WO2024259181A1

WO2024259181A1 - Optical sensing techniques for dose delivery

Info

Publication number: WO2024259181A1
Application number: PCT/US2024/033934
Authority: WO
Inventors: Mark Christopher Allen; Brian Li-Da CHANG; John Hiles; Jason Yip Jee Too
Original assignee: Eli Lilly And Company
Priority date: 2023-06-16
Filing date: 2024-06-14
Publication date: 2024-12-19

Abstract

A medication delivery device is provided having a device body and a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery. The medication delivery device further includes a sensor comprising a light source pointed in a first direction for emitting sensing light during dose setting or dose delivery, and a light sensor pointed in a second direction for receiving the sensing light during dose setting or dose delivery, wherein the light source is disposed with respect to the light sensor so that the first direction is angled with respect to the second direction. The medication delivery device further includes an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensed light by the light sensor.

Description

OPTICAL SENSING TECHNIQUES FOR DOSE DELIVERY

BACKGROUND OF THE INVENTION

[0001] Patients suffering from various diseases must frequently inject themselves with medication. To allow a person to conveniently and accurately self-administer medicine, a variety of devices broadly known as pen injectors or injection pens have been developed. Generally, these pens are equipped with a cartridge including a piston and containing a multidose quantity of liquid medication. A drive member is movable forward to advance the piston in the cartridge to dispense the contained medication from an outlet at the distal cartridge end, typically through a needle.

[0002] In disposable or prefilled pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, a user discards the entire pen and begins using a new replacement pen. In reusable pens, after a pen has been utilized to exhaust the supply of medication within the cartridge, the pen is disassembled to allow replacement of the spent cartridge with a fresh cartridge, and then the pen is reassembled for its subsequent use.

[0003] Many pen injectors and other medication delivery devices utilize mechanical systems in which members rotate and/or translate relative to one another in a manner proportional to the dose delivered by operation of the device. Accordingly, the art has endeavoured to provide reliable systems that accurately measure the relative movement of members of a medication delivery device in order to assess the dose delivered. Such systems may include a sensor which is secured to a first member of the medication delivery device, and which detects the relative movement of a sensed component secured to a second member of the device.

[0004] The administration of a proper amount of medication requires that the dose delivered by the medication delivery device be accurate. Many pen injectors and other medication delivery devices do not include the functionality to automatically detect and record the amount of medication delivered by the device during the injection event. In the absence of an automated system, a patient must manually keep track of the amount and time of each injection. Accordingly, there is a need for a device that is operable to automatically detect the dose delivered by the medication delivery device during an injection event. Further, there is a need for such a dose detection device to be removable and reusable with multiple delivery devices.

SUMMARY OF THE INVENTION

[0005] The present disclosure relates to a medication delivery device that includes a device body, a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery and a sensor that includes a light source pointed in a first direction for emitting sensing light during dose setting or dose delivery, and a light sensor positioned for receiving the sensing light during dose setting or dose delivery, wherein the light sensor is pointed in a second direction, and wherein the light source is disposed with respect to the light sensor so that the first direction is angled with respect to the second direction. The medication delivery device also includes an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensed light by the light sensor.

[0006] The present disclosure also relates to a medication delivery device that includes a device body, a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery, and a sensor including a light source for emitting sensing light during dose setting or dose delivery, and a light sensor positioned for receiving the sensing light during dose setting or dose delivery. The medication delivery device also includes a flexible printed circuit board (PCB) in an installed configuration within the medication delivery device, wherein the light source and the light sensor are disposed on the flexible PCB in an initial configuration prior to installation such that the installed configuration is shaped differently than the initial configuration. The medication delivery device also includes an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensed light by the light sensor.

[0007] The present disclosure also relates to a medication delivery device that includes a device body, a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery, and a sensed element rotationally fixed with the dose setting member, wherein the sensed element and the dose setting member rotate relative to the device body during dose delivery in relation to an amount of dose delivered, and the sensed element comprises a pliable sheet. The medication delivery device also includes a sensor including a light source for emitting sensing light during dose delivery, and a light sensor positioned for receiving the sensing light during dose delivery, wherein the light source and the light sensor are axially disposed relative to one another; and the sensed element protrudes between the light source and the light sensor during dose delivery. The medication delivery device also includes an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensed light by the light sensor.

[0008] The present disclosure also relates to a method of manufacturing a medication delivery device. The method includes obtaining a flexible PCB including a light source for emitting sensing light and a light sensor for receiving the sensing light disposed on the flexible PCB in an initial configuration. The method also includes installing the flexible PCB in an installed configuration in a medication delivery device including a device body and a dose setting member rotatable relative to the device body about an axis of rotation during dose setting or dose delivery, such that the rotation of the dose setting member causes intensities of sensing light received by the light sensor to vary, wherein the installed configuration is shaped differently than the initial configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Additional embodiments of the disclosure, as well as features and advantages thereof, will become more apparent by reference to the description herein taken in conjunction with the accompanying drawings. The components in the figures are not necessarily to scale. Moreover, in the figures, like-referenced numerals designate corresponding parts throughout the different views.

[0010] FIG. l is a perspective view of a medication delivery device having a dose detection system according to aspects of the present disclosure.

[0001] FIG. 2 is a partially exploded perspective view of the medication delivery device of FIG. 1, showing a dose button having a support and a cover, where the cover is shown separated from the support. [0002] FIG. 3 is a partially exploded perspective view of the medication delivery device of FIG. 1 showing the components of the dose detection system.

[0003] FIG. 4 is a cross-sectional view of the medication delivery device of FIG. 1.

[0004] FIG. 5 is a partial cutaway view of a proximal end of the medication delivery device of FIG. 1, showing components of the dose detection system.

[0005] FIG. 6 is an underside view of a portion of the dose button of FIG. 1, showing a printed circuit board held within the dose button cover.

[0006] FIG. 7 is an exploded view of the portion of the dose button shown in FIG. 6.

[0007] FIG. 8 A is a perspective view of the dose detection system, where the transmitter is disposed within the tubular flange and where the transmitter and sensor are angled, according to some embodiments.

[0008] FIG. 8B is a perspective view of the dose detection system, where the transmitter is disposed outside of the tubular flange and where the transmitter and sensor are angled, according to some embodiments.

[0009] FIG. 9 is a perspective view of the circuitry of FIG. 8 A, according to some embodiments.

[0010] FIG. 10 is a cross-sectional view of the dose detection system of FIG. 8 A in an exemplary medication delivery device, where the light source and light sensor are angled, according to some embodiments.

[0011] FIG. 11 is a perspective view of the dose detection system, where the light source and light sensor are axially disposed relative to one another, according to some embodiments.

[0012] FIG. 12 is a perspective view of the circuitry of FIG. 11, according to some embodiments.

[0013] FIG. 13 A is a perspective view of dose detection system FIG. 11, where the light source and light sensor are axially disposed relative to one another, according to some embodiments. [0014] FIG. 13B is a cross sectional view of the dose detection system of FIG. 11, where the light source and light sensor are axially disposed relative to one another, according to some embodiments.

[0015] FIG. 14A is a cross-sectional view of a dose detection system using a pliable sheet, according to some embodiments.

[0016] FIG. 14B is a cross-sectional view of a dose detection system, where the light source and light sensor are mounted on a flexible PCB, according to some embodiments.

[0017] FIG. 15 is a process flow for a method of manufacturing a medication delivery device, according to some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

[0018] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended.

[0019] The present disclosure relates to techniques for sensing dosing information (e.g., dose setting and/or dose delivery) of a medication delivery device. According to some embodiments, optical sensors can be used to detect dosing information. Generally, an optical sensor can include a light source and a light receiver that optically interact, in some manner, with a sensed component. The sensed component can alter the light received by the light sensor during dose setting and/or dose delivery in a predetermined manner, such that changes in the light sensed by the light sensor can be used to determine the dosing information. The inventors have appreciated that optical sensors can be used to accurately detect dosing information. During dose delivery, for example, the medication delivery device may be angled or tilted in different manners to accommodate different injection surfaces (e.g., stomach, legs, and/or arms). Advantageously, optical sensors can accurately detect dosing information over a large range of three-dimensional poses of the medication delivery device. Furthermore, optical sensors are robust. Optical sensors require few moving parts and are thus less likely to be damaged, such as when dropped or when in heavy use. Optical sensors also involve little physical interactions, which may decrease the wear on the sensor. [0020] Accordingly, the inventors have developed improved dose sensing techniques that leverage optical sensors. In some embodiments, the sensing system determines the amount of a dose delivered by a medication delivery device based on the sensing of relative rotational movement between a dose setting member and an actuator of the medication delivery device. The sensed relative rotational movements are correlated to the amount of the dose delivered. By way of illustration, in some examples the medication delivery device is described in the form of a pen injector. However, the medication delivery device may be any device which is used to set and to deliver a dose of a medication, such as a pen injector, an infusion pump or a syringe. The medication may be any of a type that may be delivered by such a medication delivery device.

