Electronic module of a drug delivery device or an auxiliary device for a drug delivery device

Abstract

An electronic module of a drug delivery device or an auxiliary device for a drug delivery device, comprising a switch configured to detect an operation performed in relation to the drug delivery device or the auxiliary device and provide respective output signals, and a monitoring electronic device, the monitoring electronic device being configured to measure an electrical characteristic of the switch and obtain at least one value corresponding to the electrical characteristic, and process the at least one value to detect a fault state of the switch.

Description

Technical Field

[0001] The present disclosure relates to an electronic module for a drug delivery device or an auxiliary device for a drug delivery device, the electronic module including a switch.

Background Art

[0002] In medical devices, for example, when a switch is used to perform a detection function, the switch must function properly over the life of the medical device so that the switch and the medical device operate reliably and correctly. However, the performance of the switch can degrade over time due to various reasons such as wear, corrosion or erosion of the switch contacts or due to contamination caused by the ingress of liquids or gases. Such degradation can prevent the switch from functioning or reduce the reliability of the switch. This can lead to a reduction in the overall reliability of the medical device.

Summary of the Invention

Problems to be Solved by the Invention

[0003] An object of the present disclosure is to provide an electronic module for a drug delivery device or an auxiliary device for a drug delivery device, the electronic module having a monitoring electronic device capable of detecting a failure state of a switch included in the electronic module, the failure state being caused, for example, by deterioration or leakage in the switch. Aspects of the present disclosure may make it possible to detect a failure state of the switch at an early stage before the failure progresses to substantially affect the reliability of the switch.

Means for Solving the Problems

[0004] According to a first aspect of the present disclosure, there is provided an electronic module for a drug delivery device or an auxiliary device for a drug delivery device, the electronic module including a switch configured to detect an operation performed in relation to the drug delivery device or the auxiliary device and provide respective output signals, and a monitoring electronic device, the monitoring electronic device being configured to measure an electrical characteristic of the switch to obtain at least one value corresponding to the electrical characteristic and process the at least one value to detect a failure state of the switch.

[0005] Deterioration or leakage in the switch can be detected at an initial stage, and the safety and / or reliability of the electronic module can be improved.

[0006] The monitoring electronic device may be configured to measure the electrical characteristic for a predetermined period after determining that the switch has transitioned from a closed state to an open state or from an open state to a closed state.

[0007] The monitoring electronic device may be configured to measure the electrical characteristic for a predetermined period after determining that the switch has transitioned from a closed state to an open state.

[0008] The monitoring electronic device may be configured to measure the electrical characteristic for a predetermined period after determining that the switch has transitioned from an open state to a closed state.

[0009] The monitoring electronic device may be configured to measure the electrical characteristic in response to determining that the switch has transitioned from an open state to a closed state and while the switch remains in the closed state. The monitoring electronic device may be configured to measure the electrical characteristic while the switch remains in the closed state after transitioning from the open state. Thereby, for example, when the switch is closed during a dose dial setting operation or a dose administration operation of the drug delivery device, a simple and rapid means for detecting a failure state of the switch can be provided.

[0010] The fault state may include at least one of a degradation state indicating that the electrical contacts of the switch have deteriorated and a leakage state indicating that leakage has occurred between the electrical contacts of the switch.

[0011] Detecting the fault state of the switch by processing at least one value may include comparing the at least one value with a threshold value and detecting the fault state of the switch based on the comparison.

[0012] The electrical characteristic may correspond to the voltage across the switch.

[0013] The electronic module may include a capacitor coupled across the switch. The capacitor may debounce the switch. The effect of the capacitor in delaying the time it takes for the voltage across the switch to rise or fall may be beneficial in determining the fault state of the switch, for example, by enabling monitoring of the rate of change of the voltage.

[0014] Measuring the electrical characteristic of the switch may include obtaining a plurality of values corresponding to the respective voltages across the switch at different respective times, and detecting the fault state of the switch by processing at least one value may include determining the rate of change of the voltage across the switch based on the plurality of values, comparing the determined rate of change with a threshold rate of change, and detecting the fault state of the switch based on the comparison.

[0015] The monitoring electronic device may include an analog-to-digital converter and a processor configuration. The analog-to-digital converter may be configured to convert the output signal into a digital signal corresponding to the electrical characteristic and provide the digital signal to the processor configuration to determine at least one fault state. This may provide a simple means of detecting the fault state.

[0016] The processor configuration may be configured to detect the fault state by at least comparing the digital signal with a threshold value.

[0017] The processor configuration can be configured to detect a fault condition by at least determining a rate of change of a digital signal.

[0018] The monitoring electronic device can be configured to generate an error signal based on detection of a fault condition of the switch. Thereby, it can be possible to notify the user of the fault condition, whereby the user can take repair measures (such as replacing an electronic module or a switch) before the fault deteriorates.

[0019] The electronic module can be further configured to wake up one or components of the electronic module based on an output signal.

[0020] Operations performed in relation to a drug delivery device or an auxiliary device can include a dose dial setting operation, and the electronic module can be configured to determine a dialed dose based on an output signal. Such operations require a high reliability of the switch to ensure that an accurately dialed dose is determined. Thus, aspects of the present disclosure can be beneficial in such scenarios in that a fault condition can be detected before the reliability of the switch substantially degrades.

[0021] Operations performed in relation to a drug delivery device or an auxiliary device can include a dose administration operation, and the electronic module can be configured to determine an administered dose based on an output signal. Such operations require a high reliability of the switch to ensure that an accurately administered dose is determined. Thus, aspects of the present disclosure can be beneficial in such scenarios in that a fault condition can be detected before the reliability of the switch substantially degrades.

[0022] The processor configuration can be configured to detect a fault condition by comparing at least one measurement value with a trend or profile of values, and the fault condition can be detected at least in part based on whether at least one measurement value corresponds to or deviates from the trend or profile.

[0023] The value trend or profile may include the trend or profile of past values previously measured for the switch.

[0024] According to a second aspect of the present disclosure, there is provided a drug delivery device or an auxiliary device attachable to a drug delivery device, including any of the electronic modules described herein.

[0025] According to a third aspect of the present disclosure, a monitoring electronic device of an electronic module of a drug delivery device or an auxiliary device for a drug delivery device measures electrical characteristics of a switch of the electronic module to obtain at least one value corresponding to the electrical characteristics, the switch being configured to detect an operation performed in relation to the drug delivery device or the auxiliary device and to provide respective output signals, and the method includes: obtaining, by the monitoring electronic device, at least one value and processing, by the monitoring electronic device, the at least one value to detect a failure state of the switch.

[0026] Measuring the electrical characteristics may be performed for a predetermined period after it is determined that the switch has transitioned from a closed state to an open state.

[0027] Measuring the electrical characteristics may be performed for a predetermined period after it is determined that the switch has transitioned from an open state to a closed state.

[0028] Measuring the electrical characteristics may be performed in response to determining that the switch is transitioning from an open state to a closed state and that the switch remains in the closed state after transitioning from the open state.

[0029] Detecting the failure state may include comparing at least one measured value with a value trend or profile, and the failure state may be detected at least in part based on whether at least one measured value corresponds to or deviates from the trend or profile.

[0030] The value trend or profile may include the trend or profile of past values previously measured for the switch.

[0031] Here, exemplary embodiments will be described with reference to the accompanying drawings.

Brief Description of the Drawings

[0032]

Figure 1

Figure 2

Figure 3

Figure 4A

Figure 4B

Figure 4C

Figure 4D

Figure 5

Figure 6

Figure 7

Figure 8

Mode for Carrying Out the Invention

[0033] Aspects of the present disclosure can provide means for monitoring switch performance in a medical device so that a failure state of a switch (such as one due to deterioration of the switch or leakage of electricity within the switch) can be detected and communicated for interpretation.

[0034] In the following, embodiments of the present disclosure will be described with respect to an infusion device, particularly an infusion pen-type infusion device. However, the present disclosure is not limited to such applications, and can be equally applied to drug delivery devices other than infusion devices, and those having shapes other than pens.

[0035] In the following, some embodiments will also be described with respect to an insulin infusion device. However, the present disclosure is not limited to such applications, and can be equally applied to infusion devices configured to eject other drugs or general drug delivery devices.

