Software udpates to dose detection module via charging base

Abstract

Disclosed embodiments relate to dose detection modules that are removably attachable to an actuator of a medication delivery device. A dose detection module may include a housing which couples to the actuator, and an electronics assembly disposed at least partially within the housing. The electronics assembly may include a processor and an actuation sensor configured to detect actuation of the actuator. The electronics assembly also 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 to the energy storage element from an external energy source. The electronics assembly also includes a communication module configured to communicate with a base communications module of the charging base to, when the dose detection module is coupled to the charging base, receive data from the base communications module, and transmit data to the base communications module.

Description

SOFTWARE UDPATES TO DOSE DETECTION MODULE VIA CHARGING BASEFIELD

[0001] Disclosed embodiments are related to rechargeable dose detection modules and software updates delivered to the dose detection module via a charging base.BACKGROUND

[0002] Various medication delivery devices have been used by patients and medical personnel to administer medications. For example, some medication delivery devices known as pen injectors or injection pens may receive a cartridge of medication (e.g., insulin or other medication) and may allow a user to select a dose of the medication. Some medication delivery devices, including some injector pens, may be equipped with a dose detection module to monitor the selection and / or delivery of a dose. Some dose detection modules may communicate data related to the use of the medication delivery device to a network, computing device, or application to allow the user and / or medical personnel to track and / or monitor the use of the device.SUMMARY

[0003] What is described are module, system, and method embodiments. In one embodiment, a dose detection module is configured to removably attach to a dose button of a medication delivery device. The module includes a housing configured to couple to the dose button. An electronics assembly is disposed at least partially within the housing. The electronics assembly includes 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 to the energy storage element from a charger of a charging base when the dose detection module is coupled to the charging base. Also, a communication module is configured to communicate with a base communications module of the charging base to, when the dose detection module is coupled to the charging base, receive data from the base communications module, and transmit data to the base communications module.

[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 communications module. The dose detection module includes a battery configured to be recharged by the charger when the dose detection module is coupled to the charging base, a module processor, a module memory, and a module communications module, all operably coupled to one another. When the dose detection module is coupled to the charging base, the base processor is configured to: receive data from the dose detection module; and transmit data to the dose detection module.

[0005] In yet another embodiment, a method of updating software of a dose detection module via a charging base is provided. The charging base has a charger, a base processor, a base memory, and a base communications module. The dose detection module has a battery configured to be recharged by the charger when the dose detection module is coupled to the charging base, a module processor, a module memory, and a module communications module, all operably coupled to one another. The method including the steps of: receiving data from the dose detection module after the dose detection module is coupled to the charging base the base; and transmitting data to the dose detection module.

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

[0007] In cases where the present specification and a document incorporated by reference include conflicting and / or inconsistent disclosure, the present specification shall control. If two or more documents incorporated by reference include conflicting and / or inconsistent disclosure with respect to each other, then the document having the later effective date shall control.BRIEF DESCRIPTION OF DRAWINGS

[0008] In the drawings, each identical or nearly identical component that is illustrated in various figures may be represented by a like numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:

[0009] Fig. 1 is a perspective view of a medication delivery device and a dose detection module according to one embodiment;

[0010] Fig. la is a perspective view of a medication delivery device with another embodiment of an actuator with the dose detection module;

[0011] Fig. 2 is an exploded view of an electronics assembly of a dose detection module according to one embodiment;

[0012] Fig. 3 is a cross-sectional view of one embodiment of a dose detection module attached to a medication delivery device;

[0013] Fig. 4A is a bottom exploded view of a proximal wall assembly of a dose detection module, according to one embodiment;

[0014] Fig. 4B is a top exploded view of the proximal wall assembly of Fig. 4A;

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

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

[0017] Fig. 7 is a partial cross-sectional view of the dose detection module placed within the charging base;

[0018] Fig. 8 is a diagram of the electronics of the dose detection module and the electronics of the charging base; and

[0019] Fig. 9 is a flow diagram, showing a method of recharging the dose detection module.

[0020] Fig. 10 shows an exemplary method of transmitting data between a dose detection module and a charging base while the dose detection module is being charged by the charging base.

[0021] Fig. 11 shows an exemplary method of checking, using a charging base, if the firmware installed on a dose detection module is the latest version of the firmware.

[0022] Fig. 12 shows an exemplary method for downloading an updated version of firmware from a remote computing resource.

[0023] Fig. 13 shows an exemplary method for transmitting an updated version of firmware from a charging base to a dose detection module.

[0024] Fig. 14 shows a method for a dose detection module to update its firmware to a new version of the firmware.DETAILED DESCRIPTION

[0025] Medication delivery devices, including pen injectors, may be used in clinical or at-home settings to facilitate accurate, reliable, and / or convenient delivery of a medication. For example, some pen injectors may be configured to receive a cartridge of a medication, and may allow a user to select a dose of medication to be delivered. In some medication delivery devices, the dose may be selected by actuating a dosing component of the device. For example, some medication delivery devices may include a dose selector, which may be rotatable by a user to select a dose to be delivered. Once the dose has been selected, the user may then 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 may be accomplished by actuating the dosing component of the device. For example, the dosing component may deliver a dose by actuating a needle assembly or other dosing mechanism in response to actuation of the dosing component by the user. Some medication delivery devices may include a dose button, which may be depressed by a user to deliver a dose. Some embodiments include an actuator that comprises two components: the dose selector and the dose button. Some medication delivery devices, such as the KwikPen® distributed by Eli Lilly and Company, may include an actuator that is a single structure that is rotatable by a user to select a dose to be delivered and that is depressed by a user to deliver a dose.

[0026] In some applications, it may be beneficial to monitor and / or track information related to delivery of the medication (e.g., a dose or drug load selected or delivered, a time and / or date of a delivery, errors associated with a delivery, and / or any other appropriate dosing information). Accordingly, a dose detection module may be coupled to, removably attached to, and / or otherwise associated with a medication delivery device or a portion thereof to detect the desired dosing information. For example, in some embodiments, a dose detecting module may be configured to removably attach to an actuator (such as a dose button and / or a dose selector) of a medication delivery device. Further, in some embodiments, a 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 dial or other dose setting component). Additionally oralternatively, a dose detection module may be configured to detect a delivery of the medication from the device, for example by detecting actuation of the dosing component (e.g., a dose button or other the dosing component). In some embodiments, the dosing components will be at least partially the same components of the device that operate during dose setting and dose delivery. Additionally, in some embodiments, a dose detection module may additionally be configured to transmit dosing information derived from the detected actuation(s) to a network and / or a separate electronic device to facilitate monitoring and / or tracking.

[0027] In some embodiments, the dose detection module may be configured to actuate with a dosing component when the dose detection module is attached to the medication delivery device, for example by rotating with a dose selector and / or depressing with a dose button. This co-actuation may facilitate detection of the actuation of the medication delivery device, while also avoiding or at least decreasing changes in how a user handles and / or operates the medication delivery device. For example, the user may rotate the dose detection module to change a dose selection by co-rotation of the dose selector, and / or may depress the dose detection module to deliver a dose by co-actuation of the dose button.

[0028] Further to the above, a dose detection module may include various electronic components for performing the functions described herein. For example, a dose detection module may include an electronics assembly comprising a processor and one or more actuation sensors configured to detect actuation of a portion of a medication delivery device (e.g., a dosing component). In some embodiments, the actuation sensor(s) may be operably connected to the processor to transmit data indicative of the detected actuation to the processor. Further, the processor may be configured to determine dosing information based at least in part on the data indicative of the detected actuation. In some embodiments, a dose detection module or electronics assembly thereof may further include a communication component configured to receive dosing information from the processor and transmit the dosing information via an appropriate wired or wireless communication protocol to a network or user device (e.g., smartphone, tablet, or other computing device). Further, a dose detection module and / or an electronics assembly thereof may include an energy storage element (e.g., a battery or other energy storage element) configured to provide electrical power to the various electronic components. U.S. Patent Application Publication No. US 2020 / 0114087, which is incorporatedby reference herein in its entirety, describes one illustrative and non-limiting example of a dose detection module.

