Drug delivery device with sensing system

Abstract

A drug delivery device is provided having a sensor in the form of a single pole double throw (SPDT) switch, a translation control module that receives a signal from the SPDT switch and generates an output signal, and associated power control circuitry. The SPDT switch can interact with a rotating component having a plurality of teeth that slide against an arm during dose delivery. Contact between the arm of the SPDT switch and the top of a tooth places the SPDT switch in a set state, while lack of contact between the arm and the top of a tooth places the SPDT switch in a reset state. The SPDT switch and SR logic switch can be used to sense the dose of drug delivered during dose delivery. The power control circuitry can include a sleep state that reduces battery consumption during periods of non-use, and a wake state that senses the dose being administered.

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 replacement of the used cartridge with a new one, and then the pen is reassembled for subsequent use.

[0003] Such devices may have components that physically interact to cause a change in the state or action of the device. 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 to wake the device, and so on. Therefore, efforts have been made in the art to provide reliable systems that accurately measure the relative movement of the components of a drug delivery device to assess the delivered dosage. Such systems may include sensors attached to a first component of the drug delivery device and detecting the relative movement of the sensed components attached to a second component of the device.

[0004] Many syringe pens and other drug delivery devices do not include the ability to automatically detect and record the amount of medication delivered by the device during an injection event. Without an automated system, patients must manually track the amount and time of each injection. Therefore, there is a need for a device operable to automatically detect information that can be correlated with the delivered dose by measuring mechanical components of the drug delivery device during an injection event. Improvements in the accuracy and reliability of the detection system are also required. Summary of the Invention

[0005] This disclosure relates to a drug delivery device having a sensor in the form of a single-pole double-throw (SPDT) switch, a conversion control module that receives signals from the SPDT switch and generates output signals, and an associated power control circuit configured to maintain battery use when the drug delivery device is not administering a dose. The SPDT switch can interact with mechanical components of the drug delivery device, such as a rotating component having a plurality of teeth that slide against an arm of the SPDT switch during dose delivery. Contact between the SPDT switch arm and the tips of the teeth places the SPDT switch in a set state, while non-contact between the arm and the teeth places the SPDT switch in a reset state.

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

[0007] The power control circuitry of the drug delivery device may include a sleep state and a wake-up state. The sleep state reduces battery consumption during periods of non-use, while the wake-up state fully powers the switching control module and associated counting circuitry to sense the delivered dose. According to some embodiments, the power control circuitry utilizes metal-oxide-semiconductor field-effect transistors (MOSFETs) to prevent battery consumption when the drug delivery device is in a sleep state.

[0008] In one embodiment, a drug delivery device is provided. The drug delivery device includes: a housing; a mechanical switch mounted to a printed circuit board, wherein the mechanical switch includes a single-pole double-throw (SPDT) switch, the SPDT switch including an arm; 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 to allow the protrusions to slide against the arm of the SPDT switch; a switching control module electrically connected to the SPDT switch and configured to generate a fluctuating unit signal based on a signal from the SPDT switch when the arm slides against the protrusions; and a controller configured to receive the fluctuating unit signal from the switching control module. Attached Figure Description

[0009] 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.

[0010] Figure 1 This is a perspective view of a drug delivery device with a dose detection system according to aspects of this disclosure.

[0011] Figure 2 yes Figure 1 A partial exploded perspective view of a drug delivery device, showing a dosing button with a support and a cover, wherein the cover is shown as separate from the support.

[0012] Figure 3 yes Figure 1 A partial exploded perspective view of the drug delivery device, showing the various components of the dose detection system.

[0013] Figure 4yes Figure 1 A cross-sectional view of a drug delivery device.

[0014] Figure 5 yes Figure 1 A partial cross-sectional view of the proximal end of the drug delivery device, showing components of the dose detection system.

[0015] 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.

[0016] Figure 7 yes Figure 6 An exploded view of a portion of the dosage button shown.

[0017] Figure 8 This is a perspective view of the flange component of the dosage detection system in a drug delivery device.

[0018] Figure 9 yes Figure 8 A top view of the flange component.

[0019] Figure 10 This is a perspective view of the dosage button support.

[0020] Figure 11 yes Figure 10 Top view of the dosage button support.

[0021] Figure 12 An exemplary SPST switch is shown based on some examples.

[0022] Figure 13 and 14 It shows Figure 5 Exploded view of the electronic components and flange members.

[0023] Figure 15-19 It shows the relationship with Figure 8 and 9 The rotating flange components interact with the switch of the cantilever.

[0024] Figure 20 This is a graph showing an exemplary waveform of the output current of the SPST switch changing over time.

[0025] Figure 21 This is a schematic diagram of an exemplary switching control module disposed between a controller of a dose detection system and a control system, according to some embodiments.

[0026] Figure 22 This is a schematic diagram of a control signal generated by a conversion control module according to some embodiments, which is transmitted to the controller of the control system.

[0027] Figure 23-24 This is a schematic diagram of a microprocessor implementing SR logic in firmware according to some embodiments.

[0028] Figure 25 This is an exemplary block diagram illustrating functional aspects of a printed circuit board for processing signals from a sensor, according to some embodiments. Detailed Implementation

[0029] To facilitate an understanding of the principles of this disclosure, reference will now be made to the embodiments illustrated in the accompanying drawings, and these embodiments will be described using specific language. However, it should be understood that this is not intended to limit the scope of the invention.

[0030] This disclosure relates to a sensing system for a drug delivery device. In one aspect, the sensing system includes a single-pole double-throw (SPDT) switch electrically connected to a switching control module (e.g., set-reset (SR) logic). The sensing system also includes power control circuitry that can configure the drug delivery device to a sleep or wake state based on the operation of the drug delivery device (e.g., whether the device is in use). MOSFETs are used to prevent battery drain during the sleep state and to provide full operation of the switching control module in the wake state.

