Liquid measurement system, apparatus, and method optimized by temperature detection.

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] The present application claims priority and benefit of U.S. Provisional Application No. 62 / 032,017, filed on August 1, 2014, entitled "Liquid Measurement System With Temperature Sensor". The disclosure of that application is hereby incorporated herein by reference in its entirety.

[0002]

[0002] The present disclosure relates generally to systems, apparatuses, and methods for measuring the amount of liquid and / or the temperature of the liquid disposed within an administration device, and in particular relates to an injection pen cap including a temperature sensor.

BACKGROUND ART

[0003]

[0003] Many patients with chronic diseases are prescribed medications that need to be self-administered using injection pens or similar drug administration devices, administered by caregivers, or administered by automated or semi-automated administration systems. For example, patients diagnosed with Type I or Type II diabetes must regularly check their blood glucose levels and administer an appropriate dose of insulin using an injection pen. In order to monitor the efficacy of medication, dosage information must be recorded. The process of manually recording dosage information is tedious and error-prone, especially when the settings are unregulated. Patients often forget to keep records of dosage information when administering medication. In addition, many such patients may be minors or elderly persons who are unable to efficiently and / or accurately track dosage information.

[0004]

[0004] Incomplete medication dosage records interfere with the patient's ability to self-manage their medical condition, and also interfere with caregivers adjusting care plans based on behavioral insights. Failure to adhere to the target medication schedule for injectable drugs may increase the need for emergency care, resulting in a significant increase in medical expenses in countries around the world.

[0005]

[0005] Therefore, there is a need for improved technical assistance, in particular for new administration devices that better support both patients' ability to self-manage their illness using drug administration devices and caregivers' ability to monitor patients' health. In particular, there is a need for systems, devices, and methods that facilitate the collection of data on 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. [Overview of the project] [Problems that the invention aims to solve]

[0006]

[0006] The embodiments described herein generally relate to systems, apparatus, and methods for measuring the volume and / or temperature of a liquid placed in a dispensing device, and more particularly to injection pen caps including a temperature sensor. The inventors have recognized and perceived that temperature may affect the characteristics of the embodiments of the systems, apparatus, and methods described herein. In particular, temperature may affect the measurement of the volume of liquid performed using some embodiments. In some embodiments, temperature may also affect the characteristics of one or more additional components, such as a glucose meter test piece.

[0007]

[0007] Temperature can also affect the quality of the drug placed in the drug delivery device. The efficacy and shelf life of a drug—including but not limited to insulin—are strongly influenced by the temperature to which a particular drug is exposed and / or the temperature to which a particular drug is stored. Injection pens containing medications are often carried by patients in places such as their pockets, backpacks, handbags, or travel bags. Therefore, the medication may be exposed to a wide range of ambient temperatures, which can affect the medication's shelf life and / or the bioavailability, bioefficacy, and / or comfort provided by the medication before it is finally administered to the patient. Furthermore, knowing the specific effects of temperature exposure can alleviate safety concerns and anxieties for patients, caregivers, and their families. [Means for solving the problem]

[0008]

[0008] In some embodiments, a dosage measurement system for measuring the volume of liquid in a container includes a plurality of light sources configured to emit electromagnetic radiation toward the container. A plurality of sensors can be optically coupled to these plurality of light sources. The sensors are configured to detect electromagnetic radiation emitted by at least a portion of the light sources. The device includes a temperature sensor configured to measure the temperature of the liquid placed in the container. The device also includes a processing unit configured to receive data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors and to convert the received data into a signature representing the electromagnetic radiation detected by the plurality of sensors. The processing unit is configured to receive temperature information from the temperature sensor and to normalize the sensor values, determine the efficacy of the liquid, determine the expiration date of the liquid, determine the ease of administration, and so on. In some embodiments, the temperature sensor is also configured to measure the temperature of the environment surrounding the liquid. [Brief explanation of the drawing]

[0009] [Figure 1]

[0009] This is a schematic block diagram of a dosage measurement system according to several embodiments. [Figure 2]

[0010] This is a perspective view of a dosage measurement system according to several embodiments. [Figure 3]

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

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

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

[0014] is a schematic ray diagram of transmission of light in different modes between a first medium and a second medium according to some embodiments. [Figure 7]

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

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

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

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

[0019] is a cross-sectional view of a dose measurement system of a first configuration according to some embodiments. [Figure 11B]

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

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

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

[0021] is a cross-sectional view taken along line B-B of the dose measurement system of Figure 11C according to some embodiments. [Figure 14]

[0022] A graph showing a reference signature signal of a sensor of a dose measurement system according to some embodiments. [Figure 15]

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

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

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

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

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

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

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

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

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

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

[0033] It is a screenshot of a user interface display for monitoring one or more liquid measurement systems according to some embodiments. [Modes for carrying out the invention]

[0010]

[0034] Embodiments described herein generally relate to systems, apparatus, and methods for measuring the volume and / or temperature of a liquid placed in an administration device, and more particularly to injection pen caps including a temperature sensor. Many patients with chronic diseases 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 1 or type 2 diabetes must regularly monitor their blood glucose levels and administer the appropriate dose of insulin using an injection pen. Dosage information must be recorded to monitor the efficacy of the medication. The process of manually recording dosage information is tedious and error-prone, especially if the settings are not regulated.

[0011]

[0035] Furthermore, temperature can affect the measurement characteristics of some embodiments and the quality characteristics of the drugs 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 to which a particular medication is stored. Injection pens containing such medications are often carried by patients, for example, in their pockets, backpacks, handbags, or suitcases. Therefore, medications may be exposed to a wide range of ambient temperatures, which can affect the expiration date 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 that medication. Also, knowing the specific effects of temperature exposure can alleviate safety concerns and anxieties of patients, caregivers, and families.

[0012]

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

[0013]

[0037] In some embodiments, a dosage measurement system for measuring the liquid volume in a container includes multiple light sources configured to emit electromagnetic radiation toward the container. Multiple light sources may include, for example, multiple light-emitting diodes (LEDs). Alternatively, a single light source (e.g., a single LED) may be used to emit electromagnetic radiation into a light pipe, which may then divide the emitted electromagnetic radiation into multiple light sources configured to emit electromagnetic radiation toward the container. In some embodiments, multiple sensors are optically coupled to multiple light sources and are configured to detect electromagnetic radiation emitted by at least a portion of the light sources. The device also includes a processing unit configured to receive data representing the portion of the detected electromagnetic radiation from each of the multiple sensors and to convert the received data into signatures representing the electromagnetic radiation detected by the multiple sensors. One or more temperature sensors are configured to measure the temperature of the liquid placed 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 bioeffectiveness of the remaining liquid.

[0014]

[0038] In some embodiments, a method for estimating the volume of liquid in a drug delivery device includes emitting electromagnetic radiation from multiple light sources toward a drug container and detecting signatures of the emitted electromagnetic radiation that has passed through the drug container using multiple sensors. The detected signatures are then compared to a plurality of reference signatures to determine the volume of liquid in the drug container. Each of the plurality of reference signatures corresponds to the volume level remaining in the drug container. In some embodiments, detecting signatures of emitted electromagnetic radiation that has passed through the drug 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 a signal signature. In some embodiments, the method further includes detecting one or more temperatures of the drug, the container, and / or the environment surrounding the container. The detected one or more temperatures may be used to indicate quality related to the drug. The one or more temperatures may also be used to indicate quality related to volumetric measurement characteristics and / or to adjust for deposition measurement characteristics.

[0015]

[0039] In some embodiments, the method also includes calculating the 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 medication schedule to monitor compliance. The method may further include correcting the signal signature with respect to background light, which may contribute to noise. This correction may include comparing the signal signature to background signatures detected by multiple sensors when each of the multiple light sources is in a dark state. The method may further include correcting the signal signature with respect to temperature. This correction may include comparing the signal signature to background signatures detected by multiple sensors when each of the multiple light sources is in a favorable temperature state. In some embodiments, the method also includes generating multiple reference signatures by recording signatures of a range of dose volumes in the drug container. The method may also include relating the signal to the reference signatures using probabilistic matching to determine the volume of liquid remaining in the dose container.