[0029] In some dose detection modules, an energy storage element may be physically mated within the structure of the module, such that a user may be unable to remove and / or replace the energy storage element without damaging or destroying the dose detection module. Because the energy storage elements conventionally used in dose detection modules are configured to provide only a single charge cycle having a limited useful life (in other words, they are conventionally non-rechargeable), a user of a conventional dose detection module may be required to replace the entire module when the energy storage element becomes fully discharged.

[0030] In view of the above, the inventors have recognized and appreciated the benefits of a dose detection module having a rechargeable energy storage element. The ability to recharge an energy storage element may reduce waste and / or costs associated with the replacement of single-charge dose detection modules which have been discharged. In some embodiments, a dose detection module may include a rechargeable battery, such as, for example, nickel-cadmium, nickel-metal-hydride, lithium-ion, lithium-polymer, lead-acid, or any other suitable type of rechargeable battery.

[0031] Additionally, in some embodiments, a dose detection module may include an energy transfer element 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 outlet, external power supply, and / or a charging base as described herein).

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

[0033] Further to the above, a charging base may be configured to couple with and / or receive a dose detection module or a portion thereof, and may be configured to provide electrical power to the dose detection module. For example, some charging bases may include a power delivery element configured to provide electrical power to a dose detection module and / or an energy transfer element thereof via any appropriate wired or wireless charging circuit. In some embodiments, a charging base and / or a power delivery element thereof may be configured to provide electrical power wirelessly to the dose detection module or energy transfer element. For example, a charging base and / or a power delivery element may include an induction coil configured to provide electrical power to a corresponding induction coil of a dose detection module. Of course, while wireless recharging is described throughout the present disclosure, it will be appreciated that some dose detection modules and / or charging bases may additionally or alternatively accommodate recharging of a dose detection module using a wired charging circuit, as the disclosure is not limited to wireless recharging.

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

[0035] In some applications, a charging base may further be configured to indicate a charge level of a dose detection module associated with the charging base in order to quickly and conveniently communicate the charge level to a user. Accordingly, some charging bases may include a processor configured to receive charge information from a dose detection module. The charge information may be indicative of a charge level of the dose detection module and / or an energy storage element thereof. In some embodiments, the processor may be operably coupled to one or more selectively activated indicators, such as one or more light(s), speaker(s), and / or any other appropriate indicator(s). The processor may be configured to selectively activate theindicator(s) to indicate a charge level of the dose detection module based at least in part on the charge information.

[0036] In addition to the above, the inventors have recognized that the dose detection module will also need the capability to receive firmware over-the-air (FOTA) updates. There are advantages to combining both the charging and FOTA capabilities. For example, providing FOTA capabilities may allow the firmware of the dose detection module to be kept up-to-date with little to no user intervention. FOTA capabilities may also provide users with some flexibility for controlling and / or determining update circumstances. A mobile application can provide the user some control of FOTA updates. For example, a user can postpone an update using a mobile application if the dose detection module needs to be used in a short period of time (e.g., such that the update may not complete before the user needs to operate the dose detection module). When the dose detection module is placed into the charging base for periodic recharging, the charging base can be configured to compare the version of firmware in the dose detection module against the most recent version stored in memory. If an update in software is available, the firmware of the dose detection module can be updated without human intervention while charging.

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

[0038] With reference to Fig. 1, a medication delivery device 100 may comprise an injection pen or pen injector. The device 100 may have a generally elongate geometry, having a distal end portion 102 and a proximal end portion 104 opposite the distal end portion along a longitudinal direction of the device 100 (e.g., along a longitudinal axis A-A). The distal end portion 102 may include a needle assembly configured to inject a medication from the device 100 into a patient or user. In the embodiment shown, the needle assembly may be contained within a cap 114 disposed at the distal end portion 102. In some embodiments, a medication delivery device may include a dosing component 115 that is configured in the device to move into a position based on the selected dose of medication to be delivered, for example by moving an actuator 105. The dosing component 115 can be one or more components that interacttogether to move to a position relative to the plunger for dose setting during movement of an actuator and to advance the plunger distally during dose delivery. For example, the dosing component 115 can be a dose dial, a flange component, dose drum, or other component, which at least one of these components, such as, for example, the flange component, dose dial, and / or dose drum, can also make the dosing components used during dose delivery. An actuator 105 is provided that can be rotated during dose setting and / or depressed to initiate delivery of the dose set. In the embodiment shown, the device 100 may include a dose selector 106, which may be rotatable by a user in the directi on(s) of arrow 108 to select a dose. Additionally or alternatively, the device 100 may include an actuator configured to allow a user to deliver a dose of medication, for example by actuating the actuator that actuates the dosing component 115 to move distally to operate the plunger within the cartridge that carries a medication. The actuation permits the plunger to advance within the cartridge to deliver the medication out the outlet end of the cartridge through an injection needle. In the embodiment shown, the device 100 may include a dose button 110, which may be depressible by a user in a longitudinal direction of the medication deliver device (e.g., in a direction towards the distal end portion 102). In some embodiments, actuation of a dose button or other dosing component may cause an actuation of the dosing component 115 and movement of the plunger and / or other portions of the medication delivery device to effectuate delivery of the dose to a user or patient.

[0039] Fig. la shows the medication delivery device 100 having the actuator 105a that may be sometimes referred to a dose button, with only the actuator being shown and the remaining parts of the device being represented by dashed lines. The actuator 105a can be rotated by the user during dose setting in either direction to set to the desired dose amount, which moves the internal dosing component 115 in the appropriate position for the desired dose. After the desired dose is set, the actuator 105a can be depressed distally to cause delivery of the dose to a user or patient. The actuator 105a is an integrated single piece component that can perform the function of the dose selector and the dose button in Fig. 1.

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

[0041] Devices according to the present disclosure may carry and dispense one or more liquid medications, which may also be referred to as medications or drugs and maybe held in the fluid chamber 158. Such medications may include, for example, epinephrine, anaesthetics, analgesics, steroids, insulins, insulin analogs such as insulin lispro or insulin glargine, inslulin Efsitora, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, combined GIP / GLP-1 agonists such as tirzepatide, retatrutide, Dacra, basal insulins, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies including but not limited to IL-23 antibody analogs or derivatives, such as mirikizumab, IL- 17 antibody analogs or derivatives, such as ixekizumab, therapeutic agents for pain-related treatments, such as galcanzeumab or lasmiditan, or lebrikizumab and any therapeutic agent that is capable of delivery by the devices described herein. Devices according to the present disclosure may be operated in a manner generally as described herein by a user (for example, a healthcare professional, a caregiver, or another person) to deliver one or more medications to a patient (for example, another person or the user).

[0042] Further to the above, a dose detection module may be provided in conjunction with a medication delivery device. For example, the dose detection module 200 may be removably attachable to the medication delivery device 100. In some embodiments, including the embodiment shown, the dose detection module 200 may be removably attachable to a proximal end portion 104 of the medication delivery device 100. In particular, some dose detection modules may be removably attachable to a dose button and / or a dose selector, although it will be appreciated that a dose detection module may be removably attachable to any appropriate portion of a medication delivery device, as the disclosure is not limited in this regard. In the embodiment shown, the dose detection module 200 may be removably attachable to the dose button 110 and the dose selector 106. Additionally, the dose detection module 200 or a portion thereof may be configured to actuate with the dose button 110 and / or the dose selector 106 when the dose detection module is attached to the medication delivery device, such that actuation of the dosedetection module 200 by a user may cause a corresponding actuation of the dose button and / or dose selector.

[0043] In some embodiments, the dose detection module or an electronics assembly thereof may include one or more actuation sensors to detect actuation of the dose detection module, the dose button, and / or the dose selector. In some embodiments, the dose detection module or electronics assembly may further include a processor and / or a communication component to receive, process, and / or transmit data obtained from the actuation sensor(s) and / or information derived from the sensor data. In some embodiments, a communication component may additionally or alternatively transmit information related to a charge level of an energy storage element, for example to an external device and / or a charging base as described herein.

