Medication delivery device with moisture sensing system

Abstract

To provide medication delivery devices having a housing comprising a reservoir sized sufficiently to hold medication, a dose button being rotatable relative to the housing to select a dose size of the medication for an injection, a printed circuit board, a conductive trace, and a microcontroller.SOLUTION: A bias source 2302, 2314 can be in electrical communication with a conductive trace, and a microcontroller 2306 can be in electrical communication with the conductive trace through a logic input. An analog-to-digital converter 2304 can be in electrical communication with the conductive trace, the microcontroller 2306, and the bias source 2302. The microcontroller 2306 is configured to receive a signal from an ADC 2304 or the logic input, and determine, based on the received signal, that moisture may be present on the printed circuit board 2300.SELECTED DRAWING: Figure 23

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 effect 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 turned to set a dose and / or actuated to deliver a dose, an "on" button to wake the device, etc.

[0004] Such devices may include electronics, such as integrated circuits having a processing unit and other components. For example, the electronics may include a sensing device, such as a switch, that communicates with the processing unit to detect the occurrence of such interactions. The electronics may not be in a watertight enclosure. The inventors understand that electronics may be exposed to moisture, which may affect the operation of the electronics. In particular, the inventors understand that moisture may cause the electronics to record, process, and / or store erroneous data regarding such interactions. Thus, the inventors recognize a need for a moisture sensing mechanism that can be used to sense moisture on an electronic device and prevent the erroneous data from being used by the system. Summary of the Invention

[0005] The present disclosure relates to a medication delivery device that includes circuitry and / or logic for monitoring the presence of moisture on a printed circuit board of the medication delivery device. According to some embodiments, the technique can use existing circuitry of the medication delivery device that is not traditionally used to sense moisture (e.g., bias sources, analog-to-digital converters, and / or the like).

[0006] In one embodiment, the medication delivery device includes a housing with a reservoir large enough to hold the medication, a dose button rotatable relative to the housing for selecting a dose size of the medication for injection, a printed circuit board, a conductive trace at least partially disposed on the printed circuit board, a bias source in electrical communication with the conductive trace, and a microcontroller in electrical communication with the conductive trace through logic inputs to the microcontroller, the microcontroller configured to receive a signal from the conductive trace through the logic input and to determine that moisture may be present on the printed circuit board based on the received signal.

[0007] In one embodiment, the medication delivery device includes a housing with a reservoir large enough to hold the medication, a dose button rotatable relative to the housing for selecting a dose size of the medication for injection, a printed circuit board, conductive traces disposed at least partially on the printed circuit board, an analog-to-digital converter (ADC) having an input and an output, the input of the ADC in electrical communication with the conductive traces, and an operating input range of the ADC being between a low input voltage and a high input voltage, a bias source in electrical communication with the input of the ADC, the bias source configured to provide a bias voltage between the low input voltage and the high input voltage, and a microcontroller in electrical communication with the output of the ADC, the microcontroller configured to receive a signal from the output of the ADC and determine that moisture may be present on the printed circuit board based on the received signal. [Brief description of the drawings]

[0008] 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.

[0009] [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] FIG. 1 is a perspective view of a printed circuit board and a sensor switch according to an aspect of the present disclosure. [Figure 13] 13 is a perspective view of a cantilever arm and a base of the sensor switch of FIG. 12. [Figure 14] FIG. 14 is a side view of the cantilever arm and base of FIG. 13. [Figure 15] FIG. 13 is a side view of the cantilever arm of FIG. 12 positioned between two teeth of a flange. [Figure 16] 16 shows the cantilever arm of FIG. 15 being pushed by one of the teeth of the flange during rotation of the flange. [Figure 17] The cantilever arm is shown being further pressed by a tooth on the flange so that a portion of the cantilever arm moves toward and contacts the conductive pad, closing the switch. [Figure 18] A cantilevered arm is shown sliding over the teeth of the flange. [Figure 19] 1 shows the cantilever arm interacting with the next adjacent tooth on the flange. [Figure 20] 1 is an exemplary schematic diagram of a printed circuit board according to some embodiments. [Figure 21] 1 illustrates an example of a printed circuit board having a bias source according to some embodiments. [Figure 22]1 is a flowchart illustrating a first exemplary computerized method that may be performed by a microcontroller of a medication delivery device to determine whether moisture may be present within the medication delivery device, according to some embodiments. [Figure 23] 1 illustrates an example of a printed circuit board having a bias source and an ADC, according to some embodiments. [Figure 24] 1 is a flowchart illustrating a first exemplary computerized method that may be performed by a microcontroller of a medication delivery device to determine whether moisture may be present within the medication delivery device, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010] For the purposes of promoting an understanding of the principles of the 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.

[0011] The present disclosure relates to a moisture sensing system for a drug delivery device. The presence of moisture on a printed circuit board of a drug delivery device can cause errors. In particular, moisture can electrically connect components on the board that are not normally electrically connected (e.g., voltage sources, test pads, ground, etc.), which can cause various errors. For example, the presence of moisture can adversely affect the operation of the drug delivery device, such as causing the drug delivery device to detect erroneous information (e.g., erroneously detect the occurrence of an event when the event did not occur) and / or detect erroneous data (e.g., detect erroneous data for an injection event). It is therefore desirable to detect the potential presence of moisture and modify the operation of the drug delivery device accordingly (e.g., to avoid erroneous data being stored and / or reported).

[0012] In some embodiments, the sensing system includes circuitry and / or logic for detecting the potential presence of moisture on a printed circuit board of the drug delivery device. In some cases, the physical space to accommodate such circuitry and / or logic on such a printed circuit board may be limited for various reasons, such as a desire to keep the form factor of such drug delivery devices small, or to prevent or reduce disruption to existing drug delivery device manufacturing processes. Also, in some cases, there may be a need to limit the additional manufacturing costs or complexity of acquiring or integrating such moisture detection circuitry and / or logic. Thus, the inventors understand that in some cases, it may not be desirable to add additional components specifically designed and / or dedicated to detecting moisture. Rather, the inventors understand that conventional circuit-based components, such as printed circuit board traces, bias sources (e.g., resistors), logic inputs (e.g., general-purpose input / output), and / or analog-to-digital converters, that are not traditionally used for moisture sensing, may be adapted in accordance with the techniques described herein to sense the potential presence of moisture.

[0013] In one aspect, the drug delivery device includes a housing having a reservoir large enough to hold a medication (e.g., insulin) and a dose button rotatable relative to the housing for selecting a dose size of the medication for injection. The drug delivery device also includes a printed circuit board, a conductive trace at least partially disposed on the printed circuit board, a bias source in electrical communication with the conductive trace, and a microcontroller in electrical communication with the conductive trace through a logic input to the microcontroller. The microcontroller is configured to receive a signal from the conductive trace through the logic input and determine that moisture may be present on the printed circuit board based on the received signal.

[0014] In one aspect, the drug delivery device includes a housing with a reservoir large enough to hold the drug, and a dose button rotatable relative to the housing for selecting a dose size of the drug for injection. The drug delivery device also includes a printed circuit board, conductive traces at least partially disposed on the printed circuit board, and an analog-to-digital converter (ADC) with an input and an output. The input of the ADC is in electrical communication with the conductive traces, and an operating input range of the ADC is between a low input voltage and a high input voltage. The drug delivery device also includes a bias source in electrical communication with the input of the ADC, the bias source configured to provide a bias voltage between the low input voltage and the high input voltage, and a microcontroller in electrical communication with the output of the ADC. The microcontroller is configured to receive a signal from the output of the ADC and determine that moisture may be present on the printed circuit board based on the received signal.

[0015] The devices described herein may include a drug, such as in a reservoir or cartridge 20 (described below). In another embodiment, a system may include one or more devices, including device 10 (described below), 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 devices described herein. Drugs as used in the devices may be formulated with one or more excipients. The device is operated by the patient, a caregiver, or a medical professional in a manner generally as described above to deliver the drug to a person.

