Injection device

Abstract

An injection device includes: a housing; an actuating member movable between a first position relative to the housing and a second position relative to the housing, wherein the actuating member is arranged to prevent mechanical operation of the injection device when the actuating member is in the first position, but to allow the mechanical operation of the injection device when the actuating member is in the second position; electronic circuitry; and an actuation sensing component 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 wherein the electronic circuitry is configured to be activated in response to the actuation sensing component detecting that the actuating member has moved from the first position relative to the housing to the second position relative to the housing.

Description

[0001] This invention relates to an injection device, and more particularly to an actuable injection device. Background Technology

[0002] Needle-based injection systems (NIS) for patient self-administration of medications such as insulin can take the convenient form of a pen (i.e., an insulin pen). In many examples of injection pens, drug delivery is a purely mechanical operation. However, more recent variations of these pens include electronic components capable of performing multiple functions, such as dose measurement, data storage, and data transmission. These electronic components require a power source to operate. However, the compact nature of many injection devices limits the size of the battery that can be accommodated within the device. Summary of the Invention

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

[0004] The mechanical operation may include dose programming operation.

[0005] The mechanical operation may include a dose dispensing operation.

[0006] Starting the electronic circuit may include switching the electronic circuit from a relatively low power state to a relatively high power state.

[0007] The actuating member may include a hinge member pivotally connected to the housing, such that the hinge member is pivotable between a first position and a second position relative to the housing.

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

[0009] The actuation sensing component may include multiple conductive contacts;

[0010] The hinge member includes a conductive portion, wherein the conductive contact and the conductive portion are arranged such that:

[0011] When the actuating member is in one of the first and second positions, the conductive part forms an electrical connection between the conductive contacts; and when the actuating member is in the other of the first and second positions, there is no electrical connection between the conductive contacts via the conductive part.

[0012] The actuation sensing component may include a hinge switch arranged to detect whether the hinge member is in the first position or the second position.

[0013] The actuation sensing component may include a reed switch; and the hinge member includes a magnet, wherein the magnet and the reed switch are arranged such that the reed switch is in a first switching state when the actuation member is in the first position and the reed switch is in a second switching state when the actuation member is in the second position.

[0014] The injection device may further include a dosage knob; wherein the dosage knob is biased from a first linear position relative to the housing toward a second linear position relative to the housing; wherein the hinge member is configured to prevent the dosage knob from moving from the first linear position to the second linear position when the hinge member is in the first position, wherein the dosage knob is configured to move from the first linear position to the second linear position in response to the hinge member moving from the first position to the second position.

[0015] The actuation sensing component is configured to detect movement of the dose knob from a first linear position relative to the housing to a second linear position relative to the housing, and the electronic circuitry is configured to be activated in response to the actuation sensing component detecting that the dose knob has moved from the first linear position relative to the housing to the second linear position relative to the housing.

[0016] The actuating component may include a container configured to hold the injection device.

[0017] The actuation component may include a container configured to hold the injection device, wherein the actuation sensing component is configured to detect the removal of the injection device from the container, and wherein the electronic circuitry is configured to be activated in response to the actuation sensing component detecting that the injection device has been removed from the container.

[0018] The actuating member may include a collar. The collar may be movable from a first position relative to the housing to a second position relative to the housing. For example, the collar may be movable along the housing from the first position relative to the housing to the second position relative to the housing. The collar may be threadedly engaged with the housing of the injection device.

[0019] The actuating member may include a collar threadedly engaged with the housing of the injection device, wherein the collar is movable along the housing from a first position relative to the housing to a second position relative to the housing.

[0020] The actuation sensing component is configured to detect movement of the collar from a first position relative to the housing to a second position relative to the housing, and the electronic circuitry is configured to be activated in response to the actuation sensing component detecting that the collar has moved from the first position relative to the housing to the second position relative to the housing.

[0021] The actuation sensing component may be further configured to detect movement of the actuating member from the second position relative to the housing to the second position relative to the housing, and the electronic circuitry may be configured to switch from an active state to a dormant state in response to the actuation sensing component detecting that the actuating member has moved from the second position relative to the housing to the first position relative to the housing.

[0022] The injection device may further include a container for holding the drug.

[0023] The injection device can be an injection pen or a patch pump.

[0024] The injection device may include a dose knob (and / or dose selection member) biased from a first position relative to the housing toward a second position relative to the housing. The first position may be a first linear position relative to the housing, and the second position may be a second linear position relative to the housing. An actuating member may be configured to prevent the dose knob (and / or dose selection member) from moving from the first position to the second position when the actuating member is in the first position. The actuating member may also be configured not to prevent the dose knob (and / or dose selection member) from moving from the first position to the second position when the actuating member is in the second position. The dose knob (and / or dose selection member) can be configured to move from the first position of the dose knob (and / or dose selection member) to the second position of the dose knob (and / or dose selection member) in response to moving the actuation member from the first position of the actuation member to the second position of the actuation member. The actuation sensing component can be configured to detect the movement of the dose knob (and / or dose selection member) from the first position relative to the housing to the second position relative to the housing, and the electronic circuitry can be configured to be activated in response to the actuation sensing component detecting that the dose knob (and / or dose selection member) has moved from the first position relative to the housing to the second position relative to the housing.

[0025] According to another aspect, a method for activating the injection device disclosed herein is provided, the method comprising: detecting movement of the actuating member from a first position relative to the housing to a second position relative to the housing, and activating the electronic circuitry in response to detecting that the actuating member has moved from the first position relative to the housing to the second position relative to the housing.

[0026] Various aspects of the present invention can better conserve energy stored in the power source of the injection device. These aspects can also provide protection, such as preventing accidental activation of the injection device during handling, transportation, and storage. Attached Figure Description

[0027] Exemplary embodiments of the present invention have been described with reference to the accompanying drawings, in which:

[0028] Figure 1 is a side view of an injection device applicable to an embodiment of the present invention;

[0029] Figure 2 is a schematic diagram of the electronic circuitry inside the injection device shown in Figure 1.

[0030] Figure 3A is a side view of an injection device according to a first embodiment of the present invention;

[0031] Figure 3B is a side view of the injection device of Figure 3A, in which the actuating components are in different positions;

[0032] Figure 4 is a schematic partial cross-sectional view of the injection device of Figure 3A, in which the hinge member is in the first position;

[0033] Figure 5 is a schematic partial cross-sectional view of the injection device of Figure 4, in which the hinge member is in the second position;

[0034] Figure 6 is a schematic partial side view of an injection device according to a second embodiment of the present invention, wherein the hinge member is in a first position;

[0035] Figure 7 is a schematic partial side view of the injection device of Figure 6, in which the hinge member is in the second position;

[0036] Figure 8 is a schematic partial side view of an injection device according to a third embodiment of the present invention, wherein the hinge member is in a first position;

[0037] Figure 9 is a schematic partial side view of the injection device of Figure 8, in which the hinge member is in the second position;

[0038] Figure 10 is a schematic partial side view of an injection device according to a fourth embodiment of the present invention, wherein the hinge member is in a first position;

[0039] Figure 11 is a schematic partial side view of the injection device of Figure 10, in which the hinge member is in the second position;

[0040] Figure 12 is a schematic partial side view of an injection device according to a fifth embodiment of the present invention, wherein the collar is in a first position;

[0041] Figure 13 is a schematic partial cross-sectional view of the injection device in Figure 12;

[0042] Figure 14 is a schematic partial side view of the injection device of Figure 12, in which the collar is in the second position;

[0043] Figure 15 is a schematic partial cross-sectional view of the injection device in Figure 14;

[0044] Figure 16A is a schematic side view of an injection device according to a sixth embodiment of the present invention, wherein the injection device is held in a container;

[0045] Figure 16B is a schematic partial side view of the injection device of Figure 16A, wherein the injection device is partially removed from the container;

[0046] Figure 17 is a flowchart illustrating a method according to another aspect of the present invention;

[0047] Figure 18 is a flowchart illustrating a method according to another aspect of the present invention.

