Drug delivery device with reduced dose measurement error

Abstract

A drug delivery device (100) comprising: a housing (102, 104) including one or more bridge contacts (304); a movable dial (108) at least partially located within the housing and arranged to move relative to the one or more bridge contacts (304), the dial comprising a series of conductive strips (306, 310, 314) on an outer surface of the dial (108), wherein the one or more bridge contacts (304) selectively connect and disconnect with conductive strips (306, 310, 314) in the series of conductive strips (306, 310, 314) when the movable dial (108) moves, thereby providing an alternating electrical signal; at least one electronic component (202, 218) configured to detect the alternating electrical signal, determine whether the electrical signal indicates contact between the conductive strips and the bridge contacts, and determine a dose of a medicament programmed into the drug delivery device based on the electrical signal.

Description

Technical Field

[0001] The present invention relates to a drug delivery device, in particular an injection device, which mitigates dose measurement errors caused by the user's body contacting electrical sensor contacts in the drug delivery device. Background Art

[0002] Pen-type drug delivery devices are suitable for situations where regular injections are performed by people without formal medical training. This is increasingly common among patients with diabetes, for whom self-treatment enables these patients to effectively manage their diabetes.

[0003] For good or optimal glycemic control, the dose of insulin or insulin glargine must be adjusted for each individual according to the blood glucose level to be obtained. The present invention relates to an injector, for example a handheld injector, in particular a pen injector; that is, the present invention relates to such an injector providing administration by injection of a medicinal product from a multi-dose cartridge. In particular, the present invention relates to such an injector in which the dose can be set by the user. The dose to be injected can be selected manually, for example at the injector by turning a dose knob and observing the actual dose from a dose window or display of the injection device.

[0004] A user who self-administers insulin will typically need to administer between 1 and 80 international units. In order to be able to monitor dosage, for example to prevent erroneous manipulation of the device or to record the dose that has been applied, it is desirable to measure information related to the condition and / or use of the drug delivery device (e.g., injection device), such as information about the dose injected. Summary of the invention

[0005] A drug delivery device is provided, comprising: a housing, the housing comprising one or more bridge contacts; a movable dial, the movable dial being at least partially located within the housing and arranged to move relative to the one or more bridge contacts, the dial comprising a series of conductive strips on an outer surface of the dial, wherein the one or more bridge contacts selectively connect and disconnect with conductive strips in the series of conductive strips when the movable dial moves, thereby providing an alternating electrical signal; at least one electronic component, the at least one electronic component being configured to detect the alternating electrical signal, determine whether the electrical signal indicates contact between the conductive strips and the bridge contacts, and determine a dose of a medicament programmed into the drug delivery device (especially an injection device) based on the electrical signal.

[0006] In one or more embodiments of the drug delivery device, one or more of the following features may be utilized:

[0007] - the signal is a digital signal;

[0008] - the dial is arranged to rotate relative to the housing and the one or more bridging contacts during a dose programming event and / or wherein the dial is arranged to be spirally moved out of the housing during a dose programming event;

[0009] - wherein the at least one electronic component comprises at least one of: a microcontroller, a comparator, an analog-to-digital converter;

[0010] - detecting the alternating electrical signal by the at least one electronic component comprises: detecting a voltage at at least one conductive strip in the series of conductive strips;

[0011] - said at least one electronic component is adapted to compare a voltage detected at said at least one conductive strip of said series of conductive strips with a threshold voltage;

[0012] - said at least one electronic component is adapted to compare an analog voltage detected at said at least one conductive strip of said series of conductive strips with a threshold voltage;

[0013] - said at least one electronic component is adapted to increase a dose count if the detected voltage is above said threshold voltage;

[0014] - said at least one electronic component is adapted to not increment a dose count if the detected voltage is below said threshold voltage;

[0015] - said series of conductive strips comprises at least one source strip connected to a battery and at least one sensor strip connected to said at least one electronic component;

[0016] - the device comprises a microcontroller, and wherein the microcontroller has a low power mode and is configured to wake up from the low power mode upon receiving an electrical signal;

[0017] - the microcontroller is configured to wake up from the low power mode upon receiving an electrical signal from the electrical connection to the conductive strip;

[0018] - the device further comprises a resistive element and a switch, the switch selectively connecting the resistor to at least one of the series of conductive strips based on whether the microcontroller is in the low power mode;

[0019] - the resistor is selectively connected to one sensor bar or to a plurality of sensor bars;

[0020] - the series of conductive strips comprises at least two sensor strips (306) and at least two source strips;

[0021] - programming the dose comprises dialing the dose;

[0022] - the series of conductive strips comprises at least one source strip (310) connected to a battery and at least one sensor strip (306) connected to at least one electronic component;

[0023] The one or more bridge contacts (304) are not connected to the electronic components, the bridge contacts (304) selectively connecting and disconnecting the source bars (310) and the sensor bars (306) when the movable dial (108) moves, thereby providing an alternating electrical signal.

[0024] In another aspect, a method of operating a drug delivery device is provided, the method comprising: detecting an alternating electrical signal; determining whether the electrical signal indicates contact between a conductive strip and a bridging contactor; and based on the electrical signal, determining a dose of a medicament programmed into the drug delivery device (particularly an injection device).

[0025] The method may further comprise: detecting a voltage at at least one conductive strip in the series of conductive strips; and comparing the voltage detected at the at least one conductive strip to a threshold voltage.

[0026] The method may further comprise, in response to determining that the detected voltage is above the threshold voltage, in this case incrementing a dose count.

[0027] The method may further include, in response to determining that the detected voltage is below the threshold voltage, not increasing a dose count if the detected voltage is below the threshold voltage.

[0028] The method may further include: entering a low power mode with a microcontroller; and waking the microcontroller from the low power mode upon receiving an electrical signal.

[0029] The method may further include: connecting a resistor to at least one of the series of conductive strips based on a determination that the microcontroller is in the low power mode; and disconnecting a resistor element from at least one of the series of conductive strips in response to a determination that the microcontroller wakes up from the low power mode.