[0036] Embodiments are provided in connection with an infusion device, particularly a variable-dose infusion device that records and / or tracks measurement data regarding the dose delivered thereby, or a variable-dose infusion device to which an auxiliary device can be attached to record and / or track measurement data regarding the dose delivered thereby. These data can include the size of the selected dose and / or the size of the actually delivered dose, the time and date of administration, the duration of administration, and the like.

[0037] Certain embodiments herein are shown with respect to an infusion device in which an infusion button is combined with a grip (dose setting member, dose setting unit or dosing knob) as disclosed in European Patent No. 2890435. The infusion button can be actuated by a user to initiate and / or execute a dose delivery operation of a drug delivery device. The grip or knob can be used by a user to initiate and / or execute a dose setting operation. These infusion devices can be of the dial extension type, i.e., the length of these devices increases during dose setting. However, the general principles of the present disclosure are not limited to their kinematic behavior. For example, certain other embodiments may be contemplated for application to Sanofi's SoloSTAR® infusion device, which has a separate infusion button and grip component / dose setting member. Thus, there may be two separate user interface members, one for dose setting operation and one for dose delivery operation.

[0038] As used herein, "distal" is used to designate a direction, end or surface that is disposed to face or be oriented toward the administration end of a drug delivery device or a component thereof and / or that faces or is oriented opposite to the proximal end. On the other hand, "proximal" is used to designate a direction, end or surface that is disposed to face or be oriented opposite to the administration end and / or the distal end of a drug delivery device or a component thereof. The distal end can be the end closest to the administration end and / or the farthest from the proximal end, and the proximal end can be the end farthest from the administration end. The proximal face can face opposite to the distal end and / or toward the proximal end. The distal face can face toward the distal end and / or opposite to the proximal end. The administration end can be, for example, the needle end where a needle unit is present or attached to the device.

[0039] FIG. 1 is an exploded view of a drug delivery device or a medicament delivery device including an electronic module 11 according to an aspect of the present disclosure. In this example, the drug delivery device is an injection device 1, such as a pen-type injector like the injection pen disclosed in European Patent No. 2890435.

[0040] The injection device 1 of FIG. 1 includes a housing 10 and is an injection pen that houses a container 14, such as an insulin container or a receptacle for such a container 14. The container 14 can contain a drug. A needle 15 can be attached to the container 14 or the receptacle. The container 14 can be a cartridge, and the receptacle can be a cartridge holder. The needle 15 can be protected by at least one of an inner needle cap 16, an outer needle cap 17, or another cap 18. The insulin dose ejected from the injection device 1 can be set, programmed, or "dialed in" by turning an injection button or a dial grip (dose knob) 12, and thus the programmed or set dose is displayed, for example, in multiple units via a dose window 13. The indicator displayed within the window 13 can be provided on a number sleeve or a dial sleeve that is partially visible through the 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), and 1 IU is biologically equivalent to about 45.5 micrograms (1 / 22 mg) of pure crystalline insulin. Other units can be employed in an injection device for delivering analog insulin or other medicaments. It should be noted that it is equally possible for the selected dose to be displayed differently from that shown in the dose window 13 of FIG. 1.

[0041] The dose window 13 can be in the form of an opening in the housing 10, whereby the user can see a limited portion of a dial sleeve assembly configured to move and thus provide a visual display of the set dose when the button or dial grip 12 is turned. The button or dial grip 12 can be rotated in a helical path with respect to the housing 10 when setting the dose.

[0042] The injection device 1 can be configured to generate a mechanical click sound by turning a button or a dial grip 12, so as to provide voice feedback to the user. In this embodiment, the button or the dial grip 12 also functions as an injection button. When the needle 15 is inserted into the skin portion of the patient and then the button or the dial grip 12 is axially pushed, the insulin dose displayed in the display window 13 is discharged from the injection device 1. After the button or the dial grip 12 is pushed, if the needle 15 of the injection device 1 stays in the skin portion for a certain period of time, the dose is injected into the patient's body. A mechanical click sound may also be generated by the discharge of the insulin dose, which may be different from the sound generated when the button or the dial grip 12 is rotated during the dial setting of the dose.

[0043] In this example, during the delivery of the insulin dose, the button or the dial grip 12 moves axially without rotating and returns to its original position, while the dial sleeve assembly rotates and returns to its original position, displaying, for example, a zero-unit dose. FIG. 1 shows the injection device 1 in this 0U dial state. As already described, the present disclosure should not be limited to insulin and should include all drugs in the drug container 14, particularly liquid drugs or drug formulations.

[0044] The injection device 1 can be used for several injection processes until the insulin container 14 becomes empty or the expiration date of the drug in the injection device 1 (e.g., 28 days after the first use) is reached. In the case of a reusable injection device 1, the insulin container can be replaced.

[0045] Before first using the injection device 1, in order to remove air from the insulin container 14 and the needle 15, for example, hold the injection device 1 with the needle 15 facing upward, select 2 units of insulin, and press the button or dial grip 12 to perform a so-called "prime shot". For the sake of brevity, since the amount ejected substantially matches the dose to be injected, hereinafter, for example, it is assumed that the amount of drug ejected from the injection device 1 is equal to the dose received by the user. However, it may be necessary to consider the difference (e.g., loss) between the ejected amount and the injected dose.

[0046] As described above, the button or dial grip 12 also functions as an injection button such that the same components are used for dose dial setting / setting and dose administration / delivery. As an alternative (not shown), a separate injection button that is axially displaceable relative to the dial grip 12 by at least a limited distance can be used to execute or trigger dose administration.

[0047] FIG. 1 shows the electronic module 11 housed within the injection device 1, particularly within the button or dial grip 12 of the injection device 1. However, in some examples, the electronic module 11 can be disposed within a different part of the injection device 1 or within an auxiliary device 20 attachable to the injection device as will be described later in connection with FIG. 2. In other examples, the electronic module 11 can be split between the injection device 1 and the auxiliary device 20 such that some components of the electronic module 11 are included in the injection device 1 and the remaining components of the electronic module 11 are included in the auxiliary device 20. The electronic module 11 will be described hereinafter, for example, in connection with FIG. 3, throughout this application.

[0048] In some examples, the button or dial grip 12 may include one or more formations to facilitate attachment of an auxiliary device 20 (also known as an add-on device), such as a data collection device. FIG. 2 shows an injection device 1' similar to the injection device 1 of FIG. 1, with an auxiliary device 20 (shown in cross-section) attached to the injection device. In this example, the auxiliary device 20 takes the form of a button module and is coupled to the button or dial grip 12 of the injection device 1'. The auxiliary device 20 may be coupled to the button or dial grip 12 of the injection device 1' such that a user can apply force to the button or dial grip 12 through the auxiliary device 20 to eject a certain dose of the drug. In other words, the user can axially press the auxiliary device 20 towards the injection device 1, whereby the axial force applied by the pressing is transmitted from the auxiliary device 20 to the button or dial grip 12, and the drug can be administered as described above with respect to FIG. 1.

[0049] FIG. 2 shows an auxiliary device 20 in the form of a button module coupled to the button or dial grip 12 of the injection device 1'. In other examples, the auxiliary device 20 may take a different form and / or may be attached to a different part of the injection device 1', such as an injection button separate from the housing 10 or the dial grip 12. The auxiliary device 20 may be configured to be removably coupled to the injection device 1' or to be permanently coupled to the injection device 1'. As shown in FIG. 2, the auxiliary device may house an electronic module 11.

[0050] In the following, the electronic module 11 according to the present disclosure will be described with reference to FIGS. 1 to 8 in relation to exemplary embodiments.

[0051] As shown in FIG. 3, the electronic module 11 may include a processor configuration 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., and one or more memory units 24, 25 such as a program memory 25 and a main memory 24 that can store software for execution by the processor configuration 23 and can store data acquired, processed or generated by the electronic module 11 or another device communicating with the electronic module 11.

[0052] The electronic module 11 may further include a communication unit or an output 27. The communication unit 27 may include a wireless communication interface for communicating with other devices such as a mobile phone via a Wi-Fi (trademark) or Bluetooth (registered trademark) wireless network and / 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. Other forms of wired and / or wireless communication interfaces may be used.