[0021] In some embodiments, the light source points in a first direction for emitting sensing light during dose setting or dose delivery, and the light sensor pointed in a second direction for receiving the sensing light during dose setting or dose delivery, such that the light source is disposed with respect to the light sensor so that the first direction is angled with respect to the second direction. In some embodiments, the angle can be approximately ninety degrees such that the first direction is substantially perpendicular to the second direction. In some embodiments, the light source and the light sensor can be disposed on a bracket, such as an L-shaped bracket, to achieve the angle between the first direction and the second direction. Such a configuration of the light source and the light sensor can provide for use of optical sensing techniques in the (small) space of the medication delivery device. Such a configuration can additionally or alternatively improve manufacturability of the medication delivery device. For example, the bracket can be arranged such that components can be assembled during manufacturing without requiring arranging the sensed element physically between the light source and light sensor.

[0022] In some embodiments, the light source and light sensor can be manufactured on a flexible printed circuit board (PCB). The flexible PCB can be manufactured in a first shape and/or configuration, such as a substantially flat configuration such that the axes of the light source and light sensor are substantially parallel to each other. After the sensors are manufactured onto the flexible PCB, the flexible PCB can be at least partially bent to conform to a bracket when installed to achieve and installed configuration of the PCB and sensor components. Once installed, the light source and light sensor can be in a second configuration such that the first direction of the light source is angled relative to the second direction of the light sensor. Use of a flexible PCB to install the sensor components can reduce handling costs during manufacturing since the PCB can be curved during installation of the flexible PCB onto the bracket. Use of a flexible PCB can additionally or alternatively reduce component counts, reduce inventory costs, and/or reduce or eliminate the need to solder some electrical connections during manufacturing (e.g., having to solder electrical connections at right angles during assembly).

[0023] In some embodiments, the sensed element is pliable such that the sensed element may be in a first configuration when the medication delivery device is not in use (e.g., such that the sensed element does not protrude between and/or interact with the light source and the light sensor). During dose setting and/or dose delivery, the sensed element can be configured to protrude in order to interact with the light source and the light sensor. Such embodiments can improve manufacturability since the sensed component can be manufactured in the first configuration, which can reduce manufacturing cost and/or manufacturing complexity. Such configurations can additionally or alternatively result in accurate dose sensing since the sensed component is not between the light source and light sensor when the medication delivery device is not in use, and thus dropping or shaking the medication delivery device when not in use will not inadvertently result in generation of dosing information.

[0024] Devices described herein may comprise a medication, such as for example, within a reservoir or cartridge 20 (described below). In another embodiment, a system may comprise one or more devices including device 10 (described below) and a medication. The term “medication” refers to one or more therapeutic agents including but not limited to insulins, insulin analogs such as insulin lispro or insulin glargine, insulin derivatives, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogs, glucagon derivatives, gastric inhibitory polypeptide (GIP), GIP analogs, GIP derivatives, oxyntomodulin analogs, oxyntomodulin derivatives, therapeutic antibodies and any therapeutic agent that is capable of delivery by the devices described herein. The medication as used in the device may be formulated with one or more excipients. The device is operated in a manner generally as described above by a patient, caregiver or healthcare professional to deliver medication to a person. [0025] An exemplary medication delivery device 10 is illustrated in FIGS. 1-4 as a pen injector configured to inject a medication into a patient through a needle. Device 10 includes a body 11 that may comprise an elongated, pen-shaped housing 12 including a distal portion 14 and a proximal portion 16. As used herein, the term “distal” refers to the direction and/or portion of a medication delivery device that is pointed towards (or located closer to) the site of injection, while the term “proximal” refers to the direction and/or portion of a medication delivery device that is pointed away from (or located further away from) the site of injection. Distal portion 14 may be received within a pen cap 18. Referring to FIG. 4, distal portion 14 may contain a reservoir or cartridge 20 configured to hold medication to be dispensed through the outlet 21 of the housing a dispensing operation. The outlet 21 of distal portion 14 may be equipped with an injection needle 24. In some embodiments, the injection needle is removable from the housing. In some embodiments, the injection needle is replaced with a new injection needle after each use.

[0026] A piston 26 may be positioned in reservoir 20. The medication delivery device may include an injecting mechanism positioned in proximal portion 16 that is operative to advance piston 26 toward the outlet of reservoir 20 during the dose dispensing operation to force the contained medicine through the needled end. The injecting mechanism may include a drive member 28, illustratively in the form of a screw, that is axially moveable relative to housing 12 to advance piston 26 through reservoir 20.

[0027] The device may include a dose-setting assembly coupled to the housing 12 for setting a dose amount to be dispensed by device 10. As best seen in FIGS. 3 and 4, in the illustrated embodiment, the dose-setting assembly includes a dose-setting screw 32 and a flange 38. The dose-setting screw 32 is in the form of a screw element operative to spiral (i.e., simultaneously move axially and rotationally) about a longitudinal axis AA of rotation relative to housing 12 during dose setting and dose dispensing. FIGS. 3 and 4 illustrate the dose-setting screw 32 fully screwed into housing 12 at its home or zero dose position. Dosesetting screw 32 is operative to screw out in a proximal direction from housing 12 until it reaches a fully extended position corresponding to a maximum dose deliverable by device 10 in a single injection. The extended position may be any position between a position corresponding to an incremental extended position (such as a dose setting a 0.5 or 1 unit) to a fully extended position corresponding to a maximum dose deliverable by device 10 in a single injection and to screw into housing 12 in a distal direction until it reaches the home or zero position corresponding to a minimum dose deliverable by device 10 in a single injection. [0028] Referring to FIGS. 3 and 4, dose-setting screw 32 includes a helically threaded outer surface that engages a corresponding threaded inner surface 13 of housing 12 to allow dosesetting screw 32 to spiral (i.e., simultaneously rotate and translate) relative to housing 12. Dose-setting screw 32 further includes a helically threaded inner surface that engages a threaded outer surface of sleeve 34 (FIG. 4) of device 10. The outer surface of dose-setting screw 32 includes dose indicator markings, such as numbers that are visible through a dosage window 36 to indicate to the user the set dose amount.

[0029] As mentioned above, in some embodiments, the dose-setting assembly further includes a tubular flange 38 that is coupled in the open proximal end of dose-setting screw 32 and is axially, and rotationally locked to the dose-setting screw 32 by protrusions 40 received within openings 41 in the dose-setting screw 32. The protrusions 40 of the flange 38 can be seen in FIG. 3, and the openings 41 of the dose-setting screw 32 can be seen in FIG. 3.

[0030] As seen in FIGS. 3 and 4, delivery device 10 may include an actuator assembly having a clutch 52 and a dose button 30. The clutch 52 is received within the dose-setting screw 32, and the clutch 52 includes an axially extending stem 54 at its proximal end. The dose button 30 of the actuator assembly is positioned proximally of the dose-setting screw 32 and flange 38. Dose button 30 includes a support 42, also referred to herein as an “under button,” and a cover 56, also referred to herein as an “over button.” As will be discussed, the support 42 and cover 56 enclose electronics components used to store and/or communicate data relating to amount of dose delivered by a medication delivery device.

[0031] The support 42 of the dose button may be attached to the stem 54 of the clutch 52, such as with an interference fit or an ultrasonic weld, so as to axially and rotatably fix together dose button 30 and clutch 52.

[0032] Proximal face 60 of the dose button 30 may serve as a push surface against which a force can be applied manually, i.e., directly by the user to push the actuator assembly (dose button 30 and clutch 52) in a distal direction. A bias member 68, illustratively a spring, may be disposed between the distal surface 70 of support 42 and a proximal surface 72 of tubular flange 38 to urge the support 42 of the actuation assembly and the flange 38 of the dosesetting assembly axially away from each other. Dose button 30 is depressible by a user to initiate the dose dispensing operation. In some embodiments, the bias member 68 is seated against this proximal surface 72 and may surround a raised collar 37 of the flange 38.

[0033] Delivery device 10 is operable in a dose setting mode and a dose dispensing mode. In the dose setting mode of operation, the dose button 30 is rotated relative to housing 12 to set a desired dose to be delivered by device 10. In some embodiments, rotating the dose button 30 in one direction relative to the housing 12 causes the dose button 30 to axially translate proximally relative to the housing 12, and rotating the dose button 30 in the opposite direction relative to the housing 12 causes the dose button 30 to axially translate distally relative to the housing. In some embodiments, clockwise rotation of the dose button moves the dose button 30 distally, and counter-clockwise rotation of the dose button moves the dose button proximally, or vice versa.

[0034] In some embodiments, rotating the dose button 30 to axially translate the dose button 30 in the proximal direction serves to increase the set dose, and rotating the dose button 30 to axially translate the dose button 30 in the distal direction serves to decrease the set dose. The dose button 30 is adjustable in pre-defined rotational increments corresponding to the minimum incremental increase or decrease of the set dose during the dose setting operation. The dose button may include a detent mechanism such that each rotational increment produces an audible and/or tactile “click.” For example, one increment or “click” may equal one-half or one unit of medication.

[0035] In some embodiments, the set dose amount may be visible to the user via the dial indicator markings shown through a dosage window 36. During the dose setting mode, the actuator assembly, which includes the dose button 30 and clutch 52, moves axially and rotationally with the dose-setting assembly, which includes the flange 38 and the dose-setting screw 32.