[0016] An exemplary drug delivery device 10 is shown in FIGS. 1-4 as a pen-type injector configured to inject a drug into a patient through a needle. The device 10 includes a body 11, which may include an elongated pen-type housing 12 including a tip portion 14 and a proximal portion 16. As used herein, the term "distal" refers to a direction and / or portion of the drug delivery device that is directed toward (or located closer to) the injection site, while the term "proximal" refers to a direction and / or portion of the drug delivery device that is directed away from (or located further away from) the injection site. 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 drug to be dispensed through an outlet 21 of the housing during a dispensing operation. 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 that is operable to advance the piston 26 towards an 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, that is 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 (i.e. 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 extended position can be any position between a position corresponding to an incremental extended 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, to thread the housing 12 distally until a home or zero position corresponding to the minimum dose deliverable by the device 10 in a single injection is reached.

[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 (i.e., 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, i.e., directly by a user, to push the actuator assembly (dose button 30 and clutch 52) in a distal direction. 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 axially urge the support 42 of the actuation assembly and the flange 38 of the dose setting assembly away from one another. 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 device 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 a 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 rotatably 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 relative to the flange 38 and the dose setting screw 32 by complementary splines 74 of the flange 38 and the clutch 52 (FIG. 4) urged together by a biasing member 68. During the process of dose setting, the dose setting screw 32, the flange 38, the clutch 52, and the dose button 30 move in a helical manner (i.e., 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, for example, properly penetrates 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 rotating 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 powering 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 dose delivered. 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 one-half 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 one unit or 0.5 units.

[0055] A recess 124 may be defined between each pair of adjacent teeth 102 (see FIG. 15). 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 urge 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] In some embodiments, the switch includes a conductive pad and a cantilever arm that is movable relative to the conductive pad, the cantilever arm may be attached to the printed circuit board at a first end and a second end of the arm is not attached to the printed circuit board and may be free to move relative thereto.

[0066] According to one aspect, the switch may have one or more features that help enable the switch to be repeatedly opened and closed. The switch may have one or more features that help prevent the switch from plastically deforming during repeated opening and closing, and therefore help maintain the durability of the switch.

[0067] In some embodiments, the arm has a first curved portion at a first end of the cantilevered arm that attaches the arm to a printed circuit board. During switch closure, this first curved portion may move toward a straight configuration, and during switch opening, the straight configuration may move back toward the curved configuration. In an unstressed state, this first portion may be biased toward the curved configuration. Thus, the cantilevered arm may act as a spring that stores potential energy as it moves during sliding interaction against the sensed component, and the stored potential energy is released when the sliding contact force against the arm is reduced, causing the arm to move back toward the unstressed state.

[0068] In some embodiments, the cantilever arm can transition from a first curved portion to a second curved portion configured to move toward and contact a conductive pad mounted on a PCB, where contact between the second curved portion and the conductive pad closes the switch, while a lack of contact between the second curved portion and the conductive pad opens the switch.

[0069] In some embodiments, the cantilever arm may include a third curved portion configured to contact and slide against the sensed component, for example against the teeth of the rotating tubular flange 38 shown in FIGS. 8 and 9. In some embodiments, the third curved portion connects the first curved portion to the second curved portion. In such embodiments, the second curved portion configured to contact the conductive pad may be located at the second end of the cantilever arm, i.e., where the cantilever arm terminates. In other embodiments, the second curved portion connects the first and third curved portions. In such embodiments, the third curved portion configured to contact the sensed component may be located at the second end of the cantilever arm, i.e., where the cantilever arm terminates.

[0070] In some embodiments, having curved portions of the cantilevered arms may help avoid high stress concentrations in the arms and therefore help prevent plastic deformation of the arms, however, it should be understood that in other embodiments, one or more of the curved portions may be shaped differently.

[0071] In some embodiments, the switch may have one or more features that help the switch provide a cleaner, more easily readable output signal so that the controller can more accurately identify when the switch is open and when the switch is closed. In some embodiments, a blocking protrusion may be provided to interact with the second curved portion of the cantilever arm when the arm contacts the conductive pad. This blocking protrusion may be located directly adjacent or near the conductive pad and may prevent the arm from moving past the conductive pad. In some embodiments, the presence of the blocking protrusion may help reduce "bounce" of the cantilever arm, which may help generate a cleaner output signal from the switch. In some cases, "bounce" from the cantilever arm may cause quick and repeated contact and separation of the arm and the conductive pad for a short period of time, which may result in a noisy output signal that may be difficult for the controller to interpret. The blocking protrusion may help provide sustained contact between the cantilever arm and the conductive pad to provide a cleaner output signal. In some embodiments, the blocking protrusion may be made from a shock absorbing material that may help dampen the impact of the cantilever arm against the blocking protrusion to reduce bouncing or other vibrations.

[0072] One example of a switch is shown in FIG 12 which depicts 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 attached to the PCB 77.

[0073] 13 and 14, the cantilevered arm 210 begins at a first curved portion 212 at its first end 201 and terminates at a second curved portion 214 at its second end 202. The arm also includes a U-shaped third curved portion 216 that connects the first curved portion 212 to the second curved portion 214. The second curved portion 214 is configured to contact a conductive pad and the third curved portion 216 is configured to contact a sensed component, such as the rotating tubular flange 38 shown in FIGS.

[0074] The switch also includes a base 200 connected to a cantilever arm 210. The base 200 is connected to the PCB to connect the cantilever arm to the PCB. The base and arm may together form a single monolithic component.

[0075] Figures 15-19 depict the cantilever arm 210 of the switch interacting with the rotating flange 38 from Figures 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. The switch may be positioned in this state when the flange 38 is in its home or zero dose position, for example, before use of the device, before setting a dose, or after dispensing is complete and the device is ready to set a dose.

[0076] 16, the flange 38 begins to rotate relative to the switch and PCB 77. As a result, the tooth 105 slides and pushes against the third curved portion 216 of the arm 210, causing the arm 210 to begin to deflect toward out of 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] As described herein, the printed circuit board (e.g., printed circuit board 77) can include various processing circuits and / or logic that generate data based on the operation of the drug delivery device. For example, the processing circuit can count the number of times a sensor (e.g., sensor 86) is activated or triggered during an injection to determine the dose size of the injection (e.g., the dose of a particular insulin injection). As described herein, relative rotational motion between a dose setting assembly and an actuator of the drug delivery device can be sensed to determine the amount of the dose delivered by the drug delivery device, as the sensed relative rotational motion can be correlated to the amount of the dose delivered.

[0081] 20 is an example schematic diagram of a printed circuit board 2000, according to some embodiments. The printed circuit board 2000 (e.g., printed circuit board 77) includes various components, including a sensor 2002 (e.g., sensor 86 of FIG. 6) in electrical communication with a microcontroller 2004 in a system on chip (SoC) 2003. The printed circuit board 2000 includes a set of pads 2006, 2008, 2010, 2012, 2014, 2016, 2018, 2020, and 2022 in electrical communication with the microcontroller 2004 / SoC 2003. The pads may be used to connect electrical components to the microcontroller 2004 / SoC 2003, for example, for testing, and / or the like. Some of the pads, such as pads 2008, 2010, 2012, 2014, 2016, and 2018, may not be in communication with the microcontroller 2004 / SoC 2003 by default. For example, the microcontroller / SoC may be initially programmed (e.g., via associated registers) such that some of the pads are not in electrical communication with the microcontroller 2004 (e.g., via programmable switches or resistors). One or more of the pads may be placed in electrical communication with a logic input, such as a general purpose input / output (GPIO) pin of the microcontroller 2004 / SoC 2003. As an example, the microcontroller may be programmed to change an internal programmable component (e.g., one or more pull-up and / or pull-down resistors) to place the pad in electrical communication with the logic input.

[0082] In some embodiments, the GPIO pin input to the microcontroller 2004 / SoC 2003 can be a logic level input. The microcontroller 2004 in the SoC 2003 can detect a logic 1 when a voltage above a certain maximum threshold is applied to the GPIO pin, while the microcontroller 2004 can detect a logic 0 when a voltage below a certain minimum threshold is applied to the GPIO pin. Some pads on the printed circuit board can be connected to a voltage source. For example, pad 2020 can be connected to a battery voltage V batAs another example, pad 2006 can provide a voltage V dcdc can be provided.