[0016]

[0040] In some embodiments, a method for determining the dosage administered by an injection pen using a drug measurement system includes: first emitting electromagnetic radiation from multiple light sources toward the injection pen; and detecting a first signature of the emitted electromagnetic radiation that has passed through the injection pen using multiple sensors. The first signature is then compared with multiple reference signatures to determine a first volume of liquid in the injection pen. The method further includes emitting electromagnetic radiation from multiple light sources 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 using multiple sensors. The second signature is then compared with multiple reference signatures to determine a second volume of liquid in the injection pen. The volume of the first volume may be subtracted from the second volume.

[0017]

[0041] In some embodiments, multiple light sources and multiple sensors are arranged inside 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 returned to the injection pen. The method may also include transmitting 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. In some embodiments, the method further includes warning the user when the volume of liquid remaining in the drug container is very low and / or when it is time to administer the drug dose.

[0018]

[0042] In some embodiments, the health management system includes a drug administration device including a drug storage container and a dosage measurement system configured to be detachably coupled to the drug administration device. The dosage measurement system includes a plurality of light sources configured to emit electromagnetic radiation toward the drug storage container and a plurality of sensors configured to detect the amount of electromagnetic radiation transmitted through the drug storage container, which can be optically coupled to the plurality of light sources. The amount of electromagnetic radiation serves as a signature representing the volume of liquid remaining in the drug storage container. The health management system also includes a display unit configured to present information to the user indicating the volume of liquid remaining in the drug storage container. The dosage measurement system may be configured to transmit data representing the volume of liquid remaining in the drug storage container to a remote device, for example, to enable the remote device to calculate the dosage administered to the patient. In some embodiments, the dosage management system is configured to receive user health data from a remote device, which may include, for example, the user's blood glucose levels, the user's dietary restrictions, the user's exercise, and / or the user's home health monitoring data.

[0019]

[0043] Figure 1 is a schematic block diagram of a dosage measurement system 100 for measuring the dosage in a drug delivery device 110 according to several embodiments. The dosage measurement system 100 includes a lighting module 140, a detection module 150, a processing unit 160, and a communication module 170. The dosage measurement system 100 may be configured to be detachably coupled to a drug delivery device 110 used to administer a drug dosage to a target T, such as a human patient.

[0020]

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

[0021]

[0045] The lighting module 140 includes a plurality of light sources configured to emit electromagnetic radiation toward the drug delivery device 110. In some embodiments, the plurality of light sources may be configured to emit electromagnetic radiation toward the drug storage container (not shown) of the drug delivery device 110. In some embodiments, each of the plurality of light sources may be a light-emitting diode (LED). In some embodiments, the plurality of light sources may be configured to emit electromagnetic radiation such that it can penetrate the housing and any internal components of the drug delivery device 110 and / or the liquid drug contained therein. In some embodiments, the plurality of light sources may be configured to emit continuous electromagnetic radiation over a predetermined period of time. In some embodiments, the plurality of light sources may be configured to emit pulses of electromagnetic radiation (e.g., a series of pulses less than 100 microseconds).

[0022]

[0046] The detection module 150 includes a plurality of sensors that can be optically coupled to a plurality of light sources of the illumination module 140. In some embodiments, each of the plurality of sensors is a photodetector. The plurality of sensors are arranged and configured to detect electromagnetic radiation emitted by at least a portion of the light sources. In some embodiments, the detected electromagnetic radiation includes a transmitted portion, a refracted portion, and a reflective portion of the electromagnetic radiation. In some embodiments, the refracted electromagnetic radiation may include multidirectional refraction caused by the lens effect of the curved surface of the housing and / or drug storage 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 multiple sensors) and to convert the received data into signal signatures representing the electromagnetic radiation detected by each of the multiple sensors. The processing unit 160 may include a processor, including but not limited to a microcontroller, microprocessor, ASIC chip, ARM chip, analog-to-digital converter (ADC), and / or 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 multiple sensors and the signal signatures generated from that electromagnetic radiation data. In some embodiments, the memory may also be configured to store a plurality of reference signatures, each of which may represent the volume of drug in the drug delivery device 110. In some embodiments, the processing unit 160 also includes an RFID chip configured to store information (e.g., remaining dose 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 associate a signal signature with a reference signature in order to determine the dose volume remaining in the drug delivery device 110 and / or the dose injected by the drug delivery device 110. In some embodiments, the processing unit 160 also includes a global positioning, infrared radiation, and / or microwave radiation navigation system (e.g., GPS) for determining the current location of the dose measurement system 100.

[0024]

[0048] The communication module 170 may be configured to enable bidirectional communication with external devices, including but not limited to smartphones, local computers, and / or remote servers. In some embodiments, the communication module 170 includes means for wireless communication with external devices, including but not limited to Wi-Fi, Bluetooth®, low-power Bluetooth®, and ZigBee. 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 unit configured to communicate to the user the status of the dosage measurement system 100, including but not limited to remaining dose, usage history, battery level, wireless connection status, and / or user alerts. In some embodiments, the communication module also includes a speaker and / or vibration mechanism for transmitting voice and / or tactile alarms. In some embodiments, the communication module 170 includes a user input interface (e.g., buttons, switches, alphanumeric keypads, touchscreens, cameras, and / or microphones) to enable the user to input information or commands to 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 behavior, manually entering details of the use of the drug administration 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 housed in a housing (not shown) configured to be detachably coupled to the drug delivery device 110. For example, the illumination module 140, the detection module 150, the processing unit 160, and the communication module 170 may be incorporated into the housing, or the individual components of the dosage measurement system 100 (e.g., the illumination module 140 and the detection module 150) may be incorporated into a first housing, while the other components (e.g., the processing unit 160 and the communication module 170) may be separate or incorporated into a second housing. In some embodiments, the housing is configured to be detachably coupled to at least a portion of the drug delivery device 110 (e.g., its shape and size can be determined). For example, the housing may have recesses and / or define holes in which a portion of the drug delivery device 110 may be housed. The housing may have alignment features to enable the dosage measurement system 100 to be coupled to the drug 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, for example, to improve 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 quite similar to, for example, a pen cap and acts as a replacement cap for the drug delivery device 110 (i.e., an injection pen).

[0027]

[0051] In some embodiments, the lighting module 140 and the sensing module 150 are arranged and / or oriented within the housing of the dosage measurement system 100 such that multiple light sources are located on a first side of the drug delivery device 110 and multiple sensors are located on a second side of the drug delivery device 110. In some embodiments, the multiple light sources are located at a first radial position relative to the drug delivery device 110, and the multiple sensors are located at a second radial position different from the first radial position (for example, the second radial position may be about 180 degrees from the first radial position). In other words, the dosage management system 100 may be configured such that multiple light sources are located on one side of the drug storage container and multiple sensors are located on the opposite side of the drug storage container. In some embodiments, each of the multiple light sources and multiple sensors is arranged substantially in a straight line. In some embodiments, the multiple light sources are arranged 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 multiple light sources and / or at least one of the multiple sensors are positioned in an oblique orientation with respect to the longitudinal axis of the drug delivery device 110. In some embodiments, the number of multiple sensors is equal to, greater than, or less than the number of multiple light sources. In some embodiments, the multiple light sources and multiple sensors are configured so that the dosage measurement system 110 can detect the volume of drug in the drug delivery device 110 with a resolution of less than 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 to enable the dosage measurement system 110 to detect the position of the plunger portion of the actuator located within the drug delivery device 110 with a resolution that includes 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, and all ranges in between.

[0028]

[0052] Having explained various general principles above, we will now describe some exemplary embodiments of these concepts. These embodiments are merely examples, and many other configurations of one or more dose measurement systems and / or methods for measuring the dose administered by a drug delivery device and the patient's overall health are anticipated.