[0048] Reference will now be made in detail to embodiments of the invention, examples of which are shown in the accompanying drawings, wherein the same reference numerals always refer to the same elements. Detailed Implementation

[0049] In the following description, embodiments of the invention may be referenced to insulin injection devices. However, the invention is not limited to this application and can also be used with injection devices that spray other medications.

[0050] 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. This invention relates to an insulin pen, but aspects of which can be applied to other types of pens or injection devices 1. Various aspects of the invention can be applied to injection devices 1 in the form of auto-injectors or patch pumps. Various aspects of the invention can be applied to injection devices 1 suitable for single-use or reusable applications.

[0051] The injection device 1 in Figure 1 is a pre-filled disposable injection pen, comprising a cylindrical housing 10 and containing an insulin container 14, to which a needle 15 can be attached. The needle is attached to the distal end of the housing 10. Throughout the text, the term "distal" refers to a position relatively closer to the injection site, and the term "proximal" refers to a position relatively farther 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.

[0052] The insulin dose to be dispensed from the injection device 1 can be programmed or 'selected' by turning the dose knob 12, and then displayed (e.g., in multiples of units) via the dose window 13. For example, when the injection device 1 is configured to administer human insulin, the dose can be displayed in so-called International Units (IU), one IU being the biological equivalent of approximately 45.5 micrograms of pure crystalline insulin (1 / 22 mg). Other units can be used in the injection device for delivering insulin analogs or other agents. It should be noted that the selected dose can be displayed just as well in a manner different from that shown in the dose window 13 in Figure 1.

[0053] The dosage window 13 may take the form of an aperture in the housing 10, allowing the user to view a limited portion of the digital sleeve 70, which is configured to move when the dosage knob 12 is turned to provide a visual indication of the currently programmed dosage. When turned during programming, the dosage knob 12 rotates in a helical path relative to the housing 10.

[0054] In this example, the dosage knob 12 includes one or more features 71a, 71b, 71c to help the user grasp the dosage number 12 during programming. Features 71a, 71b, 71c can be grooves, ridges, etc.

[0055] The injection device 1 can be configured such that turning the dosage knob 12 produces a mechanical click to provide acoustic feedback to the user. The digital sleeve 70 interacts mechanically with a piston in the insulin container 14. When the needle 15 is inserted into the patient's skin and the injection button 11 is then pushed, the insulin dose displayed in the display window 13 is dispensed from the injection device 1. Most of the dose is actually injected into the patient while the needle 15 of the injection device 1 remains in the skin for a period of time after the injection button 11 is pushed. The dispensing of the insulin dose also produces a mechanical click, but it is different from the sound produced when the dosage knob 12 is used.

[0056] In this example, during insulin dose delivery, the dose knob 12 moves axially to its initial position, that is, does not rotate, while the digital sleeve 70 rotates back to its initial position, for example, displaying a dose of zero units.

[0057] The injection device 1 can be used for several injections until the insulin container 14 is emptied or the medication in the injection device 1 reaches its expiration date (e.g., 28 days after the first use).

[0058] Furthermore, before using the injection device 1 for the first time, a so-called "preparation for injection" may be necessary to remove air from the insulin container 14 and needle 15, for example, by selecting two units of insulin and pressing the injection button 11 while keeping the needle 15 of the injection device 1 facing upwards. For ease of presentation, it will be assumed below that the ejected volume substantially corresponds to the injected dose, such that, for example, the dose of medication expelled from the injection device 1 is equal to the dose received by the user. However, the difference between the ejected volume and the injected dose (e.g., loss) may need to be considered.

[0059] According to an embodiment of the present invention, the injection device 1 further includes electronic circuitry 20, as schematically shown in FIG2.

[0060] Electronic circuitry 20 may be configured to perform one or more functions of the injection device 1. For example, the one or more functions may include one or more monitoring functions for one or more operations (such as one or more operations related to dose programming or dose dispensing) or variables associated with the injection device. For example, electronic circuitry 20 may be configured to determine at least one of the following: the dose dialed into the injection device 1, the dose dispensed from the injection device 1, the time and / or date of dose dialing and / or dose dispensing, whether the operation is a pre-injection operation or a dose dispensing operation, or the temperature of the injection device 1.

[0061] As shown in Figure 2, the electronic circuit 20 includes a processor component 23, which includes 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.; and one or more memory units 24, 25, such as a program memory 24 and a main memory 25, which can store software executed by the processor component 23 and data collected by the injection device 1.

[0062] A communication interface 27 may be provided, which can be used for communication via wireless networks (such as Wi-Fi, Bluetooth). The processor component 23 is a wireless communication interface (such as NFC) for communicating with another device; or an interface for wired communication links, such as a port for receiving Universal Serial Bus (USB), mini-USB, or micro-USB connectors. Other devices may be mobile computing devices, such as smartphones. The processor component 23 may be configured to transmit data collected by the injection device 1 to another device via the communication interface 27. For example, the processor component 23 may be configured to transmit data indicating one or more doses dispensed by the injection device 1 to another device via the communication interface 27. The other device may store and / or further process the data received from the injection device 1. In some examples, the processor component 23 may be configured to transmit data to a server and / or the cloud via the communication interface 27 for data storage or processing.

[0063] Electronic circuitry 20 may optionally include a display 22. The display 22 is located on the injection device 1 such that it can provide visual output to a user. The display 22 may include one or more LEDs, an LCD display, or any other suitable display device. The display 22 is controlled by processor component 20 to provide visual output. The visual output may indicate to the user the status of the injection device 1, such as whether the injection device 1 is turned on or ready for injection. The visual output may indicate to the user dosage values, such as the dose dialed into or dispensed from the injection device 1. The visual output may instruct the user on how or when to perform various operations using the injection device 1, such as when to perform a pre-injection operation. In some examples, electronic circuitry 20 may include an audio transducer and / or a tactile transducer (not shown) as a supplement to or alternative to the display 22. The audio transducer and / or tactile transducer is controlled by processor component 23 to provide audio or tactile output to the user.

[0064] 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.

[0065] A sensor assembly 26 may be provided. The sensor assembly 26 may include one or more sensors configured to detect or determine one or more characteristics associated with the injection device 1. For example, the sensor assembly 26 may include a dose determination unit configured to determine a dose programmed into the injection device 1 by a user, and / or a dose dispensed by the injection device 1 during an injection operation. In some examples, the sensor assembly 26 may be configured to detect one or more of the following: user actuation of the injection button 11, replacement of the medication container 14, removal or replacement of the cap 18, etc.