[0031] In some embodiments, the SPDT switch and processing circuitry (e.g., including a switching control module and / or power control circuitry) are used to sense the relative rotational motion between the dose setting component and the actuator of the drug delivery device to determine the dose delivered by the drug delivery device. The sensed relative rotational motion is related to the delivered dose. As an illustration, the drug delivery device is described in the form of a pen syringe. However, the drug delivery device can be any device for setting and delivering a dose of drug, such as a pen syringe, infusion pump, and syringe. The drug can be of any type that can be delivered by such a drug delivery device.

[0032] Compared to other sensing systems equipped with contact event counters or other devices that are susceptible to signals with higher-than-expected noise, the detection system described herein can provide improved accuracy and reliability in determining the amount of rotation, such as signal debouncing. Such a detection system can additionally or alternatively provide improved power consumption control compared to other sensing systems not configured to limit battery use when the drug delivery device is not delivering a dose. One advantage of using mechanical switches, such as SPDT switches, is that the travel distance of the sensed element for triggering between on / off states can be smaller, thus providing higher sensing resolution. In mechanical switches with a switching control module, the bounce of the switch can be ignored once the switch activation module is activated. In some applications, mechanical switches can be superior to other sensing methods, such as sliding contacts. For example, the application of sliding contacts for sensing may be limited due to the decreasing size of the circular travel and / or the decreasing radial spacing of the contact areas, making sensing in such smaller and more compact spaces more difficult and less consistent. This may ultimately result in less comparable resolution, for example, sensing capability of only 36 degrees (or two units) instead of 18 degrees or less. For a given geometry and size of a rotating sensed element, higher resolution can be achieved using mechanical switches such as SPDT switches for sensing rotating sensed elements. The teachings here can also be applied to linearly moving sensed elements and / or multiple single-pole single-throw switches.

[0033] The apparatus described herein may also include, for example, a reservoir or cartridge 20 (see...) Figure 4 The system may include a drug within the device. In another embodiment, the system may include one or more devices (including device 10) and a drug. The term "drug" refers to one or more therapeutic agents, including but not limited to insulin, insulin analogs such as 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 aforementioned device. The drug used in the device may be formulated with one or more excipients. The device is operated by a patient, caregiver, or healthcare professional in a manner generally as described above to deliver the drug to a person.

[0034] Figure 1-4 An exemplary drug delivery device 10, a pen injector configured to inject medication into a patient via a needle, is shown. Device 10 includes a body 11 comprising an elongated pen-shaped housing 12, the housing including a distal portion 14 and a proximal portion 16. The distal portion 14 is accommodated within a pen cap 18. (Reference) Figure 4 The distal portion 14 may include a reservoir or cartridge 20 configured to contain drug fluid for dispensing via an outlet 21 of the housing during 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 injection needle after each use.

[0035] 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 advance 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.

[0036] 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 4 As best shown in the illustrated embodiment, the dose setting assembly includes a dose setting screw 32 and a flange member 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 (e.g., 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 position (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 a position corresponding to 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 the home position or zero position corresponding to the minimum dose that the device 10 can deliver in a single injection.

[0037] 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 (e.g., 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 numbers visible through the dose window 36, to indicate the set dose to the user.

[0038] As described above, in some embodiments, the dose setting assembly further includes a tubular flange member 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 member 38... Figure 3 , 8 As can be seen in 9, and the opening 41 of the dose setting screw 32 is in Figure 3 As can be seen in the text.

[0039] like Figure 3 and Figure 4 As shown, the delivery device 10 may include an actuator assembly having an engagement / clamping device 52 and a dose button 30. The engagement 52 is received within a dose setting screw 32, and the engagement 52 includes an axially extending shank 54 at its proximal end. The dose button 30 of the actuator assembly is positioned proximal to the dose setting screw 32 and the flange member 38. The dose 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 dose delivered by the drug delivery device.

[0040] The support 42 of the dosage button can be attached to the handle 54 of the connector 52, for example by interference fit or ultrasonic welding, so as to fix the dosage button 30 and the connector 52 together axially and rotatably.

[0041] In some embodiments, a portion of the connector may pass through the inner cavity 39 of the flange member 38. The inner cavity 39 of the flange member... Figure 8 and 9 Ideally, it should be visible in the center. In some embodiments, the cavity 39 can be used to help the coupling 52 be centered and positioned.

[0042] The proximal surface 60 of the dosage button 30 can serve as an actuating surface to which force can be manually applied, for example, by the user directly applying force to push the actuator assembly (dosage button 30 and engagement 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 member 38. Figure 8 and 9 This allows the support 42 of the actuation assembly and the flange member 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 member 38.

[0043] 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.

[0044] In some embodiments, the set dose is increased by rotating the dose button 30 to axially translate it in the proximal direction, and the set dose is decreased by rotating the dose button 30 to axially translate it in the distal direction. During dose setting operation, the dose button 30 can be adjusted in predetermined rotational increments corresponding to the minimum increment 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 be equal to half or one unit of the drug.

[0045] 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 coupling 52 moves axially and rotationally together with a dose setting assembly including a flange member 38 and a dose setting screw 32.

[0046] Because the dose setting screw 32 is threadedly connected to the housing 12, the dose setting screw 32 and the flange member 38 are rotatably fixed to each other / non-rotatably fixed / fixed in terms of rotation, and rotate and move proximally during dose setting. During this dose setting movement, the dose button 30 is moved through the complementary keyway structure 74 of the flange member 38 and the connector 52. Figure 4 The complementary keyway structure 74 is rotatably fixed relative to the flange member 38 and the dose setting screw 32, and is driven together by the bias member 68. During dose setting, the dose setting screw 32, flange member 38, connector 52, and dose button 30 move helically (e.g., simultaneously rotating and axially translating) 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.

[0047] 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 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 connector 52) to move axially in the distal direction relative to the housing 12.

