LIQUID MEASUREMENT SYSTEM, APPARATUS, AND METHOD OPTIMIZED WITH TEMPERATURE SENSING - Patent application

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

[0001] 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 Aug. 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 of liquid and / or the temperature of liquid disposed within 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 need to be self-administered using an injection pen or similar drug administration device, administered by a caregiver, or administered by an automated or semi-automated administration system. For example, a patient diagnosed with type I or type II diabetes must periodically check his or her blood glucose level and administer the appropriate dose of insulin using an injection pen. In order 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. Also, many such patients may be minors or elderly who are unable to efficiently and / or accurately track dosage information.

[0004]

[0004] Incomplete medication records impede 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 significant increases in healthcare costs in countries around the world.

[0005]

[0005] Thus, there is a need for improved technological aids, and in particular new drug administration devices to better assist both patients in self-managing their disease treatments using drug administration devices and caregivers in monitoring the health of patients. 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, families, and financial service providers. Summary of the Invention [Problem to be solved by the invention]

[0006]

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

[0007]

[0007] Temperature may also affect the quality of the medication placed in the medication delivery device. The efficacy and shelf life of medications, including but not limited to insulin, are strongly influenced by the temperature to which the particular medication is exposed and / or the temperature at which the particular medication is stored. Injection pens containing such medications are often carried by patients, for example in the patient's pocket, backpack, purse, suitcase, 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 of the medication ultimately administered to the patient, the bioefficacy of the medication, and / or the comfort provided by the medication. Also, 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]

[0008] In some embodiments, a dosage measurement system for measuring a volume of a 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. The sensor is arranged and configured to detect electromagnetic radiation emitted by at least a portion 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 sensor and normalize the sensor value, 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 description of the drawings]

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

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

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

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

[0013] FIG. 3 is a schematic diagram of a communication interface that may be included in the dose 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. 1 is a cross-sectional view of a dosage measuring system in a second configuration according to some embodiments. [Figure 11C]

[0019] FIG. 1 is a cross-sectional view of a dosage 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] 4 is a graph showing a reference signature signal of a sensor of a dosage measuring system according to some embodiments. [Figure 15]

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

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

[0025] FIG. 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] FIG. 1 is a perspective view of a liquid measurement system including a temperature sensing module according to some embodiments. [Figure 20]

[0028] 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, in accordance with some embodiments. [Figure 24]

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

[0033] 11 is a screen shot of a user interface display for monitoring one or more liquid measurement systems according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010]

[0034] SUMMARY OF THE DISCLOSURE The embodiments described herein generally relate to systems, apparatus, and methods for measuring the amount of liquid and / or the temperature of the liquid disposed in a dispensing device, and in particular 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 I or type II 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 an unregulated setting.

[0011]

[0035] Additionally, temperature may affect the measurement characteristics of some embodiments and the quality characteristics of the medication included in some embodiments. The efficacy 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 such medications are often carried by patients, for example in their pockets, backpacks, purses, suitcases, etc. Thus, the medications may be exposed to widely varying ambient temperatures, which may affect the expiration status of the medication and / or the bioavailability of the medication ultimately administered to the patient, the bioefficacy of the medication, and / or the comfort provided by the medication. Additionally, knowing the specific effects of temperature exposure may 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 that contains 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 arranged and configured to emit electromagnetic radiation toward the container. The plurality of light sources may include, for example, a plurality of 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 into a plurality of light sources arranged and configured to emit electromagnetic radiation toward the container. In some embodiments, 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 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. 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 bioavailability of the remaining liquid.

[0014]

[0038] In some embodiments, a method of estimating a volume of a liquid in a medication delivery device includes causing a plurality of light sources to emit electromagnetic radiation toward a medication container and detecting a signature of the emitted electromagnetic radiation that has passed through the medication container with a plurality of sensors. The detected signature is then compared to a plurality of reference signatures to determine a volume of the 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 a portion 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 drug 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 dose volumes in the drug 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 of 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 a first signature of the emitted electromagnetic radiation that has passed through the injection pen with a plurality of sensors. 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 a plurality of light sources to emit electromagnetic radiation toward the injection pen again after the first time and detecting a second signature of the emitted electromagnetic radiation that has passed through the injection pen with a plurality of sensors. 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 volume may be subtracted from the first volume to determine a dose administered from the injection pen.

[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 inactivity of the pen cap. 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, the health management system includes a drug delivery device including a drug reservoir and a dosage measurement system configured to be removably coupleable to the drug delivery device. The dosage measurement system includes a plurality of light sources arranged and configured to emit electromagnetic radiation towards the drug reservoir, and a plurality of sensors optically coupleable to the plurality of light sources and arranged and configured to detect an amount of electromagnetic radiation transmitted through the drug reservoir. The amount of electromagnetic radiation serves as a signature representative of a volume of liquid remaining in the drug 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 drug reservoir. The dosage measurement system may be configured to communicate data representative of the volume of liquid remaining in the drug reservoir to a remote device, for example to enable the remote device to calculate a 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, a user's blood glucose level, a user's dietary restrictions, a user's exercise, and / or a user's home health monitoring data.

