Software update of a dose detection module via a charging base

Abstract

The disclosed embodiments relate to a dose detection module that is removably attachable to an actuator of a drug delivery device. A dose detection module can include a housing coupled to the actuator, and an electronic assembly disposed at least partially within the housing. The electronic assembly can include a processor and an actuation sensor configured to detect actuation of the actuator. The electronic assembly further includes a rechargeable energy storage element configured to deliver power to the processor and the actuation sensor, and an energy transfer element configured to deliver power from an external energy source to the energy storage element. The electronic assembly further includes a communication module configured to communicate with a base communication module of a charging base to receive data from the base communication module and send data to the base communication module when the dose detection module is coupled to the charging base.

Description

Technical Field

[0001] The disclosed implementation involves a rechargeable dose detection module and software updates delivered to the dose detection module via a charging base. Background Technology

[0002] Patients and healthcare professionals already use a variety of drug delivery devices to administer medications. For example, some drug delivery devices, known as pen syringes or injection pens, accept a cartridge of medication (e.g., insulin or other drugs) and allow the user to select the dosage. Some drug delivery devices (including some injection pens) may be equipped with a dose detection module to monitor dose selection and / or delivery. Some dose detection modules can transmit data related to the use of the drug delivery device to a network, computing device, or application, allowing users and / or healthcare professionals to track and / or monitor device use. Summary of the Invention

[0003] The description pertains to implementations of modules, systems, and methods. In one implementation, a dose detection module is configured to be removably attached to a dose button of a drug delivery device. The module includes a housing configured to be coupled to the dose button. Electronic components are at least partially disposed within the housing. The electronic components include: a processor; an actuation sensor configured to detect actuation of the dose button; a rechargeable energy storage element configured to deliver power to the processor and the actuation sensor; and an energy transmission element configured to deliver power from a charger of the charging base to the energy storage element when the dose detection module is coupled to the charging base. Furthermore, a communication module is configured to communicate with a base communication module of the charging base to receive data from and send data to the base communication module when the dose detection module is coupled to the charging base.

[0004] In another embodiment, a medical device system is provided. The system includes a charging base and a dose detection module. The charging base includes a charger, a base processor, a base memory, and a base communication module. The dose detection module includes: a battery configured to be charged by the charger when the dose detection module is connected to the charging base; a module processor; a module memory; and a module communication module, all of which are operatively connected to each other. When the dose detection module is connected to the charging base, the base processor is configured to: receive data from the dose detection module; and send data to the dose detection module.

[0005] In another embodiment, a method is provided for updating the software of a dose detection module via a charging base. The charging base has a charger, a base processor, a base memory, and a base communication module. The dose detection module has: a battery configured to be charged by the charger when the dose detection module is connected to the charging base; a module processor; a module memory; and a module communication module, all of which are operatively connected to each other. The method includes the steps of: receiving data from the dose detection module after the dose detection module is connected to the charging base; and sending data to the dose detection module.

[0006] It should be understood that the foregoing concepts and the additional concepts discussed below can be arranged in any suitable combination, as this disclosure is not limited in this respect. Furthermore, other advantages and novel features of this disclosure will become apparent from the following detailed description of various non-limiting embodiments when considered in conjunction with the accompanying drawings.

[0007] In the event of conflicting and / or inconsistent disclosures in this specification and other documents incorporated by reference, this specification shall prevail. If two or more documents incorporated by reference contain disclosures that conflict and / or are inconsistent with each other, the document with the later effective date shall prevail. Attached Figure Description

[0008] In the accompanying drawings, each identical or nearly identical component / part illustrated in the various figures may be represented by the same reference numeral. For clarity, not every component may be labeled in every drawing. In the accompanying drawings:

[0009] Figure 1 This is a perspective view of a drug delivery device and a dosage detection module according to one implementation scheme;

[0010] Figure 1a This is a perspective view of a drug delivery device with an actuator having a dose detection module, according to another embodiment.

[0011] Figure 2 This is an exploded view of the electronic components of a dose detection module according to one implementation scheme;

[0012] Figure 3 This is a cross-sectional view of one embodiment of a dose detection module attached to a drug delivery device;

[0013] Figure 4A This is an exploded bottom view of the proximal sidewall assembly of a dose detection module according to one embodiment;

[0014] Figure 4B yes Figure 4A Exploded top view of the near-sidewall assembly;

[0015] Figure 5 This is a top perspective view of a dose detection module inserted into a charging base according to one embodiment;

[0016] Figure 6 This is an exploded view of a charging base for a dose detection module according to one embodiment;

[0017] Figure 7 This is a partial cross-sectional view of the dose detection module placed inside the charging base;

[0018] Figure 8 This is a diagram showing the electronic components of the dose detection module and the electronic components of the charging base; and

[0019] Figure 9 This is a flowchart illustrating a method for charging the dose detection module.

[0020] Figure 10 An exemplary method is shown for transmitting data between the dose detection module and the charging base while the dose detection module is being charged by the charging base.

[0021] Figure 11 An exemplary method is shown for using a charging base to check whether the firmware installed on the dose detection module is the most recent version of the firmware.

[0022] Figure 12 An exemplary method for downloading an updated version of firmware from a remote computing resource is shown.

[0023] Figure 13 An exemplary method for sending an updated version of firmware from the charging base to the dose detection module is shown.

[0024] Figure 14 A method for updating the firmware of a dose detection module to a new version is shown. Detailed Implementation

[0025] Drug delivery devices, including pen injectors, can be used in clinical or home settings to facilitate accurate, reliable, and / or convenient drug delivery. For example, some pen injectors may be configured to receive a cartridge of medication and allow the user to select the dose to be delivered. In some drug delivery devices, the dose can be selected by actuating a drug delivery / dosing component of the device. For example, some drug delivery devices may include a dose selector that can be rotated by the user to select the dose to be delivered. Once the dose is selected, the user can deliver the selected dose from the delivery device, for example, by self-injection or by injection into a patient or other individual under the user's care. In some devices, dose delivery can be achieved by actuating a dosing component of the device. For example, in response to actuation of the dosing component by the user, the dosing component can deliver the dose by actuating a needle assembly or other drug delivery mechanism. Some drug delivery devices may include a dose button that can be pressed by the user to deliver the dose. Some embodiments include an actuator that includes two components: a dose selector and a dose button. Some drug delivery devices (such as the KwikPen distributed by Eli Lilly) ® It may include an actuator, which is a single structure that can be rotated by the user to select the dose to be delivered, and pressed by the user to deliver the dose.

[0026] In some applications, monitoring and / or tracking information related to drug delivery (e.g., the selected or delivered dose or drug load, the time and / or date of delivery, errors associated with delivery, and / or any other appropriate dosing information) may be beneficial. Therefore, a dose detection module may be coupled to, removably attached to, and / or otherwise associated with a drug delivery device or a portion thereof to detect desired dosing information. For example, in some embodiments, the dose detection module may be configured to be removably attached to actuators (such as dose buttons and / or dose selectors) of the drug delivery device. Furthermore, in some embodiments, the dose detection module may be configured to detect a dose selected by the user, for example, by detecting actuation of a dosing component of the device (e.g., a dose control dial or other dose setting component). Additionally or alternatively, the dose detection module may be configured to detect the delivery of drug from the device, for example, by detecting actuation of a dosing component (e.g., a dose button or other dosing component). In some embodiments, the dosing component will be at least partially identical to a component of the device that operates during dose setting and dose delivery. Additionally, in some embodiments, the dose detection module may be configured to send dosing information derived from detected actuation to a network and / or a separate electronic device to facilitate monitoring and / or tracking.

[0027] In some implementations, the dose detection module may be configured to be actuated, for example, by rotating together with the dose selector and / or by pressing together with the dose button when attached to the drug delivery device. This co-actuation facilitates the detection of actuation of the drug delivery device while avoiding or at least reducing variations in how the user handles and / or operates the drug delivery device. For example, the user may rotate the dose detection module to change the dose selection by co-rotating the dose selector, and / or press the dose detection module to deliver the dose by co-actuating the dose button.

[0028] In addition to the above, the dose detection module may include various electronic components for performing the functions described herein. For example, the dose detection module may include an electronic assembly comprising a processor and one or more actuation sensors configured to detect actuation of a portion of a drug delivery device (e.g., a dosing component). In some embodiments, the actuation sensors may be operatively connected to the processor to transmit data indicating detected actuation to the processor. Furthermore, the processor may be configured to determine dosing information based at least in part on the data indicating detected actuation. In some embodiments, the dose detection module or its electronic components may also include a communication component configured to receive dosing information from the processor and transmit the dosing information to a network or user device (e.g., a smartphone, tablet, or other computing device) via a suitable wired or wireless communication protocol. Additionally, the dose detection module and / or its electronic components may include an energy storage element (e.g., a battery or other energy storage element) configured to provide power to the various electronic components. U.S. Patent Application Publication No. 2020 / 0114087 describes an exemplary and non-limiting example of a dose detection module, the entire contents of which are incorporated herein by reference.