[0044] In the embodiment of Fig. 2, the electronics assembly 214 may comprise a circuit board 216 including operating circuitry connecting the various electronic components. In various embodiments, the circuit board may be any appropriate circuit board, including a printed circuit board (PCB), a flexible printed circuit board (FPCB), and / or any other appropriate circuit board. An energy storage element 218 may be mounted to the circuit board 216 to store electrical power and to provide electrical power to the various electronic components such as the processor and / or the actuation sensor(s). In some embodiments, the energy storage element may be a rechargeable energy storage element. For example, in some embodiments, the energy storage element 218 may be a rechargeable battery.

[0045] Further, a rechargeable energy storage element 218 (“RESE”) may be operably connected to an energy transfer element configured to transmit power from an external energy source to the rechargeable energy storage element. In various embodiments, an energy transfer element may be configured to transmit power via any appropriate wired and / or wireless charging circuit. For example, in some embodiments, the energy transfer element may be operably connected to a universal serial bus (USB) charging circuit to receive and transmit power from an external power supply via a wired USB connection. Additionally or alternatively, for example as shown in Fig. 2, an energy transfer element may be an induction coil 234 configured to receive and transmit power (shown as arrow 251 in Fig. 8) from an external power supply via a wireless inductive power supply circuit. In further embodiments, an energy transfer element may be anyappropriate conductive element configured to receive and transmit power from an external power supply via any appropriate conductive power supply circuit.

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

[0047] In some embodiments, a dose detection module or an electronics assembly thereof may include one or more selectively activated indicators to provide information to a user. For example, one or more light(s), speaker(s), or other indicator(s) may be selectively activated by a processor of the module to indicate information about the dose detection module and / or a medication delivery device to which the module may be attached. For example, indicators may be used to communicate a charge status and / or any other appropriate information regarding the dose detection module and / or the medication delivery device. In the embodiment of Fig. 2, the electronics assembly may include one or more indicator lights 222, which may be selectively activated by a processor to indicate a charge status of the rechargeable energy storage element 218. In various embodiments, an indicator light may be a light-emitting diode (LED) or any other appropriate light source.

[0048] Although not shown in Fig. 2, it should be appreciated that an electronics assembly 214 may additionally include any appropriate electronic component of a dose detection module, including one or more processors, one or more actuation sensors, and / or any other appropriate components.

[0049] Further, in some embodiments and with reference to Fig. 3, a dose detection module may include a housing in which an electronics assembly may be at least partially disposed. A housing may include a distal wall at a distal end portion of the housing, a proximal wall at a proximal end portion, and / or one or more lateral walls extending in a longitudinal direction of the dose detection module from the distal end portion to the proximal end portion. For example, the housing 224 may include a distal wall 226 at a distal end portion 242, a proximal wall 230 at a proximal end portion 244, and a lateral wall 228 extending from the distalend portion to the proximal end portion at least partially about an axial direction defined by a central axis A-A of the module 200 to define a cavity 229.

[0050] A housing of a dose detection module may be configured to cooperate with a medication delivery device in any appropriate manner. In some embodiments, a housing of a dose detection module may be configured to removably attach to the medication delivery device or a portion thereof. As shown in Fig. 3, where a medication delivery device 100 includes the actuator 105a, the housing may be configured to couple to the actuator 105a (or the dose button 110 and / or the dose selector 106 when used), and / or any other appropriate portion of the medication delivery device. For example, in some embodiments, the housing 224 may include one or more engagement features 232 configured to removably engage with the actuator 105a (or the dose selector 106, the dose button 110, and / or a corresponding engagement feature of the device 100 (e g., a ridge 116 formed in the actuator 105a, the dose selector or dose button). An engagement feature 232 may include a tab, a flange, a magnet, a snap member, a friction fitting, a gasket, a spring-loaded member, and / or any other appropriate structure configured to removably engage with the actuator 105a, the dose selector, dose button, and / or corresponding engagement feature of the device.

[0051] As described above, the dose detection module may be configured to actuate with various portions of the medication delivery device when the dose detection module is removably attached to the device. In particular, 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 directi on(s) of arrow 108) may cause the actuator 105a to rotate with the module 200. Accordingly, a user may be able to change a dose to be delivered by rotating the module 200. Similarly, when the module 200 is removably attached to the actuator 105a, depression of the dose detection module 200 (e.g., in the direction of arrow 118) may cause the actuator 105a to be depressed with the dose detection module. Accordingly, a user may be able to deliver a dose by depressing the dose detection module.

[0052] Further to the above, a dose detection module may include one or more actuation sensors configured to detect an actuation of the dose detection module and / or a portion of a medication delivery device. For example, the dose detection module 200 may include at least one rotational sensor 236 configured to detect a rotational movement of the dosing component 115 inthe device. Additionally or alternatively, the module 200 may include a translational sensor configured to detect a translational movement of the dose button 110. In various embodiments, an actuation sensor may be any appropriate type of sensor, including a magnetic sensor, a magneto-resistive sensor, a Hall effect sensor, a proximity sensor, an optical sensor, a tactile sensor, an inertial sensor, or any other appropriate sensor or combination of sensors. Additionally, an actuation sensor may be configured to detect any appropriate actuation of any appropriate portion of a medication delivery device. The dosing component may be configured to be detectable from its shape or material or may include a sensed component 117 that includes a sensed parameter that is detectable by the at least rotational sensor 236.

[0053] Further, in some embodiments, each actuation sensor may be in electrical communication with a processor 240 (shown in Fig. 8) to transmit data indicative of an actuation detected by the sensor to the processor. The processor may be configured to determine dosing information (e g., a selected dose and / or a dose delivery) based at least in part on the data received from the actuation sensor(s). Further, the processor 240 may be operably connected to a communication component 258, which may be configured to transmit the dosing information, charge information, and / or other data to an external device or network by any appropriate wired or wireless communication protocol (e.g., Bluetooth, wi-fi, near-field communication, radio frequency, USB connectivity, NFC, ANT, or others). The same communication component 258 or another communication module 241 may be utilized to transmit information to the charging base 300. Communication module 241 may be configured by the protocols listed above or by another means as described below. Dosing information may include data indicative of total movement of the dosing component, such as total angular rotation, total axial travel of the module from dose setting position to its zero position, the number of clicks based on the axial and / or rotational movement, the number of units of drug based on the number of clicks or axial and / or rotational movement, a time stamp, a battery charge level, a temperature, a color of the actuator, and the like.

[0054] In some embodiments, one or more portions of a housing may be configured to guide light from inside the housing to outside the housing. This may facilitate communication of any indications provided by an indicator light, such as a charge level of an energy storage device or other status of the dose detection module or medication delivery device. For example, in theembodiment of Fig. 3, the proximal wall 230 may be formed from an appropriate material and / or in an appropriate geometry to guide light emitted by the LED 222 from inside the housing 224 to an external surface of the proximal wall 230. In some embodiments, one or more other portions of the housing 224 may additionally or alternatively be formed as a light guide.

[0055] As will further be appreciated with reference to Fig. 3, a housing of a dose detection module may be configured to attach to a medication delivery device without preventing a user from easily determining a selected dose. For example, a length of the lateral wall 228 may be selected such that the distal end portion may terminate on a proximal side of the dosage window 112. Accordingly, the housing may be configured to allow a user to easily view the dosage window 112 of the medication delivery device while the dose detection module is attached to the medication delivery device.

[0056] In some embodiments, a proximal end portion of a housing may include a proximal wall assembly 260. The proximal wall assembly may include a proximal wall and a contact surface configured to be contacted by a user during dose delivery. In various embodiments, a contact surface may include any external face or combination of faces of the dose detection module, proximal wall assembly, and / or other portion of the module that is configured to be contacted by a user during dose delivery. In some embodiments, the contact surface may be configured to move with respect to the proximal wall, for example to produce lost motion in response to a torque applied to the contact surface such that the proximal wall does not move in response to movement of the contact surface. In some embodiments, a disc may be included in the proximal wall assembly, and the contact surface may include an external face of the disc. Additionally or alternatively, an external member may be included in the proximal wall assembly, and the contact surface may include an external face of the external member. In some embodiments, the contact surface 246 may include one or more faces of an external member 262, one or more faces of the disc 210, and / or one or more faces of any other appropriate portion of a dose detection module. In the embodiment shown, the contact surface 246 may include a proximal face 246A of the external member 262, a proximal face 246B of the disc 210, and an external face 246C of a circumferential raised portion of the disc 210. The proximal face 246B may be recessed within the proximal end of the disc 210 by a depth to definea radial wall to capture at least partially the circumferential outer edge of the external member 262.