[0036] Dose-setting screw 32 and flange 38 are fixed rotationally to one another, and rotate and move proximally during dose setting, due to the threaded connection of the dose-setting screw 32 with housing 12. During this dose setting motion, the dose button 30 is rotationally fixed relative to the flange 38 and the dose-setting screw 32 by complementary splines 74 of flange 38 and clutch 52 (FIG. 4), which are urged together by the bias member 68. In the course of dose setting, the dose-setting screw 32, flange 38, clutch 52, and dose button 30 move relative to the housing 12 in a spiral manner (e.g., simultaneous rotation and axial translation) from a “start” position to an “end” position. This rotation and translation relative to the housing is in proportion to the amount of dose set by operation of the medication delivery device 10.

[0037] Once the desired dose is set, device 10 is manipulated so the injection needle 24 properly penetrates, for example, a user's skin. The dose dispensing mode of operation is initiated in response to an axial distal force applied to the proximal face 60 of dose button 30. The axial force is applied by the user directly to dose button 30. This causes axial movement of the actuator assembly (dose button 30 and clutch 52) in the distal direction relative to housing 12.

[0038] The axial shifting motion of the actuator assembly compresses biasing member 68 and reduces or closes the gap between dose button 30 and the tubular flange 38. This relative axial movement separates the complementary splines 74 on clutch 52 and flange 38, and thereby disengages the dose button 30 from being rotationally fixed to the flange 38 and the dose-setting screw 32. In particular, the dose-setting screw 32 is rotationally uncoupled from the dose button 30 to allow backdriving rotation of the dose-setting screw 32 relative to the dose button 30 and the housing 12. Also, while the dose-setting screw 32 and flange 38 are free to rotate relative to the housing 12, the dose button 30 is held from rotating relative to the housing 12 by the user’s engagement of dose button 30 by pressing against it.

[0039] As dose button 30 and clutch 52 are continued to be axially plunged without rotation relative to housing 12, dose-setting screw 32 screws back into housing 12 as it spins relative to dose button 30. The dose markings that indicate the amount still remaining to be injected are visible through window 36. As dose-setting screw 32 screws down distally, drive member 28 is advanced distally to push piston 26 through reservoir 20 and expel medication through needle 24.

[0040] During the dose dispensing operation, the amount of medicine expelled from the medication delivery device is proportional to the amount of rotational movement of the dosesetting screw 32 relative to the housing 12 as the dose-setting screw 32 screws back into housing 12. In some embodiments, because the dose button 30 is rotationally fixed relative to the housing 12 during the dose dispensing mode, the amount of medicine expelled from the medication delivery device may be viewed as being proportional to the amount of rotational movement of the dose-setting screw 32 relative to the dose button 30 as the dose-setting 32 screws back into housing 12. The injection is completed when the internal threading of dosesetting screw 32 has reached the distal end of the corresponding outer threading of sleeve 34 (FIG. 4). Device 10 is then once again arranged in a ready state or zero dose position as shown in FIGS. 2 and 4.

[0041] As discussed above, the dose delivered may be derived based on the amount of rotation of the dose-setting assembly (flange 38 and dose-setting screw 32) relative to the actuator assembly (clutch 52 and dose button 30) during dose delivery. This rotation may be determined by detecting the incremental movements of the dose-setting assembly which are “counted” as the dose-setting assembly is rotated during dose delivery.

[0042] Further details of the design and operation of an exemplary delivery device 10 may be found in U.S. Patent No. 7,291,132, entitled Medication Dispensing Apparatus with Triple Screw Threads for Mechanical Advantage, the entire disclosure of which is hereby incorporated by reference herein. Another example of the delivery device is an auto-injector device that may be found in U.S. Patent No. 8,734,394, entitled “Automatic Injection Device With Delay Mechanism Including Dual Functioning Biasing Member,” which is hereby incorporated by reference in its entirety, where such device being modified with one or more various sensor systems described herein to determine an amount of medication delivered from the medication delivery device based on the sensing of relative rotation within the medication delivery device. Another example of the delivery device is a reusable pen device that may be found in U.S. Patent No. 7,195,616, entitled “Medication Injector Apparatus with Drive Assembly that Facilitates Reset,” which is hereby incorporated by reference in its entirety, where such device being modified with one or more various sensor systems described herein to determine an amount of medication delivered from the medication delivery device based on the sensing of relative rotation within the medication delivery device.

[0043] Described herein is a dose detection system that may be operable to determine the amount of dose delivered based on relative rotation between a dose setting member and the device body. The dose detection system utilizes a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery. A sensed element is attached to and rotationally fixed with the dose setting member. An actuator is attached to the device body and is held against rotation relative to the device body during dose delivery. The sensed element thereby rotates relative to the actuator during dose delivery in relation to the amount of dose delivered.

[0044] In some embodiments, the dose detection system comprises a sensor attached to the actuator assembly and a sensed element that includes surface features that are equally radially spaced about the axis of rotation of the sensed element.

[0045] In some embodiments, the dose detection systems may include a sensor and a sensed component attached to components of the medication delivery device. The term “attached” encompasses any manner of securing the position of a component to another component or to a member of the medication delivery device such that they are operable as described herein. For example, a sensor may be attached to a component of the medication delivery device by being directly positioned on, received within, integral with, or otherwise connected to, the component. Connections may include, for example, connections formed by frictional engagement, splines, a snap or press fit, sonic welding or adhesive.

[0046] The term “directly attached” is used to describe an attachment in which two components, or a component and a member, are physically secured together with no intermediate member, other than attachment components. An attachment component may comprise a fastener, adapter or other part of a fastening system, such as a compressible membrane interposed between the two components to facilitate the attachment. A “direct attachment” is distinguished from attachment where the components/members are coupled by one or more intermediate functional members.

[0047] The term “fixed” is used to denote that an indicated movement either can or cannot occur. For example, a first member is “fixed rotationally” with a second member if the two members are required to move together in rotation. In one aspect, a member may be “fixed” relative to another member functionally, rather than structurally. For example, a member may be pressed against another member such that the frictional engagement between the two members fixes them together rotationally, while the two members may not be fixed together absent the pressing of the first member.

[0048] Various sensor arrangements are contemplated herein. In general, the sensor arrangements comprise a sensor and a sensed component. The term “sensor” refers to any component which is able to detect the relative position or movement of the sensed component. The sensor may be used with associated electrical components to operate the sensor. The “sensed component” is any component for which the sensor is able to detect the position and/or movement of the sensed component relative to the sensor. For the dose detection system, the sensed component rotates relative to the sensor, which is able to detect the rotational movement of the sensed component. The sensor may comprise one or more sensing elements, and the sensed component may comprise one or more sensed elements. The sensor detects the movement of the sensed component and provides outputs representative of the movement of the sensed component.

[0049] Illustratively, the dose detection system includes an electronics assembly suitable for operation of the sensor arrangement as described herein. The medication delivery device may include a controller that is operably connected to the sensor to receive outputs from the sensor. The controller begins receiving generated signals from the sensor indicative of counts from first to last one for a total number of counts that is used for determining total displacement, e.g., angular displacement. In the case of detecting an angular movement of a dose-setting assembly, the controller may be configured to receive data indicative of the angular movement of the dose-setting assembly that can be used to determine from the outputs the amount of dose delivered by operation of the medication delivery device. The controller may be configured to determine from the outputs the amount of dose delivered by operation of the medication delivery device. The controller may include conventional components such as a processor, power supply, memory, microcontrollers, etc. Alternatively, at least some components may be provided separately, such as by means of a computer, smart phone or other device. Means are then provided to operably connect the external controller components with the sensor at appropriate times, such as by a wired or wireless connection. [0050] According to one aspect, the electronics assembly includes a sensor arrangement including one or more sensors operatively communicating with a processor for receiving signals from the sensor representative of the sensed rotation. An exemplary electronics assembly 76 is shown in FIGS. 5-7 and can include a sensor 86, and a printed circuit board (PCB) 77 having a plurality of electronic components. The printed circuit board may be a flexible printed circuit board. The circuit board of the electronics assembly 76 may include a microcontroller unit (MCU) as the controller comprising at least one processing core and internal memory. The electronics assembly may include a power source 79, e.g., a battery, illustratively a coin cell battery, for powering the components. The controller of electronics assembly 76 may include control logic operative to perform the operations described herein, including detecting the angular movement of the dose-setting assembly during dose setting and/or dose delivery and/or detecting a dose delivered by medication delivery device 10 based on a detected rotation of the dose-setting assembly relative to the actuator assembly. Many, if not all of the components of the electronics assembly, may be contained in a compartment 85 within the dose button 30. In some embodiments, the compartment 85 may be defined between a proximal surface 71 of support 42 of the dose button and a distal surface 81 of the cover 56 of the dose button. In the embodiment shown in FIG. 5, the electronics assembly 76 is permanently integrated within the dose button 30 of the delivery device. In other embodiments, the electronics assembly is provided as a module that can be removably attached to the actuator assembly of the medication delivery device.