[0048] 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 member 38. This relative axial movement separates the complementary keyway structure 74 on the coupling 52 and the flange member 38, thereby disengaging the dose button 30 from rotational fixation with the flange member 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 member 38 are freely rotating relative to the housing 12, rotation of the dose button 30 relative to the housing 12 is prevented by engaging the dose button 30 by the user pressing against it.

[0049] As the dose setting button 30 and connector 52 continue to be inserted axially without rotating relative to the housing 12, the dose setting screw 32 screws back into the housing 12 as it rotates relative to the dose setting button 30. A dose marker indicating the remaining amount to be injected can be seen through window 36. As the dose 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.

[0050] 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.

[0051] As described above, the delivered dose can be obtained based on the amount of rotation of the dose setting components (flange member 38 and dose setting screw 32) relative to the actuator components (engager 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.

[0052] 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 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.

[0053] 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 a 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 sensed element is attached to the dose setting member and rotatably fixed relative to it (fixed without relative rotation). An actuator is attached to the device body and remains stationary relative to the device body during dose delivery. The sensed element thus rotates relative to the actuator during dose delivery in relation to the delivered dose.

[0054] 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.

[0055] 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, keyway structures, snap-fit ​​or press-fit, acoustic welding, or adhesives.

[0056] 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.

[0057] 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 fixes them rotationally / can be rotated together, whereas without the pressing of the first component, the two components might not be fixed together.

[0058] This paper envisions various sensor devices. Typically, a sensor device 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 whose position and / or movement relative to the sensor can be detected by the sensor. In a dose detection system, the sensed component rotates relative to the sensor, which is capable of detecting 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.

[0059] Illustratively, the dose detection system includes electronic components suitable for the operation of the sensor device 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 counts from the first count to the last count, to obtain a total count for determining the 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 the operation of the drug delivery device based on the output. The controller may be configured to determine the amount of dose delivered by the 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 device 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.

[0060] According to one aspect, the electronic component includes a sensor device comprising one or more sensors operatively communicable with a processor for receiving signals representing sensed rotation from the sensors. Exemplary electronic component 76 in... Figure 5-7The electronic component 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 76 may include a microcontroller unit (MCU) serving as a controller, including at least one processing core and internal memory. The electronic component may include a power source 79, such as a battery, illustratively a coin cell battery, for powering the various components. The controller of the electronic component 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 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 76 is permanently integrated into the dosage button 30 of the delivery device. In other embodiments, the electronic component is configured as a module that can be detachably attached to the actuator assembly of the drug delivery device.

[0061] exist Figure 6 The image shows a bottom view of the electronic component 76 held within the cover 56. Figure 7 An exploded view of electronic component 76 is shown. (As shown) Figure 6 and 7 As shown, electronic component 76 may include a printed circuit board (PCB) 77 and a sensor 86 having a contact surface 111. (As...) Figure 7 As shown, electronic component 76 may also include battery 79 and battery box / battery cage 87.

[0062] 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, although only one opening 45 of the support 42 is needed to accommodate the sensor, a second opening may be provided, for example, considering the symmetry of the support member, which facilitates the fabrication of components of the drug delivery device and / or the assembly of its components.

[0063] The controller of electronic component 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.

[0064] 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 such 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 degrees, 10 degrees, 15 degrees, 20 degrees, 24 degrees, or 36 degrees, may correspond to one unit or half a unit. The sensor system is operable to determine the total angular displacement of the dose setting component during dose delivery. Thus, if the angular displacement is 90°, then 5 units of dose have been delivered.

[0065] 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.

[0066] 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.

[0067] 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.

[0068] 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 member 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 dosage button of the delivery device.

[0069] 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 76 is rotatably fixed to the dose button 30 and does not rotate during dose delivery.

[0070] like Figure 2 , 3 As shown in Figure 5, the dosage button 30 includes a cover 56 coupled to a support member 42. Electronic components 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 support member have corresponding keyway structures that engage with each other to join the cover and support member together. For example, in some embodiments, the cover 56 may be coupled to the support member 42 via one or more snap-fit ​​portions 57 on the cover 56 corresponding to one or more protrusions 43 on the support member. Figure 5 and 6 As shown, the latching part 57 on the cover 56 can extend from the inner peripheral sidewall 73 to the radially inward side. (As...) 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.

[0071] The snap-fit ​​portion 57 on the cover 56 is configured to snap onto and engage with the 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 protrusion surrounding the 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.

[0072] like Figure 8 and Figure 9As shown, the tubular flange member 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 member 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 member 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, which can be used to correspond to one unit or 0.5 units.

[0073] A recess 124 may be defined between each pair of adjacent teeth 102. 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.

[0074] In some embodiments, a sensor for detecting rotation of a tubular flange member includes a movable element having a contact portion capable of resting on the teeth of the tubular flange member and being spring-biased such that the contact surface is configured to slide against the teeth during rotation of the flange member 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 member. 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 member relative to the actuator assembly during dose delivery.

[0075] The contact surface can be biased against the physical feature structure of the tubular flange member 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 offset 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 compression, tension, or torsion coil springs. 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.

[0076] Figure 5An illustrative embodiment of a sensor 86 is depicted, having a contact surface 111 that interacts with the teeth 102 of a tubular flange member 38. When the flange member 38 rotates relative to a dose button 30 during delivery, the teeth 102 of the flange member 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 member 38. The sensor 86 can be configured to track the movement of the contact surface 111 and associate this movement with an output signal sent to a controller.

[0077] As an alternative to teeth on a tubular flange member, the surface feature structure interacting with the sensor can include any structure detectable by the sensor. The sensor device can be based on a variety of sensed 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 of, for example, 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.

[0078] 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 the helical direction relative to the housing 12. Therefore, the dose setting screw 32 and the flange member 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.

[0079] In some embodiments, the electronic component 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.

[0080] 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 electronics to be woken up or activated 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 disposed within the dose button housing, triggered when the dose button is in its distal position. After the electronics are activated, the controller begins receiving a generated signal from the rotation sensor, indicating a total count from the first count to the last count, to determine the total angular displacement and thus the amount of dose delivered.