[0029] In some dose detection modules, the energy storage element may be physically integrated within the module's structure, making it impossible for users to remove and / or replace the energy storage element without damaging or destroying the dose detection module. Because energy storage elements conventionally used in dose detection modules are configured to provide only a single charge cycle with a limited lifespan (in other words, they are conventionally non-rechargeable), users of conventional dose detection modules may need to replace the entire module when the energy storage element is fully discharged.

[0030] In view of the foregoing, the inventors have recognized and understood the benefits of a dose detection module having a rechargeable energy storage element. The ability to charge the energy storage element reduces the waste and / or cost associated with replacing a single-charged dose detection module that has already been discharged. In some embodiments, the dose detection module may include a rechargeable battery, such as, for example, nickel-cadmium, nickel hydride, lithium-ion, lithium polymer, lead-acid, or any other suitable type of rechargeable battery.

[0031] Additionally, in some embodiments, the dose detection module may include an energy transfer element that is in electrical communication with the rechargeable energy storage element to deliver power to the energy storage element from an external energy source (e.g., a wall socket, an external power supply, and / or a charging base as described herein).

[0032] In addition to the above, in some embodiments, the dose detection module may be able to charge the energy storage element via any suitable wired or wireless charging arrangement. Some dose detection modules may include an energy transfer element capable of wirelessly receiving power from an external energy source. For example, in some embodiments, the dose detection module and / or its energy transfer element may include an induction coil. The induction coil may be configured to wirelessly receive power from a corresponding induction coil of a charging base or other external energy source, and may be configured to deliver the received power to the energy storage element of the dose detection module. In some applications, wireless charging components and capabilities may facilitate faster, more reliable, and / or more convenient charging methods, for example, by reducing or eliminating the need for cables and associated ports that may become lost, damaged, or otherwise inconvenient to manage.

[0033] In addition to the above, the charging base may be configured to connect to and / or receive the dose detection module or a portion thereof, and may be configured to provide power to the dose detection module. For example, some charging bases may include a power delivery element configured to provide power to the dose detection module and / or its energy transmission element via any suitable wired or wireless charging circuitry. In some embodiments, the charging base and / or its power delivery element may be configured to wirelessly provide power to the dose detection module or energy transmission element. For example, the charging base and / or power delivery element may include an induction coil configured to provide power to a corresponding induction coil of the dose detection module. Of course, while wireless charging has been described throughout this disclosure, it should be understood that some dose detection modules and / or charging bases may additionally or alternatively use wired charging circuitry to support charging of the dose detection module, as this disclosure is not limited to wireless charging.

[0034] In some embodiments, the charging base may be configured to receive and / or couple to a dose detection module or a portion thereof. For example, in some embodiments, the charging base may include a bracket configured to receive the dose detection module. Some brackets may include a module slot, which may be an opening sized and shaped to receive and / or surround a portion of the dose detection module, such as the proximal end of the dose detection module. In some embodiments, the bracket may include an inner sidewall defining the module slot.

[0035] In some applications, the charging base may be further configured to indicate the charging level of a dose detection module associated with the charging base, so as to quickly and conveniently convey the charging level to the user. Therefore, some charging bases may include a processor configured to receive charging information from the dose detection module. The charging information may indicate the charging level of the dose detection module and / or its energy storage element. In some embodiments, the processor may be operatively coupled to one or more selectively activated indicators, such as one or more lights, speakers, and / or any other suitable indicators. The processor may be configured to selectively activate the indicators to indicate the charging level of the dose detection module, at least in part based on the charging information.

[0036] In addition to the above, the inventors have recognized that the dose detection module will also need the ability to receive firmware over-the-air (FOTA) updates. There are advantages to combining charging and FOTA capabilities. For example, providing FOTA capability allows the firmware of the dose detection module to remain up-to-date with minimal user intervention. FOTA capability also provides the user with some flexibility in controlling and / or determining the update environment. A mobile application can provide the user with some control over FOTA updates. For example, if the dose detection module needs to be used for a short period (e.g., resulting in an update potentially not being completed before the user needs to operate the dose detection module), the user can use the mobile application to postpone the update. When the dose detection module is placed in the charging dock for periodic charging, the charging dock can be configured to compare the version of the firmware in the dose detection module with the most recent / latest version stored in memory. If an update in the software is available, the firmware of the dose detection module can be updated during charging without human intervention.

[0037] Turning to the accompanying drawings, specific non-limiting embodiments are described in further detail. It should be understood that the various systems, components, features, and methods described with respect to these embodiments may be used individually and / or in any desired combination, as this disclosure is not limited to the specific embodiments described herein.

[0038] refer to Figure 1The drug delivery device 100 may include an injection pen or pen injector. The device 100 may have a generally elongated geometry, having a distal end portion 102 and a proximal end portion 104 opposite the distal end portion along the longitudinal direction of the device 100 (e.g., along the longitudinal axis AA). The distal end portion 102 may include a needle assembly configured to inject a drug from the device 100 into a patient or user. In the illustrated embodiment, the needle assembly may be contained within a cap 114 disposed at the distal end portion 102. In some embodiments, the drug delivery device may include a dosage delivery member 115 configured in the device to be moved to a position based on a selected dose of drug to be delivered, for example, by moving an actuator 105. The dosage delivery member 115 may be one or more components that interact together to move relative to a plunger to a position for dose setting during movement of the actuator and to advance the plunger distally during dose delivery. For example, the dosage delivery component 115 may be a dose control dial / knob, a flange component, a dose drum, or other components, at least one of which (such as, for example, a flange component, a dose control dial, and / or a dose drum) may also be used as a dosage delivery component during dose delivery. An actuator 105 is provided that can be rotated and / or pressed down during dose setting to initiate the delivery of the set dose. In the illustrated embodiment, the device 100 may include a dose selector 106 that can be rotated by a user in the direction of arrow 108 to select a dose. Additionally or alternatively, the device 100 may include an actuator configured to allow a user, for example, to deliver a certain dose of medication by actuating the actuator, which actuates the dosage delivery component 115 distally to operate a plunger within a cartridge carrying the medication. Actuation allows the plunger to advance within the cartridge to deliver medication through an injection needle from the outlet end of the cartridge. In the illustrated embodiments, device 100 may include a dose button 110 that can be pressed by a user in the longitudinal direction of the drug delivery device (e.g., in the direction toward the distal end portion 102). In some embodiments, actuation of the dose button or other dosing component may cause actuation of dosing component 115 and movement of the plunger and / or other portions of the drug delivery device to deliver a dose to the user or patient.

[0039] Figure 1a A drug delivery device 100 is shown with an actuator 105a, sometimes referred to as a dose button, wherein only the actuator is shown and the rest of the device is indicated by dashed lines. The actuator 105a can be rotated in either direction by the user during dose setting to set to the desired dose amount, which moves the internal dispensing member 115 to the appropriate position for the desired dose. After the desired dose is set, the actuator 105a can be pressed distally to deliver the dose to the user or patient. The actuator 105a is an actuable... Figure 1 The dose selector and dose button functions are integrated into a single component.

[0040] In some embodiments, the drug delivery device 100 may further include a dose indicator configured to indicate the currently selected dose to the user of the device. For example, in the illustrated embodiment, the device 100 may include a dose window 112 configured to allow the user to view the selected dose. In some embodiments, the dosage dispensing component and / or the dose indicator may be located at the proximal end portion of the device. For example, actuators 105, 105a, dose selector 106, dose button 110, and dose window 112 may be located at the proximal end portion 104.

[0041] The device according to this disclosure can carry and dispense one or more liquid medications, which may also be referred to as drugs or pharmaceuticals and can be held in a fluid chamber 158. Such drugs may include, for example, adrenaline, anesthetics, analgesics, steroids, insulin, insulin analogs (such as lispro insulin or glargine insulin, exetora 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, combined GIP / GLP-1 agonists (such as telposide, retaglutide, daclati), basal insulin, gastric acid regulator analogs, and gastric acid regulator derivatives. Biological and therapeutic antibodies (including, but not limited to, IL-23 antibody analogs or derivatives such as millizumab, IL-17 antibody analogs or derivatives such as ixekizumab), therapeutic agents for pain-related treatments such as gaccazumab or lasmidestan, or lebulizumab), and any therapeutic agent capable of being delivered via the device described herein. The device according to this disclosure may be operated by a user (e.g., a healthcare professional, caregiver, or another person) in a manner generally as described herein to deliver one or more medications to a patient (e.g., another person or user).

[0042] In addition to the above, the dose detection module may be provided in conjunction with a drug delivery device. For example, the dose detection module 200 may be removably attached to the drug delivery device 100. In some embodiments, including the illustrated embodiment, the dose detection module 200 may be removably attached to the proximal end portion 104 of the drug delivery device 100. In particular, some dose detection modules may be removably attached to a dose button and / or a dose selector; however, it should be understood that the dose detection module may be removably attached to any suitable portion of the drug delivery device, as this disclosure is not limited in this respect. In the illustrated embodiment, the dose detection module 200 may be removably attached to the dose button 110 and the dose selector 106. Additionally, the dose detection module 200 or a portion thereof may be configured to be actuated together with the dose button 110 and / or the dose selector 106 when the dose detection module is attached to the drug delivery device, such that actuation of the dose detection module 200 by the user causes corresponding actuation of the dose button and / or the dose selector.

