a memory) operate as a computer, while other components can operate as a radio transceiver for sending and receiving data to an external device such as a smart phone. The transceiver can utilize a wireless interface, such as Bluetooth TM or a WiFi interface. The radio transceiver can alternatively be configured to communicate with some remote service via, for example, a cellular (mobile) radio network. The module 127 is located on and electrically connected to a printed circuit board (PCB) 128. The self - injector also includes a plurality of sensors that are configured to monitor or detect respective operational steps and / or processes of the self - injector. These sensors can be attached to the PCB or otherwise electrically coupled to the PCB to facilitate electrical communication between the sensors and the electronic module. Although not shown in the figures, the self - injector includes an electrical energy source, typically a battery. This can be housed within the electronic module 127.

[0039] Examples of sensors (not shown in the figures) include sensors for the following operations: detecting the start of movement of the plunger driver from its rearmost position and emitting a signal indicating the start of drug delivery; detecting the end of movement of the plunger driver and emitting a signal indicating the end of drug delivery; detecting the opening and / or closing of the cap; and / or detecting the successful insertion of the syringe into the housing.

[0040] Sensors of the above - mentioned types typically consume energy when in an active monitoring state, even if the device is not going to be used. An obvious solution to this problem is to provide an on / off switch that the user operates when an injection is to be made and after the injection has been completed. However, this depends on the user operating the switch correctly, especially after the injection has been completed. It can also be assumed that all switches can be switched on and off synchronously.

[0041] An improved solution is to provide a dedicated sensor, referred to as a "sensor in use", which is configured to detect the start of an actual injection, i.e., the insertion of the needle into the patient's skin, and optionally, the removal of the needle. The output signal of the sensor in use is used to switch the device from a low-power or sleep mode to a relatively high-power mode. In the low-power mode, only the sensor in use is powered or otherwise monitored, while the other sensors of the device are turned off and / or not monitored. In some cases, in the low-power mode, a limited number of other sensors may be turned on and / or monitored, such as a sensor for detecting the opening and closing of the cap. In the higher-power mode, all sensors of the device are turned on and / or monitored (or at least those other sensors required during the injection phase).

[0042] Figure 5 The front end of the injection device is shown within the area generally indicated by the dashed line A in Figure 1C Particularly shown are the upper portion 108b of the protective cover 108 and the inner front end 132 of the cap 106. Also shown are a pair of springs 129a, 129b coupled between the upper portion 108b and the cap and which are operative to bias the upper portion in the forward direction as described above. When depressed, the upper portion 108b slides through the front end 132 of the cap portion with which it engages against the biasing force exerted by the springs 129a, 129b. The sensor in use 130 in the form of a microswitch is located on the front end 132 of the cap 106. The sensor in use is positioned such that it is triggered when a feature 131 at the rear end of the upper portion engages the switch. This event occurs at some point during the inward travel of the upper portion since the protective cover is pressed by a reaction force when the protective cover 108 bears against the user's skin. This is typically at or near the point when the tip of the needle penetrates the user's skin.

[0043] The sensor in use 130 is electrically connected to the electronic module 127, for example via a PCB 128. The module may apply a small voltage across the switch of the sensor, where the closing of the switch causes a voltage signal to be provided to an interrupt line of a processor within the electronic module. This operation allows the processor to detect the pressing and subsequent release of the protective cover 108 and, in turn, switch its operating mode between the low-power mode and the relatively high-power mode described above. It should be understood that the auto-injector may operate in the higher-power mode for only a relatively short period of time, such as the time taken to perform an injection. This period may be a few seconds or a few tens of seconds. This allows a very significant reduction in the power consumed by the device, thereby greatly extending the life of the power source (e.g., a battery) and, in the case where the power source is not rechargeable or replaceable, extending the life of the auto-injector.

[0044] Without departing from the scope of the appended claims, further embodiments of the present invention will be apparent to the skilled reader. For example, it will be understood that the sensor in use may be an optical sensor or other type of proximity sensor rather than an electromechanical microswitch. Alternative or additional means for switching the device from a low power mode to a high power mode may also be provided. For example, if the device is provided with Bluetooth™ functionality for transmitting sensed and other data to an external computer system, such as the user's smartphone, operating the Bluetooth switch may cause this mode change. As an alternative to integrating the switch into the protective cover, it may be integrated into the trigger button, where pressing the trigger button initiates the injection sequence. Such manually operated trigger buttons are well known in the art.

[0045] In addition, although the present invention has been described with respect to a self-injector, those skilled in the art will also understand that the present invention may be applied to other injection devices, such as pen devices, where the user selects the amount of drug to be dispensed from a cartridge or syringe. Further, the sensor in use may be a firing button or other trigger for initiating the injection sequence.

