Medication delivery device with sensing system

Abstract

To provide a medication delivery device which has a sensor in the form of a single-pole double-throw (SPDT) switch, a conversion control module that receives signals from the SPDT switch and generates an output signal, and related power control circuitry.SOLUTION: An SPDT switch may interact with a rotating component having a plurality of teeth that slide against an arm during dose delivery. Contact of the arm of the SPDT switch to a peak of a tooth places the SPDT switch in a set state, while lack of contact between the arm and the peak of the tooth places the SPDT switch in a reset state. The SPDT switch and an SR logic switch may be used to sense dosage of medication delivered during dose delivery. Power control circuitry can include a sleep state that reduces battery drain during non-use, and a wakeup state that senses the administered dose.SELECTED DRAWING: Figure 5

Description

[Background technology]

[0001] Patients suffering from various diseases frequently have to inject themselves with medication. To allow humans to conveniently and accurately self-administer medication, various devices, commonly known as pen-type injectors or injection pens, have been developed. Generally, these pens are loaded with a cartridge that includes a piston and contains multiple doses of liquid medication. A drive member is movable forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle.

[0002] In a disposable or pre-filled pen, after the pen has been used to deplete the supply of medication in the cartridge, the user discards the entire pen and begins using a new, replacement pen. In a reusable pen, after the pen has been used to deplete the supply of medication in the cartridge, the pen is disassembled to allow the used cartridge to be replaced with a new cartridge, and the pen is then reassembled for subsequent use.

[0003] Such devices may have components that physically interact with each other to result in a change of state or action by the device. For example, the device may have a cap that is removed prior to delivery, a dose button that can be rotated to set a dose and / or actuated to deliver a dose, an "on" button to wake the device, etc. Thus, there have been efforts in the art to provide a reliable system for accurately measuring the relative motion of members of a drug delivery device to assess the delivered dose. Such a system may include a sensor secured to a first member of the drug delivery apparatus that detects the relative motion of a sensed component secured to a second member of the apparatus.

[0004] Many syringe pens and other drug delivery devices do not include functionality for automatically detecting and recording the amount of drug delivered by the device during an injection event. Without an automated system, patients must manually track the amount and time of each injection. Thus, there is a need for a device operable to automatically detect information that can be correlated to the dose delivered by measuring mechanical parts of the drug delivery device during an injection event. There is also a need to improve the accuracy and reliability of the detection system. Summary of the Invention

[0005] The present disclosure relates to a drug delivery device having a sensor in the form of a single-pole double-throw (SPDT) switch, a conversion control module that receives a signal from the SPDT switch and generates an output signal, and an associated power control circuit configured to maintain battery usage when the drug delivery device is not dispensing a dose. The SPDT switch may interact with a mechanical component of the drug delivery device, such as a rotating component having a number of teeth that slide against an arm of the SPDT switch during dose delivery. When the SPDT switch arm contacts the apex of the teeth, the SPDT switch is in a set state, and when the arm and teeth are not in contact, the SPDT switch is in a reset state.

[0006] In some embodiments, the conversion control module includes set / reset (SR) logic. The SR logic generates a wavy unit signal when the SPDT switch transitions between a set state and a reset state. The wavy unit signal can be used to sense a dose of drug delivered during dose delivery. According to some embodiments, the counting unit counts rising edges, falling edges, or both of the wavy unit signal generated by the SR logic to determine the administered dose size.

[0007] The power control circuitry of the medication delivery device can include a sleep state and a wake-up state. The sleep state can reduce battery drain during non-use, and the wake-up state can fully power the conversion control module and associated counting circuitry to sense the administered dose. According to some embodiments, the power control circuitry utilizes metal oxide semiconductor field effect transistors (MOSFETs) to prevent battery drain when the medication delivery device is in the sleep state.

[0008] In one embodiment, a drug delivery device is provided, the drug delivery device includes a housing, a mechanical switch mounted on a printed circuit board, the mechanical switch including a single-pole double-throw (SPDT) switch with an arm, a rotatable element rotatable relative to the printed circuit board, the rotatable element having a series of protrusions spaced apart from one another, the rotatable element positioned to allow the protrusions to slide relative to the arm of the SPDT switch, a conversion control module in electrical communication with the SPDT switch configured to generate a wave unit signal based on a signal from the SPDT switch when the arm slides relative to the protrusions, and a controller configured to receive the wave unit signal from the conversion control module. [Brief description of the drawings]

[0009] Further embodiments of the present disclosure, as well as its features and advantages, will become more apparent by reference to the following description taken in conjunction with the accompanying drawings, in which components are not necessarily drawn to scale. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the different views.

[0010] [Figure 1] FIG. 1 is a perspective view of a medication delivery device having a dose detection system according to an aspect of the present disclosure. [Diagram 2] FIG. 2 is a partially exploded perspective view of the medication delivery device of FIG. 1 showing a dose button having a support and a cover, the cover being shown separated from the support. [Diagram 3] FIG. 2 is a partially exploded perspective view of the medication delivery device of FIG. 1 showing components of the dose detection system. [Figure 4] FIG. 2 is a cross-sectional view of the drug delivery device of FIG. 1. [Diagram 5] FIG. 2 is a partial cutaway view of the proximal end of the medication delivery device of FIG. 1 showing components of the dose detection system. [Figure 6] FIG. 2 is a bottom view of a portion of the dose button of FIG. 1, showing a printed circuit board held within the dose button cover. [Figure 7] FIG. 7 is an exploded view of a portion of the dose button shown in FIG. [Figure 8] FIG. 2 is a perspective view of a flange of a dose detection system of a medication delivery device. [Figure 9] FIG. 9 is a top view of the flange of FIG. 8. [Figure 10] FIG. 13 is a perspective view of the dose button support. [Figure 11] FIG. 11 is a top view of the dose button support of FIG. [Figure 12] 1 illustrates an example SPST switch, according to some embodiments. [Figure 13] 6 shows an exploded view of the electronics assembly and flange of FIG. 5. [Figure 14] 6 shows an exploded view of the electronics assembly and flange of FIG. 5. [Figure 15] FIG. 10 shows a cantilever arm of a switch interacting with the rotating flange from FIGS. 8 and 9. [Figure 16] FIG. 10 shows a cantilever arm of a switch interacting with the rotating flange from FIGS. 8 and 9. [Figure 17] FIG. 10 shows a cantilever arm of a switch interacting with the rotating flange from FIGS. 8 and 9. [Figure 18] FIG. 10 shows a cantilever arm of a switch interacting with the rotating flange from FIGS. 8 and 9. [Figure 19] FIG. 10 shows a cantilever arm of a switch interacting with the rotating flange from FIGS. 8 and 9. [Figure 20]FIG. 2 illustrates an example waveform graph showing the output current of a SPST switch over time. [Figure 21] FIG. 1 is a schematic diagram of an exemplary conversion control module disposed between the dose detection system and the controller of the control system, according to some embodiments. [Figure 22] 4 is a schematic diagram of a control signal generated by a conversion control module and communicated to a controller of a control system according to some embodiments. [Figure 23] FIG. 1 is a schematic diagram of a microprocessor implementing SR logic in firmware, according to some embodiments. [Figure 24] FIG. 1 is a schematic diagram of a microprocessor implementing SR logic in firmware, according to some embodiments. [Diagram 25] FIG. 2 is an exemplary block diagram illustrating functional aspects of a printed circuit board for processing signals from a sensor, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0011] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same, it being understood, however, that no limitation of the scope of the invention is intended.

[0012] The present disclosure relates to a sensing system for a drug delivery device. In one aspect, the sensing system includes a single-pole double-throw (SPDT) switch in electrical communication with a conversion control module, such as a set-reset (SR) logic. The sensing system further includes a power control circuit that can be configured to cause the drug delivery device to either sleep or wake up based on the operation of the drug delivery device (e.g., whether the device is in use or not). A MOSFET is used to prevent battery consumption during the sleep state, as well as provide full conversion control module operation in the wake up state.

[0013] In some embodiments, the SPDT switch and processing circuitry (including, for example, a conversion control module and / or a power control circuit) are used to sense relative rotational movement between the dose setting assembly and the actuator of the drug delivery device to determine the amount of the dose delivered by the drug delivery device. The sensed relative rotational movement correlates to the delivered dose. By way of example, the drug delivery device is described in the form of a pen injector. However, the drug delivery device may be any device used to set and deliver a dose of a drug, such as a pen injector, an infusion pump, and a syringe. The drug may be any of the types that can be delivered by such a drug delivery device.