[0043] In some embodiments, the dose detection module or its electronic components may include one or more actuation sensors to detect actuation of the dose detection module, dose button, and / or dose selector. In some embodiments, the dose detection module or electronic components may also include a processor and / or communication components to receive, process, and / or transmit data obtained from the actuation sensors and / or information derived from the sensor data. In some embodiments, the communication components may additionally or alternatively transmit information relating to the charge level of the energy storage element to, for example, external devices and / or charging bases as described herein.

[0044] exist Figure 2 In some embodiments, electronic component 214 may include circuit board 216, which includes operating circuitry for connecting various electronic components. In various embodiments, the circuit board may be any suitable circuit board, including printed circuit board (PCB), flexible printed circuit board (FPCB), and / or any other suitable circuit board. Energy storage element 218 may be mounted to circuit board 216 to store electrical energy and supply power to various electronic components such as processors and / or actuation sensors. In some embodiments, the energy storage element may be a rechargeable energy storage element. For example, in some embodiments, energy storage element 218 may be a rechargeable battery.

[0045] Furthermore, the rechargeable energy storage element 218 (“RESE”) can be operatively connected to an energy transfer element configured to transmit power from an external energy source to the rechargeable energy storage element. In various embodiments, the energy transfer element can be configured to transmit power via any suitable wired and / or wireless charging circuitry. For example, in some embodiments, the energy transfer element can be operatively connected to a Universal Serial Bus (USB) charging circuitry to receive and transmit power from an external power source via a wired USB connection. Additionally or alternatively, such as... Figure 2 As shown, the energy transfer element may be an induction coil 234, which is configured to receive and transmit power from an external power source via a wireless inductive power circuit (e.g., Figure 8 (As indicated by arrow 251 in the diagram). In another embodiment, the energy transfer element can be any suitable conductive element configured to receive and transmit power from an external power source via any suitable conductive power circuit.

[0046] In some embodiments, the energy transfer element may be isolated and / or insulated from various other components within the electronic assembly or dose detection module to prevent unintentional or stray conduction to other components. For example, in the illustrated embodiment, the induction coil 234 may be in electrical contact with the isolator member 220 on one or more sides. In various embodiments, the isolator member 220 may comprise a polyimide film or any other suitable insulating or insulating material.

[0047] In some embodiments, the dose detection module or its electronic components may include one or more selectively activated indicators to provide information to the user. For example, one or more lights, speakers, or other indicators may be selectively activated by the module's processor to indicate information about the dose detection module and / or a drug delivery device to which the module may be attached. For example, the indicators may be used to convey charging status and / or any other appropriate information about the dose detection module and / or the drug delivery device. Figure 2 In some embodiments, the electronic components may include one or more indicator lights 222, which may be selectively activated by a processor to indicate the charging status of the rechargeable energy storage element 218. In various embodiments, the indicator lights may be light-emitting diodes (LEDs) or any other suitable light source.

[0048] Despite Figure 2 Not shown, but it should be understood that electronic component 214 may additionally include any suitable electronic components of the dose detection module, including one or more processors, one or more actuation sensors and / or any other suitable components.

[0049] Furthermore, in some implementation schemes and references Figure 3The dose detection module may include a housing in which electronic components may be at least partially disposed. The housing may include a distal sidewall at a distal end portion, a proximal sidewall at a proximal end portion, and / or one or more sidewalls extending from the distal end portion to the proximal end portion in the longitudinal direction of the dose detection module. For example, housing 224 may include a distal sidewall 226 at the distal end portion 242, a proximal sidewall 230 at the proximal end portion 244, and a sidewall 228 extending at least partially from the distal end portion to the proximal end portion in an axial direction defined by the central axis AA of module 200 to define cavity 229.

[0050] The housing of the dose detection module can be configured to mate with a drug delivery device in any suitable manner. In some embodiments, the housing of the dose detection module can be configured to be removably attached to the drug delivery device or a portion thereof. Figure 3 As shown, when the drug delivery device 100 includes an actuator 105a, the housing may be configured to engage with the actuator 105a (or the dose button 110 and / or the dose selector 106, when in use), and / or any other suitable portion of the drug delivery device. For example, in some embodiments, the housing 224 may include one or more engagement features 232 configured to removably engage with corresponding engagement features of the actuator 105a (or the dose selector 106, dose button 110) and / or the device 100 (e.g., ridges 116 formed in the actuator 105a, dose selector, or dose button). Engagement features 232 may include tabs, flanges, magnets, snap-fit ​​members, friction fittings, washers, spring-loaded members, and / or any other suitable structure configured to removably engage with the device's actuator 105a, dose selector, dose button, and / or corresponding engagement features.

[0051] As described above, the dose detection module can be configured to be actuated together with various parts of the drug delivery device when the dose detection module 200 is removably attached to the device. Specifically, according to some embodiments, when the dose detection module 200 is removably attached to the actuator 105a, rotation of the module 200 (e.g., in the direction of arrow 108) causes the actuator 105a to rotate together with the module 200. Therefore, a user can change the dose to be delivered by rotating the module 200. Similarly, when the module 200 is removably attached to the actuator 105a, depressing the dose detection module 200 (e.g., in the direction of arrow 118) causes the actuator 105a to be depressed together with the dose detection module. Therefore, a user can deliver a dose by depressing the dose detection module.

[0052] In addition to the above, the dose detection module may include one or more actuation sensors configured to detect actuation of the dose detection module and / or a portion of the drug delivery device. For example, the dose detection module 200 may include at least one rotation sensor 236 configured to detect rotational movement of the dispensing member 115 in the device. Additionally or alternatively, the module 200 may include a translation sensor configured to detect translational movement of the dosage button 110. In various embodiments, the actuation sensor may be any suitable type of sensor, including magnetic sensors, magnetoresistive sensors, Hall effect sensors, proximity sensors, optical sensors, tactile sensors, inertial sensors, or any other suitable sensor or combination of sensors. Additionally, the actuation sensor may be configured to detect any suitable actuation of any suitable portion of the drug delivery device. The dispensing member may be configured to be detectable from its shape or material, or may include a sensing member 117 including sensing parameters detectable by at least the rotation sensor 236.

[0053] Furthermore, in some implementations, each actuation sensor may be associated with a processor 240 ( Figure 8 (As shown) Electrical communication is used to send data indicating actuation detected by the sensor to the processor. The processor can be configured to determine dosing information (e.g., selected dose and / or dose delivery) based at least in part on the data received from the actuation sensor. Furthermore, the processor 240 can be operatively connected to a communication component 258, which can be configured to send dosing information, charging information, and / or other data to an external device or network via any suitable wired or wireless communication protocol (e.g., Bluetooth, Wi-Fi, Near Field Communication, Radio Frequency, USB Connection, NFC, ANT, or others). The same communication component 258 or another communication module 241 can be used to send information to the charging base 300. The communication module 241 can be configured using the protocols listed above or another method described below. Dosing information may include data indicating the total movement of the dosing delivery component, such as total angular rotation, total axial travel of the module from the dose setting position to its zero position, number of clicks based on axial and / or rotational movement, number of drug units based on the number of clicks or axial and / or rotational movement, timestamps, battery charge level, temperature, actuator color, etc.

[0054] In some implementations, one or more portions of the housing may be configured to guide light from the interior of the housing to the exterior. This facilitates communication of any indications provided by indicator lights, such as the charging level of an energy storage device or other statuses of a dose detection module or drug delivery device. For example, in Figure 3In some embodiments, the near-sidewall 230 may be formed of a suitable material and / or in a suitable geometry to guide light emitted by the LED 222 from the interior of the housing 224 to the outer surface of the near-sidewall 230. In some embodiments, one or more other portions of the housing 224 may additionally or alternatively be shaped as light guides.

[0055] For reference Figure 3 As will be further understood, the housing of the dose detection module can be configured to attach to the drug delivery device without hindering the user from easily determining the selected dose. For example, the length of the sidewall 228 can be selected such that the distal end portion terminates proximally to the dose window 112. Thus, the housing can be configured to allow the user to easily view the dose window 112 of the drug delivery device when the dose detection module is attached to the drug delivery device.

[0056] In some embodiments, the proximal end portion of the housing may include a proximal sidewall assembly 260. The proximal sidewall assembly may include a proximal sidewall and a contact surface configured for contact by a user during dose delivery. In various embodiments, the contact surface may include any external surface or combination of surfaces of the dose detection module, the proximal sidewall assembly, and / or other portions of the module configured for contact by a user during dose delivery. In some embodiments, the contact surface may be configured to move relative to the proximal sidewall, for example, to generate free play in response to a torque applied to the contact surface, such that the proximal sidewall does not move in response to movement of the contact surface. In some embodiments, a disk may be included in the proximal sidewall assembly, and the contact surface may include an external surface of the disk. Additionally or alternatively, an external member may be included in the proximal sidewall assembly, and the contact surface may include an external surface of the external member. In some embodiments, the contact surface 246 may include one or more surfaces of the external member 262, one or more surfaces of the disk 210, and / or one or more surfaces of any other suitable portion of the dose detection module. In the illustrated embodiment, the contact surface 246 may include a proximal side 246A of the outer member 262, a proximal side 246B of the disk 210, and an outer surface 246C of the circumferential protrusion of the disk 210. The proximal side 246B may be recessed to a certain depth within the proximal end of the disk 210 to define a radial wall, thereby at least partially engaging the circumferential outer edge of the outer member 262.