[0081] In some embodiments, the electronic component may have a controller configured to receive an output signal from a rotation sensor. The controller of the electronic component 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.

[0082] 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.

[0083] As discussed herein, electronic components include sensor devices having one or more sensors that are operatively in communication with a processor to receive signals from the sensors representing sensed rotation of the sensed component. Figure 13 and 14 It shows Figure 5 Exploded view of electronic component 76 and flange member 38. Figure 13 A contact surface 111 is shown that interacts with the teeth 102 of the tubular flange member 38. When the flange member 38 rotates relative to the dose button during delivery, the teeth 102 of the flange member contact the contact surface 111 of the sensor and slide against it, thereby causing the contact surface 111 to move in an oscillating manner.

[0084] Various sensor devices can be used in drug delivery devices. Exemplary sensor devices include mechanical components (e.g., sliding contacts, switches), piezoelectric components, and / or the like. Some exemplary techniques include mechanical switches triggered on teeth of a flange member. For example, a single-pole single-throw (SPST) switch can be used to sense rotation of the flange member as the teeth slide relative to the switch. For example, an SPST switch can use, for example, a mechanical switch triggered on teeth of a flange member. Figure 12 The switch rocker arm shown is used to achieve this, or for example... Figure 13 The switch shown is a switch 86' with conductive pads 89 and a cantilever 210. The conductive pads 89 and the first end 201 of the cantilever 210 are mounted to a PCB 77. The switch also includes a base connected to the cantilever 210. The base is connected to the PCB to attach the cantilever to the PCB. The base and the cantilever together can form a single integral assembly. Figure 15-19 It shows the relationship with Figure 8 and 9 The rotating flange member 38 in the middle interacts with the cantilever 210 of the switch. Figure 15 The arm 210 is shown in a stress-free state, with the third curved portion 216 located within the recess 124 between two adjacent teeth 103 and 105. Figure 16 In the middle, the flange member 38 has begun to rotate relative to the switch and PCB 77. As a result, the tooth 105 slides and pushes against the third curved portion 216 of the arm 210, causing the arm 210 to begin to deflect away from the recess 124. The first curved portion 212 begins to move toward a straightened configuration, and the second curved portion 214 begins to move toward the conductive pad 89.

[0085] exist Figure 17 In the middle, the flange component is 38 times that of the others. Figure 16 Further rotation causes tooth 105 to slide against the third curved portion 216 and almost completely push it out of the recess 124. The first curved portion 212 has moved further toward a straightened configuration. As a result, the second curved portion 214 has been brought into contact with the conductive pad 89, thereby closing the switch. The second curved portion is also pressed 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 bouncing repeatedly relative to the conductive pad 89 in a rapid manner that could cause a noisy output signal.

[0086] exist Figure 18 In the middle, the flange member 38 is in Figure 17 The second bend 214 rotates further and the third bend 216 has exited the recess 124 and slid over the tip of the tooth 105. The second bend 214 remains in contact with both 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.

[0087] Finally, Figure 19 In the middle, the flange member 38 is in Figure 18 The arm rotates further, and the third curved portion 216 has stopped contacting tooth 105 and is now beginning to contact the next adjacent tooth 107. During this transition, as the next tooth 107 begins to press against the arm 210, it is biased by the spring towards... Figure 15 The arm at the indicated position has swung back to its stress-free state, causing the first bent portion 212 to move into a more curved shape, resulting in the third bent portion 216 moving in the opposite direction to the rotation of the flange member 38, and causing the second bent portion 214 to move away from the conductive pad 84, thereby opening the switch. As the flange member 38 rotates further, the cycle continues, and the arm moves backward toward the conductive pad to close the switch, and so on.

[0088] As described herein, the switch can close and open based on mechanical interaction with the teeth of the flange member of the drug delivery device, such that when the switch passes the teeth, a signal is sent to processing circuitry (e.g., to the general purpose input / output (GPIO) of the microprocessor of the drug delivery device). Over time, use of the drug delivery device may cause component scratching, which may affect the mechanical operation of the switch. Alternatively, the switching current may fluctuate during use of the drug delivery device. Figure 20 This is a diagram illustrating an exemplary waveform, Figure 2000, showing the change in output current of an SPST switch over time. When the switch is open, the output current is approximately zero (0), and when the switch is closed, the output current is approximately 1.6 volts. As can be seen in section 2022 of Figure 2000, the electrical bouncing of the switch between open and closed states causes fluctuations in the output current, which can be interpreted as many different trigger signals, even though the switch actually closes only once. This bouncing can be further complicated by the switch size. For example, such a switch could be an optical switch, where high impedance during transitions can cause the switch to open and / or close rapidly (e.g., in microseconds). When the measurement is actually only for a single switch transition or pulse, this bouncing transition may appear as multiple pulses to the microprocessor. Therefore, conventional sensor devices may suffer from one or more defects, including errors in dose counts or dose measurements calculated based on the sensor output due to the material and / or electrical properties of the sensor.

[0089] According to some embodiments, the techniques disclosed herein can provide software- and / or hardware-based signal processing using a single-pole double-throw (SPDT) switch as a sensing mechanism and configured to provide a low-error signal to a microprocessor of a drug delivery device. According to some embodiments, the SPDT switch can include set and reset states that can be processed using a switching control module (e.g., set / reset (SR) trigger logic) to drive high and low logic levels to downstream circuitry, such as a microcontroller (e.g., via the microcontroller's general purpose input / output (GPIO)). Such SPDT switches and associated logic can address one or more drawbacks of conventional sensor devices. For example, some embodiments can reduce and / or eliminate signal jitter compared to that caused by conventional sensor techniques. As another example, these techniques can utilize circuit designs as described herein to provide low power consumption when the drug delivery device is not in use.

