Drug delivery device with moisture sensing system

Abstract

A drug delivery device is provided having a housing including a reservoir sized to contain a drug, a dose button rotatable relative to the housing to select a size of a dose of the drug for injection, a printed circuit board, a conductive trace, and a microcontroller. In some embodiments, a biasing source can be in electrical communication with the conductive trace, and the microcontroller is in electrical communication with the conductive trace through a logic input. In some embodiments, an analog-to-digital converter can be in electrical communication with the conductive trace, the microcontroller, and the biasing source. The microcontroller is configured to receive a signal from the ADC or the logic input, and determine, based on the received signal, that moisture can be present on the printed circuit board.

Description

Background Technology

[0001] Patients with multiple illnesses often need to self-inject medications. To enable people to conveniently and accurately administer medications themselves, various devices widely known as pen injectors or injection pens have been developed. Typically, these pens are equipped with a cartridge containing a piston and holding multiple doses of liquid medication. A drive mechanism moves forward to advance the piston in the cartridge to dispense the contained medication, usually through a needle, from an outlet at the distal end of the cartridge.

[0002] In disposable or pre-filled pens, after the used pen has emptied the cartridge containing the supplied medication, the user discards the entire pen and begins using a new replacement pen. In reusable pens, after the used pen has emptied the cartridge containing the supplied medication, the pen is disassembled to allow for the replacement of the empty cartridge with a new one, and then the pen is reassembled for subsequent use.

[0003] Such devices may have components that interact physically to cause changes in the state of the device or to operate. For example, the device may have a cap that can be removed before delivery, a dosage button that can be rotated to set the dosage and / or actuated to deliver the dosage, an "on" button for activating the device, and so on.

[0004] Such devices may include electronic components, such as integrated circuits with processing units and other components. For example, the electronic components may include sensing devices, such as switches, that communicate with the processing unit to detect the occurrence of such interactions. The electronic components may not be within a waterproof enclosure. The inventors have recognized that electronic components may be exposed to humid environments, which can affect their operation. In particular, the inventors have recognized that moisture / humidity can cause electronic components to record, process, and / or store erroneous data regarding such interactions. The inventors therefore recognize the need for a moisture sensing mechanism that can be used to sense moisture on electronic devices and prevent the system from using erroneous data. Summary of the Invention

[0005] This disclosure relates to a drug delivery device including circuitry and / or logic for monitoring the presence of moisture on a printed circuit board of the drug delivery device. According to some embodiments, this technology can utilize existing circuitry (e.g., bias sources, analog-to-digital converters, etc.) in drug delivery devices that are not conventionally used for sensing moisture.

[0006] In one embodiment, a drug delivery device includes: a housing including a reservoir sized to contain a drug; a dosage button rotatable relative to the housing to select a dosage of the drug for injection; a printed circuit board; conductive traces at least partially disposed on the printed circuit board; a bias source electrically connected to the conductive traces; and a microcontroller electrically connected to the conductive traces via logic inputs, the microcontroller being configured to: receive signals from the conductive traces via the logic inputs; and determine, based on the received signals, that moisture may be present on the printed circuit board.

[0007] In one embodiment, a drug delivery device includes: a housing including a reservoir sized to accommodate a drug; a dosage button rotatable relative to the housing to select a dosage of the drug for injection; a printed circuit board; conductive traces at least partially disposed on the printed circuit board; an analog-to-digital converter (ADC) including an input and an output, wherein: the input of the ADC is electrically connected to the conductive traces; and the ADC operates with an input range from a low input voltage to a high input voltage; a bias source electrically connected to the input of the ADC, wherein the bias source is configured to provide a bias voltage from the low input voltage to the high input voltage; and a microcontroller electrically connected to the output of the ADC, the microcontroller being configured to: receive a signal from the output of the ADC; and determine, based on the received signal, that moisture may be present on the printed circuit board. Attached Figure Description

[0008] Additional embodiments of the present disclosure, along with their features and advantages, will become more apparent from the description herein in conjunction with the accompanying drawings. Components in the drawings are not necessarily drawn to scale. Furthermore, in the drawings, the same reference numerals indicate corresponding components in all different views.

[0009] Figure 1 This is a perspective view of a drug delivery device with a dose detection system according to aspects of this disclosure.

[0010] Figure 2 yes Figure 1 A partial exploded perspective view of a drug delivery device shows a dosing button with a support and a cover, wherein the cover is shown as being separate from the support.

[0011] Figure 3 yes Figure 1 A partial exploded perspective view of the drug delivery device, showing the components of the dose detection system.

[0012] Figure 4 yes Figure 1 A cross-sectional view of a drug delivery device.

[0013] Figure 5 yes Figure 1A partial cross-sectional view of the proximal end of the drug delivery device, showing components of the dose detection system.

[0014] Figure 6 yes Figure 1 A bottom view of a portion of the dose button, showing the printed circuit board held inside the dose button cover.

[0015] Figure 7 yes Figure 6 An exploded view of a portion of the dosage button shown.

[0016] Figure 8 This is a perspective view of the flange of the dosage detection system in a drug delivery device.

[0017] Figure 9 yes Figure 8 Top view of the flange.

[0018] Figure 10 This is a perspective view of the dosage button support.

[0019] Figure 11 yes Figure 10 Top view of the dosage button support.

[0020] Figure 12 This is a perspective view of a printed circuit board and sensor switch according to aspects of this disclosure.

[0021] Figure 13 yes Figure 12 A perspective view of the cantilever and base of the sensor switch.

[0022] Figure 14 yes Figure 13 Side view of the cantilever and base.

[0023] Figure 15 It is positioned between the two teeth of the flange. Figure 12 Side view of the cantilever.

[0024] Figure 16 It shows Figure 15 The cantilever is pushed by a tooth of the flange during flange rotation.

[0025] Figure 17 The diagram shows the cantilever being further pushed by the teeth of the flange, causing a portion of the cantilever to move toward and contact the conductive pad, thereby closing the switch.

[0026] Figure 18 This shows the cantilever sliding on the teeth of the flange.

[0027] Figure 19 The interaction between the cantilever and the next adjacent tooth of the flange is shown.

[0028] Figure 20 This is an exemplary schematic diagram of a printed circuit board according to some embodiments.

[0029] Figure 21 An example of a printed circuit board with a bias source according to some embodiments is shown.

[0030] Figure 22 This is a flowchart illustrating a first exemplary computerized method, according to some embodiments, that can be executed by a microcontroller of a drug delivery device to determine the possible presence of moisture in the drug delivery device.

[0031] Figure 23 An example of a printed circuit board with a bias source and an ADC according to some embodiments is shown.

[0032] Figure 24 This is a flowchart illustrating a first exemplary computerized method, according to some embodiments, that can be executed by a microcontroller of a drug delivery device to determine the possible presence of moisture in the drug delivery device. Detailed Implementation

[0033] To facilitate understanding of the principles of this disclosure, embodiments illustrated in the accompanying drawings will now be described using specific language. Nevertheless, it should be understood that this is not intended to limit the scope of the invention.

[0034] This disclosure relates to a moisture sensing system for a drug delivery device. Moisture on the printed circuit board of a drug delivery device can cause errors. In particular, moisture can electrically connect normally non-electrically connected components on the circuit board (e.g., voltage sources, test pads, grounding terminals, etc.), leading to various errors. For example, the presence of moisture can negatively affect the operation of the drug delivery device, such as causing it to detect incorrect information (e.g., erroneously detecting the occurrence of an event when it has not occurred) and / or detect incorrect data (e.g., erroneous data detecting an injection event). Therefore, it is desirable to detect the potential presence of moisture and modify the operation of the drug delivery device accordingly (e.g., to prevent erroneous data from being stored and / or reported).

[0035] In some embodiments, the sensing system includes circuitry and / or logic for detecting the possible presence of moisture on a printed circuit board of a drug delivery device. In some cases, the physical space available to house such circuitry and / or logic on such a printed circuit board may be limited for various reasons, such as the desire to keep the form factor of such drug delivery devices small, or to prevent or mitigate interference with existing drug delivery device manufacturing processes. Similarly, in some cases, it may be necessary to limit additional manufacturing costs or the complexity of acquiring or integrating such moisture detection circuitry and / or logic. Therefore, the inventors have recognized that, in some cases, adding additional components specifically designed and / or dedicated to moisture detection may be undesirable. Specifically, the inventors have recognized that conventional circuit-based components, such as printed circuit board traces, bias sources (e.g., resistors), logic inputs (e.g., general purpose inputs / outputs), and / or analog-to-digital converters that are not conventionally used for moisture sensing, can be adapted to sense the possible presence of moisture according to the techniques described herein.

[0036] On one hand, the drug delivery device includes a housing having a reservoir large enough to hold a drug (e.g., insulin), and a dosing button rotatable relative to the housing to select the dose of the drug to be injected. The drug delivery device also includes a printed circuit board, conductive traces at least partially disposed on the printed circuit board, a bias source electrically connected to the conductive traces, and a microcontroller electrically connected to the conductive traces via logic inputs. The microcontroller is configured to receive signals from the conductive traces via logic inputs and to determine, based on the received signals, the possible presence of moisture on the printed circuit board.

[0037] On one hand, the drug delivery device includes a housing with a reservoir large enough to hold a drug, and a dosage button rotatable relative to the housing to select the dosage of the drug to be injected. 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) including input and output terminals. The input terminal of the ADC is electrically connected to the conductive traces, and the ADC operates between a low input voltage and a high input voltage. The drug delivery device also includes a bias source electrically connected to the input terminal of the ADC, configured to provide a bias voltage between the low and high input voltages, and a microcontroller electrically connected to the output terminal of the ADC. The microcontroller is configured to receive a signal from the output terminal of the ADC and, based on the received signal, determine whether moisture may be present on the printed circuit board.

[0038] The device described herein may include, for example, a drug within a reservoir or cartridge 20 (hereinafter). In another embodiment, the system may include one or more devices, including device 10 (hereinafter) and a drug. The term "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as lispro insulin or glargine insulin, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory peptides (GIPs), GIP analogs, GIP derivatives, gastric acid regulator analogs, gastric acid regulator derivatives, therapeutic antibodies, and any therapeutic agent capable of being delivered via the device described herein. The drug used in the device may be formulated with one or more excipients. Patients, caregivers, or healthcare professionals typically operate the device in the manner described above to deliver the drug to a person.

[0039] Exemplary drug delivery device 10 in Figure 1-4 The image shows a pen injector configured to deliver medication into a patient via a needle. Device 10 includes a body 11, which may include an elongated pen-shaped housing 12, comprising a distal portion 14 and a proximal portion 16. As used herein, the term "distal" refers to the direction and / or portion of the drug delivery device that is toward (or near) the injection site, while the term "proximal" refers to the direction and / or portion of the drug delivery device that is away from (or away from) the injection site. The distal portion 14 may be received within a pen cap 18. (See reference...) Figure 4 The distal portion 14 may include a reservoir or cartridge 20 configured to hold medication to be dispensed through the outlet 21 of the housing for a dispensing operation. The outlet 21 of the distal portion 14 may be equipped with an injection needle 24. In some embodiments, the injection needle may be removable from the housing. In some embodiments, the injection needle is replaced with a new needle after each use.