[0030] In some embodiments of the present invention, one or more of the following features may be implemented:

[0031] - the dial is arranged to rotate relative to the housing and the one or more bridging contacts during a dose programming event;

[0032] - the dial is arranged to be spirally moved out of the housing during a dose programming event;

[0033] - the conductive strip is arranged to make electrical contact with the one or more bridge contacts in a first set of relative orientations of the dial and the one or more bridge contacts, and to break electrical contact with the one or more bridge contacts in a second set of relative orientations of the dial and the one or more bridge contacts, wherein the first set is different from the second set;

[0034] - the conductive strips are printed, plated or etched on the outer surface;

[0035] - the conductive strips are arranged such that the strips comprise source strips and sensor strips, the source strips being connected to a potential and the sensor strips comprising an input to a processor;

[0036] - the source bars and the sensor bars are arranged in an alternating manner around the dial;

[0037] - the bridge contacts alternately couple the source bars to the sensor bars to provide a conductive path between the bars, and decouple the electrical contacts;

[0038] - the source strips, the sensor strips and the bridge contacts are arranged to allow implementation of a Gray code to record the dialed dose;

[0039] - the Gray code is a 2-bit Gray code or a 3-bit Gray code;

[0040] - the dial further comprises an 0U detection strip positioned adjacent to the dose delivery button;

[0041] - the microcontroller is configured to: enter a low power mode; and wake up from the low power mode upon receiving an electrical signal.

[0042] In one embodiment, the drug delivery device includes an electronic component suitable for: detecting a voltage detected at at least one conductive strip in the series of conductive strips; comparing the voltage detected at the at least one conductive strip with a threshold voltage; and increasing a dose count if the detected voltage is above the threshold, or not increasing a dose count if the detected voltage is below the threshold. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The following description refers to the following drawings:

[0044] Figure 1 shows an external view of a drug delivery device 100 suitable for implementing the present invention;

[0045] Figure 2 Shows that there is Figure 1 Schematic diagram of electronic components in a drug delivery device 100;

[0046] Figure 3Aand Figure 3B shows a perspective view of a portion of a dose setting mechanism 108 of a drug delivery device 100 suitable for use with the present invention;

[0047] Figure 4A and Figure 4B shows a plan view of a portion of a dose setting mechanism 108 of a drug delivery device 100 suitable for use with the present invention;

[0048] Figure 5A and Figure 5B An example conductive strip arrangement is shown;

[0049] Fig. 6A and Figure 6B An example connection of the conductive strips is shown;

[0050] Fig. 7A and Figure 7B shows an example signal received from a conductive strip;

[0051] Figure 8 An embodiment of a circuit system according to the present invention is shown;

[0052] Fig. 9 An embodiment of a circuit system according to the present invention is shown;

[0053] Fig.10 is a flow chart of an example method according to the present invention. DETAILED DESCRIPTION

[0054] First reference Figure 1 , showing an external view of a drug delivery device 100 according to an embodiment of the present invention. Figure 1 The device 100 shown is a pen-type injection device having an elongated cylindrical shape for setting and delivering a medicament (such as insulin). The device 100 includes a housing 102 having a first housing portion 104 and a second housing portion 106. A rotatable dial 108 is located at a first (or proximal) end of the first housing portion 104. The rotatable dial 108 has an outer diameter substantially the same as that of the first housing portion 104. The second housing portion 106 can be detachably connected to the second end of the first housing portion 104. The second housing portion 106 is configured to have a needle (not shown) or a similar drug delivery device attached thereto. To achieve this, the second (or distal) end of the second housing portion 106 can have a threaded portion 110. The threaded portion 110 can have a smaller diameter than the rest of the second housing portion 106.

[0055] A display mount 112 is located on the first housing portion 104. A display may be supported on the display mount 112. The display may be an LCD display, a segmented display, or any other suitable type of display. The display mount 112 may cover a recess (not shown) in the first housing portion 104. A plurality of electronic components (see Figure 2 114. Described in more detail) can be disposed below the display mount 112.

[0056] The first housing portion 104 contains a drug dose setting and delivery mechanism. The second housing portion 106 contains a drug cartridge (not shown). The drug contained in the drug cartridge can be any kind of medicament and can preferably be in a liquid state. The drug delivery mechanism of the first housing portion 104 can be configured to engage with the drug cartridge of the second housing portion 106 to facilitate the discharge of the drug. The second housing portion 106 can be detached from the first housing portion 104 to insert a drug cartridge or remove a used cartridge. The first housing portion 104 and the second housing portion 106 can be connected together in any suitable manner, for example, using a screw or bayonet type connection. The first housing portion 104 and the second housing portion 106 can be irreversibly connected together in a manner that the drug cartridge is permanently contained in the drug delivery device 100. Further, the first housing portion 104 and the second housing portion 106 can form part of a single housing portion.

[0057] The rotatable dial 108 is configured to be manually rotated by a user of the drug delivery device 100 in order to set a dose of drug to be delivered. Figure 3A , Figure 3B , Figure 4A , Figure 4B 108) includes an internal thread system (not shown) that causes the dial 108 to be axially displaced from the housing 102 when the dial is rotated in a first direction. The dial 108 may be rotatable in both directions or only in the first direction. Preferably, the dial 108 is rotatable in both directions to allow for increasing (by rotating in the first direction) and decreasing (by rotating in the second direction) the desired dose.

[0058] The device 100 is configured to deliver a set dose of medication once the dose of medication has been set by rotating the rotatable dial 108. For example, when a user applies an axial force at the proximal end of the device, the set dose of medication is delivered. The rotatable dial 108 may support a dose delivery button 308 that is pressed to deliver the set dose of medication. In one embodiment, the dial 108 does not rotate when the dose delivery button 308 is pressed. When the dose delivery button 308 is pressed, the dial 108 moves toward the body 104 of the device 100 and thereby dispenses medication.