[0029]

[0053] Referring here to Figures 2 to 4, according to some embodiments, the dosage measurement system 200 may include a lighting module 240, a sensing module 250, a processing unit 260, a communication module 270, and a power supply 286. The dosage measurement system 200 may be configured to be detachably coupled to a drug delivery device 210 (also referred to herein as the “injection pen 210”). The drug delivery device 210 may be configured to administer a predefined amount of drug (e.g., a dose) to a patient. An example of the drug delivery device 210 is an insulin injection pen that can be used by a patient to self-administer insulin. As described herein, the drug delivery device 210 may include a housing 212, an actuator 214, and an injector 216. The housing 212 may be relatively opaque so as to transmit only selected wavelengths of electromagnetic radiation (e.g., infrared or microwave radiation). The housing 212 defines an internal volume (e.g., a storage container) for storing the drug. The actuator 214 may include a plunger configured to communicate fluidly with the drug and deliver a predefined amount of the drug to the patient. The actuator 214 may be configured, for example, by the user to distribute a variable amount of the drug. The injector 216 is configured to penetrate the user's skin for intramuscular, subcutaneous, and / or intravenous administration of the drug.

[0030]

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

[0031]

[0055] As shown in Figure 3, the upper housing portion 222 defines an internal volume that substantially houses, according to some embodiments, a lighting module 240, a sensing module 250, a processing unit 260, a communication module 270, and a power supply 286. The lower housing portion 224 is defined to include a hole 226 whose shape and size are determined to receive at least a portion of the drug delivery device 210. For example, the hole 226 is connected to the housing 212 and The shape and size of the injector 216 may be determined to receive only the drug-containing portion. The hole 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 hole 226 has a precision tolerance to the diameter of the drug delivery device 210, for example, to form a friction fit with the drug delivery device 210. In some embodiments, the hole 226 includes one or more notches, grooves, stoppers, any other snap-fit ​​mechanisms, or threads to removably connect 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 allow the drug delivery device 210 to be connected to the dosage measurement system 200 in a predetermined radial orientation.

[0032]

[0056] In some embodiments, the lower housing 224 includes one or more window openings 228 for receiving at least some of the multiple light sources 244 of the lighting module 240 and / or sensors 254 of the sensing module 250. The window openings 228 may be configured to provide mechanical support for the light sources 244 and / or sensors 254, or they may serve as alignment mechanisms for the lighting module 240 and / or sensing module 250.

[0033]

[0057] As shown in Figure 4, the upper housing 222 includes, according to some embodiments, 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 supply 286. In some embodiments, the upper housing 222 also includes one or more features (e.g., recesses, windows, cavities, etc.) for receiving a portion of the drug delivery device 210, such as an injector 216. In some embodiments, the housing 220 also includes a detection mechanism (not shown) for detecting whether the drug delivery device 210 is coupled to the dosage measurement system 200. The detection mechanism may include, but is not limited to, a push switch, motion sensor, position sensor, optical sensor, piezoelectric sensor, impedance sensor, or any other suitable sensor. The housing 220 may be relatively smooth and may not have sharp edges. In some embodiments, the housing 220 may be shaped to resemble a pen cap, having a shape factor that occupies minimal space (e.g., fits in a user's pocket). In some embodiments, the housing 220 also includes mounting features (e.g., clips for attaching to a user's pocket or belt) and / or decorative features. In some embodiments, the dosage measurement system 200 also serves as a replacement cap for the drug administration device 210.

[0034]

[0058] Continuing to refer to Figures 3 and 4, the multiple light sources 244 of the lighting module 240 (e.g., multiple LEDs or a single LED connected to a light pipe that divides emitted electromagnetic radiation into multiple light sources) are mounted on or otherwise arranged on a printed circuit board (PCB) 242. The PCB 242 may be any standard PCB manufactured by any commonly known process. In some embodiments, the multiple light sources 244 are arranged in a straight line and at equal intervals so that the light sources 244 illuminate the entire internal volume when the portion of the drug delivery device 210 that defines the internal volume of the housing 212 holding the drug is coupled with the dosage measurement system 200. In some embodiments, the light sources 244 are installed in any other configuration, including but not limited to zigzag, unequal spacing, staggered configuration, configuration in which the light sources 244 are arranged alternately with the sensor 254, and / or any other configurations transferred herein.

[0035]

[0059] In some embodiments, the light source 244 is configured to generate electromagnetic radiation of 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 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 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 electromagnetic radiation cone of a single light source 244 may have a wide angle, and the electromagnetic radiation cones of adjacent light sources 244 may overlap. In some embodiments, multiple light sources 244 are configured to emit pulses of electromagnetic radiation (e.g., a series of pulses less than 100 microseconds).

[0036]

[0060] The multiple sensors 254 of the detection module 250 are mounted on or otherwise arranged on a PCB 252. The PCB 252 may be any standard PCB manufactured by any commonly known process. The multiple sensors 254 may be any optical sensors (e.g., photodiodes) that are optically coupleable to multiple light sources 244 and configured to detect at least a portion of the electromagnetic radiation emitted by the multiple light sources 244. The electromagnetic radiation may be transmitted radiation (e.g., transmitted through air, drug, and / or the body of the drug delivery device 210), refracted radiation (e.g., refracted by air, drug, and / or the body of the drug delivery device 210), reflected radiation (e.g., reflected from the walls of the housing 220 or internally reflected from the walls of the drug delivery device 210), and / or multidirectional refraction / reflection caused by the lens effect of the curved surfaces of the housing 212 and / or drug storage container. The transmitted, refracted, and / or reflected electromagnetic signals received by the multiple sensors 254 may be used (e.g., by a processing unit 260) to generate a signal signature. For example, a signal signature may then be associated with a 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 usefulness indicators, such as determining the presence or absence of the injector 216 in the drug delivery device 210, and / or whether the drug delivery device 210 is coupled to or not to the dosage measurement system 200. In some embodiments, the sensors 254 are arranged in substantially the same configuration as the light sources 244. In some embodiments, the number of sensors 254 is greater than or less than the number of light sources 244. In some embodiments, the light sources 244 and sensors 254 are arranged such that each PCB 244,254 includes a combination of light sources 244 and sensors 254 (e.g., arranged alternately). In some embodiments, the light sources 244 and / or sensors 254 are arranged in a tilt orientation.

[0037]

[0061] The processing unit 260 may include a PCB 262 and a processor 264. The PCB 262 may be any standard PCB manufactured by any commonly known process and may include amplifiers, transistors, and / or any other electronic circuits as needed. The processor 264 may be any processor, including but not limited to a microprocessor, microcontroller, PLC, ASIC chip, ARM chip, ADC, or any other suitable processor. The processing unit 260 may be coupled to the lighting module 240 and the sensing module 250 using an electronic coupling 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 onboard memory for at least temporarily storing signal signatures, a reference signature database, dosage information, user health data (e.g., blood glucose levels), device location data (e.g., from a GPS receiver optionally included in the dosage measurement system 200, or from another GPS-enabled device communicably coupled to the system 200, such as a blood glucose meter or a mobile phone), and any other data that would be useful for the patient to manage their own health. In some embodiments, the processing unit 260 is configured to store and N includes an RFID chip configured to allow an FC device to read stored information. The processing unit 260 may be configured to control the operation of the dosage measurement system 200, for example, by activating and timing a light source 244 and / or reading and processing electromagnetic radiation data from sensors 254. For example, the processing unit 260 may be configured to compare electromagnetic radiation signal signatures obtained from a plurality of sensors 254 and associate them with a reference signature database in order to determine the remaining dose in the drug delivery device 210 or the position of an 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 with respect to background noise. For example, the processing unit 260 may be configured to operate the sensing module 250 to detect the background signature when the lighting module is in a dark state, i.e., when each of the multiple light sources 244 is turned off. The background signature may be associated with the signal signature in order to correct for background noise. In some embodiments, the processing unit 260 also includes electronic signal filtering algorithms, including but not limited to Fourier transforms, low-pass filters, band-pass filters, high-pass filters, Bessel filters, and / or any other digital filters, to reduce noise and improve signal quality. The processing unit 260 may be configured to acquire a reference signature by storing electromagnetic radiation signals detected by the sensing module 250 for a range of dose volumes within a typical drug delivery device 210, the range including, but not limited to, full, empty, and a series of intervals in between (e.g., for each unit of dose distributed from the drug delivery device and / or each 170 micrometer displacement of the plunger portion of the actuator 214 included in the drug delivery device 210).