Claims

1. An injection device for delivering a dose of medicament from a medicament-containing syringe or cartridge having a needle attached thereto into a patient's body, said injection device comprising: a main housing for receiving the syringe or cartridge; a drive mechanism substantially located within the main housing for providing motive power to deliver the medicament from the syringe or cartridge into the patient's body; a shield defining an opening therethrough, said shield being attached to the proximal end of the main housing and being movable relative to the housing between an extended position and a retracted position, in the extended position, the needle tip is substantially shielded by the shield, in the retracted position, the needle tip extends through the opening in the shield, the shield being coupled to the drive mechanism such that movement of the shield from the extended position to the retracted position causes or permits release of the drive mechanism to provide the motive power, and the shield being biased towards the extended position; a plurality of sensors, said plurality of sensors including a sensor-in-use, the sensor-in-use being coupled between the main housing and the shield to detect movement of the shield between the extended position and the retracted position; and an electric monitoring and reporting unit substantially housed within the main housing and electrically coupled to the plurality of sensors for monitoring the use of the injection device including successful medicament delivery and for reporting the use to an external device via a wireless interface of the unit, the unit being capable of operating in at least one of a lower power mode and a higher power mode, wherein, in the lower power mode, at least the sensor-in-use is monitored by the unit while other sensors and components are unable to operate or otherwise consume no power, and in the higher power mode, other sensors and components are able to operate, and wherein detection of movement of the shield from the extended position to the retracted position by the sensor-in-use causes the monitoring and reporting unit to switch from the lower power mode to the higher power mode.

2. The injection device according to claim 1, wherein the housing includes a first main housing portion and a second main housing portion, the first main housing portion and the second main housing portion being movable relative to each other between an open position and a closed position, in the open position, the syringe or cartridge can be inserted into a receiving slot defined within the first main housing portion, in the closed position, the inserted syringe or cartridge is firmly held within the receiving slot and within the housing, wherein, the shield includes a first shield portion and a second shield portion, the first shield portion being coupled to the first main housing portion, the second shield portion being coupled to the second main housing portion such that when the main housing portions are in the closed position, the shield portions are joined together to form a substantially integral shield, the shield is coupled to the drive mechanism through the first shield portion and the first main housing portion, and the sensor-in-use is coupled between the second shield portion and the second main housing portion.

3. The injection device according to claim 1 or 2, wherein the movement of the shield from the retracted position to the extended position detected by the in-use sensor causes the monitoring and reporting unit to switch from the higher power mode to the lower power mode.

4. The injection device according to any one of the preceding claims, wherein the monitoring and reporting unit includes a processor, and in the lower power mode and the higher power mode, the processor is configured to detect an interrupt signal at one or more inputs coupled to the in-use sensor.

5. The injection device according to any one of the preceding claims, wherein the in-use sensor includes a mechanical switch.

6. The injection device according to any one of the preceding claims, wherein the in-use sensor includes a microswitch.

7. The injection device according to any one of the preceding claims, wherein the other sensors at least include a sensor for detecting the start of drug delivery and a sensor for detecting the end of drug delivery.

8. An injection device for delivering a dose of a drug from a drug-containing syringe or cartridge having a needle attached thereto into a patient's body, the injection device comprising: a main housing for receiving the syringe or cartridge; a drive mechanism substantially located within the main housing for providing motive power to deliver the drug from the syringe or cartridge into the patient's body; a trigger coupled to the drive mechanism such that movement of the trigger from a first position to a second position relative to the main housing causes or permits release of the drive mechanism to provide the motive power; a plurality of sensors including an in-use sensor coupled between the main housing and the trigger to detect movement of the trigger from the first position to the second position; and an electric monitoring and reporting unit substantially housed within the main housing and electrically coupled to the plurality of sensors for monitoring the use of the injection device including successful drug delivery and for reporting the use to an external device via a wireless interface of the unit, the unit being capable of operating in at least one of a lower power mode and a higher power mode, wherein, in the lower power mode, at least the trigger is monitored by the unit while the other sensors and components are not operable or otherwise consume no power, and in the higher power mode, the other sensors and components are operable, and wherein detection of movement of the trigger from the first position to the second position by the in-use sensor causes the monitoring and reporting unit to switch from the lower power mode to the higher power mode.

9. The injection device according to claim 8, wherein the housing includes a first main housing portion and a second main housing portion movable relative to each other between an open position and a closed position, in the open position, the syringe or cartridge can be inserted into a receiving slot defined within the first main housing portion, and in the closed position, the inserted syringe or cartridge is firmly held within the receiving slot and within the housing; wherein, The shield includes a first shield portion and a second shield portion. The first shield portion is coupled to the first main housing portion, and the second shield portion is coupled to the second main housing portion such that when the main housing portions are in the closed position, the shield portions are joined together to form a substantially integral shield. The shield is coupled to the drive mechanism via the first shield portion and the first main housing portion, and the in-use sensor is coupled between the second shield portion and the second main housing portion.

10. The injection device according to claim 8 or 9, wherein detection by the in-use sensor of movement of the shield from the retracted position to the extended position causes the monitoring and reporting unit to switch from the higher power mode to the lower power mode.

11. The injection device according to any one of claims 8 - 10, wherein the monitoring and reporting unit includes a processor, and in the lower power mode and the higher power mode, the processor is configured to detect an interrupt signal at one or more inputs coupled to the in-use sensor.

12. The injection device according to any one of claims 8 - 11, wherein the in-use sensor includes a microswitch.

13. The injection device according to any one of claims 8 - 12, wherein the other sensors at least include a sensor for detecting the start of drug delivery and a sensor for detecting the end of drug delivery.

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