[0051] An underside view of the electronics assembly 76 held within the cover 56 is shown in FIG. 6, and an exploded view of the electronics assembly 76 is shown in FIG. 7. As shown in FIGS. 6 and 7, the electronics assembly 76 may include a printed circuit board (PCB) 77 and a sensor 86 having a contact surface 111. As shown in FIG. 7, the electronics assembly 76 may also include a battery 79 and a battery cage 87.

[0052] As described further herein, the inventors have developed improved dose sensing techniques that leverage optical sensors. Generally, the techniques leverage a light source and a light sensor that optically interacts with a sensed component. The sensed relative rotational movements of the sensed component are correlated to the amount of the dose delivered. As a result, the sensing system can determine the amount of a dose delivered by a medication delivery device based on the sensing of relative rotational movement between a dose setting member and an actuator (dose button 30 and clutch 52) of the medication delivery device. By way of illustration, in some examples the medication delivery device is described in the form of a pen injector.

[0053] In some embodiments, the light source points in a first direction for emitting sensing light during dose setting or dose delivery, and the light sensor points in a second direction for receiving the sensing light during dose setting or dose delivery, such that the light source is disposed with respect to the light sensor so that the first direction is angled with respect to the second direction. In some embodiments, the light source and the light sensor can be disposed on a bracket, such as an L-shaped or other-shaped bracket, to achieve the angle between the first direction and the second direction. Such a configuration of the light source and the light sensor can provide for use of optical sensing techniques within the limited space available within the medication delivery device. Such a configuration can additionally or alternatively improve manufacturability of the medication delivery device. For example, the bracket can be arranged such that components can be assembled during manufacturing without requiring that the sensed element be physically arranged in-between the light source and light sensor, thus reducing the need for high-precision placement of component parts in relation to one another.

[0054] FIG. 8 A is a perspective view of a dose detection system 800, according to some embodiments. Dose detection system 800 can determine data related to dosing information of a medication delivery device. Examples of medication delivery devices that can be used in accordance with dose detection system 800 can be the medication delivery devices discussed herein, including in conjunction with FIGS. 1-7. The dosing information can be determined based on, for example, a dose setting of the medication delivery device and/or dose delivery of the medication delivery device, as discussed further herein.

[0055] Dose detection system 800 includes sensed element 802, light source 804, light sensor 806, and electronics assembly 812. In some embodiments, the light source 804 and the light sensor 806 can be referred to collectively as a sensor. In some embodiments, sensed element 802, as shown in this example, can be a part of tubular flange 814 (e.g., similar to tubular flange 38 described in conjunction with FIGS. 3-5).

[0056] As discussed herein, in some embodiments the flange 814 can be part of a dosesetting assembly. During a dose setting mode, the actuator assembly (dose button 30 and clutch 52), along with the electronics assembly 812, can move axially and rotationally with the dose-setting assembly. During dose delivery, the dose delivered may be derived based on the amount of rotation of the flange 814 relative to the actuator assembly (dose button 30 and clutch 52) and the electronics assembly 812. In some embodiments, the actuator (dose button 30 and clutch 52) and the electronics assembly 812 do not rotate relative to one another. Rotation may be determined by detecting the incremental movements of the flange 814, which can be monitored or counted as the dose-setting assembly is rotated during dose delivery. The sensor (e.g., light source 804 and light sensor 806) can sense movement of the sensed element 802 and the electronics assembly 812 can use data of the sensed movement to determine dosing information of the medication delivery device.

[0057] As shown in FIG. 8A, the sensed element 802 may include a plurality of alternating teeth 808 and alternating recesses 810, although the techniques are not limited as shown and may include other configurations (e.g., such as ridges, curves, and/or the like). In the example shown in FIG. 8A, teeth 808 may be axially directed teeth that are equally radially spaced about a rotation axis and arranged to correlate to a dose (e.g., such that one or more teeth is the equivalent of one unit of dose, half a unit of a dose, two units of a dose, or some other ratio). In this illustrative embodiment, sensed element 802 includes 20 teeth 808 that are equally rotationally spaced from one another, such that the rotation distance between two adjacent teeth corresponds to 18 degrees of rotation. Thus, 18 degrees of rotation of tubular flange 814 and/or sensed element 802 may be used to represent a portion of a dosage unit, such as one dosage unit or a half dosage unit. It should be appreciated that, in other embodiments, different total numbers of teeth may be used to create other angular relationships, such as, for example, 9, 10, 15, 18, 20, 24 or 36 degrees may be used for a unit or a portion of a unit.

[0058] A recess 810 may be disposed between each pair of adjacent teeth 808. It should be appreciated that, in other embodiments, recesses 810 may instead be a surface having a different surface feature than the teeth 808. In one example, the teeth 808 may include a reflective surface and the recesses 810 may instead be replaced with a non-reflective surface. [0059] In some embodiments, the light source 804 is configured to emit a sensing light during dose setting and/or dose delivery. In some embodiments, the light sensor 806 is configured and positioned to receive the sensing light during dose setting and/or dose delivery. In an example embodiment, light source 804 and light sensor 806 may be an infrared transmitter and infrared transceiver, respectively. In some examples, the light source 804 may emit light that diffuses and propagates in multiple directions outwards from the light source 804.

[0060] During dose setting and/or dose delivery, light source 804 may point in a first direction for emitting a sensing light and light sensor 806 may point in a second direction for receiving the sensing light. In some embodiments, the first direction may be directed axially toward the distal end and the second direction may be directed radially outward. The first direction may be angled with respect to the second direction. In this illustrative embodiment, light source 804 is disposed at approximately a 90 degree angle relative to light sensor 806. It should be appreciated that, in other embodiments, light source 804 may be disposed at different approximate angles, such as, for example, approximately 15, 30, 45, 60, or 75 degrees relative to the light sensor 806. It should be appreciated that for the embodiments described herein, the light source and the light sensor can be switched in position with each other. For example, the light source 804 may point radially outward and the light sensor 806 direction may be directed axially toward the distal end.

[0061] In some embodiments, light sensor 806 is disposed such that the receiving portion of light sensor 806 faces towards the distal portion of the medication injection device. Positioning the light sensor 806 in this manner may reduce the amount of external sunlight measured by light sensor 806. Thus, this may increase the light sensor’s sensitivity to the sensing light emitted by light source 804.

[0062] In some embodiments, light sensor 806 is disposed within the interior of the sensed element 802. In some embodiments, the light sensor 806 is disposed within the interior of a hollow tubular flange 814. Light sensor 806 may be directed radially outward of the medication delivery device. Light source 804 may be directed towards the distal portion of the medication delivery device. As sensed element 802 rotates, teeth 808 and recesses 810 will successively be positioned in line with the light sensor 806. In some examples, the light source 804 may emit light that diffuses and propagates in multiple directions outwards from the light source 804 and may be reflected off other surfaces in optical communication with the light source 804. In some embodiments, when recesses 810 are positioned in line with the light sensor 806, recesses 810 may pass sensing light such that the sensing light that was diffused and propagated in multiple directions outward from the light source 804 is detected by the light sensor 806. Teeth 808 may block or reflect sensing light such that the light sensor 806 receives a lower intensity of sensing light than if the recesses 810 were in line with the light sensor 806.

[0063] Light sensor 806 is configured to collect data indicative of rotation movement of the dose setting member. In various embodiments, light sensor 806 is configured to detect varying intensities of the sensing light and thereby able to detect rotation of dose-setting assembly (tubular flange 814 and dose-setting screw, not shown) relative to actuator (dose button 30 and clutch 52) during dose setting or dose delivery. In some examples, recesses 810 may pass sensing light such that light sensor 806 receives a high intensity of sensing light. Teeth 808 may block or reflect sensing light such that light sensor 806 receives a low intensity of sensing light.

[0064] Electronics assembly 812 may be in communication with light sensor 806. Electronics assembly 812 may receive information from light sensor 806 to determine data indicative of dosing information of the medication delivery device. In some examples, electronics assembly 812 may distinguish varying intensities of sensing light to determine the dosage delivered. The different intensities of sensing light may correspond to teeth 808 or recesses 810. In some examples, the electronics assembly 812 may distinguish teeth 808 or recesses 810 using a threshold corresponding to the intensity of the sensing light. For instance, data corresponding to intensities of the sensing light below the threshold may correspond to teeth 808, and data corresponding to intensities of sensing light above the threshold may correspond to recesses 810.

[0065] FIG. 8B is perspective view of an alternative dose detection system 801 arrangement, according to some embodiments. As shown in FIG. 8B, light sensor 806 is disposed outside of the sensed element 802. Light sensor 806 may be directed radially inward of the medication delivery device. Light source 804 may be directed towards the distal portion of the medication delivery device. As discussed in conjunction with FIG. 8A, sensed element 802 rotates, teeth 808 and recesses 810 will successively be positioned in line with the light sensor 806. In some examples, the light source 804 may emit light that diffuses and propagates in multiple directions outwards from the light source 804 and may be reflected off other surfaces in optical communication with the light source 804. In some embodiments, when recesses 810 are positioned in line with the light sensor 806, recesses 810 may pass sensing light such that the sensing light that was diffused and propagated in multiple directions outward from the light source 804 is detected by the light sensor 806. Teeth 808 may block or reflect sensing light such that the light sensor 806 receives a lower intensity of sensing light than if the recesses 810 were in line with the light sensor 806.