[0053] The electronic module 11 may further include a display unit 30, such as an LCD (liquid crystal display), one or more LEDs and / or an electronic paper display. The electronic module 11 may include a user interface (UI) 31 for receiving user input to the electronic module 11, and the user interface 31 may include, for example, one or more buttons and / or a touch input device.

[0054] The electronic module 11 further includes a battery 29 for supplying power to one or more electrical components of the electronic module 11, but other means for supplying power, such as a power receiving coil or a capacitor for receiving wireless energy, may be used instead of or in addition to the battery 29. The electronic module 11 may include a power switch 28 for variably connecting one or more electrical components of the electronic module 11 to the battery 29, but in some examples, the power switch 28 is absent.

[0055] The electronic module 11 includes a sensor configuration 215 that includes a switch 33. The switch 33 can be an electromechanical switch such as a momentary switch, a detection switch, a pushbutton switch, a toggle switch, a rocker switch, a rotary switch, or a slider switch, but other forms of electromechanical switches can be used.

[0056] In some examples, the switch 33 is the power switch 28 described above, but in other examples, the switch 33 is a separate switch from the power switch 28, or the electronic module 11 includes the switch 33 but does not include the power switch 28.

[0057] The switch 33 includes at least one pair of electrical contacts. The switch 33 is movable between a closed state in which current can pass through the switch 33 between the electrical contacts in normal operation and an open state in which current cannot pass through the switch 33 between the electrical contacts (or only a negligible amount of current can pass through) in normal operation. The switch 33 can be movable from the closed state to the open state and / or vice versa. The switch 33 is configured to provide an output signal corresponding to whether the switch 33 is in the open state or the closed state. The output signal can be provided to another component (e.g., the processor configuration 23) of the electronic module 11 to be processed.

[0058] Switch 33 can be used to detect an operation (such as a mechanical operation / process) performed in relation to the auxiliary device 20 and / or the infusion device 1. For example, switch 33 can be configured to detect a dose dial setting operation and / or a dose administration operation. Switch 33 is configured within the infusion device 1 and / or the auxiliary device 20 such that the switch is actuated (and thus transitions from an open state to a closed state or vice versa) by the movement (e.g., linear or rotational) of a movable component of the infusion device 1 during a dose dial setting operation and / or a dose administration operation, so as to be configured to detect a dose dial setting operation and / or a dose administration operation. The movable component can be a dial sleeve or a dial grip 12, although other types of movable components can alternatively be used. The output signal from switch 33 can be processed by the processor configuration 23 to detect the operation. For example, the output signal can be processed to determine, for example, whether a dose dial setting operation and / or a dose administration operation has been performed, or to determine the value of the dialed dose and / or the administered dose.

[0059] In some examples, the detected operation can be a user-initiated operation to “wake up” one or more components of the electronic module 11 or a device coupled to the electronic module. Waking up a component can include transitioning the above component from a power-off state or a relatively low power state to a relatively high power state. By way of example, the user can actuate switch 33 to wake up one or more additional sensors of the sensor configuration, or to transition the processor configuration 23 from a relatively low power state (where the operation of the processor configuration 23 is restricted) to a relatively high power state (where the restriction of the operation of the processor configuration 23 is less). By actuating switch 33, an output signal is transmitted from switch 33 to the processor configuration 23, which can wake up one or more components of the electronic module 11 or a device coupled to the electronic module 11.

[0060] In some examples, the detected action may include the user applying force to the auxiliary device 20 to cause, for example, a drug dosage to be dispensed by the injection device 1 (e.g., as described above in connection with FIG. 2), to set a dosage on a dial, or to perform some other action such as waking up the electronics of the auxiliary device 20. To detect such actions, a switch 33 is disposed. For example, the switch 33 may be disposed on the lower surface of the auxiliary device 20 such that the switch 33 can contact a button or a dial grip 12 of the injection device 1 and can be actuated when the user applies force to the button or the dial grip 12 via the auxiliary device 20. However, in other examples, the switch 33 may be disposed elsewhere, such as on the upper surface of the auxiliary device 20 or within the auxiliary device 20 where force is relayed by the auxiliary device 20 and detected by the switch 33.

[0061] The sensor configuration 215 may include one or more additional sensors or sensing components such as an optical sensor, a magnetic sensor, an acoustic sensor, a capacitive sensor, or a vibration sensor, although other types of sensors may be used. For example, the sensor configuration may include an LED 215a and a photodetector 215b that together form an optical sensor. One or more additional sensors may be configured to determine, for example, the dosage set on the injection device 1 and / or the dosage administered by the injection device 1 if these actions are not performed by the switch 33. One or more additional sensors may be configured to determine the dosage set on the dial and / or the dosage administered by detecting movement (e.g., linear or rotational) of a movable component of the injection device 1 before, during, and / or after a dosage dialing action and / or a dosage administration action. The movable component may be a dial sleeve or a dial grip 12, although other types of movable components may be used instead. As an example, the sensor configuration 215 may include an optical encoder configured to output a signal corresponding to the amount of movement (linear or rotational) of the dial sleeve, and the signal may be processed, for example, by the processor configuration 23 to determine the value of the dosage set on the dial or the dosage administered. In other examples, a capacitive sensor may detect the movement.

[0062] One or more components of the sensor configuration 215 can be controlled by one or more devices of the processor configuration 23 or the sensor configuration 215.

[0063] The electronic module 11 further includes monitoring electronics for monitoring the state of the switch 33. The monitoring electronics are configured to measure an electrical characteristic of the switch 33, obtain at least one value corresponding to the electrical characteristic, and process the at least one value to detect a fault state of the switch 33.

[0064] The electrical characteristic can be a voltage across the switch 33, and the at least one value can be at least one value corresponding to the voltage across the switch. In other examples, the electrical characteristic can be a current through the switch 33, and the at least one value can be at least one value corresponding to the current through the switch 33. Monitoring the state of the switch 33 means that the monitoring electronics are configured to detect a fault state of the switch 33, and the fault state can include one or more of a degraded state of the switch 33 (i.e., the electrical contacts of the switch 33 are degraded by at least a predetermined amount, for example) or a leakage state of the switch 33 (i.e., there is leakage between the electrical contacts of the switch 33). Degradation and leakage of the switch 33 will be described later in this application.

[0065] The monitoring electronic device may include a processor configuration 23 and any suitable components for measuring electrical characteristics, such as an analog-to-digital converter (ADC) 34 as shown in FIG. 3. The ADC 34 is configured to receive, as an input from the switch 33, an analog electrical signal that may correspond to the voltage on one side of the switch 33. The analog electrical signal may correspond to the voltage across the switch 33. The electrical signal may be the output signal of the switch 33 described above. The ADC 34 is configured to convert the input electrical signal into a digital signal corresponding to the voltage across the switch 33 and output the digital signal to the processor configuration 23 for further processing. The operation of the ADC 34 is described elsewhere in this application. Although it is described herein that the monitoring means may include the ADC 34, in some examples, there is no ADC 34, and it should be understood that the monitoring means includes one or more different components for measuring the electrical characteristics of the switch 33, such as logic components of a suitable configuration.

[0066] Any of the components of the electronic module 11 shown in FIG. 3 may be soldered to a PCB including wiring for electronically coupling the components. Some of the components, such as the processor configuration 23, the main memory 24, the program memory 25, the communication unit 27, and the ADC 34, may be included in a system-on-chip (SoC) or a microcontroller. As described above, the components of the electronic module 11 may be included in the injection device 1, such as in a button or a dial grip 12 of the injection device 1, or may be included in an auxiliary device 20 configured to be attached to the injection device 1'. However, in some examples, the components of the electronic module 11 may be distributed between the injection device 1 and the auxiliary device 20. For example, the processor configuration 23 may be included in the auxiliary device 20 while the sensor configuration 215 is included in the injection device 1. Other methods of distributing the components of the electronic module 11 are also conceivable.

[0067] The firmware stored in the program memory 25 configures the processor configuration 23 to execute one or more of the method steps disclosed herein (such as the method discussed in relation to FIG. 6) and / or to control the operation of one or more other components of the electronic module 11 (such as the ADC 34 or the sensor configuration 215).