[0066] The electronic circuit 20 further includes an actuation sensing component 28. The actuation sensing component 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 is described in more detail in the following embodiments. The actuation sensing component 28 provides different outputs depending on whether the actuating member of the injection device 1 is in the first position or the second position.

[0067] The actuating member is arranged to prevent mechanical operation of the injection device 1 when it is in a first position, but to allow mechanical operation of the injection device 1 when it is in a second position. The user must move the actuating member from the first position to the second position so that mechanical operation can occur.

[0068] The mechanical operation can be a dose programming operation, also known as a dose setting operation. The actuator being in a first position prevents the user from performing a dose programming operation. For example, the actuator being in the first position prevents the dose from being transferred into the injection device 1 using the dose knob 12. When in the first position, the actuator prevents the user from rotating or translating the dose knob 12 relative to the housing 10, or from rotating or translating the dose selection member 19 relative to the housing 10, at least one of these operations. The user must move the actuator from the first position to a second position to allow the dose programming operation to occur. The actuator being in the second position allows the dose to be transferred into the injection device 1 using the dose knob 12. When in the second position, the actuator allows the user to rotate or translate the dose knob 12 relative to the housing 10, or from rotating or translating the dose selection member 19 relative to the housing 10, at least one of these operations.

[0069] The mechanical operation can be a dose dispensing operation, in which case the actuator being in a first position prevents the user from performing the dose dispensing operation. For example, the actuator being in the first position can prevent the user from actuating the injection button 11 relative to the housing. The actuator being in the first position can prevent the translation or rotation of the dose knob 12 relative to the housing 10, which would otherwise occur during the dose dispensing operation. The actuator being in the first position can prevent the translation or rotation of the dose selection member 19 relative to the housing 10, which would otherwise occur during the dose dispensing operation. The user must move the actuator from the first position to a second position to allow the dose dispensing operation to occur. The actuator being in the second position allows the injection device 1 to dispense the dose. When in the second position, the actuator can allow the user to actuate the injection button 11 relative to the housing, allow the dose knob 12 to translate or rotate relative to the housing 10, or allow the dose selection member 19 to translate or rotate relative to the housing 10.

[0070] The actuation sensing component 28 is used to activate the injection device 1. The user activates the injection device 1 by moving the actuating member relative to the housing 10 from a first position to a second position. The injection device 1 is activated in response to the actuation sensing component 28 detecting that the actuating member has moved from the first position to the second position. Specifically, the electronic circuitry 20 of the injection device 1 is activated in response to the detection that the actuating member has moved from the first position to the second position.

[0071] Activating electronic circuit 20 can mean turning on the power supply to one or more components of electronic circuit 20, or it can mean waking one or more components of electronic circuit 20 from a low-power state to a higher-power state. Before being activated, electronic circuit 20 is referred to as being in a dormant or inactive state. In the dormant state, one or more components of electronic circuit 20 do not receive power from power source 29, or are in a low-power state relative to when electronic circuit 20 is activated.

[0072] In the sleep state of electronic circuit 20, one or more sensors of sensor assembly 26 can be cut off from power supply 29 or can be in a low-power state. In the start state of electronic circuit 20, one or more sensors of sensor assembly 26 that were previously in sleep state can be immediately powered from power supply 29 or can be immediately switched to a relatively high-power state.

[0073] In some examples, when electronic circuit 20 is in a dormant state, processor component 23 may be cut off from power supply 29 or may be in a low-power state (e.g., standby / off state). Once electronic circuit 20 has been activated, processor component 23 may immediately receive power from power supply 29 or may immediately be in a relatively higher-power state compared to the previous low-power state.

[0074] Starting the electronic circuit 20 may include switching the electronic circuit 20 from an "off" or "standby" state to an "on" state. Therefore, starting the electronic circuit 20 may include connecting the electronic circuit 20 to a power supply 29.

[0075] The actuating component can be a fastener, pin, lock, clamp, etc. The actuating component prevents mechanical operation of the injection device 1 (such as dose programming or dose dispensing operations) from occurring. The actuating component prevents accidental initiation of mechanical operation, such as during storage or transportation of the injection device 1. The actuating component also prevents certain users (such as children) from intentionally initiating mechanical operation.

[0076] The presence of the actuating component can also prevent the electronic circuit 20 from being accidentally activated, for example, during the storage or transport of the injection device 1. This reduces the possibility that the power supply 29 of the injection device 1 may be accidentally depleted.

[0077] The user must move the actuating component to perform important mechanical operations, such as dose programming or dispensing. Therefore, the activation of electronic circuit 20 can be intuitive for the user, as activation is performed in response to the user performing the action they need to take to administer the dose. The actuating component can serve a dual purpose: as a safety lock for the injection device 1 and as a device for activating electronic circuit 20. This reduces the number of steps the user needs to take when administering a dose using injection device 1. It simplifies the operation of injection device 1 for the user. It improves the safety of injection device 1. It reduces unnecessary energy consumption of electronic circuit 20.

[0078] Figures 3A and 3B illustrate an injection device 1 according to a first embodiment of the present invention. The injection device 1 is similar to the injection device 1 described with respect to Figures 1 and 2; however, the injection device 1 also includes an actuating member. In this embodiment, the actuating member is formed as a hinge member 30, which may take the form of, for example, a clamp or a pin. The hinge member 30 is pivotally connected to the housing 10 of the injection device 1 via a hinge element 32 or the like.

[0079] The hinge member 30 is pivotally connected to the rest of the injection device 1, allowing the user to pivot the hinge member 30 between a first position and a second position relative to the housing 10 of the injection device 1. Figure 3A shows the hinge member 30 in the first position relative to the housing 10, while Figure 3B shows the hinge member 30 in the second position. The pivoting direction of the hinge member 30 is indicated by a curved arrow, while the translation of the dose selection member 19 and the dose knob 12 toward the housing 10 is indicated by a dashed arrow.

[0080] In the first position, the hinge member 30 is connected to the injection device 1 via the hinge 32 and the engagement feature 34 of the clamp. When the hinge member 30 is in the first position, the engagement feature 34 is configured to prevent the hinge member 30 from moving to the second position.

[0081] The hinge member 30 may include a protrusion 36 extending from the body of the hinge member 30, which can assist a user in moving the hinge member 30 from a first position to a second position. A user can insert a portion of their finger under the protrusion 36 and apply pressure to the protrusion 36 to pivot the hinge member 30 about the hinge 32 from the first position to the second position.

[0082] One or more mechanical operations of the injection device 1 can be prevented by the hinge member 30 being in a first position, but can be performed when the hinge member 30 is in a second position, as previously discussed. For example, when the hinge member 30 is in the first position, the user can be prevented from programming a dose into the injection device 1. This may be because the engagement feature 34 or another portion of the hinge member 30 engages with a mechanical part of the injection device 1, such as a dose selection element for preventing movement of the mechanical part. The user can move the hinge member 30 from the first position to the second position, allowing the dose to be programmed into the injection device 1. Moving the hinge member 30 from the first position to the second position causes the engagement feature 34 or another portion of the hinge member 30 that engages with the mechanical part of the injection device 1 to disengage from the mechanical part of the injection device 1, thereby allowing the mechanical part to move. The dose can then be programmed into the injection device 1. The mechanical part may be, for example, a dose knob 12 or a dose selection element 19.