[0014] Such detection systems described herein may provide improved accuracy and reliability in determining the amount of rotation over other sensing systems arranged with contact event counters or other means that are susceptible to signals with higher than desired noise, such as signal debounce. Such detection systems may additionally or alternatively provide improved power consumption control compared to other sensing systems that are not configured to limit battery usage when the drug delivery device is not dispensing a dose. One advantage of using a mechanical switch, such as an SPDT switch, is that the travel distance of the sensed element to trigger between on / off states can be small, thereby providing higher resolution sensing. In a mechanical switch with a conversion control module, the bounce of the switch can be ignored once the switch activates the module. In some applications, mechanical switches may be preferred over other sensing, such as sliding contacts. For example, the application of sliding contacts for sensing may be limited due to the increasingly smaller circular travel and / or radial spacing of the contact area, making sensing in such small and tight spaces much more difficult and less consistent. The end result may be a lower comparable resolution, e.g., the ability to sense only every 36 degrees (or 2 units) instead of 18 degrees or less. Higher resolution in sensing a rotating sensed element can be achieved with a mechanical switch, such as an SPDT switch, for a comparable geometry and size of the rotating sensed element. The teachings herein may also be applied to linearly moving sensed elements and / or multiple single-pole, single-throw switches.

[0015] The devices described herein may further include a drug, for example in a reservoir or cartridge 20 (see FIG. 4). In another embodiment, a system may include one or more devices, including device 10, and a drug. The term "drug" refers to one or more therapeutic agents, including, but not limited to, insulin, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dalaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered by the device described above. Drugs as used in the device may be formulated with one or more excipients. The device is operated by the patient, a caregiver, or a medical professional to deliver the drug to a human, generally in the manner described above.

[0016] An exemplary medication delivery device 10 is shown in FIGS. 1-4 as a pen-type injector configured to inject medication into a patient through a needle. The device 10 includes a body 11, which may include an elongated pen-shaped housing 12 including a tip portion 14 and a proximal portion 16. The distal portion 14 may be received within a pen cap 18. With reference to FIG. 4, the distal portion 14 may house a reservoir or cartridge 20 configured to hold a medicinal fluid to be dispensed through a dispensing action of an outlet 21 of the housing. The outlet 21 of the distal portion 14 may include an injection needle 24. In some embodiments, the injection needle is removable from the housing. In some embodiments, the injection needle is replaced with a new injection needle after each use.

[0017] A piston 26 may be positioned within the reservoir 20. The drug delivery device may include an injection mechanism positioned within the proximal portion 16 operable to advance the piston 26 towards the outlet of the reservoir 20 to force the contained drug through the needle end during a dose-dispensing operation. The injection mechanism may include a drive member 28, illustratively in the form of a screw, axially movable relative to the housing 12 to advance the piston 26 through the reservoir 20.

[0018] The device may include a dose setting assembly coupled to the housing 12 for setting the dose dispensed by the device 10. As best seen in Figures 3 and 4, in the illustrated embodiment, the dose setting assembly includes a dose setting screw 32 and a flange 38. The dose setting screw 32 is in the form of a threaded element operable to helically move (e.g., move axially and rotationally simultaneously) relative to the housing 12 about a longitudinal axis of rotation AA during dose setting and dose dispensing. Figures 3 and 4 show the dose setting screw 32 fully threaded into the housing 12 at its home or zero dose position. The dose setting member 32 is operable to unscrew proximally from the housing 12 until it reaches a fully extended position corresponding to the maximum dose deliverable by the device 10 in a single injection. The extension position can be any position between a position corresponding to an incremental extension position (such as a 0.5 or 1 unit dose setting) to a fully extended position corresponding to the maximum dose deliverable by the device 10 in a single injection, where the housing 12 is screwed distally until a home or zero position is reached, corresponding to the minimum dose deliverable by the device 10 in a single injection.

[0019] 3 and 4, the dose setting screw 32 includes a helically threaded outer surface that engages a corresponding threaded inner surface 13 of the housing 12 to allow the dose setting screw 32 to helically move (e.g., simultaneously rotate and translate) relative to the housing 12. The dose setting screw 32 further includes a helically threaded inner surface that engages a threaded outer surface of a sleeve 34 (FIG. 4) of the device 10. The outer surface of the dose setting screw 32 includes dose indicator markings, such as numbers that are visible through a dose window 36 to indicate the set dose to a user.

[0020] As mentioned above, in some embodiments, the dose setting assembly further includes a tubular flange 38 coupled to the open proximal end of the dose setting screw 32 and axially and rotationally locked to the dose setting screw 32 by a protrusion 40 received within an opening 41 in the dose setting screw 32. The protrusion 40 of the flange 38 can be seen in Figures 3, 8 and 9, and the opening 41 in the dose setting screw 32 can be seen in Figure 3.

[0021] As seen in Figures 3 and 4, the delivery device 10 may include an actuator assembly having a clutch 52 and a dose button 30. The clutch 52 is received within the dose setting screw 32, and the clutch 52 includes an axially extending stem 54 at its proximal end. The dose button 30 of the actuator assembly is positioned proximal to the dose setting screw 32 and the flange 38. The dose button 30 includes a support 42, also referred to herein as the "under button," and a cover 56, also referred to herein as the "over button." As discussed, the support 42 and cover 56 enclose electronic components used to store and / or communicate data related to the amount of a dose delivered by the medication delivery device.

[0022] The dose button support 42 may be attached to the stem 54 of the clutch 52, such as by an interference fit or ultrasonic welding, to axially and rotatably secure the dose button 30 and clutch 52 together.

[0023] In some embodiments, a portion of the clutch may pass through a lumen 39 in the flange 38. The flange lumen 39 is best seen in Figures 8 and 9. The lumen 39 may, in some embodiments, serve to aid in centering the clutch 52 in place.

[0024] The proximal face 60 of the dose button 30 may serve as a pressing surface against which a force may be applied manually, e.g., directly by a user, to push the actuator assembly (dose button 30 and clutch 52) distally. A biasing member 68, illustratively a spring, may be disposed between a distal face 70 of the support 42 and a proximal face 72 of the tubular flange 38 (FIGS. 8 and 9) to bias the support 42 of the actuation assembly and the flange 38 of the dose setting assembly axially away from each other. The dose button 30 may be depressed by a user to initiate a dose dispensing operation. In some embodiments, the biasing member 68 may be seated against this proximal face 72 and surround a raised collar 37 of the flange 38.

[0025] The delivery apparatus 10 is operable in a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, the dose button 30 is rotated relative to the housing 12 to set the desired dose to be delivered by the device 10. In some embodiments, rotating the dose button 30 in one direction relative to the housing 12 translates the dose button 30 axially proximally relative to the housing 12, and rotating the dose button 30 in the opposite direction relative to the housing 12 translates the dose button 30 axially distally relative to the housing. In some embodiments, rotating the dose button clockwise moves the dose button 30 distally and rotating the dose button counterclockwise moves the dose button proximally, or vice versa.

[0026] In some embodiments, rotating the dose button 30 and axially translating the dose button 30 in a proximal direction serves to increase the set dose, and rotating the dose button 30 and axially translating the dose button 30 in a distal direction serves to decrease the set dose. The dose button 30 is adjustable in predefined rotational increments that correspond to a minimum incremental increase or decrease in the set dose during a dose setting operation. The dose button may include a detent mechanism such that each rotational increment produces an audible and / or tactile "click." For example, one increment or "click" may be equal to ½ or 1 unit of medication.

[0027] In some embodiments, the set volume may be visible to the user via dial gauge markings shown through the dose window 36. During the dose setting mode, the actuator assembly, including the dose button 30 and clutch 52, moves axially and rotationally with the dose setting assembly, including the flange 38 and the dose setting screw 32.

[0028] The dose setting screw 32 and the flange 38 are rotatably fixed to one another by a threaded connection between the dose setting screw 32 and the housing 12, which allows them to rotate and move proximally during dose setting. During this dose setting operation, the dose setting button 30 is rotatably fixed to the flange 38 and the dose setting screw 32 by complementary splines 74 of the flange 38 and the clutch 52 (FIG. 4), which are biased together by a biasing member 68. During the course of dose setting, the dose setting screw 32, the flange 38, the clutch 52, and the dose button 30 move in a helical manner (e.g., simultaneous rotation and axial translation) relative to the housing 12 from a "start" position to an "end" position. This rotation and translation relative to the housing is proportional to the amount of dose setting due to the operation of the medication delivery device 10.