[0019]

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

[0020]

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

[0021]

[0045] The illumination module 140 includes a number of light sources configured to emit electromagnetic radiation towards the drug delivery device 110. In some embodiments, the multiple light sources may be configured to emit electromagnetic radiation towards a drug reservoir (not shown) of the drug delivery 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 such that the electromagnetic radiation may penetrate the housing and any internal components of the drug delivery device 110 and / or the liquid drug 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 number of sensors optically coupleable to the 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 arranged 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 a lens effect of a curved surface of the housing and / or the drug reservoir of the drug 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 drug volume within the drug 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 to enable a near field communication (NFC) device to read the stored information. In some embodiments, the processing unit 160 is configured to correlate the signal signature with the reference signature to determine the dosage volume remaining in the drug delivery device 110 and / or the dosage 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 dosage measurement system 100.

[0024]

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

[0025]

[0049] In some embodiments, the communication 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, battery level, wireless connection status, and / or user attention prompts. In some embodiments, the communication module also includes a speaker and / or vibration mechanism for communicating audio and / or tactile alerts. In some embodiments, the communication module 170 includes a user input interface (e.g., buttons, switches, alphanumeric keypad, touch screen, camera, and / or microphone) to allow the user to input information or commands into the dosage measurement system 100, including but not limited to powering on the system, powering off the system, resetting the system, manually entering details of patient actions, 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 coupled to the medication delivery device 110. For example, the illumination module 140, the sensing 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 sensing module 150) may be integrated into a first housing and other components (e.g. the processing unit 160 and the communication module 170) may be 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 is, for example, quite similar to a pen cap and serves 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 drug delivery device 110 and the sensors are disposed on a second side of the drug delivery device 110. In some embodiments, the light sources are disposed at a first radial position relative to the drug 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 drug reservoir and the sensors are disposed on an opposite side of the drug reservoir. In some embodiments, each of 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 located adjacent to at least one sensor and each light source is located parallel to and within the line of sight of at least one sensor. In some embodiments, at least one of the light sources and / or at least one of the sensors are positioned at an oblique orientation with respect to a longitudinal axis of the drug delivery device 110. In some embodiments, the number of sensors is equal to, greater than, or less than the number of light sources. In some embodiments, the light sources and sensors are configured such that the dosage measurement system 110 can detect the volume of drug in the drug delivery device 110 with a resolution of less than or equal to one unit of drug (e.g., fractional units of drug such as 0.1 units, 0.2 units, 0.5 units, etc.).In some embodiments, the multiple light sources and multiple sensors are configured such that the dosage measurement system 110 can detect the position of a plunger portion of an actuator disposed within the medication delivery 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, several exemplary embodiments of these concepts will now be described, which are merely exemplary and many other configurations of a dosage measurement system or systems and / or methods for measuring the dosage administered by a medication delivery device and the overall health of a patient are anticipated.

[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 communication 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 a patient 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 such that it is transparent to 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 to dispense a variable amount of the medication, for example, by a user. The injector 216 is configured to penetrate the skin of a user for intramuscular, subcutaneous, and / or intravenous administration of the medication.

[0030]

[0054] The dosage measuring system 200 includes a housing 220 with an upper housing portion 222 (also referred to herein as "upper housing 222") and a lower housing portion 224 (also referred to herein as "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, using screws, or any other suitable connecting means. The housing 220 may be made of 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, for example, an aluminum lining or any other metal sheet or foil that can serve as an electromagnetic shield.

[0031]

[0055] As shown in FIG. 3 , the upper housing portion 222 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, according to some embodiments. The lower housing portion 224 includes and defines a bore 226 that is shaped and sized to receive at least a portion of the drug delivery device 210. For example, the bore 226 may be shaped and sized to receive only the drug-containing portion of the housing 212 and 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 diameter and close tolerances 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 to removably couple the drug delivery device 210 to the lower housing 224. In some embodiments, the lower housing portion 224 includes one or more alignment features to enable the medication 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 sensing 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 sensing 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 arranged 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 equally 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 a zigzag configuration, an unevenly spaced configuration, a staggered configuration, a configuration in which the light sources 244 are staggered with the sensor 254, and / or any other configuration, including but not limited to any other configuration described herein.

[0035]

[0059] In some embodiments, the light sources 244 are 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 drug delivery devices (e.g., injection pens). In some embodiments, the electromagnetic radiation has a frequency that also penetrates the internal components of the drug 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 electromagnetic radiation beams). In other words, 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 sensors 254 of the sensing module 250 are mounted or otherwise disposed on the PCB 252. The PCB 252 may be any standard PCB fabricated by any commonly known process. The sensors 254 may be any optical sensor (e.g., photodiodes) that can be optically coupled to the light sources 244 and configured to detect at least a portion of the electromagnetic radiation emitted by the 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 the 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 sensors 254 may be used (e.g., by the processing unit 260) to create a signal signature. For example, the signal signature may then be correlated with the reference signature to determine the remaining dose in the drug 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 drug delivery device 210 and / or determining whether the drug delivery device 210 is coupled / not coupled to the dosage measurement system 200. In some embodiments, the sensors 254 are arranged in a configuration substantially similar to the light sources 244. In some embodiments, the number of sensors 254 is greater or less than the number of light sources 244. In some embodiments, the light sources 244 and the sensors 254 are arranged such that each PCB 244, 254 includes a combination of light sources 244 and sensors 254 (e.g., arranged in a staggered manner). In some embodiments, the light sources 244 and / or the 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 lighting module 240 and the sensing module 250 using electronic couplings 266 such that the lighting module 240 and the sensing module 250 are oriented perpendicular to the processing unit 260 and parallel to each other. In some embodiments, the processing unit 260 includes an on-board memory for at least temporarily storing the signal signatures, the reference signature database, the dosage information, the user's health data (e.g., blood glucose levels), device location data (e.g., from a GPS receiver optionally included in the dosage measurement system 200 or from another GPS-enabled device communicatively coupled to the system 200, such as a blood glucose meter or a mobile phone), and any other data that may be useful for a patient to manage their health. In some embodiments, the processing unit 260 includes an RFID chip configured to store information and to enable the NFC 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, for example, activating and timing the light source 244 and / or reading and processing electromagnetic radiation data from the sensor 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 drug delivery device 210 or the position of the actuator 214 (e.g., a plunger) of the drug delivery device 210.