[0059] The display 112 may be configured to display information about the dose of medication that has been set and / or delivered. The display 112 may further display additional information, such as the actual time, the time of the last use / injection, the remaining battery capacity, one or more warning symbols indicating that the dialed dose has not been fully dispensed, etc.

[0060] Reference now Figure 2 , a schematic diagram of an example circuit system 200 forming part of a drug delivery device 100 is shown. The circuit system 200 includes a microcontroller 202, a non-volatile memory such as a ROM 204, a writable non-volatile memory such as a flash memory 205, a volatile memory such as a RAM 206, a display 210, a contactor 212 (e.g., conductive strips 306, 310 as described below), and a bus 208 connecting each of these components. The circuit system 200 also includes a battery 214 or some other suitable power source for providing power to each component and a switch 216, as described in more detail below. The circuit system 200 also includes an additional component 218. In one embodiment, the additional component 218 is a comparator. In one embodiment, the additional component 218 is an analog-to-digital converter (hereinafter also referred to as an AD converter).

[0061] The circuit system 200 may be integrated with the device 100. Alternatively, the circuit system 200 may be contained within an electronic module that may be attached to the device 100. In addition, the circuit system 200 may include additional sensors, such as optical sensors or acoustic sensors. The circuit system 200 may include an audible alarm (not shown) that the processor 202 may control to sound an alarm when the dialed dose is not fully dispensed.

[0062] ROM 204 may be configured to store software and / or firmware. Such software / firmware may control the operation of processor 202. Processor 202 utilizes RAM 206 to execute software / firmware stored in ROM to control the operation of display 210. Thus, processor 202 may also include a display driver. Processor 202 utilizes flash memory 205 to store a determined dialed dose and / or a determined dispensed dose, as will be described in more detail below. Processor 202 may be a microcontroller or a microcontroller unit.

[0063] The battery 214 can provide power for each component including the contactor 212. The power supply to the contactor 212 can be controlled by the processor 202. The processor 202 can receive signals from the contactor 212. The processor 202 can determine when the contactor 212 is powered and can be configured to interpret these signals. Through the operation of the software / firmware and the processor 202, information can be provided on the display 210 at the appropriate time. Such information may include measurements determined from signals received by the processor 202 from the contactor 212. The electronic module containing the circuit system 200 can be embedded in the dial 108. For example, the electronic module can be embedded in the button 308, which can eliminate the need to remove and reuse the electronic module when used in conjunction with a disposable pen injector or other disposable drug delivery device. The embedded electronic module may be able to record the dose selected and delivered from the pen. This function may be valuable to many device users as a memory aid or support for recording a detailed dose history. It is conceivable that the electronic module can be configured to be connected to a mobile device or similar device so that the dose history can be downloaded from the module regularly.

[0064] Now, reference will be made to FIGS. 3 to Fig.10 An example operation of the dial 108 is described.

[0065] Figure 3A and Figure 3B A perspective view of a portion of a dial 108 of a drug delivery device 100 suitable for use with the present invention is shown. Figure 3A The dial 108 is shown with the button 308 removed. Figure 3B The dial 108 is shown with the button 308 in place, along with surrounding components of the body 104 of the device 100 . Figure 4A and Figure 4B A plan view of a portion of a dial 108 suitable for use with a drug delivery device 100 of the present invention is shown.

[0066] The dial 108 includes a sleeve 302. In one embodiment, the sleeve 302 is cylindrical and is arranged to rotate relative to the first portion of the housing 104 during programming of a dose (but not to rotate relative to the housing 104 during delivery of the dose).

[0067] In one embodiment, the sleeve 302 includes conductive strips 306, 310, 314. The conductive strips may be printed, plated, or etched on the outer surface of the removable dose programming component 302 (which may be contained within the housing 104 when no dose is set, such as Figure 1306, 310, 314 can be formed from a conductive ink. For example, the conductive strips 306, 310, 314 can be formed by electroplating. If printed with conductive ink, the resistance of the conductive strips 306, 310, 314 can be in the range of 100Ω to 1kΩ (depending on the ink selected). In the case where the conductive strips 306, 310, 314 are electroplated, their resistance can be in the range of 0 to 10Ω.

[0068] Some of the conductive strips 306, 310 are power strip strips 310 that are electrically connected to a voltage supply to provide a potential. The power strip strips 310 may be electrically connected to the voltage supply via a series resistor to limit the current that can flow in this circuit. Other conductive strips 306, 310 are sensor strips 306 that are electrically connected to input terminals of the processor 202.

[0069] The sleeve 302 may include at least one source strip 310 and at least one sensor strip 306. In one embodiment, the sleeve 302 includes more than one source strip 310 and sensor strip 306, respectively. For example, the sleeve 302 may include two source strips 310 and two sensor strips 306. In principle, the sleeve 302 may include any suitable number of conductive strips 306, 310, such as three conductive strips per sleeve, four conductive strips per sleeve, five conductive strips per sleeve, six conductive strips per sleeve, etc. The sleeve 302 may include the same number of conductive strips 306, 310 of various types. The source strip 310 may be formed as a continuous strip. The continuous strip may be, for example, W-shaped (or a plurality of interconnected U-shaped shapes), with the sensor strips 306 positioned in the gaps formed by the W-shape.

[0070] The strips 306, 310 may be positioned such that there is one sensor strip 306 between every two source strips 310, and vice versa. Preferably, the conductive strips 306, 310 are separated by a non-conductive gap 316. Preferably, there is a non-conductive gap between each pair of sensor strips 306 and conductive strips 310. The gap 316 may be made of the same material as the sleeve 302 (e.g., a non-conductive plastic). Alternatively, the gap 316 may be made of a suitable electrically insulating material.

