Injection device

Abstract

The injection device includes a housing; an actuation member movable between a first position relative to the housing and a second position relative to the housing, the actuation member arranged to prevent mechanical movement of the injection device when the actuation member is in the first position but to allow mechanical movement of the injection device when the actuation member is in the second position; an electronic circuit; and an actuation sensing device configured to detect movement of the actuation member from the first position relative to the housing to the second position relative to the housing, and the electronic circuit configured to be activated in response to movement of the actuation member from the first position relative to the housing to the second position relative to the housing detected by the actuation sensing device.

Description

Technical Field

[0001] The present invention relates to an injection device, particularly an injection device that can be activated.

Background Art

[0002] Needle-based injection systems (NIS) for self-administration of drugs such as insulin by patients are conveniently in pen form (i.e., insulin injection pens). In many examples of injection pens, drug delivery is a purely mechanical operation. However, recent variants of these injection pens include electronic components that can perform multiple functions such as dose measurement, data storage, and data transmission. These electronic components require a power supply to function. However, due to the compactness of many injection devices, there may be constraints on the size of the battery that can be accommodated within the injection device.

Summary of the Invention

Means for Solving the Problems

[0003] According to one aspect of the present invention, there is provided an injection device, the injection device comprising: a housing; an actuating member movable between a first position relative to the housing and a second position relative to the housing, the actuating member being arranged to prevent the mechanical operation of the injection device when the actuating member is in the first position, but to enable the mechanical operation of the injection device when the actuating member is in the second position; an electronic circuit; and an actuation sensing device, wherein the actuation sensing device is configured to detect movement of the actuating member from the first position relative to the housing to the second position relative to the housing, and the electronic circuit is configured to be activated in response to the actuation sensing device detecting that the actuating member has moved from the first position relative to the housing to the second position.

[0004] The mechanical operation can include a dose programming operation.

[0005] The mechanical operation can include a dosing operation.

[0006] Activation of the electronic circuit can include switching the electronic circuit from a relatively low power state to a relatively high power state.

[0007] The actuating member can include a hinge connecting member pivotally connected to the housing, and the hinge connecting member can pivot between a first position and a second position relative to the housing.

[0008] The hinge connecting member can be configured to engage with a mechanical member of the injection device and prevent movement of the mechanical member when the hinge connecting member is in the first position. The hinge connecting member can be disengaged from the mechanical member when in the second position.

[0009] The actuation sensing device can include a plurality of conductive contacts; The hinge connecting member includes a conductive portion, and the conductive contacts and the conductive portion are: The conductive portion forms an electrical connection between the conductive contacts when the actuating member is in one of the first position and the second position; and is arranged such that there is no electrical connection between the conductive contacts via the conductive portion when the actuating member is in the other of the first position and the second position.

[0010] The actuation sensing device can include a hinge switch arranged to detect whether the hinge connecting member is in the first position or the second position.

[0011] The actuation sensing device can include a reed switch; the hinge connecting member includes a magnet, and the magnet and the reed switch are arranged such that the reed switch is in a first switch state when the actuating member is in the first position and the reed switch is in a second switch state when the actuating member is in the second position.

[0012] The injection device can further include a dosage knob; the dosage knob is biased from a first linear position relative to the housing towards a second linear position relative to the housing; the hinge connecting member is configured to prevent the movement of the dosage knob from the first linear position to the second linear position when the hinge connecting member is in the first position, and the dosage knob is configured to move from the first linear position to the second linear position in response to the hinge connecting member being moved from the first position to the second position. The actuation sensing device is configured to detect the movement of the dosage knob from a first linear position relative to the housing to a second linear position relative to the housing, and the electronic circuit is configured to be activated in response to the actuation sensing device detecting that the dosage knob has moved from the first linear position relative to the housing to the second linear position relative to the housing.

[0013] The actuation member can include a container configured to hold the injection device.

[0014] The actuation member can include a container configured to hold the injection device, the actuation sensing device is configured to detect the removal of the injection device from the container, and the electronic circuit is configured to be activated in response to the actuation sensing device detecting that the injection device has been removed from the container.

[0015] The actuation member can include a color. The color can be movable from a first position relative to the housing to a second position relative to the housing. For example, the color can be movable along the housing from a first position relative to the housing to a second position relative to the housing. The color can be threadedly engaged with the housing of the injection device.

[0016] The actuation member can include a color threadedly engaged with the housing of the injection device, and the color is movable along the housing from a first position relative to the housing to a second position relative to the housing. The motion sensing device is configured to detect the movement of a color from a first position relative to the housing to a second position relative to the housing, and the electronic circuit is configured to be activated in response to the motion sensing device detecting that the color has moved from the first position relative to the housing to the second position relative to the housing.

[0017] The motion sensing device can further be configured to detect the movement of an actuating member from a second position relative to the housing to a first position relative to the housing, and the electronic circuit can be configured to be switched from an activated state to a deactivated state in response to the motion sensing device detecting that the actuating member has moved from the second position relative to the housing to the first position relative to the housing.

[0018] The injection device can further include a container for containing a medicament.

[0019] The injection device can be an injection pen or a patch pump.

[0020] The injection device can include a dose knob (and / or dose dial setting member) that is biased from a first position relative to the housing to a second position relative to the housing. The first position can be a first linear position relative to the housing, and the second position can be a second linear position relative to the housing. The actuating member can be configured to prevent movement of the dose knob (and / or dose dial setting member) from the first position of the dose knob (and / or dose dial setting member) to the second position of the dose knob (and / or dose dial setting member) when the actuating member is in the first position of the actuating member. The actuating member can be configured not to prevent movement of the dose knob (and / or dose dial setting member) from the first position of the dose knob (and / or dose dial setting member) to the second position of the dose knob (and / or dose dial setting member) when the actuating member is in the second position of the actuating member. The dose knob (and / or dose dial setting member) can be configured to move from the first position of the dose knob (and / or dose dial setting member) to the second position of the dose knob (and / or dose dial setting member) in response to the actuating member being moved from the first position of the actuating member to the second position of the actuating member. The actuation sensing device can be configured to detect movement of the dose knob (and / or dose dial setting member) from a first position relative to the housing to a second position relative to the housing, and the electronic circuit can be configured to be activated in response to the dose knob (and / or dose dial setting member) being detected by the actuation sensing device as having moved from a first position relative to the housing to a second position relative to the housing.

[0021] According to another aspect, a method of activating an injection device disclosed herein is provided, the method comprising: detecting movement of an actuating member from a first position relative to a housing to a second position relative to the housing; and activating an electronic circuit in response to detecting that the actuating member has moved from a first position relative to the housing to a second position relative to the housing.

[0022] Aspects of the present invention can better conserve the energy stored within the power supply of an injection device. Aspects of the present invention can also provide protection from accidental activation of the injection device, such as during handling, transportation, and storage of the injection device.

[0023] Exemplary embodiments of the present invention will be described with reference to the accompanying drawings.

Brief Description of the Drawings

[0024]

Figure 1

Figure 2

Figure 3A

Figure 3B

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Figure 10

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Figure 16A

Figure 16B

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Figure 18

[0025] Referring now to the embodiments of the present invention in detail, examples of the embodiments are shown in the accompanying drawings, and like reference numerals throughout the drawings refer to like elements.

[0026] Hereinafter, embodiments of the present invention can be described with reference to an insulin injection device. However, the present invention is not limited to such applications, and can be equally well introduced into injection devices that discharge other drugs.

[0027] Figure 1 is an exploded view of a drug delivery device. In this example, the drug delivery device is an injection device 1 such as Sanofi's SoloSTAR® insulin injection pen, but the aspects can also be applied to other types of injection pens or injection devices 1. Aspects of the present invention can be applied to injection devices 1 in the form of autoinjectors or patch pumps. Aspects of the present invention can be applied to injection devices 1 suitable for single-use or repeated use.