[0083] In some examples, when the hinge member 30 is in the first position, it may prevent the user from using the injection device 1 to dispense a dose. This may be because the engagement feature 34 or another portion of the hinge member 30 engages with a mechanical part of the injection device 1, such as a dose dispensing element for preventing movement of the mechanical part. The user can move the hinge member 30 from the first position to a second position, allowing a dose to be dispensed from the injection device 1. Moving the hinge member 30 from the first position to the second position causes the engagement feature 34 or another portion of the hinge member 30 that engages with the mechanical part of the injection device 1 to disengage from the mechanical part of the injection device 1, thereby allowing the mechanical part to move. The dose can then be dispensed from the injection device. The mechanical part may be, for example, a dose knob 12, a dose selector 19, or an injection button 11.

[0084] By preventing one or more operations of the injection device 1 by placing the hinge member 30 in the first position instead of the second position, it is ensured that the user will be forced to move the hinge member 30 from the first position to the second position each time they intend to perform the operation with the injection device 1.

[0085] The actuation sensor assembly 28 is arranged to detect when the hinge member 30 has moved from the first position to the second position. The actuation sensor assembly 28 can take various forms, as illustrated in Figures 4 through 11 and discussed below.

[0086] Figure 4 shows a schematic side view of the injection pen 1 of Figure 3A according to the first embodiment.

[0087] As discussed earlier, the hinge member 30 is movable between a first position and a second position. Figure 4 shows the hinge member 30 in the first position, while Figure 5 shows the injection pen of Figure 4, but the hinge member 30 is in the second position.

[0088] Figure 4 shows the dosage knob 12 spaced at a specific distance from the housing 10 of the injection device 1. This is the first position of the dosage knob 12 relative to the housing 10. The dosage knob 12 is capable of translation relative to the housing 10. The dosage knob 12 is biased by a biasing member 40 to move in a direction toward the housing 10. The biasing member 40 may include an elastic member, such as a spring, as shown in the cross-sectional view of Figure 4. As can be seen in Figure 4, the biasing member 40 is connected between the housing 10 and the dosage selection member 19. The biasing member 40 acts on the dosage selection member 19 to bias the dosage selection member 19 toward the housing 10 in a direction parallel to the longitudinal axis of the housing 10. The dosage knob 12 is connected to the dosage selection member 19, and therefore the dosage knob 12 is also biased toward the housing 10 by the biasing member 40.

[0089] In the example shown in Figure 4, the biasing member 40 includes a spring that is in a stretched state when the dosage knob 12 is in a first position relative to the housing 10. The spring attempts to contract to its relaxed state, thereby applying a force that attempts to pull the dosage knob 12 toward the housing 10.

[0090] Figure 4 shows an example arrangement of the biasing device 40 used to bias the dose knob 12; however, any other suitable arrangement may be used. For example, the biasing member 40 may be coupled between the proximal end of the housing 10 and the dose knob 12 without via the dose selection member 19.

[0091] When the hinge member is in the first position, the dose knob 12 is held in its first position relative to the housing 10 by the hinge member 30. In this particular example, the dose knob 12 is held in the first position by an engagement feature 35 located between the housing 10 and the dose knob 12.

[0092] To activate the injection device 1, the user moves the hinge member 30 from a first position to a second position. Figure 5 shows the injection device of Figure 4 when the hinge member has moved from its first position to its second position (as indicated by the curved arrow). Once the hinge member 30 has 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 can now move freely further toward the housing 10 and into its second position relative to the housing 10. Due to the bias applied by the bias member 40, the dosage knob 12 automatically moves from its first position to its second position. Figure 5 shows the dosage knob 12 in its second position, whereby it has been axially translated toward the housing 10. As can be seen in the cross-sectional view of Figure 5, the dosage selection member 19 also translates axially in conjunction with the dosage knob 12, further into the housing 10.

[0093] In the embodiments of Figures 4 and 5, the actuation sensor assembly 28 includes switches 42a and 42b. These switches may be miniature switches or the like. Switches 42a and 42b are arranged in the injection device 1 such that they can detect whether the dosage knob 12 is in a first position or a second position relative to the housing 10, thereby detecting whether the hinge member 30 is in a first position or a second position relative to the housing 10. When the dosage knob 12 is in its first position, switches 42a and 42b may be in a first state (e.g., open), while when the dosage knob 12 is in its second position, switches 42a and 42b may be in a different second state (e.g., closed).

[0094] Figure 4 shows two switches 42a and 42b arranged in different positions in the injection device 1; however, this is only to illustrate two example positions of switches 42a and 42b. In reality, only one of switches 42a and 42b may be present.

[0095] Figures 4 and 5 show a first example of the position of switch 42a. Switch 42a is located within housing 10. Switch 42a is positioned such that it is not activated by dose selection member 19 when dose knob 12 is in its first position (as shown in Figure 4), but is activated by dose selection member 19 when dose knob is in its second position (as shown in Figure 5). Switch 42a can be closed when activated and open when not activated, or it can be open when activated and closed when not activated. Therefore, switch 42a is capable of detecting whether the dose knob is in the first or second position. In response to switch 42a detecting that dose knob 12 is in the second position and therefore hinge member 30 has moved from its first position to its second position, electronic circuitry 20 of injection device 20 can be activated.

[0096] Figures 4 and 5 both show alternative positions for switch 42b. Here, switch 42b is located near the end of housing 10 and is arranged to be actuated by the dose knob 12 when it moves from its first position to its second position. In other examples, switch 42b may be located on the dose knob 12 and may be arranged to be actuated by housing 10 when the dose knob 12 moves to its second position. Any suitable alternative positions for switches 42a and 42b may be used.

[0097] The user can then move the dosage knob 12 from its second position back to its first position by pulling it off the housing 10. The user can then move the hinge member 30 from its corresponding second position to its first position to hold the dosage knob 12 in its first position. This movement of the dosage knob 12 from the second position to the first position can be detected by switches 42a, 42b. In response to the detection, the electronic circuit 20 can move from an active state back to a dormant state.

[0098] In other examples, the dosage knob 12 may instead be biased away from the housing 10 of the injection device 1, rather than towards the housing 10. Therefore, the second position of the dosage knob relative to the housing may be farther than the first position of the dosage knob 12 relative to the housing 10. The hinge member 30 may extend across the entire length of the dosage knob 12, wherein when the hinge member 30 is in the first position, the engagement feature 34 is positioned against the proximal end of the dosage knob 12. Thus, when the hinge member 30 is in its first position, it can hold the dosage knob 12 in its first position relative to the housing 10 and prevent the dosage knob 12 from moving to the second position relative to the housing 10. When the hinge member 30 moves from its first position to its second position, the dosage knob 12 is no longer held by the hinge member 30 and moves freely from its first position to its second position under the influence of the biasing member 40. Switches 42a, 42b are arranged in the injection device to detect the movement of the dosage knob 12 from the first position to the second position, thereby activating the electronic circuit 20.

[0099] The embodiments discussed in Figures 4 and 5 describe a dosage knob 12 biased from a first position toward a second position. However, in other examples, it is another feature of the injection device 1, rather than the dosage knob 12, that is biased. For example, the injection button 11 may be biased by the biasing member 40.

[0100] Figure 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 Figures 4 and 5; however, in this embodiment, the dosage knob 12 may not be biased toward the housing 10.