[0066] FIG. 9 is a perspective view of the circuitry 900 of FIG. 8 A, according to some embodiments. Circuitry 900 includes electronics assembly 812, light source 804, and light sensor 806. As mentioned previously, the electronics assembly 812 may include a plurality of electronic components and may be in communication with light sensor 806. The electronics assembly 812 can include a PCB having a plurality of electronic components. The PCB may be a flexible printed circuit board. The circuit board of the electronics assembly may include a MCU as the controller comprising at least one processing core and internal memory.

[0067] The controller of electronics assembly 812 may include control logic operative to perform the operations described herein, including detecting the angular movement of the dose-setting assembly during dose setting and/or dose delivery and/or detecting a dose delivered by a medication delivery device based on a detected rotation of the dose-setting assembly relative to the actuator assembly. As described herein, during dose setting and/or dose delivery, light source 804 may point in a first direction for emitting a sensing light and light sensor 806 may point in a second direction for receiving the sensing light.

[0068] In order to achieve such first and second directions, light source 804 and light sensor 806 may be disposed on flexible PCB 908. The flexible PCB 908 can be manufactured in an initial configuration, as discussed further below, and installed in an installed (bent) configuration to achieve a desired arrangement of the sensor components. Use of a flexible PCB 908 to install the sensor components can reduce handling costs or complexity during manufacturing since the flexible PCB 908 can be curved during installation of the flexible PCB 908 onto the angled bracket 910. Use of flexible PCB 908 can additionally or alternatively reduce component counts, reduce inventory costs, and/or reduce or eliminate the need to solder some electrical connections during manufacturing (e.g., having to solder electrical connections at right angles during assembly).

[0069] In some embodiments, light source 804 may be disposed towards a first end of flexible PCB 908 and light sensor 806 may be disposed towards a second end of flexible PCB 908. Flexible PCB 908 can be manufactured in an initial configuration, such as a substantially flat configuration such that the axes along which the light source and light sensor point are substantially parallel to each other. After the sensors have been manufactured onto flexible PCB 908, flexible PCB 908 may be bent and disposed on angled bracket 910 to arrange the light source 804 and the light sensor 806 in an installed configuration. Accordingly, the light source 804 and the light sensor 806 can be disposed on the flexible PCB 908 in an initial configuration prior to installation (e.g., where the flexible PCB 908 is not bent and/or is bent less than the installed configuration), such that the installed configuration of the flexible PCB 908 is shaped differently than the initial configuration of the flexible PCB 908 (and thus the initial and installed arrangements of light source 804 and the light sensor 806 are likewise different).

[0070] The flexible PCB 908 can be bent during installation to conform, at least partially, to the shape of the angled bracket 910. Angled bracket 910 may include a first portion 910A and a second portion 910B. First portion 910A of angled bracket may be angled with respect to second portion 910B of angled bracket. Light source 804, along with the first end of flexible PCB 908, may be disposed along first portion 910A of angled bracket. Light sensor 806, along with the second end of flexible PCB 908, may be disposed along second portion 910B of angled bracket so that the first direction is angled to the second direction. In this illustrative embodiment, first portion 910A and second portion 910B of angled bracket are straight, however other shapes can also be used, such as curved shapes, angled shapes, and/or the like. In this illustrative embodiment, the first portion 910A and second portion 910B of angled bracket also comprise an L-shape, such that the angle between the first and second portions is approximately 90 degrees. However, this is for exemplary purposes only, as various other curves, angles and/or shapes can be used in accordance with the techniques described herein. For example, in some embodiments as discussed further herein, the shape can be a C shape or a U shape.

[0071] FIG. 10 is a cross sectional view of the dose detection system of FIG. 8 A in an exemplary medication delivery device, showing light source 804 angled with respect to light sensor 806, according to some embodiments. In an example embodiment, the dose detection system of FIG. 8 A may at least be partially disposed under cover 1006. The doses detection system may include light source 804, light sensor 806, flexible PCB 908, battery 1010, and tubular flange 814.

[0072] As described herein, light source 804 and light sensor 806 may be disposed on flexible PCB 908 that is disposed on angled bracket 910. As shown, the angled bracket 910 positions the light source 804 such that as the sensed element rotates, teeth 808 and recesses 810 will successively be positioned in line with the light sensor 806 and emitted light source 804. Furthermore, in this illustrative embodiment, second portion 910B may be axially directed, such that second portion 910B is at least partially disposed within the interior of the hollow tubular flange 814. [0073] FIG. 11 is a perspective view of another dose detection system 1100, where the light source 1104 and light sensor 1106 are axially disposed relative to one another, according to some embodiments. The dose detection system 1100 includes sensed element 1102, light source 1104, light sensor 1106, and electronics assembly 1112. In some embodiments, the sensed element 1102, as shown in this example, can be a part of tubular flange 1114 that can be part of a dose-setting assembly and used to determine dosing data based on rotation as described herein. Sensed element 1102 in this example is a shutter wheel which may be radially directed outwards from the axis of rotation of the tubular flange 1114 and rotationally fixed to the tubular flange 1114.

[0074] The shutter wheel may include a plurality of alternating surface portions 1118 and openings 1120. Surface portions 1118 may be radially spaced about the axis of rotation of the flange 1114 and arranged to correlate to a dose (e.g., such that one or more surfaces is equivalent of one unit, or one part of one unit, of dose). In this illustrative embodiment, the shutter wheel includes 20 surface portions 1118 that are equally rotationally spaced from one another, such that the rotation distance between two adjacent surfaces corresponds to 18 degrees of rotation. Thus, 18 degrees of rotation of the tubular flange and/or the shutter wheel may be used to represent a portion of a dosage unit, such as one dosage unit, a half dosage unit, a quarter of a dosage unit, and/or the like. It should be appreciated that, in other embodiments, different total numbers of surfaces may be used to create other angular relationships, such as, for example, 9, 10, 15, 18, 20, 24 or 36 degrees may be used for a unit or a portion of a unit. The shutter wheel may also include opening 1120, which may be disposed between each pair of adjacent surface portions 1118.

[0075] In some embodiments, light source 1104 is configured to emit a sensing light during dose setting and/or dose delivery. The light sensor 1106 is configured and positioned to receive the sensing light during dose setting and/or dose delivery. In an example embodiment, the light source 1104 and light sensor 1106 may be an infrared transmitter and infrared transceiver, respectively. In some examples, the light source 1104 may emit light that diffuses and propagates in multiple directions outwards from the light source 1104.

[0076] During dose setting and/or dose delivery, light source 1104 may point axially for emit a sensing light along the axial direction 1216 (as shown in FIG. 12) and light sensor 1106 may be positioned axially from the light source 1104 to receive the sensing light. In some embodiments, as shown in FIG. 11, the shutter wheel may be disposed between the light source 1104 and light sensor 1106. As sensed element 1102 rotates, surface portions 1118 and openings 1120 will successively be positioned in line with the light sensor 1106. In some examples, the light source 1104 may emit light that diffuses and propagates in multiple directions outwards from the light source 1104. In some embodiments, when openings 1120 are positioned in line with the light sensor 1106, openings 1120 may pass sensing light such that the sensing light that was diffused and propagated in multiple directions outward from the light source 1104 is detected by the light sensor 1106. Surface portions 1118 may block or reflect sensing light such that the light sensor 1106 receives a lower intensity of sensing light than if the surface portions 1118 were in line with the light sensor 1106.

[0077] Light sensor 1106 is configured to collect data indicative of rotation movement of the dose setting member. In various embodiments, light sensor 1106 is configured to detect varying intensities of the sensing light and thereby able to detect rotation of dose-setting assembly (tubular flange 1114 and dose-setting screw, not shown) relative to a medication delivery device actuator (dose button 30 and clutch 52) during dose setting or dose delivery. In some examples, surface portions 1118 may reflect or block sensing light so that light sensor 1106 receives a low intensity of sensing light. Openings 1120 may pass sensing light so that light sensor 1106 receives a high intensity of sensing light.

[0078] Electronics assembly 1112 may be in communication with light sensor 1106. Electronics assembly 1112 may receive information from the light sensor to determine data indicative of dosing information of the medication delivery device. In some examples, electronics assembly 1112 may distinguish varying intensities of sensing light to determine the dosage delivered. The different intensities of sensing light may correspond to surface portions 1118 or openings 1120. In some examples, the electronics assembly 1112 may distinguish surface portions 1118 or openings 1120 using a threshold corresponding to the intensity of the sensing light. For instance, data corresponding to intensities of the sensing light below the threshold may correspond to surface portions 1118, and data corresponding to intensities of sensing light above the threshold may correspond to openings 1120.

[0079] FIG. 12 is a perspective view of the circuitry of FIG. 11, according to some embodiments. Circuitry 1200 includes electronics assembly 1112, light source 1104, light sensor 1106. As mentioned previously, the electronics assembly 1112 may include a plurality of electronic components and may be in communication with light sensor 1106. The electronics assembly 1112 can include a PCB having a plurality of electronic components. The PCB may be a flexible printed circuit board. The circuit board of the electronics assembly may include a MCU as the controller comprising at least one processing core and internal memory.