[0029] Once the desired dose is set, the device 10 is manipulated so that the injection needle 24 properly penetrates, for example, the user's skin. The dose dispensing mode of operation is initiated in response to an axial distal force applied to the proximal face 60 of the dose button 30. The axial force is applied directly to the dose button 30 by the user. This results in axial movement of the actuator assembly (dose button 30 and clutch 52) in the distal direction relative to the housing 12.

[0030] Axial shifting motion of the actuator assembly compresses the biasing member 68, reducing or closing the gap between the dose button 30 and the tubular flange 38. This relative axial movement separates the clutch 52 and the complementary splines 74 on the flange 38, thereby disengaging the dose button 30 from rotatable fixation to the flange 38 and the dose setting screw 32. Specifically, the dose setting screw 32 is rotatably decoupled from the dose button 30 to allow back-drive rotation of the dose setting screw 32 relative to the dose button 30 and the housing 12. Additionally, rotation of the dose button 30 relative to the housing 12 is held by a user pressing and engaging the dose button 30 while the dose setting screw 32 and flange 38 are free to rotate relative to the housing 12.

[0031] As the dose button 30 and clutch 52 continue to be depressed axially without rotation relative to the housing 12, the dose set screw 32 is threaded back into the housing 12 as it rotates relative to the dose button 30. Dose markings are visible through the window 36, indicating the amount still remaining to be injected. As the dose set screw 32 is threaded distally, the drive member 28 advances distally to push the piston 26 through the reservoir 20 and expel medication through the needle 24.

[0032] During a dose dispensing operation, the amount of drug released from the drug delivery device is proportional to the amount of rotational movement of the dose setting screw 32 relative to the housing 12 as the dose setting screw 32 is screwed back into the housing 12. In some embodiments, since the dose button 30 is rotatably fixed relative to the housing 12 during the dose dispensing mode, the amount of drug released from the drug delivery device can be considered to be proportional to the amount of rotational movement of the dose setting screw 32 relative to the dose button 30 as the dose setting screw 32 is screwed back into the housing 12. The injection is complete when the female threads of the dose setting screw 32 reach the distal end of the corresponding male threads of the sleeve 34 (FIG. 4). The device 10 is then again placed in the ready or zero dose position as shown in FIGS. 2 and 4.

[0033] As discussed above, the delivered dose may be derived based on the amount of rotation of the dose setting assembly (flange 38 and dose setting screw 32) relative to the actuator assembly (clutch 52 and dose button 30) during dose delivery. This rotation may be determined by detecting incremental movements of the dose setting assembly, which are "counted" as the dose setting assembly rotates during dose delivery.

[0034] Further details of the design and operation of the exemplary delivery device 10 can be found in U.S. Patent No. 7,291,132, entitled Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage, the entire disclosure of which is incorporated herein by reference. Another example of a delivery device is an automatic injection device that can be found in U.S. Patent No. 8,734,394, entitled "Automatic Injection Device With Delay Mechanism Including Dual Functioning Biasing Member," the entire disclosure of which is incorporated herein by reference, where such a device is modified with one or more of the various sensor systems described herein to determine the amount of medication delivered from the medication delivery device based on sensing relative rotation within the medication delivery device. Another example of a delivery device is a reusable pen-type device that can be found in U.S. Patent No. 7,195,616, entitled "Medication Injector Apparatus with Drive Assembly that Facilitates Reset," which is incorporated by reference in its entirety herein, where such a device is modified with one or more of the various sensor systems described herein to determine the amount of medication delivered from the medication delivery device based on sensing relative rotation within the medication delivery device.

[0035] Described herein is a dose detection system that may be operable to determine the amount of a delivered dose based on relative rotation between a dose setting member and a device body. The dose detection system utilises a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery. A sensed element is attached to and rotationally fixed on the dose setting member. An actuator is attached to the device body and held against rotation relative to the device body during dose delivery. The sensed element thereby rotates relative to the actuator during dose delivery in relation to the amount of the delivered dose.

[0036] In some embodiments, the dose detection system comprises a rotational sensor attached to an actuator assembly and a sensed element including surface features evenly spaced radially about an axis of rotation of the sensing element.

[0037] In some embodiments, the dose detection system may include a sensor and a sensed component attached to a component of a drug delivery device. The term "attached" encompasses any manner of fixing the position of a component to another component or member of a drug delivery device such that they are operable as described herein. For example, the sensor may be attached to the component of the drug delivery device by being positioned directly on, received within, integral with, or otherwise connected to the component. The connection may include, for example, a connection formed by frictional engagement, spline, snap or press fit, sonic welding, or adhesive.

[0038] The term "directly attached" is used to describe an attachment where two components, or a structural application and a member, are physically secured together without the use of intermediate members other than the attachment component. The attachment component may comprise a fastener, an adapter, or other part of the fastening system (such as a compression membrane) that is interposed between the two components to facilitate the attachment. A "directly attached" is distinguished from an attachment where the components / members are joined by one or more intermediate functional members.

[0039] The term "fixed" is used to indicate that the indicated motion may or may not occur. For example, if two members are required to rotate and move together, then a first member is "rotationally fixed" with a second member. In one aspect, a member may be "fixed" relative to another member functionally, rather than structurally. For example, one member may be pressed against another member such that a frictional engagement between the two members rotationally locks them together, but the two members cannot be fixed together without the pressing of the first member.

[0040] Various sensor arrangements are contemplated herein. Generally, a sensor arrangement comprises a sensor and a sensed component. The term "sensor" refers to any component capable of detecting the relative position or movement of the sensed component. The sensor may be used with associated electrical components to operate the sensor. A "sensed component" is any component capable of detecting the position and / or movement of the sensed component relative to the sensor. In the case of a dose detection system, the sensed component rotates relative to the sensor and the sensor is capable of detecting the rotational movement of the sensed component. The sensor may comprise one or more sensing elements and the sensed component may comprise one or more sensed elements. The sensor detects the movement of the sensed component and provides an output representative of the movement of the sensed component.

[0041] Exemplarily, the dose detection system includes an electronics assembly suitable for operation of the sensor arrangement as described herein. The medication delivery device may include a controller operably connected to the sensor to receive an output from the sensor. The controller begins to receive a generated signal from the sensor indicative of a count from a first to a last for a total number of counts used to determine a total displacement, e.g., an angular displacement. When detecting an angular movement of the dose setting assembly, the controller may be configured to receive data indicative of an angular movement of the dose setting assembly, which may be used to determine from the output an amount of a dose delivered by operation of the medication delivery device. The controller may be configured to determine from the output a dose delivered by operation of the medication delivery device. The controller may include conventional components such as a processor, a power supply, a memory, a microcontroller, etc. Alternatively, at least some components may be provided separately, such as by a computer, a smartphone, or other device. Means are then provided for operably connecting an external controller component with the sensor at the appropriate time, such as by a wired or wireless connection.

[0042] According to one embodiment, the electronics assembly includes a sensor arrangement including one or more sensors in operative communication with a processor for receiving a signal from the sensor representative of a sensed rotation. An exemplary electronics assembly 76 is shown in FIGS. 5-7 and can include a sensor 86 and a printed circuit board (PCB) 77 having a number of electronic components. The printed circuit board can be a flexible printed circuit board. The circuit board of the electronics assembly 76 can include a microcontroller unit (MCU) as a controller with at least one processing core and an internal memory. The electronics assembly can include a power source 79, e.g., a battery, illustratively a coin cell, for providing power to the components. The controller of the electronics assembly 76 can include control logic operative to perform the operations described herein, including detecting angular movement of the dose setting assembly during dose setting and / or dose delivery based on a detected rotation of the dose setting assembly relative to the actuator assembly and / or detecting a dose delivered by the medication delivery device 10. Some, but not all, of the components of the electronics assembly can be housed in a compartment 85 within the dose button 30. In some embodiments, the compartment 85 may be defined between the proximal surface 71 of the dose button support 42 and the distal surface 81 of the dose button cover 56. In the embodiment shown in Figure 5, the electronics assembly 76 is permanently integrated within the dose button 30 of the delivery device. In other embodiments, the electronics assembly is provided as a module that can be removably attached to the actuator assembly of the medication delivery device.

