Liquid measuring system optimized by temperature detection, apparatus and method

Abstract

To provide a liquid measuring system optimized by temperature detection.SOLUTION: An apparatus for measuring a volume of liquid in a container includes: a plurality of light sources that emit electromagnetic radiation (EMR) toward a container; a plurality of sensors that are optically coupleable to the light sources and detect EMR emitted by at least a portion of the light sources; a temperature sensor that measures at least one temperature associated with the liquid in the container; and at least one processor that receives data representing a portion of the detected EMR from each of the sensors, compares at least one measured temperature with a temperature pointer to identify a temperature event associated with the received data, normalizes the received data based on the temperature event associated with the received data, and converts the normalized data into signatures representing the EMR detected by the sensors.SELECTED DRAWING: Figure 19

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Application No. 62 / 032,017, entitled "Liquid Measurement System with Temperature Sensor," filed August 1, 2014, the disclosure of which is incorporated herein by reference in its entirety.

[0002] FIELD OF THE DISCLOSURE

[0002] The present disclosure relates generally to systems, apparatus, and methods for measuring the amount and / or temperature of a liquid placed in a dispensing device, and more particularly to an injection pen cap that includes a temperature sensor. [Background technology]

[0003]

[0003] Many chronically ill patients are prescribed medications that must be self-administered using an injection pen or similar medication delivery device, administered by a caregiver, or administered by an automated or semi-automated delivery system. For example, a patient diagnosed with type 1 or type 2 diabetes must regularly check their blood glucose levels and administer the appropriate dose of insulin using an injection pen. To monitor the efficacy of the medication, dosage information must be recorded. The process of manually recording dosage information is tedious and error-prone, especially in unregulated settings. Patients often forget to record dosage information when administering medication. Additionally, many such patients may be minors or elderly, who are unable to efficiently and / or accurately track dosage information.

[0004]

[0004] Incomplete medication records hinder patients' ability to self-manage their condition and prevent caregivers from adjusting care plans based on behavioral insights. Poor adherence to target dosing schedules for injectable medications may increase the need for critical care, resulting in significantly increased healthcare costs in countries around the world.

[0005]

[0005] Thus, there is a need for improved technological aids, particularly new dispensing devices to better assist both patients in self-managing their disease treatment using medication dispensing devices and caregivers in monitoring their health. In particular, there is a need for systems, apparatus, and methods that facilitate the collection of data about patient behavior and enable that data to be used to reduce the incidence of hospital visits (e.g., readmissions) and to inform and educate patients, caregivers, family members, and financial service providers. Summary of the Invention [Problem to be solved by the invention]

[0006]

[0006] The embodiments described herein generally relate to systems, apparatus, and methods for measuring the amount and / or temperature of a liquid disposed within a dispensing device, and more particularly, to an injection pen cap that includes a temperature sensor. The inventors have recognized and appreciated that temperature can affect the properties of the system, apparatus, and method embodiments described herein. In particular, temperature can affect the liquid quantity measurements made using some embodiments. In some embodiments, temperature can also affect the properties of one or more additional components, such as a glucose meter test strip.

[0007] Temperature can also affect the quality of the medication placed within the medication delivery device. The potency and shelf life of medications, including but not limited to insulin, are strongly influenced by the temperature to which a particular medication is exposed and / or the temperature at which a particular medication is stored. Injection pens containing various medications are often carried by patients, for example, in their pockets, backpacks, purses, luggage, etc. Thus, the medication may be exposed to widely varying ambient temperatures, which may affect the expiration status of the medication and / or the bioavailability, bioefficacy, and / or comfort provided by the medication ultimately administered to the patient. Additionally, knowing the specific effects of temperature exposure may alleviate safety concerns and anxieties of patients, caregivers, and family members. [Means for solving the problem]

[0008] In some embodiments, a dosage measurement system for measuring a volume of a liquid in a container includes a plurality of light sources positioned and configured to emit electromagnetic radiation toward the container. A plurality of sensors are optically coupleable to the plurality of light sources. The sensors are positioned and configured to detect electromagnetic radiation emitted by at least some of the light sources. The device includes a temperature sensor configured to measure a temperature of the liquid disposed in the container. The device also includes a processing unit configured to receive data from each of the plurality of sensors representative of a portion of the detected electromagnetic radiation and to convert the received data into a signature representative of the electromagnetic radiation detected by the plurality of sensors. The processing unit is also configured to receive temperature information from the temperature sensors and to normalize the sensor values, determine potency of the liquid, determine an expiration status of the liquid, determine administration comfort, etc. In some embodiments, the temperature sensor is also configured to measure a temperature of an environment surrounding the liquid. [Brief explanation of the drawings]

[0009] [Figure 1]

[0009] FIG. 1 is a schematic block diagram of a dosage measurement system according to some embodiments. [Figure 2]

[0010] FIG. 1 is a perspective view of a dose measurement system according to some embodiments. [Figure 3]

[0011] FIG. 3 is an exploded perspective view of the dose measurement system of FIG. 2 according to some embodiments. [Figure 4]

[0012] FIG. 3 is an exploded top view of the dose measurement system of FIG. 2 according to some embodiments. [Figure 5]

[0013] FIG. 3 is a schematic diagram of a communication interface that may be included in the dosage measurement system of FIG. 2 according to some embodiments. [Figure 6]

[0014] 1A-1C are schematic ray diagrams of the transmission of different modes of light between a first medium and a second medium according to some embodiments. [Figure 7]

[0015] 1 is a cross-sectional view of a dose measuring system according to some embodiments. [Figure 8]

[0016] 1 is a cross-sectional view of a dose measuring system according to some embodiments. [Figure 9]

[0017] 1 is a cross-sectional view of a dose measuring system according to some embodiments. [Figure 10]

[0018] 1 is a side cross-sectional view of a dose measuring system according to some embodiments. [Figure 11A]

[0019] FIG. 1 is a cross-sectional view of a dosage measuring system in a first configuration according to some embodiments. [Figure 11B]

[0019] FIG. 2 is a cross-sectional view of a dose measuring system in a second configuration according to some embodiments. [Figure 11C]

[0019] FIG. 1 is a cross-sectional view of a dose measuring system in a third configuration according to some embodiments. [Figure 12]

[0020] FIG. 11B is a cross-sectional view of the dose measuring system of FIG. 11A along line AA according to some embodiments. [Figure 13]

[0021] FIG. 11D is a cross-sectional view of the dose measuring system of FIG. 11C along line BB according to some embodiments. [Figure 14]

[0022] 10 is a graph illustrating a reference signature signal of a sensor of a dosage measurement system according to some embodiments. [Figure 15]

[0023] FIG. 1 is a flow diagram of a method of operation of a dose measurement system according to some embodiments. [Figure 16]

[0024] FIG. 1 is a flow diagram of a method of operation of a dose measurement system according to some embodiments. [Figure 17]

[0025] 1 is a schematic block diagram of a health management system associated with a dosage measurement system according to some embodiments. [Figure 18]

[0026] FIG. 1 is a schematic block diagram of a liquid measurement system with a temperature sensing module according to some embodiments. [Figure 19]

[0027] 1 is a perspective view of a liquid measurement system including a temperature sensing module according to some embodiments. [Figure 20]

[0028] FIG. 20 is an exploded perspective view of the liquid measurement system of FIG. 19 according to some embodiments. [Figure 21]

[0029] 21 is a rear perspective view of a lower housing included in the liquid measurement system of FIG. 20 according to some embodiments. [Figure 22]

[0030] 22 is a bottom view of a PCB included in the sensing assembly of the liquid measurement system of FIG. 21 according to some embodiments. [Figure 23]

[0031] 1 is a graph illustrating compensated and uncompensated measurements of a representative sensor of a liquid measurement system as a function of temperature, according to some embodiments. [Figure 24]

[0032] FIG. 1 is a diagram of a portion of a liquid measurement system including a temperature sensor according to some embodiments. [Figure 25]

[0033] 10A-10C are screenshots of user interface displays for monitoring one or more liquid measurement systems according to some embodiments. DETAILED DESCRIPTION OF THE INVENTION

[0010]

[0034]

[0002] Embodiments described herein generally relate to systems, apparatus, and methods for measuring the amount and / or temperature of a liquid placed in a dispensing device, and more particularly, to an injection pen cap that includes a temperature sensor. Many chronically ill patients are prescribed medications that must be self-administered using an injection pen or similar medication dispensing device, administered by a caregiver, or administered by an automated or semi-automated dispensing system. For example, patients diagnosed with Type 1 or Type 2 diabetes must regularly check their blood glucose levels and administer the appropriate dose of insulin using an injection pen. To monitor the efficacy of the medication, dosage information must be recorded. The process of manually recording dosage information is tedious and error-prone, especially in unregulated settings.

[0011]

[0035] Furthermore, temperature can affect the measurement characteristics of some embodiments and the quality characteristics of the medications included in some embodiments. The potency and shelf life of medications, including but not limited to insulin, are strongly influenced by the temperature to which a particular medication is exposed and / or stored. Injection pens containing such medications are often carried by patients, for example, in their pockets, backpacks, purses, luggage, etc. Thus, medications may be exposed to widely varying ambient temperatures, which can affect the expiration status of the medication and / or the bioavailability, bioefficacy, and / or comfort provided by the medication ultimately administered to the patient. Additionally, knowing the specific effects of temperature exposure can alleviate safety concerns and anxieties of patients, caregivers, and family members.

[0012]

[0036] Embodiments of the systems, devices, and methods described herein include one or more temperature sensors configured to measure the temperature of a liquid disposed in a container and / or the temperature of an environment surrounding the liquid, including, but not limited to, a container containing the liquid, such as an injection pen.

[0013]

[0037] In some embodiments, a dosage measuring system for measuring a volume of liquid in a container includes a plurality of light sources positioned and configured to emit electromagnetic radiation towards the container. The multiple light sources may include, for example, multiple light emitting diodes (LEDs). Alternatively, a single light source (e.g., a single LED) may be used to emit electromagnetic radiation into a light pipe, which splits the emitted electromagnetic radiation among multiple light sources arranged and configured to emit electromagnetic radiation toward the container. In some embodiments, multiple sensors are optically coupleable to the multiple light sources and arranged and configured to detect electromagnetic radiation emitted by at least some of the light sources. The device also includes a processing unit configured to receive data from each of the multiple sensors representative of the detected portions of the electromagnetic radiation and to convert the received data into a signature representative of the electromagnetic radiation detected by the multiple sensors. One or more temperature sensors are arranged and configured to measure the temperature of the liquid disposed in the container and / or the temperature of the environment surrounding the container. This temperature information may be used to determine various indicators, including the level of bioavailability and / or bioefficacy of the remaining liquid.

[0014]

[0038] In some embodiments, a method for estimating a volume of liquid in a medication delivery device includes causing a plurality of light sources to emit electromagnetic radiation toward a medication container and detecting, with a plurality of sensors, a signature of the emitted electromagnetic radiation that has passed through the medication container. The detected signature is then compared to a plurality of reference signatures to determine the volume of liquid in the medication container. Each of the plurality of reference signatures corresponds to a volume level remaining in the medication container. In some embodiments, detecting a signature of the emitted electromagnetic radiation that has passed through the medication container includes detecting at least a portion of the electromagnetic radiation emitted from at least some of the plurality of light sources. The portion of the electromagnetic radiation detected by each of the plurality of sensor devices may be incorporated into the signal signature. In some embodiments, the method further includes detecting one or more temperatures of the medication, the container, and / or an environment surrounding the container. The detected one or more temperatures may be used to indicate a quality associated with the medication. The one or more temperatures may also be used to indicate a quality associated with a volumetric measurement characteristic and / or to adjust a deposition measurement characteristic.

[0015]

[0039] In some embodiments, the method also includes calculating a dose administered to the patient based on the volume of liquid in the medication container. In some embodiments, the dose administered to the patient is compared to the patient's dosing schedule to monitor compliance. The method may further include correcting the signal signature for background light, which may contribute to noise. The correction may include comparing the signal signature to a background signature detected by the multiple sensors when each of the multiple light sources is in a dark state. The method may further include correcting the signal signature for temperature effects. The correction may include comparing the signal signature to a background signature detected by the multiple sensors when each of the multiple light sources is in a suitable temperature state. In some embodiments, the method also includes generating a plurality of reference signatures by recording signatures of a range of dosage volumes in the medication container. The method may also include correlating the signal with the reference signatures using probabilistic matching to determine the volume of liquid remaining in the dosage container.

[0016]

[0040] In some embodiments, a method for determining a dose administered by an injection pen using a drug measurement system includes causing a plurality of light sources to emit electromagnetic radiation toward the injection pen for the first time and detecting, with a plurality of sensors, a first signature of the emitted electromagnetic radiation that passes through the injection pen. The first signature is then compared to a plurality of reference signatures to determine a first volume of liquid in the injection pen. The method further includes causing the plurality of light sources to emit electromagnetic radiation toward the injection pen a second time after the first time and detecting, with the plurality of sensors, a second signature of the emitted electromagnetic radiation that passes through the injection pen. The second signature is then compared to the plurality of reference signatures to determine a second volume of liquid in the injection pen. The second signature is then compared to a plurality of reference signatures to determine a second volume of liquid in the injection pen. may be subtracted from the first volume.