[0068] The switch 33 is configured to provide an output signal that depends on whether the switch 33 is in a closed state or an open state. The output signal can be provided to the processor configuration 23 for further processing. The output signal can be processed by the processor configuration 23 to determine, for example, whether to wake up one or more components of the electronic module 11, or to determine the dosage of a drug dialed into or administered from the injection device 1, or whether a dosage administration operation or a dosage dialing operation has been performed.

[0069] In some examples, the output signal of the switch 33 can be high (i.e., including a non - negligible voltage or current) when the switch 33 is in an open state and low (i.e., including zero or a negligible voltage or current) when the switch 33 is in a closed state. To provide an appropriate output signal for use by the processor configuration 23 and / or the ADC 34, as shown in the schematic circuit diagram of FIG. 4A, the switch 33 can be included in the sensor configuration 215 as part of a potential divider (voltage divider).

[0070] FIG. 4A shows the switch 33 configured in a series circuit with a power source such as a pull - up resistor 42 and a battery 29. The output signal S is provided via an electrical connection connected to the center tap of the potential divider formed by the resistor 42 and the switch 33.

[0071] The pull - up resistor 42 has a fixed resistance R 1 and the switch 33 has a resistance R 2 When, the voltage V out(i.e., the voltage across switch 33) can be determined using the following equation. [Number] In the equation, V in is the input voltage provided by battery 29 to the voltage divider (i.e., resistor 42).

[0072] In the case of an ideal switch 33 (i.e., one without faults / deterioration / leakage) in the open state as shown in FIG. 4A, the resistance R 2 of switch 33 becomes infinite (or effectively infinite). Thus, assuming that the pull-up resistor 42 has a resistance R 2 substantially smaller than R 1 , the voltage V out of the output signal S is approximately equal to V in . Thus, the voltage V out of the output signal S is high (i.e., a non-negligible voltage).

[0073] In the case of an ideal switch 33 (i.e., one without faults / deterioration / leakage) in the closed state, the resistance R 2 of switch 33 is lower than the resistance R 2 of switch 33 in the open position. The resistance R 2 of switch 33 in the closed state can approach zero, but due to the inherent resistance in components of switch 33 such as electrical contacts, it does not become zero (even in the absence of deterioration). Approximating the resistance R 2 of switch 33 in the closed position to zero and assuming that the resistance R 1 of the pull-up resistor 42 is not zero and is non-negligible, the voltage V out of the output signal S is approximately equal to zero. Thus, the voltage V out of the output signal S is low (i.e., zero or a negligible voltage).

[0074] Therefore, the output signal S can be processed to determine whether switch 33 is in an open state or a closed state. For example, the output signal S can be processed by providing it to a processor configuration 23 that can detect whether the output signal S is high or low, and thus whether switch 33 is in an open state or a closed state.

[0075] The potential divider of the sensor configuration 215 may also have a capacitor 41 connected in parallel with the switch 33, as shown in FIG. 4A. The capacitor 41 can be used to debounce the output signal S of the switch 33. Due to the presence of the capacitor 41, as will be described later in connection with FIGS. 7 and 8, when the switch 33 transitions from a closed state to an open state or vice versa, V out increases the time it takes for to change to a new value.

[0076] Note that when the polarity of the battery 29 shown in FIG. 4A is reversed or the positions of the switch 33 and the resistor 42 are reversed, the previously described "high" and "low" voltages and signals are reversed. Therefore, it should be understood that the terms "high" and "low" generally correspond to the magnitude of the voltage and do not necessarily indicate polarity.

[0077] The output signal S can be provided to the processor configuration 23 for the processing discussed above. Based on the characteristics of the output signal (e.g., whether the output signal is high or low), the processor configuration 23 can determine whether the switch 33 is in an open state or a closed state, and as a result, use this information to, for example, wake up one or more electrical components of the electronic module 11 or determine the dial setting and / or the dosage of the dispensed drug.

[0078] Figure 4B is a schematic circuit diagram showing substantially the same circuit as in Figure 4B, but the circuit of Figure 4B shows a scenario where the switch 33 in Figure 4A has deteriorated from its normal or ideal state. The electrical contacts of switch 33 may have deteriorated (worsened) due to wear, corrosion, erosion, dirt, or a defective condition resulting from one or more other factors. Due to the deterioration of the contacts, the resistance of switch 33 may increase. This increased resistance is shown in Figure 4B as an effective (actual) resistance 330a connected in series with switch 33. The effect of the increase in the resistance of switch 33 is that when switch 33 is in the closed state, the voltage V of output signal S out is greater than the voltage V of output signal S as described in connection with Figure 4A out (i.e., the "ideal" situation without deterioration of the switch). When switch 33 is moved from the open state to the closed state, V of output signal S out still decreases, but this decrease is smaller than the scenario shown in Figure 4A. The voltage V of output signal S when switch 33 is in the closed state out is not zero and may not be negligible. As switch 33 deteriorates further over time, the resistance of the closed switch 33 may increase further, and as a result, the value of V out becomes higher when switch 33 is in the closed state.

[0079] When the resistance of switch 33 increases, the time it takes for V out to become low after switch 33 is closed also increases. This is because the debounce capacitor 41 has to discharge through the higher resistance provided by the deteriorated switch 33.

[0080] In some extreme cases, the effective resistance of the closed switch 33 may increase so much due to deterioration that the operation of switch 33 from the open state to the closed state or vice versa is not reliably detected by the processor configuration 23. Aspects of the present disclosure may attempt to avoid such scenarios by detecting the deterioration of switch 33 early, for example, before it can affect the reliability of the switch, and thus the reliability of the entire electronic module 11.

[0081] Figure 4C is a schematic circuit diagram similar to that shown in Figure 4A, but the circuit diagram shows a scenario where leakage occurs between the electrical contacts of switch 33, effectively short - circuiting switch 33. The leakage can be, for example, the result of the intrusion of a conductive fluid into switch 33 or another part of electronic module 11. The leakage acts as an impedance in parallel with the electrical contacts of switch 33, as shown by the effective resistance 330b in Figure 3C. The effect of the leakage is to reduce the voltage V of the output signal S when switch 33 is in the open state, compared to the scenario of Figure 4A. out Due to the leakage, after switch 33 transitions from the closed state to the open state, the voltage V of the output signal S out will also increase at a slower rate of change. In extreme cases, excessive leakage can prevent the detection of the transition of switch 33 from the open state to the closed state, or vice versa. The leakage can also consume power unnecessarily from battery 29 when switch 33 is in the open state. In some cases, the leakage can be a temporary condition. For example, if the leakage is caused by the intrusion of a fluid, the fluid may evaporate or be discharged over time, reducing the effect of the leakage over time.

[0082] In some cases, switch 33 may suffer from both deterioration of the electrical contacts and leakage simultaneously. This is shown in Figure 4D. Figure 4D is a schematic circuit diagram similar to Figure 4A, but shows an effective resistance 330c in series with switch 33 and an effective resistance 330d in parallel with switch 33. The effective resistance 330c represents the deterioration of the electrical contacts of switch 33, and the effective resistance 330d represents the leakage across switch 33.

[0083] The deterioration of the contacts and the leakage are not ideal constant phenomena and can occur as random perturbations. For example, leakage due to the intrusion of a fluid can vary depending on the geometric factors of the electrical contacts of switch 33 related to the liquid, as well as other highly variable parameters such as, but not limited to, the fluid composition and temperature. When an aqueous solution is present and interacts with the contacts of switch 33, an electrochemical potential can be introduced that induces an additional voltage that either pushes up or down the signal voltage V out more than expected from a pure resistive interaction.

[0084] FIG. 5 is a schematic circuit diagram showing exemplary components of the electronic module 11 according to an embodiment of the present disclosure, and the electronic module 11 may be capable of detecting a fault state of the switch 33 caused by at least one of degradation or leakage as described above in connection with FIGS. 4A-4D.