[0028] The injection device 1 of Figure 1 is a pre-filled disposable injection pen and includes a cylindrical housing 10 that houses an insulin container 14 and to which a needle 15 can be attached. The needle is attached to the distal end of the housing 10. Throughout this specification, the term "distal" refers to a location relatively close to the injection site, and the term "proximal" refers to a location relatively far from the injection site. The needle 15 is protected by an inner needle cap 16 and an outer needle cap 17 or other cap 18.

[0029] The insulin dose scheduled to be discharged from the injection device 1 can be programmed or "dialed in" by turning the dose knob 12, where the currently programmed dose is displayed, for example, in multiples of units, via the dose window 13. For example, if the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called international units (IU), where 1 IU is biologically equivalent to approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). When delivering analog insulin or other drugs, other units can also be used with the injection device. It should be noted that the selected dose can be displayed equally well in a manner different from that shown in the dose window 13 of Figure 1.

[0030] The dosage window 13 can be in the form of an aperture within the housing 10 and is configured such that as the dosage knob 12 is turned, a restricted portion of the digital sleeve 70, which moves, becomes visible to the user to provide a visual indication of the currently programmed dosage. The dosage knob 12 is rotated on a helical path relative to the housing 10 as it is turned during programming.

[0031] In this example, the dosage knob 12 includes one or more formations 71a, 71b, 71c to assist the user in gripping the dosage knob 12 during programming. The formations 71a, 71b, 71c can be grooves, ridges, etc.

[0032] The injection device 1 can be configured to produce a mechanical click sound when the dosage knob 12 is turned, providing acoustic feedback to the user. The digital sleeve 70 interacts mechanically with the piston within the insulin container 14. When the needle 15 pierces the patient's skin portion and then the injection button 11 is pressed, the insulin dosage displayed within the display window 13 is dispensed from the injection device 1. After the injection button 11 is pressed, if the needle 15 of the injection device 1 remains within the skin portion for a specific time, most of the dosage is actually injected into the patient's body. The dispensing of the insulin dosage can also produce a mechanical click sound, which is different from the sound produced when using the dosage knob 12.

[0033] In this example, during the delivery of the insulin dosage, the dosage knob 12 returns to its initial position with axial movement, i.e., without rotation, and the digital sleeve 70 rotates back to its initial position, displaying, for example, a dosage of 0 units.

[0034] The injection device 1 can be used for several injection processes until the insulin container 14 is empty or until the expiration date of the drug within the injection device 1 (e.g., 28 days from first use) is reached.

[0035] Furthermore, before using the injection device 1 for the first time, for example, select 2 units of insulin, and while holding the injection device 1 with the needle 15 facing upward, press the injection button 11 to perform a so-called "prime shot" to remove air from the insulin container 14 and the needle 15, which may be necessary. For simplicity of presentation, hereinafter, it is assumed that the amount discharged substantially corresponds to the dose to be injected, and thus, for example, the amount of the drug discharged from the injection device 1 is equal to the dose received by the user. Nevertheless, it may be necessary to consider the difference (for example, loss) between the amount discharged and the dose injected.

[0036] According to an embodiment of the present invention, the injection device 1 further houses an electronic circuit 20 schematically shown in FIG. 2.

[0037] The electronic circuit 20 can be configured to perform one or more functions of the injection device 1. For example, one or more functions can include one or more of the monitoring functions for one or more operations or variables associated with the injection device, such as a dose program or one or more operations related to the dosing of the dose. For example, the electronic circuit 20 can be configured to determine at least one of the dose dialed on the injection device 1, the dose dosed from the injection device 1, the time and / or date of the dose dialing and / or dosing, whether the operation is a priming operation or a dosing operation, or the temperature of the injection device 1.

[0038] As shown in FIG. 2, the electronic circuit 20 includes a processor device 23 including one or more processors such as a microprocessor, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), etc., together with one or more memory units 24, 25 such as a program memory 24 and a main memory 25. The memory units 24, 25 can store software for execution by the processor device 23 and data collected by the injection device 1.

[0039] A communication interface 27 can be provided. The communication interface 27 can be a wireless communication interface for communicating with another device via a wireless network such as Wi-Fi, Bluetooth (registered trademark), NFC, etc., or an interface for a wired communication link such as a socket for receiving a Universal Serial Bus (USB), mini-USB, or micro-USB connector. The other device can be a mobile computing device such as a smartphone. The processor device 23 can be configured to transmit data collected by the injection device 1 to another device via the communication interface 27. For example, the processor device 23 can be configured to transmit data indicating one or more doses administered by the injection device 1 to another device via the communication interface 27. The other device can store and / or further process the data received from the injection device 1. In some examples, the processor device 23 can be configured to transmit data to a server and / or the cloud via the communication interface 27 for storage or processing of the data.

[0040] The electronic circuit 20 can optionally include a display 22. The display 22 is disposed on the injection device 1 so as to be able to provide a visual output to the user. The display 22 can include one or more LEDs, an LCD display, or any other suitable display means. The display 22 is controlled by the processor device 23 so as to provide a visual output. The visual output can indicate to the user the state of the injection device 1, such as whether the injection device 1 is switched on or ready for injection. The visual output can indicate to the user dosage values, such as the dosage dialed into the injection device 1 or the dosage administered from the injection device 1. The visual output can indicate to the user instructions regarding how or when to perform various operations using the injection device 1, for example when to perform a priming operation. In some examples, the electronic circuit 20 can include, in addition to or instead of the display 22, an audio transducer and / or a tactile transducer (not shown). The audio transducer and / or the tactile transducer are controlled by the processor device 23 so as to provide an audio or tactile output to the user.

[0041] A power source 29, such as a battery, is provided. The power source 29 supplies power to one or more components of the electronic circuit 20.

[0042] A sensor device 26 can be provided. The sensor device 26 can include one or more sensors configured to detect or determine one or more characteristics associated with the injection device 1. For example, the sensor device 26 can include a dosage determination unit configured to determine the dosage programmed into the injection device 1 by the user and / or the dosage administered during an injection operation by the injection device 1. In some examples, the sensor device 26 can be configured to detect one or more of the following: actuation of the injection button 11 by the user, replacement of the drug container 14, removal or replacement of the cap 18.

[0043] The electronic circuit 20 further includes an actuation sensing device 28. The actuation sensing device 28 is configured to determine whether the actuating member of the injection device 1 is in a first position or a second position relative to the housing 10 of the injection device 1. This will be described in more detail in the following embodiments. The actuation sensing device 28 provides different outputs depending on whether the actuating member of the injection device 1 is in the first position or the second position.

[0044] The actuating member is arranged to prevent the mechanical operation of the injection device 1 when the actuating member is in the first position, but to enable the mechanical operation of the injection device 1 when the actuating member is in the second position. The user must move the actuating member from the first position to the second position so that the mechanical operation can be performed.

[0045] The mechanical operation can be a dose programming operation, which is also known as a dose setting operation. The presence of the actuating member in the first position prevents the dose programming operation from being performed by the user. For example, the presence of the actuating member in the first position can prevent the dose from being dialed into the injection device 1 using the dose knob 12. The actuating member in the first position can prevent at least one of the dose knob 12 from being rotated or translated relative to the housing 10 by the user, or the dose dial setting member 19 from being rotated or translated relative to the housing 10 by the user. The user must move the actuating member from the first position to the second position to enable the dose programming operation to be performed. The presence of the actuating member in the second position can enable the dose to be dialed into the injection device 1 using the dose knob 12. The actuating member in the second position can enable at least one of the dose knob 12 to be rotated or translated relative to the housing 10 by the user, or the dose dial setting member 19 to be rotated or translated relative to the housing 10 by the user.