[0017]

[0041] In some embodiments, the plurality of light sources and the plurality of sensors are disposed within the injection pen cap. In some embodiments, the method includes detecting a first signature before the injection pen cap is removed from the injection pen and detecting a second signature after the injection pen cap is replaced on the injection pen. The method may also include communicating the administered dose information to an external device. In some embodiments, the method includes switching the pen cap to a power-saving mode after a predetermined period of pen cap inactivity. In some embodiments, the method further includes alerting a user when the volume of liquid remaining in the medication container is critically low and / or when it is time to administer a dose of medication.

[0018]

[0042] In some embodiments, a health management system includes a medication delivery device including a medication reservoir and a dosage measurement system configured to be removably coupleable to the medication delivery device. The dosage measurement system includes a plurality of light sources configured to emit electromagnetic radiation toward the medication reservoir and a plurality of sensors optically coupleable to the plurality of light sources and configured to detect an amount of electromagnetic radiation transmitted through the medication reservoir. The amount of electromagnetic radiation serves as a signature representative of the volume of liquid remaining in the medication reservoir. The health management system also includes a display configured to present information to a user indicative of the volume of liquid remaining in the medication reservoir. The dosage measurement system may be configured to communicate data representative of the volume of liquid remaining in the medication reservoir to a remote device, for example, to enable the remote device to calculate the dose administered to the patient. In some embodiments, the dosage management system is configured to receive user health data from the remote device, which may include, for example, the user's blood glucose level, the user's dietary restrictions, the user's exercise, and / or the user's home health monitoring data.

[0019]

[0043] 1 is a schematic block diagram of a dose measurement system 100 for measuring a dose in a drug delivery device 110 according to some embodiments. The dose measurement system 100 includes an illumination module 140, a sensing module 150, a processing unit 160, and a communication module 170. The dose measurement system 100 may be configured to be removably coupleable to a drug delivery device 110 used to deliver a drug dose to a target T, such as a human patient.

[0020]

[0044] The medication delivery device 110 may be any medication delivery device 110 that can be used to inject medication into a patient. For example, the medication delivery device 110 may be an injection pen (e.g., an insulin injection pen), a syringe, a pump (e.g., an insulin delivery pump), an ampoule, or a vial. The dose measurement system 100 may be configured to be connectable to a wide variety of medication delivery devices 110 (e.g., different shapes, sizes, and medication volumes). In some embodiments, the dose measurement system 100 may be configured to receive a portion of the medication delivery device 110 (e.g., a portion defining an internal volume containing the medication, an injector, and / or a plunger). In some embodiments, the dose measurement system 100 is configured to be detachable from the medication delivery device 110 when a user is administering a dose to the target T. In some embodiments, the dose measurement system 110 may remain attached to the medication delivery device 110 when a user is administering a dose to the target T. In some embodiments, the dose measurement system 100 is configured to be reusable. In some embodiments, the dosage measurement system 110 may be permanently coupled to the medication delivery device 110, for example integrated into the body of the medication delivery device 110. In such embodiments, the dosage measurement system 100 may be disposable.

[0021]

[0045] The illumination module 140 includes multiple light sources configured to emit electromagnetic radiation toward the medication administration device 110. In some embodiments, the multiple light sources may be configured to emit electromagnetic radiation toward a medication reservoir (not shown) of the medication administration device 110. In some embodiments, each of the multiple light sources may be a light emitting diode (LED). In some embodiments, the multiple light sources may be configured to emit electromagnetic radiation such that the electromagnetic radiation may penetrate the housing and any internal components of the medication administration device 110 and / or a liquid medication contained therein. In some embodiments, the multiple light sources may be configured to emit continuous electromagnetic radiation over a predefined period of time. In some embodiments, the multiple light sources may be configured to emit pulses of electromagnetic radiation (e.g., a series of pulses of less than 100 microseconds).

[0022]

[0046] The sensing module 150 includes a plurality of sensors optically coupleable to the plurality of light sources of the illumination module 140. In some embodiments, each of the plurality of sensors is a light receiving element. The plurality of sensors are positioned and configured to detect electromagnetic radiation emitted by at least some of the light sources. In some embodiments, the detected electromagnetic radiation includes transmitted, refracted, and reflected portions of the electromagnetic radiation. In some embodiments, the refracted electromagnetic radiation may include multi-directional refraction caused by the lens effect of the curved surfaces of the housing and / or the drug reservoir of the medication delivery device 110.

[0023]

[0047] The processing unit 160 is configured to receive electromagnetic radiation signals from the sensing module 150 (i.e., each of the plurality of sensors) and convert the received data into a signal signature representative of the electromagnetic radiation detected by each of the plurality of sensors. The processing unit 160 may include a processor, including, but not limited to, a microcontroller, a microprocessor, an ASIC chip, an ARM chip, an analog-to-digital converter (ADC), and / or a programmable logic controller (PLC). In some embodiments, the processing unit 160 may include a memory configured to temporarily store at least one of the electromagnetic radiation data detected by each of the plurality of sensors and the signal signature generated from the electromagnetic radiation data. In some embodiments, the memory may also be configured to store a plurality of reference signatures. Each of the plurality of reference signatures may represent a medication volume within the medication delivery device 110. In some embodiments, the processing unit 160 also includes an RFID chip configured to store information (e.g., remaining dosage information) and enable the stored information to be read by a near-field communication (NFC) device. In some embodiments, the processing unit 160 is configured to correlate the signal signature with a reference signature to determine the dose volume remaining in the drug delivery device 110 and / or the dose injected by the drug delivery device 110. In some embodiments, the processing unit 160 also includes a global positioning, infrared radiation, and / or microwave radiation navigation system (e.g., GPS) to determine the current location of the dose measurement system 100.

[0024]

[0048] Communications module 170 may be configured to enable two-way communication with external devices, including, but not limited to, a smartphone, a local computer, and / or a remote server. In some embodiments, communications module 170 includes means for wireless communication with external devices, including, but not limited to, Wi-Fi, Bluetooth, low-power Bluetooth, ZigBee, etc. In some embodiments, communications module 170 includes a communications interface (e.g., a USB or firewire interface) for providing wired communication with external devices. In some embodiments, the communications interface is also used to charge a power source, such as a rechargeable battery.

[0025]

[0049] In some embodiments, the communications module 170 includes a display configured to communicate the status of the dosage measurement system 100 to the user, including, but not limited to, remaining dose, usage history, remaining battery life, wireless connection status, and / or user reminders. In some embodiments, the communications module also includes a speaker and / or vibration mechanism for delivering audio and / or tactile alerts. In some embodiments, the communications module 170 includes a user input interface (e.g., buttons, switches, an alphanumeric keypad, a touchscreen, a camera, and / or a microphone) to allow the user to input information or commands into the dosage measurement system 100, including, but not limited to, powering the system on, powering the system off, resetting the system, manually entering details of a patient action, manually entering details of use of the medication delivery device 110, and / or manually initiating communication between the dosage measurement system 100 and a remote device.

[0026]

[0050] The dosage measurement system 100 may be disposed in a housing (not shown) configured to be removably coupleable to the medication delivery device 110. For example, the illumination module 140, the detection module 150, the processing unit 160, and the communication module 170 may be integrated into the housing, or individual components of the dosage measurement system 100 (e.g., the illumination module 140 and the detection module 150) may be integrated into a first housing, while other components (e.g., the processing unit 160 and the communication module 170) are separate or integrated into a second housing. In some embodiments, the housing is configured (e.g., shaped and sized) to be removably coupled to at least a portion of the medication delivery device 110. For example, the housing may have a recess and / or define a hole within which a portion of the medication delivery device 110 may be received. The housing may have alignment features to enable the dosage measurement system 100 to be coupled to the medication delivery device 110 in a predetermined radial orientation. The housing may be opaque and may include insulating structures to prevent interference from ambient electromagnetic radiation, e.g., to enhance signal quality. For example, the insulating structure may be a metal lining configured to shield the electronic components of the dosage measurement system 100 from external electromagnetic radiation. In some embodiments, the housing resembles, for example, a pen cap and acts as a replacement cap for the medication delivery device 110 (i.e., an injection pen).

[0027]

[0051] In some embodiments, the illumination module 140 and the sensing module 150 are positioned and / or oriented within the housing of the dosage measurement system 100 such that the light sources are disposed on a first side of the medication delivery device 110 and the sensors are disposed on a second side of the medication delivery device 110. In some embodiments, the light sources are disposed at a first radial position relative to the medication delivery device 110 and the sensors are disposed at a second radial position different from the first radial position (e.g., the second radial position may be approximately 180 degrees from the first radial position). In other words, the dosage management system 100 may be configured such that the light sources are disposed on one side of the medication reservoir and the sensors are disposed on an opposite side of the medication reservoir. In some embodiments, the light sources and the sensors are disposed in a substantially straight line. In some embodiments, the light sources are disposed such that each light source is adjacent to at least one sensor and each light source is parallel to and within the line of sight of at least one sensor. In some embodiments, at least one of the plurality of light sources and / or at least one of the plurality of sensors is positioned at an oblique orientation with respect to the longitudinal axis of the medication delivery device 110. In some embodiments, the number of the plurality of sensors is equal to, greater than, or less than the number of the plurality of light sources. In some embodiments, the plurality of light sources and the plurality of sensors are configured to enable the dosage measurement system 110 to detect the volume of medication in the medication delivery device 110 with a resolution of one unit of medication or less (e.g., fractional units of medication such as 0.1 units, 0.2 units, 0.5 units, etc.). In some embodiments, the plurality of light sources and The multiple sensors are configured to enable the dosage measurement system 110 to detect the position of a plunger portion of an actuator disposed within the medication administration device 110 with a resolution of 10 micrometers, 20 micrometers, 30 micrometers, 40 micrometers, 50 micrometers, 60 micrometers, 70 micrometers, 80 micrometers, 90 micrometers, 100 micrometers, 110 micrometers, 120 micrometers, 130 micrometers, 140 micrometers, 150 micrometers, 160 micrometers, 170 micrometers, 180 micrometers, or 200 micrometers, including all ranges therebetween.

[0028]

[0052] Having described various general principles above, we now describe some exemplary embodiments of these concepts. These embodiments are by way of example only, and many other configurations of one or more dose measurement systems and / or methods for measuring the dose administered by a medication delivery device and the overall health of a patient are envisioned.

[0029]

[0053] 2-4 , according to some embodiments, the dosage measurement system 200 may include an illumination module 240, a sensing module 250, a processing unit 260, a communications module 270, and a power source 286. The dosage measurement system 200 may be configured to be removably coupled to a medication delivery device 210 (also referred to herein as an “injection pen 210”). The medication delivery device 210 may be configured to deliver a predefined amount of medication (e.g., a dose) to a patient. Examples of medication delivery devices 210 include insulin injection pens that may be used by patients to self-administer insulin. As described herein, the medication delivery device 210 may include a housing 212, an actuator 214, and an injector 216. The housing 212 may be relatively opaque so as to transmit only selected wavelengths of electromagnetic radiation (e.g., infrared or microwave radiation). The housing 212 defines an interior volume (e.g., a reservoir) for storing medication. The actuator 214 may include a plunger portion in fluid communication with the medication and configured to deliver a predefined amount of the medication to the patient. The actuator 214 may be configurable, for example, by a user, to dispense a variable amount of the medication. The injector 216 is configured to penetrate the user's skin for intramuscular, subcutaneous, and / or intravenous administration of the medication.

[0030]

[0054] The dosage measuring system 200 includes a housing 220 having an upper housing portion 222 (also referred to herein as the "upper housing 222") and a lower housing portion 224 (also referred to herein as the "lower housing 224"). The upper housing portion 222 and the lower housing portion 224 may be removably or fixedly connected, for example, by gluing, heat welding, and / or using a snap-fit mechanism, by using screws, or any other suitable connecting means. The housing 220 may be made from a rigid, lightweight, and / or opaque material, including, but not limited to, polytetrafluoroethylene, high-density polyethylene, polycarbonate, other plastics, acrylic, sheet metal, and any other suitable material or combination thereof. The housing 220 may also be configured to shield the internal electronic components of the dosage measuring system 200 from environmental electromagnetic noise. For example, the housing may include an insulating structure (not shown), such as an aluminum lining or any other metal sheet or foil, that can serve as an electromagnetic shield.

[0031]

[0055] 3, the upper housing portion 222, according to some embodiments, defines an interior volume that substantially houses the illumination module 240, the sensing module 250, the processing unit 260, the communication module 270, and the power source 286. The lower housing portion 224 includes and defines a bore 226 that is shaped and sized to receive at least a portion of the medication delivery device 210. For example, the bore 226 may extend beyond the housing 212 and the illumination module 240. The bore 226 may be shaped and sized to receive only the drug-containing portion of the injector 216. The bore 226 may be configured to receive the drug delivery device 210 in a preferred orientation, such as a preferred radial orientation. In some embodiments, the bore 226 has a close tolerance with the diameter of the drug delivery device 210, for example to form a friction fit with the drug delivery device 210. In some embodiments, the bore 226 includes one or more notches, grooves, detents, any other snap-fit mechanism, or threads for removably coupling the drug delivery device 210 to the lower housing 224. In some embodiments, the lower housing part 224 includes one or more alignment features to enable the drug delivery device 210 to be matable with the dosage measuring system 200 in a predetermined radial orientation.

[0032]

[0056] In some embodiments, the lower housing 224 includes one or more apertures 228 for receiving at least a portion of the light sources 244 of the illumination module 240 and / or the sensors 254 of the detection module 250. The apertures 228 may be configured to provide mechanical support for the light sources 244 and / or the sensors 254 or may serve as an alignment mechanism for the illumination module 240 and / or the detection module 250.