[0101] Figure 6 shows an actuated sensor assembly 28, which includes two electrical contacts 60a and 60b formed on the outer surface of a dosage knob 12. A hinge member 30 has a conductive portion 62 formed on its surface, which faces the electrical contacts 60a and 60b when the hinge member 30 is in its first position. The conductive portion 62 is located on the hinge member 30 such that when the hinge member 30 is in its first position, the conductive portion forms electrical contact with both electrical contacts 60a and 60b. The conductive portion 62 can be formed of conductive wire, film, ink, strip, etc.

[0102] The two electrical contacts 60a and 60b and the conductive portion 62 effectively form a switch that is "closed" when the hinge member 30 is in the first position, as shown in FIG6. Therefore, when the hinge member 30 is in the first position, current can flow from the first electrical contact 60a to the second electrical contact 60b via the conductive portion 62.

[0103] To activate the injection device 1, the user moves the hinge member 30 from the first position to the second position. Figure 7 shows the injection device 1 of Figure 6 after the hinge member 30 has been moved from the first position to the second position (as indicated by the curved arrow). The conductive part 62 is no longer in electrical contact with both electrical contacts 60a and 60b, and therefore current can no longer flow from the first electrical contact 60a to the second electrical contact 60b. The switch effectively formed by the two electrical contacts 60a and 60b and the conductive part 62 is thus "open".

[0104] In response to the detection via two electrical contacts 60a and 60b that the hinge member 30 has moved from the first position to the second position, the injection device 1 is activated. In this case, the detection that the electrical contacts 60a and 60b have changed from being in electrical contact via the conductive part 62 to no longer being in electrical contact via the conductive part 62 indicates that the hinge member 30 has moved from the first position to the second position.

[0105] In some examples, processor component 23 determines that current can no longer flow from the first electrical contact 60a to the second electrical contact 60b and activates electronic circuit 20 in response. In other examples, the switch effectively formed by the two electrical contacts 60a, 60b and conductive portion 62 short-circuits the connection between power supply 29 and one or more components of electronic circuit 20 when hinge member 30 is in its first state. However, when hinge member 30 is in its second position, the connection between power supply 29 and said one or more components is no longer short-circuited by the two electrical contacts 60a, 60b and conductive portion 62, thereby allowing power to be supplied from power supply 29 to one or more components of electronic circuit 20.

[0106] Figures 6 and 7 show electrical contacts 60a and 60b, both formed on the outer surface of the dosage knob 12. However, in other examples, electrical contacts 60a and 60b may be located elsewhere on the injection device 1, such as on the dosage dial sleeve 19, the housing 10, or the injection button 11. In some examples, electrical contacts 60a and 60b may be formed on the hinge member 30, while the conductive part 62 is located on the dosage knob 12, the dosage dial sleeve 19, the housing 10, or the injection button 11.

[0107] After the hinge member 30 is moved from the first position to the second position, the user can then move the hinge member 30 back from its second position to its first position, for example, after the injection has been completed. This action reconnects the first electrical contact 60a and the second electrical contact 60b via the conductive part 62. This reconnection can be detected by the processor component 23. In response to the detection, the electronic circuit 20 can move from the start-up state back to the sleep state.

[0108] Figure 8 illustrates an injection device 1 according to a third embodiment. The injection device 1 is similar to the injection device of Figure 6; however, the actuation sensor assembly 28 alternatively includes a reed switch 80 located in the dosage knob 12. The reed switch 80 is movable between an open state and a closed state. The reed switch 80 can normally be in the open state, but moves to the closed state in the presence of the magnet 82. Alternatively, the reed switch 80 can normally be in the open state, but moves to the closed state in the presence of the magnet 82.

[0109] Magnet 82 is located in hinge member 30, for example, when hinge member 30 is in its first position, the magnet is close to the surface of hinge member 30 adjacent to the outer surface of injection device 1. Reed switch 80 and magnet 82 are each positioned such that magnet 82 interacts with reed switch 80 when hinge member 30 is in the first position, but does not interact when it is in the second position.

[0110] To activate the injection device 1, the user moves the hinge member 30 from a first position to a second position. Figure 9 shows the injection device 1 of Figure 8 when the hinge member 30 has been moved to the second position (as indicated by the arrow). As the hinge member 30 moves from the first position to the second position, the magnet 82 is removed from the reed switch 80. When the hinge member 30 is in the first position, the magnet 82 interacts with the reed switch 80 to maintain it in a first switching state (open or closed). However, when the hinge member 30 moves to the second position, the interaction between the magnet 82 and the reed switch 80 is relatively small or nonexistent, causing the reed switch to move to a second switching state (closed or open).

[0111] In response to the detection via reed switch 80 that the hinge member 30 has moved from the first position to the second position, the injection device 1 is activated. In this case, the detection that the reed switch 80 has changed from a closed state to an open state (or from an open state to a closed state) indicates that the hinge member 30 has moved from the first position to the second position. In response to this detection, the injection device 1 is activated as previously described.

[0112] The user can then move the hinge member 30 from its second position back to its first position, thereby bringing the magnet 82 back to the vicinity of the reed switch 80 and causing the reed switch 80 to be activated (i.e., moved from a closed state to an open state, or vice versa). In response to detecting the hinge member 30 returning to its first position via the reed switch 80, the electronic circuitry 20 can move from an activated state back to a dormant state. This can be performed by the processor component 23.

[0113] Figures 10 and 11 illustrate an injection device 1 according to a fourth embodiment. The injection device 1 is similar to the injection device of Figure 6; however, the actuation sensor assembly 28 alternatively includes a hinge switch 100. The hinge switch 100 is located near or forms part of the hinge member 32. The hinge switch 100 is movable between a first switching state and a second switching state. As shown in Figure 10, the hinge switch 100 is in the first switching state when the hinge member 30 is in a first position relative to the housing 10. As shown in Figure 11, the hinge switch 100 is in the second switching state when the hinge member 30 is in a second position relative to the housing 10. The first switching state can be an open switch state, and the second switching state can be a closed switch state. However, in other examples, the first switching state can be a closed switch state, and the second switching state can be an open switch state.

[0114] Figure 10 shows the hinge member 30 in the first position and the hinge switch 100 in the first switching state. To activate the injection device 1, the user moves the hinge member 30 from the first position to the second position. Figure 11 shows the hinge member 30 now in the second position after being rotated in the direction indicated by the arrow, while the hinge switch 100 is now in the second switching state.

[0115] In response to the detection that the hinge switch 100 has moved from a first switch state to a second switch state, the injection device 1 is activated. The injection device 1 can be activated as previously described with respect to other embodiments.

[0116] The user can then move the hinge member 30 from its second position back to its first position. The movement of the hinge member 30 from the second position to the first position can be detected by the hinge sensor 100. In response to this detection, the processor assembly 23 can move the electronic circuitry 20 from an active state back to a sleep state.

[0117] Figure 12 illustrates an injection device 1 according to a fifth embodiment of the present invention. The injection device 1 shown in part in Figure 12 is similar to the injection device 1 previously described with respect to Figure 3; however, the actuating member of the injection device 1 includes a collar 120 instead of a hinge member 30.

[0118] The collar 120 is concentrically positioned around the cylindrical housing 10 of the injection device 1 at the proximal end of the housing 10. Therefore, the collar 120 and the dosage knob 12 are located at the same end of the housing 10.