[0085] The circuit shown in FIG. 5 is similar to the circuit shown in FIG. 4A as indicated by the presence of the battery 29, the pull-up resistor 42, the capacitor 41, and the switch 33. The circuit of FIG. 5 further includes monitoring electronics including the ADC 34 and the processor configuration 23. The ADC 34 and the processor configuration 23 may be the ADC 34 and the processor configuration 23 described above in connection with FIG. 3 and other places in the present disclosure. The circuit of the electronic module 11 may include additional components such as one or more memory units 24, 25, etc., but such additional components are not included in FIG. 5 for the sake of brevity.

[0086] FIG. 5 shows the battery 29 that supplies power to the ADC 34 and the processor configuration 23 in addition to the voltage divider formed by the resistor 42 and the switch 33. However, in other examples, one or more of the ADC 34, the processor configuration 23, and the voltage divider may use different power sources. In some examples, the ADC 34 uses the supply voltage supplied to the voltage divider by the battery 29 as its reference voltage. Thereby, fluctuations in the supply voltage can be compensated, and the accuracy with which the electronic module 11 can detect a fault state of the switch 33 can be improved.

[0087] As shown in FIG. 5, the analog output signal S from the switch 33 is provided as an input to both the ADC 34 and the processor configuration 23. This may be via the same electrical connection from the central tap of the voltage divider formed by the resistor 42 and the switch 33. However, in other examples, the signal from the switch 33 to the processor configuration 23 may be relayed in a different manner.

[0088] ADC34 receives the output signal S from switch 33 as input, converts the analog output signal S into a digital signal, and the digital signal is output by ADC34 to the processor configuration 23. In particular, ADC34 converts the analog input voltage or current provided by the output signal S into a digital number representing the magnitude of the voltage or current, and provides this digital number to the processor configuration 23 as a digital signal. As an example, the larger the input voltage provided to ADC34, the larger the digital number output by ADC34. Based on the digital signal, the processor configuration 23 can determine the voltage V out (i.e., the voltage across switch 33) by using, for example, a look-up table stored in memory units 24, 25. The look-up table may include a plurality of digital numbers and their corresponding values of V out .

[0089] As described above in connection with FIGS. 4A - 4D, the value of V out can be affected by deterioration of the electrical contacts of switch 33 and / or leakage between the electrical contacts of switch 33. Accordingly, the processor configuration 23 may be able to process the digital signal to detect a fault condition of switch 33. The fault condition of switch 33 may include a deterioration condition where the electrical contacts of switch 33 deteriorate (worsen) and thus the resistance increases, a leakage condition where leakage occurs between the contacts of switch 33, or a combination of the deterioration condition and the leakage condition. An exemplary method of processing the digital signal is discussed in connection with FIGS. 6 - 8.

[0090] ADC34 may continuously sample the output signal S and provide a digital signal output to the processor configuration 23. However, in some examples, ADC34 samples the output signal S on demand and at discrete intervals, for example, in response to a command signal received from the processor configuration 23. This can improve the energy efficiency of the monitoring electronic device.

[0091] FIG. 6 is a flowchart showing a method for determining a failure state of switch 33 according to an aspect of the present disclosure. This method can be executed by the electronic module 11 described elsewhere in this application, for example, the electronic module 11 including the circuit shown in FIG. 5. Each step can be executed by a monitoring electronic device, that is, the processor configuration 23 and / or the ADC 34.

[0092] In step 610, the electrical characteristics of switch 33 are measured to obtain at least one value representing the electrical characteristics. In the present disclosure, the electrical characteristics are described as the voltage V across switch 33. out Therefore, the at least one value can be at least one value representing the voltage V across switch 33. However, in other examples, the electrical characteristics can be, for example, the current passing through switch 33, or different electrical characteristics affected by the deterioration or leakage of the switch contacts. out If the monitoring electronic device includes the ADC 34, the measurement of the electrical characteristics can be performed using the ADC 34. In this case, step 610 may include an optional step 612 in which the analog output signal S from switch 33 is converted into a digital signal corresponding to the voltage across switch 33. The conversion can be performed by the ADC 34 in some examples in response to an instruction from the processor configuration 23. The at least one value obtained by the measurement can be at least one digital number output as a digital signal by the ADC 34.

[0093] In some examples, as will be described later in relation to FIGS. 7 and 8, the step of measuring the electrical characteristics of switch 33 may include obtaining a plurality of values corresponding to the respective voltages across switch 33 at different respective times. This may make it possible to determine the rate of change of the voltage across switch 33.

[0094] In some examples, as will be described later in relation to FIGS. 7 and 8, the step of measuring the electrical characteristics of switch 33 may include obtaining a plurality of values corresponding to the respective voltages across switch 33 at different respective times. This may make it possible to determine the rate of change of the voltage across switch 33.

[0095] In some examples, the monitoring electronic device is configured to measure electrical characteristics for a predetermined period after determining that switch 33 has transitioned from a closed state to an open state or from an open state to a closed state. This allows time for the output signal (i.e., the voltage of the output signal) to stabilize, thereby improving the accuracy of the measurement. Allowing time for the output signal to stabilize can be particularly important when a debounce capacitor 41 is coupled across switch 33. This is because the presence of capacitor 41 causes the output signal to take more time to stabilize. The electronic module 11 can determine either a transition of switch 33 from a closed state to an open state or from an open state to a closed state by monitoring the output signal S of switch 33. For example, the electronic module 11 (e.g., the processor configuration 23 of the electronic module 11) can determine that switch 33 has transitioned from a closed state to an open state in response to the processor configuration 23 detecting that the voltage of the output signal has increased. This can be achieved in various ways, such as the processor configuration 23 determining that the voltage of output signal S has risen above a threshold voltage (such as 0V), the voltage has risen by at least a threshold amount or percentage, or the voltage has risen by at least a threshold amount or percentage within a specific period. Similarly, the electronic module 11 (e.g., the processor configuration 23 of the electronic module 11) can determine that switch 33 has transitioned from an open state to a closed state in response to the processor configuration 23 detecting that the voltage of the output signal has decreased. This can be achieved in various ways, such as the processor configuration 23 determining that the voltage of output signal S has dropped below a threshold voltage (such as 0.9V), the voltage has dropped by at least a threshold amount or percentage, or the voltage has dropped by at least a threshold amount or percentage within a specific period. The monitoring electronic device can be configured to measure electrical characteristics in response to a positive determination by the monitoring electronic device that switch 33 has transitioned from a closed state to an open state or from an open state to a closed state. The measurement can be performed for a predetermined period after the positive determination.

[0096] In step 620, at least one value is processed, for example, by the processor configuration 23 to detect a fault state of the switch 33. Processing at least one value may include determining that at least one value deviates from an expected value or range of values. For example, processing at least one value may include comparing at least one value with at least one threshold value and detecting a fault state based on the comparison. In some examples, at least one threshold value may be predetermined. In other examples, at least one threshold value may be determined based on previous measurement results of the electrical characteristics of the switch 33, i.e., previous values representing past measurement results of the electrical characteristics of the switch 33.

[0097] If optional step 612 is performed, step 620 may include optional step 622, in which the digital signal output by the ADC 34 is compared with a threshold value. More specifically, the digital number included in the digital signal may be compared by the processor configuration 23 with a threshold value or range of threshold values stored, for example, in a look-up table. Based on the comparison, the processor configuration 23 may detect a fault state of the switch 33, for example, in response to determining that at least one of the digital numbers is higher than, lower than, or within the range of the threshold value.

[0098] If, in step 610, a plurality of values corresponding to respective voltages across the switch 33 at different respective times are obtained, step 620 may include determining a rate of change of the voltage across the switch 33 based on the plurality of values. The determined rate of change may be compared with a threshold rate of change, and based on the comparison, for example, if the determined rate of change is less than the threshold rate of change, a fault state of the switch 33 may be detected.

[0099] Various examples of processing at least one value to detect a fault state will be described later in connection with FIGS. 7 and 8.