[0039]

[0063] In some embodiments, the processing unit 260 is configured to include a probabilistic matching algorithm that can be used to associate a signal signature with a reference signature in order to determine the volume of liquid in the drug 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 electronic equipment supplying power to the light source 244 (e.g., operational amplifiers) when not needed. The processing unit 260 may pulse-modulate the light source 244 with high current for short periods of time, for example, to save power and / or to 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 drug 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 (e.g., GPS) to determine the current location of, for example, the dosage measurement system 200.

[0040]

[0064] The communication module 270 may be configured to transmit data to the user and / or external devices such as a smartphone application, a local computer, and / or a remote server. The data transmitted may include, but is not limited to, initial system startup, system on / off, connection / disconnection of the drug delivery device, remaining dose, dose history, time, system and / or drug temperature, system location (e.g., GPS), data from the drug delivery device 210, drug expiration date data, drug delivery rate, device collisions, remaining device power, step count, system indiscriminate changes, and / or any other user health information or other available data. In some embodiments, the communication module 270 transmits data, for example, newly It may also be configured to receive calibration data, firmware updates, user health information (e.g., blood glucose, dietary restrictions, exercise, and / or dosage information), and / or any other information entered by the user and / or transmitted from an external device. The communication module 270 may include conventional data communication electronic equipment and may use standard communication protocols including, but not limited to, Wi-Fi, Bluetooth®, Low Power Bluetooth®, ZigBee, USB, FireWire, and / or NFC (e.g., infrared). In some embodiments, the communication module 270 is configured to connect periodically (e.g., 10 times per day) to an external device (e.g., a smartphone) to record any dosage data stored in onboard memory. In some embodiments, the communication module 270 is activated / deactivated on demand by the user.

[0041]

[0065] Referring here to Figure 5, the communication module 270 may, according to some embodiments, include a communication interface 271 located on the outer surface of the housing 210 of the dosage measurement system 200 for communicating with the 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), to show the user, for example, whether the dosage measurement system 200 is on / off or whether the communication module 270 is operational. In some embodiments, the communication interface 271 includes a display unit 276 for visually communicating information to the user, including but not limited to the remaining dose 278 in the drug administration device 210, the current time 280, the remaining power of the system 282, the dose history 284 (e.g., average dose usage, time of the last dose taken, etc.), and / or the wireless connection status. In some embodiments, the communication interface 271 includes input components (e.g., an alphanumeric keypad and / or a touchscreen) to enable the user to input information (e.g., food intake, exercise data, etc.) into the dosage measurement system 200. In some embodiments, the communication module 270 includes a speaker and / or a microphone for receiving voice input from the user to provide the user with audible alarms or messages (e.g., dosage reminders and / or reinforcement messages). In some embodiments, the communication module 270 includes means for tactile alarms (e.g., a vibration mechanism). In some embodiments, the communication module 270 transmits other information about the user's health (e.g., steps taken, calories burned, blood glucose levels, etc.).

[0042]

[0066] The power supply 286 can be any power supply available for powering the dosage measurement system 200. In some embodiments, the power supply 286 includes a disposable battery. In some embodiments, the power supply 286 includes a rechargeable battery (e.g., a nickel-cadmium battery, a lithium-ion battery, a lithium polymer battery, or any other battery with a small shape factor, such as those used in mobile phones) and / or is not charged frequently (e.g., once per month). In some embodiments, the power supply 286 is charged using an external power supply (e.g., through a power socket located on the housing 220, or through the communication interface of the communication module 270, such as via a wired USB interface or wireless charging). In some embodiments, the power supply 286 is charged using solar energy and includes a photovoltaic panel. In some embodiments, the power supply 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 detect transmitted radiation, refracted radiation (e.g., air, liquid drugs, refracted by the housing 212 of the drug delivery device 210), and radiation (e.g., reflected from the walls of the housing 220 or the drug delivery device 21 It is configured to receive reflected radiation (internally reflected from the walls of the internal volume of 0) and at least one of the multidirectional reflections / refractions caused by the lens effect of the curved surface of the housing 212 of the drug delivery device 210.

[0044]

[0068] Referring now to Figure 6, according to some embodiments, a light source L (e.g., a wide-angle light source) can generate multiple rays that radiate from the light source and spread out. The light source L is in a first medium M1 (e.g., air) having a first refractive index n1. A second medium M2 (e.g., a liquid drug) having a second refractive index n2 is bounded on both sides by the first medium M1. The second refractive index n2 is greater than the first refractive index n1 (i.e., n2 > n1). The second medium M2 also includes opaque surfaces (e.g., side walls).

[0045]

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

[0046]

[0070] The second 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. The second ray L2 bends or refracts as it penetrates the second medium M2, and then bends again as it re-enters the first medium M1, returning to its original incident angle, which is parallel to the emitted ray L2 but offset from it (i.e., refracted light).

[0047]

[0071] The third 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 this angle of incidence, the ray L3 does not enter the second medium M2 but is reflected back to the first medium M1, and the angle of reflection is equal to the angle of incidence (i.e., reflected light).

[0048]

[0072] The fourth ray L4 is incident on the interface between the first medium M1 and the second medium M2 at a fourth angle smaller than the third angle (i.e., reflection from the opaque surface) such that the ray L4 is refracted in the second medium M2, but immediately incident on an opaque surface contained in the second medium M2. At least a portion of the ray L4 is reflected back to 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 sensing module 250 may include combinations of transmitted, refracted, and reflected portions of the electromagnetic radiation. Different combinations of residual dose volumes and / or portions of the electromagnetic radiation at the location of the actuator 216 of the drug delivery device 210 generate 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 residual dose volume in the drug delivery device 210, as described further in this specification.

[0050]

[0074] Referring here to Figures 7 to 10, various configurations of light sources and sensors according to several embodiments are shown and described. The transmitted and reflected portions of the electromagnetic radiation emitted by the light sources are shown, while the refracted portions are not shown for clarity. As shown in Figure 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 storage container) for containing the drug. The drug delivery device 310 also includes an injector 316 for administering the drug to the patient. In the dosage measurement system 300, the plurality of light sources 344 are arranged on a first side of the housing oriented toward the drug delivery device 310, and the plurality of sensors 354 are arranged on a second side of the housing Each of the multiple sensors 354 is configured to face and communicate optically with at least one of the multiple light sources 344. In some embodiments, the multiple light sources 344 and / or the multiple sensors 354 are arranged in a substantially linear relationship (e.g., in a straight line) with respect to each other. Each of the multiple sensors 354 receives a combination of transmitted, refracted, and / or reflected electromagnetic radiation emitted by the multiple 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 measurement 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 placed inside the drug delivery device 310. The transmitted, reflected, and refracted portions of the electromagnetic radiation detected by each of the multiple sensors yield a unique signal signature for a certain range of dose volumes remaining inside the drug delivery device 310.

[0051]

[0075] In some embodiments, multiple light sources and multiple sensors are arranged alternately on both sides of the drug delivery device. As shown in Figure 8, the dosage measurement system 400 may include multiple light sources 444 and multiple 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 storage container) 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 multiple light sources 444 and multiple sensors 454 are arranged on both sides of the drug delivery device. In other words, each side of the drug delivery device 410 has multiple light sources 444 and multiple sensors 454. This may be advantageous because the emission and detection of electromagnetic radiation are performed from both sides of the drug delivery device 410, which, for example, eliminates bias.

[0052]

[0076] In some embodiments, at least some of the multiple light sources and / or multiple sensors are arranged in an angular orientation. As shown in Figure 9, the dosage measurement system 500 includes, according to some embodiments, multiple light sources 544 and multiple sensors 554. The drug delivery device 510 includes a housing 512 and an actuator 514 that collectively define an internal volume (e.g., a storage container) 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 multiple light sources 544 and multiple sensors 554 are positioned on both sides of the drug delivery device 510 and are angularly oriented with respect to the longitudinal axis of the dosage measurement system 500 and the drug delivery device 510. This orientation can ensure that electromagnetic radiation emitted by the multiple light sources 544 enters a larger portion of the drug delivery device 510 than would be reachable by linearly oriented light sources 544. Similarly, the multiple sensors 554 can also detect a larger portion of the electromagnetic radiation. This can, for example, result in a higher resolution for the sensor 554 and / or reduce the amount of light source 544 and / or sensor 554 required to achieve the desired resolution.