[0043] An underside view of electronics assembly 76 retained within cover 56 is shown in Figure 6, and an exploded view of electronics assembly 76 is shown in Figure 7. As shown in Figures 6 and 7, electronics assembly 76 may include a printed circuit board (PCB) 77 and a sensor 86 having a contact surface 111. As shown in Figure 7, electronics assembly 76 may also include a battery 79 and a battery cage 87.

[0044] In some embodiments, at least a portion of the sensor 86 extends outside the compartment 85 of the dose button 30. As best seen in Figures 10 and 11, the support 42 of the dose button 30 may include one or more openings 45 through which the sensor 86 may extend. In some embodiments, during assembly of the drug delivery device, the contact surface 111 of the sensor 86 passes through the opening 45 of the support 42. This may allow the contact surface 111 of the sensor to interact with components that are external to the compartment 85 of the dose button 30. In some embodiments, only one of the openings 45 of the support 42 is required to accommodate the sensor, although a second opening may be provided, for example, due to symmetry of the support component, which aids in manufacturing the component and / or assembly of the component with the drug delivery device.

[0045] The controller of the electronics assembly 76 may be operable to store in a local memory (e.g., internal flash memory or on-board EEPROM) the total angular movement used to determine dose delivery and / or the detected dose delivery. The controller may be further operable to wirelessly transmit a signal representative of the total count, the total angular movement, and / or the detected dose to an external device, such as a user's mobile device or a remote server. The transmission may be via, for example, Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocol. Illustratively, the BLE control logic and the controller are integrated on the same circuit.

[0046] As discussed, according to one aspect, the dose detection system includes detecting the relative rotational movement between two assemblies of the drug delivery device. The sensor operates to detect the amount of angular movement from the start of dose injection to the end of dose injection, with the degree of rotation having a known relationship to the amount of delivered dose. For example, in some embodiments, the relationship of the pen injector is such that an angular displacement of the dose setting assembly of 18° corresponds to one dose unit, but other angular relationships are also suitable, such as 9°, 10°, 15°, 20°, 24°, or 36° for one or half unit. The sensor system is operable to determine the total angular displacement of the dose setting member during dose delivery. Thus, if the angular displacement is 90°, then 5 units of dose have been delivered.

[0047] The angular displacement is determined by counting dose increments as the injection progresses. For example, the sensing system may use a repeating pattern of sensed elements such that each repetition is indicative of a predefined degree of rotation angle. Conveniently, the pattern may be established such that each repetition corresponds to a minimum dose increment that can be set with the drug delivery device.

[0048] The dose detection system components may be permanently or removably attached to the medication delivery device. In some embodiments, at least some of the dose detection system components are provided in the form of modules that are removably attached to the medication delivery device. In other embodiments, the dose detection system components are permanently attached to the medication delivery device.

[0049] In some embodiments, the sensor may detect the relative rotation of a sensed component rotatably fixed to the dose setting screw 32, which determines the amount of dose delivered by the medication delivery device during dose delivery. In one exemplary embodiment, the rotation sensor is attached to and rotatably fixed to the actuator assembly. The actuator assembly does not rotate relative to the device housing during dose delivery.

[0050] In some embodiments, the sensed component is attached to and rotatably fixed to the dose setting screw 32 and rotates relative to the dose button 30 and device housing 12 during dose delivery. In some of the embodiments described herein, the sensed component includes a ring structure having a plurality of proximally extending projections circumferentially arranged relative to one another. The projections are shaped and sized to deflect a movable element of the rotation sensor. One embodiment of such a sensed component is a tubular flange 38 (best shown in Figures 3, 5, 8, and 9). The embodiments described herein may be provided with a module that is removably attachable to the dose button of the delivery device or integrated within the dose button of the delivery device.

[0051] During dose delivery, the dose setting screw 32 is free to rotate relative to the dose button 30. In an exemplary embodiment, the electronics assembly 76 is rotatably secured by the dose button 30 and does not rotate during dose delivery.

[0052] As seen in Figures 2, 3, and 5, the dose button 30 includes a cover 56 coupled to the support 42. The electronics assembly 76 may be at least partially housed within a compartment 85 defined between the cover 56 and the support. In some embodiments, the cover and the support have corresponding splines that engage with one another to couple the cover and the support together. For example, in some embodiments, the cover 56 may be coupled to the support 42 via one or more snaps 57 on the cover 56 and corresponding to one or more protrusions 43 on the support. As seen in Figures 5 and 6, the snaps 57 on the cover 56 may be oriented radially inward from the inner peripheral sidewall 73. As seen in Figures 5, 10, and 11, the protrusions 43 of the support 42 may be oriented radially outward from the outer peripheral sidewall 75 of the support 42. The protrusions 43 may form a triangular ramp shape.

[0053] Snaps 57 on cover 56 are configured to snap over and mate with protrusions 43 of the support to couple the cover to the support. In some embodiments, the protrusions on the support comprise a continuous annular protrusion around the outer peripheral sidewall of the support. Cover 56 may be attached to support 42 via frictional engagement, interference fit, or any other suitable fit. In some embodiments, cover 56 is permanently secured to support 42 during assembly, for example, via ultrasonic welding, adhesive, or other suitable fastening technique.

[0054] As seen in Figures 8 and 9, the tubular flange 38 may include a plurality of axially oriented teeth 102 evenly spaced radially about the axis of rotation and arranged to correlate to the equivalent of one unit of dosage. In this exemplary embodiment, the tubular flange 38 includes 20 teeth 102 that are rotatably spaced evenly from one another such that the rotational distance between two adjacent teeth corresponds to 18 degrees of rotation. Thus, with the tubular flange 38 of Figure 8, an 18 degree rotation of the tubular flange 38 may be used to represent one dosage unit or 1 / 2 dosage unit. It should be understood that in other embodiments, a different total number of teeth may be used to create other angular relationships, such as 9 degrees, 10 degrees, 15 degrees, 18 degrees, 20 degrees, 24 degrees, or 36 degrees for 1 unit or 0.5 unit.

[0055] A recess 124 may be defined between each pair of adjacent teeth 102. Each tooth 102 may have a generally triangular-shaped profile and each may have a surface 120 against which the contact surface 111 of the sensor may slide.

[0056] In some embodiments, the sensor for detecting rotation of the tubular flange includes a spring-loaded movable element having a contact portion mountable to a tooth of the tubular flange such that the contact surface is configured to slide against and over the tooth during rotation of the flange relative to the actuator assembly during dose delivery. The sensor generates a signal corresponding to the flange in response to the contact portion moving over the tooth. The controller, in response to the signal generated by the sensor, determines a dose count for determining a delivered dose based on the detected rotation of the flange relative to the actuator assembly during dose delivery.

[0057] The contact surface may be biased against the physical feature of the tubular flange to ensure proper contact between the contact surface and the physical feature during rotation. In one embodiment, the movable member is a resilient member having one portion attached to the actuator at a position displaced from the contact surface. In one example, the movable member is a compliant member comprising a beam attached to the actuator at one end and having a contact surface at the other end. The beam is bent to bias the contact surface toward the surface feature. Alternatively, the movable member may be biased in any of a variety of other ways. In addition to the use of a resilient beam, biasing may be provided, for example, by the use of a spring component. Such a spring component may comprise, for example, a compression, tension, or torsion coil spring. In yet other embodiments, the movable member may be biased against the surface feature of the sensed element by a separate resilient member or spring component that supports the movable element.

[0058] 5 depicts an embodiment of a sensor 86 having a contact surface 111 that interacts with the teeth 102 of the tubular flange 38. As the flange 38 rotates relative to the dose button 30 during delivery, the teeth 102 of the flange contact and slide against the contact surface 111 of the sensor 86, causing the contact surface 111 to move in a vibratory fashion. The movement of the contact surface 111 may be a combination of axial and lateral movement such that the contact surface 111 slides into and out of recesses 124 defined between the teeth 102 of the flange 38. The sensor 86 may be configured to track the movement of the contact surface 111 and associate the movement with an output signal that is sent to the controller.

[0059] As an alternative to teeth on the tubular flange, the surface feature that interacts with the sensor may comprise anything detectable by the sensor. The sensor arrangement may be based on a variety of sensed features, including, for example, tactile, optical, electrical, and magnetic properties. In the exemplary embodiment shown in the figures, the surface feature is a physical feature that allows for detection of incremental movement as the dose setting assembly rotates relative to the actuator assembly. In alternative embodiments, the sensor may be a piezoelectric sensor, a magnetic sensor such as a Hall effect sensor, an accelerometer for detecting vibrations, for example vibrations of a ratchet mechanism or other detent mechanism, which vibrations may be correlated with rotational movement, an optical sensor such as an accelerometer, a reflective sensor, a circuit breaker sensor, or an optical encoder, or any other sensor suitable for sensing the rotation of a first component relative to a second component.