[0033]

[0057] As shown in FIG. 4 , the upper housing 222, according to some embodiments, includes an opening 230 for receiving at least a portion of the communication module 270, such as a communication interface for providing wired communication with an external device and / or an interface for charging the power source 286. In some embodiments, the upper housing 222 also includes one or more features (e.g., a recess, a window, a cavity, etc.) for receiving a portion of the medication delivery device 210, such as the injector 216. In some embodiments, the housing 220 also includes a detection mechanism (not shown) for detecting whether the medication delivery device 210 is coupled to the dosage measurement system 200. The detection mechanism may include, but is not limited to, a push switch, a motion sensor, a position sensor, an optical sensor, a piezoelectric sensor, an impedance sensor, or any other suitable sensor. The housing 220 may be relatively smooth and free of sharp edges. In some embodiments, the housing 220 is shaped to resemble a pen cap having a form factor that occupies minimal space (e.g., fits in a user's pocket). In some embodiments, the housing 220 also includes attachment features (e.g., a clip for attachment to a user's pocket or belt) and / or decorative features. In some embodiments, the dosage measuring system 200 also serves as a replacement cap for the medication delivery device 210.

[0034]

[0058] 3 and 4 , the multiple light sources 244 (e.g., multiple LEDs or a single LED connected to a light pipe that splits the emitted electromagnetic radiation into multiple light sources) of the illumination module 240 are mounted or otherwise disposed on a printed circuit board (PCB) 242. The PCB 242 may be any standard PCB fabricated by any commonly known process. In some embodiments, the multiple light sources 244 are aligned and evenly spaced such that when the portion of the medication delivery device 210 that defines the interior volume of the housing 212 that holds the medication is mated with the dosage measurement system 200, the light sources 244 illuminate the entire interior volume. In some embodiments, the light sources 244 are arranged in any other configuration, including, but not limited to, a zigzag configuration, an unevenly spaced configuration, a staggered configuration, a configuration in which the light sources 244 are staggered relative to the sensor 254, and / or any other configuration described herein.

[0035]

[0059] In some embodiments, the light source 244 is configured to generate electromagnetic radiation at a wavelength that can penetrate the housing 212 of the drug delivery device 210, the drug contained therein, and / or a portion of the housing 220. For example, infrared radiation or Microwave radiation can penetrate many of the plastic materials commonly used in the manufacture of medication delivery devices (e.g., injection pens). In some embodiments, the electromagnetic radiation has a frequency that also penetrates internal components of the medication delivery device 210 (e.g., the plunger portion of the actuator 214). In some embodiments, each of the light sources 244 is configured to generate a wide-angle beam of electromagnetic radiation (e.g., multiple wide-angle LEDs or a single LED connected to a light pipe configured to generate multiple wide-angle beams of electromagnetic radiation). Stated differently, the cone of electromagnetic radiation of a single light source 244 may have a wide angle, and the cones of electromagnetic radiation of adjacent light sources 244 may overlap. In some embodiments, the multiple light sources 244 are configured to emit pulses of electromagnetic radiation (e.g., a series of sub-100 microsecond pulses).

[0036]

[0060] The multiple sensors 254 of the sensing module 250 are mounted or otherwise disposed on a PCB 252. The PCB 252 may be any standard PCB fabricated by any commonly known process. The multiple sensors 254 may be any optical sensors (e.g., photodiodes) optically coupled to the multiple light sources 244 and configured to detect at least a portion of the electromagnetic radiation emitted by the multiple light sources 244. The electromagnetic radiation may be transmitted radiation (e.g., transmitted through air, the drug, and / or the body of the drug administration device 210), refracted radiation (e.g., refracted by air, the drug, and / or the body of the drug administration device 210), reflected radiation (e.g., reflected from the walls of the housing 220 or internally reflected from the walls of the drug administration device 210), and / or multi-directional refraction / reflection caused by the lens effect of the curved surfaces of the housing 212 and / or the drug reservoir. The transmitted, refracted, and / or reflected electromagnetic signals received by the multiple sensors 254 may be used (e.g., by the processing unit 260) to create a signal signature. For example, the signal signature can then be correlated with a reference signature to determine the remaining dose in the medication delivery device 210. In some embodiments, the signal response of the sensor 254 may be used to measure a utility indicator, such as determining the presence or absence of the injector 216 of the medication delivery device 210 and / or determining whether the medication delivery device 210 is coupled / discoupled to the dosage measurement system 200. In some embodiments, the sensors 254 are arranged in a configuration generally similar to the light sources 244. In some embodiments, the number of sensors 254 is greater than or less than the number of light sources 244. In some embodiments, the light sources 244 and sensors 254 are arranged such that each PCB 244, 254 includes a combination of a light source 244 and a sensor 254 (e.g., arranged in a staggered manner). In some embodiments, the light sources 244 and / or sensors 254 are arranged in an oblique orientation.

[0037]

[0061] The processing unit 260 may include a PCB 262 and a processor 264. The PCB 262 may be any standard PCB fabricated by any commonly known process and may include amplifiers, transistors, and / or any other electronic circuitry as needed. The processor 264 may be any processor, including but not limited to a microprocessor, a microcontroller, a PLC, an ASIC chip, an ARM chip, an ADC, or any other suitable processor. The processing unit 260 may be coupled to the illumination module 240 and the detection module 250 using electronic coupling 266 such that the illumination module 240 and the detection module 250 are oriented perpendicular to the processing unit 260 and parallel to each other. In some embodiments, processing unit 260 includes on-board memory for at least temporarily storing signal signatures, a reference signature database, dosage information, user health data (e.g., blood glucose levels), device location data (e.g., from a GPS receiver optionally included in dosage measurement system 200 or from another GPS-enabled device communicatively coupled to system 200, such as a blood glucose meter or cell phone), and any other data that may be useful to a patient in managing their health. In some embodiments, processing unit 260 is configured to store information and The NFC device may include an RFID chip configured to enable the FC device to read the stored information. The processing unit 260 may be configurable to control the operation of the dosage measurement system 200, such as activating and timing the light source 244 and / or reading and processing electromagnetic radiation data from the sensors 254. For example, the processing unit 260 may be configured to compare electromagnetic radiation signal signatures obtained from multiple sensors 254 and correlate them with a reference signature database to determine the remaining dose in the medication delivery device 210 or the position of the actuator 214 (e.g., plunger) of the medication delivery device 210.

[0038]

[0062] In some embodiments, processing unit 260 is configured to correct the signal signature for background noise. For example, processing unit 260 may be configured to operate detection module 250 to detect a background signature when the illumination module is in a dark state, i.e., when each of multiple light sources 244 is turned off. The background signature may be correlated with the signal signature to correct for the background noise. In some embodiments, processing unit 260 also includes electronic signal filtering algorithms, including but not limited to, a Fourier transform, a low-pass filter, a band-pass filter, a high-pass filter, a Bessel filter, and / or any other digital filter, to reduce noise and improve signal quality. The processing unit 260 may be configured to obtain reference signatures by storing electromagnetic radiation signals detected by the detection module 250 for a range of dosage volumes within a representative drug administration device 210, including but not limited to full, empty, and a series of intervals therebetween (e.g., every unit of dosage dispensed from the drug administration device and / or every 170 micrometers displacement of the plunger portion of the actuator 214 included in the drug administration device 210).

[0039]

[0063] In some embodiments, the processing unit 260 is configured to include a probabilistic matching algorithm that can be used to correlate signal signatures with reference signatures to determine the volume of liquid in the medication administration device 210. The processing unit 260 may also be configured to control and operate the communications module 270. In some embodiments, the processing unit 260 is configured to operate the system in a power-efficient manner. For example, the processing unit 260 may turn off at least some of the electronics (e.g., operational amplifiers) that power the light source 244 when not needed. The processing unit 260 may pulse modulate the light source 244 with a high current for short periods of time, for example, to save power and / or improve the signal-to-noise ratio. The processing unit 260 may be configured to periodically activate the communications module 270, including, but not limited to, a predetermined number of times per day (e.g., 10 times) and / or when the dosage measurement system 200 is attached to the medication administration device 210. The processing unit 260 may also be configured to deactivate the communications module 270 when not needed. In some embodiments, the processing unit 260 also includes a global positioning / navigation system (eg, GPS), for example, to determine the current location of the dose measuring system 200 .

[0040]

[0064] The communications module 270 may be configured to communicate data to a user and / or external devices, such as, for example, a smartphone application, a local computer, and / or a remote server. The communicated data may include, but is not limited to, initial system startup, system on / off, docking / disconnecting a medication delivery device, remaining dose, dosage history, time, system and / or medication temperature, system location (e.g., GPS), medication delivery device 210 data, medication expiration data, the rate at which medication is being delivered, device collisions, remaining device power, step count, system tampering, and / or any other user health information or other usable data. In some embodiments, the communications module 270 may communicate data, such as new The communication module 270 may also be configured to receive calibration data, firmware updates, user health information (e.g., blood glucose, dietary restrictions, exercise, and / or dosage information), and / or any other information input by the user and / or transmitted from an external device. The communication module 270 may include conventional data communication electronics and may use standard communication protocols, including, but not limited to, Wi-Fi, Bluetooth, low-power Bluetooth, ZigBee, USB, firewire, and / or NFC (e.g., infrared). In some embodiments, the communication module 270 is configured to connect periodically (e.g., 10 times per day) to an external device (e.g., a smartphone) to record any dosage data stored in the on-board memory. In some embodiments, the communication module 270 is activated / deactivated on demand by the user.

[0041]

[0065] 5, the communications module 270, according to some embodiments, may include a communications interface 271 located on an exterior surface of the housing 210 of the dosage measurement system 200 for communicating with a user. The communications interface 271 may include a switch 272 (e.g., a power switch, a reset button, and / or another communications switch) for manually initiating communications with an external device (e.g., activating Bluetooth®). In some embodiments, the communications interface 271 also includes an indicator 274, such as a light source (e.g., an LED), for indicating to a user when the dosage measurement system 200 is on / off or when the communications module 270 is operational. In some embodiments, the communications interface 271 includes a display 276 for visually communicating information to a user, including, but not limited to, the remaining dose 278 in the medication delivery device 210, the current time 280, the remaining power 282 of the system, the dosage history 284 (e.g., average dose usage, time the last dose was taken, etc.), and / or wireless connection status. In some embodiments, communications interface 271 includes input components (e.g., an alphanumeric keypad and / or a touch screen) to allow a user to input information (e.g., food intake, exercise data, etc.) into dosage measurement system 200. In some embodiments, communications module 270 includes a speaker for providing audible alerts or messages (e.g., dosage reminders and / or reinforcement messages) to the user and / or a microphone for receiving voice input from the user. In some embodiments, communications module 270 includes means for tactile alerts (e.g., a vibration mechanism). In some embodiments, communications module 270 communicates other information related to the user's health (e.g., number of steps, calories burned, blood glucose levels, etc.).

[0042]

[0066] Power supply 286 can be any power source that can be used to power dosage measurement system 200. In some embodiments, power supply 286 includes a disposable battery. In some embodiments, power supply 286 includes a rechargeable battery (e.g., a NiCd battery, a Li-ion battery, a Li-polymer battery, or any other battery with a small form factor such as the type used in cell phones) and / or is not charged frequently (e.g., once per month). In some embodiments, power supply 286 is charged using an external power source (e.g., through a power socket located on housing 220 or through a communication interface of communication module 270, such as via a wired USB interface or wireless charging). In some embodiments, power supply 286 is charged using solar energy and includes a solar panel. In some embodiments, power supply 286 is charged using kinetic energy and includes a mechanical energy conversion element.

[0043]

[0067] As described above, the plurality of sensors 254 of the sensing module 250 detects transmitted radiation, refracted radiation (e.g., air, liquid medicament, refracted by the housing 212 of the medication delivery device 210), refracted radiation (e.g., reflected from the walls of the housing 220 or reflected from the walls of the medication delivery device 210), and reflected radiation (e.g., reflected from the walls of the housing 220 or reflected from the walls of the medication delivery device 210). The housing 212 of the medication delivery device 210 is configured to receive at least one of reflected radiation (internal reflection from the walls of the interior volume of the housing 212) and multi-directional reflection / refraction caused by the lens effect of the curved surface of the housing 212 of the medication delivery device 210.

[0044]

[0068] 6, according to some embodiments, a light source L (e.g., a wide-angle light source) may generate multiple diverging light beams emanating from the light source. The light source L is in a first medium M1 (e.g., air) having a first refractive index n1. A second medium M2 (e.g., a liquid drug) having a second refractive index n2 is bounded on both sides by the first medium M1. The second refractive index n2 is greater than the first refractive index n1 (i.e., n2>n1). The second medium M2 also includes opaque surfaces (e.g., sidewalls).

[0045]

[0069] A first light ray L1 emitted by a light source L is incident at a first angle on the interface between a first medium M1 and a second medium M2, and is not bent as it passes through the second medium M2 and back into the first medium M1 at the original angle of incidence (i.e., transmitted light).

[0046]

[0070] A second light ray L2 is incident on the interface between the first medium M1 and the second medium M2 at a second angle greater than zero degrees, is bent or refracted as it passes through the second medium M2, and then is bent again as it re-enters the first medium M1, at an original angle of incidence that is parallel to but offset from the emitted light ray L2 (i.e., refracted light).