[0071] In one embodiment, the sensor strip is electrically connected to the processor 202 embedded in the button 308 through a conductive contact 312. The contact 312 is positioned within the sleeve 302. The contact 312 is formed of a conductive material (e.g., metal). In one embodiment, one contact 312 is provided for each source conductive strip 310, and one contact 312 is provided for each sensor conductive strip 306. Therefore, the number of contacts 312 can correspond to the total number of all conductive strips 306, 310. As described above, in the case where the source strip is arranged in a U-shape, a W-shape, or a continuous W-shape, the number of contacts 312 can be less than the total number of all conductive strips 306, 310. The contact 312 can be fixed to the sleeve 302 in a manner that is in permanent contact with the corresponding adjacent conductive strips 306, 310.

[0072] The body 104 of the device 100 includes a bridge contact 304. The bridge contact 304 is formed of a conductive material (e.g., metal). The bridge contact 304 is positioned within the body 104 adjacent to a first (proximal) end of the housing 104. The bridge contact 304 is fixed within the body 104 and is configured to allow contact between the sensor bar 306 and the source bar 310, between the sensor bar 306 and the gap 316, or between the source bar 310 and the gap 316, depending on the rotation of the dial 108 and, therefore, the sleeve 302. The bridge contact 304 is not electrically connected to the processor 202.

[0073] Preferably, each bridge contact 304 has a contact 304 a that is narrower than the gap 316 to ensure that when the contact 304 a contacts any non-conductive gap 316 , no signals are transmitted from the surrounding conductive strips 306 , 310 .

[0074] In one embodiment, the bridge contact 304 is formed using metal pressing (e.g., using stainless steel), wherein the three contacts 304a are formed as bumps. This manufacturing method can facilitate providing a low-cost bridge contact. The bump contacts 304a are formed at one end of the cantilever member to allow for preloading to ensure good radial contact pressure with the conductive strips 306, 310 even under the worst tolerance conditions. The bridge contact 304 can be aligned in the cylindrical housing 104 along the rotational and axial directions.

[0075] The rotation of the dial 108 is encoded by selectively connecting and disconnecting the contactors 212 (conductive strips 306, 310) on the dose programming component, thereby making the electrical signal received by the processor 202 alternating. The processor 202 can be implemented in any suitable electronic module containing the circuit system 200. Rotating the dial 108 and thus rotating the sleeve 302 makes the bridge contactor contact the conductive strips 306, 310. The contact between the sensor strip 306 and the source strip 310 via the bridge contactor 304 closes the circuit between the sensor strip 306 and the source strip 310, and the bridge contactor 304 and the contactor 312 are associated with the corresponding conductive strips 306, 310. Therefore, the voltage is detected. This can be recorded as "1" (logical high). The contact between the source strip 310 or the sensor strip 306 and the gap 316 via the bridge contactor 304 opens the circuit. This can be detected as "0" (logical low).

[0076] In this way, using the known positioning of the conductive strips 306, 310 and the gap 316, the rotation of the dial 108 and sleeve 302 relative to the body 104 and the bridge contact 304 can be detected. The known movement of the dial 108 and sleeve 302 can then be converted into a dialed dose, which can then be stored in a memory and / or displayed and / or transmitted to an external device as appropriate. Various ways of encoding information can be used; for example, a Gray code can be used. For example, the number of conductive strips 306, 310, the width of each conductive strip 306, 310 and gap 316, the configuration of the bridge contact, etc. can be considered to generate a cyclic Gray code during rotation.

[0077] Figure 3A , Figure 3B and Figure 4A , Figure 4B as well as Figure 5A An embodiment including four vertical conductive strips 306, 310 (two power strips 310 and two sensor strips 306 arranged alternately) is shown, which is suitable for encoding 24 units of dose. Alternatively or in addition to the code (e.g., number) printed on the sleeve 302, an embodiment of the present invention uses the electrical state of the conductive strips 306, 310 themselves to form an input to the microcontroller 202. The rotation of the dial 108 can be electronically encoded to identify the selected dose value before delivering the dose. The simplest Gray code that can be used to count doses and detect the direction of rotation is a 2-bit Gray code. The embodiment shown above uses three bridge contacts 304, which are equally spaced around the circumference of the sleeve 302. In this embodiment, the contacts 304a of the bridge contact 304 extend between two points 60° apart on the cylinder.

[0078] Other arrangements are possible, such as Figure 5B2D in FIG. For example, the conductive pattern can have a variable strip width and gap ratio and, in combination with three equally spaced bridge contacts 304 as described above, form a 2-bit quadrature signal during rotation. The black areas represent areas of conductive material (conductive strips 306, 310), while the white areas represent areas where no conductive material is deposited (gap 316). However, the conductive strips 306, 310 and bridge contacts 304 can be configured to generate a cyclic Gray code during rotation and can therefore be used to encode a desired dose setting.

[0079] Typically, all sensor bars 306 may have the same width, or their widths may be different. Alternatively or additionally, source bars 310 may have the same width, or their widths may be different. Figure 5A As will be apparent, one of the gaps 316 may be wider than the remaining gaps. Figure 5B A pattern that can be used to generate a 3-bit Gray code is shown.

[0080] The sleeve 302 may further include an 0U detection strip 314. The 0U detection strip 314 may be positioned on the sleeve 302 adjacent to the dose delivery button 308. During the process of dispensing the dialed dose, the 0U detection strip is typically the last portion of the contactor 212 to contact the bridge contactor 304. Thus, the 0U detection strip 314 may be provided to ensure that once the button 308 is pushed all the way down toward the body 104 and the dialed dose is dispensed, this fact is recorded as a separate signal. In other words, the 0U detection strip 314 is configured to not be engaged by the bridge contactor 314 if the dose is not dispensed or not fully dispensed.

[0081] Fig. 6A , Figure 6B Two embodiments of the electronic circuit to be used are shown in . In both embodiments, the source bar 310 is connected to a given potential, as described above. In both embodiments, the potential of the sensor bar 306 is measured and used as an input to the microcontroller 202.