[0060] In some embodiments, when a user presses axially on surface 60 of dose button 30, the dose button 30 advances distally relative to housing 12, compressing spring 68. Continued distal pressing of dose button 30 results in back-driving of dose setting screw 32 in a helical direction relative to housing 12. As a result, axial pressing of dose button 30 drives dose setting screw 32 and flange 38 to rotate. In some embodiments, the dose detection system is operable to detect a dose only while the dose button is pressed.

[0061] In some embodiments, the electronics assembly may include a clock or timer to determine the time elapsed between counts caused by the triggering of the rotational sensor from the surface features of the sensed element. If no counts are detected by the controller after a period of time, this may be used to indicate that the dose is complete.

[0062] In some embodiments, a single sensing system may be used for both dose detection sensing and wake-up activation. For example, the controller is configured to enable the electronics assembly to wake up or activate to a higher or full power state upon the sensor first sensing rotation of the sensed element. The wake-up feature is configured to enable power transfer from a power source (shown as a battery) to power up the electronic components to sense the dose, to minimize inadvertent power loss or usage when no dose dispensing event occurs. In other embodiments, a separate wake-up switch is provided and disposed within the dose button housing and may be triggered when the dose button is in its distal position. After actuation of the electronics assembly, the controller begins receiving a generated signal from the rotation sensor indicative of the total angular displacement and thus the first to last count of the total number of counts used to determine the delivered dose.

[0063] In some embodiments, the electronics assembly may have a controller configured to receive the output signal from the rotation sensor. The controller of the electronics assembly may be programmed to convert the intermediate signal into a conditioned digital signal, which may be a single step / square wave with a predetermined width representing a predetermined time. In some embodiments, output signals below a predetermined level may be filtered out or ignored.

[0064] According to one aspect, the medication delivery device includes a repeatedly actuable switch that can act as a sensor. In some embodiments, the switch acts as a rotational sensor in the dose detection system described above. However, in other embodiments, the switch can be used to detect other activities, such as cap removal.

[0065] As discussed herein, the electronics assembly includes a sensor arrangement having one or more sensors in operative communication with a processor to receive a signal from the sensor representative of a sensed rotation of a sensed member. Figures 13 and 14 show exploded views of the electronics assembly 76 and flange 38 of Figure 5. Figure 13 shows a contact surface 111 that interacts with the teeth 102 of the tubular flange 38. As the flange 38 rotates relative to the dose button during delivery, the teeth 102 of the flange contact and slide against the sensor contact surface 111, causing the contact surface 111 to move in a vibratory fashion.

[0066] Various sensor arrangements can be employed for the drug delivery device. Exemplary sensor arrangements include mechanical components (e.g., sliding contacts, switches), piezoelectric components, and / or the like. Some exemplary techniques include a mechanical switch that is triggered with a tine on a flange. For example, a single-pole, single-throw (SPST) switch can be used to sense the rotation of the flange as the tine slides relative to the switch. For example, an SPST switch can be implemented using a switch rocker arm as shown in FIG. 12, or the switch of FIG. 13, which shows a switch 86' having a conductive pad 89 and a cantilever arm 210. The conductive pad 89 and a first end 201 of the cantilever arm 210 are mounted to the PCB 77. The switch also includes a base connected to the cantilever arm 210. The base is connected to the PCB to connect the cantilever arm to the PCB. The base and the arm may together form a single monolithic component. FIGS. 15-19 depict the cantilever arm 210 of the switch interacting with the rotating flange 38 from FIGS. 8 and 9. Figure 15 shows the arm 210 in an unstressed state when the third curved portion 216 is in the recess 124 between two adjacent teeth 103, 105. In Figure 16, the flange 38 has begun to rotate relative to the switch and PCB 77. As a result, the teeth 105 slide and push against the third curved portion 216 of the arm 210, causing the arm 210 to begin to deflect toward exiting the recess 124. The first curved portion 212 begins to move toward a straight configuration and the second curved portion 214 begins to move toward the conductive pad 89.

[0067] In FIG. 17, the flange 38 has been rotated further than in FIG. 16, causing the teeth 105 to slide against the third curved portion 216 and almost completely out of the recess 124. The first curved portion 212 has moved even further toward a straight configuration. As a result, the second curved portion 214 contacts the conductive pad 89, thereby closing the switch. The second curved portion is also pressed against the blocking protrusion 204, preventing the second curved portion from moving further toward the first curved portion 212 and may also help prevent the second curved portion from repeatedly bouncing against the conductive pad 89 in a rapid manner that could result in a noisy output signal.

[0068] In Figure 18, the flange 38 has been rotated further than in Figure 17, with the third curved portion 216 exiting the recess 124 and sliding across the top of the tooth 105. The second curved portion 214 remains in contact with both the conductive pad 89 and the blocking protrusion 204. The blocking protrusion 204 prevents the second curved portion 214 from moving closer to the first curved portion 212.

[0069] Finally, in Figure 19, flange 38 has rotated further than in Figure 18, with third curved portion 216 ceasing to contact tooth 105 and now beginning to contact the next adjacent tooth 107. During this transition, just as the next tooth 107 begins to press against arm 210, the arm, which is spring biased toward the position shown in Figure 15, swings back toward its unstressed state, thus moving first curved portion 212 toward a more curved shape, thereby moving third curved portion 216 toward the opposite direction to the direction of rotation of flange 38, and moving second curved portion 214 away from conductive pad 84, thereby opening the switch. As flange 38 rotates further, the cycle continues, with the arm moving back toward the conductive pad to close the switch, and so on.

[0070] As described herein, the switch can open and close based on mechanical interaction with teeth on a flange of the drug delivery device such that as the switch passes across the teeth a signal is sent to a processing circuit (e.g., a general purpose input / output (GPIO) of a microprocessor of the drug delivery device). Extended use of the drug delivery device can damage components that can affect the mechanical operation of the switch. Additionally or alternatively, during use of the drug delivery device, the opening and closing current of the switch can bounce. FIG. 20 illustrates an example waveform graph 2000 showing the output current of an SPST switch over time. The output current is approximately zero (0) when the switch is open and approximately 1.6 volts when the switch is closed. As seen in portion 2022 of graph 2000, the electrical bounce of the switch between opening and closing causes the output current to fluctuate, which can be interpreted as many different trigger signals, even though the switch is actually only closed once. The bounce can be further complicated by the dimensions of the switch. For example, such a switch may be an optical switch where a high impedance during the transition can cause the switch to open and close rapidly (e.g., in microseconds). Such bouncing transitions may appear to a microprocessor as multiple pulses when the measurement is actually only one switch transition or pulse. Thus, conventional sensor arrangements may suffer from one or more imperfections, including those due to the material and / or electrical properties of the sensor, that may cause errors in the dose count or dose measurement calculated based on the sensor output.

[0071] According to some embodiments, the technology disclosed herein can provide for the use of a single-pole double-throw (SPDT) switch as a sensing mechanism, as well as software and / or hardware-based signal processing configured to provide a low error signal to a microprocessor of a medication delivery device. According to some embodiments, the SPDT switch can include set and reset states that can be processed using a conversion control module (e.g., set / reset (SR) flip-flop logic) to drive high and low logic levels to downstream circuitry, such as a microcontroller (e.g., via a general-purpose input / output (GPIO) of the microcontroller). Such SPDT switches and associated logic can address one or more deficiencies of conventional sensor arrangements. For example, some embodiments can reduce and / or eliminate signal bounce compared to that caused by conventional sensor technology. As another example, the technology can leverage circuit designs as described herein to provide low power consumption when the medication delivery device is not in use.

[0072] In some embodiments, the SPDT switch includes a cantilever arm that is movable to place the SPDT switch in multiple states. For example, the SPDT switch can include a set state, a reset state, and / or a neutral state. The cantilever arm can be attached to a printed circuit board at a first end, and a second end of the arm is not attached to the printed circuit board and can move freely relative thereto.

[0073] In some embodiments, the set and reset states may be associated with respective conductive pads mounted on a PCB and / or a housing device that is in turn mounted on the PCB, with contact between the cantilever arm and the conductive pad closing the switch for that associated state and lack of contact between one or both pads opening the switch.