[0119] Figure 13 shows the same injection device 1 as in Figure 12; however, for clarity, the collar 120 is shown in cross-section. The collar 120 has threads 124 formed on its inner surface. 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 rotation of the collar 120 about the housing 10 causes the collar 120 to translate axially along the longitudinal axis of the housing 10.

[0120] Rotation of the collar 120 about the longitudinal axis of the housing 10 in a first rotational direction, and relative to the housing 10, causes the collar 120 to translate axially along the longitudinal axis of the housing 10 in the first axial direction, for example, from the proximal end of the housing 10 toward the distal end. Conversely, rotation of the collar 120 about the longitudinal axis of the housing 10 in a second rotational direction opposite to the first rotational direction, and relative to the housing 10, causes the collar 120 to translate axially along the longitudinal axis of the housing 10 in the second axial direction opposite to the first axial direction, for example, from the distal end of the housing 10 toward the proximal end.

[0121] Figure 13 shows a collar 120 having a flange 128 located at the proximal end of the collar 120. The flange 128 is arranged such that it extends between the housing 10 and the dose knob 12, projecting radially toward 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. Therefore, the flange 128 restricts the movement of the dose knob 12 toward the housing 10. The dose knob 12 can be translated toward the housing 10 until the distal surface 129 of the dose knob 12 contacts the flange 128, after which further movement of the dose knob 12 toward the housing 10 is prevented.

[0122] In some examples, the diameter of the dose knob 12 can be larger than the diameter of the orifice of the collar 120, thereby preventing the dose knob 12 from moving through the collar 120. Therefore, a flange 128 is not required on the collar 120.

[0123] One or more mechanical operations of the injection device 1 can be prevented by the collar 120 being in a first position, but can be performed in a similar manner to that described in the embodiment of FIG. 3A when the collar 120 is in a second position. For example, the collar 120 being in the first position prevents the dose knob 12 from being used for dose selection and / or dose dispensing operations. If the collar 120 is moved to the second position, dose selection and / or dose dispensing operations are immediately permitted.

[0124] The dosage knob 12 can be biased toward the housing 10 from a first position relative to the housing 10 toward a second position relative to the housing 10, as previously described with respect to Figures 4 and 5.

[0125] 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 previously discussed. The rotation of the collar 120 relative to the housing 10 causes it to translate along the housing 10 from the proximal end toward the distal end. Therefore, the first and second positions of the collar 120 relative to the housing 10 are linear positions relative to the housing 10, but they can also be rotational positions.

[0126] Figure 14 shows the injection device 1 of Figure 12 when the collar 120 is moved to the second position by the user rotating the collar 120. Figure 15 shows the injection device 1 of Figure 14, but for convenience, the collar 120 is shown in cross section. As can be seen in Figures 14 and 15, the collar 120 has been translated along the longitudinal axis of the injection device 1 and along the length of the housing 10. The biasing of the dosage knob 12 toward the housing 10 has caused the dosage knob 12 to also move toward the housing 10 from the first position relative to the housing 10 to the second position, in cooperation with the collar 120. The dosage knob 12 is adjacent to the flange 128, but cannot move further toward the housing 10 due to the presence of the flange 128.

[0127] Figures 12 and 13 show the dosage knob 12 in a first position relative to the housing 10, while Figures 14 and 15 show the dosage knob 12 in a second position relative to the housing 10. The actuation sensing component 28 is configured to detect whether the collar 120 has moved from its first position to its second position by detecting whether the dosage knob 12 has moved from its first position to its second position. In response to the actuation sensing component 28 detecting that the dosage knob 12 has moved from its first position to its second position, the injection device 1 is activated.

[0128] Similar to the embodiments described with respect to Figures 4 and 5, the actuation sensing component 28 may include switches 42a, 42b, which are activated by the dose knob 12 being moved to its second position due to the bias member 400.

[0129] In other examples, the actuation sensing component 28 includes a switch 42c, which is arranged to be directly actuated by the collar 120. Figures 13 and 15 show the switch 42c located on surface 127 near the proximal end of the housing 10. As shown in Figure 13, when the collar 120 is in its first position along the housing 10, the switch 42c is arranged in a first state (open or closed). However, as shown in Figure 15, when the collar 120 has moved to its second position along the housing 10, the switch 42c is arranged to move to a different second state (closed or open). Figure 15 shows the switch 42c pressed by the flange 128 of the collar 120 when the collar is in its second position; however, the switch 42c can alternatively be pressed by another portion of the collar 120.

[0130] Switch 42c is therefore able to detect whether collar 120 has moved from its first position to its second position. In such an example, dose knob 12 does not need to be biased toward housing 10. This means that as collar 120 moves from its first position to its second position, dose knob 12 can remain in its first position relative to housing 10.

[0131] Figures 16A and 16B illustrate an injection device 1 according to a sixth embodiment. The injection device 1 shown in Figures 16A and 16B is similar to the injection device described with respect to Figures 1 and 2; however, the injection device 1 now 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 circuitry 20 within the injection device 1. Various aspects of this embodiment may be particularly suitable for single-use injection devices 1, such as auto-injectors and injection devices 1 that are not returned to the container 160 after removal.

[0132] Container 160 is configured to hold injection device 1. Figure 16A shows injection device 1 when held in container 160, while Figure 16B shows injection device 1 when partially removed from container 160 as shown in Figure 16A.

[0133] The container 160 is formed by a body 162, a first retaining feature 164, and a second retaining feature 166. The first retaining feature 164 and the second retaining feature 166 each extend upward from the body 162 of the container 160 to form a recess 168 therebetween. The recess 168 is sized to at least partially accommodate the injection device 1.

[0134] The injection device 1 of Figures 16A and 16B is similar to the injection device 1 previously described with respect to Figure 4 in that the dosage knob 12 is biased relative to the housing 10. However, in the embodiments of Figures 16A and 16B, the dosage knob 12 is biased away from the housing 10 rather than toward the housing 10. The bias can be facilitated using elastic members as discussed above or any other suitable means.

[0135] Figure 16A shows the dose knob 12 in a first position relative to the housing 10. Figure 16B shows the dose knob in a second position relative to the housing 10. The second position of the dose knob 12 is further away from the housing 10 than the first position. 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.

[0136] The first holding feature 164 and the second holding feature 166 of the container 160 are separated by a distance that allows the injection device 1 to be held between the first holding feature 164 and the second holding feature 166 when the dosage knob 12 is in its first position relative to the housing 10, but not when the dosage knob 12 is in its second position relative to the housing 10. This is because the injection device 1 has a shorter longitudinal length when the dosage knob 12 is in its first position compared to when it is in its second position.

[0137] Figure 16A shows the dosage knob 12 in a first position, thus holding the injection device 1 between a first holding feature 164 and a second holding feature 166 of the container 160. The second holding feature 166 contacts the dosage knob 12 and / or the injection button 11, while the first holding feature 164 contacts a feature at the distal end of the injection device 1 (such as the distal end of the cap 18). The dosage knob 12 is biased from the first position toward the second position, thereby applying force to the first holding feature 164 and the second holding feature 166. The force applied to the first holding feature 164 and the second holding feature 166 can hold the injection device 1 in the proper position within the container 160.