[0046] The mechanical operation can be a dosing operation. In that case, the presence of the actuating member in the first position prevents the dosing operation from being performed by the user. For example, the presence of the actuating member in the first position can prevent the user from actuating the injection button 11 with respect to the housing. The presence of the actuating member in the first position can prevent the translational movement or rotation of the dose knob 12 with respect to the housing 10, which would normally occur during the dosing operation. The presence of the actuating member in the first position can prevent the translational movement or rotation of the dose dial setting member 19 with respect to the housing 10, which would normally occur during the dosing operation. The user must move the actuating member from the first position to the second position in order to enable the dosing operation to be performed. The presence of the actuating member in the second position can enable the injection device 1 to dispense a dose. The actuating member when in the second position can enable the user to actuate the injection button 11 with respect to the housing, enable the translational movement or rotation of the dose knob 12 with respect to the housing 10, or enable the translational movement or rotation of the dose dial setting member 19 with respect to the housing 10.

[0047] The actuation sensing device 28 is used to activate the injection device 1. The user activates the injection device 1 by moving the actuating member with respect to the housing 10 from the first position to the second position. The injection device 1 is activated in response to the actuation sensing device 28 detecting that the actuating member has moved from the first position to the second position. In particular, the electronic circuit 20 of the injection device 1 is activated in response to detecting that the actuating member has moved from the first position to the second position.

[0048] Activation of the electronic circuit 20 can mean switching on the power to one or more components of the electronic circuit 20, or can mean waking one or more components of the electronic circuit 20 from a low-power state to a high-power state. Before the electronic circuit 20 is activated, it is considered to be in a resting state or a non-activated state. In the resting state, one or more components of the electronic circuit 20 do not receive power from the power supply 29, or are in a lower-power state compared to when the electronic circuit 20 is activated.

[0049] In the resting state of the electronic circuit 20, one or more sensors of the sensor device 26 can be disconnected from the power from the power supply 29, or can be put into a low-power state. In the activated state of the electronic circuit 20, one or more sensors of the sensor device 26 that were previously in a resting state can then be supplied with power from the power supply 29, or can then be switched to a relatively higher-power state.

[0050] In some examples, when the electronic circuit 20 is in a resting state, the processor device 23 can be disconnected from the power from the power supply 29, or can be put into a low-power state (e.g., standby / stop state). After the electronic circuit 20 is activated, the processor device 23 can then receive power from the power supply 29, or can then be in a relatively higher-power state compared to the previous low-power state.

[0051] Activating the electronic circuit 20 can include switching the electronic circuit 20 from an "off" state or a "standby" state to an "on" state. Thus, activating the electronic circuit 20 can include connecting the electronic circuit 20 to the power supply 29.

[0052] The actuating member can be, for example, a catch, a latching part, a lock, a clamp, etc. The actuating member can prevent mechanical operations of the injection device 1, such as a dosing program operation or a dosing operation, from being performed. The actuating member can prevent the mechanical operation from being started accidentally, for example, during storage or transportation of the injection device 1. The actuating member can also prevent the mechanical operation from being intentionally started by a specific user, such as a child.

[0053] The presence of the actuating member in the first position can also prevent accidental activation of the electronic circuit 20, for example, during storage or transportation of the injection device 1. Thereby, the possibility of accidental consumption of the power supply 29 of the injection device 1 can be reduced.

[0054] The user has to move the actuating member in order to perform important mechanical operations, such as a dosing program or a dosing operation. Thus, the activation of the electronic circuit 20 can be intuitive for the user, since the activation is performed in response to the user having performed the operations that need to be performed in order to administer a dose. The actuating member can serve a dual purpose, both as a safety lock for the injection device 1 and as a means for activating the electronic circuit 20. Thereby, the number of steps performed by the user when administering a dose using the injection device 1 can be reduced. The operation of the injection device 1 can be simplified for the user. The safety of the injection device 1 can be improved. Unnecessary energy consumption by the electronic circuit 20 can be reduced.

[0055] Figures 3A and 3B show an injection device 1 according to a first embodiment of the invention. The injection device 1 is similar to the injection device 1 described in connection with Figures 1 and 2, but the injection device 1 also includes an actuating member. In this embodiment, the actuating member is formed as a hinge connecting member 30 and can take the form of, for example, a clamp or a latching part. The hinge connecting member 30 is pivotally connected to the housing 10 of the injection device 1 by means of a hinge 32 or the like.

[0056] By pivotally connecting the hinge connecting member 30 to the remaining portion of the injection device 1, the hinge connecting member 30 can be pivoted between a first position and a second position relative to the housing 10 of the injection device 1 by the user. FIG. 3A shows the hinge connecting member 30 in the first position relative to the housing 10, and FIG. 3B shows the hinge connecting member 30 in the second position. The pivoting direction of the hinge connecting member 30 is indicated by the curved arrow, and the translational movement of the dose dial setting member 19 and the dose knob 12 relative to the housing 10 is indicated by the dotted arrow.

[0057] In the first position, the hinge connecting member 30 is connected to the injection device 1 by the hinge 32 and the engagement function 34 of the clamp. When the hinge connecting member 30 is in the first position, the engagement function 34 is configured to prevent the hinge connecting member 30 from moving to the second position.

[0058] The hinge connecting member 30 can include a protrusion 36 extending from the body of the hinge connecting member 30, and the protrusion 36 can assist the user in moving the hinge connecting member 30 from the first position to the second position. The user can insert a part of their finger under the protrusion 36 and apply pressure to the protrusion 36 to pivot the hinge connecting member 30 from the first position to the second position around the hinge 32.

[0059] One or more mechanical operations of the injection device 1 can be blocked by the hinge connecting member 30 being in the first position, as already discussed, but can be carried out when the hinge connecting member 30 is in the second position. For example, when the hinge connecting member 30 is in the first position, the user can be prevented from programming a dose into the injection device 1. This is made possible because the engaging function 34 or another member of the hinge connecting member 30 engages with a mechanical member of the injection device 1, such as a dose dial setting element, to prevent the movement of the mechanical member. The user can move the hinge connecting member 30 from the first position to the second position so that a dose can be programmed into the injection device 1. By moving the hinge connecting member 30 from the first position to the second position, the engaging function 34 or another member of the hinge connecting member 30 that engages with the mechanical member of the injection device 1 is disengaged from the mechanical member of the injection device 1, thereby enabling the mechanical member to move. Thus, a dose can be programmed into the injection device 1. The mechanical member can be, for example, the dose knob 12 or the dose dial setting member 19.

[0060] In some examples, when the hinge connecting member 30 is in the first position, the user can be prevented from dispensing a dose using the injection device 1. This is made possible because the engaging function 34 or another member of the hinge connecting member 30 engages with a mechanical member of the injection device 1, such as a dose dispensing element, to prevent the movement of the mechanical member. The user can move the hinge connecting member 30 from the first position to the second position so that a dose can be dispensed from the injection device 1. By moving the hinge connecting member 30 from the first position to the second position, the engaging function 34 or another member of the hinge connecting member 30 that engages with the mechanical member of the injection device 1 is disengaged from the mechanical member of the injection device 1, thereby enabling the mechanical member to move. Thus, a dose can be dispensed from the injection device. The mechanical member can be, for example, the dose knob 12, the dose dial setting member 19, or the injection button 11.

[0061] By the hinge connecting member 30 being in the first position rather than the second position, preventing one or more operations of the injection device 1, it can be ensured that every time the injection device 1 is intended to perform that operation, the user must move the hinge connecting member 30 from the first position to the second position.

[0062] The actuation sensor device 28 is arranged to detect that the hinge connecting member 30 has moved from the first position to the second position. The actuation sensor device 28 can take a plurality of forms, as illustrated in FIGS. 4 - 11 discussed below.