[0082] exist Fig. 6A In the embodiment of FIG. 1 , the sensor bar 306 is at a low voltage (relative to the battery 214) when it is not connected to the source bar 310 via the bridge contact 304. Once the sensor bar 306 is connected to the source bar 310 via the bridge contact 304, the sensor bar 306 is at a potential close to the battery 214. This higher potential is used as an input to the microcontroller 202. Figure 6BIn the embodiment of the present invention, the sensor bar is at a high voltage (i.e., a potential close to the battery potential) when it is not connected to the source bar 310. Once the sensor bar 306 is connected to the source bar 310 through the bridge contact 304, the potential on the sensor bar 306 is reduced. This lower potential is then used as an input to the microcontroller 202.

[0083] In the following, about Fig. 6A The present invention is described in detail with reference to the embodiments of the present invention. It is obvious to those skilled in the art that the present invention is applicable to Figure 6B implementation plan.

[0084] Resistor R1 (see Fig. 6A ) ensures that the sensor bar 306 is at a stable potential until connected to the source bar 310 through the bridge contact 304. Preferably, in order to limit the current drawn from the battery, the resistance R1 is as high as possible. For example, the resistance R1 can be on the order of 1 MΩ. The resistance R1 can be, for example, 0.5 MΩ to 1.5 MΩ, 0.8 MΩ to 1.2 MΩ, 0.9 MΩ to 1.1 MΩ, or 1 MΩ. A relatively high value of R1 (e.g., on the order of 1 MΩ) can help limit the current that flows to a user who accidentally touches the bars 306, 310, 314.

[0085] The resistance of the bridge contactor 304 is preferably low, for example, in the order of 1Ω. The resistance of the bridge contactor 304 can be, for example, 0.5Ω to 1.5Ω, 0.8Ω to 1.2Ω, 0.9Ω to 1.1Ω, 1MΩ. Therefore, the resistance R1 is high compared to the resistance of the bridge contactor 304. Therefore, the microcontroller 202 can read the voltage on the sensor strip. This configuration is advantageous because it reduces power consumption and thus limits the necessary battery size. Preferably, whenever the device 100 is not in use (i.e., ideally most of the time), the microcontroller 202 is in low power mode to further save battery. The microcontroller 202 preferably uses a digital signal generated by the potential change on the sensor strip 306 to wake up the microcontroller 202 from the low power mode without consuming additional power.

[0086] As described above, as the dial 108 is rotated, the sleeve 302 extends axially (helical) outwardly from the body 104 of the device 100. This exposes the conductive strips 306, 310. The conductive strips 306, 310 may therefore be accidentally connected together by other means than the bridging contact 304. For example, a user may connect the conductive strips 306, 310 with their finger upon accidentally touching the sleeve 302 and the conductive strips 306, 310. If such an accidental connection occurs during a valid contact sequence (i.e., a sequence that the bridging contact 304 may make when turning the dial 108 and thereby setting a dose), such contact may cause errors in recoding the dialed and / or dispensed dose.

[0087] exist Fig. 7A and Figure 7B . Preferably, the microcontroller 202 is configured to detect a range of values ​​of "1" (i.e., a high potential) and a range of values ​​of "0" (i.e., a low potential). This is schematically illustrated by lines 702 and 706. Any signal above the high potential value 706 is detected as a high potential, i.e., "1". Any signal below the low potential value 702 is detected as a low potential, i.e., "0". The area between lines 702 and 706 is not defined.

[0088] Fig. 7A The readings are shown when the dial 108 is turned and the conductive strips 306, 310 are not in contact with the user's finger. As discussed above, the resistance of the bridge contact 304 is low. Therefore, in the absence of contact between the sensor bar 306 and the source bar 310 via the bridge contact 304, the potential on the sensor bar 306 is close to 0V (i.e., lower than the low potential line 702). Therefore, in the presence of contact between the sensor bar 306 and the source bar 310 via the bridge contact 304, the potential on the sensor bar 306 is close to the battery voltage 708 (i.e., higher than the high potential line 706).

[0089] Figure 7B The readings are shown when the dial 108 is turned and the conductive strips 306, 310 come into contact with the user's finger between points 712 and 714. In addition to any circuit formed by the bridge contactor, the conductive strips 306, 310 may also come into contact with the user's finger. The resistance of the user's finger is higher than the resistance of the bridge contactor 304. When the bridge contactor 304 connects the sensor bar 306 and the source bar 310, the effect on the sensor bar 306 is negligible. However, when the bridge contactor 304 does not connect the sensor bar 306 and the source bar 310, the effect on the potential of the sensor bar 306 is not negligible, and the potential between points 712 and 714 falls within the undefined region between the lines 702 and 706. This may introduce measurement errors in the case where the undefined value is interpreted as no longer below the low potential line 702 (logical low, "0") and is therefore a high potential value (logical high, "1").

[0090] To mitigate the above issues, the circuit system 200 is configured to detect potential changes caused by the conductive strips 306 , 310 connected by the bridge contact 304 and reject any potential changes caused by the conductive strips 306 , 310 connected by the user's finger.

[0091] exist Figure 8 In the embodiment shown, a comparator 218 is provided. The comparator has two analog input terminals (at Figure 8The comparator 100 includes a first input terminal 220 and a second input terminal 221. The comparator 100 includes a first input terminal 220 and a second input terminal 222 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 223 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 224 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 225 of the comparator 100. The comparator 100 includes a second input terminal 220 and a second input terminal 226 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 225 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 226 of the comparator 100. The comparator 100 includes a second input terminal 220 and a second input terminal 225 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 226 of the comparator 100. The comparator 100 includes a first input terminal 220 and a second input terminal 220 ...