[0038]

[0062] In some embodiments, the processing unit 260 is configured to correct the signal signature for background noise. For example, the processing unit 260 may be configured to operate the detection module 250 to detect the background signature when the illumination module is in a dark state, i.e., when each of the plurality of light sources 244 is turned off. The background signature may be associated with the signal signature to correct for the background noise. In some embodiments, the processing unit 260 also includes electronic signal filtering algorithms, including but not limited to Fourier transform, low pass filter, band pass filter, high pass filter, Bessel filter, and / or any other digital filter, to reduce noise and improve signal quality. The processing unit 260 may be configured to obtain a reference signature by storing electromagnetic radiation signals detected by the detection module 250 for a range of dosage volumes within a representative drug dispensing 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 dispensing device and / or every 170 micrometer displacement of a plunger portion of the actuator 214 included in the drug dispensing 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 the signal signature with a reference signature to determine the volume of liquid in the medication delivery device 210. The processing unit 260 may also be configured to control and operate the communication 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 a short period 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 communication 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 delivery device 210. The processing unit 260 may also be configured to deactivate the communication 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 communication 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 boot-up, system on / off, docking / disconnecting a drug delivery device, remaining dose, dose history, time, system and / or drug temperature, system location (e.g., GPS), drug delivery device 210 data, drug expiration data, rate at which the drug 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 communication module 270 may also be configured to receive data, such as new 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 communicated from an external device. The communications module 270 may include conventional data communications electronics and may use standard communications 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 communications module 270 is configured to periodically (e.g., 10 times per day) connect to an external device (e.g., a smartphone) to record any dosage data stored in the on-board memory. In some embodiments, the communications module 270 is activated / deactivated on demand by the user.

[0041]

[0065] 5, the communication module 270 may, according to some embodiments, include a communication interface 271 located on an exterior surface of the housing 210 of the dosage measurement system 200 for communicating with a user. The communication interface 271 may include a switch 272 (e.g., a power switch, a reset button, and / or another communication switch) for manually initiating communication with an external device (e.g., activating Bluetooth®). In some embodiments, the communication 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 communication module 270 is operational. In some embodiments, the communication interface 271 includes a display 276 for visually conveying 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 of the system 282, the dosage history 284 (e.g., average dose usage, the time the last dose was taken, etc.), and / or wireless connection status. In some embodiments, the 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 the dosage measurement system 200. In some embodiments, the 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, the communications module 270 includes a means for tactile alerts (e.g., a vibration mechanism). In some embodiments, the communications module 270 communicates other information regarding the user's health (e.g., number of steps, calories burned, blood glucose levels, etc.).

[0042]

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

[0043]

[0067] As described above, the multiple sensors 254 of the detection module 250 are configured to receive at least one of transmitted radiation, refracted radiation (e.g., refracted by air, liquid drug, or the housing 212 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 interior volume of the drug administration device 210), and multi-directional reflection / refraction caused by the lens effect of the curved surface of the housing 212 of the drug administration device 210.

[0044]

[0068] 6, according to some embodiments, a light source L (e.g., a wide-angle light source) may generate multiple light beams emanating from the light source and diverging. 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 an opaque surface (e.g., a sidewall).

[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 the light ray does not bend as it transmits through the second medium M2 back into the first medium M1 at the original angle of incidence (i.e., transmitted light).

[0046]

[0070] The 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, resulting in 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 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 in 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 drug 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 drug 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, the dosage measurement system 300 includes a plurality of light sources 344 and a plurality of sensors 354. A drug delivery device 310 is coupled to the dosage measurement system 300 according to some embodiments. The drug delivery device 310 includes a housing 312 and an actuator 314 that collectively define an internal volume (e.g., a reservoir) for containing a drug. The drug delivery device 310 also includes an injector 316 for delivering the drug to the patient. The dosage measurement system 300 is configured such that the plurality of light sources 344 are disposed on a first side of the housing oriented towards the drug delivery device 310, and the plurality of sensors 354 are disposed on a second side of the housing, each of the plurality of sensors 354 facing and in optical communication with at least one of the plurality of light sources 344. In some embodiments, the light sources 344 and / or the sensors 354 are arranged in a substantially linear relationship (e.g., in a line) with respect to one another. Each of the sensors 354 receives a combination of transmitted, refracted, and / or reflected electromagnetic radiation emitted by the 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 drug delivery device 310. The refraction may be from the housing 312 and / or from the liquid drug disposed in the drug delivery device 310. The transmitted, reflected, and refracted portions of the electromagnetic radiation detected by each of the sensors provide a unique signal signature for a range of dosage volumes remaining in the drug delivery device 310.