[0040] Piston 26 may be positioned within reservoir 20. The drug delivery device may include an injection mechanism positioned in the proximal portion 16, operable to push piston 26 toward the outlet of reservoir 20 during a dosing operation to force the contained drug through the needle tip. The injection mechanism may include a drive member 28, illustratively in the form of a screw, axially movable relative to housing 12 to push piston 26 through reservoir 20.

[0041] The device may include a dose setting assembly coupled to the housing 12 for setting the dose to be dispensed by the device 10. For example... Figure 3 and Figure 4As best shown 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 helical element, operable during dose setting and dose dispensing to perform helical movement (i.e., simultaneous axial and rotational movement) relative to the housing 12 about a longitudinal axis of rotation AA. Figure 3 and Figure 4 The dosage setting screw 32 is shown fully screwed into the housing 12 in its home / initial position or zero-dose position. The dosage setting screw 32 is operable to be screwed out of the housing 12 in a proximal direction until it reaches a fully extended position corresponding to the maximum dose that the device 10 can deliver in a single injection. The extended position can be any position between an incremental extended position (e.g., a dose setting of 0.5 or 1 unit) and a fully extended position corresponding to the maximum dose that the device 10 can deliver in a single injection, and is screwed into the housing 12 in a distal direction until it reaches an initial or zero position corresponding to the minimum dose that the device 10 can deliver in a single injection.

[0042] Reference Figure 3 and Figure 4 The dose setting screw 32 includes a helical threaded outer surface that engages with a corresponding threaded inner surface 13 of the housing 12 to allow the dose setting screw 32 to helically move relative to the housing 12 (i.e., simultaneously rotate and translate). The dose setting screw 32 also includes a sleeve 34 of the device 10 ( Figure 4 The outer surface of the dose setting screw 32 engages with the inner surface of the helical thread. The outer surface of the dose setting screw 32 includes dose indicator markings, such as the number 36 visible through the dose window, to indicate the set dose to the user.

[0043] As described above, in some embodiments, the dose setting assembly further includes a tubular flange 38, which is coupled in the proximal end of the opening of the dose setting screw 32 and is axially and rotatably locked to the dose setting screw 32 by means of a protrusion 40 received within the opening 41 in the dose setting screw 32. The protrusion 40 of the flange 38... Figure 3 , 8 As can be seen in Figure 9, and the opening 41 of the dose setting screw 32 is in Figure 3 As can be seen in the text.

[0044] like Figure 3 and Figure 4As shown, the delivery device 10 may include an actuator assembly having a clutch 52 and a dosage button 30. The clutch 52 is received within a dosage setting screw 32 and includes an axially extending rod 54 at its proximal end. The dosage button 30 of the actuator assembly is positioned proximal to the dosage setting screw 32 and the flange 38. The dosage button 30 includes a support 42 (also referred to herein as the “lower button”) and a cover 56 (also referred herein as the “upper button”). As will be discussed, the support 42 and the cover 56 enclose electronic components for storing and / or transmitting data related to the dosage delivered by the drug delivery device.

[0045] The support 42 of the dosage button can be attached to the lever 54 of the clutch 52, for example by interference fit or ultrasonic welding, so as to axially and rotatably fix the dosage button 30 and the clutch 52 together.

[0046] In some embodiments, a portion of the clutch may pass through the inner cavity 39 of the flange 38. The inner cavity 39 of the flange... Figure 8 and 9 Ideally, it should be visible in the center. In some embodiments, the cavity 39 can be used to help center the clutch 52 in place.

[0047] The proximal surface 60 of the dosage button 30 can serve as an actuating surface onto which force can be manually applied, i.e., by the user directly applying force to push the actuator assembly (dosage button 30 and clutch 52) in the distal direction. A biasing member 68 (illustratively a spring) can be disposed between the distal surface 70 of the support 42 and the proximal surface 72 of the tubular flange 38. Figure 8 and 9 This allows the support 42 of the actuation assembly and the flange 38 of the dose setting assembly to be axially separated from each other. The user can press the dose button 30 to initiate the dose dispensing operation. In some embodiments, the biasing member 68 is positioned against the proximal surface 72 and may surround the raised collar 37 of the flange 38.

[0048] The delivery device 10 can operate in a dose setting mode and a dose dispensing mode. In the dose setting mode, the dose button 30 is rotated relative to the housing 12 to set the desired dose to be delivered through the device 10. In some embodiments, rotating the dose button 30 relative to the housing 12 in one direction causes the dose button 30 to be axially translated proximally relative to the housing 12, and rotating the dose button 30 relative to the housing 12 in the opposite direction causes the dose button 30 to be axially translated distally relative to the housing. In some embodiments, clockwise rotation of the dose button moves the dose button 30 distally, while counterclockwise rotation of the dose button moves the dose button proximally, or vice versa.

[0049] In some embodiments, rotating the dose button 30 to cause it to translate axially in a proximal direction increases the set dose, and rotating the dose button 30 to cause it to translate axially in a distal direction decreases the set dose. During dose setting operation, the dose button 30 can be adjusted in predetermined rotational increments corresponding to the minimum incremental increase or decrease of the set dose. The dose button may include a ratchet mechanism such that each rotational increment produces an audible and / or tactile "click". For example, an increment or "click" may equal half or one unit of the drug.

[0050] In some embodiments, the user can see the set dose via dial indicator marks shown through the dose window 36. During dose setting mode, an actuator assembly including a dose button 30 and a clutch 52 moves axially and rotationally together with the dose setting assembly, which includes a flange 38 and a dose setting screw 32.

[0051] Because the dose setting screw 32 is threadedly connected to the housing 12, the dose setting screw 32 and the flange 38 are rotatably fixed to each other and rotate and move proximally during dose setting. During this dose setting movement, the dose button 30 is activated by the complementary spline 74 of the flange 38 and the clutch 52. Figure 4 The complementary spline 74 is rotatably fixed relative to the flange 38 and the dose setting screw 32, and is pressed together by the biasing member 68. During dose setting, the dose setting screw 32, flange 38, clutch 52, and dose button 30 move helically (i.e., simultaneously rotate and translate axially) 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 dose set by the operation of the drug delivery device 10.

[0052] Once the desired dose is set, the device 10 is manipulated so that the injection needle 24 is correctly inserted into, for example, the user's skin. The dose dispensing operation mode is activated in response to an axial distal force applied to the proximal side 60 of the dose button 30. The axial force is applied directly to the dose button 30 by the user. This causes the actuator assembly (dose button 30 and clutch 52) to move axially in the distal direction relative to the housing 12.

[0053] The axial displacement of the actuator assembly compresses the bias member 68 and reduces or closes the gap between the dose button 30 and the tubular flange 38. This relative axial movement separates the clutch 52 and the complementary spline 74 on the flange 38, thereby disengaging the dose button 30 from the rotational fixation of the flange 38 and the dose setting screw 32. Specifically, the dose setting screw 32 is rotated apart from the dose button 30 to allow the dose setting screw 32 to rotate in the opposite direction relative to the dose button 30 and the housing 12. Moreover, when the dose setting screw 32 and the flange 38 are freely rotating relative to the housing 12, the user prevents the dose button 30 from rotating relative to the housing 12 by pressing it against the dose button 30 to engage the dose button 30.

[0054] As the dosage button 30 and clutch 52 continue to be inserted axially without rotating relative to the housing 12, the dosage setting screw 32 screws back into the housing 12 as it rotates relative to the dosage button 30. The dosage marker indicating the amount to be injected can be seen through window 36. As the dosage setting screw 32 is screwed distally downwards, the drive member 28 is pushed distally to push the piston 26 through the reservoir 20 and through the needle 24 to expel the drug.

[0055] During the dosage dispensing operation, the amount of drug dispensed from the drug delivery device is proportional to the amount of rotational movement of the dosage setting screw 32 relative to the housing 12 when the dosage setting screw 32 is screwed back into the housing 12. In some embodiments, since the dosage button 30 is rotated and fixed relative to the housing 12 during the dosage dispensing mode, the amount of drug dispensed from the drug delivery device can be considered proportional to the amount of rotational movement of the dosage setting screw 32 relative to the dosage button 30 when the dosage setting screw 32 is screwed back into the housing 12. The injection is completed when the internal thread of the dosage setting screw 32 has reached the distal end of the corresponding external thread of the sleeve 34. Figure 4 Then device 10 is positioned again in the ready state or zero-dose position, such as... Figure 2 and Figure 4 As shown.

[0056] As described above, the delivered dose can be obtained based on the amount of rotation of the dose setting components (flange 38 and dose setting screw 32) relative to the actuator components (clutch 52 and dose button 30) during dose delivery. This rotation can be determined by detecting incremental movements of the dose setting components, which are "counted" as the dose setting components rotate during dose delivery.

[0057] 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 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 contents of which are incorporated herein by reference, wherein such a device is modified with one or more different sensor systems described herein to determine the amount of drug delivered from the drug delivery device based on sensing of relative rotation within the drug 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,” the entire contents of which are incorporated herein by reference, wherein such a device uses one or more of the different sensor systems described herein, modified to determine the amount of drug delivered from the drug delivery device based on sensing of relative rotation within the drug delivery device.

[0058] This document describes a dose detection system operable to determine the amount of dose delivered based on the relative rotation between a dose setting member and the device body. The dose detection system utilizes a dose setting member attached to the device body and rotatable relative to the device body about a rotation axis during dose delivery. A sensing element is attached to the dose setting member and is non-rotatable relative to it (fixed in rotation). An actuator is attached to the device body and remains non-rotatable relative to the device body during dose delivery. The sensing element thus rotates relative to the actuator during dose delivery, in relation to the amount of dose delivered / amount of the agent.

[0059] In some embodiments, the dose detection system includes a rotary sensor attached to an actuator assembly and a sensed element, the sensed element including surface feature structures equidistantly radially spaced around a rotation axis of the sensed element.

[0060] In some embodiments, a dose detection system may include a sensor and a sensed component attached to a component of a drug delivery device. The term "attachment" encompasses any manner in which a component is positioned onto another component or onto a component of a drug delivery device such that they can operate as described herein. For example, a sensor may be attached to a component of a drug delivery device by being positioned directly on a component, received within a component, integrated with a component, or otherwise connected to a component. Connections may include, for example, connections formed by friction engagement, spline engagement, snap-fit ​​or press-fit, acoustic welding, or adhesive.

[0061] The term "direct attachment" describes an attachment in which two parts, or one part and one component, are physically fixed together without any intermediate parts other than the attachment component. The attachment component may include fasteners, adapters, or other parts of the fastening system, such as a compressible membrane interposed between the two parts to facilitate attachment. "Direct attachment" differs from attachment where parts / components are joined via one or more intermediate functional components.

[0062] The term "fixed" is used to indicate that the indicated movement may or may not occur. For example, if two components need to rotate and move together, the first component is "rotationally fixed" to the second component. In another aspect, a component may be functionally but not structurally "fixed" relative to another component. For example, one component can be pressed against another component, such that the frictional engagement between the two components rotates them together, whereas without the pressing of the first component, the two components might not be fixed together.

[0063] This paper envisions various sensor arrangements. Typically, a sensor arrangement includes 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. A sensor can be used with associated electrical components to operate the sensor. A "sensed component" is any component that the sensor can detect the position and / or movement of relative to the sensor. In a dose detection system, the sensed component rotates relative to the sensor, and the sensor can detect the rotational motion of the sensed component. The sensor may include one or more sensing elements, and the sensed component may include one or more sensed elements. The sensor detects the movement of the sensed component and provides an output representing the movement of the sensed component.