[0083] As described herein, the microcontroller 2004 (e.g., including based on input from the sensor 2002) may be operable to process dose data and / or other data of the medication delivery device. For example, the microcontroller 2004 may be configured 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 microcontroller 2004 may further be operable to wirelessly transmit (e.g., via BLE control logic and controller integrated into the printed circuit board 2000) 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.

[0084] The inventors have understood that moisture, if present on the printed circuit board, may affect various data of the medication delivery device. For example, moisture on the printed circuit board may cause the microcontroller to receive data indicative of dose information when in fact no dose has occurred. As another example, moisture may cause the microcontroller to receive erroneous dose information (e.g., erroneous count information). Thus, moisture may cause the microcontroller to sense erroneous data, which may cause the medication delivery device to process (e.g., store, transmit, etc.) erroneous data. Thus, the inventors have developed a technique for sensing the potential presence of moisture on the printed circuit board by detecting a voltage change. Aspects of the technology herein utilize conductive traces (including, but not limited to, circuit pads, wires, and / or conductive materials (e.g., graphite)) and other circuitry (e.g., circuitry not typically used to sense for the presence of moisture) of the printed circuit board 2000 to determine that moisture may be present on the printed circuit board 2000. Some embodiments of the technology described herein may connect one or more circuit pads to logic inputs to the microcontroller 2004 for use with the moisture sensing technology described herein. For example, as described herein, one or more of the pads, such as pad 2008 and / or pad 2006, may be connected to a corresponding GPIO pin of the microcontroller 2004 (e.g., via a programmable component controlled by firmware of the microcontroller, as described herein). The pads may be biased such that the microcontroller can monitor changes in logic inputs to monitor for the potential presence of moisture. As another example, the present technology may use an ADC to monitor for the presence of moisture. The input of the ADC may be connected to the pads and / or other conductive traces, and the output of the ADC may be monitored by the microcontroller to determine the potential presence of moisture. The pads or traces may be biased with a voltage that allows the microcontroller to bidirectionally detect changes in the voltage output by the ADC.Upon detecting the potential presence of moisture, the microcontroller may be configured to alter its operation accordingly (e.g., to prevent the moisture from causing the microcontroller to process erroneous data).

[0085] Aspects of the technology described herein may be used with a medication delivery device to sense moisture. As described herein, the medication delivery device may include a housing having a reservoir that is large enough to hold a medication (e.g., insulin) and a dose button that is rotatable relative to the housing to select a dose size of the medication for injection. The medication delivery device includes a printed circuit board having various circuits. The circuits may include conductive traces. The conductive traces may be conductive materials such as metal (e.g., copper) and / or other conductive materials (e.g., graphite). According to some examples, the conductive traces may be conductive materials (e.g., one or more of pads 2006, 2008, 2010, 2012, 2014, 2016, 2018, 2020, and 2022) that are at least partially disposed on the printed circuit board (e.g., within the plane of the printed circuit board). For example, a portion of the solder mask of the printed circuit board may be omitted and / or exposed to allow fluid communication to the conductive traces that may be disposed under the solder mask. According to some examples, the conductive traces can be wires and / or other conductive material not disposed on the printed circuit board, such as wires that extend from the printed circuit board (e.g., through a solder mask). The circuitry can further include a bias source in electrical communication with the conductive traces and a microcontroller in electrical communication with the conductive traces through logic inputs to the microcontroller. According to some embodiments, a bias voltage can be applied to the conductive traces such that the bias can be sensed by the microcontroller at a logic interface, such as a GPIO interface.

[0086] FIG. 21 illustrates an example of a printed circuit board 2100 having a bias source 2102, according to some embodiments. As shown in FIG. 21, the printed circuit board 2100 includes a microcontroller 2104 (e.g., a processor such as an ARM Cortex processor) in electrical communication with various circuits 2106 (e.g., memory, clocks, etc.) and a set of GPIOs 2108. A sensor switch 2110 is in electrical communication with a first bias source 2112 and a logic input of the microcontroller, which in this example is one of the GPIOs 2108. According to some embodiments of the technology described herein, a PCB trace 2114 can be in electrical communication with the bias source 2102 and the GPIOs 2108. According to some embodiments, the bias source 2102 can be a resistor. The resistor can be a pull-up resistor (e.g., V bat 2116) or a pull-down resistor (e.g., connected to ground). The printed circuit board 2100, in some embodiments, may include a system on a chip (SoC) (e.g., SoC 2003), as indicated by the dashed box 2116. Although the microcontroller 2104, GPIO 2108, bias source 2102, and bias source 2112 are shown as part of the SoC 2116, this is for illustrative purposes only. For example, one or more of the microcontroller 2104, GPIO 2108, bias source 2102, and / or bias source 2112 may be additional components on the printed circuit board 2100 that are not included as part of the SoC 2116. In embodiments that do not use a SoC 2116, one or more of the microcontroller 2104, GPIO 2108, bias source 2102, and / or bias source 2112 may be mounted on the printed circuit board 2100 as separate components.

[0087] The bias source, such as a resistor, can be internal or external to the SoC. According to some embodiments, one or more resistors are used as the bias source 2102 that is external to the SoC 2116. According to some embodiments, one or more resistors are used as the bias source 2102 that is internal and / or part of the SoC 2116. For example, one or more on-silicon (e.g., system-on-chip (SoC) integrated circuit) programmable bias resistors can be used to create the bias source 2102. Whether to use an internal resistor or an external resistor can be a design consideration. For example, if it is desired to select a bias resistor, using an external resistor can allow for the selection of the resistance characteristics of the resistor added to the printed circuit board 2000. For example, assume that the built-in resistor available in the SoC 2116 has a resistance value of 25 kΩ. If it is desired to use a resistor with characteristics that allow for the detection of liquid at a conductivity that cannot be detected when using such a resistor, an external resistor can be used and added to the printed circuit board 2110 accordingly. Thus, selection of an appropriate bias resistor may allow for incorporating an early detection feature that is more available than using a programmable bias resistor within the SoC 2116. However, adding an additional bias resistor may increase the space used on the printed circuit board 2000 and / or increase material and / or manufacturing costs. In contrast, using a programmable bias resistor inside the SoC 2116 may not require the use of additional space on the printed circuit board 2000 and may not increase material or manufacturing costs. Further, continuing with the example of an available internal resistor at 25 kΩ, such a resistor may be sufficient to detect moisture, since the amount / type of water that trips the switch 2002 will also trip the GPIO connected to the pad to which the bias voltage is applied by the internal resistor.

[0088] In some embodiments, bias source 2102 and / or bias source 2112 may be any electrical component that has a small but measurable leakage current and can act as a weak current source. Such electrical components may be resistors as described above, but may also be diodes, transistors, and / or capacitors. In general, bias source 2102 and / or bias source 2112 may be any electrical component that (i) conducts a small but measurable leakage current sufficient to pull GPIO 2108 to a specified voltage in the absence of moisture, but (ii) does not conduct so much current in the presence of moisture that it prevents GPIO 2108 from being biased to another detectable voltage level. In some cases, it may be easier and / or more efficient to use electrical components already built into or integrated into the SoC, e.g., diodes, transistors, and / or capacitors, rather than adding additional resistors.

[0089] According to some configurations of the printed circuit board 2000, one or more circuit traces and / or pads may not be connected to a GPIO by default (e.g., and therefore available for use if desired). The present techniques may include connecting such GPIOs to a microcontroller (e.g., via programming of the microcontroller 2004). According to some embodiments, the default configuration of one or more unused GPIO pins may be "output" instead of "input". Thus, the present techniques may also include modifying the microcode of the microcontroller 2004 to change a GPIO pin used in accordance with the techniques described herein to an "input" to the microcontroller 2004. However, simply connecting a pad to a GPIO allows the voltage to float at any value from that pad. According to some embodiments, as described herein, a bias is provided to the pad connected to the GPIO to allow detection of the voltage source.