[0074] In some embodiments, the cantilever arm may be configured to contact and slide against the sensed component, for example against a tooth of the rotating tubular flange 38 shown in Figures 8 and 9. In some embodiments, contact of the SPDT switch arm with a portion of the tooth (e.g., contact with the apex of the tooth) places the SPDT switch in one state (e.g., a set state), while contact of the SPDT switch arm with a second portion of the tooth and / or lack of contact between the arm and the tooth places the SPDT switch in a second state (e.g., a reset state).

[0075] In some embodiments, the conversion control module may be disposed between the sensor and the processing core of the MCU. In some embodiments, the conversion control module may be implemented by a microprocessor (e.g., in firmware and / or software). As further described in FIG. 21, according to some embodiments, the conversion control module is configured to generate a wave-like unit signal S3 from the generated first and second signals S1, S2 (alternately arranged), which may also be referred to as a set signal S and a reset signal R, respectively.

[0076] In some embodiments, the conversion control module comprises a latch circuit, an SR latch circuit, and / or the like. The latch circuit may include an output signal that switches high or low in response to an alternating contact input signal received by the latch circuit. The conversion control module is operable to convert the first and second signals S1, S2 shown in FIG. 21 into a GPIO signal, such as a switch, as a single input to the processing core of the MCU. One potential advantage of providing a latch circuit is that processing power demands may be reduced compared to other configurations.

[0077] FIG. 21 exemplarily illustrates an example of a system 2100 having an SPDT switch 2102 and an SR latch circuit 2104. Although not illustrated, in some embodiments described herein, the SR latch circuit 2104 may be disposed between the SPDT switch 2102 and a processing core of a controller MCU (e.g., in electrical communication with the Q signal). In some embodiments, the SR latch circuit 2104 may be implemented in part and / or entirely by the processing core of the MCU. The SPDT switch 2102 generates a sense signal. Each throw of the SPDT switch 2102 is associated with a corresponding set S circuit or reset R circuit. The latch circuit 2104 of the conversion control module is shown to receive a reset signal R, shown as S2, and a set S signal, shown as S1, and to flip-flop between set and reset to generate a Q signal and a non-Q signal. Examples of Q and non-Q signals are shown in FIG. 22.

[0078] In some embodiments, the processing core of the MCU is operable to receive and process the Q signal, shown as S3, to determine the unit of rotation based on the number of rising edges C, or can be switched to be set in the Q signal, and stored in memory. Additionally or alternatively, the unit of rotation can be determined based on the number of falling edges, or can be switched to be reset in the Q signal, and then stored in memory. The dose count can be stored in memory by the processing core prior to the step of determining the unit of rotation. The non-Q signal can be used as a contingency signal, providing a redundancy function to the control system in case the expected pattern of the Q signal is not demonstrated. In other embodiments, the non-Q signal can be ignored when sent to the processing core, or can be omitted from the processing core. The system may require only one GPIO input. The latch circuit 2104, for example, can advantageously result in each unit being counted once. As another exemplary advantage, the system 2100 can be configured to avoid repeated dose counts if the contact arm contacts the same pad on the next dose.

[0079] Another exemplary advantage of the system 2100 is that it can function as a robust debounce circuit. That is, if there is a non-uniform signal coming into the latch circuit 2104, due to the latch function, even if the signal S1 is seen repeatedly, there will be no state change because this only occurs when there is a signal from S2. These techniques can provide advantages over systems that simply use debounce circuits and / or software debounce. For example, the amount of debounce required for a non-uniform signal can depend on the frequency of the signal. Some debounce techniques add a delay so that the controller stops for a certain amount of time so that the controller does not count during the delay. If the frequency of the non-uniform signal is high and the debounce is set high (e.g., the delay used to force the controller to stop for a certain amount of time is greater than the signal frequency), then the signals will smear together and the controller will determine a dose count that is lower than expected. Similarly, if the frequency of the non-uniform signal is low and the debounce is set low (e.g., the delay used to force the controller to stop for a certain amount of time is less than the signal frequency), the controller will determine a dose count that is higher than expected. Additionally, due to the presence of an AC signal, the system described herein can improve the mechanical tolerance of the system when the diameter of the tooth ring is small. For example, if there is only one signal, the position indicator may maintain contact and keep the switch closed as it moves between the teeth, and the controller may not be able to detect such transitions between the teeth (and therefore such transitions are not counted). In another embodiment, two or more single-pole, single-throw (SPST) switches, such as two SPST switches, can be applied to the circuit of FIG. 21, thereby replacing the SPDT switch. The two SPST switches can be offset to generate a signal representing a reset signal and another signal representing a set signal for input to the latch circuit 2104.

[0080] In some embodiments, the MCU can be configured to power on the system or wake up the system from a low power state to a high power state based on receiving a first count from a single input signal (e.g., Q). When the system is in a low power state configuration, the associated hardware and / or logic (e.g., a counter block as described herein) has enough power to determine at least a first one of the many units.

[0081] According to some embodiments, the microprocessor may implement the SR logic in firmware, as shown in Figures 23-24, according to some embodiments. Figures 23-24 show the software (SW) SR logic 2302 in the microprocessor 2304. According to some embodiments, the microprocessor 2304 may use a MOSFET 2310 to prevent consumption of power from the battery 2306 when the drug delivery device is in a sleep state (e.g., a state before the first injection). For example, an initial sleep state may occur when the switch rocker of the SPDT switch is in a valley between mechanical teeth as discussed herein. As shown in Figure 23, in the sleep state, the switch 2314, implemented as any of the rotational sensors described herein, is in a first state that applies a voltage from the battery 2306 to the MOSFET 2310. The SW control switch 2308 is open such that no voltage from the voltage source 2312 is applied to the MOSFET 2310, so that the MOSFET 2310 is in an off position and therefore does not conduct. Thus, in the off position, minimal and / or no current is drawn from battery 2306. Figures 23 and 24 include a general circuit portion 2320 that indicates a resistive load on the GPIO input and an indicator that indicates a logic state, with indicator 2322 indicating a first state in Figure 23 and a second state in Figure 24. According to some embodiments, general circuit portion 2320 can provide a signal to a detection or counting function or circuit (e.g., a counter block), as discussed further herein.

[0082] When a dose is injected using the drug delivery device, the circuit can be configured to detect the dose injection and wake up the SR logic. For example, the circuit can be configured to detect the dose by detecting when the rocker arm of the SPDT switch crosses the apex of a mechanical tooth as discussed herein. As shown in FIG. 24, when a dose is detected, the switch 2314 changes to a second state that sends a wake-up signal to the microprocessor 2304 for full debounce operation of the software SR logic 2302. Additionally, the SW control switch 2308 is closed to apply voltage from the voltage source 2312 and allow the MOSFET 2310 to provide a GPIO reset signal to the SW SR logic 2302. Although the embodiments herein describe the use of a power switch embodied as the SW control switch 2308, the power switch may include other switches, such as a contact sensor.

[0083] In some embodiments, the counter block may be disposed between the sensor (e.g., including the conversion control module) and the processing core of the MCU and / or implemented by the processing core. In some embodiments, the counter block may be configured to determine the number of units by counting and logging the number of rising and / or falling edges of a single input signal, such as the number of times switching the set of Q signals or the rising C in FIG. 22. The total number of rising edges of the generated signal S3 correlates with the total number of units, which represents the amount of rotation of the dose member. In some embodiments, the counter block may count both rising and falling edges to make the determination of the amount of rotation. The counter block may be operable to communicate the determined total count number C to the MCU.

[0084] 25 is an exemplary block diagram pictorially illustrating functional aspects of a printed circuit board 2500 for processing signals from a sensor 2502 (e.g., a SPDT switch), according to some embodiments. The sensor 2502 is in communication with both a counter block 2504 and a quadrature encoder 2506, both of which are in communication with a controller 2508. The sensor 2502 can be, for example, the sensor 86 of FIG. 6. For example, as described herein, the sensor 86 can be configured to track the movement of the contact surface 111 and associate the movement with an output signal that is sent to the counter block 2504 and the quadrature encoder 2506, which can count the number of times the contact surface 111 slides in and out of the recess 124 defined between the teeth 102 of the flange 38, and provide the determined count to the controller 2508 (which can be used to determine the dose of the injection). It should be appreciated that the quadrature encoder 2506 may be implemented in firmware, hardware, and / or the like.