[0057] The disc and / or external member may be configured to rotate with respect to the proximal wall. For example, as shown in Fig. 3, the disc 210 may be rotatably coupled to the proximal wall 230 such that a torque applied to the disc 210 and / or the external member 262 (e.g., in the direction of arrow 248) may cause the disc 210 to rotate relative to the proximal wall 230.

[0058] With additional reference to Figs. 4A-4B, a disc 210 may be rotatably coupled to a proximal wall 230 or other portion of a dose detection module in any appropriate manner. For example, a disc may be coupled to a proximal wall by a rotatable snap fitting, a roller track, a bearing arrangement, a tongue and groove arrangement, and / or any other appropriate rotatable coupling. In the embodiment shown, the disc 210 may be rotatably coupled to the proximal wall 230 by a rotatable snap fitting. The disc may include one or more snap members 250 configured to pass through and snap into a corresponding bore 252 of the proximal wall 230. Additionally, in some embodiments, a disc may include a stabilizing feature to reduce a tendency of the disc to wobble about its center of rotation. For example, the disc 210 may include a stabilizing ring 254 extending from a distal face of the disc to cooperate with a proximal face of the proximal wall 230. Additionally, in some embodiments, a proximal wall may be configured to guide a rotation and / or limit a translational movement of the disc. For example, the proximal wall 230 may include an annular guide 256 extending from a proximal face of the proximal wall. In some embodiments, the annular guide 256 may be sized and shaped to receive the stabilizing ring 254 and may cooperate with the stabilizing ring to limit a radial translation and / or other unwanted movement of the disc 210.

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

[0060] With reference to Fig. 5, a charging base for a dose detection module may be configured to couple with the dose detection module and may be configured to provide electrical power to the dose detection module when the dose detection module is coupled thereto. For example, a charging base 300 may be configured to receive and / or at least partially surround a portion of the dose detection module 200. In the embodiment of Fig. 5, the charging base 300 may include a cradle 302 configured to receive at least a portion of the dose detection module. The cradle 302 may be configured to align and position the module for facilitating the wireless charging of the module 200. In one example, the cradle 302 includes at least one external sidewall 304. Although the cradle 302 is shown in a generally cylindrical or partially tapered geometry having only a single external sidewall 304, it will be appreciated that a cradle may be formed in any appropriate geometry having any appropriate number of external sidewalls, as the disclosure in not limited in this regard.

[0061] As seen in Fig. 6, the cradle 302 may further include at least one internal sidewall 330 defining a module well 306. The module well 306 may be sized and shaped to receive and surround a dose detection module 200 or a portion thereof, for example a proximal end and / or a distal end of the dose detection module. In various embodiments, the module well 306 may be sized and shaped to receive a dose detection module when the module is attached to a medication delivery device (e.g., by sizing the module well with a sufficient depth to stabilize the medication delivery device), when the module is detached from a medication delivery device (e.g., by sizing the module well with an appropriate depth to allow a user to grip the sides of the module to remove the module from the well), or both when the module is coupled to the medication delivery device, and when the module is decoupled from the medication delivery device (e g., by providing the well with a moderate and / or variable depth around a perimeter of the well to stabilize the device while also allowing a user to grip the sides of the module). In some embodiments and as shown in Fig. 5, the module well may be sized and shaped to receive the dose detection module without receiving a distal end of the medication delivery device when the dose detection module is operably coupled to the proximal end of the medication deliverydevice. In this regard, a majority of the medication delivery device may be exposed to allow a user to easily remove the device from the charging base.

[0062] With reference to Fig. 6 and Fig. 8, the charging base 300 may include appropriate circuitry and components for receiving electrical power from an external power supply (e.g., a wall outlet, a portable power supply, a computer or other powered device, or any other appropriate power supply). In some embodiments, the charging base 300 may include a cable port 310 formed in an external sidewall 304 to permit a power supply cable to be operably connected to the internal circuitry of the charging base 300. For example, a cable port 310 may be configured to accept a USB cable, an alternating current (AC) power supply cable, a direct current (DC) power supply cable, and / or any other appropriate power supply cable. Further, in some embodiments, the charging base 300 may include a circuit board 312 including operating circuitry for and connectivity between the various components of the charging base 300 (e.g., a printed circuit board (PCB) and / or any other appropriate circuit board). In some embodiments, the charging base 300 may include a processor 314 operably connected to various components and configured to send and receive signals to and from the various components, including operating instructions and / or any other appropriate data. In some embodiments, the processor may be configured to receive, process, and / or derive information related to a charge level of a dose detection module (e.g., by receiving charge information from a communication component of the dose detection module at a corresponding communication component 308 of the charging base). The processor may further be configured to selectively activate an indicator (e.g., an indicator light or other indicator operably coupled to the processor) based at least in part on the charge 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 electrical power to the dose detection module when the dose detection module is disposed in the module well. Detection can occur via the charging circuit of the base 300. In various embodiments, the power delivery element may be configured to receive and transmit power via any appropriate wired and / or wireless charging circuit. For example, in some embodiments, the power delivery element may be a USB charging circuit to receive and transmit power from an external power supply to a dose detection module via a wired USB connection. Additionally or alternatively, the power delivery element 316 mayinclude an induction coil configured to receive power from an external power supply and to provide electrical power to a corresponding induction coil of a dose detection module via a wireless induction power supply circuit. Cradle 302 may be configured to axially align the coils of the respective components to facilitate the charging process. In further embodiments, an energy transfer element may be any appropriate conductive element configured to receive power from an external power supply to transmit power to a dose detection module via any appropriate conductive power supply circuit.

[0064] Additionally, in some embodiments, the charging base 300 may include one or more selectively activated indicators, such as one or more light(s), speaker(s), and / or any other appropriate indicator(s). For example, one or more indicator lights 318 (e.g., an LED or other appropriate light source) may be operably coupled to the processor 314, such that the processor 314 may selectively activate the indicator light(s) to indicate a charge level of the dose detection module based at least in part on charge information received from the dose detection module. In some embodiments, a charging base 300 may additionally include components to facilitate communication of information to a user. For example, in embodiments which include one or more indicator light(s), a charging base may include a light guide 320 to direct light from an internal indicator light source (e.g., the 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 towards an external surface 322 of the light guide 320.

[0065] Also shown in Fig. 6, the charging base 300 may include a pedestal 326, which may be configured to stabilize the charging base on a supporting surface. For example, in some embodiments, a pedestal 326 may include a weighted portion near a bottom of the charging base to maintain a center of gravity of the charging base near the bottom. Additionally or alternatively, the charging base may include a foot 328, which may provide or enhance a frictional engagement between the charging base 300 and a supporting surface.

[0066] Fig. 7 illustrates at least a partial cross-section of the charging base 300 receiving the dose detection module 200. The dose detection module 200 is shown with the energy transfer element (shown as the induction coil 234) operably coupled with the energy storage element 218 via the circuit board (not shown). The charging base 300 is shown with the power delivery element 316 disposed along the circuit board 312. The cable port 310 is extended within theexternal sidewall 304 to permit a power supply cable (not shown) to be operably connected to the circuit board and internal circuitry of the charging base 300. Indicator lights (not shown) are coupled to the circuit board 312 and positioned to light the light guide 320. Light member 320 is shown as a ring; however, other embodiments such as an elongate member to form a window can be provided for less than 360 degrees of light indication that would be provided by the ring. The well 306 of the charging base 300 can be configured to align and position the power delivery element 316 and the energy transfer element 234 for facilitating the wireless charging of the module 200. For example, the power delivery element 316 and the energy transfer element 234 can be coaxially aligned along the axis AA and / or the axial distance X between the power delivery element 316 and the energy transfer element 234 for enhanced wireless charging.