[0092] This allows to distinguish Fig. 7A and Figure 7B The situation shown. Fig. 7A In the case of , the comparator output is "1" every time. However, in Figure 7B , the output of the comparator is "1" only outside of points 712 and 714 (i.e., only when the signal 704 from the sensor bar 306 rises above not only the low potential value 702 but also the high potential value 706). In general, the tolerance of the comparator can be much smaller than the width of the undefined area between lines 702 and 706. In addition, because the reference value can be set, the comparator allows for greater flexibility (e.g., compared to an embodiment where the low / high potential values ​​702, 706 are properties of the particular microcontroller used).

[0093] In the case of a 2-bit rotary encoder (i.e., a sleeve 302 having two sensor bars 306, two source bars 310, and one 0U bar 314, as described above), three comparators are preferably used, one for each input to the microcontroller 202. The first and second comparators are associated with the two encoder lines (sensor bars 306 and source bars 310), while the third comparator is associated with the 0U bar 314. This arrangement is beneficial in mitigating the risk of contacting the corresponding sensor bar 306, source bar 310, or 0U bar 314 with the user's finger.

[0094] Another advantage of the comparator as described above is its digital output, which can be used as a digital input and wake-up signal for the microcontroller 202 in case the microcontroller 202 is in a low power mode.

[0095] In one embodiment, an AD converter (not shown) can be used instead of a comparator. The AD converter can be used to convert the sensor bar 306 voltage from an analog signal to a digital signal. The digital signal can then be compared with a threshold value set by the software. In this way, the AD converter replicates the behavior of an external electronic comparator in software. Since many microcontrollers include embedded AD converters, this arrangement eliminates the need for additional components (such as additional integrated circuits to implement the comparators of the above-mentioned embodiments). Therefore, this solution is particularly suitable for devices where cost is an issue.

[0096] In order to reduce the power consumption of a continuously running (reading) AD converter and thus reduce the necessary battery size, the following approach can be implemented. Fig.10 An example implementation of the method is shown in FIG.

[0097] By reconfiguring the pins of the microcontroller 202, the signal (voltage) from the sensor bar 306 can be configured as a digital input to wake the microcontroller from a low power mode. Contact between the source bar 310, the sensor bar 306, and one or more fingers of the user may result in the detection of a transition that causes the microcontroller to leave the low power mode. Subsequently, the signal can be read by the AD converter to determine whether the voltage is above a threshold (e.g., a high potential value 706), and therefore determine whether the signal corresponds to the source bar 310 and the sensor bar 306 being connected by the bridge contactor 304 or by one or more fingers of the user.

[0098] In particular, before entering the low power mode, the microcontroller 202 (which preferably includes an embedded AD converter) can configure the input pins connected to each of the two sensor bars 306 and the 0U bar 314 (not shown) as digital inputs with interrupts to wake up the microcontroller when the logic level transitions (step S1). The microcontroller can then enter the low power mode (step S2). Therefore, when a transition is detected on the input pins of the sensor bar 306 and / or the 0U bar 314, the microcontroller 202 wakes up from the low power mode (step S3). The microcontroller 202 can then reconfigure the input pins connected to each of the three sensor bars 306 as analog inputs (step S4). The AD converter can be used to read the voltage on the input pin corresponding to the sensor bar 306 and / or the 0U bar 314 (step S5). The obtained voltage can be compared with a threshold set by software (step S6). The microcontroller 202 can therefore determine whether the transition is caused by the source bar 310 and the sensor bar 306 and / or the 0U bar 314 being connected by the bridge contactor 304 (step S8). In the event that it is determined that the transition is not caused by the source bar 310 and the sensor bar 306 and / or the 0U bar 314 being connected by the bridge contact 304, the microcontroller 202 can wait for a suitable delay, return to configuring the input pins connected to each of the two sensor bars 306 and the 0U bar 314 (not shown) as digital inputs with interrupts to wake up the microcontroller when the logic level transitions, and continue the above sequence of steps (step S9'). In the event that it is determined that the transition is caused by the source bar 310 and the sensor bar 306 and / or the 0U bar 314 being connected by the bridge contact 304, the microcontroller 202 can increment or decrement the current count of the selected dose (step S9). It can then continue to poll the analog voltage on the input pin corresponding to the sensor bar 306 and / or the 0U bar 314 and record the selected dose until no activity is detected within the appropriate delay time, and the microcontroller returns to the first step in this sequence, i.e., step S1 (step S10).

[0099] As mentioned above, from a battery life perspective, it is advantageous to make the value of resistor R1 as high as possible, and particularly significantly higher than the resistance of bridging contact 304. However, the lower the resistance R1, the lower the resistance value bridging the source and sensor bars, which results in measurement errors.

[0100] To solve this problem, in one embodiment (which can be combined with any of the above embodiments), it is possible to use Fig. 9 The arrangement. Fig. 9The circuit system shown includes an additional resistive element R8. The resistive element can be, for example, a resistor. The resistance value of the resistive element R8 is lower than that of the resistor R1. For example, the value of the resistor R8 can be on the order of 100 kΩ. For example, the value of the resistor R8 can be less than 200 kΩ, less than 180 kΩ, or less than 170 kΩ. For example, the value of the resistor R8 can be 164 kΩ. Typically, the value of R8 is selected so that it is sufficiently low compared to the resistor R1 (described above), but high enough to comply with any given safety limits that limit the current that may flow through the user's finger if the user accidentally touches the contactor.

[0101] Resistor R8 is arranged in parallel with resistor R1. Q1 is a switch operated by microcontroller 202. Switch Q1 may be, for example, a transistor. When microcontroller 202 is in low power mode, switch Q1 is open. The resistance connected to sensor bar 306 is therefore high (e.g., on the order of 1 MΩ; possible values ​​of R1 are discussed above). When microcontroller 202 wakes up from low power mode, microcontroller 202 closes switch Q1. The effective value of the resistance is reduced from R1 to the parallel combination of R1 and R8, thus making the circuit tolerant to a smaller resistance finger bridging the source bar and the sensor bar.