[0064] Illustratively, the dose detection system includes an assembly of electronic components suitable for operation of the sensor arrangement as described herein. The drug delivery device may include a controller operatively connected to the sensor to receive output from the sensor. The controller begins receiving generated signals from the sensor indicating a count from first to last for determining a total displacement (e.g., angular displacement). In the event of detected angular movement of the dose setting component, the controller may be configured to receive data indicating the angular movement of the dose setting component, which can be used to determine the amount of dose delivered by operation of the drug delivery device based on the output. The controller may be configured to determine the amount of dose delivered by operation of the drug delivery device based on the output. The controller may include conventional components such as a processor, power supply, memory, microcontroller, etc. Alternatively, at least some components may be provided individually, such as by means of a computer, smartphone, or other device. A means is then provided to operatively connect an external controller component to the sensor, for example, via a wired or wireless connection, at an appropriate time.

[0065] According to one aspect, an electronic component assembly includes a sensor arrangement structure comprising one or more sensors operatively communicable to a processor for receiving signals representing sensed rotation from the sensors. An exemplary electronic component assembly 76 is described in... Figure 5-7 The electronic component assembly 76, as shown herein, may include a sensor 86 and a printed circuit board (PCB) 77 having multiple electronic components. The PCB may be a flexible printed circuit board. The PCB of the electronic component assembly 76 may include a microcontroller unit (MCU) as a controller, the controller including at least one processing core and internal memory. The electronic component assembly may include a power source 79, such as a battery, illustratively a button cell battery, for powering the various components. The controller of the electronic component assembly 76 may include control logic operable to perform the operations described herein, including detecting angular movement of the dose setting component during dose setting and / or dose delivery and / or detecting the dose delivered via the drug delivery device 10 based on the detected rotation of the dose setting component relative to the actuator assembly. Many (if not all) components of the electronic component assembly may 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 support 42 of the dose button and the distal surface 81 of the cover 56 of the dose button 30. Figure 5 In the illustrated embodiment, the electronic component assembly 76 is permanently integrated into the dosage button 30 of the delivery device. In other embodiments, the electronic component assembly is configured as a module that can be detachably attached to the actuator assembly of the drug delivery device.

[0066] exist Figure 6 The image shows a bottom view of the electronic component assembly 76 held within the cover 56. Figure 7An exploded view of electronic component assembly 76 is shown. (As shown) Figure 6 and 7 As shown, the electronic component assembly 76 may include a printed circuit board (PCB) 77 and a sensor 86 having a contact surface 111. For example... Figure 7 As shown, the electronic component assembly 76 may also include a battery 79 and a battery cage 87.

[0067] In some embodiments, at least a portion of the sensor 86 extends from the compartment 85 of the dosage button 30. For example... Figure 10 and 11 As best shown, the support 42 of the dosage button 30 may include one or more openings 45 through which the sensor 86 extends. In some embodiments, during the assembly of the drug delivery device, the contact surface 111 of the sensor 86 passes through the opening 45 of the support 42. This allows the contact surface 111 of the sensor to interact with components outside the compartment 85 of the dosage button 30. In some embodiments, while only one opening 45 of the support 42 is needed to accommodate the sensor, a second opening may be provided, for example for symmetry of the support component, which facilitates the fabrication of components of the drug delivery device and / or the assembly of its components.

[0068] The controller of electronic component assembly 76 is operable to store total angular motion used to determine dose delivery and / or detected dose delivery in local memory (e.g., internal flash memory or onboard EEPROM). The controller is also operable to wirelessly transmit signals representing the total count, total angular motion, and / or detected dose to an external device, such as a user's mobile device or a remote server. Transmission can be made, for example, via Bluetooth Low Energy (BLE) or other suitable short-range or long-range wireless communication protocols. Illustratively, the BLE control logic and the controller are integrated on the same circuitry.

[0069] As discussed, according to one aspect, a dose detection system involves detecting the relative rotational motion between two components of a drug delivery device. Where the degree of rotation has a known relationship with the amount of dose delivered, the sensor operates to detect the amount of angular motion from the start to the end of the dose injection. For example, in some embodiments of a pen injector, the relationship is that an 18° angular displacement of the dose setting component corresponds to one dose unit, although other angular relationships are also suitable, such as 9, 10, 15, 20, 24, or 36 degrees, which may be used for one unit or half a 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.

[0070] Angular displacement is determined by counting dose increments as the injection progresses. For example, the sensing system can use a repetitive configuration of the sensed element such that each repetition indicates a predetermined angular rotation. Conveniently, the configuration can be configured such that each repetition corresponds to a minimum dose increment that can be set using a drug delivery device.

[0071] Components of the dose detection system may be permanently or detachably attached to the drug delivery device. In some embodiments, at least some of the components of the dose detection system are provided as modules detachably attached to the drug delivery device. In other embodiments, the components of the dose detection system are permanently attached to the drug delivery device.

[0072] In some embodiments, the sensor can detect the relative rotation of a sensed component that is rotatably fixed to the dose setting screw 32 during dose delivery, thereby determining the amount of dose delivered by the drug delivery device. In one illustrative embodiment, the rotation sensor is attached to and rotatably fixed to an actuator assembly. The actuator assembly does not rotate relative to the device housing during dose delivery.

[0073] In some embodiments, the sensed component is attached and rotatably fixed to a dose setting screw 32, which rotates relative to the dose button 30 and the device housing 12 during dose delivery. In some embodiments described herein, the sensed component includes an annular structure having a plurality of proximal protrusions arranged circumferentially relative to each other. The shape and size of the protrusions are designed to deflect a movable element of a rotating sensor. An illustrative embodiment of such a sensed component is... Figure 3 , 5 The tubular flange 38 is best shown in 8 and 9. The embodiments described herein can be configured as modules for detachable attachment to or integration into the dose button of the delivery device.

[0074] During dose delivery, the dose setting screw 32 is free to rotate relative to the dose button 30. In the illustrative embodiment, the electronic component assembly 76 is rotatably fixed to the dose button 30 and does not rotate during dose delivery.

[0075] like Figure 2 , 3 As shown in Figure 5, the dosage button 30 includes a cover 56 coupled to a support member 42. An electronic component assembly 76 may be at least partially housed within a compartment 85 defined between the cover 56 and the support member. In some embodiments, the cover and the support member have corresponding splines that engage with each other to join the cover and the support member together. For example, in some embodiments, the cover 56 may be coupled to the support member 42 via one or more snaps 57 on the cover 56 corresponding to one or more protrusions 43 on the support member. Figure 5 and6 As shown, the snap 57 on the cover 56 can point radially inward from the inner peripheral sidewall 73. Figure 5 , 10 As shown in Figure 11, the protrusion 43 on the support member 42 can extend radially outward from the outer peripheral sidewall 75 of the support member 42. The protrusion 43 can form a triangular ramp shape.

[0076] A snap 57 on the cover 56 is configured to snap onto and engage with a protrusion 43 on the support member to attach the cover to the support member. In some embodiments, the protrusion on the support member includes a continuous annular projection around an outer peripheral sidewall of the support member. The cover 56 may be attached to the support member 42 via friction engagement, interference fit, or any other suitable fit. In some embodiments, the cover 56 is permanently secured to the support member 42 during assembly, for example, via ultrasonic welding, adhesive, or other suitable fastening methods.

[0077] like Figure 8 and Figure 9 As shown, the tubular flange 38 may include a plurality of axially oriented teeth 102, which are radially spaced at equal intervals about a rotation axis and arranged in relation to the equivalent of a dose unit. In this illustrative embodiment, the tubular flange 38 includes 20 teeth 102, which are equidistant from each other in the rotational direction such that the rotational distance between two adjacent teeth corresponds to an 18-degree rotation. Therefore, for Figure 8 The tubular flange 38, with an 18-degree rotation, can be used to represent one dose unit or half a dose unit. It should be understood that in other embodiments, different total numbers of teeth can be used to produce 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.

[0078] A recess 124 may be defined between each pair of adjacent teeth 102 (see...) Figure 15 Each tooth 102 may have an approximately triangular profile, and each profile has a surface 120 against which the sensor's contact surface 111 may slide.

[0079] In some embodiments, a sensor for detecting rotation of a tubular flange includes a movable element having a contact portion capable of resting on teeth of the tubular flange and being spring-biased such that the contact surface is configured to slide against the teeth during rotation of the flange relative to the actuator assembly during dose delivery. The sensor responds to movement of the contact portion on the teeth and generates a signal corresponding to the flange. A controller responds to the signal generated by the sensor to determine a dose count for determining the delivered dose based on the detected rotation of the flange relative to the actuator assembly during dose delivery.

[0080] The contact surface can be biased against the physical feature structure of the tubular flange to ensure proper contact between the contact surface and the physical feature structure during rotation. In one embodiment, the movable element is an elastic member, a portion of which is attached to the actuator at a location remote from the contact surface. In one example, the movable element is a following 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 push the contact surface in the direction of the surface feature structure. Alternatively, the movable element can be biased in any of a variety of other ways. In addition to using an elastic beam, biasing can be provided, for example, by using a spring member. Such a spring member can, for example, include a compression, tension, or torsion coil spring. In yet another embodiment, the movable element can be biased against the surface feature structure of the sensed element by a separate elastic member or a spring member abutting against the movable element.

[0081] Figure 5 An illustrative embodiment of a sensor 86 is depicted, having a contact surface 111 that interacts with the teeth 102 of a tubular flange 38. When the flange 38 rotates relative to a 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 an oscillating manner. The movement of the contact surface 111 can be a combination of axial and lateral movement as it slides into and out of recesses 124 defined between the teeth 102 of the flange 38. The sensor 86 can be configured to track the movement of the contact surface 111 and correlate this movement with an output signal sent to a controller.

[0082] As an alternative to teeth on a tubular flange, the surface feature structure interacting with the sensor can include anything that can be detected by the sensor. The sensor arrangement can be based on a variety of sensing characteristics, including, for example, tactile, optical, electrical, and magnetic properties. In the illustrative embodiment shown in the figures, the surface feature structure is a physical feature structure that allows the detection of incremental motion as the dose setting component rotates relative to the actuator assembly. In alternative embodiments, the sensor can be a piezoelectric sensor, a magnetic sensor such as a Hall effect sensor, an accelerometer for detecting vibrations, such as those of a ratchet or other stop mechanism, where the vibrations can be associated with rotational motion, an optical sensor, such as a reflective sensor, a discontinuity sensor, or an optical encoder, or any other sensor suitable for sensing rotation of the first component relative to the second component.

[0083] In some embodiments, when a user presses axially on face 60 of the dose button 30, the dose button 30 is advanced distally relative to the housing 12, thereby compressing the spring 68. Continued distal pressing of the dose button 30 causes the dose setting screw 32 to reverse in a helical direction relative to the housing 12. Therefore, the dose setting screw 32 and flange 38 are driven to rotate by axial pressing of the dose button 30. In some embodiments, the dose detection system is operable to perform dose detection only when the dose button is pressed.