[0067] Communication between the dose detection module 200 and the charging base 300 may occur with the communication modules 241, 341, respectively. The mode of communication can be with direct contact electrical interface, wirelessly, or triggering a sensor, such as, a mechanical switch, Hall Effect magnet sensor, inductive sensor, optical sensor, or the like. In one example, the communication module 241 include activating an optical pattern with an optical source as the module 241, and detecting the optical pattern with an optical sensor as the communication module 341 in the charging base 300. The optical pattern is detected by the charging base to determine at least one of a full charge, a need of charge, or an error state, as described above.

[0068] Fig. 9 shows a method 900 of recharging a dose detection module including one or more of the following steps. In operation, a method of recharging a dose detection module may include connecting a charging base to a power supply (step 902), for example using a cable port of a charging base as described herein. A proximal end of the dose detection module may then be inserted into a module well of the charging base (step 904). In some embodiments, the proximal end of the dose detection module may be surrounded by an inner sidewall of the charging base. Inserting the proximal end of the dose detection module into the module well may optionally include inserting a proximal end of a medication delivery device to which the dose detection module is coupled at least partially into the module well. As a further option, inserting the proximal end of the medication delivery device into the module well may include insertingthe proximal end of the medication delivery device without inserting a distal end of the medication delivery device into the module well.

[0069] In some embodiments, after the inserting step 904, the power can be increased to (or wakes up) the dose detection module 200. Once inserted, a charge level from a stored plurality of levels of the rechargeable energy storage element in memory 217 of the module 200 can be determined. The stored plurality of levels can be any one or more of the following a full charge, a need of charge, or an error state. The full charge may be indicative of the capacity of the rechargeable energy storage element being 90%-100% of full capacity. The need of charge state may be indicative of the capacity of the rechargeable energy storage element being 0%-90% of full capacity. Error state may be that the rechargeable energy storage element is not chargeable, overheating, etc. Based on the determined charge level, the step of communicating between the dose detection module 200 and the charging base 300 a signal indicative of the determined charge level can occur. The charging base 300 can be configured to indicate to the user a status of the dose detection module 200 from a plurality of statuses. In some embodiments, prior to the increasing power step above, an insertion status of the dose detection module 200 into the charging base 300 can be determined. If the insertion status is positive, then proceed to the increasing power step, and if the insertion status is negative, then disallow the increasing power step, that is, do not start charging. In other words, when something other than the module is inserted within the charging base, it may be desirable to not activate the charging circuit so that power and heat generated may be avoided.

[0070] The insertion status can be determined by several means. For example, the insertion status can be determined by a charging circuit of the charging base 300. The charging circuit may be activated based on a presence of an inductive field being generated from the energy transfer element 234 of the dose detection module 200. Such inductive field may have certain electrical parameters that is known by the charging circuit to be certain as to the expected kind of module inserted into the base. In some examples, even when the right kind of module is inserted within the charging base (that is, the insertion status is positive), if the charge status is a full charge (or substantially full 90% to!00%), the charging circuit in the charging base may still be deactivated to avoid unnecessary charging.

[0071] Communication between the dose detection module and the charging base may occur via each of their communication modules 241, 341, respectively. Each of the communication modules can be a transmitter, a receiver, or a transceiver. In one example, the communication module 241 functions as a communication channel using sensed parameter such as, for example, optical, BLE, NFC, ANT, and the communication module 341 functions a receiver configured to receive the information communicated from the channel. In one embodiment, the processor of the module 200 is configured to activate an optical pattern, shown as arrow 261 in Fig. 8, with an optical source as the communication module 241. In response, an optical sensor in the charging base 300, as the communication module 341, can detect the optical pattern. The optical pattern is indicative of the charge status of the module and is detected by the charging base to determine at least one of a full charge, a need of charge, or an error state, as described above. Fig. 7 shows the communication modules 341, 241 in a radial arrangement relative to one another, where the communication module 341 is disposed radially outward relative to the communication module 241. In some embodiments, the communication module 341 may be disposed axially relative (or underneath) to the communication module 241. In some embodiments, there are more than one pair of communication modules 341, 241 such that one of each pair could be disposed axially and / or radially relative to another of the pair.

[0072] Power may be received at the charging base from the power supply (step 906), and 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 may then be delivered from the induction coil of the dose detection module to the energy storage element. Additionally, in some embodiments, a charge level of the energy storage element may be indicated by the charging base, for example by selectively activating at least one indicator light of the charging base, such as, e.g., at least one red, green, amber, blue lights, in an optical pattern of many patterns stored in memory 317 of the charging base 300. The optical pattern may include the same or different colors remaining on or blinking repetitive sequences of on-off of same or different periods of time. For example, a red light may be blinking in an optical pattern when the error state discussed above isdetermined, a green light may be blinking in an optical pattern when the need of full charge is determined, and a green light may remain on when the full charge is determined.

[0073] Generally, data (e.g., firmware updates) can be transmitted between a dose detection module and a charging base by inserting the dose detection module into the charging base for charging and then allowing data transmissions during charging. Fig. 10 shows an exemplary method 1000 of transmitting data between a dose detection module and a charging base while the dose detection module is being charged by the charging base. According to method 1000, At step 1002, a dose detection module 200 is inserted into a charging base 300 to charge the dose detection module 200. Inserting the dose detection module 200 into the charging base 300 may be performed according to the techniques described herein, such as described in conjunction with step 904 of FIG. 9 and / or any other suitable method. Further, the dose detection module 200 may be recharged by any technique described herein, such as described in conjunction with method 900 and / or any other suitable method. At step 1004, the dose detection module 200 may then transfer data to, and receive data from, the charging base 300 while the dose detection module 200 is charging. In some embodiments, transmitting data between a dose detection module 200 and a charging base 300 may be facilitated wirelessly by their respective communications modules 241 and 341 as described with reference to Fig. 9, as an example (e.g., Bluetooth, wi-fi, near-field communication, radio frequency, NFC, ANT, and / or the like). But it should be appreciated that the data transfer may be facilitated by any other suitable components or methods, including wired communications and / or a combination of wired and wireless communications. For example, wired communications can be effectuated via a wired and / or contact connection between the dose detection module 200 and charging base 300. The transmitted data may further include, additionally or alternatively to insertion status and charge status as discussed herein, firmware data. The firmware data can be used to check if a new firmware version is available, as well as to effectuate the firmware update. For example, the dose detection module 200 may transmit information to the charging base 300 indicative of the current version of the firmware installed on the dose detection module 200 (e.g., so the charging base 300 can check for new firmware versions or updates). The dose detection module 200 may also receive firmware data from the charging base 300, such as a new and / or latest available version of the firmware and / or a firmware update. In some embodiments, the transfer of datamay begin as soon as the dose detection module 200 is inserted into the charging base 300. In some embodiments, the data transfer may occur only after the dose detection module 200 has reached a certain threshold charge level, for example, 30% charged, 50% charged, 80% charged, and / or any desired threshold for the charge percentage. In some embodiments, the data transfer may occur only after an indication that the dose detection module 200 is fully, or almost fully, charged. In some embodiments, the data transfer may occur on the basis of the size of data to be transferred (X) and the threshold charge level (Y). For example, if the size of data to be transferred is over 10 megabytes, the threshold charge level may be 90%, while if the size of data to be transferred is 1 megabyte, the threshold charge level may be 50%. The amounts of X and Y can be adjusted depending on the technology capability of the dose detection module and the charging base. The amounts of X and Y can be stepped (X:Y), meaning, such as, for example, 1 megabyte:50%; 5 megabytes:75%; 10 megabytes: 90%, or gradually sloped, such as, for example, from 0.5 megabyte:30% to over 10 megabytes: 100%.

[0074] After a user places a dose detection module in the charging base, the charging base may charge the dose detection module and obtain a version of the firmware installed on the dose detection module. The charging base may then receive the latest version of the firmware of the dose detection module and may determine if the firmware installed on the dose detection module is the current version. If it is, the charging base may complete charging of the dose detection module. If it is not, the system may then update the firmware of the dose detection module.