[0053]

[0077] In some embodiments, wider-angle light sources (e.g., wide-angle LEDs or a single LED connected to a light pipe that splits the emitted electromagnetic radiation into multiple wide-angle beams) may be used to ensure that the electromagnetic radiation emitted by multiple light sources 544 enters a larger portion of the drug delivery device 510 than is reachable by the narrower beams of the light sources 544. In other words, the wider the beam emitted by the light sources 544, the more the larger portion of the drug delivery device 510 (or drug storage) communicates optically with the light sources 544. As the larger portion of the delivery device 510 communicates optically with the light sources 544, the spectrum of electromagnetic radiation transmitted, reflected, and / or refracted through the drug delivery device becomes wider, increasing the signal intensity detectable by the multiple sensors 554. In other words, the variability of the signal signature increases with the broadening of the beam of light entering the delivery device (as opposed to an increase in the intensity of light entering the sensors), thus increasing the resolution of the dosage measurement system 500. For example, the angle While widening the field of view might lower the overall light intensity, it could improve the ability to distinguish between states of a drug delivery device. This is because distinguishing between states is more about optimizing how the light intensity changes for each state than about the absolute intensity of the light.

[0054]

[0078] In some embodiments, the dosage measurement system is configured to detect a signal signature from the position of the actuator of the drug delivery device, which can be used to estimate the remaining dose in the drug delivery device. As shown in Figure 10, the dosage measurement system 600 includes, according to some embodiments, a plurality of light sources 644 and a plurality of sensors 654. A drug delivery device 610 is coupled to the dosage measurement system 600. The drug delivery device 610 includes a housing 612 and an actuator 614 that collectively define an internal volume (e.g., a storage container) for containing the drug. The dosage measurement system 600 is generally centered on the actuator 614 portion of the drug delivery device 610, in contrast to the dosage measurement systems 300, 400 and 500 shown in Figures 7 to 9, which are generally centered on the drug storage container. The plurality of light sources 644 and sensors 654 are configured and arranged in substantially the same manner as described above with reference to Figure 7. Electromagnetic radiation emitted by multiple light sources 644 may be transmitted without being blocked 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 transmitted, reflected, and refracted portions of the electromagnetic radiation detected by multiple sensors 654 is then used to generate a signal signature at a given position of the actuator 614. The 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 with the dose volume remaining in the drug delivery device 610 (e.g., in association with a reference signature).

[0055]

[0079] Referring here to Figures 11A to 11C, each of the multiple sensors in the dosage measurement system is capable of detecting electromagnetic radiation emitted by at least some of the multiple light sources, and the detected electromagnetic radiation may be a combination of transmitted, reflected, and refracted electromagnetic radiation. As shown in the figures, the dosage measurement system 700 includes, for simplicity, two light sources 744a and 744b and two sensors 754a and 754b. The dosage measurement system 700 is coupled to a drug delivery device 710 which includes a housing 712 and an actuator 714 that collectively define an internal volume (e.g., a storage container) for containing liquid drug. The drug storage container and at least the plunger portion of the actuator 714 are located substantially inside the dosage measurement system 700, between the light sources 744a, 744b and the sensors 754a, 754b.

[0056]

[0080] As shown in Figure 11A, the plunger portion of the actuator 714 is in a first position ("position 1") such that, according to some embodiments, the plunger portion is not in line of sight between the light sources 744a and 744b and the sensors 754a and 754b. When electromagnetic radiation is emitted toward the drug delivery device 710 by the light sources 744a and 744b, the majority of that electromagnetic radiation is detected by the sensors 754a and 754b in 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 multidirectional reflected / refracted radiation (e.g., caused by the curved surface of the housing 712 of the drug delivery device 710), as will be described in more detail below. As shown in this example, the value for sensor 754a is 15.3 and the value for sensor 754b is 13.7, which indicates that the majority of the electromagnetic radiation is detected by sensors 754a and 754b.

[0057]

[0081] As shown in Figure 11B, according to some embodiments, 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. 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 some of the electromagnetic radiation emitted by the light source 744a, along with multidirectional reflected / refracted electromagnetic radiation, can still reach the sensor 754b. Sensor 754a can also receive refracted electromagnetic radiation from sensor 744b and transmitted and refracted radiation from sensor 744a. Sensor 754a also receives electromagnetic radiation reflected by the surface of the plunger that at least partially defines the drug reservoir. Thus, in position 2, sensor 754a detects an electromagnetic radiation value of 15.5 (higher than in position 1), and sensor 754b detects an electromagnetic radiation value of 8.8 (lower than in position 1). The eigenvalues ​​measured at position 2 can serve as signal signature values ​​for position 2.

[0058]

[0082] As shown in Figure 11C, the plunger portion of the actuator 714 is in a third position ("position 3"), according to some embodiments, such that the plunger portion of the actuator 714 completely blocks the line of sight of the sensor 754a from electromagnetic radiation emitted by the light source 744a, so that transmitted and / or reflected radiation from the light source 744a cannot reach the sensor 754a at all. Some 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 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 source 744a and / or 744b. Thus, in position 3, sensor 754a detects an electromagnetic radiation value of 2.2 (smaller than in positions 1 and 2), and sensor 754b detects an electromagnetic radiation value of 12.0 (smaller than in position 1 but greater than in position 2). The eigenvalues ​​measured at position 3 can serve as signal signature values ​​for position 3.

[0059]

[0083] Referring here to Figure 12, according to some embodiments, a cross-section of the dosage measurement system 700 along line AA in Figure 11A shows a lens effect caused by the curvature of the drug storage container. As illustrated, a ray emitted by the light source 744b at a zero-degree angle is transmitted unbent toward the sensor 754b. Two further rays emitted by the light source 744b at angles away from the transmitted ray are refracted (i.e., bent) toward the transmitted ray as they enter the drug storage container, because the liquid drug has a higher refractive index than air. This phenomenon is referred to herein as the “lens effect” and can result in the focusing of the ray toward the sensor 754b. A fourth ray is emitted at an angle even further away from the transmitted ray so as to be refracted at the air / drug interface, and is then reflected by the inner surface of the housing 712 of the drug administration system 710 so as to enter the sensor 754b. A fifth ray is emitted at a certain angle and, even after refraction, does not enter the sensor 754b. As described above, these combinations of light rays yield electromagnetic radiation detection values ​​of 15.3 according to sensor 754a and 13.7 according to sensor 754b. These eigenvalues ​​measured at position 1 can serve as signal signature values ​​for position 1.

[0060]

[0084] Referring now to Figure 13, according to some embodiments, a cross-section of the dosage measurement system 700 along line BB in Figure 11C shows the effect of the actuator 714 on light transmission. As shown, a ray emitted by the light source 744b at a zero-degree angle is blocked by a portion of the actuator 714. Two further rays emitted by the light source 744b at angles away from the transmitted ray pass through a portion of the housing 712 of the drug delivery device 710 without being acted upon (refraction through the housing is ignored) (i.e., there is no drug in this portion of the device 710) and are incident on the sensor 754b. The fourth ray is emitted at a certain angle by the light source 744b, internally reflected by the housing 712, and incident on the sensor 754b, while the fifth ray is internally reflected by the housing 712 but does not incident on the sensor 754b. The combination of these rays yields electromagnetic radiation detection values ​​of 2.2 according to sensor 754a and 12.0 according to sensor 754b. These eigenvalues ​​measured at position 3 can serve as signal signature values ​​for position 3. Although the line of sight of sensor 754a is completely blocked from the light source 744a, the reflected and refracted portions of the electromagnetic radiation still contribute to the generation of positive values.

[0061]

[0085] While sensor values ​​for specific locations are listed as absolute values, individual sensor values ​​relative to other sensor values ​​may be used to estimate and / or determine the volume of liquid remaining in the drug storage container. For example, if sensor 754a has a specific value that differs from the value of sensor 754b by a certain amount or percentage, that value may represent the volume of drug remaining in the location / drug dispensing device. Additionally, a sensor value relative to two or more other sensor values ​​may be used to generate a calibration curve for the drug dispensing device.