[0084] In some embodiments, the electronic component assembly may include a clock or timer to determine the elapsed time between counts triggered by a rotation sensor from a surface feature structure of the sensed element. This can be used to indicate that a dose has been completed when the controller has not detected any counts after a period of time.

[0085] In some embodiments, a single sensing system can be used for both dose detection sensing and wake-up activation. For example, when the sensor initially senses rotation of the sensed element, the controller is configured to allow the electronic component assembly to wake up or activate to a higher or full-power state. The wake-up feature is configured to allow power to be transferred from a power source (shown as a battery) to power the electronics used for dose sensing, minimizing unintentional power loss or usage when no dose dispensing event occurs. In other embodiments, a separate wake-up switch may be provided and arranged within the dose button housing and triggered when the dose button is in its distal position. After the electronic component assembly is activated, the controller begins receiving a generated signal from the rotation sensor, indicating a count from the first to the last for determining the total angular displacement and thus the amount of dose / amount delivered.

[0086] In some embodiments, the electronic component assembly may have a controller configured to receive an output signal from a rotation sensor. The controller of the electronic component assembly may be programmed to convert the intermediate signal into a regulated digital signal, which may be a single-order / square wave of a predetermined width representing a predetermined time. In some embodiments, output signals smaller than a predetermined level may be filtered out and ignored.

[0087] According to one aspect, the drug delivery device includes a re-activated switch that can be used as a sensor. In some embodiments, the switch functions as a rotation sensor in the aforementioned dose detection system. However, in other embodiments, the switch can be used to detect other activities, such as the removal of a cap.

[0088] In some embodiments, the switch includes conductive pads and a cantilever that is movable relative to the conductive pads. The cantilever may be mounted to a printed circuit board at a first end, and a second end of the cantilever may be unattached and freely movable relative to the printed circuit board.

[0089] According to one aspect, a switch may have one or more structural features that facilitate repeated opening and closing of the switch. A switch may also have one or more structural features that help prevent plastic deformation of the switch during repeated opening and closing, thereby contributing to maintaining the switch's durability.

[0090] In some embodiments, at a first end of the cantilever, where the cantilever is attached to a printed circuit board, the arm has a first curved portion. During switch closure, this first curved portion is movable toward a straight configuration, and during switch open, the straight configuration is movable back toward the curved configuration. In a stress-free state, this first portion can be biased toward the curved configuration. Therefore, the cantilever can serve as an elastic element that stores potential energy as the cantilever moves during sliding interaction with the sensed component, wherein the stored potential energy is released to allow the cantilever to return to a stress-free state when the sliding contact force acting on the arm has decreased.

[0091] In some embodiments, the cantilever may transition from a first curved portion to a second curved portion, the second curved portion being configured to move toward and contact a conductive pad mounted on a PCB. Contact between the second curved portion and the conductive pad closes the switch, while no contact between the second curved portion and the conductive pad opens the switch.

[0092] In some embodiments, the cantilever may include a third curved portion configured to contact and abut against the sensed component (e.g., against). Figure 8 and 9 The teeth of the rotating tubular flange 38 shown slide. In some embodiments, the third curved portion connects the first curved portion to the second curved portion. In such an embodiment, the second curved portion configured to contact the conductive pad may be located at the second end of the cantilever, i.e., where the cantilever is truncated. In other embodiments, the second curved portion connects the first and third curved portions. In such an embodiment, the third curved portion configured to contact the sensed component may be located at the second end of the cantilever, i.e., where the cantilever is truncated.

[0093] In some embodiments, the cantilever having a curved portion can help avoid high strain concentration in the arm and thus help prevent plastic deformation of the arm. However, it should be understood that in other embodiments, the shape of one or more curved portions may be different.

[0094] In some embodiments, the switch may have one or more features that help the switch provide a clearer, more readable output signal so that the controller can more accurately identify when the switch is open and when it is closed. In some embodiments, a blocking protrusion may be provided to interact with a second curved portion of the cantilever when the cantilever contacts the conductive pad. The blocking protrusion may be positioned directly adjacent to or near the conductive pad and may prevent the arm from moving across the conductive pad. In some embodiments, the presence of the blocking protrusion may help reduce cantilever “bouncing,” which can contribute to a clearer output signal from the switch. In some cases, cantilever “bouncing” may cause the cantilever to rapidly and repeatedly contact and separate from the conductive pad in a short period of time, which can produce a noisy output signal that is difficult for the controller to interpret. The blocking protrusion can help provide continuous contact between the cantilever and the conductive pad to provide a clearer output signal. In some embodiments, the blocking protrusion may be made of a damping material that can help reduce the impact of the cantilever on the blocking protrusion to reduce bouncing or other vibrations.

[0095] An illustrative example of a switch is in Figure 12 As shown in the figure, Figure 12 A switch 86' with conductive pads 89 and cantilever 210 is depicted. The first end 201 of the conductive pads 89 and cantilever 210 is mounted on PCB 77.

[0096] like Figure 13 and 14 As best shown, the cantilever 210 begins at a first bend 212 at its first end 201 and terminates at a second bend 214 at its second end 202. The cantilever also includes a U-shaped third bend 216 that connects the first bend 212 to the second bend 214. The second bend 214 is configured to contact a conductive pad, while the third bend 216 is configured to contact a sensed component, such as... Figure 8 and Figure 9 The rotating tubular flange 38 shown is in contact.

[0097] The switch also includes a base 200 connected to the cantilever 210. The base 200 is connected to the PCB to connect the cantilever to the PCB. The base and the cantilever can be together to form a single integral part.

[0098] Figures 15-19 The cantilever 210 of the switch is depicted. Figure 8 and Figure 9 The rotating flange 38 interacts. Figure 15The arm 210 is shown in a stress-free state because the third curved portion 216 is located within the recess 124 between two adjacent teeth 103, 105. The switch can be positioned in this state when the flange 38 is in its initial or zero-dose position, such as before using the device, before setting the dose, or after dispensing has been completed and the device is ready to set the dose.

[0099] exist Figure 16 In the middle, flange 38 has begun to rotate relative to the switch and PCB 77. As a result, tooth 105 slides and pushes against the third curved portion 216 of arm 210, causing arm 210 to begin to deflect in the direction away from recess 124. First curved portion 212 begins to move toward a straight configuration, and second curved portion 214 begins to move toward conductive pad 89.

[0100] exist Figure 17 In the middle, the flange 38 is compared to Figure 16 The rotation extends further, causing tooth 105 to slide and almost completely push the third curved portion 216 out of recess 124. The first curved portion 212 even tends to move further toward the straightening configuration. As a result, the second curved portion 214 contacts the conductive pad 89, thereby closing the switch. The second curved portion also presses against the blocking protrusion 204, which prevents the second curved portion from moving further toward the first curved portion 212 and helps prevent the second curved portion from repeatedly bouncing against the conductive pad 89 in a rapid manner, which could generate a noisy output signal.

[0101] exist Figure 18 In the middle, the flange 38 is compared to Figure 17 The second bend 214 rotates further and the third bend 216 has left the notch 124 and slid over the top of the tooth 105. The second bend 214 remains in contact with the conductive pad 89 and the blocking protrusion 204. The blocking protrusion 204 prevents the second bend 214 from moving closer to the first bend 212.

[0102] Finally, Figure 19 In the middle, the flange 38 is compared to Figure 18 The third curved section 216 rotates further and stops contacting tooth 105, now beginning to contact the next adjacent tooth 107. During this transition, just as the next tooth 107 begins to push the arm 210, it is directed towards... Figure 15 The spring-biased arm at the indicated position has swung back toward its stress-free state, causing the first bent portion 212 to move toward a more curved shape, causing the third bent portion 216 to move in the opposite direction to the rotation of the flange 38, and causing the second bent portion 214 to move away from the conductive pad 84, thereby opening the switch. As the flange 38 rotates further, the cycle continues and the arm moves back to the conductive pad to close the switch, and so on.

[0103] As described herein, a printed circuit board (e.g., printed circuit board 77) may include various processing circuitry and / or logic that generates data based on the operation of the drug delivery device. For example, the processing circuitry may calculate the number of times a sensor (e.g., sensor 86) is activated or triggered during injection to determine the dose size of the injection (e.g., the dose of a specific insulin injection). As described herein, relative rotational motion between the dose setting component and the actuator of the drug delivery device may be sensed to determine the amount of dose delivered through the drug delivery device, since the sensed relative rotational motion can be correlated with the delivered dose.

[0104] Figure 20 This is an exemplary 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., [missing information]) electrically connected to a microcontroller 2004 within a system-on-chip (SoC) 2003. Figure 6 (e.g., sensor 86 in the circuit). The printed circuit board 2000 includes a set of pads 2006, 2008, 2010, 2012, 2014, 2016, 2018, 2020, and 2022 that are electrically connected to the microcontroller 2004 / SoC 2003. The pads can be used to connect electrical components to the microcontroller 2004 / SoC 2003, for example, for testing, etc. Some pads, such as pads 2008, 2010, 2012, 2014, 2016, and 2018, may not communicate with the microcontroller 2004 / SoC 2003 by default. For example, the microcontroller / SoC may initially be programmed (e.g., via associated registers) such that some pads are not electrically connected to the microcontroller 2004 (e.g., via programmable switches or resistors). One or more pads may be electrically connected to logic inputs / logic input terminals, such as general purpose input / output (GPIO) pins of the microcontroller 2004 / SoC 2003. As an example, a microcontroller can be programmed to modify internal programmable components (e.g., one or more pull-up resistors and / or pull-down resistors) to place pads in electrical connection with logic inputs.

[0105] In some embodiments, the GPIO pins input to the microcontroller 2004 / SoC 2003 can be logic-level inputs. If a voltage higher than a certain maximum threshold is applied to the GPIO pin, the microcontroller 2004 within the SoC 2003 can detect a logic 1, while if a voltage lower than a certain minimum threshold is applied to the GPIO pin, the microcontroller 2004 can detect a logic 0. Some pads on the printed circuit board can be connected to a voltage source. For example, pad 2020 can provide a battery voltage V. batAs another example, pad 2006 can provide voltage V from the DC / DC converter. dcdc .

[0106] As described herein, the microcontroller 2004 (e.g., including input based on sensor 2002) is operable to process dose data and / or other data from the drug delivery device. For example, the microcontroller 2004 may be configured to store total angular motion used to determine dose delivery and / or detected dose delivery in local memory (e.g., internal flash memory or onboard EEPROM). The microcontroller 2004 may also be operable to wirelessly transmit signals representing total count, total angular motion, and / or detected dose to external devices, such as a user's mobile device or a remote server (e.g., via BLE control logic and controller integrated on printed circuit board 2000).