[0051]

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

[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, the dosage measurement system 500 includes a plurality of light sources 544 and a plurality of sensors 554 according to some embodiments. The drug delivery device 510 includes a housing 512 and an actuator 514 that collectively define an internal volume (e.g., a reservoir) for containing the drug. The drug delivery 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 delivery device 510 and have an angular orientation with respect to the longitudinal axis of the dosage measurement system 500 and the drug delivery device 510. This orientation may ensure that the electromagnetic radiation emitted by the light sources 544 is incident on a larger portion of the drug delivery 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 a 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 drug administration device 510 than can be reached by a narrower beam light source 544. In other words, the wider the beam emitted by the light source 544, the larger the portion of the entire drug administration device 510 (or drug reservoir) is in optical communication with the light source 544. Because a larger portion of the administration device 510 is in optical communication with the light source 544, the spectrum of electromagnetic radiation being transmitted, reflected, and / or refracted through the drug administration device is broader, which can increase the signal strength detectable by the multiple sensors 554. In other words, the resolution of the dosage measurement system 500 is increased, since the variability of the signal signature increases with the spread of the beam of light incident on the administration device (as opposed to an increase in the intensity of the light incident on the sensor). For example, a wider angle may result in a lower overall intensity of light, but may increase the ability to distinguish states of the medication delivery device, since distinguishing states is less about the absolute intensity of the light and more about optimizing how the intensity of the light changes from state to state.

[0054]

[0078] In some embodiments, the dose measurement system is configured to detect a signal signature from the position of the actuator of the drug delivery device, which may be used to estimate the remaining dose in the drug delivery device. As shown in Fig. 10, the dose measurement system 600, according to some embodiments, includes a plurality of light sources 644 and a plurality of sensors 654. A drug delivery device 610 is coupled to the dose measurement system 600. The drug delivery device 610 includes a housing 612 and an actuator 614 that collectively define an interior volume (e.g., a reservoir) for containing a drug. The dose measurement system 600 is generally centered on the actuator 614 portion of the drug delivery device 610, in contrast to the dose measurement systems 300, 400 and 500 shown in Figs. 7-9, which are generally centered on the drug 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 Fig. 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 delivery 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 the 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 delivery device 610.

[0055]

[0079] 11A-11C, each sensor of the plurality of sensors of the dosage measuring 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 measuring system 700 includes, for the sake of clarity, two light sources 744a and 744b and two sensors 754a and 754b. The dosage measuring 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 measuring system 700 between the light sources 744a, 744b and the sensors 754a, 754b.

[0056]

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

[0057]

[0081] 11B, the actuator 714 is displaced to a second position ("position 2") such that the plunger portion partially blocks the line of sight between the light source 744b and the sensor 754b, according to some embodiments. In position 2, most of the electromagnetic radiation emitted by the light source 744b is blocked by the actuator 714 from reaching the sensor 754b, but at least a portion of the electromagnetic radiation emitted by the light source 744a can still reach the sensor 754b, along with the multi-directional reflected / refracted electromagnetic radiation. The sensor 754a can also receive the refracted electromagnetic radiation from the sensor 744b and the transmitted and refracted radiation from the sensor 744a. The sensor 754a also receives the electromagnetic radiation reflected by the surface of the plunger that at least partially defines the drug reservoir. Thus, in position 2, the sensor 754a detects an electromagnetic radiation value of 15.5 (greater than in position 1), and the 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 the actuator 714 is in a third position ("position 3") such that, according to some embodiments, the plunger portion of the actuator 714 completely blocks the line of sight of the sensor 754a from the electromagnetic radiation emitted by the light source 744a, such that substantially no transmitted and / or reflected radiation from the light source 744a can reach the sensor 754a. A portion of the transmitted electromagnetic radiation emitted by the light source 744b is also blocked from reaching the sensor 754b by at least a portion of the actuator 714. Nevertheless, both the sensors 754a and 754b can receive at least a portion of the reflected and refracted portions of the electromagnetic radiation emitted by either the light sources 744a and / or 744b. Thus, in position 3, the sensor 754a detects an electromagnetic radiation value of 2.2 (less than in positions 1 and 2) and the sensor 754b detects an electromagnetic radiation value of 12.0 (less than in position 1 but more than in position 2). The eigenvalue measured at location 3 may serve as the signal signature value for location 3.