[0085] In some embodiments, the counter block 2504 and the quadrature encoder 2506 may be configured to process the signal from the sensor 2502 using different techniques. Using different techniques may provide some redundancy in measuring the signal from the sensor 2502 (e.g., to assess whether the measurement is accurate). Still referring to FIG. 22, FIG. 22 illustrates a portion of example signals 2202, 2204, and 2206, each of which is a square wave in this example (where the horizontal axis represents time and the vertical axis represents voltage). The counter block 2504 may analyze the received signal using a first technique to generate a first count of the signal. For example, the counter block 2504 may be configured to count the rising edges C of each square wave 2202-2206. The quadrature encoder 2506 may analyze the received signal using a second technique to generate a second count of the signal. For example, the quadrature encoder 2506 may be configured to count both the rising and falling edges of each square wave 2202-2206, one of the falling edges being labeled as falling edge 2202B of square wave 2202 for illustrative purposes.

[0086] In some embodiments, the counter block 2504 and the quadrature encoder 2506 may be configured to process signals from the sensor 2502 using different sampling rates. For example, the counter block 2504 may have a sample rate configured to sample signals from the sensor 2502 to sense rising edges of each signal, and the quadrature encoder 2506 may have a different sampling rate configured to sample signals from the sensor 2502 to sense both rising and falling edges of each signal. By way of example, the counter block 2504 may be configured to use a sampling rate of 10 ms (100 Hz), while the quadrature encoder 2506 may be configured to use a sampling rate of 1 ms (1000 Hz).

[0087] The illustrated device is what is commonly referred to as a reusable pen-type drug injection device that is manually manipulated by a user to selectively set a dose and then inject the set dose. This type of injection device is well known, and the description of the device is merely exemplary, as the sensing system can be adapted for use with variously configured drug delivery devices, including otherwise constructed pen-type drug injection devices, alternatively shaped injection devices, and infusion pump devices. The drug can be any of the types that can be delivered by such drug delivery devices. The device is intended to be exemplary and not limiting, as the sensing system described herein can be used with other otherwise configured devices.

[0088] In order to clarify its use and to inform the public hereof, 、 , ...and <n> "At least one of the following" or "< / n> 、 、... <n> "At least one of, or a combination thereof" or "< / n> 、 ...and / or <n>The phrase " " is defined by applicant in its broadest sense and, unless expressly asserted to the contrary by applicant, supersedes any other implied definition above or below, and means one or more elements selected from the group including A, B... and N. In other words, the phrase means any combination of one or more of the elements A, B,... or N, including any one element alone or that one element in combination with one or more of the other elements, which may also include additional unlisted elements.

[0089] While various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples and are not the only possible embodiments and implementations. Moreover, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the advantages described will be achieved in each embodiment.

[0090] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0091] 1. A drug delivery device comprising: a housing; a mechanical switch mounted on a printed circuit board, the mechanical switch including a single pole double throw (SPDT) switch with an arm; a rotatable element that is rotatable relative to the printed circuit board, the rotatable element having a series of protrusions spaced apart from one another, the rotatable element positioned to allow the protrusions to slide relative to the arm of the SPDT switch; a conversion control module in electrical communication with the SPDT switch configured to generate a wave unit signal based on a signal from the SPDT switch when the arm slides relative to the protrusions; and a controller configured to receive the wave unit signal from the conversion control module.

[0092] 2. The drug delivery device of aspect 1, wherein the SPDT switch includes a set state that generates a set signal and a reset state that generates a reset signal, and the conversion control module includes SR logic configured to generate the wave-like unit signal based on the set signal and the reset signal from the SPDT switch.

[0093] 3. The drug delivery device of aspect 2, wherein the drug delivery device comprises a counter block configured to determine the number of rotational units of the rotatable element based on the number of rising edges, falling edges, or both of the generated wave-like unit signal.

[0094] 4. The medication delivery device of any one of aspects 1-3, further comprising a battery and a microprocessor.

[0095] 5. The medication delivery device of aspect 4, wherein the microprocessor comprises one or more of the SR logic and the controller.

[0096] 6. The medication delivery device of aspect 4, further comprising a metal oxide semiconductor field effect transistor (MOSFET), wherein the SPDT switch is in electrical communication with the battery.

[0097] 7. The medication delivery device of aspect 6, wherein the microprocessor comprises a software (SW) controlled switch disposed between a voltage source and the MOSFET, and in a sleep state, the SPDT switch is in a first state in which the battery is in electrical communication with the MOSFET, and the SW controlled switch is open so that the MOSFET is not in electrical communication with the voltage source to prevent battery drain, and in a wake-up state, the SW controlled switch is closed so that the MOSFET is in electrical communication with the voltage source.

[0098] 8. The medication delivery device of aspect 7, wherein the microprocessor includes a reset input and a wake-up input.

[0099] 9. The medication delivery device of aspect 8, wherein in the wake-up state, the MOSFET applies a voltage to the reset input and the SPDT switch is in a second state in which the battery is in electrical communication with the wake-up input to the microprocessor.

[0100] 10. A drug delivery device according to any one of aspects 1 to 9, further comprising an outlet and a dose button axially translatable relative to the housing to activate a dose dispensing mode in which drug is dispensed from the outlet, the dose button being rotatable relative to the housing in a dose setting mode to select a drug dose size to be delivered from the outlet.

[0101] 11. The medication delivery device of aspect 10, wherein the rotatable element is positioned such that as the rotatable element rotates, the protrusion slides against the arm of the SPDT switch to enable the arm to move between set and reset states of the SPDT switch.

[0102] 12. The drug delivery device of aspect 10, wherein the rotatable element is rotatable with the dose button in a dose setting mode and rotatable relative to the dose button in the dose dispensing mode, and the degree of rotation of the rotatable element during the dose dispensing mode determines the amount of drug dispensed from the outlet.

[0103] 13. The medication delivery device of aspect 11, wherein the SPDT switch is configured to sense rotation of the rotatable element relative to the dose button.

[0104] 14. The medication delivery device of any one of aspects 1-13, wherein the printed circuit board is fixed to the dose button.

[0105] 15. The medication delivery device of any one of aspects 1-14, wherein the mechanical switch comprises a base connected to an arm of the SPDT switch, the base being mounted to the printed circuit board.

[0106] 16. The medication delivery device of any one of aspects 1-15, wherein the housing further comprises a reservoir and a medication within the reservoir.

[0107] 17. A dose detection system for a medication delivery device comprising: a mechanical switch mounted on a printed circuit board, the mechanical switch including a single pole double throw (SPDT) switch with an arm; a rotatable element that is rotatable relative to the printed circuit board, the rotatable element having a series of protrusions spaced apart from one another, the rotatable element positioned to allow the protrusions to slide relative to the arm of the SPDT switch; a conversion control module in electrical communication with the SPDT switch configured to generate a wave unit signal based on a signal from the SPDT switch when the arm slides relative to the protrusions; and a controller configured to receive the wave unit signal from the conversion control module.

[0108] 18. The SPDT switch includes a set state that generates a set signal and a reset state that generates a reset signal;

[0109] The dose detection system of embodiment 17, wherein the conversion control module comprises SR logic configured to generate the wave-like unit signal based on the set signal and the reset signal from the SPDT switch.

[0110] 19. The dose detection system of aspect 18, wherein the drug delivery device comprises a counter block configured to determine the number of rotational units of the rotatable element based on the number of rising edges, falling edges, or both of the generated wave unit signal.

[0111] 20. The dose detection system of aspect 19, further comprising: a battery in electrical communication with the SPDT switch; a metal oxide semiconductor field effect transistor (MOSFET); and a microprocessor, the microprocessor comprising one or more of the SR logic and the controller.

[0112] 21. The dose detection system of aspect 20, wherein the microprocessor comprises a software (SW) controlled switch disposed between a voltage source and the MOSFET, and in a sleep state, the SPDT switch is in a first state in which the battery is in electrical communication with the MOSFET and the SW controlled switch is open so that the MOSFET is not in electrical communication with the voltage source to prevent battery drain, and in a wake-up state, the SW controlled switch is closed so that the MOSFET is in electrical communication with the voltage source.

[0113] 22. The dose detection system of aspect 21, wherein the microprocessor includes a reset input and a wake-up input.

[0114] 23. The dose detection system of aspect 22, wherein in the wake-up state, the MOSFET applies a voltage to the reset input and the SPDT switch is in a second state in which the battery is in electrical communication with the wake-up input to the microprocessor.