[0090] In some embodiments, the SPDT switch includes a cantilever that is movable to place the SPDT switch in multiple states. For example, the SPDT switch may include a set state, a reset state, and / or a neutral state. The cantilever may be mounted to a printed circuit board at a first end, and the second end of the cantilever may be unattached and freely movable relative to the printed circuit board.

[0091] In some embodiments, the set state and reset state may be associated with corresponding conductive pads mounted to the PCB and / or to a housing device (which in turn is mounted to the PCB). Contact between the cantilever and the conductive pad causes the switch to close in the associated state, while the absence of contact between any one or both pads causes the switch to open.

[0092] In some embodiments, the cantilever may be configured to contact and slide against the sensed component, for example, against... Figure 8 and 9 The rotating tubular flange member 38 shown in the figure slides with teeth. In some embodiments, contact between the SPDT switch arm and a portion of the tooth (e.g., with the tooth tip) places the SPDT switch in a state (e.g., set state), while contact between the SPDT switch arm and a second portion of the tooth and / or the absence / non-contact between the arm and the tooth places the SPDT switch in a second state (e.g., reset state).

[0093] In some embodiments, the conversion control module may be located between the sensor and the processing core of the MCU. In some embodiments, the conversion control module may be implemented by a microprocessor (e.g., in firmware and / or software). Figure 21As further described herein, according to some embodiments, the conversion control module is configured to generate a fluctuating unit signal S3 from the generated first and second signals S1, S2 (which are arranged in an alternating manner), which may also be referred to as the set signal S and the reset signal R, respectively.

[0094] In some embodiments, the conversion control module includes a latch circuit, an SR latch circuit, etc. The latch circuit may include an output signal that is triggered high or low based on alternating contact input signals received by the latch circuit. The conversion control module is operable to... Figure 21 The first and second signals S1 and S2 shown are converted into switch-like GPIO signals, serving as a single input to the MCU's processing core. One potential benefit of providing latching circuitry is that processing power requirements can be reduced compared to other configurations.

[0095] Figure 21 An example of a system 2100 having an SPDT switch 2102 and an SR latch circuit 2104 is described exemplarily. Although not shown, in some embodiments as described herein, the SR latch circuit 2104 may be arranged between the SPDT switch 2102 and the processing core of the controller MCU (e.g., which is in electrical communication with the Q signal). In some embodiments, the SR latch circuit 2104 may be partially and / or entirely implemented by the processing core of the MCU. The SPDT switch 2102 generates a sensing signal. Each “throw” of the SPDT switch 2102 is associated with a corresponding set S circuit or reset R circuit. The latch circuit 2104 of the switching control module is shown to receive a reset signal R as shown in S2 and a reset S signal as shown in S1, as well as a flip-flop between “set” and “reset” to generate a Q signal and a non-Q signal. Figure 22 Examples of Q signals and non-Q signals are shown in the figure.

[0096] In some embodiments, the MCU's processing core is operable to receive and process Q signals, as shown in S3, to determine a rotation unit based on the number of rising edges C in the Q signal or the number of times it switches to set, which can be stored in memory. Alternatively, the rotation unit can also be determined based on the number of falling edges in the Q signal or the number of times it switches to reset, which can then be stored in memory. Prior to the step of determining the rotation unit, the dose count can be stored in memory by the processing core. Non-Q signals can be used as contingent signals to provide redundancy to the control system if the expected pattern of the Q signal is not demonstrated. In other embodiments, if a non-Q signal is sent to the processing core, it can be ignored or omitted from the processing core. The system may require only one GPIO input. Latch circuit 2104 can, for example, advantageously count each unit once. As another exemplary advantage, system 2100 can be configured to avoid duplicate dose counting if the contact arm contacts the same pad during the next administration.

[0097] Another exemplary advantage of system 2100 is that it can be used as a robust de-jitter circuit. That is, if a non-uniform signal is present in latch circuit 2104, due to the latching function, if signal S1 is repeatedly seen, no state change will occur, as this will only happen when a signal from S2 is present. This technique can provide advantages over systems that only use de-jitter circuitry and / or software de-jitter. For example, the amount of de-jitter that a non-uniform signal might require can depend on the frequency of the signal. Some de-jitter techniques add a delay to force the controller to stop for a period of time, causing the controller not to count during the delay. If the frequency of the non-uniform signal is high, and the de-jitter is set high (e.g., such that the delay used to force the controller to stop for a specific time period is greater than the signal frequency), multiple signals are blurred together, and the controller determines a dose count lower than expected. Similarly, if the frequency of the non-uniform signal is low, and the de-jitter is set low (e.g., such that the delay used to force the controller to stop for a specific time period is shorter than the signal frequency), the controller determines a dose count higher than expected. Additionally, due to the presence of alternating signals, the system described herein can improve the mechanical tolerances of the system when the diameter of the toothed ring is small. For example, using only a single signal, the position indicator can maintain contact and keep the switch closed as the teeth move between them, and the controller may not be able to detect this transition between the teeth (resulting in no count for this transition). In another embodiment, more than one single-pole single-throw (SPST) switch, such as two SPST switches, can be applied. Figure 21The circuit in the circuit will replace the SPDT switches. The two SPDT switches can be biased in such a way that they generate a signal representing a reset signal and another signal representing a reset signal for input to latch circuit 2104.

[0098] In some embodiments, the MCU may be configured to power on or wake up the system from a lower power state to a higher power state based on receiving a first count from a single input signal (e.g., Q). When the system is configured in a low power state, the associated hardware and / or logic (e.g., a counter block as described herein) has sufficient power to determine at least an initial cell among a plurality of cells.