[0059]

[0083] 12, a cross section of the dosage measurement system 700 along line AA in FIG. 11A illustrates the lens 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 an angle of zero degrees is transmitted toward the sensor 754b without bending. Two more 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 is referred to herein as the "lens effect" and may result in the focusing of the light beam toward the sensor 754b. The fourth light beam is emitted at an angle further away from the transmitted light beam so 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 is incident on the sensor 754b. The fifth light beam is emitted at an angle and does not enter 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 a 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 the transmission of light. 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 drug delivery device 710 without being acted upon (ignoring refraction through the housing) (i.e., no drug is present in this portion of the device 710) and are incident on the sensor 754b. A fourth light beam is emitted by the light source 744b at an angle and is internally reflected by the housing 712 and is incident on the sensor 754b, while a fifth light beam is internally reflected by the housing 712 but is not incident on the sensor 754b. The combination of these light beams results in electromagnetic radiation detection values ​​of 2.2 according to the sensor 754a and 12.0 according to the sensor 754b. These eigenvalues ​​measured at position 3 may serve as the signal signature value for position 3. Note that even though the line of sight of sensor 754a is completely blocked from light source 744a, the reflected and refracted portions of electromagnetic radiation still contribute to producing positive values.

[0061]

[0085] Although the sensor values ​​for a particular location are described as absolute values, an individual sensor value 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 location / volume of drug remaining in the 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 volume dispensed by the drug dispensing device can be used to obtain a reference signature (calibration curve) of the dose measurement system. FIG. 14 is a graph showing an example of a reference signal signature obtained for a drug dispensing 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 a reference signature. As can be seen from the reference signature, when the drug dispensing device is almost full, sensor 1 records a low amplitude electromagnetic radiation, while sensor 7 records a very high amplitude electrode, and all other sensors detect an intermediate signal signature. Conversely, when the drug dispensing device is completely empty, sensor 1 records a very high amplitude electromagnetic radiation, while sensor 7 records a low amplitude electrode, and all other sensors detect an intermediate signal signature.

[0063]

[0087] The sensor 8 detects a uniform sensor signal for a significant portion of the administered dose until almost all 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 (e.g. an injector) that should be included in the drug delivery device.

[0064]

[0088] Thus, in this manner, the signal values ​​recorded from all sensors for a range of remaining drug volumes results in 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, the background signature may be detected by detecting a signal signature from the multiple sensors when the multiple light sources are in a dark state. 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 multiple light sources and the multiple sensors are configured such that the dosage measurement system can detect the volume of drug in the drug delivery device with a resolution of one unit of drug and / or the position of a plunger portion of an actuator disposed in the drug 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, including all ranges therebetween.

[0066]

[0090] FIG. 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 a reference signature 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 a memory that is part of the processing unit of the dose measurement system). In step 808, the dose measurement system may warn the user if the remaining dose is very low. Audio, visual, and / or tactile indications may be used to warn the user.

[0067]

[0091] In step 810, the communication module of the dose 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 dose measurement system pairs with the external device, the system may record remaining dose 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, step 816. The user may then administer (e.g. inject) a dose of a predetermined volume with the medication delivery device, step 818. The user finally replaces the dose measuring system on the medication delivery device, step 820. At this point, the method 800 may be repeated.

[0069]

[0093] FIG. 16 is a flow diagram illustrating a method 900 for saving power when the dose measurement system is not in use, according to some embodiments. The method 900 described herein may be used with any of the dose measurement systems described herein. In a first step, a detection mechanism of the dose measurement system checks for a medication delivery device 902. The medication delivery device may or may not be coupled to the dose measurement system 904. If no medication delivery device is attached, the dose measurement system may automatically check for raw data in memory to be recorded on an external device or the user may activate the communication module of the dose measurement system 906. In some embodiments, the communication module is only activated when the dose measurement system is attached to the medication delivery device. The dose measurement system then determines 908 whether there is on-board data to be recorded and whether an external device has been found. If there is no on-board data to be recorded and no external device has been found, the dose 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 the electronics controlling the light sources and / or sensors of the dosage measurement system. 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 found, the dosage measurement system pairs with the external device and records data to and / or receives 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 scans the medication delivery device and collects 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 916 the signal signature with a reference signature to estimate the remaining dose in the medication delivery device. 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 times and stores the dose in an 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 suffering from type I or type II 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 may bidirectionally communicate with a dosage measurement system 1100 reversibly coupled to a drug delivery device 1110. The drug delivery device 1110 may be an insulin injection pen or a syringe for delivering insulin to a user U. The dosage measurement system may also communicate information to or receive input from a user. The health management system 1000 may be configured to receive exercise data E and dietary restriction data D of a user. 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 health data of the user, such as weight, blood pressure, electrocardiogram, oxygen saturation, autography measures, lung function, water retention, temperature, etc., from a home health monitor 1300. The health management system 1000 may bidirectionally communicate 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 drug dispenser DD. The monitor M may be, for example, a physician, a caregiver, a pharmacy, and / or a clinical trial administrator. The authorized drug 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 a memory for storing the insulin dosage regimen of the user U and / or any other drug delivery schedule. The drug delivery regimen of the user U may be communicated to the health management system 1100, for example, by the monitor M and / or the authorized drug dispenser DD over the network 1400. In some embodiments, the health management system 1100 may also be used to process health data of the user U, such as the user U's blood glucose level, exercise data E, dietary restriction data D, and / or home health monitoring data, to determine the status of the patient's health. In some embodiments, the health management system 1000 is also configured to compare the doses administered to the patient with the patient's drug delivery schedule to monitor compliance.