[0063] FIG. 4 shows a schematic side view of the injection pen 1 of FIG. 3A according to the first embodiment.

[0064] The hinge connecting member 30 is movable between the first position and the second position, as already discussed. FIG. 4 shows the hinge connecting member 30 in the first position, and FIG. 5 shows the injection pen of FIG. 4 with the hinge connecting member 30 in the second position.

[0065] FIG. 4 shows the dose knob 12 separated from the housing 10 of the injection device 1 by a specific distance. This is the first position of the dose knob 12 relative to the housing 10. The dose knob 12 is capable of translational movement towards the housing 10 relative to the housing 10. The dose knob 12 is biased by a biasing member 40 to move in the direction of the housing 10. The biasing member 40 can include an elastic member such as a spring, as shown in the cut - away portion of FIG. 4. In FIG. 4, it can be seen that the biasing member 40 is connected between the housing 10 and the dose dial setting member 19. The biasing member 40 acts on the dose dial setting member 19 to bias the dose dial setting member 19 towards the housing 10 in a direction parallel to the longitudinal axis of the housing 10. The dose knob 12 is connected to the dose dial setting member 19, and thus the dose knob 12 is also biased towards the housing 10 by the biasing member 40.

[0066] In the example shown in FIG. 4, the biasing member 40 includes a spring, and when the dosage knob 12 is in the first position relative to the housing 10, the spring is in an extended state. The spring attempts to contract to its relaxed state, thereby applying a force to pull the dosage knob 12 towards the housing 10.

[0067] FIG. 4 shows one exemplary arrangement of the biasing means 40 used to bias the dosage knob 12, but any other suitable arrangement can also be used. For example, instead of connecting via the dosage dial setting member 19, the biasing member 40 can be connected between the proximal end of the housing 10 and the dosage knob 12.

[0068] The dosage knob 12 is held in its first position relative to the housing 10 by the hinge connecting member 30 when the hinge connecting member is in the first position. In this particular example, the dosage knob 12 is held in the first position by an engagement function 34 disposed between the housing 10 and the dosage knob 12.

[0069] To activate the injection device 1, the user moves the hinge connecting member 30 from the first position to the second position. FIG. 5 shows the injection device of FIG. 4 after the hinge connecting member has been moved from its first position to its second position, as indicated by the curved arrow. After the hinge connecting member 30 has been moved from its first position to its second position, the dosage knob 12 is no longer held in its first position relative to the housing 10. The dosage knob 12 then moves freely further towards the housing 10 and can reach its second position relative to the housing 10. The dosage knob 12 moves automatically from its first position to its second position due to the biasing applied by the biasing member 40. FIG. 5 shows the dosage knob 12 in its second position and thereby axially translated towards the housing 10. In the cut-away section of FIG. 5, it can be seen that the dosage dial setting member 19 also moves axially further into the housing 10 together with the dosage knob 12.

[0070] In the embodiments of FIGS. 4 and 5, the actuation sensor device 28 includes switches 42a, 42b. The switches can be microswitches or the like. Switches 42a, 42b are disposed within the injection device 1, and thus can detect whether the dose knob 12 is in its first position or its second position relative to the housing 10, thereby detecting whether the hinge connecting member 30 is in its first position or its second position relative to the housing 10. Switches 42a, 42b can be in a first state (e.g., open state) when the dose knob 12 is in its first position, and can be in a different second state (e.g., closed state) when the dose knob 12 is in its second position.

[0071] FIG. 4 shows two switches 42a, 42b disposed at different locations within the injection device 1, which is merely for showing two exemplary positions for switches 42a, 42b. In reality, it is likely that only one of switches 42a, 42b exists.

[0072] FIGS. 4 and 5 show a first exemplary location of switch 42a. Switch 42a is disposed within the housing 10. Switch 42a is arranged not to be activated by the dose dial setting member 19 when the dose knob 12 is in its first position as shown in FIG. 4, but to be activated by the dose dial setting member 19 when the dose knob is in its second position as shown in FIG. 5. Switch 42a can be in a closed state when activated and in an open state when not activated, or can be in an open state when activated and in a closed state when not activated. Thus, switch 42a can detect whether the dose knob is in its first position or its second position. The electronic circuit 20 of the injection device 1 can be activated in response to switch 42a detecting that the dose knob 12 is in its second position, and thus the hinge connecting member 30 has been moved from its first position to its second position.

[0073] Both FIGS. 4 and 5 show alternative locations for switch 42b. Here, switch 42b is disposed at the proximal end of housing 10 and is arranged to be actuated by dosage knob 12 when moving from its first position to its second position. In other examples, switch 42b can be disposed on dosage knob 12 and can be arranged to be actuated by housing 10 when dosage knob 12 moves to its second position. Any alternative suitable location for switches 42a, 42b can also be used.

[0074] The user can later return dosage knob 12 from its second position to its first position by pulling dosage knob 12 away from housing 10. The user can then move hinge link members 30 from their respective second positions to their first positions to hold dosage knob 12 in its first position. This movement of dosage knob 12 from the second position to the first position can be detected by switches 42a, 42b. In response to this detection, electronic circuit 20 can be returned from an active state to an inactive state.

[0075] Alternatively, in other examples, rather than the housing 10, the dosage knob 12 can be biased away from the housing 10 of the injection device 1. Thus, the second position of the dosage knob relative to the housing can be further away from the housing than the first position of the dosage knob 12 relative to the housing 10. The hinge connecting member 30 can extend over the entire length of the dosage knob 12, and when the hinge connecting member 30 is in the first position, the engaging function 34 is disposed relative to the proximal end of the dosage knob 12. Thus, when the hinge connecting member 30 is in its first position, the dosage knob 12 can be held in its first position relative to the housing 10, preventing the dosage knob 12 from moving to its second position relative to the housing 10. When the hinge connecting member 30 is moved from its first position to its second position, the dosage knob 12 is no longer held by the hinge connecting member 30 and can freely move from its first position to its second position under the influence of the biasing member 40. Switches 42a, 42b are disposed within the injection device to detect this movement of the dosage knob 12 from the first position to the second position and activate the electronic circuit 20.

[0076] The foregoing embodiments discussed in connection with FIGS. 4 and 5 illustrate that the dosage knob 12 is biased from the first position towards the second position. However, in other examples, a different function of the injection device 1 rather than the dosage knob 12 is biased. For example, the injection button 11 can be biased by the biasing member 40.

[0077] FIG. 6 shows the injection device 1 according to the second embodiment, particularly the proximal end of the injection device 1. The injection device is similar to the injection device 1 of FIGS. 4 and 5, but in this embodiment, the dosage knob 12 is not biased towards the housing 10.

[0078] Figure 6 shows an actuation sensor device 28 that includes two electrical contacts 60a, 60b formed on the outer surface of the dosage knob 12. The hinge connecting member 30 has a conductive portion 62 formed on a surface facing the electrical contacts 60a, 60b when the hinge connecting member 30 is in its first position. The conductive portion 62 is disposed on the hinge connecting member 30 and thus forms an electrical contact with both of the electrical contacts 60a, 60b when the hinge connecting member 30 is in the first position. The conductive portion 62 can be formed from a conductive wire, film, ink, strip, or the like.

[0079] As shown in Figure 6, the two electrical contacts 60a, 60b and the conductive portion 62 substantially form a switch that is in a "closed" state when the hinge connecting member 30 is in the first position. Thus, when the hinge connecting member 30 is in the first position, current can flow from the first electrical contact 60a to the second electrical contact 60b through the conductive portion 62.