[0047]

[0071] A third light ray L3 is incident on the interface between the first medium M1 and the second medium M2 at a third angle greater than the second angle, at which angle of incidence the light ray L3 does not enter the second medium M2 but is reflected back into the first medium M1, with the angle of reflection being equal to the angle of incidence (i.e., reflected light).

[0048]

[0072] A fourth light ray L4 is incident on the interface between the first medium M1 and the second medium M2 at a fourth angle less than the third angle (i.e., reflection from the opaque surface), such that the light ray L4 is refracted in the second medium M2 but immediately strikes an opaque surface contained within the second medium M2. At least a portion of the light ray L4 is reflected back into the second medium M2 and then re-enters the first medium M1 at a fifth angle, which is not equal to the fourth angle.

[0049]

[0073] As described herein, the electromagnetic radiation signals received by the multiple sensors 254 of the detection module 250 may include a combination of transmitted, refracted, and reflected portions of electromagnetic radiation. The combination of portions of the electromagnetic radiation at different remaining dose volumes and / or positions of the actuator 216 of the medication delivery device 210 produces a unique signal signature. This signal signature may be compared to a reference signal signature database (also referred to herein as a "calibration curve") to obtain the volume of the remaining dose in the medication delivery device 210, as described in further detail herein.

[0050]

[0074] 7-10, various configurations of light sources and sensors are shown and described according to some embodiments. Transmitted and reflected portions of electromagnetic radiation emitted by the light sources are shown, while refracted portions are not shown for clarity. As shown in FIG. 7, a dosage measurement system 300 includes a plurality of light sources 344 and a plurality of sensors 354. A medication delivery device 310, according to some embodiments, is coupled to the dosage measurement system 300. The medication delivery device 310 includes a housing 312 and an actuator 314 that collectively define an interior volume (e.g., a reservoir) for containing a medication. The medication delivery device 310 also includes an injector 316 for administering the medication to a patient. The dosage measurement system 300 includes a plurality of light sources 344 disposed on a first side of the housing oriented toward the medication delivery device 310, and a plurality of sensors 354 disposed on a second side of the housing. , configured such that each of the plurality of sensors 354 is positioned opposite and in optical communication with at least one of the plurality of light sources 344. In some embodiments, the plurality of light sources 344 and / or the plurality of sensors 354 are positioned in a substantially linear relationship (e.g., in a straight line) with respect to one another. Each of the plurality of sensors 354 receives a combination of transmitted, refracted, and / or reflected electromagnetic radiation emitted by the plurality of light sources 344. The reflected portion of the electromagnetic radiation may be reflected from the plunger portion of the actuator 314 and / or from the housing of the dosage measuring system 300 or the housing 312 of the medication delivery device 310. The refraction may be from the housing 312 and / or from the liquid medication disposed within the medication delivery device 310. The transmitted, reflected, and refracted portions of the electromagnetic radiation detected by each of the plurality of sensors provide a unique signal signature for a range of dosage volumes remaining within the medication delivery device 310.

[0051]

[0075] In some embodiments, the multiple light sources and multiple sensors are arranged alternately on both sides of the medication delivery device. As shown in FIG. 8 , the dosage measurement system 400, according to some embodiments, may include multiple light sources 444 and multiple sensors 454. The medication delivery device 410 includes a housing 412 and an actuator 414 that collectively define an internal volume (e.g., a reservoir) for containing a medication. The medication delivery device 410 also includes an injector 416 for delivering the medication to the patient. The dosage measurement system 400 is configured such that the multiple light sources 444 and multiple sensors 454 are arranged on both sides of the medication delivery device. In other words, each side of the medication delivery device 410 has multiple light sources 444 and multiple sensors 454. This can be advantageous because the emission and detection of electromagnetic radiation is performed from both sides of the medication delivery device 410, which, for example, eliminates bias.

[0052]

[0076] In some embodiments, at least some of the light sources and / or sensors are arranged in an angular orientation. As shown in FIG. 9 , a dosage measurement system 500, according to some embodiments, includes a plurality of light sources 544 and a plurality of sensors 554. The drug administration device 510 includes a housing 512 and an actuator 514 that collectively define an interior volume (e.g., a reservoir) for containing a drug. The drug administration device 510 also includes an injector 516 for delivering the drug to the patient. The dosage measurement system 500 is configured such that the light sources 544 and the sensors 554 are disposed on opposite sides of the drug administration device 510 and have an angular orientation with respect to the longitudinal axes of the dosage measurement system 500 and the drug administration device 510. This orientation may ensure that electromagnetic radiation emitted by the light sources 544 is incident on a larger portion of the drug administration device 510 than would be reachable by a linearly oriented light source 544. Similarly, the sensors 554 may also detect a larger portion of the electromagnetic radiation. This may, for example, result in higher resolution of the sensor 554 and / or may reduce the amount of light source 544 and / or sensor 554 needed to achieve a desired resolution.

[0053]

[0077] In some embodiments, a wider-angle light source (e.g., a wide-angle LED or a single LED connected to a light pipe that splits the emitted electromagnetic radiation into multiple wide-angle beams) may be used, for example, to ensure that the electromagnetic radiation emitted by the multiple light sources 544 is incident on a larger portion of the medication delivery device 510 than would be reachable by a narrower beam of light source 544. In other words, the wider the beam emitted by the light source 544, the larger the portion of the entire medication delivery device 510 (or medication reservoir) is in optical communication with the light source 544. Because a larger portion of the delivery device 510 is in optical communication with the light source 544, a broader spectrum of electromagnetic radiation is transmitted, reflected, and / or refracted through the medication delivery device, which can increase the signal strength detectable by the multiple sensors 554. Stated differently, the resolution of the dosage measurement system 500 is increased because the variability of the signal signature increases with the spread of the beam of light incident on the delivery device (as opposed to an increase in the intensity of the light incident on the sensor). For example, if the angle A wider range may result in a lower overall intensity of light, but may increase the ability to distinguish between states of the medication delivery device, since distinguishing between states is less about the absolute intensity of light and more about optimizing how the intensity of light changes from state to state.

[0054]

[0078] In some embodiments, the dosage measurement system is configured to detect a signal signature from the position of the actuator of the medication delivery device, which can be used to estimate the remaining dose in the medication delivery device. As shown in Figure 10, a dosage measurement system 600, according to some embodiments, includes a plurality of light sources 644 and a plurality of sensors 654. A medication delivery device 610 is coupled to the dosage measurement system 600. The medication delivery device 610 includes a housing 612 and an actuator 614 that collectively define an interior volume (e.g., a reservoir) for containing a medication. The dosage measurement system 600 is generally centered around the actuator 614 of the medication delivery device 610, in contrast to the dosage measurement systems 300, 400, and 500 shown in Figures 7 to 9, which are generally centered around the medication reservoir. The plurality of light sources 644 and the sensor 654 are configured and arranged in a manner generally similar to that described above with reference to Figure 7. The electromagnetic radiation emitted by the multiple light sources 644 may be transmitted unblocked by the actuator 614, blocked by the plunger portion of the actuator 614, reflected by the body or plunger portion of the actuator 614, and / or reflected / refracted by the housing of the drug administration device 610. The combination of the transmitted, reflected, and refracted portions of the electromagnetic radiation detected by the multiple sensors 654 is then used to generate a signal signature at a given position of the actuator 614. Displacement of the actuator 614 from a first position to a second position changes the transmission, reflection, and refraction patterns of electromagnetic radiation detected by the sensors 654, creating a unique signal signature at each position of the actuator 614. This signature may be correlated (e.g., by association with a reference signature) with the dosage volume remaining in the drug administration device 610.

[0055]

[0079] 11A-11C, each sensor of the plurality of sensors of the dosage measurement system may detect electromagnetic radiation emitted by at least some of the plurality of light sources, and the detected electromagnetic radiation may be a combination of transmitted, reflected, and refracted electromagnetic radiation. As shown, the dosage measurement system 700 includes, for clarity, two light sources 744a and 744b and two sensors 754a and 754b. The dosage measurement system 700 is coupled to a medication delivery device 710 including a housing 712 and an actuator 714 that collectively define an interior volume (e.g., a reservoir) for containing a liquid medication. The medication reservoir and at least a plunger portion of the actuator 714 are located substantially inside the dosage measurement system 700, between the light sources 744a, 744b and the sensors 754a, 754b.

[0056]

[0080] 11A , the plunger portion of the actuator 714, according to some embodiments, is in a first position (“Position 1”) such that the plunger portion is not within the line of sight of the light sources 744a and 744b and the sensors 754a and 754b. When electromagnetic radiation is emitted by the light sources 744a and 744b toward the medication delivery device 710, a majority of the electromagnetic radiation is detected by the sensors 754a and 754b at Position 1. The electromagnetic radiation may include transmitted radiation, reflected radiation (e.g., reflected by the housing 712 of the medication delivery device 710), refracted radiation (e.g., refracted by the liquid medication and / or the housing 712), and multi-directional reflected / refracted radiation (e.g., caused by the curved surface of the housing 712 of the medication delivery device 710), as described in more detail below. As shown in this example, the value for sensor 754a is 15.3 and the value for sensor 754b is 13.7, indicating that the majority of the electromagnetic radiation is detected by sensors 754a and 754b.

[0057]

[0081] 11B, according to some embodiments, actuator 714 is displaced to a second position (“Position 2”) such that the plunger portion partially blocks the line of sight between light source 744b and sensor 754b. In Position 2, while a majority of the electromagnetic radiation emitted by light source 744b is blocked by actuator 714 from reaching sensor 754b, at least a portion of the electromagnetic radiation emitted by light source 744a can still reach sensor 754b, along with multi-directional reflected / refracted electromagnetic radiation. Sensor 754a can also receive refracted electromagnetic radiation from sensor 744b and transmitted and refracted radiation from sensor 744a. Sensor 754a also receives electromagnetic radiation reflected by the surface of the plunger that at least partially defines the medication reservoir. Thus, in Position 2, sensor 754a detects an electromagnetic radiation value of 15.5 (greater than in Position 1), and sensor 754b detects an electromagnetic radiation value of 8.8 (less than in Position 1). The eigenvalue measured at location 2 may serve as the signal signature value for location 2.

[0058]

[0082] 11C , the plunger portion of actuator 714, according to some embodiments, is in a third position (“Position 3”) such that the plunger portion of actuator 714 completely blocks the line of sight of sensor 754a from the electromagnetic radiation emitted by light source 744a, such that substantially none of the transmitted and / or reflected radiation from light source 744a can reach sensor 754a. A portion of the transmitted electromagnetic radiation emitted by light source 744b is also blocked from reaching sensor 754b by at least a portion of actuator 714. Nevertheless, both sensors 754a and 754b can receive at least some of the reflected and refracted portions of the electromagnetic radiation emitted by either light source 744a and / or 744b. Thus, in Position 3, sensor 754a detects an electromagnetic radiation value of 2.2 (less than in Positions 1 and 2), and sensor 754b detects an electromagnetic radiation value of 12.0 (less than in Position 1 but greater than in Position 2). The eigenvalue measured at location 3 may serve as the signal signature value for location 3.

[0059]

[0083] Referring now to FIG. 12 , a cross-section of the dosage measurement system 700 along line AA in FIG. 11A illustrates the lensing effect caused by the curvature of the drug reservoir, according to some embodiments. As shown, the light beam emitted by the light source 744b at a zero-degree angle is transmitted toward the sensor 754b without bending. Two additional light beams emitted by the light source 744b at angles away from the transmitted light beam are refracted (i.e., bent) toward the transmitted light beam as they enter the drug reservoir because the liquid drug has a higher refractive index than air. This phenomenon, referred to herein as a “lensing effect,” can result in the focusing of the light beam toward the sensor 754b. A fourth light beam is emitted at an angle even further away from the transmitted light beam, such that it refracts at the air / drug interface, and is then further reflected by the inner surface of the housing 712 of the drug delivery system 710, so that it strikes the sensor 754b. A fifth light beam is emitted at an angle and does not strike the sensor 754b, even after refraction. As discussed above, the combination of these rays results in an electromagnetic radiation detection value of 15.3 by sensor 754a and 13.7 by sensor 754b. These characteristic values measured at location 1 may serve as the signal signature value for location 1.

[0060]

[0084] 13, according to some embodiments, a cross section of the dosage measurement system 700 along line BB in FIG. 11C illustrates the effect of the actuator 714 on light transmission. As shown, the light beam emitted by the light source 744b at an angle of zero degrees is blocked by a portion of the actuator 714. Two more light beams emitted by the light source 744b at angles away from the transmitted light beam pass through a portion of the housing 712 of the medication delivery device 710 without being affected (neglecting refraction through the housing) (i.e., no medication is present in this portion of the device 710) and are incident on the sensor 754b. A fourth ray is emitted at an angle by light source 744b and is internally reflected by housing 712 to impinge on sensor 754b, while a fifth ray is internally reflected by housing 712 but is not incident on sensor 754b. The combination of these rays results in electromagnetic radiation detection values of 2.2 by sensor 754a and 12.0 by sensor 754b. These unique values measured at location 3 may serve as the signal signature value for location 3. Note that even though sensor 754a's line of sight is completely blocked from light source 744a, the reflected and refracted portions of the electromagnetic radiation still contribute to producing a positive value.