[0107] The inventors have recognized that the presence of moisture on a printed circuit board (PCB) can affect various data in a drug delivery device. For example, moisture on the PCB can cause a microcontroller to receive data indicating dosage information when no drug delivery actually occurs. As another example, moisture can cause the microcontroller to receive incorrect dosage information (e.g., incorrect counting information). Therefore, moisture can cause the microcontroller to sense erroneous data, which can lead to the drug delivery device processing (e.g., storing, transmitting, etc.) incorrect data. Therefore, the inventors have developed a technique for sensing the possible presence of moisture on a PCB by detecting voltage changes. Several aspects of the technique described herein utilize conductive traces (including, but not limited to, circuit pads, wires, and / or conductive materials (e.g., graphite)) of the PCB 2000 and other circuitry (e.g., circuitry not typically used for sensing the presence or absence of moisture) to determine the possible presence of moisture on the PCB 2000. Some embodiments of the technique described herein may connect one or more circuit pads to the logic inputs of a microcontroller 2004 for use with the moisture sensing technique described herein. For example, as described herein, one or more pads, such as pad 2008 and / or pad 2006, may be connected to corresponding GPIO pins of microcontroller 2004 (e.g., via programmable components controlled by the microcontroller's firmware, as described herein). These pads may be biased such that the microcontroller can monitor changes in the logic input to detect the potential presence of moisture. As another example, this technique can use an ADC to detect the presence of moisture. The inputs of the ADC may be connected to pads and / or other conductive traces, and the outputs 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 detect changes in the ADC output voltage bidirectionally. Upon detecting the potential presence of moisture, the microcontroller may be configured to modify its operation accordingly (e.g., to prevent moisture from causing the microcontroller to process erroneous data).

[0108] Several aspects of the technology described herein can be used with drug delivery devices to sense moisture. As described herein, a drug delivery device may include a housing having a reservoir large enough to contain a drug (e.g., insulin) and a dosing button rotatable relative to the housing to select the dose size of the injected drug. The drug 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 metals (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) at least partially disposed on the printed circuit board (e.g., in the plane of the printed circuit board). For example, a portion of the solder mask layer of the printed circuit board may be omitted and / or exposed to allow fluid communication to conductive traces that may be disposed beneath the solder mask layer. According to some examples, the conductive traces may be wires and / or other conductive materials not disposed on the printed circuit board, such as wires extending from the printed circuit board (e.g., through the solder mask layer). The circuit may also include a bias source electrically connected to the conductive trace, and a microcontroller electrically connected to the conductive trace via logic input to the microcontroller. According to some embodiments, a bias voltage may be applied to the conductive trace such that the bias can be sensed by the microcontroller at a logic interface, such as a GPIO interface.

[0109] Figure 21 An example of a printed circuit board 2100 having a bias source 2102 according to some embodiments is shown. Figure 21 As shown, the printed circuit board 2100 includes a microcontroller 2104 (e.g., a processor, such as an ARM Cortex processor) electrically connected to various circuits 2106 (e.g., memory, clock, etc.) and a set of GPIOs 2108. A sensor switch 2110 is electrically connected to 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, PCB trace 2114 may be electrically connected to the bias source 2102 and the GPIOs 2108. According to some embodiments, the bias source 2102 may be a resistor. The resistor may be a pull-up resistor (e.g., connected to V...). bat(or connected to a voltage source corresponding to logic 1) or a pull-down resistor (e.g., ground). In some embodiments, the printed circuit board 2100 may include a system-on-a-chip (SoC) (e.g., SoC 2003), as shown in dashed box 2116. Although microcontroller 2104, GPIO 2108, bias source 2102, and bias source 2112 are shown as part of SoC 2116, this is for illustrative purposes only. For example, one or more of 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 SoC 2116. In embodiments that do not use SoC 2116, one or more of microcontroller 2104, GPIO 2108, and bias source 2102 may be mounted on the printed circuit board 2100 as discrete components.

[0110] A bias source (e.g., a resistor) may be located inside or outside the SoC. According to some embodiments, one or more resistors are used as a bias source 2102 outside the SoC 2116. According to some embodiments, one or more resistors are used as a bias source 2102 inside and / or a portion 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 or external resistor can be a design consideration. For example, if it is desirable to select a bias resistor, using an external resistor allows selection of the resistor characteristics of the resistor added to the printed circuit board 2000. For example, suppose the built-in resistor available in the SoC 2116 has a resistance of 25 kΩ. If it is desirable to use a resistor with characteristics that allow detection of liquid conductivity, which may not be detectable with the use of such a resistor, an external resistor can be used and added accordingly to the printed circuit board 2110. Therefore, selecting an appropriate bias resistor can allow for the incorporation of early detection capabilities, which is better than the capabilities available when using a programmable bias resistor within the SoC 2116. However, adding an extra bias resistor could increase the space required on the PCB 2000 and / or potentially increase material and / or manufacturing costs. In contrast, using the programmable bias resistors within the SoC 2116 might not require any additional space on the PCB 2000 and could likely not increase material or manufacturing costs. Furthermore, continuing with the example of the available 25kΩ internal resistor, such a resistor would likely be sufficient to detect moisture, as the amount / type of moisture that would trip the switch 2002 would also cause the GPIO connected to the pads with the bias voltage applied by the internal resistor to trip.

[0111] In some embodiments, bias source 2102 and / or bias source 2112 can be any electrical component having a small but measurable leakage current and capable of functioning as a weak current source. Such an electrical component can be a resistor as described above, but can also be a diode, transistor, and / or capacitor. Generally, bias source 2102 and / or bias source 2112 can 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 such a large current to prevent GPIO 2108 from being biased to another detectable voltage level in the presence of moisture. In some cases, it may be easier and / or more efficient to use electrical components already embedded and / or integrated into the SoC (e.g., diodes, transistors, and / or capacitors) instead of adding additional resistors.

[0112] Depending on some configurations of the printed circuit board 2000, by default, one or more circuit traces and / or pads may not be connected to GPIOs (e.g., therefore available when needed). 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 as "outputs" rather than "inputs". Therefore, these techniques may also include modifying the microcode of the microcontroller 2004 to change the GPIO pins used according to the techniques described herein to be "inputs" to the microcontroller 2004. However, simply connecting a pad to a GPIO allows the voltage from that pad to float at any value. According to some embodiments, as described herein, a bias voltage is provided to the pad connected to the GPIO to allow the detection of a voltage source.

[0113] Figure 22 This is a flowchart illustrating a first exemplary computerized method 2200, which can be executed by a microcontroller of a drug delivery device according to some embodiments, to determine the presence of moisture in the drug delivery device. In step 2202, the microcontroller monitors a logic input that is electrically connected to a conductive trace on a printed circuit board. In step 2204, the microcontroller receives a signal from the logic input. In step 2206, the microcontroller determines, based on the received signal, that moisture may be present on the printed circuit board. In step 2208, the microcontroller may modify its operation based on the determination that moisture may be present on the printed circuit board.

[0114] Referring to step 2202, as described herein, the pads on the printed circuit board can be appropriately voltage biased such that, in normal, non-faulty operating modes, the traces remain in a state that allows the microcontroller firmware to read the expected logic inputs via GPIO. The bias voltage can be configured based on a variety of voltages. For example, the bias voltage can be ground voltage and / or an available voltage that can be read by GPIO logic levels (e.g., according to the specifications of the electronic device used in the technology described herein). For example, if the bias voltage is a positive voltage (e.g., V...), bat If the bias voltage is ground (e.g., approximately 0 volts), the microcontroller can be expected to read logic 1 under normal operating conditions. The positive voltage can be, for example, 1 volt, 1.5 volts, 2 volts, etc. As another example, if the bias voltage is ground (e.g., approximately 0 volts), the microcontroller can be expected to read logic 0 under normal operating conditions.

[0115] Referring to steps 2204-2206, if the microcontroller reads the voltage from the GPIO at the expected logic level, normal firmware operation is permitted. However, if the microcontroller detects that the GPIO has been pulled away from its 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 conductive contaminants (e.g., conductive liquids, condensation, etc.) that are in contact with the traces on the printed circuit board and electrically connect the traces to other components (e.g., grounded and / or connected to a voltage source) that would not normally be electrically connected to the traces when no conductive contaminants are present. If the voltage applied to the GPIO changes from the expected voltage level by more than the threshold amount, the microcontroller can read the voltage change on the GPIO as a change in the GPIO logic level state, and the firmware can enter a fault state that modifies normal firmware operation (e.g., to adjust for the possibility that the data may be erroneous, and thus prevent the saving and / or reporting of simultaneously delivered drug information). For example, if a GPIO is biased to ground (e.g., causing the microcontroller 2004 to normally read logic 0), and if liquid conducts a sufficiently high voltage to the pads to the layout-local voltage, causing the voltage on the GPIO to increase beyond a threshold amount, the microcontroller will read logic 1. This change from the expected logic 0 to logic 1 will cause the microcontroller to determine that moisture may be present. As another example, if a GPIO is biased to a positive voltage (e.g., causing the microcontroller 2004 to expect to read logic 1), grounded conductive liquid can reduce the voltage on the GPIO beyond a threshold amount, causing the processor to read logic 0 and triggering a detection condition. This change from the expected logic 1 to logic 0 will cause the microcontroller to detect the possible presence of moisture.

[0116] In step 2208, according to some embodiments, the microcontroller may be configured to take one or more actions when it is determined that moisture may be present on the printed circuit board. For example, an algorithm programmed in the microcontroller may be configured to trigger a fail-safe condition. According to some embodiments, the microcontroller may be configured not to send some information that the microcontroller would normally send to an external device. For example, the microcontroller may be configured not to send (e.g., via Bluetooth) injection-related information, such as count information, dosage information, the occurrence of an injection, etc. For example, as described herein, a drug delivery device may include a switch mounted to a printed circuit board, wherein 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 each other, and the rotatable element is positioned to allow protrusions to slide against the switch so that the switch can move between a closed position and an open position as the rotatable element rotates. The microcontroller generates a count of the received set of signals. According to some embodiments, the microcontroller may be configured not to store some information that the microcontroller would store during normal operation. For example, the microcontroller may discard the signal count generated from the switch, such that the generated count is not stored in a memory communicating with the microcontroller.

[0117] In some embodiments, the drug delivery device may include one or more aspects of controlling whether the drug delivery device stores and / or discards data to be written to non-volatile memory. For example, the drug delivery device may be configured to include a field or flag that the controller checks before writing data, such that the flag can 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.

[0118] According to some embodiments, the microcontroller can be configured to shut down, restart, and / or enter a low-power state (e.g., sleep state). According to some embodiments, the microcontroller can be configured to transmit data to one or more external devices. For example, the microcontroller can be configured to transmit Bluetooth data indicating that a drug delivery device may have moisture on its printed circuit board. Such transmitted data can cause a receiving device to perform one or more actions, such as ignoring recently received data, providing an error warning, etc.

[0119] According to some embodiments, the microcontroller may be additionally or alternatively configured to typically monitor voltage and perform a specific action (e.g., reset) when a voltage is detected. For example, the microcontroller may monitor the voltage of one or more pads (e.g., V). bat If water electrically connects the solder pads to V bat Then it may occur. If the microcontroller detects a sufficient voltage (e.g., a voltage above a threshold, such as 1 / 2V) bat If it is enabled, it can reset the microcontroller, power off it, modify the firmware, etc.

[0120] According to some embodiments, multiple GPIOs can be connected to different traces having the same and / or different bias voltages. For example, multiple pads can be connected to associated GPIO pins and biased with a positive voltage. Using multiple traces in this way can increase the likelihood of moisture detection (e.g., because using multiple pads can increase the area of ​​the moisture-detectable printed circuit board 2000).