[0099] According to some embodiments, the microprocessor can be as follows: Figure 23-24 The firmware shown implements SR logic. Figure 23-24 The software (SW)SR logic 2302 within the microprocessor 2304 is shown. According to some embodiments, the microprocessor 2304 may use a MOSFET 2310 to prevent power consumption from the battery 2306 when the drug delivery device is in a sleep state (e.g., a state prior to the first injection). For example, an initial sleep state may occur when the switching rocker arm of the SPDT switch is in a groove between mechanical teeth as discussed herein. Figure 23 As shown, in sleep mode, switch 2314, implemented as any of the rotary sensors described herein, is in a first state that applies voltage from battery 2306 to MOSFET 2310. SW control switch 2308 is open, so that no voltage from voltage source 2312 is applied to MOSFET 2310, causing MOSFET 2310 to be in the off position and therefore not conducting. Thus, in the off position, minimal and / or no current is drawn from battery 2306. Figure 23 and Figure 24 Includes a general-purpose circuit section 2320 showing the resistive load on the GPIO input and an indicator showing the logic state, such that the indicator 2322... Figure 23 The first state is shown in the diagram and... Figure 24 The second state is shown in the diagram. According to some embodiments, the general-purpose circuit section 2320 may provide signals to detection or counting functions or circuits (e.g., counter blocks), as further discussed herein.

[0100] When a dose is administered using a drug delivery device, the circuitry can be configured to detect the dose injection and activate the SR logic. For example, the circuitry can be configured to detect the dose by detecting when the rocker arm of the SPDT switch crosses the tip of a mechanical tooth, as discussed herein. Figure 24As shown, when a dose is detected, switch 2314 enters a second state, which sends a wake-up signal to microprocessor 2304 for full debouncing operation of software SR logic 2302. Additionally, SW control switch 2308 is closed to apply voltage from voltage source 2312, enabling MOSFET 2310 to provide a GPIO reset signal to SW SR logic 2302. Although the embodiments described herein use a power switch implemented as SW control switch 2308, power switches may include other switches, such as contact sensors.

[0101] In some embodiments, the counter block may be disposed between the sensor (e.g., including a conversion control module) and the processing core of the MCU, and / or implemented by the processing core. In some embodiments, the counter block may be configured to determine the unit quantity by counting and recording the number of rising and / or falling edges of a single input signal, for example... Figure 22 The number of times the signal switches to the setting or the number of rising edges C in the Q signal. The total number of rising edges in the generated signal S3 is related to the total number of units, which represents the amount of rotation of the dosing element. In some embodiments, the counter block can count both rising and falling edges to determine the amount of rotation. The counter block is operable to transmit the determined total number of counts C to the MCU.

[0102] Figure 25 This is an exemplary block diagram illustrating functional aspects of a printed circuit board 2500 for processing signals from a sensor 2502 (e.g., an SPDT switch) according to some embodiments. The sensor 2502 communicates with a counter block 2504 and a quadrature encoder 2506, both of which communicate with a controller 2508. The sensor 2502 may be, for example... Figure 6 The sensor 86 is used in this process. For example, as described herein, the sensor 86 can be configured to track movement of the contact surface 111 and associate that movement with output signals sent to a counter block 2504 and a quadrature encoder 2506, which can count the number of times the contact surface 111 slides into and out of the recess 124 defined between the teeth 102 of the flange member 38, and provide the determined count to a controller 2508 (which can be used to determine the injection dose). It should be understood that the quadrature encoder 2506 can be implemented using firmware, hardware, etc.

[0103] In some embodiments, the counter block 2504 and the quadrature encoder 2506 may be configured to process the signal from the sensor 2502 using different techniques. Using different techniques can provide some redundancy when measuring the signal from the sensor 2502 (e.g., to ensure measurement accuracy). Further reference Figure 22 , Figure 22A portion of exemplary signals 2202, 2204, and 2206 are shown, in which each signal is a square wave (where the horizontal axis represents time and the vertical axis represents voltage). Counter block 2504 can analyze the received signals using a first technique to generate a first count of the signals. For example, counter block 2504 can be configured to count the rising edge C of each square wave 2202-2206. Quadrature encoder 2506 can use a second technique to analyze the received signals to generate a second count of the signals. For example, quadrature encoder 2506 can be configured to count both the rising and falling edges of each square wave 2202-2206, one of which is labeled as falling edge 2202B of square wave 2202 for illustrative purposes.

[0104] In some embodiments, the counter block 2504 and the quadrature encoder 2506 may be configured to use different sampling rates to process the signal from the sensor 2502. For example, the counter block 2504 may have a sampling rate configured to sample the signal from the sensor 2502 to sense the rising edge of each signal, and the quadrature encoder 2506 may have a different sampling rate configured to sample the signal from the sensor 2502 to sense both the rising and falling edges of each signal. As an illustrative example, the counter block 2504 may be configured to use a 10 ms (100 Hz) sampling rate, while the quadrature encoder 2506 may be configured to use a 1 ms (1000 Hz) sampling rate.

[0105] The device illustrated 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 this device is merely illustrative, as the sensing system can be adapted for use in various constructions of drug delivery devices, 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 such a drug delivery device. This device is exemplary and not limiting, as the sensing system described herein can be used in other devices with different configurations.

[0106] 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."

[0107] 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.

[0108] This disclosure describes several aspects, including but not limited to the following:

[0109] 1. A drug delivery device comprising: a housing; a mechanical switch mounted to a printed circuit board, wherein the mechanical switch includes a single-pole double-throw (SPDT) switch, the SPDT switch including an arm; 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 to allow the protrusions to slide against the arm of the SPDT switch; a switching control module electrically connected to the SPDT switch and configured to generate a fluctuating unit signal based on a signal from the SPDT switch when the arm slides against the protrusions; and a controller configured to receive the fluctuating unit signal from the switching control module.

[0110] 2. The drug delivery device according to aspect 1, wherein: the SPDT switch includes a setting state that generates a setting signal and a reset state that generates a reset signal; and the conversion control module includes SR logic configured to generate the fluctuation unit signal based on the setting signal and the reset signal from the SPDT switch.

[0111] 3. The drug delivery device according to aspect 2, wherein the drug delivery device includes a counter block configured to determine the number of rotation units of the rotatable element based on the number of rising edges, falling edges, or both rising and falling edges of the generated oscillating unit signal.