[0090] 22 is a flow chart illustrating a first exemplary computerized method 2200 that may be executed by a microcontroller of a medication delivery device to determine whether moisture may be present in the medication delivery device, according to some embodiments. At step 2202, the microcontroller monitors a logic input in electrical communication with a conductive trace on a printed circuit board. At step 2204, the microcontroller receives a signal from the logic input. At step 2206, the microcontroller determines that moisture may be present on the printed circuit board based on the received signal. At step 2208, the microcontroller may alter its operation based on the determination that moisture may be present on the printed circuit board.

[0091] Referring to step 2202, as described herein, pads on a printed circuit board may be appropriately voltage biased such that in a normal non-fault mode of operation, the traces are held in a state that allows the firmware of the microcontroller to read the expected logic inputs via the GPIO. The bias voltage may be configured according to various voltages. For example, the bias voltage may be an available voltage that can be read by ground and / or GPIO logic levels (e.g., according to the specifications of the electronics used in the techniques described herein). For example, the bias may be a positive voltage (e.g., V bat ), the microcontroller can expect to read a logical 1 under normal operating conditions. The positive voltage can be, for example, 1 volt, 1.5 volts, 2 volts, and / or the like. As another example, if the bias is ground (e.g., about 0 volts), the microcontroller can expect to read a logical 0 during normal operating conditions.

[0092] Referring to steps 2204-2206, if the microcontroller reads the voltage from the GPIO at the expected logic level, normal firmware operation is allowed to proceed. However, if the microcontroller detects that the GPIO is pulled away from the normal bias voltage state by more than a predetermined voltage threshold, the microcontroller can determine that a fault condition may exist on the printed circuit board. For example, the fault condition may be caused by a conductive contaminant (e.g., conductive liquid, condensed moisture, etc.) contacting a trace on the printed circuit board and electrically connecting the trace to another component (e.g., ground and / or voltage source) that is not normally electrically connected to the trace when the conductive contaminant is not present. If the voltage applied to the GPIO changes from the expected voltage level by more than a threshold amount, the microcontroller can read the change in voltage on the GPIO as a change in the state of the logic level of the GPIO, and the firmware can enter a fault state that can modify normal firmware operation (e.g., to adapt to the fact that data may be erroneous and at the same time prevent the storage and / or reporting of delivered drug information). For example, if the GPIO is biased to ground (e.g., such that the microcontroller 2004 would normally read a logic 0), then when liquid conducts down the pad to a layout local voltage high enough that the voltage on the GPIO increases by an amount greater than the threshold, the microcontroller will read a logic 1. Such a change from an expected logic 0 to a logic 1 can cause the microcontroller to determine that there is a potential presence of moisture. As another example, if the GPIO is biased to a positive voltage (e.g., such that the microcontroller 2004 would expect to read a logic 1), then ground conducting liquid can cause the voltage on the GPIO to drop by an amount greater than the threshold, such that the processor will read a logic 0, triggering a detection condition. Such a change from an expected logic 1 to a logic 0 can cause the microcontroller to detect that there is a potential presence of moisture.

[0093] At step 2208, according to some embodiments, the microcontroller may be configured to take one or more actions upon determining that there may be moisture on the printed circuit board. For example, an algorithm programmed into the microcontroller may be configured to trigger a fail-safe condition. According to some embodiments, the microcontroller may be configured to not transmit some information that the microcontroller normally transmits to an external device. For example, the microcontroller may be configured to not transmit (e.g., via Bluetooth) information related to an injection, such as count information, dose information, occurrence of an injection, and / or the like. For example, as described herein, the medication delivery device may include a switch mounted on the printed circuit board, and the microcontroller is configured to receive a set of signals from the switch. According to some embodiments, the switch is actuated by rotation of a 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 switch as the rotatable element rotates to move the switch between a closed position and an open position. The microcontroller generates a count of the set of signals based on the set of signals received. According to some embodiments, the microcontroller may be configured to not save some information that the microcontroller saves during normal operation. For example, the microcontroller may discard the generated count of the signal from the switch such that the generated count is not stored in a memory in communication with the microcontroller.

[0094] In some embodiments, the medication delivery device may include one or more aspects that control whether the medication delivery device stores and / or discards data that is to be written to non-volatile memory. For example, the medication delivery device may be configured to include a field or flag that the controller checks before writing data, and the flag can then be used to control whether the controller writes the data to non-volatile memory or discards the data without writing it to non-volatile memory.

[0095] According to some embodiments, the microcontroller may be configured to shut down, restart, and / or enter a low power state (e.g., hibernate). According to some embodiments, the microcontroller may be configured to transmit data to one or more external devices. For example, the microcontroller may be configured to transmit Bluetooth data indicating that the medication delivery device potentially has moisture on the printed circuit board. Such transmitted data may cause the receiving device to perform one or more actions, such as ignoring recently received data, providing an error warning, and / or the like.

[0096] According to some embodiments, the microcontroller may additionally or alternatively be configured to monitor the voltage generally in order to perform a particular action (e.g., reset) upon detection of a voltage. For example, the microcontroller may monitor the voltage (e.g., water is causing the pad to drop to V bat This can occur when electrically connecting V bat ) to monitor one or more pads for sufficient voltage (e.g., 1 / 2V bat Detection of a voltage exceeding a threshold, such as a Vcc, can cause the microcontroller to reset, power down, change firmware operation, and / or the like.

[0097] According to some embodiments, multiple GPIOs may be connected to different traces having the same and / or different bias voltages. For example, multiple pads may be connected to associated GPIO pins and biased with positive voltages. Using multiple traces in this manner may increase the probability of detecting moisture (e.g., because using multiple pads may increase the area of ​​the printed circuit board 2000 where moisture may be detected).

[0098] According to some embodiments, other conductive traces surrounding the conductive trace to which the GPIO is connected may be biased to a voltage different than the voltage to which the GPIO connection trace is biased. For example, if a GPIO is connected to pad 2014 and pad 2014 is biased to a positive voltage (e.g., V bat ), other pads, such as pads adjacent or near pad 2014 (e.g., pads 2008, 2010, 2012, and / or 2016), may be connected to ground. Conversely, if pad 2014 is biased to approximately 0 volts such that a microcontroller connected to pad 2014 reads a logic 0 in the absence of moisture, other pads, such as pads adjacent or near pad 2014 (e.g., pads 2008, 2010, 2012, and / or 2016), may be connected to a positive voltage (e.g., V bat ) Biasing the pads surrounding the connected conductive traces to opposite voltages increases the chance that moisture will connect the traces connected to the GPIOs (e.g., pad 2014) to another voltage source that pulls the traces connected to the GPIOs away from their default voltage, increasing the likelihood that moisture on the PCB will be detected more quickly and / or more reliably.

[0099] According to some embodiments, the circuitry used to monitor moisture may include an analog-to-digital converter (ADC). A microcontroller may use the ADC to detect potential moisture on the printed circuit board. For example, the microcontroller may monitor the analog-to-digital steady state voltage of the ADC to detect a change in voltage, which may indicate a potential moisture condition. According to some embodiments, an ADC (e.g., having a high impedance input node as described herein) may be included on the printed circuit board 2000 shown in FIG. 20. An input of the ADC may be connected to one or more traces on the printed circuit board 2000, and an output of the ADC may be connected to the microcontroller 2004. According to some embodiments, a bias voltage may be applied to the ADC at the input interface. The ADC may be configured to output a word based on an input voltage to the ADC. The word may be, for example, 9-bit, 10-bit, 11-bit, and / or the like. The microcontroller 2004 may monitor the output of the ADC for a voltage change, which may indicate the presence of moisture as described herein. For example, if the output of the ADC can range from 0 to 1023 decimal, an input voltage of 0.45 volts, which is half the ADC's operating range, can result in the ADC outputting a value of 3FF hex or close to it. If the word received from the ADC is at or close to the expected value (e.g., 3FF hex), the microcontroller 2004 can continue under normal firmware operation. If the ADC is instead pulled away from the normal biased voltage condition, the output value can be significantly higher and / or lower than the expected value (e.g., closer to 1023 and / or 0), which can indicate a fault condition being applied to the PCB traces by a conductive material (e.g., conductive liquid, condensing moisture, etc., as described herein). The microcontroller can read the ADC output, observe the change in the output value, and modify it from normal firmware operation (e.g., to prevent reporting simultaneously delivered medication information to an end user).