[0121] According to some embodiments, other conductive traces around the conductive trace to which the GPIO is connected can be biased to a voltage different from the voltage to which the trace to which the GPIO is connected is biased. For example, if the GPIO is connected to pad 2014 and pad 2014 is biased to a positive voltage (e.g., V), bat If pad 2014 is biased to approximately 0 volts, such that a microcontroller connected to pad 2014 reads logic 0 without moisture, then other pads, such as pads adjacent to or close to pad 2014 (e.g., pads 2008, 2010, 2012, and / or 2016), can be grounded. Conversely, if pad 2014 is biased to approximately 0 volts, such that a microcontroller connected to pad 2014 reads logic 0 without moisture, then other pads, such as pads adjacent to or close to pad 2014 (e.g., pads 2008, 2010, 2012, and / or 2016), can be connected to a positive voltage (e.g., V). bat Biasing the pads around the connected conductive traces to the opposite voltage increases the likelihood of detecting any moisture on the PCB more quickly and / or reliably, because moisture has a greater chance of connecting the traces connected to the GPIO (e.g., pad 2014) to another voltage source that pulls the traces connected to the GPIO away from their default voltage.

[0122] According to some embodiments, the circuitry for monitoring moisture may include an analog-to-digital converter (ADC). A microcontroller can use the ADC to detect potential moisture on a printed circuit board. For example, the microcontroller may monitor the steady-state analog-to-digital voltage of the ADC to detect voltage changes that may indicate a potential moisture condition. According to some embodiments, Figure 20The printed circuit board 2000 shown may include an ADC (e.g., with a high-impedance input node, as described herein). The input of the ADC may be connected to one or more traces on the printed circuit board 2000, while the output of the ADC may be connected to a microcontroller 2004. According to some embodiments, a bias voltage may be applied at the input interface of the ADC. The ADC may be configured to output a word based on the input voltage of the ADC. This word may be, for example, 9 bits, 10 bits, 11 bits, etc. The microcontroller 2004 may monitor voltage changes at the ADC output, which may indicate the presence of moisture as described herein. For example, if the output range of the ADC may be decimal 0 to 1023, an input voltage of 0.45 volts (half of the ADC's operating range) may result in an ADC output equal to or close to a 3FF hexadecimal value. If the word received from the ADC is at or close to the expected value (e.g., 3FF hexadecimal), the microcontroller 2004 may continue under normal firmware operation. Conversely, if the ADC is pulled away from its normal bias voltage state, the output value may be significantly higher and / or lower than expected (e.g., close to 1023 and / or 0), which may indicate that conductive materials (e.g., conductive liquids, condensation, etc., as described herein) are applying fault conditions to the PCB traces. The microcontroller can read the ADC output and observe changes in the output value, as well as changes from normal firmware operation (e.g., to prevent simultaneous reporting of delivered drug information to the end user).

[0123] Figure 23 An example of a printed circuit board 2300 having a bias source 2302 and an ADC 2304 according to some embodiments is shown. Figure 23 As shown, the printed circuit board 2300 includes a microcontroller 2306 electrically connected to various circuits 2308 (e.g., memory, clock, etc.) and a set of GPIOs 2310. A sensor switch 2312 is electrically connected to a first bias source 2314 and GPIOs 2310. According to some embodiments of the technology described herein, the input of the ADC 2304 may be electrically connected to PCB trace 2316 and bias source 2302, and its output may be electrically connected to the microcontroller 2306. As described herein, according to some embodiments, the bias source 2302 may be any electrical component previously described with respect to bias sources 2102 and / or 2112, such as a resistor, diode, transistor, capacitor, and / or other impedance source.

[0124] In some embodiments, the printed circuit board 2300 may include a SoC (e.g., SoC 2003), as shown in dashed box 2318. Although ADC 2304, microcontroller 2306, GPIO 2310, bias source 2302, and bias source 2314 are shown as... Figure 23This is part of the SoC 2318, but this is for illustrative purposes only. For example, according to some embodiments, one or more resistors and / or ADCs are used external to the SoC 2318. According to some embodiments, one or more ADCs and / or resistors may be used internal to the SoC 2318 and / or as part of the SoC 2318. In embodiments that do not use the SoC 2318, one or more of the microcontroller 2306, ADC 2304, GPIO 2310, bias source 2302, and / or bias source 2314 may be mounted as discrete components on the printed circuit board 2300. As described herein, whether to use internal or external bias sources, such as internal or external resistors, can be a design choice issue (e.g., including resistor selection, PCB space usage, cost, etc.). According to some embodiments, for example, using external resistors with the ADC can allow unidirectional or bidirectional sensing methods (e.g., using an external resistor network that biases the ADC input voltage to half the voltage of the ADC input measurement range). As another example, using an internally programmable bias resistor may only allow unidirectional detection (e.g., depending on the programmability and / or capability of the internal resistor). According to some embodiments, using an internal resistor can allow earlier detection capability based on finer voltage measurement resolution (e.g., only relative to the GPIO method, since GPIO only allows detection of two logic states).

[0125] According to some embodiments, the ADC does not require a separate bias source. For example, an internal capacitor bias can be used to bias the ADC input voltage to half of the ADC measurement range voltage. According to some embodiments, a SoC integrated circuit that includes a high-impedance and capacitive coupler ADC input stage (e.g., such that only a small PCB trace for water detection runs from the ADC input to the PCB) can allow the ADC voltage to approximate half of the normal steady-state reading voltage.

[0126] The ADC 2304 can be electrically connected to a microcontroller in various configurations. According to some embodiments, the ADC 2304 may share a path to the microcontroller with one or more other components (e.g., the circuitry may include a multiplexer that multiplexes the ADC 2304 output with pins used by the GPIO 2310 block, allowing the processor to switch between the ADC 2304 and the GPIO 2310 block). According to some embodiments, the ADC 2304 has its own path to the microcontroller (e.g., not shared with other circuitry).

[0127] Figure 24This is a flowchart illustrating a first exemplary computerized method 2400 according to some embodiments, which can be executed by a microcontroller of a drug delivery device to determine the possible presence of moisture in the drug delivery device. In step 2402, the microcontroller monitors the output of an ADC, wherein the input of the ADC is electrically connected to conductive traces 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, based on the received signal, that moisture may be present on the printed circuit board. In step 2408, the microcontroller may modify its operation based on the determination that moisture may be present on the printed circuit board.

[0128] Referring to step 2402, the microcontroller can monitor the expected voltage at the output of the ADC. The ADC can be configured to operate over an operating input range from a low input voltage (e.g., the lower rail) to a high input voltage (e.g., the upper rail). Therefore, according to some embodiments, the ADC can operate based on two rails defining a voltage range that can be received by the ADC to feed into an analog stage (ultimately converted to a digital value). According to some embodiments, the low input voltage can be ground (e.g., approximately 0 volts, where the voltage is identified as ground by the controller), and the high input voltage can be a positive voltage (e.g., a supply voltage, such as V). bat For example, V bat It can be 1.0 volt, 1.5 volt, 2 volt, etc. According to some embodiments, a regulator can be used to adjust the V... bat Reduce the voltage to the upper limit required by the ADC, for example, reduce 1.5 volts to 0.9 volts. As described in the text, the ADC outputs a word value based on the input voltage.

[0129] Referring to step 2404, according to some embodiments, a resistor or impedance source can be used to bias the ADC input. The bias voltage provided by the bias source can be a percentage of the ADC operating input range, such as 25% to 75%, or 40% to 60%. According to some embodiments, the bias voltage is approximately 50% of the ADC operating voltage range. For example, if the ADC input range is 0.0 to 0.9 volts, the ADC input can be biased to half of 0.9 volts, or 0.45 volts. According to some embodiments, the resistor or impedance can be configured such that it is greater than the liquid conductive path on the printed circuit board relative to ground or voltage source (e.g., V) in the presence of moisture on the printed circuit board. bat The expected resistance or impedance is high. According to some embodiments, a percentage of the ADC's operating range (e.g., 1 / 2V) is considered high. rail This can be created using two megohm-level resistors, which can have equal and / or scaled values, depending on the situation. For example, one resistor can be pulled up to a higher voltage V. rail(For example, 0.9 volts), while the second resistor can be pulled to ground, for example, to create a voltage divider (in this case, a voltage divider to half the ADC input range). Because the resistance of the bias resistor is greater than that of the liquid conductive path to ground or voltage source in the presence of moisture (e.g., V...), the bias resistor's resistance is lower than that of the liquid conductive path to ground or voltage source in the presence of moisture. bat The expected resistance or impedance of the ADC is high, therefore, in the presence of moisture, the bias resistor should not prevent the ADC input from being pulled to ground or a voltage source. According to some embodiments, a percentage of the operating range can be created using a capacitive coupler that uses leakage current to drive a certain percentage of the voltage rail.

[0130] Referring to step 2406, the microcontroller determines the potential presence of moisture on the printed circuit board based on the received signal. Adding a bias to the ADC input allows the microcontroller to detect the presence of moisture bidirectionally, such that in the event of conductive liquid ingress, the configured voltage rail percentage impedance input can be disrupted. For example, suppose the bias is configured to bias the ADC input voltage to 1 / 2 of the ADC input measurement range voltage. Under normal conditions, the microcontroller can expect to receive a value from the ADC indicating that the normal operating voltage input to the ADC is at 1 / 2 voltage normal steady state. If the ADC is also biased to ground or one or more other voltage sources due to a fault (e.g., via moisture), the microcontroller can detect a shift in the ADC output away from the 1 / 2 voltage normal steady state (e.g., toward a lower or higher output value for the ADC), which may allow the microcontroller to detect the potential presence of conductive fluid. Therefore, if water on the printed circuit board only grounds the PCB trace, the microcontroller can detect a drop in the input ADC voltage. Similarly, if water only connects the PCB trace to V... bat Similarly, the microcontroller can detect an increase in the voltage change input to the ADC. Therefore, when a liquid with a certain degree of conductivity disrupts the bias balance, the ADC can measure the disruption of the balance, and the microcontroller can process the detection accordingly.

[0131] According to some embodiments, one or more thresholds can be used to determine whether a change in the ADC output indicates a fault condition. For example, a change in expected output greater than 3 / 8 of the possible range of expected ADC output in steady state can indicate a fault condition. For instance, if the steady-state output is typically about half the output range, an output value below 1 / 8 or above 7 / 8 of the output range can indicate a fault. As another example, a threshold of 1 / 4 of the possible range of expected output can be used such that for a steady-state output value that is approximately half the output range, an output value below 1 / 4 or above 3 / 4 of the output range can indicate the presence of a fault.

[0132] Referring to step 2408, the microcontroller can modify its operation based on the determination that moisture may be present on the printed circuit board. For example, according to some embodiments, a combination of... Figure 22 Step 2208 discusses one or more of the modifications.

[0133] Based on some examples, when using logic inputs such as GPIOs as described in this article, there may be a voltage range between a minimum voltage threshold (below which the microcontroller will detect logic 0) and a potentially uncertain maximum threshold (above which the microcontroller will detect logic 1). Since an ADC outputs a word (e.g., a 9, 10, or 11-bit word), it can provide finer-grained monitoring. However, using an ADC may require adding it to a printed circuit board. Using an ADC may additionally or alternatively require more complex microcontroller programming compared to using logic inputs. Therefore, using logic inputs can use less space, may require simpler programming, and so on.