[0074]

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

[0076]

[0100] Embodiments of the liquid measurement system 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, for example, the temperature of a medication or medication (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 variations in temperature. The liquid measurement system 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 on July 17, 2014; 3. U.S. Patent Application No. 62 / 032,017, entitled “Liquid Measurement System with Temperature Sensor,” filed on August 1, 2014; and 4. U.S. Patent Application No. 14 / 548,679, entitled “Dosage Measurement System and Method,” filed November 20, 2014.

[0077]

[0101] Embodiments of the liquid measurement system described herein provide several advantages, including, but not limited to: (1) enabling real-time measurement of the temperature of a liquid disposed within a liquid container, e.g., a medication, and / or the environment surrounding it; (2) using the temperature information to determine one or more characteristics of a liquid disposed within the liquid container, including, e.g., the potency, expiration status, ease of administration, or any other physical and / or chemical characteristics of the liquid; (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 ingredients of the liquid to heat, as heat is related to the kinetics of the decomposition of the active chemical ingredients; and (5) optimizing measurements (e.g., dosage volume data or blood glucose data) by compensating for temperature disturbances, such as, for example, 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 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 of the above-mentioned device is also configured to receive temperature information from the temperature sensor and to at least one of normalize the sensor value, determine potency of the liquid, determine an expiration status of the liquid, and determine administration comfort. In some embodiments, the temperature sensor is also configured to measure a 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 "dosage measurement system") for measuring a volume of liquid (also referred to herein as a "dosage") 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 communication module 1812. The dose measurement system 1800 may be configured to be removably coupleable to a drug delivery device 1802 used to deliver a drug dose to a target T, such as a human patient.

[0080]

[0104] The drug delivery device 1802 may be any drug delivery device usable to deliver a medication to a subject. For example, the drug 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 measuring system 1800 may be configured to be connectable to a wide variety of drug delivery devices, e.g., having different shapes, sizes, and drug volumes. In some embodiments, the dose measuring system 1800 may be configured to receive a portion of the drug delivery device 1802, a portion defining an internal volume containing a drug, an injector, and / or a plunger. In some embodiments, the dose measuring system 1800 is configured to be removable from the drug delivery device 1802 when a user is delivering a dose to a target T. In some embodiments, the dose measuring system 1800 may remain attached to the drug delivery device 1802 when a user is delivering a dose to a target T. In some embodiments, the dose measuring system 1800 is configured to be reusable. In some embodiments, the dosage measuring system 1800 is permanently coupled to the drug delivery device 1802, for example integrated into the body of the drug 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 number of light sources configured to emit electromagnetic radiation towards the medication administration device 1802. The sensing module 1806 may include a number of sensors optically coupleable to the number of light sources of the illumination module 1804.

[0082]

[0106] The processing unit 1808 may be configured as described above, according to some embodiments. For example, the processing unit 1808 may be configured to receive electromagnetic radiation signals from the sensing module 1806 (i.e., from each of the multiple sensors) and convert the received data into a signal signature representative of the electromagnetic radiation detected by each of the multiple 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 in 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 a substantially accurate temperature reading of the liquid and / or the environment surrounding the liquid. For example, the temperature sensor may be positioned sufficiently far away from one or more components of the dosage measurement system 1800 that may affect the temperature reading, 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 to the temperature sensor and the liquid such 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 detection module 1810 includes a printed circuit board (PCB) and / or other electronics configured to process the temperature measurements and / or communicate the temperature information, for example to 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 may affect signal quality (e.g., measurement of liquid volume 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 an 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 a 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 temperature to which the medication is exposed and / or the temperature at which the medication is stored. Drug administration devices containing such medications, particularly injection pens, or additional components, are often carried by patients, for example in their pockets, backpacks, handbags, suitcases, etc. Thus, the medications may be exposed to widely varying ambient temperatures, with at least implications on administration, costs, and safety associated with said medications.

[0091]

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

[0092]

[0116] According to some embodiments, guidelines such as maximum threshold temperature, minimum threshold temperature, temperature range, rate of temperature change, frequency of temperature fluctuation, and / or duration of temperature exposure are recommended, permitted, and / or determined as acceptable based on at least one of a particular liquid measuring system (e.g., dosage measuring 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 be configured to compare one or more temperature readings from the liquid and / or its environment to these indicators to determine whether a user should be notified, for example, via a display, alert, and / or alarm (e.g., via the communications module 1812), that, for example, 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; (4) indicate a rate of temperature change that exceeds a recommended, permitted, and / or determined rate; (5) indicate a frequency of temperature fluctuation that exceeds a recommended, permitted, and / or determined frequency; and / or (6) indicate a period 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, temperature of the medication, temperature of the dosage measuring system 1800, temperature of the medication delivery device 1802, efficacy of the medication, expiration status of the medication, quality of the medication, and / or a reminder 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 drug delivery device 1802. For example, the illumination module 1804, the sensing module 1806, the processing unit 1808, the temperature sensing module 1810, and the communication 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, and other components (e.g., the processing unit 1808, the temperature sensing module 1810, and the communication module 170) may be 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 drug delivery device 1802. For example, the housing may have a recess and / or define a hole within which at least a portion of the drug delivery device 1802 may 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 into account the effects of temperature 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 source 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 a 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 coupled 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., a 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 such that it may 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 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 2014 may be configurable to dispense a variable amount of the medication, for example, by a user. The injector 2016 (e.g., a needle) may be configured to penetrate tissue of a user for intramuscular, subcutaneous, and / or intravenous administration of the medication. The housing 2012 may be configured to allow the temperature sensing module 2004 to 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 with 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] As shown in FIG. 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 communication 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 drug 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 drug delivery device 2010 in a particular orientation (e.g., radial orientation). In some embodiments, the bore 2024 has a close tolerance to the diameter of the drug delivery device 2010, for example to form a friction fit with the drug delivery device 2010. In some embodiments, the bore 2024 includes 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 part 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 a portion of a plurality of 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 serve as an alignment mechanism for the illumination module and / or sensing module.