[0138] To activate the injection device 1, the user at least partially removes the injection device 1 from the container 160. Figure 16B shows the injection device 1 after it has been partially removed from the container 160 as shown in Figure 16A. The user has lifted the injection device 1 from the container 160. As the proximal end of the injection device 1 is removed from the container 160, the dosage knob 12 disengages from the second holding feature 166. The dosage knob 12 can no longer apply force to the second holding feature 166, and therefore the bias of the dosage knob 12 away from the housing 10 causes the dosage knob 12 to move from a first position to a second position relative to the housing 10. Figure 16B shows the dosage knob 12 in the second position relative to the housing 10.

[0139] The injection device 1 includes an actuation sensing component 28 configured to detect when the dosage knob 12 has moved from a first position relative to the housing 10 to a second position relative to the housing 10, and thus detects that the injection device 1 has been at least partially removed from the container 160. The actuation sensing component may include switches 42a, 42b, 42c, such as those described previously with respect to other embodiments. Switches 42a, 42b, 42c are arranged in the injection device and 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. Switches 42a, 42b, 42c thus detect whether the dosage knob 12 is in the first or second position. In response to detecting that the dosage knob 12 has moved from its first position to its second position, electronic circuitry 20 can be activated.

[0140] In some examples, the electronic circuitry 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 that described previously with reference to Figures 16A and 16B, but in the reverse direction. When the injection device 1 is not in the container 160, the dosage knob 12 starts from a second position relative to the housing 10. However, when the user places the injection device 1 into the container 160 between the first holding feature 164 and the second holding feature 166, they must move the dosage knob 12 from the second position to the first position. As previously discussed, this can be detected by sensors 42a, 42b, and 42c. In response to the detection that the dosage knob 12 has moved from the second position to the first position, the electronic circuitry 20 can be placed into a dormant state.

[0141] As shown in Figure 16A, the injection device 1 is held in a container 160, which can be considered a first position of container 160 relative to the housing 10 of the injection device 1. As discussed earlier, when container 160 is in its first position, at least one mechanical operation of the injection device can be prevented. In this example, container 160 is preventing movement of the dosage knob 12, and therefore preventing both dosage programming and dosage dispensing operations from occurring. As shown in Figure 16B, the container 160 is at least partially removed from the injection device 1, which can be considered a second position of container 160 relative to the housing 10 of the injection device 1. As discussed earlier, when container 160 is in its second position, at least one mechanical operation of the injection device can now no longer be prevented. In this example, container 160 no longer prevents movement of the dosage knob 12, and therefore no longer prevents both dosage programming and dosage dispensing operations from occurring.

[0142] Figure 17 is a flowchart illustrating a method for activating the injection device 1 according to any of the foregoing embodiments. For example, the method is performed by an actuation sensing component 28 and a processor component 23.

[0143] In step 170, the 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 actuation sensing component 28. The actuating member may have been moved from the first position to the second position by the user of the injection device 1.

[0144] In step 172, and in response to the detection of movement of the actuating member from the first position to the second position, the electronic circuit 20 is activated, as previously discussed.

[0145] In some examples, step 172 is executed once the actuation sensing component 28 detects 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 executed within a predetermined time period after the actuation sensing component 28 detects this. The predetermined time period may be, for example, between 1 second and 110 seconds.

[0146] In some examples, after the predetermined time period has elapsed, it is checked again whether the actuating member remains in its second position. If the actuating member still remains in its second position, step 172 is executed. However, if the actuating member no longer remains in its second position, step 172 is not executed and the electronic circuit remains in its dormant state. In some examples, step 172 may be executed only if it has been detected that the actuating member has remained in its second position throughout the entire predetermined time period.

[0147] Figure 18 is a flowchart illustrating another method according to another aspect of the invention, which can be performed by the injection device 1 of any of the foregoing embodiments. The method steps of Figure 18 can be performed after method step 172 of Figure 17.

[0148] In step 180, the movement of the actuating member from a second position relative to the housing 10 to a first position relative to the housing 10 is detected by the actuation sensing component 28.

[0149] In step 182, the electronic circuit 20, in response to the detection by the actuation sensing component 28, waits for a predetermined time period to pass. The predetermined time period may be, for example, between 1 second and 10 seconds, such as 3 seconds.

[0150] In step 184, after a predetermined time period has elapsed, it is detected whether the actuating member remains in the first position. If yes, the method proceeds to step 186, in which the electronic circuit 20 moves from an active state to a dormant state. If not, the electronic circuit 20 remains in the active state. In some examples, the actuating member must remain in the first position for the entire predetermined time period to put the electronic circuit 20 into a dormant state.

[0151] In some examples, step 184 is not present. Therefore, the method moves directly from step 182 to step 186. By waiting for a predetermined period of time before moving electronic circuit 20 to a sleep state, processor component 23 is given additional time to complete any currently running functions.

[0152] In some examples, steps 180 and 184 are not present. In this case, the method moves directly from step 182 to step 186. Therefore, in response to detecting that the actuating member has moved from its first position to its second position, the electronic circuit 20 almost immediately moves to a dormant state.

[0153] The above embodiments have generally described the injection device 1 as a pen-type syringe. However, it should be noted that the present invention can also be applied to other types of injection devices 1, including but not limited to auto-injectors and patch pumps.

[0154] The terms "drug" or "pharmaceutical preparation" are used synonymously herein and describe pharmaceutical preparations containing one or more active pharmaceutical ingredients or their pharmaceutically acceptable salts or solvates, and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or pharmaceutical preparation is used to treat, cure, prevent, or diagnose a disease, or to otherwise enhance physical or mental health. Drugs or pharmaceutical preparations may be used for a limited period of time or periodically for chronic diseases.

[0155] As described below, in various types of formulations, a drug or agent for treating one or more diseases may include at least one API or a combination thereof. Examples of APIs may 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 may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also envisioned.

[0156] A drug or pharmaceutical agent may be contained in a primary package or "drug container" suitable for use in a drug delivery device. The drug container may be, for example, a cartridge, syringe, reservoir, or other robust or flexible vessel configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., from 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about one month to about two years. Storage may be carried out at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or may include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one component in each chamber.

[0157] In such cases, the two chambers of a dual-chamber cartridge can be configured to allow mixing between two or more components before and / or during administration to a human or animal. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., through a catheter between the two chambers), allowing the user to mix the two components as needed before administration. Alternatively or additionally, the two chambers can be configured to allow mixing during administration of the components to a human or animal.

[0158] The drugs or agents contained in the drug delivery devices described herein can be used to treat and / or prevent many different types of medical conditions. Examples of conditions include, for example, diabetes or diabetes-related complications (such as diabetic retinopathy), thromboembolic diseases (such as deep vein or pulmonary thromboembolism). Further examples of conditions are acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis, and / or rheumatoid arthritis. Examples of APIs and drugs are those described in the following manuals: such as Rote Liste 2014 (e.g., but not limited to, main group 12 (antidiabetic drugs) or 86 (oncology drugs)) and Merck Index, 15th edition.