[0075] Fig. 11 shows an exemplary method 1100 of checking, using a charging base, whether the firmware installed on a dose detection module is the latest version of the firmware. At step 1102, a user places a dose detection module (e.g. dose detection module 200) into a charging base (e.g. dose detection module 300). The charging base may then charge the dose detection module 200 at step 1104. At step 1106, the charging base 300 obtains the firmware version of the dose detection module 200. For example, the communication module 241 of the dose detection module 200 may receive a request for the version of the firmware installed on the dose detection module 200 from the base communications module 341 of the charging base 300. The communication module 241 may then transmit the version of the firmware installed on the dose detection module 200 to the base communications module 341. As discussed above, thedose detection module may need to be charged to a minimum battery level (e.g., 50%) before moving to step 1106 and / or subsequent steps to check for, or attempt, a firmware update. It can be appreciated that this method of obtaining the firmware version of the dose detection module is for exemplary purposes only and the charging base may be done by any suitable method (e.g., such as where no request is used, and instead the dose detection module 200 is configured to automatically transmit the version information).

[0076] At step 1108, the charging base 300 obtains the latest firmware version from a remote computing resource. The remote computing resource may 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), and / or the like. In some embodiments, the charging base 300 may receive the latest firmware version directly from the remote computing resource, for example, using base communications module 341. In some embodiments, the charging base 300 may be operatively coupled with a local computing device and may cause the local computing device to receive the latest firmware version from the remote computing resource and transmit 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, or near-real time without having the dose detection module 200 placed into the charging base. For example, 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 base communications module 341, before the dose detection module 200 is placed into the charging base 300. The charging base may 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 into the charging base 300. The charging base 300 may then check and update the firmware of the dose detection module 200 with the firmware version stored on the charging base 300, fore example, as described in step 1110, when the dose detection module 200 is placed into the charging base 300.

[0077] At step 1110, the system may check if the firmware of the dose detection module is the current version. In some embodiments, the base communications module 341 may perform the check of the firmware version. In some embodiments, the communication module 241 or anyother suitable component may perform the check of the firmware. Checking if 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 latest version of the firmware received by the charging base 300. For example, the system may compare version numbers of the firmware version installed on the dose detection module 200 and the latest version, or may compare the date the firmware version installed on dose detection module 200 was installed with the date the latest version was available, or any other suitable information that may 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 may proceed to step 1112A and complete 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 may proceed to step 1112B and update the firmware of the dose detection module 200. An exemplary method of updating the firmware of the dose detection module 200 will be described further with reference to Figs. 12, 13, and / or 14. Although 1112A and 1112B are depicted as separate steps, it can be appreciated that step 1112B can be done with step 1112A if the system determines that the firmware version installed on the dose detection module 200 is not the current version, as described with respect to Fig. 10.

[0079] If the system determines that the firmware version installed on a dose detection module is not the current version, a charging base may download a new and / or latest firmware version to be installed on a dose detection module from a remote computing resource. Alternatively, the charging base may download the new and / or latest firmware version (e.g., if a firmware version stored at the charging base is not current) before or while determining whether the firmware version installed on the dose detection module is the current version. The charging base may then verify that the download was successful or not. If the download was successful, the charging base may transmit the new firmware version to the dose detection module. If the download was not successful, the charging base may check how many download attempts have been made by the charging base. To prevent an endless loop 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 may cause the charging base to attempt to download the new and / or latest version again. If the total number of attempts is greater than the threshold number of attempts, the system may determine that the firmware update has failed. The system may provide related notifications to the user via the dose detection module and / or the network or user device. For example, the system may provide a notification to the user that the firmware update has failed. The system may also provide a notification to the provider of the firmware of the failed download (e.g., as that may indicate that something may be wrong with the system). In some embodiments, the provider of the firmware may be the host of the remote computing resource and / or the company using the remote computing to provide the firmware updates, for example, the company that provides the dose detection module 200. Alternatively or additionally, the system may present an option to the user to contact the host of the remote computing resource, for example through a mobile application.

[0080] Fig. 12 shows a method 1200 for downloading an updated version of firmware from a remote computing resource. At step 1202, the charging base 300 may download the new and / or latest firmware version from the remote computing resource, or any suitable computing resource as described herein. In some embodiments, base communications 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 that the download was successful. In some embodiments, the charging base 300 may verify that the download was successful by running a checksum algorithm, for example, a longitudinal parity check, sum complement, or cyclic redundancy check. In some embodiments, the charging base 300 may verify that the download was successful by examining the download file of the new and / or latest firmware version to check the file size or potential corruption of the download file, or for any other indication that the new and / or latest firmware version was properly downloaded. In some examples, the new and / or latest firmware version may be downloaded as an encrypted file and verifying whether the download was successful may include decrypting the encrypted file. For example, the firmware file may include a firmware image signed by a developer of the firmware using a private key to cause the device to proceed through a verification process prior to accepting and installing the firmware. At step 1206A, the charging base 300 may determine if the download was successful. In some embodiments,simultaneously or after step 1204, the charging base 300 may transmit a signal to the remote computing resource indicating whether the download was successful or not.

[0081] If the download was unsuccessful, at step 1206B, the system may keep track of and / or determine a number of download attempts that the system has tried. For example, at each attempt, the charging base 300 may store a value indicating the total number of attempts that have been made. On each successive attempt, the charging base 300 may increase the value of the number of attempts by one. In some embodiments, the total number of attempts may be an aggregated number of attempts with any other calculated number of attempts described herein, for example, the total number of attempts for transferring the new and / or latest firmware to the dose detection module as described with reference to Fig. 13, or the total number of attempts for updating the dose detection module’s firmware as described with reference to Fig. 14, or any other suitable value or combination thereof. The system may then compare the total number of download attempts with a threshold number of attempts, for example, 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 may attempt the download again. If the total number of attempts is greater than the threshold number, the system may determine that the firmware update has failed. The charging base 300 may provide a notification to the user that the firmware update has failed. The notification may be provided in any suitable manner as described herein, for example using an indicator light on the charging base as described with reference to Fig. 9, although a separate indicator light or optical pattern may be used different than the charge status indicator, or through a connected mobile application.

[0082] If the download was successful, the system may proceed to step 1208 A and cause the charging base 300 to transmit the new and / or latest firmware version to the dose detection module 200, for example, using communications modules 241 and 341 communicating in any suitable manner described herein.

[0083] A charging base may first transmit the updated firmware version to a dose detection module. The dose detection module may then verify receipt and respond to the charging base. For example, the dose detection module may respond to the charging base by providing a signal to the charging base that the transfer was successful or unsuccessful after determining whether the transfer was successful. If the transfer was successful, the dosedetection module may the update the firmware installed on the dose detection module to the new version. If the transfer was unsuccessful, the system may determine a total number of transfer attempts the system has made. Depending on the determined total number of transfer attempts, the system may proceed differently. If the total number of transfer attempts is less than a first certain number of attempts, the charging base may try to transfer the updated firmware version again. If the total number of transfer attempts is between the first certain number of attempts and a second certain number of attempts greater than the first certain number, the charging base may redownload the new and / or latest firmware version from the remote computing resource. If the total number of attempts is greater than the second certain number of attempts, the system may determine that the firmware update has failed and may provide a notification to the user indicating the failure.

[0084] Fig. 13 shows a method 1300 for transmitting an updated version of firmware from a charging base to a dose detection module. At step 1302, a charging base 300 may transmit the new and / or latest firmware version to a dose detection module 200. In some embodiments, this transfer may be facilitated by communications modules 241 and 341 in any manner described herein, for example, as described with respect to Fig. 9, or any other suitable method. In some embodiments, method 1300 may proceed directly from and / or immediately following method 1200, for example, step 1208 A of method 1200 and step 1302 of method 1300 may coincide as the same step. At step 1304, the dose detection module 200 may verify receipt of the new and / or latest firmware version and respond to the charging base 300. For example, communications module 241 may send to base communications module 341 a signal indicating that the new and / or latest firmware version has been received. At step 1306A, the system may determine if the transfer was successful.