[0080] To activate the injection device 1, the user moves the hinge connecting member 30 from the first position to the second position. Figure 7 shows the injection device 1 of Figure 6 after the hinge connecting member 30 has been moved from the first position to the second position, as indicated by the curved arrow. The conductive portion 62 no longer makes electrical contact with both of the electrical contacts 60a, 60b, and thus current can no longer flow from the first electrical contact 60a to the second electrical contact 60b. The switch is substantially formed by the two electrical contacts 60a, 60b, and thus the conductive portion 62 is in an "open" state.

[0081] The injection device 1 is activated in response to the two electrical contacts 60a, 60b detecting that the hinge connecting member 30 has moved from the first position to the second position. In this case, it is detected that the electrical contacts 60a, 60b have changed from a state of being in electrical contact through the conductive portion 62 to a state of not being in electrical contact through the conductive portion 62, thereby indicating that the hinge connecting member 30 has moved from the first position to the second position.

[0082] In some examples, the processor device 23 determines that current can no longer flow from the first electrical contact 60a to the second electrical contact 60b, and in response, activates the electronic circuit 20. In other examples, when the hinge connecting member 30 is in its first position, a switch substantially formed by the two electrical contacts 60a, 60b and the conductive portion 62 shorts the connection between the power supply 29 and one or more components of the electronic circuit 20. However, when the hinge connecting member 30 is in its second position, the connection between the power supply 29 and one or more components is no longer shorted by the two electrical contacts 60a, 60b and the conductive portion 62, and power can be supplied from the power supply 29 to one or more components of the electronic circuit 20.

[0083] Figures 6 and 7 both show the electrical contacts 60a, 60b formed on the outer surface of the dosage knob 12. However, in other examples, the electrical contacts 60a, 60b can also be placed at other locations on the injection device 1, such as on the dosage dial sleeve 19, the housing 10, or the injection button 11. In some examples, both of the electrical contacts 60a, 60b can be formed on the hinge connecting member 30, and the conductive portion 62 is disposed on the dosage knob 12, the dosage dial sleeve 19, the housing 10, or the injection button 11.

[0084] After moving the hinge connecting member 30 from the first position to the second position, for example, after the injection is completed, the user can subsequently move the hinge connecting member 30 back from its second position to its first position. By this operation, the first electrical contact 60a and the second electrical contact 60b are reconnected via the conductive portion 62. This reconnection can be detected by the processor device 23. In response to this detection, the electronic circuit 20 can be returned from the activated state to the dormant state.

[0085] Figure 8 shows the injection device 1 according to the third embodiment. The injection device 1 is similar to the injection device of FIG. 6, but the actuation sensor device 28 instead includes a reed switch 80 disposed within the dose knob 12. The reed switch 80 is movable between an open state and a closed state. The reed switch 80 is normally in the open state, but can move to the closed state when a magnet 82 is present. Alternatively, the reed switch 80 is normally in the open state, but can also move to the closed state when a magnet 82 is present.

[0086] The magnet 82 is disposed within the hinge connecting member 30, for example, proximate to the surface of the hinge connecting member 30 adjacent to the outer surface of the injection device 1 when the hinge connecting member 30 is in its first position. The reed switch 80 and the magnet 82 are each arranged such that the magnet 82 interacts with the reed switch 80 when the hinge connecting member 30 is in the first position, but does not interact when in the second position.

[0087] To activate the injection device 1, the user moves the hinge connecting member 30 from the first position to the second position. FIG. 9 shows the injection device 1 of FIG. 8 after the hinge connecting member 30 has been moved to the second position, as indicated by the arrow. When the hinge connecting member 30 is moved from the first position to the second position, the magnet 82 is moved away from the reed switch 80. When the hinge connecting member 30 is in the first position, the magnet 82 interacts with the reed switch 80 to maintain the reed switch 80 in a first switch state (open or closed). However, when the hinge connecting member 30 is moved to the second position, the magnet 82 has a relatively small or zero interaction with the reed switch 80, and as a result, the reed switch moves to a second switch state (closed or open).

[0088] The injection device 1 is activated in response to the reed switch 80 detecting that the hinge connecting member 30 has moved from a first position to a second position. In this case, it is detected that the reed switch 80 has changed from a closed state to an open state (or from an open state to a closed state), thereby indicating that the hinge connecting member 30 has moved from the first position to the second position. As described above, in response to this detection, the injection device 1 is activated.

[0089] The user can subsequently return the hinge connecting member 30 from its second position to its first position, thereby bringing the magnet 82 closer to the reed switch 80 again and activating the reed switch 80 (i.e., moving it from a closed state to an open state or vice versa). In response to the reed switch 80 detecting that the hinge connecting member 30 has returned to its first position, the electronic circuit 20 can be returned from an activated state to a standby state. This can be performed by the processor device 23.

[0090] Figures 10 and 11 show the injection device 1 according to the fourth embodiment. The injection device 1 is similar to the injection device of FIG. 6, but the actuation sensor device 28 includes a hinge switch 100 instead. The hinge switch 100 is arranged close to the hinge 32 or forms part of the hinge 32. The hinge switch 100 is movable between a first switch state and a second switch state. As shown in FIG. 10, when the hinge connecting member 30 is in a first position relative to the housing 10, the hinge switch 100 is in the first switch state. As shown in FIG. 11, when the hinge connecting member 30 is in a second position relative to the housing 10, the hinge switch 100 is in the second switch state. The first switch state can be an open switch state, and the second switch state is a closed switch state. However, in other examples, the first switch state can be a closed switch state, and the second switch state is an open switch state.

[0091] Figure 10 shows the hinge connecting member 30 in the first position and the hinge switch 100 in the first switch state. To activate the injection device 1, the user moves the hinge connecting member 30 from the first position to the second position. Figure 11 shows the hinge connecting member 30 in the second position after being rotated in the direction indicated by the arrow, and the hinge switch 100 is in the second switch state here.

[0092] The injection device 1 is activated in response to detecting that the hinge switch 100 has moved from the first switch state to the second switch state. The injection device 1 can be activated as previously described in connection with other embodiments.

[0093] The user can then return the hinge connecting member 30 from its second position to its first position. The movement of the hinge connecting member 30 from the second position to the first position can be detected by the hinge switch 100. In response to this detection, the processor device 23 can return the electronic circuit 20 from the active state to the inactive state.

[0094] Figure 12 shows the injection device 1 according to the fifth embodiment of the present invention. The injection device 1 partially shown in Figure 12 is similar to the injection device 1 previously described in connection with Figure 3, but the actuating member of the injection device 1 includes a collar 120 instead of the hinge connecting member 30.

[0095] The collar 120 is concentrically arranged around the cylindrical housing 10 of the injection device 1 at the proximal end of the housing 10. Thus, the collar 120 is arranged at the same end of the housing 10 as the dose knob 12.

[0096] Figure 13 shows the same injection device 1 of FIG. 12, but the collar 120 is shown in cross section for clarity. The collar 120 has threads 124 formed on the inner surface of the collar 120. The threads 124 are configured to interact with corresponding threads 126 formed on the outer surface of the housing 10. The threads 124 of the collar 120 and the threads 126 of the housing are arranged to interact such that when the collar 120 rotates about the housing 10, the collar 120 translates axially along the longitudinal axis of the housing 10.

[0097] When the collar 120 rotates relative to the housing 10 in a first rotational direction about the longitudinal axis of the housing 10, the collar 120 translates axially in a first axial direction along the longitudinal axis of the housing 10, for example, from the proximal end of the housing 10 towards the distal end. Conversely, when the collar 120 rotates relative to the housing 10 in a second rotational direction opposite the first rotational direction about the longitudinal axis of the housing 10, the collar 120 translates axially in a second axial direction opposite the first axial direction along the longitudinal axis of the housing 10, for example, from the distal end of the housing 10 towards the proximal end.