[0134] According to some embodiments, the moisture detection techniques described herein (e.g., using GPIO and / or ADC) may include one or more additional features. According to some embodiments, one or more additional nodes (e.g., in addition to the PCB trace used for detection) may be exposed to allow more conductive liquid paths to the PCB trace used for detection. In some embodiments, nodes may be exposed without including 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 that to which the PCB trace used for detection is biased. Such test points may be biased using internal and / or external resistors. Biasing such test points can improve the conditions for detecting fault conditions (e.g., by providing a known steady state for normal operation, this can allow for easier detection of state changes). For example, such techniques can enhance the ability of detection circuitry to detect moisture because there are more moisture sources that may connect to the PCB trace used for detection, thereby triggering a fault condition.

[0135] The device shown is a reusable pen-shaped drug delivery device, typically designed for manual operation by a user to selectively set and then inject that set dose. This type of injection device is well-known, and the description of the device is merely illustrative, as the sensing system can be adapted to a variety of drug delivery device configurations, including pen-shaped drug delivery devices of different constructions, injection devices of different shapes, and infusion pump devices. The drug can be of any type that can be delivered by this drug delivery device. The device shown is intended to be illustrative and not limiting, as the sensing system described further below can be used with other devices of different configurations.

[0136] The techniques operating according to the principles described herein can be implemented in any suitable manner. The processing and decision blocks in the flowcharts above represent steps and actions that can be included in algorithms that perform these different processes. Algorithms derived from these processes can be implemented as software integrated with and directing the operation of one or more single-purpose or multi-purpose processors, can be implemented as functionally equivalent circuits, such as digital signal processing (DSP) circuits or application-specific integrated circuits (ASICs), or can be implemented in any other suitable manner. It should be understood that the flowcharts included herein do not depict the syntax or operations of any particular circuit or any particular programming language or type of programming language. Rather, the flowcharts illustrate functional information that a person skilled in the art can use to fabricate circuits or implement computer software algorithms to perform the processing of a particular device that performs the types of techniques described herein. It should also be understood that, unless otherwise stated herein, the specific order of steps and / or actions described in each flowchart is merely an illustration of algorithms that can be implemented and may vary in implementations and embodiments of the principles described herein.

[0137] Therefore, in some embodiments, the techniques described herein can 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 can be written using a variety of suitable programming languages ​​and / or any of programming or scripting tools, and can also be compiled into executable machine language code or intermediate code that executes on a framework or virtual machine.

[0138] When the techniques described herein are embodied as computer-executable instructions, these instructions can be implemented in any suitable manner, including a number of functional facilities, each providing one or more operations to perform the execution of an algorithm based on these techniques. A “functional facility,” however instantiated, is a structural component of a computer system that, when integrated with and executed by one or more computers, enables one or more computers to perform a specific operational role. A functional facility can be part of a software element or an entire software element. For example, a functional facility can be implemented according to a process, or as a discrete process or as any other suitable processing unit. If the techniques described herein are implemented as multiple functional facilities, each functional facility can be implemented in its own way; none need to be implemented in the same way. Furthermore, these functional facilities can be executed in parallel and / or serially as appropriate, and can exchange information with each other using shared memory on the computer on which they are executing, using message passing protocols, or in any other suitable manner.

[0139] Typically, functional facilities include routines, programs, objects, components, data structures, etc., that perform specific tasks or implement specific abstract data types. The functionality of functional facilities can generally be combined or distributed as needed within the system in which they operate. In some implementations, one or more functional facilities performing the techniques described herein can together form a complete software package. In alternative embodiments, these functional facilities may be adapted to interact with other unrelated functional facilities and / or processes to enable software program applications.

[0140] Some exemplary functional facilities have been described herein for performing one or more tasks. However, it should be recognized that the described functional facilities and task divisions are merely illustrative of the types of functional facilities that can implement the exemplary techniques described herein, and embodiments are not limited to implementation in any particular number, division, or type of functional facilities. In some embodiments, all functions may be implemented in a single functional facility. It should also be recognized that in some embodiments, some of the functional facilities described herein may be implemented together with other functional facilities or separately (i.e., as a single unit or a separate unit), or some of these functional facilities may not be implemented.

[0141] In some embodiments, computer-executable instructions implementing the techniques described herein (when implemented as one or more functional facilities or in any other way) may be encoded on one or more computer-readable media to provide functionality to that medium. Computer-readable media include magnetic media such as hard disk drives, optical media such as optical discs (CDs) or digital versatile discs (DVDs), permanent or non-permanent solid-state storage (e.g., flash memory, magnetic RAM, etc.), or any other suitable storage medium. Such computer-readable media can be implemented in any suitable manner. As used herein, a “computer-readable medium” (also referred to as a “computer-readable storage medium”) means a tangible storage medium. Tangible storage media are non-transitory and have at least one physical structural component. In a “computer-readable medium” as used herein, at least one physical structural component has at least one physical characteristic that can be changed in some way during the creation of a medium with embedded information, during the recording of information thereon, or during any other process of encoding information into the medium. For example, the magnetization state of a portion of the physical structure of a computer-readable medium can be changed during the recording process.

[0142] Furthermore, some of the aforementioned technologies include the act of storing information (e.g., data and / or instructions) in a specific manner for use by these technologies. In some embodiments of these technologies—e.g., embodiments where the technology is implemented as computer-executable instructions—information can be encoded on a computer-readable storage medium. Where specific structures are described herein as advantageous formats for storing this information, these structures can be used to give the information a physical organization when encoded on the storage medium. These advantageous structures can then provide functionality to the storage medium by influencing the operation of one or more processors interacting with the information; for example, by improving the efficiency of computer operations performed by the processors.

[0143] In some, but not all, implementations, these techniques may be embodied as computer-executable instructions that can 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. The computing device or processor may be programmed to execute the instructions when they are stored in a manner accessible to the computing device or processor, such as in data memory (e.g., on-chip cache or instruction register, computer-readable storage medium accessible via a bus, computer-readable storage medium accessible via one or more networks and accessible by the device / processor, etc.). Functional facilities including these computer-executable instructions may be integrated with and direct the operation of: a single multipurpose programmable digital computing device; a coordinated system of two or more multipurpose computing devices sharing processing power and jointly executing the techniques described herein; a single computing device or a collaborative system of computing devices (located in the same location or geographic area) dedicated to executing the techniques described herein; one or more field-programmable gate arrays (FPGAs) for executing the techniques described herein; or any other suitable system.

[0144] A computing device may include at least one processor, a network adapter, and a computer-readable storage medium. The computing device may be, for example, a desktop or laptop computer, a personal digital assistant (PDA), a smartphone, 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 via any suitable computing network. The computing network may include wireless access points, switches, routers, gateways, and / or other network devices, as well as any suitable wired and / or wireless communication media or media for exchanging data between two or more computers, including the Internet. The computer-readable medium may be adapted to store data to be processed by the processor and / or instructions to be executed by the processor. The processor is capable of processing data and executing instructions. Data and instructions may be stored on the computer-readable storage medium.

[0145] Computing devices may additionally include one or more components and peripheral devices, including input and output devices. These devices can be used to present user interfaces, etc. Examples of output devices that can be used to provide user interfaces include printers or displays for visual presentation and speakers or other sound-producing devices for auditory presentation. Examples of input devices that can be used for user interfaces include keyboards and pointing devices such as mice, touchpads, and digitizers. As another example, computing devices can receive input information through speech recognition or in other audible formats.

[0146] Embodiments of implementing the technology in circuits and / or computer-executable instructions have been described. It should be recognized that some embodiments may be in the form of methods, at least one example of which has been provided. Actions performed as part of a method may be ordered in any suitable manner. Therefore, embodiments in which actions are performed in an order different from that shown in the illustrations can be constructed, which may include performing some actions simultaneously, even if they are shown as sequential in the illustrative embodiments.

[0147] The various aspects of the above embodiments can be used individually, in combination, or in various arrangements not specifically discussed in the foregoing embodiments. Therefore, their application is not limited to the details and arrangements of the components described in the foregoing description or shown in the figures. For example, an aspect described in one embodiment can be combined in any way with aspects described in other embodiments.

[0148] The use of ordinal terms such as “first,” “second,” and “third” to modify a claim element does not imply any priority, order, or temporal sequence of actions of one claim element relative to another. Rather, it serves merely as a label to distinguish one claim element with a specific name from another element with the same name (but using ordinal terms) to differentiate claim elements.

[0149] Furthermore, the wording and terminology used herein are for descriptive / illustrating purposes and should not be considered limiting. The use of “including,” “comprising,” “having,” “containing,” “involving,” and their variations herein is intended to cover the items listed thereafter and their equivalents as well as additional items.

[0150] The term “exemplary” is used in this document to refer to any instance, example, or illustration. Unless otherwise stated, any embodiment, implementation, process, feature, etc., described herein as exemplary should be understood as an illustrative example and not as a preferred or advantageous example.

[0151] To clarify the intended use and to issue this notice to the public, the phrase " 、 and <n> At least one of them… or “< / n> ， ，... <n> "or a combination thereof" or "< / n> ， , ... and / or <n>"As defined by the applicant in the broadest sense, superseding any other implied definition above or below, unless the applicant expressly indicates otherwise that it refers to one or more elements selected from the group comprising A, B, ... and N. In other words, these phrases mean any combination of one or more of elements A, B, ... and N, including any single element or a combination of that single element with one or more other elements of the element, which may also include combinations of other elements not listed."

[0152] While various embodiments have been described, it will be apparent to those skilled in the art that many more embodiments and implementations are possible. Therefore, the embodiments described herein are examples, not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that every embodiment will achieve all the advantages described.

[0153] This disclosure describes several aspects, including but not limited to the following:

[0154] 1. A drug delivery device, comprising:

[0155] The casing includes a reservoir of sufficient size to contain the drug;

[0156] A dosage button that can rotate relative to the housing to select the dosage of the drug to be injected;

[0157] Printed circuit boards;

[0158] Conductive traces are at least partially disposed on the printed circuit board;

[0159] A bias source electrically connected to the conductive trace; and

[0160] A microcontroller, electrically connected to the conductive trace via its logic input, the microcontroller being configured to:

[0161] Signals are received from the conductive traces via the logic input terminals; and

[0162] The received signal is used to determine if there may be moisture on the printed circuit board.

[0163] 2. The drug delivery device according to aspect 1, wherein the logic input terminal is a general purpose input / output (GPIO) terminal of the microcontroller.

[0164] 3. The drug delivery device according to any one of aspects 1-2, further comprising a switch mounted on the printed circuit board, wherein the microcontroller is configured to:

[0165] Receive a set of signals from the switch;

[0166] A count of the signals is generated based on the set of signals.

[0167] 4. The drug delivery device according to aspect 3, wherein the drug delivery device further includes a rotatable element rotatable relative to the printed circuit board, the rotatable element having a series of protrusions spaced apart from each other, the rotatable element being positioned such that when the rotatable element is rotated, the protrusions are allowed to slide against the switch to move the switch between a closed position and an open position.

[0168] 5. The drug delivery device according to aspect 3, wherein the switch comprises a piezoelectric sensor, a magnetic sensor, an accelerometer, an optical sensor, a discontinuity sensor, an optical encoder, or some combination thereof.