[0085] If the transfer was unsuccessful, at step 1306B, the system may determine a number of transfer attempts the system has tried. For example, the dose detection module 200 may store a value indicating the total number of transfer attempts as described further with respect to step 1206B of method 1200. The system may proceed to a different step depending on the determined number of transfer attempts. If the number of transfer attempts is less than a first number of attempts, for example three, five, or ten attempts, or any suitable number of attempts, the system may cause the charging base 300 to attempt to transfer the new and / or latest versionof 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 may proceed to step 1308B, and may cause the charging base 300 to re- download the new and / or latest version of the firmware from the remote computing resource as described with respect to Fig. 12 or any other suitable method. If the total number of attempts is greater than the second number of attempts, the system proceed to step 1308C, and may determine that the firmware update has failed and may send the user a notification as described further herein, for example with respect to Fig. 12.

[0086] If the download was successful, the system may proceed to step 1308A and cause the dose detection module 200 to update the firmware installed on the dose detection module 200 to the new version of the firmware. In some embodiments, a module processor 240 of communications module 241 may execute the firmware update by receiving the new and / or latest firmware from base communications module 341 and overwriting the current version of the firmware installed on dose detection module 200. Updating the firmware is further described herein with respect to Fig. 14.

[0087] A dose detection module may perform an update process to update the firmware to the new version. The dose detection module may then check if the update process was successful. If the update was unsuccessful, the system may determine a number of update attempts and proceed to different steps depending on how many update attempts have been tried. If more than a threshold number of attempts, the system may alert the user of the update failure and stop the update process (e.g., and revert back to using the prior firmware version). If the number of attempts is within a first range, the system may return to the transfer step and cause the charging base to re-transfer the firmware to the dose detection module. If the number of attempts is within a second range between the first range and the threshold number of attempts, the system may return to the download step and cause the charging base to redownload the new and / or latest firmware from the remote computing resource (e.g., since there may be an error with the download that is causing the firmware update to fail). If the update was successful, the system may alert the user that charging and updating the firmware are complete.

[0088] Fig. 14 shows a method 1400 for a dose detection module to update its firmware to an updated version of the firmware. At step 1402, a dose detection module 200 may update thefirmware installed on the dose detection module 200 to the new version. For example, the module processor 240, or any other component, may cause the dose detection module to update the firmware to the new version. In some embodiments, method 1400 may proceed directly from and / or immediately following method 1300, for example step 1208A of method 1200 and step 1302 of method 1300 may coincide as the same step. At step 1404A, the system may check if the update was successful. If the update was unsuccessful, the system, for example, using the dose detection module 200, may determine a total number of update attempts as described with respect to Fig. 11. If the total number of update attempts is greater than a threshold number of attempts, the system may determine that the update has failed and may notify the user as described with respect to FIGs. 11-13. If the total number of update attempts is below a first range, for example the first range being 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 go back to the transfer step as described with respect to Fig. 13 and cause the charging base 300 to re-transfer the firmware to the dose detection module 200. If the total number of update attempts is within a second range between the first range and the threshold number of attempts, the system may return to the download step as described with respect to FIG. 12, and cause the charging base 300 to redownload the new and / or latest firmware from the remote computing resource.

[0089] If the update was successful, the system may proceed to step 1406 A, and alert the user that charging and updating the firmware are complete. The notification may be provided to user by any method described herein, for example, as described with respect to Fig. 11-13. The notification may be done through a mobile application, an indicator light or indicator lights on the charging base 300, or any other suitable method.

[0090] Although the FOTA methods and techniques have been described with respect to Figs. 10-14, it can be appreciated that these are for exemplary purposes only and may be modified according to the needs of the system and the user. For example, although the above embodiments have been described with respect to dose detection module 200 and charging base 300, it can be appreciated that a particular charging base may be compatible with any number of dose detection modules. For example, a user may have multiple pen injectors or other medication delivery devices for the same or different potential medications which may each have arespective dose detection module. A single charging base may be compatible with all of the respective dose detection modules so that a user may only need to have one charging base to both charge and update the firmware on each of the respective dose detection modules.

[0091] In some embodiments, the latest firmware version may be more than one version removed from the firmware version installed on the dose detection module. For example, the version installed on the dose detection module may be version one and the latest version may be version three, four, or any other later version. It can be appreciated that the firmware may not be able to be directly updated to the latest version if depending on the differences between the version installed on the dose detection module and the latest version. In some embodiments, the charging base may update the firmware version installed on the dose detection module in one or more incremental updates. Any or all of the incremental updates may follow the methods described with respect to Figs. 10-14. The incremental updates may proceed in successive equal increments, for example, from version one to version two to version three or version one to version three to version five, or may proceed to the latest compatible version. For example, if version one can be directly updated to any of version two, three, or four, the incremental update may update the version directly to version four which may then be updated to the next latest compatible version or the latest version. In these embodiments, the charging base may determine the latest compatible version instead of the latest firmware version as described above with respect to Fig. 11. Following the update, the system may check the version again to ensure that the firmware has been updated to the latest version available.

[0092] The above-described embodiments of the technology described herein can be implemented in any of numerous ways. For example, the embodiments may be implemented using hardware, software or a combination thereof. When implemented in software, the software code can be executed on any suitable processor or collection of processors, whether provided in a single computing device or distributed among multiple computing devices. Such processors may be implemented as integrated circuits, with one or more processors in an integrated circuit component, including commercially available integrated circuit components known in the art by names such as CPU chips, GPU chips, microprocessor, microcontroller, or co-processor. Alternatively, a processor may be implemented in custom circuitry, such as an ASIC, or semicustom circuitry resulting from configuring a programmable logic device. As yet a furtheralternative, a processor may be a portion 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 may constitute a processor. Though, a processor may be implemented using circuitry in any suitable format.

[0093] Further, it should be appreciated that a computing device including one or more processors may be embodied in any of a number of forms, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, a computing device may be embedded in a device not generally regarded as a computing device but with suitable processing capabilities, including a Personal Digital Assistant (PDA), a smart phone, tablet, or any other suitable portable or fixed electronic device.

[0094] Also, a computing device may have one or more input and output devices. These devices can be used, among other things, to present a user interface. Examples of output devices that can be used to provide a user interface include display screens 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, touch pads, and digitizing tablets. As another example, a computing device may receive input information through speech recognition or in other audible format.

[0095] Such computing devices may be interconnected by one or more networks in any suitable form, including as a local area network or a wide area network, such as an enterprise network or the Internet. Such networks may be based on any suitable technology and may operate according to any suitable protocol and may include wireless networks, wired networks or fiber optic networks.

[0096] Also, the various methods or processes outlined herein may be coded as software that is executable on one or more processors that employ any one of a variety of operating systems or platforms. Additionally, such software may be written using any of a number of suitable programming languages and / or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine.

[0097] In this respect, the embodiments described herein may be embodied as a computer readable storage medium 217, 317 (or multiple computer readable media) (e.g., a computer memory, one or more floppy discs, compact discs (CD), optical discs, digital video disks (DVD), magnetic tapes, flash memories, RAM, ROM, EEPROM, circuit configurations in Field Programmable Gate Arrays or other semiconductor devices, or other tangible computer storage medium) encoded with one or more programs that, when executed on one or more computers or other processors, perform methods that implement the various embodiments discussed above. As is apparent from the foregoing examples, a computer readable storage medium may retain information for a sufficient time to provide computer-executable instructions in a non-transitory form. Such a computer readable storage medium or media can be transportable, such that the program or programs stored thereon can be loaded onto one or more different computing devices or other processors to implement various aspects of the present disclosure as discussed above. As used herein, the term "computer-readable storage medium" encompasses only a non-transitory computer-readable medium that can be considered to be a manufacture (i.e., article of manufacture) or a machine. Alternatively or additionally, the disclosure may be embodied as a computer readable medium other than a computer-readable storage medium, such as a propagating signal.