[0159] Examples of APIs used to treat and / or prevent type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide-1 (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms “analyte” and “derivative” refer to a polypeptide having a molecular structure that is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deletion and / or exchange of at least one amino acid residue present in a naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or exchanged amino acid residues may be encoding amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as “insulin receptor ligands”. Specifically, the term "derivative" refers to a polypeptide having a molecular structure that can be formally derived from the structure of a naturally occurring peptide, such as human insulin, wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Optionally, one or more amino acids present in a naturally occurring peptide may have been omitted and / or substituted with other amino acids (including non-coding amino acids), or amino acids (including non-coding amino acids) may have been added to a naturally occurring peptide.

[0160] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (glargine insulin); Lys(B3), Glu(B29) human insulin (glutamate insulin); Lys(B28), Pro(B29) human insulin (lispro insulin); Asp(B28) human insulin (aspart insulin); human insulin wherein the proline at position B28 is replaced by Asp, Lys, Leu, Val, or Ala and wherein Lys at position B29 can be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0161] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (detemir insulin, 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-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (degludec insulin, Tresiba) ); B29-N-(N-lithochyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecyl) human insulin.

[0162] Examples of GLP-1, GLP-1 analogs, and GLP-1 receptor agonists include, for example, lixumide (Lyxumide). ), Exendin-4, Byetta Bydureon A 39-amino acid peptide produced by the salivary glands of the Gila monster, liraglutide (Victoza Semaglutide, Taspoglutide, and Syncria Dulaglutide (Trulicity) (), rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langnatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-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.

[0163] Examples of oligonucleotides include, for instance, mirtazapine sodium (Kynamro) It is a cholesterol reducing antisense agent used to treat familial hypercholesterolemia.

[0164] Examples of DPP4 inhibitors include vedagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0165] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, human chorionic gonadotropin, fertility-stimulating hormone), growth hormone (Somatropine), desmopressin, terlipressin, gosorelin, triptorelin, leuprorelin, buserorelin, nafarelin, and goserelin.

[0166] Examples of polysaccharides include glucosaminoglycane, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 (Synviscosine). It is a sodium hyaluronate.

[0167] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments that retain the ability to bind antigens. Antibodies can be polyclonal antibodies, monoclonal antibodies, recombinant antibodies, chimeric antibodies, deimmunized or humanized antibodies, whole-human antibodies, non-human antibodies (e.g., mouse antibodies), or single-chain antibodies. In some embodiments, antibodies have effector function and can immobilize complement. In some embodiments, antibodies have reduced or no ability to bind to Fc receptors. For example, antibodies can be isotypes or subtypes that do not support binding to Fc receptors, antibody fragments, or mutants, for example, having a mutagenic or missing Fc receptor-binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or bivariate antibody-like binding proteins (CODVs) with cross-binding region orientation.

[0168] The term "fragment" or "antibody fragment" refers to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy chain and / or light chain polypeptide), excluding full-length antibody polypeptides but still including at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments may include cleaved portions of full-length antibody polypeptides, although the term is not limited to such cleaved fragments. Antibody fragments that may be used in this disclosure include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific, and multispecific antibodies (e.g., double-chain, triple-chain, and quadruple-chain antibodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, quadruvalent, and multivalent antibodies), microantibodies, chelated recombinant antibodies, tri- or bispecific antibodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelified antibodies, and antibodies containing VHH. Further examples of antigen-binding antibody fragments are known in the art.

[0169] The term "complementarity-determining region" or "CDR" refers to a short polypeptide sequence within the variable region of both heavy and light chain polypeptides, primarily responsible for mediating specific antigen recognition. The term "frame region" refers to an amino acid sequence within the variable region of both heavy and light chain polypeptides; these are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequence to allow antigen binding. Although frame regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the frame regions of some antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0170] Examples of antibodies are anti-PCSK-9 mAb (e.g., Alirocumab), anti-IL-6 mAb (e.g., Sarilumab), and anti-IL-4 mAb (e.g., Dupilumab).

[0171] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in drug delivery devices for drugs or pharmaceutical preparations. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0172] Those skilled in the art will understand that various components of the APIs, formulations, devices, methods, systems, and implementations described herein may be modified (added and / or removed) without departing from the full scope and spirit of this disclosure, which covers such modifications and any and all equivalents thereof.

Claims

1. An injection device (1), comprising: Shell (10); Dosage knob (12); A hinge member (30) is pivotally connected to the housing and is movable between a first position relative to the housing and a second position relative to the housing; Electronic circuits (20); as well as Actuation sensing component (28), When the hinge member is in a first position relative to the housing, the hinge member engages with the dose knob to prevent the dose knob from translating or rotating relative to the housing, thereby preventing the mechanical operation of the injection device, including dose programming or dose dispensing operations. When the hinge member is in the second position relative to the housing, the hinge member disengages from the dose knob to allow the dose knob to translate or rotate relative to the housing, thereby enabling mechanical operation of the injection device, including the dose programming operation or the dose dispensing operation. The actuation sensing component is configured to detect movement of the hinge member from a first position relative to the housing to a second position relative to the housing, and The electronic circuitry is configured to be activated in response to the actuation sensing component detecting that the hinge member has moved from the first position relative to the housing to the second position relative to the housing.

2. The injection device of claim 1, wherein activating the electronic circuitry comprises switching the electronic circuitry from a relatively low power state to a relatively high power state.

3. The injection device according to claim 1 or 2, The actuation sensing component includes a plurality of conductive contacts (60a, 60b); The hinge member includes a conductive part (62). The conductive contacts and the conductive portions are arranged such that: When the hinge member is in one of the first and second positions, the conductive portion forms an electrical connection between the conductive contacts; and When the hinge member is in another position between the first position and the second position, there is no electrical connection between the conductive contacts via the conductive portion.

4. The injection device of claim 3, wherein the actuation sensing component includes a hinge switch (100) arranged to detect whether the hinge member is in the first position or the second position.

5. The injection device according to claim 1 or 2, The actuation sensing component includes a reed switch (80); and The hinge member includes a magnet (82). The magnet and the reed switch are arranged such that the reed switch is in a first switching state when the hinge member is in the first position and in a second switching state when the hinge member is in the second position.

6. The injection device according to claim 1 or 2, The dosage knob is biased from a first linear position relative to the housing toward a second linear position relative to the housing; The hinge member is configured to prevent the dosage knob from moving from the first linear position to the second linear position when the hinge 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 member moving from the first position to the second position. The actuation sensing component is configured to detect movement of the dose knob from a first linear position relative to the housing to a second linear position relative to the housing, and The electronic circuitry is configured to be activated in response to the actuation sensing component detecting that the dose knob has moved from a first linear position relative to the housing to a second linear position relative to the housing.

7. The injection device according to claim 1 or 2, The actuation sensing component is further configured to detect movement of the hinge member from the second position relative to the housing to the second position relative to the housing, and The electronic circuitry is configured to switch from an active state to a dormant state in response to the actuation sensing component detecting that the hinge member has moved from the second position relative to the housing to the first position relative to the housing.

8. The injection device according to claim 1 or 2, further comprising a container (14) for containing the pharmaceutical agent.

9. The injection device according to claim 1 or 2, wherein the injection device is an injection pen or a patch pump.

10. A method for activating the injection device (1) according to any one of claims 1 to 9, the method comprising: Detect (170) the movement of the hinge member from a first position relative to the housing to a second position relative to the housing, and In response to detecting that the hinge member has moved from the first position relative to the housing to the second position relative to the housing, the electronic circuit is activated (172).

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