[0100] 23 illustrates an example of a printed circuit board 2300 having a bias source 2302 and an ADC 2304, according to some embodiments. As shown in FIG. 23, the printed circuit board 2300 includes a microcontroller 2306 in electrical communication with various circuits 2308 (e.g., memory, clock, etc.) and a set of GPIOs 2310. A sensor switch 2312 is in electrical communication with a first bias source 2314 and the GPIOs 2310. According to some embodiments of the technology described herein, the input of the ADC 2304 can be in electrical communication with the PCB trace 2316 and the bias source 2302, and the output is in electrical communication with the microcontroller 2306. As described herein, according to some embodiments, the bias source 2302 can be any electrical component previously described with respect to the bias sources 2102 and / or 2112, such as a resistor, a diode, a transistor, a capacitor, and / or other impedance source.

[0101] The printed circuit board 2300 may include an SoC (e.g., SoC 2003) in some embodiments, as indicated by the dashed box 2318. Although the ADC 2304, microcontroller 2306, GPIO 2310, bias source 2302, and bias source 2314 are shown in FIG. 23 as part of the SoC 2318, this is for illustrative purposes only. For example, according to some embodiments, one or more resistors and / or ADCs are used outside the SoC 2318. According to some embodiments, one or more ADCs and / or resistors may be used that are internal and / or part of the SoC 2318. In embodiments that do not use a SoC 2318, one or more microcontrollers 2306, ADC 2304, GPIO 2310, bias source 2302, and / or bias source 2314 may be mounted on the printed circuit board 2300 as separate components. As described herein, whether to use an internal or external bias source, such as an internal or external resistor, can be a matter of design choice (e.g., including resistor selection, PCB space usage, cost, etc.). According to some embodiments, for example, using an external resistor with the ADC may enable unidirectional or bidirectional detection methods (e.g., with an external resistor network that biases the ADC input voltage to 1 / 2 voltage ADC input measurement range). As another example, using an internal programmable bias resistor may only enable unidirectional detection (e.g., depending on the programmability and / or capabilities of the internal resistor). According to some embodiments, using an internal resistor may enable early detection capabilities based on finer voltage measurement resolution (e.g., versus only the GPIO method, since GPIO only enables detection of two logic states).

[0102] According to some embodiments, a separate bias source is not required for the ADC. For example, an internal capacitive bias can be used to bias the ADC input voltage to 1 / 2 the voltage of the ADC measurement range. According to some embodiments, an SoC integrated circuit containing a high impedance and capacitively coupled ADC input stage (e.g., where only a small PCB trace for water detection is routed from the ADC input to the PCB) can allow the ADC to go to about 1 / 2 the voltage of the normal steady state reading.

[0103] The ADC2304 can be in electrical communication with the microcontroller in a variety of configurations. According to some embodiments, the ADC2304 can share a path to the microcontroller with one or more other components (e.g., the circuitry can include a multiplexer that multiplexes the output of the ADC2304 with a pin used by the GPIO2310 block so that the processor can switch between the ADC2304 and the GPIO2310 block). According to some embodiments, the ADC2304 has its own path to the microcontroller (e.g., not shared with other circuitry).

[0104] 24 is a flow chart illustrating a first exemplary computerized method 2400 that may be executed by a microcontroller of a drug delivery device to determine whether moisture may be present in the drug delivery device, according to some embodiments. In step 2402, the microcontroller monitors the output of an ADC, the input of which is in electrical communication with a conductive trace at least partially disposed on a printed circuit board. In step 2404, the microcontroller receives a signal from the ADC output. In step 2406, the microcontroller determines that moisture may be present on the printed circuit board based on the received signal. In step 2408, the microcontroller may modify its operation based on the determination that moisture may be present on the printed circuit board.

[0105] Referring to step 2402, the microcontroller may monitor the output of the ADC for expected voltages. The ADC may be configured to operate with an operating input range that is between a low input voltage (e.g., a lower rail) and a high input voltage (e.g., an upper rail). Thus, according to some embodiments, the ADC may operate according to two rails that define a range of voltages that can be received by the ADC and fed into an analog stage (and ultimately converted to a digital value). According to some embodiments, the low input voltage may be a ground voltage (e.g., approximately 0 volts, which is the voltage that the controller recognizes as ground), and the high input voltage may be a positive voltage (e.g., V bat For example, V batは , 1.0 volts, 1.5 volts, 2 volts, etc. According to some embodiments, the regulator batを It may be used to step down to a desired upper voltage limit for the ADC, for example, 1.5 volts down to 0.9 volts. As described herein, the ADC outputs a word value based on the input voltage.

[0106] Referring to step 2404, according to some embodiments, the ADC input may be biased using a resistor or impedance source. The bias voltage provided by the bias source may be a percentage of the ADC's operating input range, such as 25%-75%, or 40%-60% of the ADC's operating input range. According to some embodiments, the bias voltage is approximately 50% of the ADC's operating voltage range. For example, if the ADC input can range from 0.0 to 0.9 volts, the ADC input may be biased to 1 / 2 of 0.9 volts, or 0.45 volts. According to some embodiments, the resistor or impedance may be biased to a ground or voltage supply (e.g., V bat) compared to the expected resistance or impedance of a liquid conductive path on the printed circuit board to either the V rail or the V rail. According to some embodiments, a percentage of the ADC operating range (e.g., ½ V rail) may be created using two megaohm-scale resistors, which can be equal and / or ratio-scaled, as desired. For example, one resistor is connected to the higher voltage V rail (e.g., 0.9 volts) and the second resistor can be pulled to ground to create a voltage divider (in this example, dividing in half the ADC input range). The resistance of the bias resistor will change to 0.5 V, which is the resistance of the bias resistor when moisture is present, either to ground or to the voltage supply (e.g., V bat ), the bias resistor must prevent the input to the ADC from being pulled to either ground or the voltage supply when moisture is present. According to some embodiments, the percentage of operating range can be created using capacitive coupling, using leakage current to drive to a percentage of the voltage rail.

[0107] Referring to step 2406, the microcontroller determines that moisture may be present on the printed circuit board based on the received signal. Adding bias to the ADC input allows the microcontroller to detect the presence of moisture in a bidirectional manner, such that an impedance input at a configured percentage of the voltage rail may be disrupted in the event of intrusion of a conductive liquid. For example, assume that is configured to bias the ADC input voltage to ½ of the voltage of the ADC input measurement range. Under normal conditions, the microcontroller may expect to receive a value from the ADC indicating that the normal operating voltage input to the ADC is at ½ voltage of the normal steady state. Also, if the ADC is fault biased to either ground or one or more other voltage sources (e.g., via moisture), the microcontroller may detect that the ADC output is moving away from the normal steady state of ½ voltage (e.g., toward the lower or upper output value of the ADC), which may allow the microcontroller to detect the possible presence of a conductive fluid. Thus, if water on the printed circuit board only connects the PCB trace to ground, the microcontroller may detect a drop in the input ADC voltage. Similarly, if water biases the PCB trace to V bat If you simply connect it to the ADC, the microcontroller can similarly detect the increase in the input voltage change to the ADC. So if a liquid of some conductivity upsets the bias balance, the ADC can measure that the balance has shifted and the microcontroller can process that detection accordingly.

[0108] According to some embodiments, one or more thresholds may be used to determine whether a change in the ADC output indicates a fault condition. For example, a change from the expected output that exceeds 3 / 8 of the possible ADC output range from the expected output at steady state may indicate a fault condition. For example, if the steady state typically outputs values ​​at approximately 1 / 2 the output range, an output value less than 1 / 8 of the output range or more than 7 / 8 of the output range may indicate a fault. As another example, for a steady state that outputs values ​​at approximately 1 / 2 the output range, a threshold of 1 / 4 of the possible output range from the expected output may be used, such that a value less than 1 / 4 of the output range or more than 3 / 4 of the output range may indicate a fault.