[0061]

[0085] Although sensor values for a particular location are described as absolute values, individual sensor values relative to other sensor values may be used to infer and / or determine the volume of liquid remaining in the drug reservoir. For example, if sensor 754a has a particular value that differs from the value of sensor 754b by a certain amount or percentage, that value may represent the drug volume remaining in the location / drug delivery device. Additionally, a sensor value relative to two or more other sensor values may be used to generate a calibration curve for the drug delivery device.

[0062]

[0086] The unique signal signatures obtained for various configurations of the dose volumes dispensed by the medication delivery device can be used to derive a reference signature (calibration curve) for the dose measurement system. Figure 14 is a graph illustrating an example of a reference signal signature obtained for a medication delivery device using a dose measurement system including a total of seven sensors, according to some embodiments. The dose measurement system may be any of the dose measurement systems described herein. The electromagnetic radiation signatures detected by each of the multiple sensors for a range of dispensed dose volumes are stored and used to create the reference signature. As can be seen from the reference signature, when the medication delivery device is almost full, sensor 1 records low amplitude electromagnetic radiation, while sensor 7 records very high amplitude, and all other sensors detect intermediate signal signatures. Conversely, when the medication delivery device is completely empty, sensor 1 records very high amplitude electromagnetic radiation, while sensor 7 records low amplitude, and all other sensors detect intermediate signal signatures.

[0063]

[0087] The sensor 8 detects a uniform sensor signal for a significant portion of the administered dose until almost all of the dose has been administered or the drug delivery device is nearly empty. In some embodiments, the sensor 8 is used as a very low volume sensor (e.g., to indicate that the drug delivery device is completely empty). In some embodiments, the sensor 8 is also used as a usability indicator sensor, for example, to detect whether the drug delivery device is coupled to a dosage measurement system and / or the presence or absence of a component that should be included in the drug delivery device (e.g., an injector).

[0064]

[0088] Thus, in this manner, the signal values recorded from all sensors for a range of remaining drug volumes will yield a signal signature for the total volume of drug in the drug delivery device. The range of drug volumes used to derive the signal signature may include, but is not limited to, completely full, completely empty, and / or a sufficient number of intermediate signatures (e.g., obtained for each unit of total dispensed fluid, and / or including all percentages in between).

[0065]

[0089] In some embodiments, the reference signature may be corrected for background light. For example, a background signature may be detected by detecting signal signatures from multiple sensors when multiple light sources are dark. The signal signature may be compared to the background signature to remove background noise. In some embodiments, the signal signature is correlated with the reference signature using a probabilistic matching algorithm to determine the drug volume in the drug delivery device. In some embodiments, The plurality of light sources and the plurality of sensors are configured to enable the dosage measurement system to detect the volume of medication in the medication delivery device with a resolution of one unit of medication and / or the position of a plunger portion of an actuator disposed in the medication delivery device with a resolution of 100 micrometers, 110 micrometers, 120 micrometers, 130 micrometers, 140 micrometers, 150 micrometers, 160 micrometers, 170 micrometers, 180 micrometers, or 200 micrometers, and all ranges therebetween.

[0066]

[0090] 15 is a flow diagram illustrating a method 800 for measuring the remaining dose in a medication delivery device using any of the dose measurement systems described herein, according to some embodiments. In step 802, a user attaches the dose measurement system to the medication delivery device. In step 804, multiple sensors disposed in the dose measurement system scan the medication delivery device to determine the remaining dose. For example, a processing unit of the dose measurement system may correlate signal signatures detected by the multiple sensors with reference signatures to determine the remaining dose. In step 806, the sensor data may be recorded in an on-board memory (e.g., an RFID chip and / or memory that is part of the processing unit of the dose measurement system). In step 808, the dose measurement system may alert the user if the remaining dose is critically low. Audio, visual, and / or tactile indications may be used to alert the user.

[0067]

[0091] In step 810, the communications module of the dosage measurement system may search for an external device (e.g., a smartphone, a local computer, a remote server, etc.). For example, a Bluetooth® connection may be initiated to search for the external device. In step 812, if the dosage measurement system pairs with the external device, the system may record remaining dosage data on the external device and / or receive firmware updates.

[0068]

[0092] Optionally, the dose measuring system may also alert the user when it is time to take the dose, as in step 814. After the dose data has been recorded and transmitted to the external device, the user may remove the dose measuring system from the medication delivery device, as in step 816. The user may then administer (e.g., inject) a predetermined volume of the dose using the medication delivery device, as in step 818. The user finally replaces the dose measuring system on the medication delivery device, as in step 820. At this point, method 800 may be repeated.

[0069]

[0093] 16 is a flow diagram illustrating a method 900 for conserving power when a dosage measurement system is not in use, according to some embodiments. The method 900 described herein may be used with any of the dosage measurement systems described herein. In a first step, a detection mechanism of the dosage measurement system checks for a medication delivery device 902. The medication delivery device may or may not be coupled to the dosage measurement system 904. If a medication delivery device is not attached, the dosage measurement system automatically checks for raw data in memory to be recorded on an external device, or the user may activate the dosage measurement system's communications module 906. In some embodiments, the communications module is activated only when the dosage measurement system is attached to the medication delivery device. The dosage measurement system then determines 908 whether there is onboard data to be recorded and whether an external device has been discovered. If there is no onboard data to be recorded and no external device has been discovered, the dosage measurement system enters a power-saving mode for a predefined period of time "X" 910. For example, the processing unit of the system may turn off the communication module of the dosage measurement system and / or control the light sources and / or sensors of the dosage measurement system. The electronics may be turned off. The period "X" may be, for example, 1 minute, 10 minutes, 1 hour, or any time in between. Alternatively, if there is data to be recorded and an external device is discovered, the dosage measurement system may pair with the external device, record data to the external device, and / or receive firmware updates from the external device 912. The dosage measurement system may then enter a power save mode 910. Alternatively, if a medication delivery device is found to be attached to the dosage measurement system 904, the dosage measurement system may scan the medication delivery device and collect signals from all of the multiple sensors. 914. The signals from each of the multiple sensors may be used to create a signal signature corresponding to the remaining dose in the medication delivery device. A processing unit of the dose measurement system compares the signal signature to a reference signature to estimate the remaining dose in the medication delivery device 916. The dose measurement system determines 918 whether the injected dose was greater than zero. If the injected dose was greater than zero, the dose measurement system records the time and stores the dose in on-board memory 920. The dose measurement system then enters a power save mode for a period of time "X" 910. If the injected dose was equal to or less than zero 918, the dose measurement system directly enters a power save mode for a period of time "X" 910.

[0070]

[0094] In some embodiments, any of the dosage measurement systems described herein may be associated with a health management system to manage the health of a patient with type 1 or type 2 diabetes. Figure 17 shows a schematic block diagram of a health management system 1000 for managing the health of a diabetic user U, according to some embodiments. The health management system may be a mobile application used, for example, on a smartphone, tablet, or handheld computer. In some embodiments, the health management system is a local computer or a remote server.

[0071]

[0095] The health management system 1000 may be in bidirectional communication with a dosage measurement system 1100 reversibly coupled to a medication delivery device 1110. The medication delivery device 1110 may be an insulin injection pen or a syringe for administering insulin to a user U. The dosage measurement system may also communicate information to or receive input from the user. The health management system 1000 may be configured to receive a user's exercise data E and dietary restriction data D. The health management system 1000 may also be configured to receive blood glucose data from a blood glucose sensor 1200. The health management system 1000 may further be configured to receive a user's health data, such as weight, blood pressure, electrocardiogram, oxygen saturation, autography measures, pulmonary function, hydration, temperature, etc., from a home health monitor 1300. The health management system 1000 may be in bidirectional communication with a network 1400.

[0072]

[0096] The network may be, for example, a remote server or a call center. The network 1400 may be in bidirectional communication with a monitor M and an authorized medication dispenser DD. The monitor M may be, for example, a physician, a caregiver, a pharmacy, and / or a clinical trial administrator. The authorized medication dispenser DD may be, for example, a pharmacy or a clinical trial administrator.

[0073]

[0097] In some embodiments, the dosage measurement system 1100 communicates to the health management system the remaining insulin doses in the drug delivery device 1110 and / or the insulin doses administered to the user U by the drug delivery device 1110. In some embodiments, the health management system also includes memory for storing the user U's insulin dosage regimen and / or any other medication schedule. The user U's medication regimen may be communicated to the health management system 1100, for example, by the monitor M and / or an authorized drug dispenser DD over the network 1400. In some embodiments, the health management system 1100 analyzes the user U's health data to determine the patient's health status. The health management system 1000 may also be used to process data, such as blood glucose levels, exercise data E, dietary restriction data D, and / or home health monitoring data of the user U. In some embodiments, the health management system 1000 is also configured to compare the dosage administered to the patient with the patient's medication schedule to monitor compliance.

[0074]

[0098] In some embodiments, the health management system can communicate user health and dosage information to monitor M over network 1400. Monitor M can analyze user U's health data to determine whether changes need to be made to the patient's medication regimen, e.g., dosages of insulin and / or any other medications. If changes are required, in some embodiments, monitor M can communicate the changes to user U's medication regimen to an authorized medication dispenser DD. In some embodiments, monitor M also communicates this information to health management system 1100 over network 1400. In some embodiments, health management system 1100 can update and store user U's medication regimen and can also communicate user U's new medication regimen to dosage measurement system 1100. User U can then access dosage measurement system 1400 to obtain a new measurement regimen, e.g., a new insulin dosage.

[0075]

[0099] In this manner, the user U's health may be managed, the user U's diabetes may be managed, and the user U's medication schedule may be dynamically personalized to the user U. In some embodiments, the health management system also periodically communicates the user U's health and medication history. The health and medication history may be used, for example, to inform the user U of changes that need to be made to improve the user U's overall health. The medication history may be communicated to a monitor M for analyzing the user U's progressive health.

[0076]

[0100] Embodiments of the liquid measurement systems described herein may include one or more temperature sensors configured to measure the temperature of the liquid and / or the temperature of the environment surrounding the liquid, such as the temperature of a medication or dosage (e.g., insulin) contained within a container (e.g., an injection pen), the container, and / or the ambient air surrounding the container. Knowing the temperature of the liquid may enable one or more characteristics of the liquid to be determined, including, but not limited to, the level of bioavailability and / or bioeffectiveness of one or more active ingredients of the liquid, the expiration status of the liquid, and the ease of use of the liquid (e.g., comfort during and after administration of a medication or dosage), as well as enable normalization of fluid volume data to compensate for changes or variations in liquid volume due to changes or fluctuations in temperature. The liquid measurement systems including one or more temperature sensors described herein may be any suitable liquid measurement system, such as, for example, an injection pen cap configured for use with an injection pen (e.g., an insulin injection pen). Examples of such liquid measurement systems are described in the following sources, which are incorporated herein by reference in their entireties: 1. U.S. Patent No. 8,817,258, entitled "Dose Metering System and Method," filed as U.S. Patent Application No. 13 / 796,889 on March 12, 2013, and issued on August 26, 2014; 2. U.S. Patent Application No. 14 / 334,181, entitled "Dosage Metering System and Method," filed July 17, 2014; 3. U.S. Patent Application No. 62 / 032,017, entitled "Liquid Measurement System with Temperature Sensor," filed August 1, 2014; and 4. U.S. Patent Application No. 14 / 548,679, entitled "Dosage Metering System and Method," filed November 20, 2014

[0077]

[0101] The embodiments of the liquid measurement system described herein are: (1) for dispensing liquids, e.g., medications; The present invention provides several advantages, including, but not limited to, (1) enabling real-time measurement of the temperature of a liquid disposed within a liquid container and / or the environment surrounding it; (2) using temperature information to determine one or more characteristics of a liquid disposed within the liquid container, including, for example, the liquid's potency, expiration status, ease of administration, or any other physical and / or chemical characteristics; (3) providing one or more indications or alarms when the temperature is above or below a predetermined, recommended, and / or acceptable range; (4) tracking the cumulative exposure of one or more active chemical components of the liquid to heat, as heat is related to the kinetics of the decomposition of the active chemical components; and (5) optimizing measurements (e.g., dose volume data or blood glucose data) by compensating for temperature disturbances, for example, by normalizing the data based on real-time temperature measurements to ensure that the data is substantially free of temperature disturbances.

[0078]

[0102] In some embodiments, a liquid measurement system for measuring a volume of liquid in a container includes a plurality of light sources arranged and configured to emit electromagnetic radiation toward the container. A plurality of sensors are optically coupleable to the plurality of light sources and arranged and configured to detect electromagnetic radiation emitted by at least some of the light sources. The device includes a temperature sensor configured to measure the temperature of the liquid disposed in the container. The device also includes a processing unit configured to receive data from each of the plurality of sensors representing a portion of the detected electromagnetic radiation and to convert the received data into a signature representative of the electromagnetic radiation detected by the plurality of sensors. The processing unit of the above-described device is also configured to receive temperature information from the temperature sensor and to perform at least one of normalizing the sensor value, determining potency of the liquid, determining an expiration status of the liquid, and determining comfort of administration. In some embodiments, the temperature sensor is also configured to measure the temperature of an environment surrounding the liquid.

[0079]

[0103] 18 is a schematic block diagram of a liquid measurement system 1800 (also referred to herein as a "dose measurement system") for measuring the volume of liquid (also referred to herein as a "dose") remaining in a drug delivery device 1802, according to some embodiments. The dose measurement system 1800 includes an illumination module 1804, a sensing module 1806, a processing unit 1808, a temperature sensing module 1810, and a communications module 1812. The dose measurement system 1800 may be configured to be removably coupleable to a drug delivery device 1802 used to administer a drug dose to a target T, such as a human patient.