[0057] The disk and / or external components can be configured to rotate relative to the proximal sidewalls. For example, such as... Figure 3 As shown, disk 210 can be rotatably coupled to proximal sidewall 230 such that (e.g., in the direction of arrow 248) a torque applied to disk 210 and / or external member 262 can cause disk 210 to rotate relative to proximal sidewall 230.

[0058] For further reference Figures 4A to 4BThe disc 210 can be rotatably coupled to the proximal sidewall 230 or other parts of the dosing module in any suitable manner. For example, the disc can be coupled to the proximal sidewall via a rotatable snap-fit, roller track, bearing arrangement, tongue and groove structure, and / or any other suitable rotatable coupling. In the illustrated embodiment, the disc 210 is rotatably coupled to the proximal sidewall 230 via a rotatable snap-fit. The disc may include one or more snap-fit ​​members 250 configured to pass through and engage with corresponding holes 252 in the proximal sidewall 230. Additionally, in some embodiments, the disc may include stabilizing features to reduce the tendency of the disc to oscillate about its center of rotation. For example, the disc 210 may include a stabilizing ring 254 extending from the distal side of the disc to engage with the proximal side of the proximal sidewall 230. Additionally, in some embodiments, the proximal sidewall may be configured to guide the rotation of the disc and / or restrict the translational movement of the disc. For example, the proximal sidewall 230 may include an annular guide 256 extending from the proximal side of the proximal sidewall. In some implementations, the size and shape of the annular guide 256 may be designed to receive the stabilizing ring 254 and may cooperate with the stabilizing ring to limit radial translation and / or other unwanted movement of the disk 210.

[0059] like Figures 4A to 4B As further shown, the proximal sidewall assembly 260 may include an external member 262. The external member 262 may include a contact surface or a portion thereof and may be configured to provide or enhance frictional engagement between the user and the contact surface (e.g., to prevent slippage). Additionally or alternatively, the external member 262 may be configured to control and / or guide light emitted within the housing. For example, in some embodiments, the external member 262 may be formed of a reflective material to prevent light from escaping through the proximal side of the disk 210. In some embodiments, the external member 262 may be formed of a translucent material to allow light to be seen through the proximal side of the disk.

[0060] refer to Figure 5 A charging base for the dose detection module can be configured to connect to the dose detection module and to provide power to the dose detection module when it is connected to the charging base. For example, the charging base 300 can be configured to receive and / or at least partially surround a portion of the dose detection module 200. Figure 5 In one embodiment, the charging base 300 may include a bracket 302 configured to receive at least a portion of the dose detection module. The bracket 302 may be configured to align and position the module to facilitate wireless charging of the module 200. In one example, the bracket 302 includes at least one outer sidewall 304. Although the bracket 302 is shown as having a generally cylindrical or partially conical geometry with only a single outer sidewall 304, it should be understood that the bracket may be formed with any suitable geometry having any suitable number of outer sidewalls, as this disclosure is not limited in this respect.

[0061] like Figure 6 Seen, the bracket 302 may also include at least one internal sidewall 330 defining the module slot 306. The size and shape of the module slot 306 may be designed to receive and surround the dose detection module 200 or a portion thereof, such as the proximal and / or distal ends of the dose detection module. In various embodiments, the size and shape of the module slot 306 may be designed to receive the dose detection module when: the module is attached to a drug delivery device (e.g., by designing the module slot to have sufficient depth to stabilize the drug delivery device); when the module is detached from the drug delivery device (e.g., by designing the module slot to have appropriate depth to allow a user to grasp the sides of the module to remove the module from the slot); or when the module is coupled to a drug delivery device and when the module is detached from the drug delivery device (e.g., by providing a moderate and / or variable depth around the periphery of the slot to stabilize the device while also allowing a user to grasp the sides of the module). In some embodiments and as Figure 5 As shown, the size and shape of the module slot can be designed to receive the dose detection module but not the distal end of the drug delivery device when the dose detection module is operatively coupled to the proximal end of the drug delivery device. In this respect, most of the drug delivery device is exposed to allow the user to easily remove the device from the charging base.

[0062] refer to Figure 6 and Figure 8The charging base 300 may include suitable circuitry and components for receiving power from an external power source, such as a wall socket, portable power supply, computer, or other powered device, or any other suitable power source. In some embodiments, the charging base 300 may include a cable port 310 formed in an outer side wall 304 to allow a power cable to be operatively connected to the internal circuitry of the charging base 300. For example, the cable port 310 may be configured to accept a USB cable, an AC power cable, a DC power cable, and / or any other suitable power cable. Furthermore, in some embodiments, the charging base 300 may include a circuit board 312 that includes operating circuitry for various components of the charging base 300 (e.g., a printed circuit board (PCB) and / or any other suitable circuit board) and connectivity between them. In some embodiments, the charging base 300 may include a processor 314 operatively connected to the various components and configured to transmit and receive signals to and from the various components, including operating instructions and / or any other suitable data. In some implementations, the processor may be configured to (e.g., by receiving charging information from the communication component of the dose detection module at a corresponding communication component 308 of the charging base) receive, process, and / or derive information relating to the charging level of the dose detection module. The processor may be further configured to selectively activate an indicator (e.g., an indicator light or other indicator operatively coupled to the processor) based at least in part on the charging information received and / or derived by the processor.

[0063] In some embodiments, the charging base 300 may further include a power delivery element 316 configured to provide power to the dose detection module when it is positioned in the module slot. Detection may occur via a charging circuit of the base 300. In various embodiments, the power delivery element may be configured to receive and transmit power via any suitable wired and / or wireless charging circuitry. For example, in some embodiments, the power delivery element may be a USB charging circuitry to receive power from an external power source via a wired USB connection and transmit power to the dose detection module. Additionally or alternatively, the power delivery element 316 may include an induction coil configured to receive power from an external power source and provide power to a corresponding induction coil of the dose detection module via a wireless induction power circuitry. The bracket 302 may be configured to axially align the coils of the corresponding component to facilitate the charging process. In further embodiments, the energy transfer element may be any suitable conductive element configured to receive power from an external power source and transmit power to the dose detection module via any suitable conductive power circuitry.

[0064] Additionally, in some embodiments, the charging base 300 may include one or more selectively activated indicators, such as one or more lamps, speakers, and / or any other suitable indicators. For example, one or more indicator lights 318 (e.g., LEDs or other suitable light sources) may be operatively coupled to the processor 314 such that the processor 314 may selectively activate the indicator lights to indicate the charge level of the dose detection module, at least in part, based on charging information received from the dose detection module. In some embodiments, the charging base 300 may additionally include components for facilitating the communication of information to a user. For example, in embodiments including one or more indicator lights, the charging base may include a light guide 320 to direct light from an internal indicating light source (e.g., indicator light 318) to an external portion of the charging base. The light guide 320 may be configured to direct light from the indicator light 318 toward an outer surface 322 of the light guide 320.

[0065] In addition, such as Figure 6 As shown, the charging base 300 may include a base 326 configured to stabilize the charging base on a support surface. For example, in some embodiments, the base 326 may include a weighted portion near the bottom of the charging base to keep the center of gravity of the charging base near the bottom. Additionally or alternatively, the charging base may include feet 328 that provide or enhance frictional engagement between the charging base 300 and the support surface.

[0066] Figure 7 A partial cross-section of a charging base 300 for receiving a dose detection module 200 is illustrated. The dose detection module 200 is shown as having an energy transmission element (shown as an induction coil 234) operatively coupled to an energy storage element 218 via a circuit board (not shown). The charging base 300 is shown as having a power delivery element 316 disposed along a circuit board 312. A cable port 310 extends within an outer sidewall 304 to allow a power cable (not shown) operatively connected to the circuit board and internal circuitry of the charging base 300. An indicator light (not shown) is coupled to the circuit board 312 and positioned to illuminate a light guide 320. The light member 320 is shown as a ring; however, other embodiments, such as an elongated member for forming a window, may be provided to achieve a light indication of less than 360 degrees less than that provided by the ring. A slot 306 of the charging base 300 may be configured to align and position the power delivery element 316 and the energy transmission element 234 to facilitate wireless charging of the module 200. For example, the power delivery element 316 and the energy transfer element 234 may be coaxially aligned along axis AA, and / or there may be an axial distance X between the power delivery element 316 and the energy transfer element 234 to achieve enhanced wireless charging.

[0067] Communication between the dose detection module 200 and the charging base 300 can occur using communication modules 241 and 341, respectively. The communication mode can utilize a direct contact electrical interface, wireless grounding, or a trigger sensor, such as a mechanical switch, a Hall effect magnetic sensor, an inductive sensor, or an optical sensor. In one example, communication module 241 includes activating an optical pattern using a light source (module 241) and detecting the optical pattern using an optical sensor (communication module 341) within the charging base 300. The optical pattern is detected by the charging base to determine at least one of a fully charged, charging-needed, or error state, as described above.