[0102] supply Fig. 9 The arrangement can help save battery life. Because the microcontroller 202 is expected to be in a low power state for most of its life, this resistor switching between R1 and the parallel combination of R1 and R8 may have only a negligible effect on battery life.

[0103] The terms "drug" or "medicament" are used synonymously herein and describe a pharmaceutical preparation comprising one or more active pharmaceutical ingredients or a pharmaceutically acceptable salt or solvate thereof and optionally a pharmaceutically acceptable carrier. In the broadest sense, an active pharmaceutical ingredient ("API") is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used to treat, cure, prevent, or diagnose disease or to otherwise enhance physical or mental health. A drug or medicament may be used for a limited duration, or periodically for a chronic disorder.

[0104] As described below, a drug or medicament may include at least one API or a combination thereof in various types of formulations for treating one or more diseases. Examples of APIs may include small molecules (having a molecular weight of 500 Da or less); polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double-stranded or single-stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems (such as vectors, plasmids, or liposomes). Mixtures of one or more drugs are also contemplated.

[0105] In a primary package or "drug container" suitable for a drug delivery device, a drug or medicament may be included. The drug container may be, for example, a cartridge, a syringe, a reservoir or other solid or flexible vessel, which is configured to provide a suitable chamber for storing (e.g., short-term or long-term storage) one or more drugs. For example, in some cases, the chamber may be designed to store the drug for at least one day (e.g., 1 day to at least 30 days). In some cases, the chamber may be designed to store the drug for about 1 month to about 2 years. It may be stored at room temperature (e.g., about 20°C) or at a refrigerated temperature (e.g., from about -4°C to about 4°C). In some cases, the drug container may be or may include a dual-chamber cartridge, which is configured to store two or more components (e.g., API and diluent, or two different drugs) of a pharmaceutical preparation to be administered separately, one being stored in each chamber. In this case, the two chambers of the dual-chamber cartridge may be configured to allow mixing between two or more components before and / or during distribution to a human or animal body. For example, the two chambers can be configured so that they are in fluid communication with each other (e.g., through a conduit between the two chambers), and allow the user to mix the two components if necessary before dispensing. Alternatively or additionally, the two chambers can be configured to allow mixing when dispensing the components into the human or animal body.

[0106] The medicine or medicament included in the drug delivery device described herein can be used to treat and / or prevent many different types of medical diseases. The example of obstacle includes, for example, diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic obstacles (such as deep vein or pulmonary thromboembolism). Another example of obstacle is acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. The example of API and medicine is those described in the following manual: such as Rote Liste 2014 (for example, but not limited to, main group (main group) 12 (antidiabetic drugs) or 86 (tumor drugs)) and Merck Index, the 15th edition.

[0107] Examples of APIs for treating and / or preventing type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin (e.g., human insulin, or human insulin analogs or derivatives); glucagon-like peptide (GLP-1), GLP-1 analogs or GLP-1 receptor agonists, or analogs or derivatives thereof; dipeptidyl peptidase-4 (DPP4) inhibitors, or pharmaceutically acceptable salts or solvates thereof; or any mixture thereof. As used herein, the terms "analogs" and "derivatives" refer to polypeptides having a molecular structure that can be formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin) by deleting and / or exchanging at least one amino acid residue present in a naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residues can be codable amino acid residues or other natural 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 is formally derived from the structure of a naturally occurring peptide (e.g., the structure of human insulin), wherein one or more organic substituents (e.g., fatty acids) are bound to one or more amino acids. Alternatively, one or more amino acids present in the naturally occurring peptide may have been deleted and / or replaced by other amino acids (including non-encodable amino acids), or amino acids (including non-encodable amino acids) have been added to the naturally occurring peptide.

[0108] Examples of insulin analogs are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala and in which the Lys at position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0109] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, ); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin, B29-N-ω-carboxypentadecanoyl-γ-L-glutamyl-des(B30) human insulin (insulindegludec, ); B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0110] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists are e.g. lixisenatide Exenatide (exendin-4, Liraglutide (a 39-amino acid peptide produced by the salivary glands of the Gila monster) Semaglutide, Taspoglutide, Albiglutide Dulaglutide rExendin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C, CM-3, GLP-1Eligen, ORMD-0901, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZY OG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-03 4. MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, Exenatide-XTEN and Glucagon-Xten.

[0111] Examples of oligonucleotides are e.g. Mipomersen sodium It is a cholesterol-reducing antisense therapeutic used to treat familial hypercholesterolemia.

[0112] Examples of DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0113] Examples of hormones include pituitary hormones or hypothalamic hormones or regulatory activity peptides and their antagonists, such as gonadotropins (follicle-stimulating hormone, luteinizing hormone, chorionic gonadotropin, tocopherol), somatropine (growth hormone), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin and goserelin.

[0114] Examples of polysaccharides include glucosaminoglycanes, hyaluronic acid, heparin, low molecular weight heparin or ultra low molecular weight heparin or derivatives thereof, or sulfated polysaccharides (e.g., polysulfated forms of the above polysaccharides), and / or pharmaceutically acceptable salts thereof. An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan GF 20 It is a sodium hyaluronate.

[0115] As used herein, the term "antibody" refers to an immunoglobulin molecule or an antigen binding portion thereof. Examples of antigen binding portions of immunoglobulin molecules include F (ab) and F (ab') 2 fragments, which retain the ability to bind antigens. The antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., mouse) antibody, or a single-chain antibody. In some embodiments, the antibody has effector functions and can fix complement. In some embodiments, the antibody has reduced or no ability to bind to Fc receptors. For example, the antibody can be an isotype or subtype, an antibody fragment or a mutant, which does not support binding to Fc receptors, for example, it has a mutagenic or missing Fc receptor binding region. The term antibody also includes antigen binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTI) and / or dual variable region antibody-like binding proteins with cross-binding region orientation (CODV).