[0062]

[0086] Unique signal signatures obtained in various configurations relating to the volume of doses distributed by a drug delivery device can be used to obtain a reference signature (calibration curve) for the dosage measurement system. Figure 14 is a graph showing examples of reference signal signatures obtained for a drug delivery device using a dosage measurement system comprising a total of seven sensors, according to several embodiments. The dosage measurement system may be any of the dosage measurement systems described herein. The electromagnetic radiation signatures detected by each of the multiple sensors for a range of distributed dose volumes are stored and used to create a reference signature. As can be seen from the reference signature, when the drug delivery device is nearly full, sensor 1 records low-amplitude electromagnetic radiation, while sensor 7 records very high-amplitude electrodes, and all other sensors detect intermediate signal signatures. Conversely, when the drug delivery device is completely empty, sensor 1 records very high-amplitude electromagnetic radiation, while sensor 7 records low amplitude, and all other sensors detect intermediate signal signatures.

[0063]

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

[0064]

[0088] Therefore, the signal values ​​recorded from all sensors for a certain range of residual drug volumes yield a signal signature for the total volume of drug in the drug delivery device. The range of drug volumes used to obtain the signal signature may include, but is not limited to, a fully full, fully empty, and / or a sufficient number of intermediate signatures (including, for example, those obtained for each unit of the total distributed fluid and / or all proportions in between).

[0065]

[0089] In some embodiments, the reference signature may be corrected with respect to background light. For example, the background signature may be detected by detecting signal signatures from multiple sensors when 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 associated with the reference signature using a probabilistic matching algorithm to determine the drug volume in the drug delivery device. In some embodiments, Multiple light sources and multiple sensors are configured to enable the dosage measurement system to detect the volume of drug in the drug delivery device with a drug resolution of one unit, and / or the position of the plunger portion of the actuator located in the drug delivery device with a resolution that includes 100 micrometers, 110 micrometers, 120 micrometers, 130 micrometers, 140 micrometers, 150 micrometers, 160 micrometers, 170 micrometers, 180 micrometers, or 200 micrometers, and all ranges in between.

[0066]

[0090] Figure 15 is a flowchart illustrating a method 800 for measuring the remaining dose in a drug delivery device using one of the dosage measurement systems described herein, in several embodiments. In step 802, the user attaches the dosage measurement system to the drug delivery device. In step 804, multiple sensors located within the dosage measurement system scan the drug delivery device to determine the remaining dose. For example, a processing unit of the dosage measurement system may associate the 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 onboard memory (e.g., an RFID chip and / or memory that is part of the processing unit of the dosage measurement system). In step 808, the dosage measurement system may warn the user if the remaining dose is extremely low. Audio, visual, and / or tactile displays may be used to warn the user.

[0067]

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

[0068]

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

[0069]

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

[0070]

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

[0071]

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

[0072]

[0096] The network may be, for example, a remote server or a call center. Network 1400 may communicate bidirectionally with Monitor M and an authorized drug dispenser DD. Monitor M may be, for example, a physician, caregiver, pharmacy, and / or clinical trial administrator. The authorized drug dispenser DD may be, for example, a pharmacy or clinical trial administrator.

[0073]

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

[0074]

[0098] In some embodiments, the health management system can transmit the user's health and dosage information to a monitor M via 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, such as the dosage of insulin and / or any other medications. If changes are needed, 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 transmits this information to the health management system 1100 via 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, such as a new insulin dosage.

[0075]

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

[0076]

[0100] Embodiments of liquid measurement systems described herein may include one or more temperature sensors configured to measure the temperature of the liquid and / or the temperature of the environment surrounding the liquid, such as the temperature of the drug or medication (e.g., insulin) contained in a container (e.g., an injection pen), the container, and / or the ambient air around the container. Knowing the temperature of the liquid may enable the determination of one or more properties of the liquid, including but not limited to the level of bioavailability and / or bioefficacy of one or more active ingredients in the liquid, the liquid's shelf life, and the liquid's ease of use (e.g., comfort during and after drug administration or dispensing), and may enable the normalization of liquid volume data to compensate for changes or fluctuations in liquid volume caused by changes or fluctuations in temperature. Liquid measurement systems including one or more temperature sensors described herein may be any suitable liquid measurement system, such as 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 entirety. 1. U.S. Patent No. 8,817,258, titled “Dosage Measurement System and Method,” filed on 12 March 2013 as U.S. Patent Application No. 13 / 796,889 and issued on 26 August 2014; 2. U.S. Patent Application No. 14 / 334,181, filed on 17 July 2014, entitled “Dosage Measurement System and Method”; 3. U.S. Patent Application No. 62 / 032,017, filed on 1 August 2014, entitled “Liquid Measurement System with Temperature Sensor”; and 4. U.S. Patent Application No. 14 / 548,679, filed on November 20, 2014, entitled “Dosage Measurement System and Method”.

[0077]

[0101] Embodiments of liquid measurement systems described herein include: (1) liquids such as medications. (1) enabling real-time measurement of the temperature of the liquid and / or the surrounding environment contained within a container; (2) using temperature information to determine one or more properties of the liquid contained within a container, including, for example, the efficacy of the liquid, its expiration date, ease of administration, or any other physical and / or chemical properties; (3) providing one or more indicators or alarms when the temperature exceeds or falls below a predetermined, recommended, and / or acceptable range; (4) tracking the cumulative thermal exposure of one or more active chemical components of the liquid, since heat is related to the reaction kinetics of the decomposition of active chemical components; and (5) providing several advantages, including, but not limited to, optimizing measured values ​​(e.g., dose volume data or blood glucose data) by compensating for temperature disturbances, such as normalizing the data based on real-time temperature measurements to ensure that there are substantially no temperature disturbances in the data.

[0078]

[0102] In some embodiments, a liquid measuring system for measuring the volume of liquid in a container includes a plurality of light sources configured to emit electromagnetic radiation toward the container. A plurality of sensors are optically coupled to these plurality of light sources and are configured to detect electromagnetic radiation emitted by at least a portion of the light sources. The device includes a temperature sensor configured to measure the temperature of the liquid contained in the container. The device also includes a processing unit configured to receive data representing the portion of the detected electromagnetic radiation from each of the plurality of sensors and to convert the received data into a signature representing the electromagnetic radiation detected by the plurality of sensors. The processing unit of the device described above is also configured to receive temperature information from the temperature sensor and to perform at least one of the following: normalizing the sensor value, determining the efficacy of the liquid, determining the expiration date of the liquid, and determining the ease of administration. In some embodiments, the temperature sensor is also configured to measure the temperature of the environment surrounding the liquid.

[0079]

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

[0080]

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

[0081]

[0105] The illumination module 1804 and the detection module 1806 may be configured as described above according to several embodiments. For example, the illumination module 1804 may include a plurality of light sources configured to emit electromagnetic radiation toward the drug delivery device 1802. The detection module 1806 may include a plurality of sensors that can be optically coupled to the plurality 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 detection module 1806 (i.e., from each of the multiple sensors) and to convert the received data into signal signatures representing 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 the liquid located within the drug delivery device 1802, and / or the environment surrounding the liquid, for example, the temperature of the internal volume of the housing in which the components of the dosage measurement system 1800 and at least a portion of the drug delivery device 1802 are located, as described herein. The temperature sensing module 1810 may include one or more suitable temperature sensors, including but not limited to thermocouples, resistance temperature devices (RTDs), thermistors, bimetallic temperature sensors, and / or silicon diodes.

[0084]

[0108] For substantially accurate temperature readings of the liquid and / or the environment surrounding the liquid, one or more temperature sensors may be positioned, configured, mounted on and / or placed inside the dosage measurement system 1800. For example, the temperature sensors may be positioned at a sufficient distance from one or more components of the dosage measurement system 1800 that could affect the temperature reading, such as hotter electronic equipment (e.g., contained within the processing unit 1808), power supplies (e.g., rechargeable batteries), and / or any other heat-generating electronic equipment. Alternatively, the temperature sensors may be positioned close enough to the liquid located within the drug delivery device 1802 to allow heat to diffuse evenly between the temperature sensor and the liquid so that the temperature sensor and the liquid are approximately the same.

[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 a linear row, a rectangular array, a square array, a circular array, and / or any other suitable configuration, but not limited to these. 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 the temperature of a liquid, and a second temperature sensor or a second set of temperature sensors positioned and / or configured to measure the temperature of the environment surrounding the liquid.