[0115] 24. A method comprising: rotating a rotatable element relative to a printed circuit board, the rotatable element having a series of spaced apart protrusions positioned to allow the protrusions to slide against an arm of a single-pole, double-throw (SPDT) switch of a mechanical switch mounted to the printed circuit board; and generating a wave-like signal via a conversion control module in electrical communication with the SPDT switch based on a signal from the SPDT switch as the arm slides against the protrusions.

[0116] 25. The method of claim 24, further comprising generating a set signal and / or a reset signal via the SPDT switch, and the step of generating the wave signal further comprises generating the wave unit signal via SR logic of the conversion control module based on the set signal and reset signal from the SPDT switch.

[0117] 26. The method of embodiment 25, comprising determining a number of rotational units of the rotatable element via a counter block based on the number of rising edges, falling edges, or both of the generated wave unit signal.

[0118] 27. The method of embodiment 26, comprising switching the SPDT switch to a first state in which the battery is in electrical communication with a metal-oxide-semiconductor field effect transistor (MOSFET), and switching a microprocessor software (SW) controlled switch to open so that the MOSFET is not in electrical communication with a voltage source to prevent battery drain and define a sleep state, or switching the SW controlled switch to close so that the MOSFET is in electrical communication with the voltage source to define a wake-up state.

[0119] 28. The method of embodiment 27, wherein the step of switching the SW control switch closed further includes applying a voltage to a reset input of the microprocessor via the MOSFET and switching the SPDT switch to a second state in which the battery is in electrical communication with a wake-up input to the microprocessor.< / n>

Claims

1. 1. A drug delivery device comprising: Housing and a mechanical switch mounted on a printed circuit board, the mechanical switch including a single-pole double-throw (SPDT) switch having an arm; a rotatable element that is rotatable relative to the printed circuit board, the rotatable element having a series of protrusions spaced apart from one another, the rotatable element positioned to allow the protrusions to slide relative to the arm of the SPDT switch; a conversion control module in electrical communication with the SPDT switch, configured to generate a wave-like unit signal based on a signal from the SPDT switch when the arm slides relative to the protrusion; A controller configured to receive the wave unit signal from the conversion control module.

2. The SPDT switch includes a set state that generates a set signal and a reset state that generates a reset signal, The medication delivery device of claim 1 , wherein the conversion control module comprises an SR logic configured to generate the wave unit signal based on the set signal and the reset signal from the SPDT switch.

3. The drug delivery device of claim 2 , further comprising a counter block configured to determine the number of rotational units of the rotatable element based on the number of rising edges, falling edges, or both of the generated wave-like unit signal.

4. Batteries and The medication delivery device of any one of claims 1 to 3, further comprising a microprocessor.

5. The medication delivery device of claim 4 , wherein the microprocessor comprises one or more of the SR logic and the controller.

6. 5. The medication delivery device of claim 4, further comprising a metal oxide semiconductor field effect transistor (MOSFET), the SPDT switch being in electrical communication with the battery.

7. the microprocessor includes a software (SW) controlled switch disposed between a voltage source and the MOSFET; In a sleep state, the SPDT switch is in a first state in which the battery is in electrical communication with the MOSFET, and the SW control switch is open so that the MOSFET is not in electrical communication with the voltage source to prevent battery drain; The medication delivery device of claim 6 , wherein in a wake-up state, the SW control switch is closed such that the MOSFET is in electrical communication with the voltage source.

8. The medication delivery device of claim 7 , wherein the microprocessor includes a reset input and a wake-up input.

9. In the wake-up state, The MOSFET applies a voltage to the reset input; 9. The medication delivery device of claim 8, wherein the SPDT switch is in a second state in which the battery is in electrical communication with the wake-up input to the microprocessor.

10. The exit, 10. The drug delivery device of claim 1, further comprising a dose button axially translatable relative to the housing to activate a dose dispensing mode in which drug is dispensed from the outlet, the dose button being rotatable relative to the housing in a dose setting mode to select a drug dose size to be delivered from the outlet.

11. 11. The medication delivery device of claim 10, wherein the rotatable element is positioned such that as the rotatable element rotates, the protrusion slides against the arm of the SPDT switch to enable movement of the arm between set and reset states of the SPDT switch.

12. 11. The drug delivery device of claim 10, wherein the rotatable element is rotatable with the dose button in a dose setting mode and rotatable relative to the dose button in the dose dispensing mode, and the degree of rotation of the rotatable element during the dose dispensing mode determines the amount of drug dispensed from the outlet.

13. The medication delivery device of claim 11 , wherein the SPDT switch is configured to sense rotation of the rotatable element relative to the dose button.

14. A medication delivery device according to any one of claims 1 to 13, wherein the printed circuit board is fixed to the dose button.

15. The medication delivery device according to any one of claims 1 to 14, wherein the mechanical switch comprises a base connected to an arm of the SPDT switch, the base being mounted to the printed circuit board.

16. A medication delivery device according to any preceding claim, wherein the housing comprises a reservoir and a medication within the reservoir.

17. 1. A dose detection system for a medication delivery device, comprising: a mechanical switch mounted on a printed circuit board, the mechanical switch including a single-pole double-throw (SPDT) switch having an arm; a rotatable element that is rotatable relative to the printed circuit board, the rotatable element having a series of protrusions spaced apart from one another, the rotatable element positioned to allow the protrusions to slide relative to the arm of the SPDT switch; a conversion control module in electrical communication with the SPDT switch, configured to generate a wave-like unit signal based on a signal from the SPDT switch when the arm slides relative to the protrusion; A controller configured to receive the wave unit signal from the conversion control module.

18. The SPDT switch includes a set state that generates a set signal and a reset state that generates a reset signal, 18. The dose detection system of claim 17, wherein the conversion control module comprises SR logic configured to generate the wave unit signal based on the set signal and the reset signal from the SPDT switch.

19. The dose detection system of claim 18, wherein the medication delivery device comprises a counter block configured to determine the number of rotational units of the rotatable element based on the number of rising edges, falling edges, or both of the generated wave unit signal.

20. a battery in electrical communication with the SPDT switch; a metal oxide semiconductor field effect transistor (MOSFET); 20. The dose detection system of claim 19, further comprising: a microprocessor, the microprocessor comprising one or more of the SR logic and the controller.

21. the microprocessor includes a software (SW) controlled switch disposed between a voltage source and the MOSFET; In a sleep state, the SPDT switch is in a first state in which the battery is in electrical communication with the MOSFET, and the SW control switch is open so that the MOSFET is not in electrical communication with the voltage source to prevent battery drain; 21. The dose detection system of claim 20, wherein in a wake-up state, the SW control switch is closed such that the MOSFET is in electrical communication with the voltage source.

22. 22. The dose detection system of claim 21, wherein the microprocessor includes a reset input and a wake-up input.

23. In the wake-up state, The MOSFET applies a voltage to the reset input; 23. The dose detection system of claim 22, wherein the SPDT switch is in a second state in which the battery is in electrical communication with the wake-up input to the microprocessor.

24. 1. A method comprising: rotating a rotatable element relative to a printed circuit board, the rotatable element having a series of spaced apart protrusions positioned to allow the protrusions to slide against an arm of a single-pole, double-throw (SPDT) switch of a mechanical switch mounted to the printed circuit board; generating a wave-like signal via a conversion control module in electrical communication with the SPDT switch based on a signal from the SPDT switch when the arm slides relative to the protrusion.

25. 25. The method of claim 24, comprising generating a set signal and / or a reset signal via the SPDT switch, wherein the generating step of the wave-like signal further comprises generating the wave-like unit signal via an SR logic of the conversion control module based on the set signal and the reset signal from the SPDT switch.

26. 26. The method of claim 25, comprising determining a number of rotational units of the rotatable element via a counter block based on a number of rising edges, falling edges, or both of the generated wave unit signal.

27. switching the SPDT switch to a first state in which a battery is in electrical communication with a metal oxide semiconductor field effect transistor (MOSFET); 27. The method of claim 26, comprising: switching a microprocessor software (SW) controlled switch open so that the MOSFET is not in electrical communication with a voltage source to prevent battery drain and define a sleep state, or switching the SW controlled switch closed so that the MOSFET is in electrical communication with the voltage source to define a wake-up state.

28. 28. The method of claim 27, wherein switching the SW control switch closed further comprises: applying a voltage to a reset input of the microprocessor through the MOSFET; and switching the SPDT switch to a second state in which the battery is in electrical communication with a wake-up input to the microprocessor.

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