[0068] Figure 9 A method 900 for charging a dose detection module is illustrated, the method comprising one or more of the following steps. In operation, charging the dose detection module may include, for example, connecting a charging base to a power source using a cable port of a charging base as described herein (step 902). The proximal end of the dose detection module is then inserted into a module slot of the charging base (step 904). In some embodiments, the proximal end of the dose detection module may be surrounded by an inner wall of the charging base. Inserting the proximal end of the dose detection module into the module slot may optionally include at least partially inserting the proximal end of a drug delivery device to which the dose detection module is coupled into the module slot. Alternatively, inserting the proximal end of the drug delivery device into the module slot may include inserting the proximal end of the drug delivery device into the module slot without inserting the distal end of the drug delivery device into the module slot.

[0069] In some embodiments, after insertion step 904, power can be increased (or activated) to the dose detection module 200. Once inserted, the charge level of multiple stored levels of the rechargeable energy storage element in the memory 217 of module 200 can be determined. These multiple stored levels can be any one or more of fully charged, charging required, or an error state. A fully charged state indicates that the capacity of the rechargeable energy storage element is 90%-100% of its full capacity. A charging required state indicates that the capacity of the rechargeable energy storage element is 0%-90% of its full capacity. An error state can be that the rechargeable energy storage element is unchargeable, overheated, etc. Based on the determined charge level, a step can occur where a signal indicative of the determined charge level is transmitted between the dose detection module 200 and the charging base 300. The charging base 300 can be configured to indicate to the user the status of the dose detection module 200 from multiple states. In some embodiments, the insertion state of the dose detection module 200 into the charging base 300 can be determined prior to the aforementioned power increase step. If the insertion status is positive, the power-increasing step proceeds; if the insertion status is negative, the power-increasing step is not allowed, i.e., charging does not begin. In other words, when something other than the module is inserted into the charging base, it may be desirable not to activate the charging circuit, thus avoiding the generation of power and heat.

[0070] The insertion state can be determined in several ways. For example, the insertion state can be determined by the charging circuit of the charging base 300. The charging circuit can be activated based on the presence of a sensing field generated from the energy transfer element 234 of the dose detection module 200. This sensing field may have specific electrical parameters, which the charging circuit uses to determine whether the module inserted into the base is of the expected type. In some examples, even when the correct type of module is inserted into the charging base (i.e., the insertion state is positive), the charging circuit in the charging base can still be deactivated to avoid unnecessary charging if the charging state is fully charged (or substantially 90% to 100%).

[0071] Communication between the dose detection module and the charging base can occur via each of its communication modules 241 and 341, respectively. Each communication module can be a transmitter, a receiver, or a transceiver. In one example, communication module 241 serves as a communication channel using sensing parameters (such as, for example, optical, BLE, NFC, ANT), and communication module 341 serves as a receiver configured to receive information transmitted from the channel. In one embodiment, the processor of module 200 is configured to activate an optical pattern using a light source, such as communication module 241. Figure 8As indicated by arrow 261 in the diagram. In response, an optical sensor (as communication module 341) in the charging base 300 can detect an optical pattern. The optical pattern indicates the charging state of the module and is detected by the charging base to determine at least one of a fully charged, charging-in-demand, or error state, as described above. Figure 7 Communication modules 341, 241 are shown arranged radially relative to each other, with communication module 341 disposed radially outward relative to communication module 241. In some embodiments, communication module 341 may be disposed axially relative to (or below) communication module 241. In some embodiments, there are more than one pair of communication modules 341, 241, such that one of each pair may be disposed axially and / or radially relative to the other of the pair.

[0072] Power can be received from a power source at the charging base (step 906), and the power can be delivered from the charging base to a rechargeable energy storage element of the dose detection module (step 908) (e.g., a rechargeable battery of the dose detection module). In some embodiments, delivering power from the charging base to the energy storage element may include delivering power from an induction coil of the charging base to a corresponding induction coil of the dose detection module. Power can then be delivered from the induction coil of the dose detection module to the energy storage element. Additionally, in some embodiments, the charge level of the energy storage element may be indicated by the charging base, for example, by selectively activating at least one indicator light (such as, for example, at least one red, green, yellow, or blue light) of the charging base with an optical pattern among a plurality of patterns stored in a memory 317 of the charging base 300. The optical patterns may include the same or different colors that remain on or flash a repeating sequence of on-off states for the same or different time periods. For example, when an error state as discussed above is determined, the red light may flash the optical pattern; when a full charge is determined, the green light may flash the optical pattern; and when a full charge is determined, the green light may remain on.

[0073] Generally, data (e.g., firmware updates) can be sent between the dose detection module and the charging base by inserting the dose detection module into the charging base for charging and then allowing data transmission during charging. Figure 10 An exemplary method 1000 for transmitting data between a dose detection module and a charging base while the dose detection module is being charged by the charging base is illustrated. According to method 1000, at step 1002, the dose detection module 200 is inserted into the charging base 300 to charge the dose detection module 200. Inserting the dose detection module 200 into the charging base 300 can be done according to the description herein (such as in conjunction with...). Figure 9The technique described in step 904 and / or any other suitable method is used to perform this action. Furthermore, the dose detection module 200 can be charged using any technique described herein (such as in combination with method 900 and / or any other suitable method). At step 1004, the dose detection module 200 can then transmit and receive data from the charging base 300 while the dose detection module 200 is charging. In some embodiments, as an example, see reference... Figure 9 As described, data transmission between the dose detection module 200 and the charging base 300 can be wirelessly facilitated via their respective communication modules 241 and 341 (e.g., Bluetooth, Wi-Fi, Near Field Communication, Radio Frequency, NFC, ANT, etc.). However, it should be understood that data transmission can be facilitated by any other suitable component or method, including wired communication and / or a combination of wired and wireless communication. For example, wired communication can be achieved via a wired and / or contact connection between the dose detection module 200 and the charging base 300. In addition to the insertion and charging states discussed herein, or as alternatives, the transmitted data may also include firmware data. Firmware data can be used to check for the availability of a new firmware version and to enable firmware updates. For example, the dose detection module 200 may send information to the charging base 300 indicating the current version of the firmware installed on the dose detection module 200 (e.g., so that the charging base 300 can check for a new firmware version or update). The dose detection module 200 may also receive firmware data from the charging base 300, such as new and / or latest available firmware versions and / or firmware updates. In some embodiments, data transfer may begin once the dose detection module 200 is inserted into the charging base 300. In some embodiments, data transfer may occur only after the dose detection module 200 has reached a certain threshold charge level (e.g., 30%, 50%, 80%, and / or any desired charge percentage threshold). In some embodiments, data transfer may occur only after an indication that the dose detection module 200 is fully or nearly fully charged. In some embodiments, data transfer may occur based on the size of the data to be transferred (X) and the threshold charge level (Y). For example, if the size of the data to be transferred exceeds 10 megabytes, the threshold charge level may be 90%, while if the size of the data to be transferred is 1 megabyte, the threshold charge level may be 50%. The amounts of X and Y may be adjusted depending on the technical capabilities of the dose detection module and the charging base. The amounts of X and Y can be stepped (X:Y), meaning, for example, 1 megabyte: 50%; 5 megabytes: 75%; 10 megabytes: 90%, or gradually tilted, for example, from 0.5 megabytes: 30% to over 10 megabytes: 100%.

[0074] After the user places the dose detection module in the charging base, the charging base charges the dose detection module and obtains the firmware version installed on the dose detection module. The charging base then receives the most recent firmware version of the dose detection module and determines whether the firmware installed on the dose detection module is the current version. If so, the charging base completes charging the dose detection module. If not, the system updates the firmware of the dose detection module.

[0075] Figure 11 An exemplary method 1100 is shown for using a charging dock to check whether the firmware installed on a dose detection module is the most recent version. At step 1102, the user places the dose detection module (e.g., dose detection module 200) into the charging dock (e.g., dose detection module 300). Then, at step 1104, the charging dock can charge the dose detection module 200. At step 1106, the charging dock 300 obtains the firmware version of the dose detection module 200. For example, the communication module 241 of the dose detection module 200 can receive a request for the firmware version installed on the dose detection module 200 from the dock communication module 341 of the charging dock 300. The communication module 241 can then send the firmware version installed on the dose detection module 200 to the dock communication module 341. As discussed above, the dose detection module may need to be charged to a minimum power level (e.g., 50%) before proceeding to step 1106 and / or subsequent steps to check or attempt a firmware update. It is understood that the method of obtaining the firmware version of the dose detection module is for illustrative purposes only, and the charging base can be used by any suitable method (e.g., such as without request, and alternatively the dose detection module 200 is configured to send version information automatically).