[0109] Referring to step 2408, the microcontroller may modify its operation based on the determination that moisture may be present on the printed circuit board. For example, according to some embodiments, one or more of the modifications discussed in connection with step 2208 of FIG. 22 may be used.

[0110] According to some examples, when using logic inputs such as GPIOs as described herein, there may be a range of voltages between a minimum voltage threshold (below which the microcontroller detects a logic 0) and a maximum threshold (above which the microcontroller detects a logic 1) that may be indeterminate. Because the ADC outputs words (e.g., 9, 10, or 11 bit words), the ADC may provide finer grained monitoring. However, using an ADC may require adding the ADC to a printed circuit board. Using an ADC may additionally or alternatively require more complex programming of the microcontroller as compared to using logic inputs. Thus, using logic inputs may use less space, may not require more complex programming, and / or the like.

[0111] According to some embodiments, the moisture detection techniques described herein (e.g., using GPIOs and / or ADCs) may include one or more additional features. According to some embodiments, one or more additional nodes (e.g., other than the PCB trace used for detection) may be exposed to allow for additional conductive liquid paths to the PCB trace used for detection. In some embodiments, the nodes may be exposed without including a solder mask. According to some embodiments, test points (e.g., circuit pads) adjacent to the PCB trace used for detection may be biased to a voltage different from the voltage to which the PCB trace used for detection is biased. Such test points may be biased with internal and / or external resistors. Biasing such test points may improve the conditions for detecting fault conditions (e.g., by providing a known steady state for normal operation that may facilitate detection of state changes). Such techniques may enhance the ability of the detection circuit to detect moisture, for example, because there are more voltage sources to which moisture may connect the PCB trace used for detection, thus causing a fault condition.

[0112] The illustrated device is what is commonly referred to as a reusable pen-type medication 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 medication delivery devices, including otherwise constructed pen-type medication injection devices, alternatively shaped injection devices, and infusion pump devices. The medication can be any of the types that can be delivered by such medication delivery devices. The device shown is intended to be exemplary and not limiting, as the sensing system described further below can be used with other otherwise configured devices.

[0113] Techniques operating according to the principles described herein may be implemented in any suitable manner. The process and decision blocks of the flow charts above represent steps and acts that may be included in algorithms that perform these various processes. The algorithms derived from these processes may be implemented as software integrated with and directing the operation of one or more single-purpose or multi-purpose processors, as functionally equivalent circuitry such as digital signal processing (DSP) circuits or application specific integrated circuits (ASICs), or in any other suitable manner. It should be understood that the flow charts included herein do not represent any particular circuitry, or the syntax or operation of any particular programming language or type of programming language. Rather, the flow charts illustrate functional information that one skilled in the art may use to manufacture circuits that perform the processing of a particular device implementing the techniques of the types described herein, or to implement computer software algorithms that perform the processing of that particular device. It should also be understood that, unless otherwise indicated herein, the particular sequence of steps and / or acts depicted in each flow chart are merely illustrative of algorithms that may be implemented and varied in implementations and embodiments of the principles described herein.

[0114] Thus, in some embodiments, the techniques described herein may be embodied in computer-executable instructions implemented as software, including application software, system software, firmware, middleware, embedded code, or any other suitable type of computer code. Such computer-executable instructions may be written using any of a number of suitable programming languages ​​and / or programming or scripting tools, and may be compiled as executable machine code or intermediate code that runs on a framework or virtual machine.

[0115] When the techniques described herein are embodied as computer-executable instructions, these computer-executable instructions may be implemented in any suitable manner, including as a number of functional facilities, each of which provides one or more operations for completing the execution of an algorithm operating according to these techniques. A "functional facility" is an instantiated but structural component of a computer system that is integrated with one or more computers and that, when executed by one or more computers, causes the one or more computers to perform a particular operational role. A functional facility may be a portion or an entire software element. For example, a functional facility may be implemented as a function of a process, or as a separate process, or as other suitable processing units. When the techniques described herein are implemented as multiple functional facilities, each functional facility may be implemented in its own way, and need not all be implemented in the same way. In addition, these functional facilities may be executed in parallel and / or serially as needed, and may pass information between each other using shared memory on the computer on which they are executed, using a message passing protocol, or in other suitable manners.

[0116] Generally, functional facilities include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically, the functionality of the functional facilities may be combined or distributed as desired in the systems in which they operate. In some implementations, one or more functional facilities that implement the techniques herein may together form a complete software package. These functional facilities may, in alternative embodiments, be adapted to interact with other unrelated functional facilities and / or processes to implement a software program application.

[0117] Several exemplary functional facilities for performing one or more tasks are described herein. However, it should be understood that the described functional facilities and divisions of tasks are merely examples of types of functional facilities that may implement the exemplary techniques described herein, and that the embodiments are not limited to being implemented with any particular number, division, or type of functional facilities. In some implementations, all functionality may be implemented in a single functional facility. It should also be understood that in some implementations, some of the functional facilities described herein may be implemented together with others or separately (i.e., as a single unit or separate units), or some of these functional facilities may not be implemented.

[0118] Computer-executable instructions implementing the techniques described herein (when implemented as one or more functional facilities or in any other manner) may, in some embodiments, be encoded on one or more computer-readable media to provide functionality to the media. Computer-readable media include magnetic media such as hard disk drives, optical media such as compact disks (CDs) or digital versatile disks (DVDs), persistent or non-persistent solid-state memory (e.g., flash memory, magnetic RAM, etc.), or any other suitable storage media. Such computer-readable media may be implemented in any suitable manner. As used herein, a "computer-readable medium" (also referred to as a "computer-readable storage medium") refers to a tangible storage medium. A tangible storage medium is non-transitory and has at least one physical structural component. In a "computer-readable medium," as used herein, the at least one physical structural component has at least one physical characteristic that may be altered in some way during the process of creating a medium with embedded information, recording information thereon, or any other process of encoding the medium with information. For example, the magnetization state of portions of the physical structure of the computer-readable medium may be altered during the recording process.

[0119] Further, some of the techniques described above involve the act of storing information (e.g., data and / or instructions) in a particular manner for use by those techniques. In some implementations of these techniques, such as those in which the techniques are implemented as computer-executable instructions, the information may be encoded on a computer-readable storage medium. Where particular structures are described herein as advantageous formats for storing this information, those structures may be used to impart a physical organization of the information when encoded on the storage medium. Those advantageous structures may then provide functionality to the storage medium by affecting the operation of one or more processors that interact with the information, for example, by enhancing the efficiency of computer operations performed by the processors.

[0120] While the techniques may be embodied as computer-executable instructions, in some, but not all, implementations these instructions may be executed on one or more suitable computing devices operating in any suitable computer system, or one or more computing devices (or one or more processors of one or more computing devices) may be programmed to execute the computer-executable instructions. A computing device or processor may be programmed to execute the instructions when the instructions are stored in a manner accessible to the computing device or processor, such as a data store (e.g., an on-chip cache or instruction register, a computer-readable storage medium accessible via a bus, a computer-readable storage medium accessible via one or more networks and accessible by the device / processor, etc.). The functional facilities containing these computer-executable instructions may be integrated with and direct the operation of a single general-purpose programmable digital computing device, a cooperative system of two or more general-purpose computing devices that share processing power and jointly perform the techniques described herein, a single computing device or a cooperative system of computing devices (either co-located or geographically distributed) dedicated to performing the techniques described herein, one or more field programmable gate arrays (FPGAs) for implementing the techniques described herein, or any other suitable system.

[0121] The computing device may comprise at least one processor, a network adapter, and a computer-readable storage medium. The computing device may be, for example, a desktop or laptop personal computer, a personal digital assistant (PDA), a smart mobile phone, a server, or any other suitable computing device. The network adapter may be any suitable hardware and / or software that enables the computing device to communicate wired and / or wirelessly with any other suitable computing device over any suitable computing network. The computing network may include wireless access points, switches, routers, gateways, and / or other network equipment, as well as any suitable wired and / or wireless communication medium for exchanging data between two or more computers, including the Internet. The computer-readable medium may be adapted to store data to be processed and / or instructions to be executed by the processor. The processor enables the processing of data and execution of instructions. The data and instructions may be stored on the computer-readable storage medium.