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

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

[0100] The embodiments described herein may be embodied as a method, of which an example has been provided. The acts performed as part of the method may be ordered in any suitable way. Accordingly, embodiments may be constructed in which acts are performed in an order different than illustrated, which may include performing some acts simultaneously, even though shown as sequential acts in illustrative embodiments.

[0101] Further, some actions are described as taken by a “user.” It should be appreciated that a “user” need not be a single individual, and that in some embodiments, actions attributable to a “user” may be performed by a team of individuals and / or an individual in combination with computer-assisted tools or other mechanisms.

[0102] While several embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and / or structures for performing the functions and / or obtaining the results and / or one or more of the advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the present invention. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and / or configurations will depend upon the specific application or applications for which the teachings of the present invention is / are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments of the invention described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, the invention may be practiced otherwise than as specifically described and claimed. The present invention is directed to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent, is included within the scope of the present invention.

[0103] Various aspects are described in this disclosure, including the summary, which include, but are not limited to, the following aspects:

[0104] In various aspects of the disclosure, a dose detection module configured to removably attach to a dose button of a medication delivery device, the module including: a housing configured to couple to the dose button; an electronics assembly disposed at least partially within the housing, the electronics assembly 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 to the energy storage element from a charger of a charging base when the dose detection module is coupled to the charging base; and a communication module configured to communicate with a base communications module of the charging base to, when the dose detection module is coupled to the charging base: receive data from the base communications module; and transmit data to the base communications module.

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

[0106] In various aspects of the disclosure, the processor is configured to: install the new version of the firmware of the dose detection module when the new version is received from the base communications module.

[0107] In various aspects of the disclosure, a medical device system, including: a charging base having a charger; a base processor; a base memory; and a base communications module; and a dose detection module having a battery configured to be recharged by the charger when the dose detection module is coupled to the charging base; a module processor; a module memory; and a module communications module, all operably coupled to one another, wherein when the dose detection module is coupled to the charging base the base processor is configured to: receive data from the dose detection module; and transmit data to the dose detection module.

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

[0109] In various aspects of the disclosure, the base communications module checks if the version of the firmware of the dose detection module is current by: obtaining a latest version of the firmware stored in the remote computing resource; and determining if the version of the firmware of the dose detection module is the latest version of the firmware or not.

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

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

[0112] In various aspects of the disclosure, the module processor is configured to: update the firmware of the dose detection module to the new version of the firmware; determine if the update is successful; and output a first notification when the update is not successful.

[0113] In various aspects of the disclosure, the module processor is further configured to: determine a number of failures when the update is not successful; and retry updating the firmware of the dose detection module to the new version of the firm when the number of failures is less than a 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 the disclosure, a method of 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 communications module, and the dose detection module having a battery configured to be recharged by the charger when the dose detection module is coupled to the charging base, a module processor, a module memory, and a module communications module, all operably coupled to one another, the method including the steps of: receiving data from the dose detection module after the dose detection module is coupled to the charging base the base; and transmitting data to the dose detection module.

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

[0116] In various aspects of the disclosure, the method including wherein the base communications module checks if the version of the firmware of the dose detection module is current by: obtaining a latest version of the firmware stored in the remote computing resource; and determining if the version of the firmware of the dose detection module is the latest version of the firmware or not.

[0117] In various aspects of the disclosure, the method further including, wherein the module communications module is configured for: receiving the new version of the firmware of the dose detection module from the base communications module.

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

[0119] In various aspects of the disclosure, the method including the module processor is configured for: updating the firmware of the dose detection module to the new version of the firmware; determining if the update is successful; and outputting a first notification when the update is not successful.

[0120] In various aspects of the disclosure, the method including wherein the module processor is further configured for: determining a number of failures when the update is not successful; and retrying updating the firmware of the dose detection module to the new version of the firm when the number of failures is less than a maximum number of failures; and outputting a second notification when the number of failures is greater than the maximum number of failures.

[0121] In various aspects of the disclosure, a medication delivery device having a dose button dose coupled to the detection module when coupled to the charging base, the medication delivery device comprising a reservoir having a medication.

Claims

CLAIMSWe claim:

1. A dose detection module configured to removably attach to a dose button of a medication delivery device, the module comprising: a housing configured to couple to the dose button; an electronics assembly disposed at least partially within the housing, the electronics assembly comprising: 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 to the energy storage element from a charger of a charging base when the dose detection module is coupled to the charging base; and a communication module configured to communicate with a base communications module of the charging base to, when the dose detection module is coupled to the charging base: receive data from the base communications module; and transmit data to the base communications module.

2. The dose detection module of claim 1, wherein the communication module is configured to: receive a request for a version of a firmware of the dose detection module from the base communications module; transmit the version of the firmware of the dose detection module to the base communications module; receive a new version of the firmware of the dose detection module from the base communications module when the base communications module determines thatthe version of the firmware of the dose detection module is older than the new version of the firmware.

3. The dose detection module of claim 2, wherein the processor is configured to: install the new version of the firmware of the dose detection module when the new version is received from the base communications module.

4. A medical device system, comprising: a charging base having a charger; a base processor; a base memory; and a base communications module; and a dose detection module having a battery configured to be recharged by the charger when the dose detection module is coupled to the charging base; a module processor; a module memory; and a module communications module, all operably coupled to one another, wherein when the dose detection module is coupled to the charging base the base processor is configured to: receive data from the dose detection module; and transmit data to the dose detection module.

5. The medical device system of claim 4, wherein the base communications module is configured to: obtain a version of a firmware of the dose detection module; check if the version of the firmware of the dose detection module is current; if the version of the firmware is not current, download a new version of the firmware from a remote computing resource; and transmit the new version of the firmware to the dose detection module.

6. The medical device system of claim 5, wherein the base communications module checks if the version of the firmware of the dose detection module is current by: obtaining a latest version of the firmware stored in the remote computing resource; anddetermining if the version of the firmware of the dose detection module is the latest version of the firmware or not.

7. The medical device system of claim 5, wherein the module communications module is configured to: receive the new version of the firmware of the dose detection module from the base communications module.

8. 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 when the new version of the firmware is received; and output a notification 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 if the update is successful; and output a first notification when the update is not successful.

10. The medical device system of claim 9, wherein the module processor is further configured to: determine a number of failures when the update is not successful; and retry updating the firmware of the dose detection module to the new version of the firm when the number of failures is less than a maximum number of failures; and output a second notification when the number of failures is greater than the maximum number of failures.

11. A method of 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 communications module, and the dose detection module having a battery configured to be recharged by the charger when the dose detection module is coupled to the charging base, a module processor, amodule memory, and a module communications module, all operably coupled to one another, the method comprising the steps of: receiving data from the dose detection module after the dose detection module is coupled to the charging base the base; and transmitting data to the dose detection module.

12. The method of claim 11, further comprising: obtaining a version of a firmware of the dose detection module by the base communications module; wherein the receiving data step includes checking if the version of the firmware of the dose detection module is current; if the version of the firmware is not current, downloading a new version of the firmware from a remote computing resource; and wherein the transmitting data step includes transmitting the new version of the firmware to the dose detection module.

13. The method of claim 12, further comprising wherein the base communications module checks if the version of the firmware of the dose detection module is current by: obtaining a latest version of the firmware stored in the remote computing resource; and determining if the version of the firmware of the dose detection module is the latest version of the firmware or not.

14. The method of claim 12, wherein the module communications module is configured for: receiving the new version of the firmware of the dose detection module from the base communications module.

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

16. The method of claim of claim 14, wherein the module processor is configured for: updating the firmware of the dose detection module to the new version of the firmware; determining if the update is successful; and outputting a first notification when the update is not successful.

17. The method of claim of claim 16, wherein the module processor is further configured for: determining a number of failures when the update is not successful; and retrying updating the firmware of the dose detection module to the new version of the firm when the number of failures is less than a maximum number of failures; and outputting a second notification when the number of failures is greater than the maximum number of failures.

18. The medical device system of claim 4, further comprising a medication delivery device having a dose button dose coupled to the detection module, the medication delivery device comprising a reservoir having a medication.

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