[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, for example, glass, acrylic (e.g., Plexiglas®), or a plastic sheet, may be disposed below the slot 2030 to protect the display 2032 and 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 devoid of sharp edges. In some embodiments, the housing 2018 is shaped to resemble a pen cap, having a form factor that occupies minimal space, e.g., 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, the sensing module, and the processing unit may be mounted, as shown in Fig. 22. The illumination module and the sensing module may be substantially similar to the illumination module 1804 and the sensing module 1806 described with respect to the dosage measurement system 1800 above. Also, 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 a portion 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 the 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 may include a number of sensors 2038, which may be mounted or otherwise disposed on a PCB 2034 included in the sensing module 230, as shown in FIG. 5. The PCB 252 may be any standard PCB fabricated by any commonly known process. The number of sensors 2038 may be any optical sensor (e.g., photodiodes) that may be optically coupled to the number of light sources 2036 and configured to detect at least a portion of the electromagnetic radiation emitted by the number of light sources 2036. The electromagnetic radiation may be transmitted radiation, refracted radiation (e.g., refracted by air, the drug, and / or the body of the drug administration device 2010), reflected radiation (e.g., reflected from a wall of the housing 2018 or internally reflected from a wall of the drug administration device 2010), and / or multi-directional refraction / reflection (e.g., caused by a lens effect of a curved surface of the housing 2012). The transmitted, refracted, and / or reflected electromagnetic signals received by the number of sensors 2038 may be used (e.g., by a processing unit) to create a signal signature. The signal signature may be correlated with the reference signature to determine the remaining dose in the drug delivery device 2010. In some embodiments, the signal response of the sensor 2038 may be used to measure a utility indicator, such as, for example, 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 dose 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 drug delivery device 2010 and / or the temperature of the environment surrounding the liquid, for example, the temperature of an interior volume of the bore 2024 of the lower housing 2022 in which at least a portion of the drug 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] Also, the one or more temperature sensors may be positioned sufficiently far away 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 power source 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 such that the diffusion of heat 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 the 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 in the sensing assembly 2002. The at least one processing unit is configured to use the temperature data 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 comfort). For example, information about the thermal stability and efficacy of a liquid drug disposed in the drug administration 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 drug and / or the environment surrounding the drug provided by the temperature sensing module 2004 to the thermal stability information of a particular drug to determine the physical and / or chemical state / quality of the drug. In some embodiments, thermal stability information for multiple drugs (e.g., insulin, epinephrine, etc.) or for only specific drugs 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 drug delivery devices that may contain different drugs, specific drug delivery devices that may contain different drugs, drug delivery devices that contain substantially similar drugs, or specific drug delivery devices that contain substantially similar drugs.

[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 illustrating compensated 2300 and uncompensated 2302 measurements of a representative sensor of 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 varies. In some embodiments, it may be preferable to adjust the temperature measurement as the actual temperature changes and / or varies to more accurately monitor the actual temperature of the remaining liquid, thereby generating 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 with individual sensor designs, 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 with the temperature data with respect to the thermal expansion coefficient of the drug. In this way, errors due to the expansion or contraction of the volume of the liquid drug or other temperature related interferences with the sensor may be corrected.

[0115]

[0139] In some embodiments, the processing unit is configured to perform a 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. A positive or negative offset may be generated based on the difference between the external calibration temperature and an internal temperature measured by a temperature sensor included in the temperature sensing module 2004. For future temperature sensing, the processing unit may then calculate a 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 FIG. 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 measurement. The temperature at which the test strips are stored and the temperature at which the glucose meter or blood glucose meter is operated are both important. In particular, temperature can affect the response of the electronics in the blood glucose meter as well as the dosage measurement system 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 the test strip is important.

[0118]

[0142] In some embodiments, the blood glucose meter is communicatively and / or physically coupled to the dosage measurement system (e.g., integrated into the housing). One or more temperature sensors may be placed in proximity to the blood glucose meter to compensate the blood glucose reading for drift due to temperature. 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 into 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 placed on or in proximity 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 attention, and / or temperature readings. A display, speaker, and / or vibration mechanism may be used to communicate visual, audio, and / or tactile indications or alarms to the user. In some embodiments, a user input interface (e.g., buttons, switches, alphanumeric keypad, touch screen, 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 inputting details of a patient action, and / or manually inputting 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, the user may receive a notification from the system or from an external device communicatively coupled to the system when the temperature exceeds the recommended, permitted, and / or determined operating range of the medication. Action by the user may be required to stop the notification. In some embodiments, a time display tracks when the temperature event occurred. Thus, the user may check the notification and / or the time display to identify the temperature event in order to recalibrate the system or discard the medication or test strip.