[0112] 4. The drug delivery device according to any one of aspects 1-3 further includes: a battery; and a microprocessor.

[0113] 5. The drug delivery device according to aspect 4, wherein the microprocessor includes one or both of SR logic and a controller.

[0114] 6. The drug delivery device according to aspect 4 further includes a metal-oxide-semiconductor field-effect transistor (MOSFET), wherein the SPDT switch is electrically connected to the battery.

[0115] 7. The drug delivery device according to aspect 6, wherein the microprocessor includes a software (SW) control switch disposed between the voltage source and the MOSFET, wherein: in a sleep state, the SPDT switch is in a first state where the battery and the MOSFET are electrically connected, and the SW control switch is open, so that the MOSFET is not electrically connected to the voltage source to prevent battery depletion; and in a wake-up state, the SW control switch is closed, so that the MOSFET is electrically connected to the voltage source.

[0116] 8. The drug delivery device according to aspect 7, wherein the microprocessor includes a reset input and a wake-up input.

[0117] 9. The drug delivery device according to aspect 8, wherein, in the wake-up state: the MOSFET applies a voltage to the reset input terminal; and the SPDT switch is in a second state in which the battery is electrically connected to the wake-up input terminal of the microprocessor.

[0118] 10. The drug delivery device according to any one of aspects 1-9, further comprising: an outlet; and a dosage button, the dosage button being axially translatable relative to the housing to activate a dosage dispensing mode in which drug is dispensed from the outlet, the dosage button being rotatable relative to the housing in a dosage setting mode to select a dosage of drug to be delivered from the outlet.

[0119] 11. The drug delivery device according to aspect 10, wherein the rotatable element is positioned to allow the protrusion to slide against the arm of the SPDT switch, such that the arm moves between a set state and a reset state of the SPDT switch as the rotatable element rotates.

[0120] 12. The drug delivery device according to aspect 10, wherein the rotatable element is rotatable with the dose button in the dose setting mode and rotatable relative to the dose button in the dose dispensing mode, wherein the degree of rotation of the rotatable element during the dose dispensing mode determines the amount of drug to be dispensed from the outlet.

[0121] 13. The drug delivery device according to aspect 11, wherein the SPDT switch is configured to sense the rotation of the rotatable element relative to the dosage button.

[0122] 14. The drug delivery device according to any one of aspects 1-13, wherein the printed circuit board is fixed to the dosage button.

[0123] 15. The drug delivery device according to any one of aspects 1-14, wherein the mechanical switch includes a base connected to an arm of the SPDT switch, the base being mounted to the printed circuit board.

[0124] 16. The drug delivery device according to any one of aspects 1-15, wherein the housing comprises a reservoir and a drug within the reservoir.

[0125] 17. A dosage detection system for a drug delivery device, comprising: a mechanical switch mounted to a printed circuit board, wherein the mechanical switch includes a single-pole double-throw (SPDT) switch, the SPDT switch including an arm; 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 to allow the protrusions to slide against the arm of the SPDT switch; a switching control module electrically connected to the SPDT switch and configured to generate a fluctuating unit signal based on a signal from the SPDT switch when the arm slides against the protrusions; and a controller configured to receive the fluctuating unit signal from the switching control module.

[0126] 18. The dose detection system according to aspect 17, wherein: the SPDT switch includes a setting state that generates a setting signal and a reset state that generates a reset signal; and

[0127] The conversion control module includes SR logic, which is configured to generate a fluctuating unit signal based on the set signal and reset signal from the SPDT switch.

[0128] 19. The dose detection system according to aspect 18, wherein the drug delivery device includes a counter block configured to determine the number of rotation units of the rotatable element based on the number of rising edges, falling edges, or both rising and falling edges of the generated oscillation unit signal.

[0129] 20. The dose detection system according to aspect 19 further includes: a battery electrically connected to the SPDT switch; a metal-oxide-semiconductor field-effect transistor (MOSFET); and a microprocessor, wherein the microprocessor includes one or both of the SR logic and the controller.

[0130] 21. The dose detection system according to aspect 20, wherein the microprocessor includes a software (SW) control switch disposed between the voltage source and the MOSFET, wherein: in a sleep state, the SPDT switch is in a first state where the battery and the MOSFET are electrically connected, and the SW control switch is open, so that the MOSFET is not electrically connected to the voltage source to prevent battery depletion; and in a wake-up state, the SW control switch is closed, so that the MOSFET is electrically connected to the voltage source.

[0131] 22. The dose detection system according to aspect 21, wherein the microprocessor includes a reset input and a wake-up input.

[0132] 23. The dose detection system according to aspect 22, wherein, in the wake-up state: the MOSFET applies a voltage to the reset input; and the SPDT switch is in a second state in which the battery is electrically connected to the wake-up input of the microprocessor.

[0133] 24. A method comprising: rotating a rotatable element relative to a printed circuit board, the rotatable element having a series of protrusions spaced apart from each other, the rotatable element being positioned to allow the protrusions to slide against an arm of a single-pole double-throw (SPDT) switch in the form of a mechanical switch mounted to the printed circuit board; and generating a wave signal via a switching control module electrically connected to the SPDT switch based on a signal from the SPDT switch as the arm slides against the protrusions.

[0134] 25. The method according to aspect 24, comprising: generating a setting signal and / or a reset signal via the SPDT switch, wherein the step of generating a fluctuation signal further comprises generating a fluctuation unit signal via the SR logic of the conversion control module based on the setting signal and the reset signal from the SPDT switch.

[0135] 26. The method according to aspect 25, comprising: determining the number of rotation units of the rotatable element via a counter block based on the number of rising edges, falling edges, or both rising and falling edges of the generated oscillating unit signal.