[0076] At step 1108, the charging base 300 obtains the latest firmware version from a remote computing resource. The remote computing resource can be any suitable computing device, such as a server, a remote computing device, a combination of computing resources forming a distributed network of remote computing devices (e.g., cloud computing devices), etc. In some embodiments, the charging base 300 may receive the latest firmware version directly from the remote computing resource, for example, using a base communication module 341. In some embodiments, the charging base 300 may be operatively coupled to a local computing device, enabling the local computing device to receive the latest firmware version from the remote computing resource and send the latest firmware version to the charging base 300. Alternatively or additionally, the charging base 300 may check and receive the latest firmware version from the remote computing resource in real-time or near real-time without placing the dose detection module 200 in the charging base. For example, before the dose detection module 200 is placed in the charging base 300, the charging base may periodically communicate with the remote computing resource and may receive the latest firmware version from the remote computing resource, for example, using the base communication module 341. The charging base can then store the latest firmware version on the charging base 300, for example, in memory 317, for use when the dose detection module 200 is placed in the charging base 300. Then, when the dose detection module 200 is placed in the charging base 300, the charging base 300 can use the firmware version stored on the charging base 300 to check and update the firmware of the dose detection module 200, for example, as described in step 1110.

[0077] At step 1110, the system may check whether the firmware of the dose detection module is the current version. In some embodiments, the base communication module 341 may perform the firmware version check. In some embodiments, the communication module 241 or any other suitable component may perform the firmware check. Checking whether the firmware of the dose detection module is the current version may include comparing information associated with the firmware version installed on the dose detection module 200 with information associated with the most recent version of the firmware received by the charging base 300. For example, the system may compare the version number of the firmware version installed on the dose detection module 200 with the most recent version, or it may compare the installation date of the firmware version installed on the dose detection module 200 with the date the most recent version became available, or it may use any other suitable information to indicate whether the firmware version installed on the dose detection module is the current version.

[0078] If the system determines that the firmware version installed on the dose detection module 200 is the current version, the system can proceed to step 1112A and complete the charging of the dose detection module 200. If the system determines that the firmware version installed on the dose detection module 200 is not the current version, the system can proceed to step 1112B and update the firmware of the dose detection module 200. (Refer to...) Figure 12, Figure 13 and / or Figure 14 An exemplary method for updating the firmware of the dose detection module 200 is further described. Although 1112A and 1112B are depicted as separate steps, it is understood that if the system determines that the firmware version installed on the dose detection module 200 is not the current version, step 1112B may be performed together with step 1112A, as per [reference to...]. Figure 10 As described.

[0079] If the system determines that the firmware version installed on the dose detection module is not the current version, the charging base can download a new and / or latest firmware version to be installed on the dose detection module from a remote computing resource. Alternatively, the charging base can download the new and / or latest firmware version before or simultaneously with determining whether the firmware version installed on the dose detection module is the current version (e.g., if the firmware version stored at the charging base is not the current version). The charging base can then verify whether the download was successful. If the download is successful, the charging base can send the new firmware version to the dose detection module. If the download is unsuccessful, the charging base can check how many download attempts have been made. To prevent infinite looping of attempts, if the total number of download attempts is less than or equal to a threshold number of attempts (e.g., three attempts), the system can cause the charging base to attempt to download the new and / or most recent version again. If the total number of attempts exceeds the threshold number of attempts, the system can determine that the firmware update has failed. The system can provide relevant notifications to the user via the dose detection module and / or network or user equipment. For example, the system can provide the user with a notification that the firmware update has failed. The system may also notify the firmware provider of download failures (e.g., because this may indicate a problem with the system). In some implementations, the firmware provider may be a host of a remote computing resource and / or a company that uses remote computing to provide firmware updates, such as the company providing the dose detection module 200. Alternatively or additionally, the system may present the user with options for contacting the host of the remote computing resource, for example, via a mobile application.

[0080] Figure 12A method 1200 for downloading an updated version of firmware from a remote computing resource is illustrated. At step 1202, the charging base 300 may download a new and / or latest firmware version from the remote computing resource or any suitable computing resource as described herein. In some embodiments, the base communication module 341 may communicate with the remote computing resource using any communication method described herein to download the new and / or latest firmware version. At step 1204, the charging base 300 may verify successful download. In some embodiments, the charging base 300 may verify successful download by running a checksum algorithm (e.g., longitudinal parity check, sum-of-component complement, or cyclic redundancy check). In some embodiments, the charging base 300 may verify successful download by examining the downloaded file of the new and / or latest firmware version to check for file size or potential corruption, or any other indication that the new and / or latest firmware version has been downloaded correctly. In some examples, the new and / or latest firmware version may be downloaded as an encrypted file, and verifying successful download may include decrypting the encrypted file. For example, the firmware file may include a firmware image signed by the firmware developer using a private key, allowing the device to proceed with the verification process before accepting and installing the firmware. At step 1206A, the charging base 300 may determine whether the download was successful. In some embodiments, the charging base 300 may send a signal indicating whether the download was successful to a remote computing resource simultaneously with or after step 1204.

[0081] If the download fails, at step 1206B, the system may track and / or determine the number of download attempts the system has made. For example, at each attempt, the charging base 300 may store a value indicating the total number of attempts made. At each subsequent attempt, the charging base 300 may increment the attempt count by one. In some embodiments, the total number of attempts may be the sum of any other calculated number of attempts described herein, for example, as referenced... Figure 13 The total number of attempts described for transferring new and / or latest firmware to the dose detection module, or as referenced. Figure 14 The total number of attempts to update the firmware for the dose detection module, or any other suitable value or combination thereof. The system can then compare the total number of download attempts with a threshold number of attempts (e.g., three attempts, five attempts, ten attempts, or any suitable number of attempts). If the total number of attempts is less than the threshold number, the system can attempt to download again. If the total number of attempts is greater than the threshold number, the system can determine that the firmware update has failed. The charging base 300 can provide the user with a notification that the firmware update has failed. This can be done in any suitable manner as described herein (e.g., using references...). Figure 9The described indicator light on the charging base may be used, but a separate indicator light or optical pattern different from the charging status indicator may be used to provide notifications (or via a connected mobile app).

[0082] If the download is successful, the system can proceed to step 1208A and cause the charging base 300 to send the new and / or latest firmware version to the dose detection module 200, for example using communication modules 241 and 341 that communicate in any suitable manner described herein.

[0083] The charging base may first send the updated firmware version to the dose detection module. The dose detection module then verifies receipt and responds to the charging base. For example, the dose detection module may respond to the charging base by providing a signal indicating success or failure after determining whether the transmission was successful. If the transmission is successful, the dose detection module may update the firmware installed on it to the new version. If the transmission fails, the system may determine the total number of transmission attempts made. Depending on the determined total number of transmission attempts, the system may proceed differently. If the total number of transmission attempts is less than a first specific number of attempts, the charging base may attempt to transmit the updated firmware version again. If the total number of transmission attempts is between the first specific number of attempts and a second specific number of attempts greater than the first specific number, the charging base may re-download the new and / or latest firmware version from a remote computing resource. If the total number of attempts is greater than the second specific number of attempts, the system may determine that the firmware update has failed and may provide the user with a notification indicating the failure.

[0084] Figure 13 A method 1300 for sending an updated firmware version from a charging base to a dose detection module is illustrated. At step 1302, the charging base 300 may send the new and / or latest firmware version to the dose detection module 200. In some embodiments, this may be achieved by communication modules 241 and 341 in any manner described herein (e.g., as per [reference to...]). Figure 9 (as described) or any other suitable method to facilitate the transfer. In some embodiments, method 1300 may proceed directly from and / or immediately follow method 1200; for example, step 1208A of method 1200 and step 1302 of method 1300 may overlap as the same step. At step 1304, dose detection module 200 may verify the reception of the new and / or latest firmware version and respond to charging base 300. For example, communication module 241 may transmit a signal to base communication module 341 indicating that a new and / or latest firmware version has been received. At step 1306A, the system may determine whether the transfer was successful.

[0085] If the transfer fails, at step 1306B, the system can determine the number of transfer attempts the system has made. For example, the dose detection module 200 can store a value indicating the total number of transfer attempts, as further described with respect to step 1206B of method 1200. The system may proceed to different steps depending on the determined number of transfer attempts. If the number of transfer attempts is less than a first number of attempts, such as three, five, or ten attempts, or any suitable number of attempts, the system can cause the charging base 300 to attempt to transfer the new and / or most recent version of the firmware to the dose detection module again. If the number of transfer attempts is between the first number of attempts and a second number of attempts greater than the first number of attempts, the system can proceed to step 1308B, and the charging base 300 can re-download the new and / or most recent version of the firmware from a remote computing resource, as further described with respect to step 1206B of method 1200. Figure 12 Or any other suitable method as described herein. If the total number of attempts is greater than the second attempt, the system proceeds to step 1308C, and it can determine that the firmware update has failed, and a notification can be sent to the user, as described herein for example regarding... Figure 12 Further description.

[0086] If the download is successful, the system can proceed to step 1308A, and the dose detection module 200 will update the firmware installed on the dose detection module 200 to the new version. In some embodiments, the module processor 240 of the communication module 241 can perform a firmware update by receiving new and / or latest firmware from the base communication module 341 and rewriting the current version of the firmware installed on the dose detection module 200. This document is about Figure 14 The firmware update is described further.

[0087] The dose detection module can execute an update process to update the firmware to a new version. The dose detection module can then check if the update process was successful. If the update fails, the system can determine the number of update attempts and proceed with different steps depending on the number of attempts. If the number of attempts exceeds a threshold, the system can warn the user of the update failure and stop the update process (e.g., revert to the previous firmware version). If the number of attempts is within a first range, the system can return to the delivery step and have the charging base re-deliver the firmware to the dose detection module. If the number of attempts is within a second range between the first and the threshold, the system can return to the download step and have the charging base re-download the new and / or latest firmware from a remote computing resource (e.g., because the download may contain errors that caused the firmware update to fail). If the update is successful, the system can notify the user that the firmware charging and update are complete.