[0086]

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

[0087]

[0111] In some embodiments, a temperature sensing module 1810, a processing unit 1808, and / or an external computing device process the temperature data. The temperature data may be used to determine one or more characteristics of the liquid in the dosage measurement system 1800 and / or the environment surrounding the liquid, including one or more characteristics of the embodiments of the systems, apparatus, and methods described herein.

[0088]

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

[0089]

[0113] In some embodiments, a temperature sensing module 1810, a 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 can 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 some embodiments 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 drug depend heavily on the temperature to which the drug is exposed and / or the temperature to which it is stored. Drug administration devices containing such drugs, particularly injection pens, or additional components, are often carried by patients, for example, in their pockets, backpacks, handbags, or suitcases. Therefore, drugs may be exposed to a wide range of ambient temperatures, which has at least the aforementioned impacts on administration, cost, and safety related to the drug.

[0091]

[0115] For example, the effectiveness of insulin can be reduced by high temperatures. Patients may develop hyperglycemia if they are administered ineffective insulin. Manufacturers instruct users to dispose of insulin that has been exposed to such high temperatures, although this often happens accidentally. Even if the ambient temperature is below the maximum threshold temperature for maintaining quality (e.g., above approximately 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 can change (e.g., decrease) once the container has been opened (e.g., above approximately 30°C or 86°F). Similarly, the quality of insulin can be affected by low temperatures. For example, manufacturers instruct users not to store insulin in the refrigerator once the container has been opened.

[0092]

[0116] According to some embodiments, guidelines such as the highest threshold temperature, the lowest threshold temperature, the temperature range, the rate of temperature change, the frequency of temperature fluctuations, and / or the duration of temperature exposure are recommended, permitted, and / or determined to be acceptable based on at least one of a specific liquid measurement system (e.g., a dosage measurement system 1800), a specific liquid container (e.g., a drug delivery device 1802), and a specific liquid (e.g., insulin). The temperature sensing module 1810, processing unit 1808, and / or external computing unit compare one or more temperature readings from the liquid and / or its environment with these indicators and inform the user, for example via display, alarm, and / or notification (e.g., via communication module 1812), that a predetermined number of temperature readings have: (1) exceeded the recommended, permitted, and / or determined highest threshold temperature value; (2) fallen below the recommended, permitted, and / or determined lowest threshold temperature value; (3) been outside the recommended, permitted, and / or determined range of temperature values; or (4) shown a rate of temperature change exceeding the recommended, permitted, and / or determined rate. The system may be configured to determine whether it should be notified that (5) the frequency of temperature fluctuations exceeds the frequency recommended, permitted, and / or determined to be higher than that which is acceptable; and / or (6) the duration of temperature exposure is longer than that which is recommended, permitted, and / or determined to be acceptable.

[0093]

[0117] The communication module 1812 may be configured as described above according to several embodiments. For example, the communication module 1812 may be configured to enable bidirectional communication with the user and / or an external device. In some embodiments, the communication module 1812 includes a display unit configured to communicate to the user the status of the dosage measurement system 1800, including but not limited to the remaining dose, usage history, battery level, wireless connection status, drug temperature, temperature of the dosage measurement system 1800, temperature of the drug administration device 1802, drug efficacy, drug expiration date status, drug quality, and / or a warning to administer the drug.

[0094]

[0118] The dosage measurement system 1800 may be housed in a housing that can be configured to be detachably coupled to the drug delivery device 1802. For example, the illumination module 1804, the detection module 1806, the processing unit 1808, the temperature detection module 1810, and the communication module 1812 may be incorporated into the housing. Alternatively, the individual components of the dosage measurement system 1800 (e.g., the illumination module 1804 and the detection module 1806) may be incorporated into a first housing, while the other components (e.g., the processing unit 1808, the temperature detection module 1810, and the communication module 170) may be separate or incorporated into a second housing. In some embodiments, the housing is configured to be detachably coupled to at least a portion of the drug delivery device 1802 (e.g., its shape and size can be determined). For example, the housing may have recesses and / or define holes into which at least a portion of the drug delivery device 1802 can be received.

[0095]

[0119] Having described various general principles above, we will now describe some exemplary embodiments of these concepts. These embodiments are merely examples, and many other configurations of liquid measuring systems that take temperature effects into account can be imagined, particularly dosage measuring systems that measure the amount administered to a patient and / or remaining in a drug delivery device.

[0096]

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

[0097]

[0121] The dosage measurement system 2000 may be configured to be detachably coupled to a drug delivery device 2010 (also referred to herein as the “injection pen 2010”). The drug delivery device 2010 may be configured to administer a predefined amount (i.e., dose) of liquid drug (e.g., insulin) to a patient. An example of the drug delivery device 2010 is an insulin injection pen that can be used by a patient to administer insulin. According to some embodiments, as shown in Figure 20, the drug delivery device 2010 includes a housing 2012, an actuator 2014, and an injector 2016. The housing 2012 may be relatively opaque so as to transmit only selected wavelengths of electromagnetic radiation (e.g., infrared or microwave radiation). The housing 2012 may define an internal volume (e.g., a storage container) for storing the drug. The actuator 2014 is configured to fluidly communicate with the drug and deliver a predefined amount of the drug to the patient. It may include a plunger section. The actuator 2014 may be configured, for example, by the user to distribute a variable amount of drug. The injector 2016 (e.g., a needle) may be configured to penetrate the user's tissue for intramuscular, subcutaneous, and / or intravenous administration of the drug. The housing 2012 may be configured so that the temperature sensing module 2004 can measure the temperature of the drug directly or indirectly through the housing 2012, actuator 2014, and / or injector 2016.

[0098]

[0122] In some embodiments, as shown in Figure 19, the dosage measurement system 2000 includes a housing 2018 comprising an upper housing portion 2020 (also referred herein as the “upper housing 2020”) and a lower housing portion 2022 (also referred herein as the “lower housing 2022”). The upper housing portion 2020 comprises a first portion 2020a and a second portion 2020b, which may be connected to form the upper 2020. The first portion 2020a and the second portion 2020b may be detachably or permanently connected, for example, by gluing, heat welding, a snap-fit ​​mechanism, one or more screws, and / or any other suitable means. The upper housing 2020 and the lower housing 2022 may also be detachably or permanently connected, for example, by gluing, heat welding, mechanical connections (e.g., one or more snap-fit ​​mechanisms or screws), and / or any other suitable 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 a combination thereof. The housing 2018 may also be configured to shield the internal electronic components of the dosage measurement 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 Figure 19, the first housing portion 2022a and the second housing portion 2022b may define an internal volume that substantially houses the sensing assembly 2002, the temperature sensing module 2004, the communication module 2006, and the power supply 2008. As shown in Figure 21, the lower housing portion 2022 may define a hole 2024. The hole 2024 may be shaped and sized to receive at least a portion of the drug delivery device 2010. For example, the hole 2024 may be shaped and sized to receive only the drug containment portion of the housing 2012 and the injector 2016. The hole 2024 may be configured to receive the drug delivery device 2010 in a specific orientation (e.g., radial orientation). In some embodiments, the hole 2024 has a precision tolerance with respect 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 hole 2024 includes one or more notches, grooves, locking mechanisms, snap-fit ​​mechanisms, threads, and / or other coupling mechanisms for removably coupling the drug delivery device 2010 to the lower housing 2022. In some embodiments, the lower housing portion 2022 includes one or more alignment features for removably coupling the drug delivery device 2010 so that it can be coupled to the dosage measurement system 2000 in a predetermined radial orientation.

[0101]

[0125] In some embodiments, the lower housing 2022 defines one or more window openings 2026 for receiving at least some of a plurality of light sources and / or sensors included in the sensing module of the sensing assembly 2002, which may be included in the lighting module of the sensing assembly 2002. The one or more window openings 2026 may be configured to provide mechanical support for the light sources and / or sensors, and the lighting module and / or sensing module It could also serve as an alignment mechanism.