[0080] Light source 1104 and light sensor 1106 may be disposed on flexible PCB 1208. Light source 1104 may be disposed towards a first end of flexible PCB 1208 and light sensor 1106 may be disposed towards a second end of flexible PCB 1208. Prior to installation within the medication injection device, the flexible PCB may be in an initial configuration. In some embodiments, the initial configuration may be flat. The initial configuration of the flexible PCB may thus have light sensor 1106 arranged with respect to the light source 1104 in a first orientation. After installation within the medication injection device, the flexible PCB 1208 may be in an installed configuration. The installed configuration of the flexible PCB may be shaped differently than the initial configuration. In some embodiments, the installed configuration may be at least partially bent to conform to a shape of a bracket. The installed configuration may include light sensor 1106 arranged with respect to light source 1104 in a second orientation. In some embodiments, the second orientation may have the light sensor 1106 arranged axially along 1216 with respect to the light source 1104. In the installed configuration, the flexible PCB 1208 may be disposed on shaped bracket 1210. Shaped bracket 1210 may form a curved shape (e.g., C-shape or U-shape) as shown in FIG. 12. The flexible PCB may be disposed on the shaped bracket such that the light sensor 1106 is positioned to directly point at the light source 1104 to receive light emitted by the light source 1104.

[0081] FIG. 13 A is another perspective view of dose detection system of FIG. 11, according to some embodiments. FIG. 13B is a cross-sectional view of the dose detection system of FIG. 11, according to some embodiments. In some embodiments, dose detection system includes light source 1104 axially disposed in relation to light sensor 1106 as described herein. As shown in FIG. 13B, the dose detection system 1100 of FIG. 11 may at least be partially disposed under cover 1308. The dose detection system may include, as shown in this example, light source 1104, light sensor 1106, sensing element 1102, flexible PCB 1310, battery 1312, and flange 1114.

[0082] In some embodiments, the sensed element may be pliable. For example, the sensed element can remain in a first configuration (e.g., a retracted state) when the medication delivery device is not in use, such that it does not protrude between the light source and light sensor. During dose setting and/or dosing, the sensed element can be configured to protrude between the light source and light sensor in a second configuration. Such embodiments can improve manufacturability since the sensed component can be manufactured in the first configuration, which can reduce manufacturing costs and/or manufacturing complexity. Such configurations can additionally or alternatively result in accurate dose sensing since the sensed component is not between the light source and light sensor when the medication delivery device is not in use, and thus dropping or shaking the medication delivery device when not in use will not inadvertently result in possibly generating incorrect sensing dosing information.

[0083] FIG. 14A is a cross-sectional view of a dose detection system using a pliable sheet, according to some embodiments. Dose detection system 1400 includes a sensed element, light source 1404, and light sensor 1406. In some embodiments, the sensed element, as shown in the example, can be a part of tubular flange. Sensed element may include a plurality of protrusions 1408 and recessions, not shown.

[0084] As discussed above, the pliable sheet can include surface portions and corresponding spaces along the protrudable portion of the sensed element 1408 that are equally radially spaced about a rotation axis and are arranged to correlate to a dose (e.g., such that one or more protrusions is the equivalent of one unit of, or a part of one unit of, a dose). Prior to dose setting and/or dose delivery, protrudable portion of the sensed element 1408 may be axially directed (e.g., such that it does not protrude into the sensor. During dose setting and/or dose delivery, protrudable portion of the sensed element 1408 may be pushed onto a curved surface on an under-mount 1414 that causes the protrudable portion of the sensed element 1408 to deform and protrude radially between the light source 1404 and the light sensor 1406. In some embodiments, after dose setting or dose delivery has been performed, the protrudable portion of the sensed element 1408 may again retracted and be axially directed as shown in FIG. 14 A.

[0085] As described herein, light source 1404 and light sensor 1406 may be disposed on flexible PCB 1418 and bent along a bracket 1410. In the example shown in FIG. 14B, the shaped bracket 1410 may form a C-shape. Flexible PCB 1418 may be disposed on the shaped bracket 1410 such that the light sensor 1406 is positioned to directly point at the light source 1404 to receive light emitted by the light source 1404. The shown device is a reusable penshaped medication injection device, generally designated, which is manually handled by a user to selectively set a dose and then to inject that set dose. Injection devices of this type are well known, and the description of device is merely illustrative as the sensing system can be adapted for use in variously configured medication delivery devices, including differently constructed pen-shaped medication injection devices, differently shaped injection devices, and infusion pump devices. The medication may be any of a type that may be delivered by such a medication delivery device. Device is intended to be illustrative and not limiting as the sensing system described further below may be used in other differently configured devices.

[0086] FIG. 15 is an exemplary method 1500 of manufacturing a medication delivery device by installing a flexible PCB into the medication delivery device, according to some embodiments. The process 1500 begins at 1501 with a light source and light sensor disposed on a flexible PCB with the flexible PCB in an initial configuration. In some embodiments, the light source may be disposed towards a first end of the flexible PCB and light sensor may be disposed towards a second end of the flexible PCB. The flexible PCB can be manufactured in the initial configuration, such as a substantially flat configuration such that the axes along which the light source and light sensor point are substantially parallel to each other. In some embodiments, at step 1501, the light source and light sensor are manufactured onto the flexible PCB as part of the manufacturing process. In some embodiments, at step 1501, the light source and light sensor may already be manufactured on the flexible PCB (e.g., as part of a separate manufacturing process), and thus at step 1501 the flexible PCB may be obtained in the initial configuration for installation at stap 1502, as discussed below. [0087] At 1502, the flexible PCB is installed in a medication delivery device, such that the flexible PCB is in an installed configuration. The installed configuration of the flexible PCB is shaped differently than the initial configuration of the flexible PCB (and thus the initial and installed arrangements of the light source and the light sensor are likewise different). The flexible PCB may be bent and disposed on an angled bracket to arrange the light source and the light sensor in the installed configuration. In some embodiments, the angled bracket may be an L-shape bracket as discussed herein (e.g., where the bracket may have a first and second portion such the angle between the first and second portions is approximately 90 degrees). In another embodiment, the angled bracket may be curved shaped (e.g., C-shape or U-shape) as also discussed herein, such that the light sensor is positioned to directly point at the light source to receive light emitted by the light source. The use of a flexible PCB to install the sensor components can reduce handling costs or complexity during manufacturing since the flexible PCB can be curved during installation. The use of the flexible PCB can additionally or alternatively reduce component counts, reduce inventory costs, and/or reduce or eliminate the need to solder some electrical connections during manufacturing (e.g., having to solder electrical connections at right angles during assembly).

[0088] Techniques operating according to the principles described herein may be implemented in any suitable manner. The processing and decision blocks of the flow charts above represent steps and acts that may be included in algorithms that carry out these various processes. Algorithms derived from these processes may be implemented as software integrated with and directing the operation of one or more single- or multi-purpose processors, may be implemented as functionally-equivalent circuits such as a Digital Signal Processing (DSP) circuit or an Application-Specific Integrated Circuit (ASIC), or may be implemented in any other suitable manner. It should be appreciated that the flow charts included herein do not depict the syntax or operation of any particular circuit or of any particular programming language or type of programming language. Rather, the flow charts illustrate the functional information one skilled in the art may use to fabricate circuits or to implement computer software algorithms to perform the processing of a particular apparatus carrying out the types of techniques described herein. It should also be appreciated that, unless otherwise indicated herein, the particular sequence of steps and/or acts described in

T1 each flow chart is merely illustrative of the algorithms that may be implemented and can be varied in implementations and embodiments of the principles described herein.

[0089] Accordingly, in some embodiments, the techniques described herein may be embodied in computer-executable instructions implemented as software, including as application software, system software, firmware, middleware, embedded code, or any other suitable type of computer code. Such computer-executable instructions may be written using any of a number of suitable programming languages and/or programming or scripting tools, and also may be compiled as executable machine language code or intermediate code that is executed on a framework or virtual machine.

[0090] When techniques described herein are embodied as computer-executable instructions, these computer-executable instructions may be implemented in any suitable manner, including as a number of functional facilities, each providing one or more operations to complete execution of algorithms operating according to these techniques. A “functional facility,” however instantiated, is a structural component of a computer system that, when integrated with and executed by one or more computers, causes the one or more computers to perform a specific operational role. A functional facility may be a portion of or an entire software element. For example, a functional facility may be implemented as a function of a process, or as a discrete process, or as any other suitable unit of processing. If techniques described herein are implemented as multiple functional facilities, each functional facility may be implemented in its own way; all need not be implemented the same way. Additionally, these functional facilities may be executed in parallel and/or serially, as appropriate, and may pass information between one another using a shared memory on the computer(s) on which they are executing, using a message passing protocol, or in any other suitable way.

[0091] Generally, functional facilities include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically, the functionality of the functional facilities may be combined or distributed as desired in the systems in which they operate. In some implementations, one or more functional facilities carrying out techniques herein may together form a complete software package. These functional facilities may, in alternative embodiments, be adapted to interact with other, unrelated functional facilities and/or processes, to implement a software program application.