[0088] Figure 14A method 1400 for updating the firmware of a dose detection module to an updated version of the firmware is shown. At step 1402, the dose detection module 200 may update the firmware installed on the dose detection module 200 to the new version. For example, the module processor 240 or any other component may enable the dose detection module to update the firmware to the new version. In some embodiments, method 1400 may be performed directly from and / or immediately following method 1300; for example, step 1208A of method 1200 and step 1302 of method 1300 may overlap as the same step. At step 1404A, the system may check whether the update was successful. If the update is unsuccessful, the system may, for example, use the dose detection module 200 to determine the total number of update attempts, such as regarding... Figure 11 As described. If the total number of update attempts exceeds the threshold number of attempts, the system can determine that the update has failed and can notify the user, as per the description. Figures 11 to 13 As described. If the total number of update attempts is less than a first range, such as three to five attempts or five to ten attempts or any other suitable range, the dose detection module 200 may retry updating the firmware. If the total number of update attempts is within the first range, the system may return to the state described above. Figure 13 The described transfer steps, and cause the charging base 300 to retransmit the firmware to the dose detection module 200. If the total number of update attempts is within a second range between a first range and a threshold number of attempts, the system can return to the state as described above. Figure 12 The described download steps enable the charging base 300 to re-download new and / or the latest firmware from a remote computing resource.

[0089] If the update is successful, the system can proceed to step 1406A and notify the user that the firmware charging and update are complete. This can be achieved through the methods described herein (e.g., as per [reference to...]). Figures 11 to 13 The notification may be delivered to the user by any method described herein. The notification may be delivered via a mobile application, one or more indicator lights on the charging base 300, or any other suitable method.

[0090] Although it has been discussed Figures 10 to 14FOTA methods and techniques have been described, but it is understood that these are for illustrative purposes only and can be modified according to the needs of the system and the user. For example, although the above embodiments have been described with respect to the dose detection module 200 and the charging base 300, it is understood that a particular charging base may be compatible with any number of dose detection modules. For example, a user may have multiple pen syringes or other drug delivery devices for the same or different possible drugs, each of which may have a corresponding dose detection module. A single charging base may be compatible with all corresponding dose detection modules, such that the user may only need one charging base to charge and update the firmware on each of the corresponding dose detection modules.

[0091] In some implementations, the latest firmware version may differ from the firmware version installed on the dose detection module by more than one version. For example, the version installed on the dose detection module may be version one, and the most recent version may be version three, four, or any other newer version. It is understood that whether the firmware can be directly updated to the most recent version depends on the difference between the version installed on the dose detection module and the most recent version. In some implementations, the charging base may update the firmware version installed on the dose detection module in one or more incremental updates. Any or all incremental updates may follow the guidelines regarding... Figures 10 to 14 The described method. Incremental updates can be performed in consecutive equal increments, for example, from version one to version two to version three, or from version one to version three to version five, or up to the latest compatible version. For example, if version one can be directly updated to any of versions two, three, or four, an incremental update can directly update the version to version four, and then update version four to the next latest compatible version or the most recent version. In these implementations, the charging base can determine the latest compatible version rather than as described above. Figure 11 The described latest firmware version. After the update, the system can check the version again to ensure that the firmware has been updated to the most recent available version.

[0092] The embodiments described above in this document can be implemented in any of a variety of ways. For example, the embodiments can be implemented using hardware, software, or a combination thereof. When implemented in software, the software code can execute on any suitable processor or set of processors, whether provided in a single computing device or distributed across multiple computing devices. Such processors can be implemented as integrated circuits, wherein one or more processors are in integrated circuit components, including commercially available integrated circuit components known in the art, such as CPU chips, GPU chips, microprocessors, microcontrollers, or coprocessors. Alternatively, the processor can be implemented in custom circuitry such as ASICs or in semi-custom circuitry produced by configuring programmable logic devices. As yet another alternative, the processor can be part of a larger circuit or semiconductor device, whether commercially available, semi-custom, or custom. As a specific example, some commercially available microprocessors have multiple cores, such that one or a subset of those cores can constitute a processor. However, the processor can be implemented using circuitry of any suitable format.

[0093] Furthermore, it should be understood that a computing device including one or more processors can be embodied in any of a variety of forms, such as a rack-mount computer, desktop computer, laptop computer, or tablet computer. Additionally, the computing device can be embedded in a device that is not typically considered a computing device but has suitable processing capabilities, including a personal digital assistant (PDA), smartphone, tablet computer, or any other suitable portable or fixed electronic device.

[0094] In addition, computing devices may have one or more input and output devices. These devices are particularly useful for presenting user interfaces. Examples of output devices that can be used to provide a user interface include displays for visual presentation of output and speakers or other sound-generating devices for audible presentation of output. Examples of input devices that can be used for a user interface include keyboards, individual buttons, and pointing devices such as mice, touchpads, and digitizers. As another example, computing devices may receive input information via voice recognition or in other audible formats.

[0095] Such computing devices can be interconnected via one or more networks of any suitable form, including local area networks (LANs) or wide area networks (WANs), such as corporate networks or the Internet. Such networks can be based on any suitable technology and operate according to any suitable protocol, and may include wireless networks, wired networks, or fiber optic networks.

[0096] Furthermore, the various methods or processes outlined herein can be decoded into software that can be executed on one or more processors of any of a variety of operating systems or platforms. Additionally, such software can be written using any of a variety of suitable programming languages ​​and / or 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.

[0097] In this regard, the embodiments described herein may be embodied in computer-readable storage media 217, 317 (or multiple computer-readable media) (e.g., computer memory, one or more floppy disks, optical disks (CDs), digital video disks (DVDs), magnetic tape, flash memory, RAM, ROM, EEPROM, field-programmable gate arrays or other semiconductor devices, or other tangible computer storage media) encoded with one or more programs that, when executed on one or more computers or other processors, perform methods implementing the various embodiments discussed above. It is evident from the foregoing examples that a computer-readable storage medium can retain information for a sufficient time to provide computer-executable instructions in a non-transitory form. Such one or more computer-readable storage media may be transportable, such that one or more programs stored thereon can be loaded onto one or more different computing devices or other processors to implement the various aspects of this disclosure as described above. As used herein, the term "computer-readable storage medium" covers only non-transitory computer-readable media that can be considered an article of manufacture (i.e., an article of production) or a machine. Alternatively or additionally, this disclosure may be embodied in computer-readable media other than computer-readable storage media, such as propagating signals.

[0098] The terms “program” or “software” are used herein in a general sense to refer to any type of computer code or set of computer-executable instructions that can be used to program computing devices or other processors to implement the various aspects of this disclosure as discussed above. Additionally, it should be understood that, according to one aspect of this embodiment, one or more computer programs that perform the methods of this disclosure when executed do not need to reside on a single computing device or processor, but can be distributed in a modular manner among multiple different computers or processors to implement the various aspects of this disclosure.

[0099] Computer-executable instructions can take many forms, such as program modules, and can be executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc., that perform specific tasks or implement specific abstract data types. Typically, the functionality of program modules can be combined or distributed in various implementation schemes as needed.

[0100] The implementations described herein can be embodied in methods for which examples have been provided. Actions performed as part of a method can be ordered in any suitable manner. Therefore, implementations in which actions are performed in an order different from the illustrative order can be constructed, and these implementations may include the simultaneous execution of some actions, even if they are shown as sequential actions in the illustrative implementation.

[0101] Furthermore, some actions are described as being performed by a “user.” It should be understood that a “user” does not need to be a single individual, and in some implementations, actions attributable to a “user” may be performed by a group of individuals and / or by individuals in combination with computer-aided tools or other mechanisms.

[0102] While several embodiments of the invention have been described and illustrated herein, those skilled in the art will readily conceive of a variety of other components and / or structures for performing the functions and / or achieving one or more of the results and / or advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the invention. More generally, those skilled in the art will readily understand that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on one or more specific applications using the teachings of the invention. Those skilled in the art will recognize or be able to discover many equivalents of the specific embodiments of the invention described herein using no more than conventional experimentation. Therefore, it should be understood that the foregoing embodiments are presented by way of example only, and the invention may be practiced in ways other than those specifically described and claimed within the scope of the appended claims and their equivalents. The invention relates to each individual feature, system, article, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the invention if they do not contradict each other.

[0103] Various aspects are described in this disclosure (including the summary of the invention), including but not limited to the following:

[0104] In various aspects of this disclosure, a dose detection module is configured to be removably attached to a dose button of a drug delivery device. The module includes: a housing configured to be coupled to the dose button; electronic components at least partially disposed within the housing, the electronic components including: a processor; an actuation sensor configured to detect actuation of the dose button; a rechargeable energy storage element configured to deliver power to the processor and the actuation sensor; an energy transmission element configured to deliver power from a charger of the charging base to the energy storage element when the dose detection module is coupled to the charging base; and a communication module configured to communicate with a base communication module of the charging base to: receive data from the base communication module and send data to the base communication module when the dose detection module is coupled to the charging base.