[0136] 27. The method according to aspect 26, comprising: switching the SPDT switch to a first state in which the battery is electrically connected to a metal-oxide-semiconductor field-effect transistor (MOSFET); and switching a microprocessor software (SW) control switch to open such that the MOSFET is not electrically connected to a voltage source to prevent battery depletion and to define a sleep state, or switching the SW control switch to close such that the MOSFET is electrically connected to the voltage source to define a wake-up state.

[0137] 28. The method according to aspect 27, wherein the step of switching the SW control switch to closed further includes applying a voltage to the reset input terminal of the microprocessor via the MOSFET; and switching the SPDT switch to a second state in which the battery is electrically connected to the wake-up input terminal of the microprocessor.< / n>

Claims

1. A drug delivery device, comprising: case; exit; Mechanical switches mounted to printed circuit boards, wherein the mechanical switches include single-pole double-throw switches, the single-pole double-throw switches including arms; A rotatable element, which is rotatable relative to the printed circuit board, wherein the degree of rotation of the rotatable element during the dosage dispensing mode of the drug delivery device determines the amount of drug dispensed from the outlet, the rotatable element having a series of protrusions spaced apart from each other, the rotatable element being positioned to allow the protrusions to slide against the arm of a single-pole double-throw switch; A switching control module, which is electrically connected to a single-pole double-throw switch and is configured to generate a fluctuating unit signal based on a signal from the single-pole double-throw switch when the arm slides against the protrusion; as well as A controller is configured to receive the fluctuation unit signal from the conversion control module; wherein: The single-pole double-throw switch includes a setting state that generates a setting signal and a reset state that generates a reset signal; The conversion control module includes SR logic, which is configured to generate the fluctuation unit signal based on the set signal and reset signal from the single-pole double-throw switch; The drug delivery device includes a counter block configured to determine the number of rotation units of the rotatable element based on the number of rising edges, falling edges, or both rising and falling edges of the generated oscillating unit signal. The controller is configured to determine the amount of drug dispensed from the outlet based on the number of rotation units of the rotatable element determined during the dose dispensing mode.

2. The drug delivery device according to claim 1, further comprising: Battery; as well as A microprocessor, wherein the microprocessor includes one or both of SR logic and a controller.

3. The drug delivery device according to claim 2 further includes a metal-oxide-semiconductor field-effect transistor, wherein, The single-pole double-throw switch is electrically connected to the battery.

4. The drug delivery device according to claim 3, wherein, The microprocessor includes a software-controlled switch disposed between the voltage source and the metal-oxide-semiconductor field-effect transistor, wherein: In sleep mode, the single-pole double-throw switch is in a first state where the battery and the metal-oxide-semiconductor field-effect transistor are electrically connected, and the software-controlled switch is disconnected, so that the metal-oxide-semiconductor field-effect transistor is not electrically connected to the voltage source to prevent the battery from being depleted; and In the wake-up state, the software-controlled switch closes, making the metal-oxide-semiconductor field-effect transistor electrically connected to the voltage source.

5. The drug delivery device according to claim 4, wherein, The microprocessor includes a reset input and a wake-up input, wherein, in the wake-up state: a metal-oxide-semiconductor field-effect transistor applies a voltage to the reset input; and The single-pole double-throw switch is in a second state where the battery and the wake-up input terminal of the microprocessor are electrically connected.

6. The drug delivery device according to any one of claims 1-5, further comprising: exit; as well as A dosage button is axially translatable relative to the housing to activate a dosage dispensing mode in which medication is dispensed from the outlet. In a dosage setting mode, the dosage button is rotatable relative to the housing to select the dosage of medication to be delivered from the outlet.

7. The drug delivery device according to claim 6, wherein, The rotatable element is rotatable together with the dose button in the dose setting mode and is rotatable relative to the dose button in the dose dispensing mode, wherein the degree of rotation of the rotatable element during the dose dispensing mode determines the amount of drug to be dispensed from the outlet.

8. The drug delivery device according to claim 6, wherein, The single-pole double-throw switch is configured to sense the rotation of the rotatable element relative to the dosage button, wherein the printed circuit board is fixed to the dosage button.

9. The drug delivery device according to any one of claims 1-5, wherein, The mechanical switch includes a base connected to an arm of the single-pole double-throw switch, the base being mounted to the printed circuit board.

10. The drug delivery device according to any one of claims 1-5, wherein, The housing includes a reservoir and the drug within the reservoir.

11. A method for controlling drug delivery, comprising: A rotatable element that rotates relative to a printed circuit board has a series of protrusions spaced apart from each other, and the rotatable element is positioned to allow the protrusions to slide against the arm of a single-pole double-throw switch in the form of a mechanical switch mounted to the printed circuit board; The single-pole double-throw switch generates a setting signal and / or a reset signal; Based on the signal from the single-pole double-throw switch when the arm slides against the protrusion, a fluctuation signal is generated via a conversion control module electrically connected to the single-pole double-throw switch. The step of generating the fluctuation signal further includes generating the fluctuation signal via the SR logic of the conversion control module based on the setting signal and reset signal from the single-pole double-throw switch. as well as The number of rotation units of the rotatable element is determined by a counter block based on the number of rising edges, falling edges, or both rising and falling edges of the generated oscillating unit signal.

12. The method for controlling drug delivery according to claim 11, comprising: Switch the single-pole double-throw switch to the first state in which the battery and the metal-oxide-semiconductor field-effect transistor are electrically connected; as well as Switching the microprocessor's software control switch to open prevents the metal-oxide-semiconductor field-effect transistor from being electrically connected to the voltage source to prevent battery depletion and limit the sleep state; or switching the software control switch to close connects the metal-oxide-semiconductor field-effect transistor to the voltage source to limit the wake-up state.

13. The method for controlling drug delivery according to claim 12, wherein, The step of switching the software control switch to closed also includes applying a voltage to the reset input of the microprocessor via the metal-oxide-semiconductor field-effect transistor; and switching the single-pole double-throw switch to a second state in which the battery is electrically connected to the wake-up input of the microprocessor.

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