[0100] In an optional step 630, an error signal may be generated based on the detection of a fault condition. The error signal may be generated by the processor configuration 23 and may be generated in response to the detection of the fault condition. In some examples, the error signal may be used to issue an alert to the user indicating that the switch 33 of the electronic module 11 has deteriorated or is in a leakage state. Thus, the alert may indicate to the user that the device including the electronic module 11 (e.g., the injection device 1 or the auxiliary device 20) should probably be replaced or repaired. The alert may include, for example, at least one of an audible, visual, or tactile alert. The alert may be output by the electronic module 11 under the control of the processor configuration 23 as a visual alert via, for example, the display unit 30, an audible alert via an audio output device such as a speaker, or a tactile alert via a tactile output device. In some examples, the processor configuration 23 may output the error signal to an external device such as a mobile phone or a computer via, for example, the communication unit 27. An alert may be output by the external device based on the error signal. As an example, the processor configuration 23 may output the error signal as an encoded wireless message via the communication unit 27 using the Bluetooth protocol. The encoded Bluetooth message may be received by the external device, which may decode and process the message and issue a corresponding alert.

[0101] Figure 7 is a graph showing the variation of the voltage across the switch 33 in the circuit shown in Figure 5 as a function of time, indicating the effect of the deterioration of the electrical contacts of the switch 33. V out is the voltage of the signal output S (i.e., the voltage across the switch 33).

[0102] The dotted line represents the voltage across switch 33 whose electrical contacts are not deteriorated. This may be, for example, a newly manufactured switch 33, and shall be referred to as an "ideal" switch 33. Such a switch 33 may correspond to the scenario described above in relation to FIG. 4A. The solid line in FIG. 7 is after the electrical contacts of switch 33 have deteriorated, thereby representing the voltage across the same switch 33 whose intrinsic resistance increases when closed. Such a switch 33 shall be referred to as a "deteriorated" switch 33 and may correspond to the scenario described above in relation to FIG. 4B.

[0103] Time T 0 represents the initial time when switch 33 is in the open state. For simplicity, in this example, it is assumed that there is no leakage between the electrical contacts of the ideal switch 33 or the deteriorated switch 33. Therefore, the initial voltages of both the ideal switch 33 and the deteriorated switch 33 are the same, and are shown as V in FIG. 7. To determine whether switch 33 is in the closed state or the open state, when V is provided as an input to the processor configuration 23, V may be, for example, about 1V. 1 When determining whether switch 33 is in the closed state or the open state, when V is provided as an input to the processor configuration 23, V out is provided, V 1 may be, for example, about 1V.

[0104] When the ideal switch 33 is closed, the voltage across the ideal switch 33 decreases until it reaches a new steady-state voltage V at time T. V is not zero due to the intrinsic resistance of switch 33 (not due to deterioration), but V is close to zero because no additional resistance due to deterioration is introduced. The decrease in voltage V between T and T is not instantaneous but gradual due to the presence of the debounce capacitor 41 coupled across switch 33. The voltage across the ideal switch 33 remains substantially constant at V after time T as long as the ideal switch 33 remains closed. 1 at time T reaches a new steady-state voltage V 2 . V 2 is not zero due to the intrinsic resistance of switch 33 (not due to deterioration), but V 2 is close to zero because no additional resistance due to deterioration is introduced. T 0 and T 1 The decrease in voltage V out between is not instantaneous but gradual due to the presence of the debounce capacitor 41 coupled across switch 33. The voltage across the ideal switch 33 remains substantially constant at V after time T 1 as long as the ideal switch 33 remains closed after time T. The voltage across the ideal switch 33 remains substantially constant at V 2 .

[0105] For comparison, when the degraded switch 33 is closed at time T 0 the voltage across the degraded switch 33 also gradually decreases until it reaches a new, lower voltage, but this new, lower voltage V 3 is higher than the voltage V of the ideal switch 33 due to an increase in the resistance of the degraded switch 33 caused by degradation of the electrical contacts of the degraded switch 33 compared to the ideal switch 33. Further, in the degraded switch 33, it takes a time T 2 to reach the steady-state voltage V 3 and T 2 occurs after a certain period of T 2 which is T 1 after a certain period of time.

[0106] To detect the fault state of the switch 33 (e.g., the degraded switch 33), the electronic module 11 according to the present disclosure measures the voltage V 0 across the switch 33 at a time T 3 after a predetermined period after the switch 33 has transitioned from the open state to the closed state, i.e., T 3 after the time T 3 The time T 0 is selected as the period after the switch 33 has transitioned from the open state to the closed state at time T 3 and may be selected to provide sufficient time for the voltage across the switch 33 to settle to a new steady-state level V 3 The period may be predetermined, for example, 0.1 seconds or the like. By the processor configuration 23, it can be determined that the switch 33 has transitioned from the open state to the closed state by detecting that the voltage across the switch 33 has decreased by a predetermined amount, by a predetermined percentage, or below a predetermined threshold, and then the voltage V

[0107] across the switch 33 is measured for a certain period after the detection. Various methods for detecting that the switch 33 has transitioned from the open state to the closed state were discussed above in connection with FIG. 6. 3 Once the value of the voltage V3 The value of 4 can be compared with a predetermined threshold voltage V 4 and V 2 (to allow for a slight deviation from the ideal voltage V 2 ) is selected to be greater than V 3 . The faulty state of switch 33 can be detected from the comparison if the measured voltage V 4 is determined to be greater than the threshold V 4 . In this case, the faulty state indicates that the electrical contacts of switch 33 have deteriorated, for example, beyond the allowable tolerance. In some examples, V 3 can be about 0.1 V. Thus, if the value of V 0 is determined to be greater than 0.1 V at time T 3 after T 4 , it can be detected that switch 33 is in a deteriorated state. In other examples, V

[0108] can be about 0 V. 3 In some examples, the measured voltage V 4 is compared with two or more thresholds, for example, threshold V 5 and threshold V 5 , and V 4 corresponds to a voltage that is higher than V 1 but lower than the voltage V 4 of the switch in the initial open state. Detecting the faulty state of switch 33 may include comparing V 3 with thresholds V 5 and V 3 to determine whether V 4 >V 5 >V 4 >V 3 >V 5 is satisfied. If V 4 >V 5 >V

[0109] is satisfied, the faulty state indicates that the electrical contacts of switch 33 have deteriorated. In some examples, V 4 and V 5 can represent 0 V and 0.1 V respectively, and in other examples, they can represent 0.1 V and 0.2 V respectively, but other values are also possible.In FIG. 7, the voltage across the deteriorated switch 33 decreases at a lower rate of change than the voltage across the ideal (non-deteriorated) switch 33, as indicated by the shallower slope of the solid line compared to the dashed line when transitioning from the open state to the closed state. This is due to the fact that the debounce capacitor 41 takes more time to discharge through the deteriorated switch 33 having a relatively high resistance compared to the ideal switch 33 having a relatively low resistance. Aspects of the present disclosure can utilize this phenomenon to detect the failure state or condition of the switch 33. Thus, in some examples, measuring the electrical characteristics of the switch 33 can include obtaining two or more values of the voltage across the switch 33 at different respective times and determining the rate of change of the voltage based on the obtained voltage values. For example, the measurement of the voltage across the deteriorated switch 33 is performed after the switch 33 transitions from the open state to the closed state, at time T 4 and time T 5 . The rate of change of the voltage can be determined based on the difference between the two voltage measurement values and the difference between time T 4 and time T 5 . Next, detecting the failure state of the switch 33 can include comparing the determined rate of change with a threshold rate of change. The threshold rate of change can be selected such that if the determined rate of change is lower than the threshold rate of change, the failure state of the switch 33 is considered to be detected, and the failure state can be a deteriorated state indicating that the electrical contacts of the switch 33 have deteriorated.

[0110] FIG. 8 is a graph showing the change in the voltage across the switch 33 in the circuit shown in FIG. 5 as a function of time, showing the effect of leakage between the electrical contacts of the switch 33. V out is the voltage of the signal output S (i.e., the voltage across the switch 33).

[0111] The dotted line represents the voltage across the switch 33 where there is no leakage between the electrical contacts of the switch 33. This may be, for example, a newly manufactured switch 33 and shall be referred to as an "ideal" switch. Such a switch 33 may correspond to the scenario described above in relation to FIG. 4A. The solid line represents the voltage across the same switch 33 where there is leakage between the electrical contacts of the switch 33, thereby reducing the resistance of the switch 33 when in the open state. Such a switch 33 shall be referred to as a "leaky" switch and shall correspond to the scenario described above in relation to FIG. 4C.