[0116] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule, which does not include a full-length antibody polypeptide, but still includes at least a portion of a full-length antibody polypeptide capable of binding an antigen. Antibody fragments can include cleavage portions of full-length antibody polypeptides, although the term is not limited to such cleavage fragments. Antibody fragments that can be used in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments (such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies)), monovalent or multivalent antibody fragments (such as bivalent, trivalent, tetravalent and multivalent antibodies), mini antibodies, chelated recombinant antibodies, triabodies or diabodies, intracellular antibodies, nanobodies, small modular immunopharmaceuticals (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies and antibodies comprising VHH. Other examples of antigen-binding antibody fragments are known in the art.

[0117] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term "framework region" refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the correct positioning of the CDR sequences to allow antigen binding. Although the framework region itself is generally not directly involved in antigen binding, as known in the art, certain residues within the framework region of certain antibodies may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with the antigen.

[0118] Examples of antibodies are anti-PCSK-9 mAb (eg, Alirocumab), anti-IL-6 mAb (eg, Sarilumab), and anti-IL-4 mAb (eg, Dupilumab).

[0119] Pharmaceutically acceptable salts of any API described herein are also contemplated for use as drugs or medicaments in drug delivery devices. Pharmaceutically acceptable salts are, for example, acid addition salts and basic salts.

[0120] Those skilled in the art will appreciate that modifications (additions and / or removals) may be made to the various components of the API, formulations, apparatus, methods, systems and embodiments described herein without departing from the overall scope and spirit of the invention, and that the invention encompasses such modifications and any and all equivalents thereof.

Claims

1. A drug delivery device (100), wherein include: A housing (102, 104) comprising one or more bridge contactors (304); and a movable dial (108) at least partially located within the housing and arranged to move relative to the one or more bridge contacts (304), the dial comprising a series of conductive strips (306, 310, 314) on an outer surface of the dial (108), wherein the series of conductive strips includes at least one source strip (310) connected to a battery and at least one sensor strip (306) connected to at least one electronic component, wherein the one or more bridge contacts (304) selectively connect and disconnect the source strips (310) with the sensor strips (306) when the movable dial (108) moves, thereby providing an alternating electrical signal; wherein the one or more bridging contacts are not connected to the at least one electronic component except when connected via the sensor bar; wherein the at least one electronic component (202, 218) is configured to: detecting the alternating electrical signal; determining whether the electrical signal indicates contact between the conductive bar and the bridge contactor; and Based on the electrical signal, a dose of medicament is determined to be programmed into the drug delivery device.

2. The drug delivery device of claim 1, wherein the signal is a digital signal.

3. A drug delivery device according to claim 1 or claim 2, wherein the dial is arranged to rotate relative to the housing and the one or more bridging contacts during a dose programming event and / or wherein the dial is arranged to be spirally moved out of the housing during a dose programming event.

4. The drug delivery device of claim 1, wherein the at least one electronic component (202, 218) comprises at least one of the following: a microcontroller, a comparator, an analog-to-digital converter.

5. The drug delivery device according to claim 1, wherein the alternating electrical signal is detected by the at least one electronic component (202, 218) include: A voltage is detected at at least one conductive strip in the series of conductive strips (306, 310, 314).

6. The drug delivery device of claim 5, wherein the at least one electronic component (202, 218) is adapted to compare a voltage detected at the at least one conductive strip in the series of conductive strips (306, 310) with a threshold voltage.

7. The drug delivery device of claim 5, wherein the at least one electronic component (202, 218) is adapted to compare an analog voltage detected at the at least one conductive strip in the series of conductive strips (306, 310) with a threshold voltage.

8. A drug delivery device according to claim 6 or claim 7, wherein the at least one electronic component (202, 218) is adapted to increment a dose count if the detected voltage is above the threshold voltage.

9. A drug delivery device according to claim 6 or claim 7, wherein the at least one electronic component (202, 218) is adapted to not increment a dose count if the detected voltage is below the threshold voltage.

10. The drug delivery device of claim 1, wherein the device comprises a microcontroller, and wherein the microcontroller has a low power mode and is configured to wake up from the low power mode upon receiving an electrical signal.

11. The drug delivery device of claim 10, wherein the microcontroller is configured to wake from the low power mode upon receiving an electrical signal from the electrical connection to the conductive strip.

12. The drug delivery device of claim 10, wherein the device further comprises a resistive element and a switch that selectively connects the resistor to at least one of the series of conductive strips based on whether the microcontroller is in the low power mode.

13. The drug delivery device of claim 12, wherein the resistor is selectively connected to one sensor strip (306) or a plurality of sensor strips (306).

14. The drug delivery device of claim 1, wherein the series of conductive strips includes at least two sensor strips (306) and at least two source strips (310).

15. The drug delivery device of claim 1, wherein programming the dose comprises dialing the dose.

16. A method of operating a drug delivery device according to any one of claims 1 to 15, the method include: detecting the alternating electrical signal; determining whether the electrical signal indicates contact between the conductive bar and the bridge contactor; as well as Based on the electrical signal, a dose of medicament is determined to be programmed into the drug delivery device.

17. The method according to claim 16, further comprising: include: detecting a voltage at at least one conductive strip in the series of conductive strips; as well as A voltage detected at the at least one conductive strip is compared to a threshold voltage.

18. The method according to claim 17, further comprising: include: In response to determining that the detected voltage is above the threshold voltage, in this case the dose count is incremented.

19. The method according to claim 17, further comprising: include: In response to determining that the detected voltage is below the threshold voltage, a dose count is not incremented if the detected voltage is below the threshold voltage.

20. The method according to claim 16, further comprising: include: Use the microcontroller to enter low-power mode; as well as The microcontroller is awakened from the low power mode upon receiving an electrical signal.

21. The method according to claim 20, further comprising: include: connecting a resistor to at least one of the series of conductive strips based on a determination that the microcontroller is in the low power mode; as well as Responsive to determining that the microcontroller is awake from the low power mode, a resistive element is disconnected from at least one of the series of conductive strips.

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