[0092] Some exemplary functional facilities have been described herein for carrying out one or more tasks. It should be appreciated, though, that the functional facilities and division of tasks described is merely illustrative of the type of functional facilities that may implement the exemplary techniques described herein, and that embodiments are not limited to being implemented in any specific number, division, or type of functional facilities. In some implementations, all functionality may be implemented in a single functional facility. It should also be appreciated that, in some implementations, some of the functional facilities described herein may be implemented together with or separately from others (i.e., as a single unit or separate units), or some of these functional facilities may not be implemented.

[0093] Computer-executable instructions implementing the techniques described herein (when implemented as one or more functional facilities or in any other manner) may, in some embodiments, be encoded on one or more computer-readable media to provide functionality to the media. Computer-readable media include magnetic media such as a hard disk drive, optical media such as a Compact Disk (CD) or a Digital Versatile Disk (DVD), a persistent or non-persistent solid-state memory (e.g., Flash memory, Magnetic RAM, etc.), or any other suitable storage media. Such a computer-readable medium may be implemented in any suitable manner. As used herein, “computer-readable media” (also called “computer-readable storage media”) refers to tangible storage media. Tangible storage media are non-transitory and have at least one physical, structural component. In a “computer-readable medium,” as used herein, at least one physical, structural component has at least one physical property that may be altered in some way during a process of creating the medium with embedded information, a process of recording information thereon, or any other process of encoding the medium with information. For example, a magnetization state of a portion of a physical structure of a computer-readable medium may be altered during a recording process.

[0094] Further, some techniques described above comprise acts of storing information (e.g., data and/or instructions) in certain ways for use by these techniques. In some implementations of these techniques — such as implementations where the techniques are implemented as computer-executable instructions — the information may be encoded on a computer-readable storage media. Where specific structures are described herein as advantageous formats in which to store this information, these structures may be used to impart a physical organization of the information when encoded on the storage medium. These advantageous structures may then provide functionality to the storage medium by affecting operations of one or more processors interacting with the information; for example, by increasing the efficiency of computer operations performed by the processor(s).

[0095] In some, but not all, implementations in which the techniques may be embodied as computer-executable instructions, these instructions may be executed on one or more suitable computing device(s) operating in any suitable computer system, or one or more computing devices (or one or more processors of one or more computing devices) may be programmed to execute the computer-executable instructions. A computing device or processor may be programmed to execute instructions when the instructions are stored in a manner accessible to the computing device or processor, such as in a data store (e.g., an on-chip cache or instruction register, a computer-readable storage medium accessible via a bus, a computer- readable storage medium accessible via one or more networks and accessible by the device/processor, etc.). Functional facilities comprising these computer-executable instructions may be integrated with and direct the operation of a single multi-purpose programmable digital computing device, a coordinated system of two or more multi-purpose computing device sharing processing power and jointly carrying out the techniques described herein, a single computing device or coordinated system of computing device (co-located or geographically distributed) dedicated to executing the techniques described herein, one or more Field-Programmable Gate Arrays (FPGAs) for carrying out the techniques described herein, or any other suitable system.

[0096] A computing device may comprise at least one processor, a network adapter, and computer-readable storage media. A computing device may be, for example, a desktop or laptop personal computer, a personal digital assistant (PDA), a smart mobile phone, a server, or any other suitable computing device. A network adapter may be any suitable hardware and/or software to enable the computing device to communicate wired and/or wirelessly with any other suitable computing device over any suitable computing network. The computing network may include wireless access points, switches, routers, gateways, and/or other networking equipment as well as any suitable wired and/or wireless communication medium or media for exchanging data between two or more computers, including the Internet. Computer-readable media may be adapted to store data to be processed and/or instructions to be executed by processor. The processor enables processing of data and execution of instructions. The data and instructions may be stored on the computer-readable storage media. [0097] A computing device may additionally have one or more components and peripherals, including 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 printers or 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, 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.

[0098] Embodiments have been described where the techniques are implemented in circuitry and/or computer-executable instructions. It should be appreciated that some embodiments may be in the form of a method, of which at least one 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.

[0099] Various aspects of the embodiments described above may be used alone, in combination, or in a variety of arrangements not specifically discussed in the embodiments described in the foregoing and is therefore not limited in its application to the details and arrangement of components set forth in the foregoing description or illustrated in the drawings. For example, aspects described in one embodiment may be combined in any manner with aspects described in other embodiments.

[0100] Use of ordinal terms such as “first,” “second,” “third,” etc., in the claims to modify a claim element does not by itself connote any priority, precedence, or order of one claim element over another or the temporal order in which acts of a method are performed, but are used merely as labels to distinguish one claim element having a certain name from another element having a same name (but for use of the ordinal term) to distinguish the claim elements. [0101] Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” “having,” “containing,” “involving,” and variations thereof herein, is meant to encompass the items listed thereafter and equivalents thereof as well as additional items.

[0102] The word “exemplary” is used herein to mean serving as an example, instance, or illustration. Any embodiment, implementation, process, feature, etc. described herein as exemplary should therefore be understood to be an illustrative example and should not be understood to be a preferred or advantageous example unless otherwise indicated.

[0103] To clarify the use of and to hereby provide notice to the public, the phrases “at least one of <A>, <B>, . . . and <N>” or “at least one of <A>, <B>, . . . <N>, or combinations thereof’ or “<A>, <B>, . . . and/or <N>” are defined by the Applicant in the broadest sense, superseding any other implied definitions hereinbefore or hereinafter unless expressly asserted by the Applicant to the contrary, to mean one or more elements selected from the group comprising A, B, . . . and N. In other words, the phrases mean any combination of one or more of the elements A, B, . . . or N including any one element alone or the one element in combination with one or more of the other elements which may also include, in combination, additional elements not listed.

[0104] While various embodiments have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible. Accordingly, the embodiments described herein are examples, not the only possible embodiments and implementations. Furthermore, the advantages described above are not necessarily the only advantages, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment.

[0105] Various aspects are described in this disclosure, which include, but are not limited to, the following aspects:

[0106] 1. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery; a sensor comprising: a light source pointed in a first direction for emitting sensing light during dose setting or dose delivery; and a light sensor positioned for receiving the sensing light during dose setting or dose delivery, wherein the light sensor is pointed in a second direction, and wherein the light source is disposed with respect to the light sensor so that the first direction is angled with respect to the second direction such that the first direction is not parallel to the second direction; and an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensing light by the light sensor.

[0107] 2. The medication delivery device of aspect 1, further comprising an angled bracket that includes a first portion angled with respect to a second portion, wherein: the light source is disposed along the first portion; and the light sensor is disposed along the second portion so that the first direction is angled with respect to the second direction.

[0108] 3. The medication delivery device of aspect 2, wherein: the light source and the light sensor are disposed on a flexible printed circuit board (PCB); the flexible PCB is bent; and the flexible PCB is disposed on the angled bracket.

[0109] 4. The medication delivery device of aspect 3, wherein: the light source is disposed towards a first end of the flexible PCB; and the light sensor is disposed towards a second end of the flexible PCB; and the flexible PCB is bent so that the first end of the flexible PCB is disposed on the first portion of the angled bracket and the second end of the flexible PCB is disposed on the second portion of the angled bracket.

[0110] 5. The medication delivery device of aspect 2, wherein the first portion and the second portion are straight.

[0111] 6. The medication delivery device of aspect 2, wherein the first portion and the second portion form an L-shape.

[0112] 7 The medication delivery device of aspect 6, wherein the L-shape comprises an angle of approximately ninety degrees between the first portion and the second portion. [0113] 8. The medication delivery device of aspect 1, wherein the light sensor is configured to collect data indicative of rotational movement of the dose setting member.

[0114] 9. The medication delivery device of aspect 1, wherein the electronics assembly comprises at least one processor.

[0115] 10. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery; a sensor comprising: a light source for emitting sensing light during dose setting or dose delivery; and a light sensor positioned for receiving the sensing light during dose setting or dose delivery; a flexible printed circuit board (PCB) in an installed configuration within the medication delivery device, wherein: the light source and the light sensor are disposed on the flexible PCB in an initial configuration prior to installation such that the installed configuration is shaped differently than the initial configuration; and an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensing light by the light sensor.

[0116] 11. The medication delivery device of aspect 10, wherein: the initial configuration includes the light sensor arranged with respect to the light source in a first orientation; and the installed configuration includes the light sensor arranged with respect to the light source in a second orientation that is different from the first orientation.

[0117] 12. The medication delivery device of aspect 10, wherein the flexible PCB in the installed configuration is disposed on a shaped bracket.

[0118] 13. The medication delivery device of aspect 12, wherein the shaped bracket comprises a curved shape.

[0119] 14. The medication delivery device of aspect 13, wherein the curved shape comprises a C shape or a U shape.

[0120] 15. The medication delivery device of aspect 13, wherein the curved shape results in the light sensor being positioned to directly point at the light source.

[0121] 16. The medication delivery device of aspect 13, wherein the curved shape results in the light sensor and the light source being axially disposed relative to one another.

[0122] 17. The medication delivery device of aspect 10, wherein: the light source is disposed towards a first end of the flexible PCB; the light sensor is disposed towards a second end of the flexible PCB; and the flexible PCB is bent so that the first end of the flexible PCB is bent towards the second end of the flexible PCB.