[0080]

[0104] The medication delivery device 1802 may be any medication delivery device usable to administer medication to a subject. For example, the medication delivery device 1802 may be an injection pen (e.g., an insulin injection pen), a syringe, a pump (e.g., an insulin delivery pump), an ampoule, and / or a vial. The dose measurement system 1800 may be configured to be connectable to a wide variety of medication delivery devices, e.g., having different shapes, sizes, and medication volumes. In some embodiments, the dose measurement system 1800 may be configured to receive a portion of the medication delivery device 1802, a portion defining an internal volume containing medication, an injector, and / or a plunger. In some embodiments, the dose measurement system 1800 is configured to be detachable from the medication delivery device 1802 when a user is administering a dose to the target T. In some embodiments, the dose measurement system 1800 may remain attached to the medication delivery device 1802 when a user is administering a dose to the target T. In some embodiments, the dose measurement system 1800 is configured to be reusable. In some embodiments, the dosage measuring system 1800 is permanently coupled to the medication delivery device 1802, for example integrated into the body of the medication delivery device. In such embodiments, the dosage measuring system 1800 may be disposable.

[0081]

[0105] The illumination module 1804 and the sensing module 1806 may be configured as described above, according to some embodiments. For example, the illumination module 1804 may include a plurality of light sources configured to emit electromagnetic radiation toward the medication administration device 1802. The sensing module 1806 may include a plurality of sensors optically coupleable to the plurality of light sources of the illumination module 1804.

[0082]

[0106] Processing unit 1808, according to some embodiments, may be configured as described above. For example, processing unit 1808 may be configured to receive electromagnetic radiation signals from sensing module 1806 (i.e., from each of the plurality of sensors) and convert the received data into a signal signature representative of the electromagnetic radiation detected by each of the plurality of sensors.

[0083]

[0107] The temperature sensing module 1810 may be configured to measure the temperature of a liquid disposed within the medication delivery device 1802 and / or the environment surrounding the liquid, for example, the temperature of an internal volume of a housing within which the components of the dosage measurement system 1800 and at least a portion of the medication delivery device 1802 are disposed, as described herein. The temperature sensing module 1810 may include one or more suitable temperature sensors, including, but not limited to, a thermocouple, a resistance temperature device (RTD), a thermistor, a bimetallic temperature sensor, and / or a silicon diode.

[0084]

[0108] One or more temperature sensors may be positioned, configured, attached to, and / or disposed within the dosage measurement system 1800 for substantially accurate temperature readings of the liquid and / or the environment surrounding the liquid. For example, the temperature sensor may be positioned a sufficient distance from one or more components of the dosage measurement system 1800 that may affect the temperature readings, such as hotter electronics (e.g., contained within the processing unit 1808), a power source (e.g., a rechargeable battery), and / or any other heat-generating electronics. The temperature sensor may also be positioned sufficiently close to the liquid disposed within the medication delivery device 1802 to allow heat to diffuse evenly through the temperature sensor and the liquid so that the temperature sensor and the liquid are at substantially the same temperature.

[0085]

[0109] In some embodiments, the temperature sensing module 1810 includes a single temperature sensor. In other embodiments, the temperature sensing module 1810 includes multiple temperature sensors positioned in any suitable configuration, including, but not limited to, a linear array, a rectangular array, a square array, a circular array, and / or any other suitable configuration. In some embodiments, the temperature sensing module 1810 includes a first temperature sensor or a first set of temperature sensors positioned and / or configured to measure substantially the temperature of the liquid, and a second temperature sensor or a second set of temperature sensors positioned and / or configured to measure substantially the temperature of the environment surrounding the liquid.

[0086]

[0110] In some embodiments, the temperature sensing module 1810 includes a printed circuit board (PCB) and / or other electronics configured to process the temperature measurements and / or communicate the temperature information to, for example, the processing unit 1808 and / or the communications module 1812 for further processing and / or to communicate the temperature measurements to a user.

[0087]

[0111] In some embodiments, the temperature sensing module 1810, the processing unit 1808, and / or an external computing device processes the temperature data, which may be used to determine one or more characteristics of the liquid within the dosage measuring system 1800 and / or the environment surrounding the liquid, including one or more characteristics of the system, device, and method embodiments described herein.

[0088]

[0112] In particular, according to some embodiments, temperature can affect signal quality (e.g., measuring the amount of liquid using the sensing module 1806). Temperature data may be used to normalize data received from the sensing module 1806 so that the sensor data is substantially free of disturbances or contributions caused by extreme temperatures and / or temperature changes or fluctuations. Due to changes in components with temperature, optical measurement sensor readings drift with temperature. In some embodiments, this sensor drift with temperature is approximately linear. In some embodiments, the illumination module 1804 and the sensing module 1806 are optimized to maintain approximately linear sensor drift with temperature.

[0089]

[0113] In some embodiments, the temperature sensing module 1810, the processing unit 1808, and / or an external computing device may be used to perform temperature calibration. For example, an external temperature measurement system including an independent temperature sensor may be used to obtain the calibration temperature. A positive or negative offset may be calculated based on the difference between the external calibration temperature and the internal temperature measured by the temperature sensor in the temperature sensing module 1810. The positive or negative offset may be added to future internal temperature readings.

[0090]

[0114] Extreme temperatures and / or temperature changes or fluctuations may also affect one or more properties of the liquid or components of the liquid being measured, as well as one or more properties of additional components of or associated with some embodiments, such as the accuracy of a glucose meter test strip or blood glucose meter. For example, the bioavailability, bioefficacy, and shelf life of a medication are highly dependent on the temperatures to which the medication is exposed and / or at which the medication is stored. Drug delivery devices containing such medications, particularly injection pens, or additional components, are often carried by patients, for example, in their pockets, backpacks, purses, suitcases, etc. Thus, medications may be exposed to widely varying ambient temperatures, with implications for at least the administration, costs, and safety associated with the aforementioned medications.

[0091]

[0115] For example, the effectiveness of insulin can be reduced by high temperatures. Patients may develop hyperglycemia if administered ineffective insulin. Manufacturers instruct users to discard insulin that has been exposed to such high temperatures, but this often happens accidentally. Even if the ambient temperature is below the maximum threshold temperature for maintaining quality (e.g., above about 37°C or 98.6°F), the temperature of the insulin itself can exceed the ambient temperature when the container is exposed to sunlight or radiant heat. The maximum threshold temperature for maintaining quality can change (e.g., become lower) once the container is opened (e.g., above about 30°C or 86°F). Similarly, insulin quality can be affected by low temperatures. For example, manufacturers instruct users not to store insulin in the refrigerator once the container has been opened.

[0092]

[0116] According to some embodiments, guidelines such as a maximum threshold temperature, a minimum threshold temperature, a temperature range, a rate of temperature change, a frequency of temperature fluctuations, and / or a duration of temperature exposure are recommended, permitted, and / or determined as acceptable based on at least one of a particular liquid measurement system (e.g., dosage measurement system 1800), a particular liquid container (e.g., medication delivery device 1802), and a particular liquid (e.g., insulin). The temperature sensing module 1810, the processing unit 1808, and / or an external computing device may compare one or more temperature readings from the liquid and / or its environment to these indicators and notify the user, e.g., via a display, alert, and / or alarm (e.g., via the communications module 1812), that a predetermined number of temperature readings: (1) exceed a recommended, permitted, and / or determined maximum threshold temperature value; (2) fall below a recommended, permitted, and / or determined minimum threshold temperature value; (3) are outside a recommended, permitted, and / or determined range of temperature values; or (4) indicate a rate of temperature change that exceeds a recommended, permitted, and / or determined rate. (5) indicating a frequency of temperature fluctuations that exceeds a recommended, permitted, and / or determined frequency; and / or (6) indicating a duration of temperature exposure that is longer than recommended, permitted, and / or determined as acceptable.

[0093]

[0117] The communications module 1812, according to some embodiments, may be configured as described above. For example, the communications module 1812 may be configured to enable two-way communication with a user and / or an external device. In some embodiments, the communications module 1812 includes a display configured to communicate to a user the status of the dosage measuring system 1800, including, but not limited to, the remaining dose, usage history, battery level, wireless connection status, medication temperature, the temperature of the dosage measuring system 1800, the temperature of the medication delivery device 1802, medication potency, medication expiration status, medication quality, and / or reminders to administer a medication.

[0094]

[0118] The dosage measurement system 1800 may be disposed in a housing that is configurable to be removably coupled to the medication delivery device 1802. For example, the illumination module 1804, the sensing module 1806, the processing unit 1808, the temperature sensing module 1810, and the communications module 1812 may be integrated into the housing. Alternatively, individual components of the dosage measurement system 1800 (e.g., the illumination module 1804 and the sensing module 1806) may be integrated into a first housing, while other components (e.g., the processing unit 1808, the temperature sensing module 1810, and the communications module 1812) are separate or integrated into a second housing. In some embodiments, the housing is configured (e.g., shaped and sized) to be removably coupled to at least a portion of the medication delivery device 1802. For example, the housing may have a recess and / or define a hole within which at least a portion of the medication delivery device 1802 can be received.

[0095]

[0119] Having described various general principles above, we now describe some exemplary embodiments of these concepts. These embodiments are by way of example only, and many other configurations of liquid measurement systems that take temperature effects into account are envisioned, particularly dosage measurement systems that measure the dosage administered to a patient and / or remaining in a medication delivery device.

[0096]

[0120] 19-22, according to some embodiments, a liquid measurement system 2000 (also referred to herein as "dosage measurement system 2000") may include a sensing assembly 2002, a temperature sensing module 2004, a communications module 2006, and a power supply 2008. Figure 19 is a perspective view of the liquid measurement system 2000. Figure 20 is an exploded perspective view, Figure 21 is a rear perspective view of the lower housing, and Figure 22 is a bottom view of the PCB included in the sensing assembly 2002 of the dosage measurement system 2000.

[0097]

[0121] The dosage measurement system 2000 may be configured to be removably coupleable to a medication delivery device 2010 (also referred to herein as an "injection pen 2010"). The medication delivery device 2010 may be configured to deliver a predefined amount (i.e., dose) of a liquid medication (e.g., insulin) to a patient. Examples of medication delivery devices 2010 include insulin injection pens that may be used by a patient to deliver insulin. According to some embodiments, as shown in FIG. 20 , the medication delivery device 2010 includes a housing 2012, an actuator 2014, and an injector 2016. The housing 2012 may be relatively opaque so as to transmit only select wavelengths of electromagnetic radiation (e.g., infrared or microwave radiation). The housing 2012 may define an interior volume (e.g., a reservoir) for storing the medication. The actuator 2014 is in fluid communication with the medication and configured to deliver a predefined amount of the medication to the patient. The housing 2012 may include a plunger portion that is secured to the housing 2012. The actuator 2014 may be configurable, for example, by a user, to dispense a variable amount of medication. The injector 2016 (e.g., a needle) may be configured to penetrate a user's tissue for intramuscular, subcutaneous, and / or intravenous administration of the medication. The housing 2012 may be configured such that the temperature sensing module 2004 can measure the temperature of the medication directly or indirectly via the housing 2012, the actuator 2014, and / or the injector 2016.

[0098]

[0122] In some embodiments, as shown in FIG. 19 , the dose measuring system 2000 includes a housing 2018 having an upper housing portion 2020 (also referred to herein as “upper housing 2020”) and a lower housing portion 2022 (also referred to herein as “lower housing 2022”). The upper housing portion 2020 includes a first portion 2020a and a second portion 2020b, which may be coupled to form the upper portion 2020. The first portion 2020a and the second portion 2020b may be removably or fixedly coupled, for example, by glue, heat welding, a snap-fit mechanism, one or more screws, and / or any other suitable means. Additionally, the upper housing 2020 and the lower housing 2022 may be removably or fixedly coupled, for example, by glue, heat welding, a mechanical coupling (e.g., one or more snap-fit mechanisms or screws), and / or any other suitable coupling means.

[0099]

[0123] The housing 2018 may be made from a rigid, lightweight, and / or opaque material, including, but not limited to, polytetrafluoroethylene, high density polyethylene, polycarbonate, other plastics, acrylic, sheet metal, any other suitable material, or combinations thereof. The housing 2018 may also be configured to shield the internal electronic components of the dosage measuring system 2000 from environmental electromagnetic noise. For example, the housing 2018 may include an insulating structure, such as an aluminum lining or any other metal sheet or foil that can serve as an electromagnetic shield.

[0100]

[0124] 19, the first housing portion 2022a and the second housing portion 2022b may define an interior volume that substantially houses the sensing assembly 2002, the temperature sensing module 2004, the communications module 2006, and the power source 2008. As shown in FIG. 21, the lower housing portion 2022 may define a bore 2024. The bore 2024 may be shaped and sized to receive at least a portion of the medication delivery device 2010. For example, the bore 2024 may be shaped and sized to receive only the drug containing portion of the housing 2012 and the injector 2016. The bore 2024 may be configured to receive the medication delivery device 2010 in a particular orientation (e.g., radial orientation). In some embodiments, the bore 2024 has a close tolerance with the diameter of the medication delivery device 2010, for example, to form a friction fit with the medication delivery device 2010. In some embodiments, the holes 2024 include one or more notches, grooves, detents, snap-fit features, threads, and / or other coupling features for releasably coupling the medication delivery device 2010 to the lower housing 2022. In some embodiments, the lower housing portion 2022 includes one or more alignment features for releasably coupling the medication delivery device 2010 such that it can be coupled to the dosage measuring system 2000 in a predetermined radial orientation.