[0122]

[0146] conclusion While various embodiments of the invention have been described and illustrated herein, those of ordinary skill in the art will readily envision various other means and / or structures for performing the functions and / or obtaining the results and / or one or more advantages described herein, and each such variation and / or modification is deemed to be within the scope of the embodiments of the 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 invention are used. Those skilled in the art will recognize or be able to ascertain, using no more than routine experimentation, many equivalent embodiments to the specific embodiments of the invention described herein. Thus, it should be understood that the foregoing embodiments are presented by way of example only, and that embodiments of the invention may be practiced within the scope of the appended claims and their equivalents other than as specifically described and claimed. The embodiments of the invention 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] Where 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 are in accordance with variations of the invention. Also, some of the steps may be performed simultaneously in a parallel process 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 details may be made.

[0124]

[0148] For example, although various embodiments have been described as having certain combinations of features and / or 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, although some embodiments have been described as having a dose measuring system resembling a pen cap, the dose measuring 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 be varied. For example, the size and specific shapes 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 can be implemented using hardware, software, or a combination thereof. When implemented in software, the software code can be executed on any suitable processor or collection of processors, whether provided within a single computer or distributed among multiple computers.

[0126]

[0150] It should also be appreciated that a 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, etc. Additionally, a computer may be embedded in devices not generally considered to be computers but equipped with suitable processing capabilities, including a personal digital assistant (PDA), a smart phone, 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 (INs) 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 encoded 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 example embodiments.

[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 govern any dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0133]

[0157] The indefinite articles "a" and "an," as 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 conjointly present in some cases and disjointly present 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 the elements specifically identified by the "and / or" clause may optionally be present, whether related or not to the elements specifically identified. Thus, as a non-limiting example, "A and / or B," when used in conjunction with open-ended language such as "comprising," may 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 forth.

[0135]

[0159] When 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 being inclusive, i.e., including at least one of a number or list of elements, but also including more than one, and optionally including further unlisted items. Only terms expressly 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. In general, 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 a term 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 or not related 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, and optionally more than one, A, and no B (and optionally including elements other than B); in another embodiment, to at least one, and optionally more than one, B, and no A (and optionally including elements other than A); in yet another embodiment, to at least one, and optionally more than one, A, and at least one, and optionally more than one, B (and optionally including other elements), and so forth.

[0137]

[0161] In the claims, as well as in the above 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 intended to be closed or semi-closed transitional phrases, respectively, as set forth in Section 2111.03 of the United States Patent Office Manual of Patent Examining Procedures.

Claims

1. 1. An apparatus for measuring a 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 a portion of the plurality of light sources; a temperature sensor positioned and configured to measure at least one temperature associated with a liquid in the container; 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 at least one processor comparing the at least one measured temperature to temperature guidelines to determine a quality of the liquid and / or a quality of administration in conjunction with the received data, the temperature guidelines including at least one of a baseline temperature, a maximum temperature, and a minimum temperature; normalizing the received data based on a temperature event associated with the received data, the temperature event being at least one of a relationship and a difference between the at least one measured temperature and the at least one temperature indication; converting the normalized data into a signature representative of the electromagnetic radiation detected by the plurality of sensors; 23. An apparatus operable to:

2. 2. The apparatus of claim 1, 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.

3. The apparatus of claim 1 , wherein the temperature indication is specific to at least one of the device, the container, and the liquid.

4. 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 indication.

5. 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 a temperature event associated with the received data.

6. 6. The device of claim 5, 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.

7. 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 apparatus of claim 1 configured as follows:

8. 1. A method for estimating a volume of liquid in a medication container, performed by a liquid measurement system, comprising: causing a plurality of light sources to emit electromagnetic radiation toward the medication container; detecting the emitted electromagnetic radiation that passes through the medication container with a plurality of sensors; measuring at least one temperature associated with the liquid in the medicament container with a temperature sensor; receiving, by a processing unit, 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; comparing the at least one measured temperature with temperature indicators by the processing unit to determine a quality of the liquid and / or a quality of administration together with the received data, the temperature indicators including at least one of a baseline temperature, a maximum temperature, and a minimum temperature; normalizing, by the processing unit, data representative of 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, the temperature event being at least one of a relationship and a difference between the at least one measured temperature and the at least one temperature indication; converting, by the processing unit, the normalized data into a signature representative of the electromagnetic radiation detected by the plurality of sensors; comparing the signature with a plurality of reference signatures by the processing unit to determine a volume of the liquid within the medication container; A method comprising:

9. 9. The method of claim 8, 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.

10. The method of claim 8 , wherein the temperature indication is specific to at least one of the device, the container, and the liquid.

11. The method of claim 8 , further comprising storing at least one of the at least one measured temperature and the temperature indication by the processing unit in a memory.

12. The method of claim 8, further comprising determining by the processing unit 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 a temperature event associated with the received data.

13. 13. The method of claim 12, further comprising communicating to a user via a communications interface 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.

14. receiving a blood glucose level of a subject by the processing unit; normalizing, by the processing unit, the blood glucose measurement based on a temperature event associated with the blood glucose measurement; The method of claim 8 , further comprising:

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