[0098] Figure 13 shows a collar 120 having a flange 128 disposed at the proximal end of the collar 120. The flange 128 extends between the housing 10 and the dose knob 12 and is disposed to project radially towards the center of the aperture formed by the collar 120. The flange 128 is arranged to prevent the dose knob 12 from moving through the collar 120. Thus, the flange 128 restricts movement of the dose knob 12 towards the housing 10. The dose knob 12 can translate towards the housing 10 until the distal surface 129 of the dose knob 12 contacts the flange 128, and after the distal surface 129 of the dose knob 12 contacts the flange 128, further movement of the dose knob 12 towards the housing 10 is prevented.

[0099] In some examples, the diameter of the dose knob 12 can be made larger than the diameter of the aperture of the collar 120, thereby preventing the dose knob 12 from moving through the collar 120. Accordingly, the flange 128 is not required on the collar 120.

[0100] One or more mechanical operations of the injection device 1 can be blocked by the presence of the collar 120 in the first position, similar to those described in the embodiment of FIG. 3A, but can be executed when the collar 120 is in the second position. For example, the presence of the collar 120 in the first position can prevent the dose knob 12 from being used for dose dial setting operations and / or dose dispensing operations. When the collar 120 is moved to the second position of the collar 120, the dose dial setting operation and / or dose dispensing operation can then be permitted.

[0101] The dose knob 12 can be biased towards the housing 10 from a first position relative to the housing 10 to a second position relative to the housing 10, as previously described in connection with FIGS. 4 and 5.

[0102] To activate the injection device 1, the user moves the collar 120 from a first position relative to the housing 10 to a second position relative to the housing 10 by rotating the collar 120 as already discussed. As the collar 120 rotates relative to the housing 10, the collar 120 translates along the housing 10 from the proximal end to the distal end of the housing 10. Accordingly, the first and second positions of the collar 120 relative to the housing 10 are linear positions relative to the housing 10, but can also be rotational positions.

[0103] Figure 14 shows the injection device 1 of FIG. 12 after the user rotates the color 120 and the color 120 is moved to the second position. FIG. 15 shows the injection device 1 of FIG. 14, where the color 120 is shown in a sectional view for convenience. In FIGS. 14 and 15, it can be seen that the color 120 is being translated along the length of the housing 10 and along the longitudinal axis of the injection device 1. When the dose knob 12 is biased towards the housing 10, the dose knob 12 also moves towards the housing 10 from the first position to the second position of the dose knob 12 relative to the housing 10 together with the color 120. The dose knob 12 abuts against the flange 128, but due to the presence of the flange 128, it cannot move further towards the housing 10.

[0104] FIGS. 12 and 13 show the dose knob 12 in the first position relative to the housing 10, and FIGS. 14 and 15 show the dose knob 12 in the second position relative to the housing 10. The actuation sensing device 28 is configured to detect whether the color 120 has moved from its first position to its second position by detecting whether the dose knob 12 has moved from its first position to its second position. The injection device 1 is activated in response to the actuation sensing device 28 detecting that the dose knob 12 has been moved from its first position to its second position.

[0105] Similar to the embodiment described in connection with FIGS. 4 and 5, the actuation sensing device 28 can include switches 42a, 42b that are activated when the dose knob 12 is moved to its second position due to the biasing member 40.

[0106] In another example, the motion sensing device 28 includes a switch 42c arranged to be directly activated by the color 120. FIGS. 13 and 15 show the switch 42c disposed on the surface 127 at the proximal end of the housing 10. The switch 42c is arranged to be in a first state (open or closed) when the color 120 is in its first position along the housing 10, as shown in FIG. 13. However, the switch 42c is arranged to be moved to a second different state (closed or open) after the color 120 is moved to its second position along the housing 10, as shown in FIG. 15. FIG. 15 shows that the switch 42c is pressed by the flange 128 of the color 120 when the color is in its second position, but alternatively, the switch 42c can be pressed by a different member of the color 120.

[0107] Accordingly, the switch 42c is capable of detecting whether the color 120 has moved from its first position to its second position. In such an example, it is not necessary for the dose knob 12 to be biased towards the housing 10. This means that the dose knob 12 can remain in its first position relative to the housing 10 when the color 120 is moved from its first position to its second position.

[0108] FIGS. 16A and 16B show an injection device 1 according to a sixth embodiment. The injection device 1 shown in FIGS. 16A and 16B is similar to the injection device described in relation to FIGS. 1 and 2, but here the injection device 1 includes an actuating member formed as a container 160. Removal or at least partial removal of the injection device 1 from the container 160 causes activation of the electronic circuit 20 within the injection device 1. Aspects of this embodiment are particularly suitable for single-use injection devices 1 such as auto-injectors that should not be returned into the container 160 after removal.

[0109] Container 160 is configured to hold the injection device 1. FIG. 16A shows the injection device 1 when held within the container 160, and FIG. 16B shows the injection device 1 of FIG. 16A when partially removed from the container 160.

[0110] Container 160 is formed from a body 162, a first holding function 164, and a second holding function 166. The first holding function 164 and the second holding function 166 each extend upward from the body 162 of the container 160 to form a recess 168 between the first holding function 164 and the second holding function 166. The recess 168 is dimensioned to at least partially accommodate the injection device 1.

[0111] The injection devices 1 of FIGS. 16A and 16B are similar to the injection device 1 described above in relation to FIG. 4 in that the dose knob 12 is biased relative to the housing 10. However, in the embodiments of FIGS. 16A and 16B, the dose knob 12 is biased in a direction away from the housing 10 rather than in a direction toward the housing 10. This biasing can be facilitated by using an elastic member or the like as already discussed, or any other suitable means.

[0112] FIG. 16A shows the dose knob 12 in a first position relative to the housing 10. FIG. 16B shows the dose knob in a second position relative to the housing 10. The second position of the dose knob 12 is farther from the housing 10 than the first position of the dose knob 12. The dose knob 12 is biased from the first position toward the second position. When the dose knob 12 moves from the first position to the second position, the dose knob 12 translates away from the housing 10 in a direction parallel to the longitudinal axis of the housing 10.

[0113] The first holding function 164 and the second holding function 166 of the container 160 are separated by a distance such that the injection device 1 can be held between the first holding function 164 and the second holding function 166 when the dose knob 12 is in its first position relative to the housing 10, but is not held when the dose knob 12 is in its second position relative to the housing 10. This is because when the dose knob 12 is in the first position, the injection device 1 has a shorter longitudinal length compared to when it is in the second position.

[0114] Figure 16A shows the dose knob 12 in its first position, and thus the injection device 1 is held between the first holding function 164 and the second holding function 166 of the container 160. The second holding function 166 contacts the dose knob 12 and / or the injection button 11, and the first holding function 164 contacts a function at the distal end of the injection device 1, such as the distal end of the cap 18. The dose knob 12 is biased from the first position towards the second position, thereby applying a force to the first holding function 164 and the second holding function 166. The force applied to the first holding function 164 and the second holding function 166 can hold the injection device 1 in a fixed position within the container 160.

[0115] To activate the injection device 1, the user removes the injection device 1 from the container 160 at least partially. Figure 16B shows the injection device 1 of Figure 16A after being partially removed from the container 160 by the user. The user is lifting the injection device 1 out of the container 160. When the proximal end of the injection device 1 is separated from the container 160, the dose knob 12 no longer contacts the second holding function 166. The dose knob 12 can no longer apply a force to the second holding function 166, and thus by biasing the dose knob 12 away from the housing 10, the dose knob 12 moves from its first position to its second position relative to the housing 10. Figure 16B shows the dose knob 12 in its second position relative to the housing 10.