[0101]

[0125] In some embodiments, the lower housing 2022 defines one or more apertures 2026 for receiving at least some of the light sources that may be included in an illumination module of the sensing assembly 2002 and / or sensors that may be included in a sensing module of the sensing assembly 2002. The one or more apertures 2026 may be configured to provide mechanical support for the light sources and / or sensors, and may be configured to support the illumination module and / or sensing module. This may serve as an alignment mechanism for

[0102]

[0126] 19 , the upper housing 2020 may define an opening 2028 for receiving at least a portion of the communications module 2006, such as a communications interface for providing wired communications with an external device and / or an interface for charging the power source 2008. As shown in FIGS. 19 and 20 , the upper housing 2020 may define a slot 2030 for viewing a display 2032 included in the communications module 2006 described herein. A transparent layer 2034, such as glass, acrylic (e.g., Plexiglas®), or a plastic sheet, may be disposed below the slot 2030 to protect the display 2032 and to provide a window for viewing the display 2032.

[0103]

[0127] In some embodiments, the housing 2018 also includes a detection mechanism (not shown) for detecting whether the medication delivery device 2010 is coupled to the dosage measurement system 2000. The detection mechanism may include, for example, a push switch, a motion sensor, a position sensor, an optical sensor, a piezoelectric sensor, an impedance sensor, and / or any other suitable sensor. The housing 2018 may be relatively smooth and free of sharp edges. In some embodiments, the housing 2018 has a form factor that occupies minimal space, for example, shaped to resemble a pen cap that can fit in a user's pocket. In some embodiments, the housing 2018 also includes features such as a clip for attachment to, for example, a user's shirt pocket, and / or other decorative features. In some embodiments, the dosage measurement system 2000 also serves as a replacement cap for the medication delivery device 2010.

[0104]

[0128] The sensing assembly 2002 may include an illumination module, a sensing module, and a processing unit that may be configured to determine the remaining dose in the medication delivery device 2010. The sensing assembly may include a printed circuit board (PCB) 2034 on which the illumination module, sensing module, and processing unit may be mounted, as shown in Figure 22. The illumination module and sensing module may be substantially similar to the illumination module 1804 and sensing module 1806 described with respect to the dosage measurement system 1800 above, and the processing unit may be substantially similar to the processing unit 1808 described above.

[0105]

[0129] In some embodiments, the illumination module includes multiple light sources 2036 disposed on the PCB 2034, which may be configured to generate electromagnetic radiation at wavelengths that can penetrate the housing 2012 of the medication delivery device 2010, the medication contained therein, and / or portions of the housing 2018. For example, infrared radiation or microwave radiation can penetrate many of the plastic materials commonly used in the manufacture of medication delivery devices (e.g., injection pens). In some embodiments, the electromagnetic radiation has a frequency that can penetrate internal components of the medication delivery device 2010, such as the plunger portion of the actuator 2014. In some embodiments, the light source 244 is configured to generate a wide beam of electromagnetic radiation (e.g., a wide-angle LED or a single LED connected to a light pipe that splits the emitted electromagnetic radiation into multiple wide-angle beams). Stated another way, the cone of electromagnetic radiation of a single light source 244 may have a wide angle, and the cones of electromagnetic radiation of adjacent light sources 244 may overlap. In some embodiments, the multiple light sources 2036 are configured to emit pulses of electromagnetic radiation (e.g., a series of sub-100 microsecond pulses).

[0106]

[0130] The sensing module includes a plurality of sensors 2038 that may be mounted or otherwise disposed on a PCB 2034 contained within the sensing module 230, as shown in FIG. The plurality of sensors 2038 may include a PCB 252. The PCB 252 may be any standard PCB fabricated by any commonly known process. The plurality of sensors 2038 may be any optical sensors (e.g., photodiodes) optically coupleable with the plurality of light sources 2036 and configured to detect at least a portion of the electromagnetic radiation emitted by the plurality of light sources 2036. The electromagnetic radiation may be transmitted radiation, refracted radiation (e.g., refracted by air, the medicament, and / or the body of the drug administration device 2010), reflected radiation (e.g., reflected from the walls of the housing 2018 or internally reflected from the walls of the drug administration device 2010), and / or multi-directional refraction / reflection (e.g., caused by the lens effect of the curved surface of the housing 2012). The transmitted, refracted, and / or reflected electromagnetic signals received by the plurality of sensors 2038 may be used (e.g., by a processing unit) to create a signal signature. The signal signature may be correlated with a reference signature to determine the remaining dose in the drug administration device 2010. In some embodiments, the signal response of the sensor 2038 may be used to measure a usability indicator, such as determining the presence or absence of the injector 2016 of the drug delivery device 2010 and / or determining whether the drug delivery device 2010 is coupled or not coupled to the dosage measurement system 2000. In some embodiments, the signal response of the sensor 2038 may be further processed (e.g., calibrated) based on the temperature data.

[0107]

[0131] The temperature sensing module 2004 may include one or more temperature sensors configured to measure the temperature of the liquid disposed within the medication delivery device 2010 and / or the environment surrounding the liquid, for example, the temperature of the interior volume of the bore 2024 of the lower housing 2022 in which at least a portion of the medication delivery device 2010 may be disposed. The one or more temperature sensors may include one or more thermocouples, RTDs, thermistors, bimetallic temperature sensors, silicon diodes, and / or any other suitable temperature sensors. The one or more temperature sensors may be positioned and / or disposed within the interior volume defined by the upper housing 2020a to enable a substantially accurate temperature reading of the liquid volume and / or the environment surrounding the liquid. For example, the one or more temperature sensors may be disposed along an exterior surface of a sidewall of the lower housing 2020b.

[0108]

[0132] Additionally, the one or more temperature sensors may be positioned a sufficient distance from components of the dosage measurement system 2000 that may affect the temperature reading, such as, for example, hotter electronic components 2040 (e.g., capacitors or resistors) or the power supply 2008 shown in FIG. 20 . Furthermore, the one or more temperature sensors may be positioned sufficiently close to a volume of liquid disposed within the medication dispensing device 2010 so that heat diffusion to the one or more temperature sensors and the liquid is substantially even so that the one or more sensors accurately reflect the temperature of the liquid. In some embodiments, the temperature sensing module 2004 includes a first temperature sensor or a first set of temperature sensors configured to measure only the temperature of the liquid, and a second temperature sensor or a second set of temperature sensors configured to measure only the temperature of the environment surrounding the liquid. In some embodiments, the temperature sensing module 2004 consists of a single temperature sensor. In other embodiments, the temperature sensing module 2004 includes multiple temperature sensors arranged, for example, in a linear array, a rectangular array, a square array, a circular array, or any other suitable configuration. In some embodiments, the temperature sensing module 2004 includes a printed circuit board (PCB) and / or other electronics configured to process data and / or communicate temperature data to, for example, the communications module 2006.

[0109]

[0133] In some embodiments, the temperature sensing module 2004 includes a processing unit. In some embodiments, the temperature sensing module 2004 is configured to communicate temperature data to a processing unit included within the sensing assembly 2002. The at least one processing unit may be configured to determine the quality of the liquid (e.g., bioavailability, bioefficacy, and / or expiration status of one or more components) and / or the quality of administration (e.g., ease and / or safety). The processor 2000 may be configured to use the temperature data to determine the efficacy (thermal stability) of a liquid medication disposed within the medication delivery device 2010. For example, information about the thermal stability and potency of a liquid medication disposed within the medication delivery device 2010 may be stored in a memory coupled to the processing unit. The processing unit may compare the real-time temperature of the liquid medication and / or the environment surrounding the medication provided by the temperature detection module 2004 with the thermal stability information of a particular medication to determine the physical and / or chemical state / quality of the medication. In some embodiments, thermal stability information for multiple medications (e.g., insulin, epinephrine, etc.) or for only a particular medication may be stored in an external or internal memory device communicatively coupled to the processor, thereby allowing the dosage measurement system 2000 to be compatible with different medication delivery devices that may contain different medications, particular medication delivery devices that may contain different medications, medication delivery devices containing substantially similar medications, or particular medication delivery devices containing substantially similar medications.

[0110]

[0134] In some embodiments, the temperature data is used to normalize or correct the data received from the sensing module so that the sensor data (i.e., signal signature) is substantially free of disturbances or contributions caused by extreme temperatures, temperature changes, and / or temperature fluctuations.

[0111]

[0135] 23 is a graph showing compensated 2300 and uncompensated 2302 measurements of a representative sensor in a liquid measurement system as a function of temperature, according to some embodiments. The uncompensated sensor measurement 2302 may deviate significantly from the actual temperature as the actual temperature changes and / or fluctuates. In some embodiments, it may be preferable to adjust the temperature measurement as the actual temperature changes and / or fluctuates to more accurately monitor the actual temperature of the remaining liquid, thereby producing the compensated measurement 2300.

[0112]

[0136] In some embodiments, compensation for temperature changes is performed by applying the following correction factors: A×ΔT×S raw (1) where A is a scaling factor that can vary depending on the individual sensor design, and S raw is the raw sensor reading, and ΔT is the difference between the measured temperature and the baseline temperature, which can be any temperature (e.g., 0° C.) as long as it is constant. ΔT=T meas -T base (2) Thus, the compensated sensor value is S comp =S raw +A×ΔT×S raw (3) can be determined by

[0113]

[0137] In some embodiments, the scaling factor takes into account the case of saturation edges: if a particular sensor is already saturated, it may not be able to become unsaturated due to temperature compensation.

[0114]

[0138] The temperature data may also be used to normalize the calibration signature, for example, if the calibration is performed at a first temperature and the signal signature is measured at a second temperature different from the first temperature. In some embodiments, the sensor data is normalized using the temperature data with respect to the thermal expansion coefficient of the drug. In this way, errors due to volumetric expansion or contraction of the liquid drug or other temperature-related interference with the sensor may be corrected.

[0115]

[0139] In some embodiments, the processing unit is configured to perform temperature calibration. For example, in such embodiments, the processing unit may be configured to receive a calibration temperature measured by an external temperature measurement system including an independent temperature sensor. The external calibration temperature and the temperature sensor included in the temperature sensing module 2004 may be used to calibrate the temperature. A positive or negative offset may be generated based on the difference between the internal temperature measured by the sensor and the internal temperature measured by the sensor. For future temperature sensing, the processing unit can then calculate the final temperature reading by adding the positive or negative offset to the internal temperature.

[0116]

[0140] The placement of the temperature sensor is important for accurate temperature compensation and / or calibration. In some embodiments, the temperature sensor is placed in close proximity to the component that changes most with temperature. In some embodiments, the component that changes most with temperature is the emitter or light source. In Figure 24, a diagram of a portion of a dosage measurement system shows a temperature sensor 2400 placed in close proximity to a light source 2402 (e.g., multiple LEDs or a single LED connected to a light pipe that splits the emitted electromagnetic radiation to multiple light sources), according to some embodiments.

[0117]

[0141] Temperature is also a key factor affecting blood glucose measurements. The temperature at which test strips are stored and the temperature at which a glucose meter or blood glucose meter is operated are both important. In particular, temperature can affect the response of the electronics within the blood glucose meter, as well as the dosage measurement systems described above. Temperature can also affect the kinetics of chemical reactions in the test strip. Therefore, according to some embodiments, a temperature sensor placed in close proximity to the blood glucose meter and / or test strip is important.

[0118]

[0142] In some embodiments, the blood glucose meter is communicatively and / or physically coupled (e.g., integrated within the housing) to the dosage measurement system. One or more temperature sensors may be located proximate to the blood glucose meter to compensate the blood glucose reading for temperature-induced drift. In some embodiments, a removable and / or refillable test strip storage device is communicatively and / or physically coupled to the dosage measurement system (e.g., integrated within the housing) and / or a blood glucose meter that is communicatively and / or physically coupled to the dosage measurement system. One or more temperature sensors may be located on or proximate to the storage device to identify quality issues related to test strip temperature exposure.

[0119]

[0143] In some embodiments, a communication interface on the dosage measurement system or on an external device communicatively coupled to the dosage measurement system is configured to communicate to the user the status of the dosage measurement system, including, but not limited to, remaining dose, usage history, battery level, wireless connection status, user reminders, and / or temperature readings. A display, speaker, and / or vibration mechanism may be used to communicate visual, audio, and / or tactile indications or alerts to the user. In some embodiments, a user input interface (e.g., buttons, switches, alphanumeric keypad, touchscreen, camera, and / or microphone) allows the user to input information or commands into the dosage measurement system, including, but not limited to, initiating or terminating communication between the system and a remote device, powering the system on, powering the system off, resetting the system, manually entering details of patient actions, and / or manually entering details of use of the medication delivery device.

[0120]

[0144] FIG. 25 is a screenshot of a user interface display on a remote device (e.g., a smartphone) for initiating or terminating communication between the device and one or more dose measuring systems, and for monitoring the remaining volume, battery life, and temperature of each of the one or more dose measuring systems once communication has been initiated, according to some embodiments.