[0105] In various aspects of this disclosure, the communication module is configured to: receive a request for a firmware version of the dose detection module from the base communication module; send the firmware version of the dose detection module to the base communication module; and receive the new firmware version from the base communication module when the base communication module determines that the firmware version of the dose detection module is older than a newer firmware version of the dose detection module.

[0106] In various aspects of this disclosure, the processor is configured to install the new version of the firmware of the dose detection module when it receives the new version from the base communication module.

[0107] In various aspects of this disclosure, a medical device system includes: a charging base having a charger; a base processor; a base memory; and a base communication module; a dose detection module having a battery configured to be charged by the charger when the dose detection module is connected to the charging base; a module processor; a module memory; and a module communication module, wherein the battery, the module processor, the module memory, and the module communication module are all operatively connected to each other, wherein when the dose detection module is connected to the charging base, the base processor is configured to: receive data from the dose detection module; and send data to the dose detection module.

[0108] In various aspects of this disclosure, the base communication module is configured to: obtain the firmware version of the dose detection module; check whether the firmware version of the dose detection module is the current version; if the firmware version is not the current version, download a new version of the firmware from a remote computing resource; and send the new version of the firmware to the dose detection module.

[0109] In various aspects of this disclosure, the base communication module checks whether the version of the firmware of the dose detection module is the current version by: obtaining the most recent version of the firmware stored in the remote computing resource; and determining whether the version of the firmware of the dose detection module is the most recent version of the firmware.

[0110] In various aspects of this disclosure, the module communication module is configured to receive the new version of the firmware of the dose detection module from the base communication module.

[0111] In various aspects of this disclosure, the module processor is configured to: update the firmware to the new version of the firmware when a new version of the firmware of the dose detection module is received; and output a notification when the update is complete.

[0112] In various aspects of this disclosure, the module processor is configured to: update the firmware of the dose detection module to the new version of the firmware; determine whether the update is successful; and output a first notification when the update is unsuccessful.

[0113] In various aspects of this disclosure, the module processor is further configured to: determine the number of failures when the update is unsuccessful; and retry updating the firmware of the dose detection module to the new version of the firmware when the number of failures is less than the maximum number of failures; and output a second notification when the number of failures is greater than the maximum number of failures.

[0114] In various aspects of this disclosure, a method for updating software of a dose detection module via a charging base having a charger, a base processor, a base memory, and a base communication module, and the dose detection module having a battery, a module processor, a module memory, and a module communication module, the battery being configured to be charged by the charger when the dose detection module is connected to the charging base, the battery, the module processor, the module memory, and the module communication module all being operatively interconnected, the method comprising the steps of: receiving data from the dose detection module after the dose detection module is connected to the charging base; and sending data to the dose detection module.

[0115] In various aspects of this disclosure, the method includes: obtaining a firmware version of the dose detection module from the base communication module; wherein the data receiving step includes checking whether the firmware version of the dose detection module is a current version; if the firmware version is not a current version, downloading a new version of the firmware from a remote computing resource; and wherein the data sending step includes sending the new version of the firmware to the dose detection module.

[0116] In various aspects of this disclosure, the method includes wherein the base communication module checks whether the version of the firmware of the dose detection module is a current version by: obtaining the most recent version of the firmware stored in the remote computing resource; and determining whether the version of the firmware of the dose detection module is the most recent version of the firmware.

[0117] In various aspects of this disclosure, the method further includes wherein the module communication module is configured to: receive the new version of the firmware of the dose detection module from the base communication module.

[0118] In various aspects of this disclosure, the method further includes the module processor being configured to: update the firmware to the new version of the firmware when the new version of the firmware of the dose detection module is received; and output a notification when the update is complete.

[0119] In various aspects of this disclosure, the method includes the module processor being configured to: update the firmware of the dose detection module to the new version of the firmware; determine whether the update is successful; and output a first notification when the update is unsuccessful.

[0120] In various aspects of this disclosure, the method includes wherein the module processor is further configured to: determine the number of failures when the update is unsuccessful; and retry updating the firmware of the dose detection module to the new version of the firmware when the number of failures is less than the maximum number of failures; and output a second notification when the number of failures is greater than the maximum number of failures.

[0121] In various aspects of this disclosure, a drug delivery device has a dosage button that is connected to the detection module when the detection module is connected to the charging base, and the drug delivery device includes a reservoir containing a drug.

Claims

1. A dose detection module configured to be removably attached to a dose button of a drug delivery device, the module comprising: A housing configured to be coupled to the dosage button; An electronic component, at least partially disposed within the housing, the electronic component comprising: processor; An actuation sensor is configured to detect actuation of the dosage button; A rechargeable energy storage element configured to deliver power to the processor and the actuation sensor; An energy transfer element configured to supply power from a charger of the charging base to the energy storage element when the dose detection module is connected to the charging base; and A communication module, configured to communicate with a base communication module of the charging base, when the dose detection module is connected to the charging base: Receive data from the base communication module; and Send data to the base communication module.

2. The dose detection module according to claim 1, wherein the communication module is configured as follows: Receive a request for a firmware version of the dose detection module from the base communication module; Send the firmware version of the dose detection module to the base communication module; When the base communication module determines that the firmware version of the dose detection module is older than the new firmware version of the dose detection module, it receives the new firmware version from the base communication module.

3. The dose detection module according to claim 2, wherein the processor is configured to: When the new version of the firmware of the dose detection module is received from the base communication module, the new version is installed.

4. A medical device system, the medical device system comprising: A charging base, wherein the charging base has a charger; Base processor; Base memory; Communication module with base; as well as A dose detection module having a battery configured to be charged by the charger when the dose detection module is connected to the charging base; a module processor; and a module memory. The battery, the module processor, the module memory, and the module communication module are all operatively interconnected. When the dose detection module is connected to the charging base, the base processor is configured as follows: Receive data from the dose detection module; as well as Data is sent to the dose detection module.

5. The medical device system according to claim 4, wherein the base communication module is configured as follows: Obtain the firmware version of the dose detection module; Check whether the firmware version of the dose detection module is the current version; If the firmware version is not the current version, download a new version of the firmware from a remote computing resource; and Send the new version of the firmware to the dose detection module.

6. The medical device system of claim 5, wherein the base communication module checks whether the firmware version of the dose detection module is the current version by the following operation: Obtain the most recent version of the firmware stored in the remote computing resource; and Determine whether the firmware version of the dose detection module is the most recent firmware version.

7. The medical device system according to claim 5, wherein the module communication module is configured as follows: The new version of the firmware of the dose detection module is received from the base communication module.

8. The medical device system according to claim 7, wherein the module processor is configured to: When a new version of the firmware for the dose detection module is received, the firmware is updated to the new version; and A notification is output when the update is complete.

9. The medical device system of claim 7, wherein the module processor is configured to: update the firmware of the dose detection module to the new version of the firmware; Determine whether the update was successful; and if the update was unsuccessful, output a first notification.

10. The medical device system of claim 9, wherein the module processor is further configured to: If the update fails, determine the number of failures; and When the number of failures is less than the maximum number of failures, retry updating the firmware of the dose detection module to the new firmware version; and When the number of failures exceeds the maximum number of failures, a second notification is output.

11. A method for updating software of a dose detection module via a charging base, the charging base having a charger, a base processor, a base memory, and a base communication module, and the dose detection module having a battery, a module processor, a module memory, and a module communication module, the battery being configured to be charged by the charger when the dose detection module is connected to the charging base, the battery, the module processor, the module memory, and the module communication module being all operatively interconnected, the method comprising the following steps: After the dose detection module is connected to the charging base, data is received from the dose detection module; as well as Data is sent to the dose detection module.

12. The method according to claim 11, further comprising: The firmware version of the dose detection module is obtained from the base communication module; The data receiving step includes checking whether the firmware version of the dose detection module is the current version; If the firmware version is not the current version, download a new version of the firmware from a remote computing resource; and The data transmission step includes sending the new version of the firmware to the dose detection module.

13. The method of claim 12, further comprising wherein the base communication module checks whether the version of the firmware of the dose detection module is the current version by: Obtain the most recent version of the firmware stored in the remote computing resource; and Determine whether the firmware version of the dose detection module is the most recent firmware version.

14. The method of claim 12, wherein the module communication module is configured to: The new version of the firmware of the dose detection module is received from the base communication module.

15. The method of claim 14, wherein the module processor is configured to: When a new version of the firmware for the dose detection module is received, the firmware is updated to the new version; and A notification is output when the update is complete.

16. The method of claim 14, wherein the module processor is configured to: Update the firmware of the dose detection module to the new firmware version; determine whether the update was successful; and If the update fails, output the first notification.

17. The method of claim 16, wherein the module processor is further configured to: If the update fails, determine the number of failures; and When the number of failures is less than the maximum number of failures, retry updating the firmware of the dose detection module to the new firmware version; and When the number of failures exceeds the maximum number of failures, a second notification is output.

18. The medical device system according to claim 4, further comprising a drug delivery device having a dosage button connected to the detection module, the drug delivery device including a reservoir containing a drug.

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