[0116] The injection device 1 houses an actuation sensing device 28 configured to detect that the dosage knob 12 moves from its first position relative to the housing 10 to its second position relative to the housing 10, and thus that the injection device 1 has been at least partially removed from the container 160. The actuation sensing device can include switches 42a, 42b, 42c as described above in connection with other embodiments, for example. The switches 42a, 42b, 42c are arranged within the injection device such that they are closed when the dosage knob 12 is in its first position and open when the dosage knob 12 is in its second position, or vice versa. Thus, the switches 42a, 42b, 42c detect whether the dosage knob 12 is in its first position or its second position. In response to detecting that the dosage knob 12 has moved from its first position to its second position, the electronic circuit 20 can be activated.

[0117] In some examples, the electronic circuit 20 of the injection device 1 can be returned to a dormant state by placing the injection device 1 back into the container 160. This process is similar to but the reverse of that described above with reference to FIGS. 16A and 16B. The dosage knob 12 starts in the second position relative to the housing 10 when the injection device 1 is not within the container 160. However, the user must move the dosage knob 12 from the second position to the first position when the injection device 1 is placed between the first retaining feature 164 and the second retaining feature 166 within the container 160. This can be detected by the sensors 42a, 42b, 42c as already discussed. In response to detecting that the dosage knob 12 has moved from the second position to the first position, the electronic circuit 20 can be placed in a dormant state.

[0118] As shown in FIG. 16A, the injection device 1 held within the container 160 can be considered to be in a first position relative to the housing 10 of the injection device 1. As already discussed, when the container 160 is in its first position, at least one mechanical operation of the injection device can be blocked. In this example, the container 160 prevents movement of the dose knob 12 and thus prevents both the dose programming operation and the dose dispensing operation from being performed. As shown in FIG. 16B, removing the container 160 at least partially from the injection device 1 can be considered that the container 160 is in a second position relative to the housing 10 of the injection device 1. As already discussed, when the container 160 is in its second position, here at least one mechanical operation of the injection device can no longer be blocked. In this example, the container 160 no longer prevents movement of the dose knob 12 and thus no longer prevents either the dose programming operation or the dose dispensing operation from being performed.

[0119] FIG. 17 is a flowchart showing a method of activating the injection device 1 according to any of the foregoing embodiments. This method is executed, for example, by the motion sensing device 28 and the processor device 23.

[0120] In step 170, movement of the actuating member from a first position relative to the housing 10 of the injection device 1 to a second position relative to the housing 10 of the injection device 1 is detected by the motion sensing device 28. The actuating member is moved from the first position to the second position by a user of the injection device 1.

[0121] In step 172, in response to detection of movement of the actuating member from the first position to the second position, as already discussed, the electronic circuit 20 is activated.

[0122] In some examples, step 172 is performed as soon as it is detected by the actuation sensing device 28 that the actuating member has moved from its first position relative to the housing 10 of the injection device 1 to its second position relative to the housing 10 of the injection device 1. However, in other examples, step 172 is performed after a predetermined period of time has elapsed since detection by the actuation sensing device 28. The predetermined period can be, for example, a period of 1 second to 110 seconds.

[0123] In some examples, after a predetermined period of time has elapsed, it is detected again whether the actuating member remains in its second position. If the actuating member remains in its second position, step 172 is performed. However, if the actuating member does not remain in its second position, step 172 is not performed and the electronic circuit remains in its standby state. In some examples, step 172 can be performed only if it is detected that the actuating member has remained in its second position throughout the predetermined period.

[0124] FIG. 18 is a flowchart showing a further method according to a further aspect of the present invention that can be implemented by any of the injection devices 1 of the foregoing embodiments. The method steps of FIG. 18 can be performed after the method step 172 of FIG. 17.

[0125] In step 180, movement of the actuating member from its second position relative to the housing 10 to its first position relative to the housing 10 is detected by the actuation sensing device 28.

[0126] In step 182, the electronic circuit 20 waits for a predetermined period of time to elapse in response to detection by the actuation sensing device 28. The predetermined period can be, for example, a period of 1 second to 10 seconds, 3 seconds, etc.

[0127] In operation 184, after a predetermined period has elapsed, it is detected whether the actuating member remains in the first position. If the actuating member remains in the first position, the method proceeds to operation 186, where the electronic circuit 20 is moved from an active state to a standby state. If the actuating member does not remain in the first position, the electronic circuit 20 remains in the active state. In some examples, the actuating member must remain in the first position throughout the predetermined period such that the electronic circuit 20 enters the standby state.

[0128] In some examples, operation 184 does not exist. Thus, the method proceeds directly from operation 182 to operation 186. By waiting for a predetermined period before putting the electronic circuit 20 into the standby state, additional time is provided to the processor device 23 to complete the currently running function.

[0129] In some examples, neither operation 180 nor operation 184 exists. In such cases, the method proceeds directly from operation 182 to operation 186. Thus, the electronic circuit 20 enters the standby state almost immediately in response to detecting that the actuating member has moved from its first position to its second position.

[0130] The above embodiments have been described generally with respect to the injection device 1 which is a pen injector. However, it should be noted that the present invention is not limited thereto and can also be applied to other types of injection devices 1 including autoinjectors and patch pumps.

[0131] The terms "drug" or "agent" are used synonymously herein to describe a pharmaceutical formulation comprising one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, optionally together with a pharmaceutically acceptable carrier. An active pharmaceutical ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicine is used to treat, cure, prevent, or diagnose a disease or, alternatively, to improve physical or mental well-being. A drug or agent can be used for a limited duration or, in the case of a chronic disorder, periodically.

[0132] As described below, a drug or agent can contain at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs include small molecules having a molecular weight of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids can be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0133] A drug or medicament can be contained in a primary package or “drug container” adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for containing one or more drugs (e.g., short-term or long-term containment). For example, in some cases, the chamber can be designed to contain the drug for at least one day (e.g., one day to at least 30 days). In some cases, the chamber can be designed to contain the drug for about one month to about two years. The containment can be carried out at room temperature (e.g., about 20 °C) or refrigerated temperature (e.g., about -4 °C to about 4 °C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately contain in each chamber two or more components of the pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs). In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during dosing into a human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and allow mixing of the two components by the user before dosing if desired. Alternatively or additionally, the two chambers can be configured to allow mixing during dosing of the components into a human or animal body.

[0134] The drugs or agents included in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes such as diabetic retinopathy, thromboembolic disorders such as deep vein thrombosis or pulmonary embolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those described in handbooks such as the Rote Liste 2014 (for example, but not limited to, main group 12 (antidiabetic agents) or 86 (oncological agents)) or the Merck Index, 15th edition.

[0135] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, such as human insulin, or human insulin analogs or derivatives, glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof, or mixtures of any of them. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, such as the structure of human insulin, by deletion and / or exchange of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues can be any of the codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example, a molecular structure of human insulin in which one or more organic substituents (for example, fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids including non-codable amino acids, or amino acids are added including those non-codable for the naturally occurring peptide.

[0136] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 may be replaced by Asp, Lys, Leu, Val or Ala and the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28 - B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0137] Examples of insulin derivatives are, for example, B29 - N - myristoyl - des(B30) human insulin, Lys(B29)(N - tetradecanoyl) - des(B30) human insulin (insulin detemir, Levemir®); B29 - N - palmitoyl - des(B30) human insulin; B29 - N - myristoyl human insulin; B29 - N - palmitoyl human insulin; B28 - N - myristoyl LysB28ProB29 human insulin; B28 - N - palmitoyl - LysB28ProB29 human insulin; B30 - N - myristoyl - ThrB29LysB30 human insulin; B30 - N - palmitoyl - ThrB29LysB30 human insulin; B29 - N - (N - palmitoyl - gamma - glutamyl) - des(B30) human insulin, B29 - N - omega - carboxypentadecanoyl - gamma - L - glutamyl - des(B30) human insulin (insulin degludec, Tresiba®); B29 - N - (N - lithocholyl - gamma - glutamyl) - des(B30) human insulin; B29 - N - (omega - carboxyheptadecanoyl) - des(B30) human insulin and B29 - N - (omega - carboxyheptadecanoyl) human insulin.