[0112] Time T 0 Now, both the ideal switch 33 and the leaky switch 33 transition from their respective closed states to their respective open states. When in the closed state, the voltages across both the ideal switch 33 and the leaky switch 33 are similar and at time T 0 Voltage at V 6 When the ideal switch 33 is opened, the voltage across the ideal switch 33 changes over a period of time T 6 At steady state voltage V 7 Similarly, when the leaking switch 33 is opened, the voltage across the leaking switch 33 increases until it reaches 7 At steady state voltage V 8 The leakage current between the electrical contacts of the leaky switch 33 reduces the effective resistance of the leaky switch 33 compared to the ideal switch 33, causing V 8 V 7 In Fig. 8, T 6 Later than T 7 As shown by , the leaky switch 33 also takes more time to reach its steady state voltage than the ideal switch 33, and the rate of voltage rise of the leaky switch 33 is less than that of the ideal switch 33 due to the longer it takes for the debounce capacitor 41 to recharge due to the leakage.

[0113] To detect a fault condition of switch 33 (e.g., a leaking switch 33), the electronic module 11 according to the present disclosure measures the voltage V across switch 33 for a predetermined period after switch 33 has transitioned from a closed state to an open state, i.e., T 0 the subsequent time T 8 across switch 33. The time T 8 is selected as the period after switch 33 has transitioned from a closed state to an open state at time T 8 and may be selected to provide sufficient time for the voltage across switch 33 to settle to a new, higher steady - state level V 0 if applicable. The period can be pre - determined, for example, 0.1 seconds. By the processor configuration 23 detecting that the voltage across switch 33 has risen by a predetermined amount, a predetermined percentage, or above a predetermined threshold, it can be determined that switch 33 has transitioned from a closed state to an open state, and then the voltage V 8 across switch 33 is measured for a predetermined period after its detection. Various methods of detecting that switch 33 has transitioned from a closed state to an open state were discussed above in relation to FIG. 6. 8 Once the value of the voltage V

[0114] across switch 33 is measured, as discussed in relation to step 620 of FIG. 6, the value can be processed to detect the fault condition of switch 33. For example, the measured voltage V 8 value can be compared with a predetermined threshold voltage V 8 and V 10 is selected to be less than V 10 (to allow for a slight deviation from the ideal voltage V 7 ). The fault condition of switch 33 can be detected if, from the comparison, it is determined that the measured voltage V 7 is less than the threshold V 8 10 . In this case, the fault condition is a leakage condition indicating that leakage has occurred between the electrical contacts of switch 33, for example, exceeding the allowable amount. In some examples, V 10 can be about 0.9V. Thus, the value of V 8 at time T 0 is measured at the subsequent time T 8 ​If it is determined to be less than 0.9V, it can be detected that the switch 33 is in a leakage state. In other examples, V 10 can be about 1V.

[0115] In some examples, the measured voltage V 8 is compared with two or more threshold values, for example, threshold value V 10 and threshold value V 9 and V 9 is lower than V 10 but corresponds to a voltage greater than the voltage V 6 of the switch in the initial open state. Detecting a fault state of the switch 33 includes determining whether V 10 >V 8 >V 9 is satisfied, and comparing V 8 with threshold value V 9 and threshold value V 10 . If V 10 >V 8 >V 9 is satisfied, the fault state is a leakage state indicating that leakage has occurred between the electrical contacts of the switch 33. In some examples, V 9 and V 10 can represent 0.8V and 0.9V respectively, and in other examples, they can represent 0.9V and 1V respectively, but other values are also possible.

[0116] In FIG. 8, the voltage across the leaking switch 33 rises at a lower rate of change than the voltage across an ideal (non-leaking) switch 33, as indicated by the shallower slope of the solid line compared to the dashed line when transitioning from the open state to the closed state. This is due to the fact that when current leaks through the leaking switch 33, it takes more time to recharge the debounce capacitor 41. Aspects of the present disclosure can utilize this phenomenon to detect the fault state or condition of the switch 33. Thus, in some examples, measuring the electrical characteristics of the switch 33 can include obtaining two or more values of the voltage across the switch 33 at different respective times and determining the rate of change of the voltage based on the obtained voltage values. For example, measuring the voltage across the degraded switch 33 can be performed after the switch 33 transitions from the closed state to the open state, at time T 9 and time T 10 . The rate of change of the voltage can be determined based on the difference between the two voltage measurement values and the difference between time T 9 and time T 10 . Next, detecting the fault state of the switch 33 can include comparing the determined rate of change to a threshold rate of change. The threshold rate of change can be selected such that if the determined rate of change is lower than the threshold rate of change, the fault state of the switch 33 is considered detected, and the fault state is a leakage state indicating that leakage is occurring between the contacts of the switch 33.

[0117] In connection with FIGS. 7 and 8, it has been discussed that processing at least one measurement value corresponding to a voltage may include comparing the at least one measurement value with one or more thresholds or ranges, but it should be understood that the at least one measurement value can be processed in different ways to detect a fault condition of switch 33. For example, the at least one measurement value can be compared with a trend or profile of values, and the fault condition can be detected at least in part based on whether the at least one measurement value corresponds to or deviates from the trend or profile. For example, the trend or profile of values can include the trend or profile of past values previously measured for switch 33, and the fault condition can be detected at least in part based on whether the at least one measurement value deviates from the trend or profile by, for example, a certain amount. In other examples, the trend or profile of values can include the trend or profile of predicted values for switch 33, and the fault condition can be detected at least in part based on whether the at least one measurement value deviates from the trend or profile by, for example, a certain amount. Other methods and / or statistical processes for processing and interpreting at least the values to detect a fault condition can be used.

[0118] Although the embodiments described herein have been discussed as those in which various processing steps (such as step 620) are performed by processor configuration 23, it should be noted that in other examples, the processing can be performed by different components of electronic module 11 or actually by an external device such as a mobile device. In this case, electronic module 11 can transmit data including at least one value obtained by the monitoring electronic device in step 610 to an external device, for example via communication unit 27, such that the external device can be configured to process the at least one value to detect a fault condition of the switch. Electronic module 11 can store the at least one value in memories 24, 25 before transmitting it to the external device.

[0119] The terms "drug" or "agent" are used synonymously herein and refer to a pharmaceutical preparation comprising one or more pharmaceutical active ingredients or a pharmaceutically acceptable salt or solvate thereof, and optionally, a pharmaceutically acceptable carrier. A pharmaceutical active ingredient ("API") is, in the broadest sense, a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or agent is used for the treatment, cure, prevention or diagnosis of a disease or, otherwise, for the improvement of physical or mental health. A drug or agent can be used for a limited duration or, in the case of chronic diseases, regularly.

[0120] 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.

[0121] A drug or medicament can be contained within a primary package or “drug container” adapted for use with a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible container configured to provide a chamber suitable for storage of one or more drugs (e.g., short-term or long-term storage). For example, optionally, the chamber can be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). Optionally, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20° C.) or refrigerated temperature (e.g., about -4° C. to about 4° C.). Optionally, the drug container can be or include a dual-chamber cartridge configured to separately store one-by-one two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent or two different drugs) within each chamber. 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 administration into a human or animal body. For example, the two chambers can be configured such that they are in fluid communication with each other (e.g., by a conduit between the two chambers), allowing the user to mix the two components if desired before administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components into a human or animal body.

[0122] Drugs or agents contained in a drug delivery device as described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, type 1 diabetes or complications associated with type 1 diabetes, such as diabetic retinopathy, thromboembolism, such as deep vein thrombosis or pulmonary embolism. Further examples of disorders include 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 Rote Liste 2014, for example, but not limited to, main group 12 (antidiabetic drugs) or 86 (oncological drugs) and handbooks such as the Merck Index, 15th edition.

[0123] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus 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 or their analogs or derivatives, dipeptidyl peptidase-4 (DPP4) inhibitors or their pharmaceutically acceptable salts or solvates or any mixtures thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that can be formally derived 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 addition of at least one amino acid residue. The amino acid residues added and / or exchanged can be any of 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 that can be formally derived from the structure of a naturally occurring peptide, such as the structure of human insulin, in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide can be deleted and / or substituted by other amino acids containing non-codable amino acids, or amino acids containing non-codable amino acids can be added to the naturally occurring peptide.