[0122] A computing device may additionally have one or more components and peripherals, including input devices and output devices. These devices may be used, among other things, to present a user interface. Examples of output devices that may be used to provide a user interface include a printer or display screen for visual presentation of output, and a speaker or other sound generating device for audible presentation of output. Examples of input devices that may be used for a user interface include pointing devices such as a keyboard, mouse, touchpad, digitizer tablet, etc. As another example, a computing device may receive input information through speech recognition or in other audible forms.

[0123] Embodiments have been described in which the present technology is implemented in circuits and / or computer-executable instructions. It should be understood that some embodiments may be in the form of a method, of which at least one example is provided. The acts performed as part of the method may be ordered in any suitable manner. Thus, while shown as sequential acts in the exemplary embodiments, embodiments may be constructed in which acts are performed in an order different from that shown, which may include performing some acts simultaneously.

[0124] Various aspects of the above embodiments may be used alone, in combination, or in various arrangements not specifically discussed in the foregoing embodiments, and therefore are not limited in their application to the details and arrangements of components set forth in the foregoing description or illustrated in the drawings. For example, aspects described in one embodiment may be combined in any manner with aspects described in other embodiments.

[0125] The use of ordinal terms such as "first," "second," "third," etc. in the claims to modify claim elements does not, by itself, imply any priority, precedence, or ordering of a claim element relative to another or the temporal order in which acts of a method are performed, but is used merely as a label to distinguish a claim element having a particular name from another element having the same name (but because of the use of ordinal terms) to distinguish between claim elements.

[0126] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of "including," "comprising," "having," "containing," "involving," and variations thereof are meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0127] The term "exemplary" is used herein to mean serving as an example, instance, or illustration. Thus, any embodiment, implementation, process, feature, etc. described herein as illustrative is to be understood as an example and not as a preferred or advantageous example, unless otherwise specified.

[0128] In order to clarify its use and inform the public hereby, 、 , ...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.

[0129] 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.

[0130] Various aspects are described in this disclosure, including but not limited to the following aspects.

[0131] 1. A drug delivery device comprising: a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; A printed circuit board; a conductive trace disposed at least partially on the printed circuit board; a bias source in electrical communication with the conductive trace; a microcontroller in electrical communication with the conductive traces through logic inputs to the microcontroller, the microcontroller comprising: receiving a signal from the conductive trace through a logic input; and A medication delivery device comprising: a microcontroller configured to determine, based on the received signal, that moisture may be present on the printed circuit board. 2. The medication delivery device of aspect 1, wherein the logic input is a general purpose input / output (GPIO) to the microcontroller. 3. The device further includes a switch mounted on the printed circuit board, and the microcontroller Receive a set of signals from the switch, 3. The medication delivery device of aspect 1 or 2, configured to generate a count of the set of signals based on the set of signals. 4. The drug delivery device of aspect 3, further comprising 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 enable the protrusions to slide relative to the switch to move the switch between a closed position and an open position when the rotatable element is rotated. 5. The medication delivery device of aspect 3, wherein the switch comprises a piezoelectric sensor, a magnetic sensor, an accelerometer, an optical sensor, a circuit breaker sensor, an optical encoder, or some combination thereof. 6. If the microcontroller determines that moisture may be present on the printed circuit board, A medication delivery device according to any one of aspects 3 to 5, further configured to discard the generated count of the set of signals, such that the generated count is (a) not stored in a memory in communication with the microcontroller, (b) not transmitted to a remote device through a communication module in communication with the microcontroller, or some combination thereof. 7. If the microcontroller determines that moisture may be present on the printed circuit board, A medication delivery device according to any one of aspects 1 to 6, wherein the microcontroller is further configured to change the operational state of the microcontroller to (a) enter a hibernation state, (b) power off, (c) restart, or some combination thereof. 8. If the microcontroller determines that moisture may be present on the printed circuit board, A medication delivery device described in any one of aspects 1 to 7, further configured to transmit at least one message including data indicative of a determination of possible moisture on the printed circuit board via a communication module in communication with the microcontroller. 9. The medication delivery device of aspect 8, wherein at least one message is configured to cause an external mobile device in communication with the medication delivery device to discard or ignore one or more previously transmitted count values. 10. The drug delivery device of any one of aspects 1-9, wherein the bias source comprises a resistor located as part of a system-on-chip (SoC) including a microcontroller. 11. The medication delivery device of any one of aspects 1-9, wherein the bias source comprises a resistor located at least partially on a printed circuit board and external to the SoC including the microcontroller. 12. The drug delivery device of any one of aspects 1-9, wherein the bias source comprises at least one of a diode, a transistor, and a capacitor. 13. the bias source is configured to provide approximately 0 volts to the conductive trace such that the microcontroller reads a logic 0 from the logic input; Receiving the signal includes reading a logic one from the logic input; A drug delivery device described in any one of aspects 1 to 12, wherein determining that moisture may be present on the printed circuit board based on the received signal includes determining that the logic input has changed from a logic 0 to a logic 1. 14. the bias source is configured to provide a positive voltage to the conductive trace such that the microcontroller reads a logic one from the logic input; Receiving a signal from the conductive trace through the logic input includes reading a logic 0 from the logic input; A drug delivery device described in any one of aspects 1 to 12, wherein determining that moisture may be present on the printed circuit board based on the received signal includes determining that a logic input has changed from a logic 1 to a logic 0. 15. The drug delivery device of any one of aspects 1-13, wherein the device further comprises a drug retained in the reservoir. 16. The drug delivery device of aspect 15, wherein the drug is insulin. 17. The medication delivery device of any one of aspects 1-16, wherein the conductive traces are in the plane of the printed circuit board. 18. The medication delivery device of any one of aspects 1-17, wherein the conductive trace is an exposed test pad. 19. A computerized method for execution by a microcontroller of a medication delivery device, comprising: The drug delivery device comprises a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; the microcontroller being in electrical communication with conductive traces disposed at least in part on the printed circuit board through logic inputs to the microcontroller; The method is: receiving a signal from the conductive trace via a logic input; and determining that moisture may be present on the printed circuit board based on the received signal. 20. A drug delivery device comprising: a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; A printed circuit board; a conductive trace disposed at least partially on the printed circuit board; An analog-to-digital converter (ADC) having an input and an output, The inputs of the ADC are in electrical communication with the conductive traces. The ADC's operating input range is between a low input voltage and a high input voltage. a bias source in electrical communication with the input of the ADC, the bias source configured to provide a bias voltage between a low input voltage and a high input voltage; a microcontroller in electrical communication with the output of the ADC, the microcontroller comprising: Receives the signal from the output of the ADC, and A medication delivery device comprising: a microcontroller configured to determine, based on the received signal, that moisture may be present on the printed circuit board. twenty one. The lower input voltage of the ADC's operating input range is the ground voltage, 21. The medication delivery device of claim 20, wherein the high input voltage of the operating input range of the ADC is a positive voltage. 22. The drug delivery device of aspect 21, wherein the ground voltage is about 0 volts and the positive voltage is about 0.9 volts. 23. The drug delivery device of any one of aspects 20-22, wherein the bias voltage provided by the bias source is 25%-75% of the operating input range of the ADC. 24. The drug delivery device of any one of aspects 20-22, wherein the bias voltages provided by the bias source are 40% and 60% of the operating input range of the ADC. 25. The drug delivery device according to any one of aspects 20-24, wherein the bias voltage is 50% of the operating voltage range of the ADC. 26. The drug delivery device of any one of aspects 20-25, wherein the bias source includes capacitive coupling between the input of the ADC and the power supply. 27. The bias source is a first resistor connected to the circuit configured to provide a substantially low input voltage; 26. The medication delivery device of any one of aspects 20-25, comprising: a second resistor connected to a circuit configured to provide a substantially high input voltage. 28. The drug delivery device of any one of aspects 20 to 25, wherein the bias source comprises at least one of a diode, a transistor, and a capacitor. 29. Receiving the signal includes reading a voltage from an output of the ADC; A drug delivery device as described in any one of aspects 20 to 28, wherein determining that moisture may be present on the printed circuit board based on the received signal includes determining that the received voltage is greater than a preset threshold voltage amount that differs from the bias voltage. 30. The drug delivery device of any one of aspects 20-29, wherein the device further comprises a drug retained in the reservoir. 31. The drug delivery device of aspect 30, wherein the drug is insulin. 32. A computerized method implemented by a microcontroller of a medication delivery device, comprising: The drug delivery device comprises a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; The microcontroller is in electrical communication with the output of the analog-to-digital converter (ADC). The operating input range of the ADC is between a low input voltage and a high input voltage. an input of the ADC in electrical communication with (a) a conductive trace at least partially disposed on a printed circuit board; and (b) a bias source configured to provide a bias voltage between a low input voltage and a high input voltage; The method is: receiving a signal from an output of the ADC; and determining that moisture may be present on the printed circuit board based on the received signal.< / n>