[0121]

[0145] In some embodiments, when the temperature exceeds the recommended, allowed, and / or determined operating range of the medication, the user may receive a notification from the system or from an external device communicatively coupled to the system. Action by the user may be required to stop the notification. In some embodiments, a time display indicates when Tracks if a temperature event occurs, so the user can check the notification and / or time display to identify the temperature event in order to recalibrate the system or discard medication or test strips.

[0122]

[0146] conclusion While various embodiments of the present invention have been described and illustrated herein, those of ordinary skill in the art will readily envision numerous other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each of such variations and / or modifications is deemed to be within the scope of the embodiments of the present invention described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are intended to be exemplary, and that the actual parameters, dimensions, materials, and / or configurations will depend on the specific application for which the teachings of the present invention are used. Those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalents to the specific embodiments of the present invention described herein. Accordingly, it should be understood that the foregoing embodiments are presented by way of example only, and that embodiments of the present invention may be practiced within the scope of the appended claims and their equivalents other than as specifically described and claimed. The inventive embodiments in this disclosure are directed to each individual feature, system, component, material, kit, and / or method described herein. Furthermore, any combination of two or more such features, systems, components, materials, kits, and / or methods is included within the scope of the invention in this disclosure, if such features, systems, components, materials, kits, and / or methods are not mutually inconsistent.

[0123]

[0147] While the methods and steps described above show certain events occurring in a certain order, a person of ordinary skill in the art having the benefit of this disclosure will recognize that the ordering of certain steps may be changed and that such changes would be variations of the invention. Also, some of the steps may be performed simultaneously in parallel processes when possible, or may be performed sequentially as described above. While embodiments have been specifically shown and described, it will be understood that various changes in form and detail may be made.

[0124]

[0148] For example, while various embodiments have been described as having certain features and / or combinations of components, other embodiments are possible having any combination or subcombination of any of the features and / or components of any of the embodiments described herein. For example, while some embodiments have been described as having a dose measurement system resembling a pen cap, the dose measurement system may be integral to the medication delivery device. In some embodiments, vibrations and / or ultrasound are used instead of electromagnetic radiation to generate the signal signature. The specific configurations of the various components may also vary. For example, the size and specific shape of the various components may differ from the illustrated embodiments while still providing the functionality described herein.

[0125]

[0149] The above-described embodiments can be implemented in any of numerous ways. For example, the embodiments disclosed herein may be implemented using hardware, software, or a combination thereof. When implemented in software, the software code may be executed on any suitable processor or collection of processors, whether provided within a single computer or distributed among multiple computers.

[0126]

[0150] It should also be appreciated that the computer may be embodied in any of a number of forms, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. The present invention may also be implemented in devices not generally considered computers but equipped with suitable processing capabilities, including personal digital assistants (PDAs), smartphones, or any other suitable portable or fixed electronic device.

[0127]

[0151] A computer may also have one or more input and output devices. These devices may be used, among other things, to provide a user interface. Examples of output devices that may be used to provide a user interface include a printer or display screen for visual presentation of output and a speaker or other sound-generating device for audible presentation of output. Examples of input devices that can be used for a user interface include a keyboard, a mouse, a pointing device such as a touchpad, and a digitizing tablet. As another example, a computer may receive input information through voice recognition or in other audible formats.

[0128]

[0152] Such computers may be interconnected by one or more networks of any suitable form, including local or wide area networks such as enterprise networks, and intelligent networks (IN) or the Internet. Such networks may be based on any suitable technology and operate according to any suitable protocol, and may include wireless networks, wired networks, or fiber optic networks.

[0129]

[0153] The various methods or processes outlined herein may be coded as software executable on one or more processors employing any one of a variety of operating systems or platforms, and such software may be written using any of a number of suitable programming languages and / or programming or scripting tools, and compiled as executable machine code or intermediate code that runs on a framework or virtual machine.

[0130]

[0154] Also, various inventive concepts may be embodied as one or more methods, examples of which are provided. The acts performed as part of a method may be ordered in any suitable manner. Thus, embodiments may be constructed in which acts are performed in an order different from that described, which may include performing some acts simultaneously even though they are shown as sequential acts in the exemplary embodiment.

[0131]

[0155] All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety.

[0132]

[0156] All definitions defined and used herein should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0133]

[0157] The indefinite articles "a" and "an," when used in the specification and claims of this application, unless clearly indicated otherwise, should be understood to mean "at least one."

[0134]

[0158] The term "and / or," as used in the specification and claims of this application, should be understood to mean "one or both" of the elements so conjoined, i.e., elements that are present conjointly in some cases and separately in other cases. Multiple elements listed with "and / or" should be construed in the same manner, i.e., "one or more" of the elements so conjoined. Elements other than those specifically identified by the "and / or" clause may or may not be related to the elements specifically identified. Thus, as a non-limiting example, "A and / or B," when used in combination with open-ended language such as "comprising," can refer in one embodiment to A only (optionally including elements other than B); in another embodiment to B only (optionally including elements other than A); in yet another embodiment to both A and B (optionally including other elements), and so on.

[0135]

[0159] As used in the specification and claims of this application, "or" should be understood to have the same meaning as "and / or" as defined above. For example, when separating items in a list, "or" or "and / or" shall be construed as inclusive, i.e., including at least one, but also including more than one, and optionally further including unlisted items, of a number or list of elements. Only terms clearly indicated otherwise, such as "only one of" or "only one of," or, when used in the claims, "consisting of," refer to the inclusion of only one element of a number or list of elements. Generally, the term "or" as used herein shall be construed only as an exclusive alternative (i.e., "one or the other, but not both") when preceded by terms of exclusivity, such as "either," "one of," "only one of," or "only one of." "Consisting essentially of," when used in the claims, shall have its ordinary meaning as used in the field of patent law.

[0136]

[0160] As used in the specification and claims of this application, the phrase "at least one" in connection with a list of one or more elements should be understood to mean at least one element selected from any one or more of the elements in the list of elements, but not necessarily including at least one of each and every element specifically listed in the list of elements, and not excluding any combination of elements in the list of elements. This definition also allows for the optional presence of elements other than those specifically identified in the list of elements to which the phrase "at least one" refers, whether related or not to the specifically identified elements. Thus, as a non-limiting example, "at least one of A and B" (or, equivalently, "at least one of A or B," or, equivalently, "at least one of A and / or B") can refer, in one embodiment, to at least one, optionally two or more, A, and no B (and optionally including elements other than B); in another embodiment, to at least one, optionally two or more, B, and no A (and optionally including elements other than A); in yet another embodiment, to at least one, optionally two or more, A, and at least one, optionally two or more, B (and optionally including other elements), and so on.

[0137]

[0161] In the claims, as well as in the foregoing specification, all transitional phrases such as "comprising," "including," "carrying," "having," "containing," "involving," "holding," "composed of," and the like, are to be understood to be open-ended, i.e., to mean including but not limited to. Only the transitional phrases "consisting of" and "consisting essentially of" are used in accordance with the United States Patent Office Manual of Patent Examining Procedure. Each shall be a transitional phrase in closed or semi-closed form, as set forth in Section 2111.03 of the Patent Office Manual of Patent Examining Procedures.

Claims

1. 1. An apparatus for measuring the volume of a liquid in a container, comprising: a plurality of light sources arranged to emit electromagnetic radiation towards the container; a plurality of sensors optically coupleable to the plurality of light sources, each sensor positioned and configured to detect the electromagnetic radiation emitted by at least some of the plurality of light sources; a temperature sensor positioned and configured to measure at least one temperature associated with the liquid in the container; and at least one processor configured to receive data representative of the detected portion of the electromagnetic radiation from each of the plurality of sensors and the at least one measured temperature from the temperature sensor; the processor operable to: compare the at least one measured temperature to a temperature guideline to identify a temperature event associated with the received data; normalize the received data based on the temperature event associated with the received data; and convert the normalized data into a signature representative of the electromagnetic radiation detected by the plurality of sensors.

2. The device of claim 1 , wherein the temperature indicators include at least one of a baseline temperature, a maximum temperature, and a minimum temperature.

3. 3. The device of claim 2, wherein the temperature guidelines further include at least one of an amount of a single exposure above the maximum temperature and the minimum temperature, an amount of a single exposure below the minimum temperature, an amount of cumulative exposure above the maximum temperature, an amount of cumulative exposure below the minimum temperature, a maximum rate of temperature change, and a maximum frequency of temperature fluctuations.

4. The apparatus of claim 1 , wherein the temperature indicator is specific to at least one of the apparatus, the container, and the liquid.

5. The apparatus of claim 1 , wherein a temperature event is at least one of a relationship and a difference between the at least one measured temperature and the at least one temperature indication.

6. The apparatus of claim 1 , further comprising a memory configured to store at least one of the at least one measured temperature and the temperature indicator.

7. 10. The device of claim 1, wherein the at least one processor is further configured to determine at least one of a level of efficacy, a level of safety, a subject's comfort, and an expiration status associated with the liquid based on temperature events associated with the received data.

8. 8. The device of claim 7, further comprising at least one communication interface configured to communicate to a user information relating to at least one of the efficacy level, the safety level, the subject's comfort, and the expiration status associated with the liquid.

9. a blood glucose meter configured to measure blood glucose of the subject; The at least one processor further comprises: Receive blood glucose readings, normalizing the blood glucose measurement based on a temperature event associated with the blood glucose measurement; The device of claim 1 configured to:

10. 1. A method for estimating a volume of liquid in a medication container, comprising: causing a plurality of light sources to emit electromagnetic radiation toward the medication container; detecting the emitted electromagnetic radiation that has passed through the medication container with a plurality of sensors; measuring at least one temperature associated with the liquid in the drug container with a temperature sensor; comparing the at least one measured temperature to a temperature indicator to identify a temperature event associated with the detected electromagnetic radiation; normalizing data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors based on a temperature event associated with the detected electromagnetic radiation; converting the normalized data into a signature representative of the electromagnetic radiation detected by the plurality of sensors; comparing the signature to a plurality of reference signatures to determine the volume of the liquid in the medication container; A method comprising:

11. The method of claim 10 , wherein the temperature indicators include at least one of a baseline temperature, a maximum temperature, and a minimum temperature.

12. 12. The method of claim 11, wherein the temperature guidelines further include at least one of: an amount of a single exposure above the maximum temperature and the minimum temperature, an amount of a single exposure below the minimum temperature, an amount of cumulative exposure above the maximum temperature, an amount of cumulative exposure below the minimum temperature, a maximum rate of temperature change, and a maximum frequency of temperature fluctuations.

13. The method of claim 10 , wherein the temperature indicator is specific to at least one of the device, the container, and the liquid.

14. The method of claim 10 , wherein a temperature event is at least one of a relationship and a difference between the at least one measured temperature and the at least one temperature indication.

15. The method of claim 10 , further comprising storing at least one of the at least one measured temperature and the temperature indication.

16. The method of claim 10, further comprising determining at least one of a level of efficacy, a level of safety, a subject's comfort, and an expiration status associated with the liquid based on temperature events associated with the received data.

17. 17. The method of claim 16, further comprising communicating to a user information related to at least one of the efficacy level, the safety level, the subject's comfort level, and the expiration status associated with the liquid.

18. measuring a blood glucose level of a subject; normalizing the blood glucose measurement based on a temperature event associated with the blood glucose measurement; The method of claim 10 further comprising:

19. causing a plurality of light sources to emit electromagnetic radiation toward an injection pen for the first time; detecting the emitted electromagnetic radiation that passes through the injection pen with a plurality of sensors; measuring at least one temperature associated with a fluid within the injection pen with a temperature sensor; comparing the at least one measured temperature to a temperature indicator to identify a temperature event associated with the detected electromagnetic radiation; normalizing data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors based on a temperature event associated with the detected electromagnetic radiation; converting the normalized data into a first signature representative of the electromagnetic radiation detected by the plurality of sensors; comparing the first signature to a plurality of reference signatures to determine a first volume of liquid in the injection pen; repeating the steps of causing the plurality of light sources to emit electromagnetic radiation, detecting the emitted electromagnetic radiation, measuring at least one temperature associated with a fluid in the injection pen, comparing the at least one measured temperature to a temperature indicator to identify a temperature event associated with the detected electromagnetic radiation, and normalizing data representing a portion of the detected electromagnetic radiation from each of the plurality of sensors based on the temperature event; converting the normalized data into a second signature; comparing the second signature to the plurality of reference signatures to determine a second volume of liquid within the injection pen; estimating a dose administered from the injection pen based on the first volume and the second volume; A method comprising:

20. a drug delivery device including a drug reservoir; a dose measuring system configured to be removably coupleable to the medication delivery device; a display configured to present information to a user indicative of the volume of liquid remaining in the medication reservoir; The dose measuring system comprises: a plurality of light sources positioned and configured to emit electromagnetic radiation toward the drug reservoir; a temperature sensor positioned and configured to measure at least one temperature associated with a liquid within the medication delivery device; a plurality of sensors optically coupleable to the plurality of light sources, each sensor positioned and configured to detect an amount of electromagnetic radiation transmitted through the medication reservoir; at least one processor configured to receive data representative of the detected portion of electromagnetic radiation from each of the plurality of sensors and the at least one measured temperature from the temperature sensor, the processor being operable to: compare the at least one measured temperature to a temperature guideline to identify a temperature event associated with the received data; normalize the received data based on the temperature event associated with the received data; and convert the normalized data into a signature representative of a volume of liquid remaining in the medicament reservoir; A health management system having:

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