[0138] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39-amino acid peptide produced by the salivary gland of the Gila monster), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), r exendin-4, CJC-1134-PC, PB-1023, TTP-054, langlenatide / HM-11260C, CM-3, GLP-1 eligon, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexen, biadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN, and glucagon-Xten.

[0139] Examples of oligonucleotides include, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic agent for the treatment of familial hypercholesterolemia.

[0140] Examples of DPP4 inhibitors include vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0141] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, for example, gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (Somatropine) (Somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0142] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives, or sulfated polysaccharides such as the polysaccharides described above in poly-sulfated form, and / or their pharmaceutically acceptable salts. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. Examples of hyaluronic acid derivatives are hylan G-F20 (Synvisc (registered trademark)), sodium hyaluronate.

[0143] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab’)2 fragments that retain the ability to bind to an antigen. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, fully human antibodies, non-human (e.g., murine) antibodies, or single-chain antibodies. In some embodiments, the antibody has effector functions and is capable of fixing complement. In some embodiments, the antibody has a reduced or no ability to bind to an Fc receptor. For example, the antibody can be an isotype or subtype, antibody fragment or mutant that does not assist in binding to an Fc receptor, for example, having a mutation or deletion in the Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable domain antibody-like binding proteins having a crossover binding region orientation (CODV).

[0144] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., an antibody heavy chain and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include a full-length antibody polypeptide but still includes at least a portion of the full-length antibody polypeptide that is capable of binding to an antigen. An antibody fragment can include a cleaved portion of a full-length antibody polypeptide, but the term is not limited to such cleaved fragments. Antibody fragments useful in the present disclosure include, for example, Fab fragments, F(ab’)2 fragments, scFv (single-chain Fv) fragments, linear antibodies, single-specific or multispecific antibody fragments, such as bispecific, trispecific, tetra-specific, and multispecific antibodies (e.g., diabodies, triabodies, tetra-bodies), monovalent or polyvalent antibody fragments, such as divalent, trivalent, tetravalent, and polyvalent antibodies, minibodies, chelated recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0145] The term "complementary determining region" or "CDR" refers to short polypeptide sequences within the variable regions of both heavy and light chain polypeptides that primarily play a role in mediating specific antigen recognition. The term "framework region" refers to the amino acid sequences within the variable regions of both heavy and light chain polypeptides that are not CDR sequences and primarily play a role in maintaining the proper arrangement of the CDR sequences to enable antigen binding. The framework region itself typically does not directly participate in antigen binding, but as is known in the art, certain residues within the framework region of a particular antibody can directly participate in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0146] Examples of antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0147] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use in a drug or agent in a drug delivery device. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0148] Without departing from the full scope and spirit of the present disclosure, various components of the APIs, formulations, devices, methods, systems, and embodiments described herein can be modified (added and / or removed), and it will be understood by those skilled in the art that the present disclosure encompasses such modified forms and any equivalents thereof.

Claims

1. An injection device (1), comprising: a housing (10); an actuating member movable between a first position relative to the housing and a second position relative to the housing, the actuating member being arranged to prevent the mechanical operation of the injection device when in the first position and to enable the mechanical operation of the injection device when in the second position; an electronic circuit (20); an actuation sensing device (28), wherein the actuating member includes a collar (120) screwed to the housing of the injection device, the collar being movable along the housing from a first position relative to the housing to a second position relative to the housing, the actuation sensing device being configured to detect movement of the collar from a first position relative to the housing to a second position relative to the housing, wherein the actuation sensing device is configured to detect movement of the actuating member from a first position relative to the housing to a second position relative to the housing, and the electronic circuit is configured to be activated in response to the actuation sensing device detecting that the collar has moved from a first position relative to the housing to a second position relative to the housing.

2. The injection device according to claim 1, wherein the mechanical operation includes a dose programming operation.

3. The injection device according to claim 1 or 2, wherein the mechanical operation includes a dose dispensing operation.

4. The injection device according to claim 1, 2 or 3, wherein activation of the electronic circuit includes switching the electronic circuit from a relatively low power state to a relatively high power state.

5. An injection device (1), comprising: a housing (10); an actuating member movable between a first position relative to the housing and a second position relative to the housing, the actuating member being arranged to prevent the mechanical operation of the injection device when in the first position and to enable the mechanical operation of the injection device when in the second position; an electronic circuit (20); an actuation sensing device (28), wherein the actuation sensing device is configured to detect movement of the actuating member from a first position relative to the housing to a second position relative to the housing, and the actuating member includes a hinge connecting member (30) pivotally connected to the housing, the hinge connecting member being pivotable between a first position and a second position relative to the housing. The electronic circuit is configured to be activated in response to the activation sensing device detecting that the actuating member has moved from a first position relative to the housing to a second position relative to the housing. The activation sensing device includes a reed switch (80); The hinge connecting member includes a magnet (82), The magnet and the reed switch are arranged such that when the actuating member is in the first position, the reed switch is in a first switch state, and when the actuating member is in the second position, the reed switch is in a second switch state. Said injection device.

6. The activation sensing device includes a plurality of conductive contacts (60a, 60b); The hinge connecting member includes a conductive portion (62), The conductive contacts and the conductive portion are: When the conductive portion is in one of the first position and the second position of the actuating member, an electrical connection is formed between the conductive contacts; When the actuating member is in the other of the first position and the second position, the arrangement is such that there is no electrical connection between the conductive contacts via the conductive portion. The injection device according to claim 5.

7. The injection device according to claim 5, wherein the activation sensing device includes a hinge switch (100) arranged to detect whether the hinge connecting member is in the first position or the second position.

8. Further includes a dosage knob (12); Here, the dosage knob is biased from a first linear position relative to the housing towards a second linear position relative to the housing; The hinge connecting member is configured to prevent the movement of the dosage knob from the first linear position to the second linear position when the hinge connecting member is in the first position, The dosage knob is configured to move from the first linear position to the second linear position in response to the hinge connecting member being moved from the first position to the second position, The activation sensing device is configured to detect the movement of the dosage knob from a first linear position relative to the housing to a second linear position relative to the housing, The electronic circuit is configured to be activated in response to the activation sensing device detecting that the dosage knob has moved from a first linear position relative to the housing to a second linear position relative to the housing. The injection device according to claim 5.

9. The actuating member includes a container (160) configured to hold the injection device, The activation sensing device is configured to detect the removal of the injection device from the container. The electronic circuit is configured to be activated in response to the operating sensing device detecting that the injection device has been removed from the container. The injection device according to any one of claims 1 to 4. **Claim 10** The operating sensing device is further configured to detect the movement of the operating member from a second position relative to the housing to a first position relative to the housing. The electronic circuit is configured to be switched from an activated state to a standby state in response to the operating sensing device detecting that the operating member has moved from a second position relative to the housing to a first position relative to the housing. The injection device according to any one of claims 1 to 9. **Claim 11** The injection device according to any one of claims 1 to 10, further comprising a container (14) for containing a drug. **Claim 12** The injection device according to any one of claims 1 to 11, wherein the injection device is an injection pen or a patch pump. **Claim 13** A method of activating the injection device (1) according to any one of claims 1 to 12, comprising: detecting (170) the movement of the operating member from a first position relative to the housing to a second position relative to the housing; and activating (172) the electronic circuit in response to detecting that the operating member has moved from a first position relative to the housing to a second position relative to the housing. ​ ​ ​ ​

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