Claims

1. 1. A drug delivery device comprising: a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; A printed circuit board; a conductive trace disposed at least partially on the printed circuit board; a bias source in electrical communication with the conductive traces; a microcontroller in electrical communication with the conductive traces through logic inputs to the microcontroller, the microcontroller comprising: receiving a signal from the conductive trace through the logic input; and A microcontroller configured to determine that moisture may be present on the printed circuit board based on the received signal.

2. The medication delivery device of claim 1 , wherein the logic input is a general purpose input / output (GPIO) to the microcontroller.

3. a switch mounted on the printed circuit board, the microcontroller further comprising: receiving a set of signals from the switch; 3. A medication delivery device according to claim 1 or 2, configured to generate a count of the set of signals based on the set of signals.

4. 4. The medication delivery device of claim 3, further comprising 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 switch to move the switch between a closed position and an open position when the rotatable element is rotated.

5. 4. The medication delivery device of claim 3, wherein the switch comprises a piezoelectric sensor, a magnetic sensor, an accelerometer, an optical sensor, a circuit breaker sensor, an optical encoder, or some combination thereof.

6. If the microcontroller determines that moisture may be present on the printed circuit board, A medication delivery device as described in any one of claims 3 to 5, further configured to discard the generated count of the set of signals such that the generated count is (a) not stored in a memory in communication with the microcontroller, (b) not transmitted to a remote device through a communication module in communication with the microcontroller, or some combination thereof.

7. If the microcontroller determines that moisture may be present on the printed circuit board, The medication delivery device of any one of claims 1 to 6, wherein the microcontroller is further configured to change an operational state of the microcontroller to (a) enter a hibernation state, (b) power down, (c) restart, or some combination thereof.

8. If the microcontroller determines that moisture may be present on the printed circuit board, A medication delivery device according to any one of claims 1 to 7, further configured to transmit at least one message including data indicative of a determination of possible moisture on the printed circuit board via a communications module in communication with the microcontroller.

9. The medication delivery device of claim 8 , wherein the at least one message is configured to cause an external mobile device in communication with the medication delivery device to discard or ignore one or more previously transmitted count values.

10. A medication delivery device according to any preceding claim, wherein the bias source comprises a resistor located as part of a system-on-chip (SoC) including the microcontroller.

11. A drug delivery device according to any one of claims 1 to 9, wherein the bias source comprises a resistor located at least partially on the printed circuit board and external to a system-on-chip including the microcontroller.

12. The drug delivery device according to any one of claims 1 to 9, wherein the bias source comprises at least one of a diode, a transistor, and a capacitor.

13. the bias source is configured to provide approximately 0 volts to the conductive trace such that the microcontroller reads a logic 0 from the logic input; receiving the signal includes reading a logic one from the logic input; 13. The drug delivery device of claim 1, wherein determining that moisture may be present on the printed circuit board based on the received signal comprises determining that the logic input has changed from a logic 0 to a logic 1.

14. the bias source is configured to provide a positive voltage to the conductive trace such that the microcontroller reads a logic one from the logic input; receiving the signal from the conductive trace through the logic input includes reading a logic 0 from the logic input; 13. The drug delivery device of claim 1, wherein determining that moisture may be present on the printed circuit board based on the received signal comprises determining that the logic input has changed from a logic 1 to a logic 0.

15. A drug delivery device according to any preceding claim, further comprising a drug held in the reservoir.

16. The drug delivery device of claim 15 , wherein the drug is insulin.

17. A medication delivery device according to any preceding claim, wherein the conductive traces lie in the plane of the printed circuit board.

18. A medication delivery device according to any preceding claim, wherein the conductive trace is an exposed test pad.

19. 1. A computerized method for execution by a microcontroller of a medication delivery device, comprising: The drug delivery device comprises: a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; the microcontroller in electrical communication with conductive traces disposed at least in part on a printed circuit board through logic inputs to the microcontroller; The method comprises: receiving a signal from the conductive trace through the logic input; determining that moisture may be present on the printed circuit board based on the received signal.

20. 1. A drug delivery device comprising: a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; A printed circuit board; a conductive trace disposed at least partially on the printed circuit board; An analog-to-digital converter (ADC) having an input and an output, the input of the ADC is in electrical communication with the conductive trace; an ADC, the operating input range of which is between a low input voltage and a high input voltage; a bias source in electrical communication with the input of the ADC, the bias source configured to provide a bias voltage between the low input voltage and the high input voltage; a microcontroller in electrical communication with the output of the ADC, the microcontroller comprising: receiving a signal from the output of the ADC; and A microcontroller configured to determine that moisture may be present on the printed circuit board based on the received signal.

21. the lower input voltage of the operating input range of the ADC is ground voltage; 21. The medication delivery device of claim 20, wherein the high input voltage of the operating input range of the ADC is a positive voltage.

22. 22. The medication delivery device of claim 21, wherein the ground voltage is about 0 volts and the positive voltage is about 0.9 volts.

23. The medication delivery device of any one of claims 20 to 22, wherein the bias voltage provided by the bias source is 25% to 75% of the operational input range of the ADC.

24. A drug delivery device according to any one of claims 20 to 22, wherein the bias voltages provided by the bias source are 40% and 60% of the operational input range of the ADC.

25. A drug delivery device according to any one of claims 20 to 24, wherein the bias voltage is 50% of the operating voltage range of the ADC.

26. A drug delivery device according to any one of claims 20 to 25, wherein the bias source comprises a capacitive coupling between the input of the ADC and a power supply.

27. The bias source includes: a first resistor connected in a circuit configured to provide substantially the low input voltage; A medication delivery device according to any one of claims 20 to 25, comprising: a second resistor connected in a circuit configured to provide substantially the high input voltage.

28. The medication delivery device according to any one of claims 20 to 25, wherein the bias source comprises at least one of a diode, a transistor, and a capacitor.

29. Receiving the signal includes reading a voltage from the output of the ADC; A drug delivery device as described in any one of claims 20 to 28, wherein determining that moisture may be present on the printed circuit board based on the received signal comprises determining that the received voltage is greater than a preset threshold voltage amount that differs from the bias voltage.

30. A drug delivery device according to any one of claims 20 to 29, further comprising a drug held in the reservoir.

31. 31. The drug delivery device of claim 30, wherein the drug is insulin.

32. 1. A computerized method executed by a microcontroller of a medication delivery device, comprising: The drug delivery device comprises: a housing having a reservoir large enough to hold the medicament; a dose button rotatable relative to the housing for selecting a dose size of the medication for injection; the microcontroller in electrical communication with an output of an analog-to-digital converter (ADC); an operating input range of the ADC is between a low input voltage and a high input voltage; an input of the ADC in electrical communication with (a) a conductive trace disposed at least partially on a printed circuit board; and (b) a bias source configured to provide a bias voltage between the low input voltage and the high input voltage; The method comprises: receiving a signal from the output of the ADC; determining that moisture may be present on the printed circuit board based on the received signal.

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