[0123] 18. The medication delivery device of aspect 17, wherein the first end bent towards the second end results in the flexible PCB forming an L-shape.

[0124] 19. The medication delivery device of aspect 17, wherein a portion of the first end and a portion of the second end are straight.

[0125] 20. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery; a sensed element rotationally fixed with the dose setting member, wherein: the sensed element and the dose setting member rotate relative to the device body during dose delivery in relation to an amount of dose delivered; and the sensed element comprises a pliable sheet; a sensor comprising: a light source for emitting sensing light during dose delivery; and a light sensor positioned for receiving the sensing light during dose delivery, wherein: the light source and the light sensor are axially disposed relative to one another; and the sensed element protrudes between the light source and the light sensor during dose delivery; an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensing light by the light sensor.

[0126] 21. The medication delivery device of aspect 20, wherein the sensed element includes alternating first and second features radially-spaced about the axis of rotation of the dose setting member during dose delivery.

[0127] 22. The medication delivery device of aspect 21, wherein during dose delivery the alternating first and second features are in a path of the sensing light to vary light intensities detected by the light sensor.

[0128] 23. The medication delivery device of aspect 20, wherein the pliable sheet does not protrude between the light source and the light sensor before dose delivery.

[0129] 24. The medication delivery device of aspect 20, wherein the pliable sheet is pushed onto a curved surface on an under-mount during dose delivery that causes the pliable sheet to deform and protrude between the light source and the light sensor during dose delivery.

[0130] 25. The medication delivery device of aspect 24, wherein the pliable sheet is configured to protrude radially during dose delivery.

[0131] 26. The medication delivery device of any of aspects 1-24, further comprising a medication stored within the device body.

[0132] 27. A method of manufacturing a medication delivery device, the method comprising: obtaining a flexible printed circuit board (PCB) comprising a light source for emitting sensing light and a light sensor for receiving the sensing light disposed on the flexible PCB in an initial configuration; and installing the flexible PCB in an installed configuration in a medication delivery device comprising a device body and a dose setting member rotatable relative to the device body about an axis of rotation during dose setting or dose delivery, such that the rotation of the dose setting member causes intensities of sensing light received by the light sensor to vary, wherein the installed configuration is shaped differently than the initial configuration.

[0133] 28. The method of claim 27, wherein: the initial configuration includes the light sensor arranged with respect to the light source in a first orientation; and the installed configuration includes the light sensor arranged with respect to the light source in a second orientation that is different from the first orientation.

[0134] 29. The method of claim 27, wherein: the light source is disposed towards a first end of the flexible PCB; the light sensor is disposed towards a second end of the flexible PCB; and installing the flexible PCB in the installed configuration in the medication delivery device comprises bending the first end towards the second end.

[0135] 30. The method of claim 29, wherein installing the flexible PCB in the installed configuration in the medication delivery device comprises installing the flexible PCB on a curved bracket.

[0136] 31. The method of claim 30, wherein the curved bracket forms a C shape or a U shape.

[0137] 32. The method of claim 30, wherein the curved bracket forms an L shape.

Claims

CLAIMS We claim:

1. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery; a sensor comprising: a light source pointed in a first direction for emitting sensing light during dose setting or dose delivery; and a light sensor positioned for receiving the sensing light during dose setting or dose delivery, wherein the light sensor is pointed in a second direction, and wherein the light source is disposed with respect to the light sensor so that the first direction is angled with respect to the second direction such that the first direction is not parallel to the second direction; and an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensing light by the light sensor.

2. The medication delivery device of claim 1, further comprising an angled bracket that includes a first portion angled with respect to a second portion, wherein: the light source is disposed along the first portion; and the light sensor is disposed along the second portion so that the first direction is angled with respect to the second direction.

3. The medication delivery device of claim 2, wherein: the light source and the light sensor are disposed on a flexible printed circuit board (PCB); the flexible PCB is bent; and the flexible PCB is disposed on the angled bracket.

4. The medication delivery device of claim 3, wherein: the light source is disposed towards a first end of the flexible PCB; and the light sensor is disposed towards a second end of the flexible PCB; and the flexible PCB is bent so that the first end of the flexible PCB is disposed on the first portion of the angled bracket and the second end of the flexible PCB is disposed on the second portion of the angled bracket.

5. The medication delivery device of claim 2, wherein the first portion and the second portion are straight.

6. The medication delivery device of claim 2, wherein the first portion and the second portion form an L-shape.

7. The medication delivery device of claim 6, wherein the L-shape comprises an angle of approximately ninety degrees between the first portion and the second portion.

8. The medication delivery device of claim 1, wherein the light sensor is configured to collect data indicative of rotational movement of the dose setting member.

9. The medication delivery device of claim 1, wherein the electronics assembly comprises at least one processor.

10. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose setting or dose delivery; a sensor comprising: a light source for emitting sensing light during dose setting or dose delivery; and a light sensor positioned for receiving the sensing light during dose setting or dose delivery; a flexible printed circuit board (PCB) in an installed configuration within the medication delivery device, wherein: the light source and the light sensor are disposed on the flexible PCB in an initial configuration prior to installation such that the installed configuration is shaped differently than the initial configuration; and an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensing light by the light sensor.

11. The medication delivery device of claim 10, wherein: the initial configuration includes the light sensor arranged with respect to the light source in a first orientation; and the installed configuration includes the light sensor arranged with respect to the light source in a second orientation that is different from the first orientation.

12. The medication delivery device of claim 10, wherein the flexible PCB in the installed configuration is disposed on a shaped bracket.

13. The medication delivery device of claim 12, wherein the shaped bracket comprises a curved shape.

14. The medication delivery device of claim 13, wherein the curved shape comprises a C shape or a U shape.

15. The medication delivery device of claim 13, wherein the curved shape results in the light sensor being positioned to directly point at the light source.

16. The medication delivery device of claim 13, wherein the curved shape results in the light sensor and the light source being axially disposed relative to one another.

17. The medication delivery device of claim 10, wherein: the light source is disposed towards a first end of the flexible PCB; the light sensor is disposed towards a second end of the flexible PCB; and the flexible PCB is bent so that the first end of the flexible PCB is bent towards the second end of the flexible PCB.

18. The medication delivery device of claim 17, wherein the first end bent towards the second end results in the flexible PCB forming an L-shape.

19. The medication delivery device of claim 17, wherein a portion of the first end and a portion of the second end are straight.

20. A medication delivery device comprising: a device body; a dose setting member attached to the device body and rotatable relative to the device body about an axis of rotation during dose delivery; a sensed element rotationally fixed with the dose setting member, wherein: the sensed element and the dose setting member rotate relative to the device body during dose delivery in relation to an amount of dose delivered; and the sensed element comprises a pliable sheet; a sensor comprising: a light source for emitting sensing light during dose delivery; and a light sensor positioned for receiving the sensing light during dose delivery, wherein: the light source and the light sensor are axially disposed relative to one another; and the sensed element protrudes between the light source and the light sensor during dose delivery; an electronics assembly in communication with the light sensor to determine data indicative of dosing information of the medication delivery device based on reception of the sensing light by the light sensor.

21. The medication delivery device of claim 20, wherein the sensed element includes alternating first and second features radially-spaced about the axis of rotation of the dose setting member during dose delivery.

22. The medication delivery device of claim 21, wherein during dose delivery the alternating first and second features are in a path of the sensing light to vary light intensities detected by the light sensor.

23. The medication delivery device of claim 20, wherein the pliable sheet does not protrude between the light source and the light sensor before dose delivery.

24. The medication delivery device of claim 20, wherein the pliable sheet is pushed onto a curved surface on an under-mount during dose delivery that causes the pliable sheet to deform and protrude between the light source and the light sensor during dose delivery.

25. The medication delivery device of claim 24, wherein the pliable sheet is configured to protrude radially during dose delivery.

26. The medication delivery device of any of claims 1-24, further comprising a medication stored within the device body.

27. A method of manufacturing a medication delivery device, the method comprising: obtaining a flexible printed circuit board (PCB) comprising a light source for emitting sensing light and a light sensor for receiving the sensing light disposed on the flexible PCB in an initial configuration; and installing the flexible PCB in an installed configuration in the medication delivery device comprising a device body and a dose setting member rotatable relative to the device body about an axis of rotation during dose setting or dose delivery, such that the rotation of the dose setting member causes intensities of sensing light received by the light sensor to vary, wherein the installed configuration is shaped differently than the initial configuration.

28. The method of claim 27, wherein: the initial configuration includes the light sensor arranged with respect to the light source in a first orientation; and the installed configuration includes the light sensor arranged with respect to the light source in a second orientation that is different from the first orientation.

29. The method of claim 27, wherein: the light source is disposed towards a first end of the flexible PCB; the light sensor is disposed towards a second end of the flexible PCB; and installing the flexible PCB in the installed configuration in the medication delivery device comprises bending the first end towards the second end.

30. The method of claim 29, wherein installing the flexible PCB in the installed configuration in the medication delivery device comprises installing the flexible PCB on a curved bracket.

31. The method of claim 30, wherein the curved bracket forms a C shape or a U shape.

32. The method of claim 30, wherein the curved bracket forms an L shape.