[0124] 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 proline at position B28 is substituted with Asp, Lys, Leu, Val or Ala and Lys at position B29 can be substituted with Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0125] 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 (registered trademark)); 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 (registered trademark)); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0126] 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 (efpeglenatide), HM-15211, CM-3, GLP-1 erigen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, nodexen, viadorl-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (pegapamodotide), BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, tildesatide (LY3298176), bamaductide (SAR425899), exenatide-XTEN, and glucagon-Xten.

[0127] An example of an oligonucleotide is, for example, mipomersen sodium (Kynamro®), a cholesterol-lowering antisense therapeutic for the treatment of familial hypercholesterolemia, or RG012 for the treatment of Alport syndrome.

[0128] Examples of DPP4 inhibitors are linagliptin, vildagliptin, sitagliptin, denagliptin, saxagliptin, and berberine.

[0129] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory active peptides such as gonadotropins (folitropin, lutropin, chorionic gonadotropin, menotropin), somatropin (somatropin), desmopressin, terlipressin, gonadorelin, tryptorelin, leuprorelin, buserelin, nafarelin and goserelin, and their antagonists.

[0130] Examples of polysaccharides include glucosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or ultra-low molecular weight heparin or their derivatives or sulfated forms of the above polysaccharides, such as poly-sulfated forms and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of poly-sulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), sodium hyaluronate.

[0131] As used herein, the term "antibody" refers to an immunoglobulin molecule or its antigen-binding portion. Examples of the antigen-binding portion of an immunoglobulin molecule 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., mouse) antibodies or single-chain antibodies. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no binding ability to Fc receptors. For example, the antibody can be an isotype or subtype, antibody fragment or mutant that does not assist in binding to Fc receptors, e.g., 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).

[0132] 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 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 invention 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.

[0133] 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 CDR sequences to enable antigen binding. The framework region itself is typically not directly involved in antigen binding, but as is known in the art, specific residues within the framework region of a particular antibody can be directly involved in antigen binding or can affect the ability of one or more amino acids within the CDR to interact with the antigen.

[0134] 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).

[0135] Any pharmaceutically acceptable salts of the APIs described herein are contemplated for use as drugs or agents within a drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and basic salts.

[0136] Without departing from the full scope and spirit of the present invention, various components of the APIs, formulations, devices, methods, systems, and embodiments described herein may be modified (added and / or removed), and it will be understood by those skilled in the art that the present invention encompasses such modified forms and all their equivalents.

[0137] Exemplary drug delivery devices may include needle-based injection systems as described in Table 1 of Section 5.2 of ISO11608-1:2014(E). As described in ISO11608-1:2014(E), needle-based injection systems can be broadly classified into multi-dose container systems and single-dose (partial or full discharge) container systems. The container can be an exchangeable container or an integrated non-exchangeable container.

[0138] As further described in ISO11608-1:2014(E), multi-dose container systems may include needle-based injection devices with exchangeable containers. In such systems, each container holds multiple doses, and its size can be fixed or variable (preset by the user). Other multi-dose container systems may include needle-based injection devices with integrated non-exchangeable containers. In such systems, each container holds multiple doses, and its size can be fixed or variable (preset by the user).

[0139] As further described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an interchangeable container. In one example of such a system, each container holds a single-dose amount, whereby the entire deliverable volume is discharged (full discharge). In a further example, each container holds a single-dose amount, whereby a portion of the deliverable volume is discharged (partial discharge). Also as described in ISO 11608-1:2014(E), a single-dose container system may include a needle-based injection device with an integrated interchangeable container. In one example of such a system, each container holds a single-dose amount, whereby the entire deliverable volume is discharged (full discharge). In a further example, each container holds a single-dose amount, whereby a portion of the deliverable volume is discharged (partial discharge).

Claims

1. An electronic module (11) of a drug delivery device (1, 1') or an auxiliary device (20) for a drug delivery device (1, 1'), comprising: a switch (33) configured to detect an operation performed in relation to the drug delivery device or the auxiliary device and provide respective output signals; a monitoring electronic device; wherein the monitoring electronic device is configured to: measure electrical characteristics of the switch to obtain at least one value corresponding to the electrical characteristics; process the at least one value to detect a fault state of the switch. The electronic module (11) is configured to perform the above operations.

2. The electronic module (11) according to claim 1, wherein the monitoring electronic device is configured to measure the electrical characteristics for a predetermined period after determining that the switch (33) has transitioned from a closed state to an open state.

3. The electronic module (11) according to claim 1, wherein the monitoring electronic device is configured to measure the electrical characteristics for a predetermined period after determining that the switch (33) has transitioned from an open state to a closed state.

4. The electrical module according to claim 1, wherein the monitoring electronic device is configured to measure the electrical characteristics in response to determining that the switch has transitioned from an open state to a closed state and while the switch remains in the closed state.

5. The electronic module (11) according to any one of claims 1 to 4, further comprising a debounce capacitor (41) coupled across the switch.

6. The electronic module (11) according to any one of claims 1 to 5, wherein the fault state includes at least one of a degradation state indicating that electrical contacts of the switch (33) have deteriorated and a leakage state indicating that leakage has occurred between the electrical contacts of the switch (33).

7. The electronic module (11) according to any one of claims 1 to 6, wherein processing the at least one value to detect a fault state of the switch (33) includes comparing the at least one value with a threshold value and detecting the fault state of the switch based on the comparison.

8. The electronic module (11) according to any one of claims 1 to 7, wherein the electrical characteristics correspond to a voltage across the switch (33).

9. Measuring the electrical characteristics of the switch includes obtaining a plurality of values corresponding to respective voltages across the switch at different respective times, Processing the at least one value to detect a fault state of the switch includes: Determining a rate of change of voltage across the switch based on the plurality of values; Comparing the determined rate of change with a threshold rate of change; Detecting the fault state of the switch based on the comparison. The electronic module (11) according to claim 8, comprising the above.

10. The monitoring electronic device includes an analog-to-digital converter (34) and a processor configuration (23), The analog-to-digital converter is configured to convert the output signal into a digital signal corresponding to the electrical characteristics and provide the digital signal to the processor configuration for determining the at least one fault state. The electronic module (11) according to any one of claims 1 to 9.

11. The processor configuration (23) is configured to detect the fault state by comparing at least the digital signal with a threshold value. The electronic module (11) according to claim 10.

12. The processor configuration (23) is configured to detect the fault state by determining at least a rate of change of the digital signal. The electronic module (11) according to claim 10 or 11.

13. The monitoring electronic device is configured to generate an error signal based on the detection of the fault state of the switch (33). The electronic module (11) according to any one of claims 1 to 12.

14. The electronic module (11) according to any one of claims 1 to 13 is further configured to wake up one or components of the electronic module based on the output signal.

15. The operations performed in relation to the drug delivery device or the auxiliary device include a dose dial setting operation, and the electronic module is configured to determine the dial-set dose based on the output signal. The electronic module (11) according to any one of claims 1 to 14.

16. The operation performed in relation to the drug delivery device or the auxiliary device includes a dosing operation, and the electronic module is configured to determine the administered dose based on the output signal, according to any one of claims 1 to 15, the electronic module (11).

17. The processor configuration (23) is configured to detect the fault state by comparing the at least one measurement with a trend or profile of values, and the fault state is detected at least in part based on whether the at least one measurement corresponds to or deviates from the trend or profile, according to any one of claims 1 to 16, the electronic module (11).

18. The trend or profile of values includes the trend or profile of past values previously measured for the switch, according to claim 17, the electronic module (11).

19. A drug delivery device (1, 1') or an auxiliary device (20) attachable to the drug delivery device, comprising the electronic module (11) according to any one of claims 1 to 18.

20. Measuring, by a monitoring electronics of the electronic module (11) of a drug delivery device (1, 1') or an auxiliary device (20) for a drug delivery device, an electrical characteristic of a switch (33) of the electronic module to obtain at least one value corresponding to the electrical characteristic (610), wherein the switch is configured to detect an operation performed in relation to the drug delivery device or the auxiliary device and to provide a respective output signal, obtaining (610); Processing, by the monitoring electronics, the at least one value to detect a fault state of the switch (620); A method comprising the steps of.

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