[0169] 6. The drug delivery device according to any one of aspects 3-5, wherein the microcontroller is further configured to, upon determining that moisture may be present on the printed circuit board:

[0170] The counts of the generated set of signals are discarded such that the generated counts (a) are not stored in the memory communicating with the microcontroller, (b) are not transmitted to a remote device via the communication module communicating with the microcontroller, or a combination thereof.

[0171] 7. The drug delivery device according to any one of aspects 1-6, wherein the microcontroller is further configured to, upon determining that moisture may be present on the printed circuit board:

[0172] Change the operating state of the microcontroller such that the microcontroller (a) enters a sleep state, (b) is powered off, (c) is restarted, or some combination thereof.

[0173] 8. The drug delivery device according to any one of aspects 1-7, wherein the microcontroller is further configured to, upon determining that moisture may be present on the printed circuit board:

[0174] At least one message is transmitted via a communication module that communicates with the microcontroller. The at least one message contains data indicating that moisture may be present on the printed circuit board.

[0175] 9. The drug delivery device according to aspect 8, wherein the at least one message is configured to cause an external mobile device communicating with the drug delivery device to discard or ignore one or more previously transmitted count values.

[0176] 10. The drug delivery device according to any one of aspects 1-9, wherein the bias source includes a resistor configured as part of a system-on-a-chip (SoC) including the microcontroller.

[0177] 11. The drug delivery device according to any one of aspects 1-9, wherein the bias source includes a resistor, the resistor being disposed at least partially on the printed circuit board and external to the SoC including the microcontroller.

[0178] 12. The drug delivery device according to any one of aspects 1-9, wherein the bias source comprises at least one of a diode, a transistor, and a capacitor.

[0179] 13. The drug delivery device according to any one of aspects 1-12, wherein:

[0180] The bias source is configured to provide approximately 0 volts to the conductive trace, enabling the microcontroller to read logic 0 from the logic input; and

[0181] Receiving the signal includes reading logic 1 from the logic input; and

[0182] Determining the presence of moisture on the printed circuit board based on the received signal includes identifying the logic input that changes from logic 0 to logic 1.

[0183] 14. The drug delivery device according to any one of aspects 1-12, wherein:

[0184] The bias source is configured to provide a positive voltage to the conductive trace, enabling the microcontroller to read a logic 1 from the logic input; and

[0185] Receiving a signal from the conductive trace via the logic input terminal includes reading a logic 0 from the logic input terminal; and

[0186] Determining the presence of moisture on the printed circuit board based on the received signal includes identifying logic inputs that change from logic 1 to logic 0.

[0187] 15. The drug delivery device according to any one of aspects 1-13, wherein the device further comprises a drug contained in the reservoir.

[0188] 16. The drug delivery device according to aspect 15, wherein the drug is insulin.

[0189] 17. The drug delivery device according to any one of aspects 1-16, wherein the conductive trace is located in the plane of the printed circuit board.

[0190] 18. The drug delivery device according to any one of aspects 1-17, wherein the conductive trace is an exposed test pad.

[0191] 19. A computerized method executed by a microcontroller of a drug delivery device, wherein:

[0192] The drug delivery device includes:

[0193] The casing includes a reservoir of sufficient size to contain the drug; and

[0194] A dosage button, which can rotate relative to the housing, selects the dosage of the drug to be injected; and

[0195] The microcontroller is electrically connected to conductive traces, at least partially disposed on a printed circuit board, via its logic input terminals.

[0196] The method includes:

[0197] Receive signals from the conductive trace via the logic input terminal; and

[0198] Based on the received signal, it was determined that there might be moisture on the printed circuit board.

[0199] 20. A drug delivery device, comprising:

[0200] The casing includes a reservoir of sufficient size to contain the drug;

[0201] A dosage button that can rotate relative to the housing to select the dosage of the drug to be injected;

[0202] Printed circuit boards;

[0203] Conductive traces are at least partially disposed on the printed circuit board;

[0204] An analog-to-digital converter (ADC) includes an input terminal and an output terminal, wherein:

[0205] The input terminal of the ADC is electrically connected to the conductive trace; and

[0206] The ADC operates within a low input voltage to a high input voltage range.

[0207] A bias source electrically connected to the input of the ADC, wherein the bias source is configured to provide a bias voltage from the low input voltage to the high input voltage; and

[0208] A microcontroller electrically connected to the output of the ADC, the microcontroller being configured to:

[0209] Receive the signal from the output of the ADC; and

[0210] Based on the received signal, it was determined that there might be moisture on the printed circuit board.

[0211] 21. The drug delivery device according to aspect 20, wherein:

[0212] The low input voltage of the ADC's operating input range is ground voltage; and

[0213] The high input voltage of the ADC's operating input range is a positive voltage.

[0214] 22. The drug delivery device according to aspect 21, wherein the grounding voltage is approximately 0 volts and the positive voltage is approximately 0.9 volts.

[0215] 23. The drug delivery device according to any one of aspects 20-22, wherein the bias voltage provided by the bias source is 25% to 75% of the operating input range of the ADC.

[0216] 24. The drug delivery device according to any one of aspects 20-22, wherein the bias voltage provided by the bias source is 40% to 60% of the operating input range of the ADC.

[0217] 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.

[0218] 26. The drug delivery device according to any one of aspects 20-25, wherein the bias source includes a capacitive coupler between the input terminal of the ADC and the power supply.

[0219] 27. The drug delivery device according to any one of aspects 20-25, wherein the bias source comprises:

[0220] A first resistor connected to the circuit is configured to approximately provide the low input voltage; and

[0221] A second resistor is connected to the circuit, which is configured to approximately provide the high input voltage.

[0222] 28. The drug delivery device according to any one of aspects 20-25, wherein the bias source comprises at least one of a diode, a transistor, and a capacitor.

[0223] 29. The drug delivery device according to any one of aspects 20-28, wherein:

[0224] Receiving the signal includes reading the voltage from the output of the ADC; and

[0225] Determining the presence of moisture on the printed circuit board based on the received signal includes determining that the received voltage is greater than a preset threshold voltage amount different from the bias voltage.

[0226] 30. The drug delivery device according to any one of aspects 20-29, wherein the device further comprises a drug contained in the reservoir.

[0227] 31. The drug delivery device according to aspect 30, wherein the drug is insulin.

[0228] 32. A computerized method executed by a microcontroller of a drug delivery device, wherein:

[0229] The drug delivery device includes:

[0230] The casing includes a reservoir large enough to hold the drug; and

[0231] A dosage button, which can rotate relative to the housing, selects the dosage of the drug to be injected; and

[0232] The microcontroller is electrically connected to the output of the analog-to-digital converter (ADC), wherein:

[0233] The ADC operates within a low input voltage to a high input voltage range; and

[0234] The input terminal of the ADC is electrically connected to (a) a conductive trace at least partially disposed on a printed circuit board and (b) a bias source, wherein the bias source is configured to provide a bias voltage from the low input voltage to the high input voltage; and

[0235] The method includes:

[0236] Receive the signal from the output of the ADC; and

[0237] The received signal is used to determine if there may be moisture on the printed circuit board.< / n>

Claims

1. A drug delivery device, comprising: The casing includes a reservoir of sufficient size to contain the drug; A dosage button that can be rotated relative to the housing to select the dosage of the drug to be injected; Flat printed circuit board; A first conductive trace and a second conductive trace are at least partially disposed on the planar printed circuit board, wherein the first conductive trace and the second conductive trace are not electrically connected to each other in the absence of moisture. A first bias source is electrically connected to the first conductive trace, and the first bias source is configured to maintain the first conductive trace at a first voltage level in the absence of moisture. A second bias source is electrically connected to the second conductive trace, and the second bias source is configured to maintain the second conductive trace at a second voltage level different from the first voltage level. and A microcontroller disposed on the planar printed circuit board is electrically connected to the first conductive trace via its logic input terminals, and the microcontroller is configured to: Signals are received from the conductive traces through the logic input terminals; and When moisture causes the first conductive trace to electrically connect with the second conductive trace, resulting in the logic input terminal deviating from the first voltage level by more than a threshold amount, it is determined based on the received signal that moisture may exist on the printed circuit board.

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

3. The drug delivery device of claim 1, further comprising a switch mounted on the printed circuit board, wherein the microcontroller is configured to: Receive a set of signals from the switch; and A count of the signals is generated based on the set of signals.

4. The drug delivery device according to claim 3, wherein, The drug delivery device further includes a rotatable element that is rotatable relative to the printed circuit board. The rotatable element has a series of protrusions spaced apart from each other. The rotatable element is positioned such that when the rotatable element is rotated, the protrusions slide against the switch to move the switch between a closed position and an open position.

5. The drug delivery device according to claim 3, wherein, The switch includes a piezoelectric sensor, a magnetic sensor, an accelerometer, an optical sensor, a discontinuity sensor, an optical encoder, or some combination thereof.

6. The drug delivery device according to any one of claims 3-5, wherein, The microcontroller is also configured to, when it determines that moisture may be present on the printed circuit board: The count of the generated set of signals is discarded such that the generated count (a) is not stored in the memory communicating with the microcontroller, (b) is not transmitted to a remote device via the communication module communicating with the microcontroller, or a combination thereof.

7. The drug delivery device according to any one of claims 1-5, wherein, The microcontroller is also configured to, when it determines that moisture may be present on the printed circuit board: Change the operating state of the microcontroller such that the microcontroller (a) enters a sleep state, (b) is powered off, (c) is restarted, or some combination thereof.

8. The drug delivery device according to any one of claims 1-5, wherein, The microcontroller is also configured to, when it determines that moisture may be present on the printed circuit board: At least one message is transmitted via a communication module that communicates with the microcontroller, the at least one message containing data indicating that moisture may be present on the printed circuit board.

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

10. The drug delivery device according to any one of claims 1-5, wherein, The first bias source includes a resistor that is configured as part of a system-on-chip (SoC) that includes the microcontroller.

11. The drug delivery device according to any one of claims 1-5, wherein, The first bias source includes a resistor, which is at least partially disposed on the printed circuit board and external to the system-on-a-chip (SoC) including the microcontroller.

12. The drug delivery device according to any one of claims 1-5, wherein, The first bias source includes at least one of a diode, a transistor, and a capacitor.

13. The drug delivery device according to any one of claims 1-5, wherein: The first bias source is configured to maintain the first conductive trace at a voltage of 0 volts in the absence of moisture, so that the microcontroller can read logic 0 from the logic input. The second bias source is configured to maintain the second conductive trace at a positive voltage; Receiving the signal includes reading logic 1 from the logic input; and Determining the presence of moisture on the printed circuit board based on the received signal includes identifying the logic input that changes from logic 0 to logic 1.

14. The drug delivery device according to any one of claims 1-5, wherein: The first bias source is configured to maintain the first conductive trace at a positive voltage in the absence of moisture, so that the microcontroller can read logic 1 from the logic input. The second bias source is configured to ground the second conductive trace; Receiving a signal from the conductive trace via the logic input terminal includes reading a logic 0 from the logic input terminal; and Determining the presence of moisture on the printed circuit board based on the received signal includes identifying logic inputs that change from logic 1 to logic 0.

15. The drug delivery device according to any one of claims 1-5, wherein, The device also includes a drug contained within the reservoir.

16. The drug delivery device according to claim 15, wherein, The drug in question is insulin.

17. The drug delivery device according to any one of claims 1-5, wherein, The conductive traces are located in the plane of the printed circuit board.

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