[0102]

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

[0103]

[0127] In some embodiments, the housing 2018 also includes a detection mechanism (not shown) for detecting whether the drug administration 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 not have sharp edges. In some embodiments, the housing 2018 may be shaped to resemble a pen cap, for example, one that can fit in a user's pocket, having a shape factor that occupies the least space. In some embodiments, the housing 2018 may also include features such as a clip for attaching to 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 drug administration device 2010.

[0104]

[0128] The detection assembly 2002 may include an illumination module, a detection module, and a processing unit which may be configured to determine the remaining dose in the drug administration device 2010. The detection assembly may also include a printed circuit board (PCB) 2034 on which the illumination module, detection module, and processing unit may be mounted, as shown in Figure 22. The illumination module and detection module may be substantially the same as the illumination module 1804 and detection module 1806 described in relation to the dose measurement system 1800 above. The processing unit may also be substantially the same as the processing unit 1808 described above.

[0105]

[0129] In some embodiments, the lighting module includes multiple light sources 2036 arranged on the PCB 2034, and these light sources may be configured to produce electromagnetic radiation of wavelengths that can penetrate the housing 2012 of the drug delivery device 2010, the drug contained therein, and / or part of the housing 2018. 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 can penetrate internal components of the drug delivery device 2010, such as the plunger portion of the actuator 2014. In some embodiments, the light source 244 is configured to produce a broad 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). In other words, the electromagnetic radiation cone of a single light source 244 may have a wide angle, and the electromagnetic radiation cones of adjacent light sources 244 may overlap. In some embodiments, multiple light sources 2036 are configured to emit pulses of electromagnetic radiation (e.g., a series of pulses less than 100 microseconds).

[0106]

[0130] The detection module includes a plurality of sensors 2038 that may be mounted on or otherwise arranged on the PCB 2034 contained within the detection module 230, as shown in Figure 5. It may be so. PCB252 may be any standard PCB fabricated by any commonly known process. The multiple sensors 2038 may be any optical sensors (e.g., photodiodes) that are optically coupleable to multiple light sources 2036 and configured to detect at least a portion of the electromagnetic radiation emitted by the multiple light sources 2036. The electromagnetic radiation may be transmitted radiation, refracted radiation (e.g., refracted by air, drugs, and / or the body of the drug delivery device 2010), reflected radiation (e.g., reflected from the walls of the housing 2018 or internally reflected from the walls of the drug delivery device 2010), and / or multidirectional refraction / reflection (e.g., caused by the lens effect of the curved surface of the housing 2012). The transmitted, refracted, and / or reflected electromagnetic signals received by the multiple sensors 2038 may be used (e.g., by a processing unit) to create a signal signature. The signal signature may be associated with a reference signature to determine the remaining dose in the drug delivery device 2010. In some embodiments, the signal response of sensor 2038 may be used to measure usefulness indicators, such as determining the presence or absence of the injector 2016 of drug delivery device 2010, and / or whether drug delivery device 2010 is coupled to or not to the dosage measurement system 2000. In some embodiments, the signal response of sensor 2038 may be further processed (e.g., calibrated) based on temperature data.

[0107]

[0131] The temperature sensing module 2004 may include one or more temperature sensors configured to measure the temperature of the liquid placed within the drug delivery device 2010 and / or the environment surrounding the liquid, for example, the temperature of the internal volume of the hole 2024 in the lower housing 2022 in which at least a portion of the drug delivery device 2010 may be placed. These 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 placed within the internal volume defined by the upper housing 2020a to enable substantially accurate temperature readings of the liquid volume and / or the environment surrounding the liquid. For example, one or more temperature sensors may be positioned along the outer surface of the side wall of the lower housing 2020b.

[0108]

[0132] Furthermore, one or more temperature sensors may be positioned at a sufficient distance from components of the dosage measurement system 2000 that could affect temperature readings, such as hotter electronic components 2040 (e.g., capacitors or resistors) or power supply 2008 shown in Figure 20. Additionally, one or more temperature sensors may be positioned close enough to the liquid volume located within the drug delivery device 2010 so that the heat diffusion to the one or more temperature sensors and the liquid is substantially uniform and the one or more sensors accurately reflect the liquid temperature. 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 liquid temperature, 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 in, for example, a straight line, 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 electronic equipment configured to process data and / or transmit the temperature data to, for example, a communication 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 transmit temperature data to a processing unit contained within the sensing assembly 2002. At least one processing unit processes the quality of the liquid (e.g., the bioavailability, bioefficacy, and / or expiration date of one or more components) and / or the quality of administration (e.g., ease and / or safety). The system is configured to use temperature data to determine the degree of efficacy. For example, information about the thermal stability and efficacy of a liquid drug placed 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, with the thermal stability information of a particular drug in order to determine the physical and / or chemical state / quality of the drug. In some embodiments, thermal stability information for a number of drugs (e.g., insulin, epinephrine, etc.) or for only a specific drug may be stored in an external or internal memory device communicably coupled to the processor, thereby enabling the dosage measurement system 2000 to be compatible with different drug administration devices that can accommodate different drugs, a specific drug administration device that can accommodate different drugs, a drug administration device that accommodates substantially similar drugs, or a specific drug administration device that accommodates substantially similar drugs.

[0110]

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

[0111]

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

[0112]

[0136] In some embodiments, temperature change compensation is performed by applying the following correction coefficients. A×ΔT×S raw (1) However, A is a scaling factor that can vary depending on the individual sensor design, S raw ΔT is the unprocessed 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) Therefore, the compensated sensor value is, S comp =S raw +A×ΔT×S raw (3) It can be determined by [the following].

[0113]

[0137] In some embodiments, the scaling factor considers the case of a saturation edge. If a particular sensor is already saturated, it may not be able to become unsaturated due to temperature compensation.

[0114]

[0138] Temperature data can also be used to normalize the calibration signature, for example, if 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, sensor data is normalized with respect to the thermal expansion coefficient of the drug using temperature data. In this way, errors caused by the expansion or contraction of the liquid drug volume or interference with other temperature-related sensors can be corrected.

[0115]

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

[0116]

[0140] The placement of the temperature sensor is crucial for accurate temperature compensation and / or calibration. In some embodiments, the temperature sensor is placed in close proximity to the component that is most affected by temperature. In some embodiments, the component that is most affected by temperature is the emitter or light source. In Figure 24, a partial diagram of the dosage measurement system shows, in some embodiments, 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 divides emitted electromagnetic radiation into multiple light sources).

[0117]

[0141] Temperature is also a key factor affecting blood glucose measurement. Both the temperature at which the test specimen is stored and the temperature at which the glucose meter or blood glucose meter operates are important. In particular, temperature can affect the reaction of electronic components within the blood glucose meter, as with the dosage measurement system described above. Temperature can also affect the kinetics of chemical reactions in the test specimen. Therefore, according to some embodiments, a temperature sensor placed in close proximity to the blood glucose meter and / or test specimen is important.

[0118]

[0142] In some embodiments, the blood glucose meter is communicatively and / or physically coupled (e.g., integrated within a housing) to a dosage measurement system. One or more temperature sensors may be placed close to the blood glucose meter to compensate for blood glucose measurements with respect to temperature drift. In some embodiments, a removable and / or refillable specimen storage device is communicatively and / or physically coupled to a dosage measurement system (e.g., integrated within a 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 close to the storage device to identify quality issues related to specimen 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 alerts, and / or temperature readings. A display, speaker, and / or vibration mechanism may be used to communicate visual, audible, and / or tactile displays or alarms to the user. In some embodiments, a user input interface (e.g., buttons, switches, alphanumeric keypads, touchscreens, cameras, and / or microphones) allows the user to input information or commands to the dosage measurement system, including but not limited to initiating or ending communication between the system and a remote device, powering on the system, powering off the system, resetting the system, manually entering details of patient behavior, and / or manually entering details of the use of the drug administration device.

[0120]

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

[0121]

[0145] In some embodiments, when the temperature exceeds the recommended, acceptable, and / or determined operating range of the drug, the user may receive a notification from the system or from an external device communicatively coupled to the system. User action may be required to stop the notification. In some embodiments, the time display unit may indicate when The system tracks whether a temperature event has occurred. Therefore, the user can check the notification and / or time display to identify the temperature event in order to recalibrate the system or discard the chemical or test specimen.

[0122]

[0146] conclusion While various embodiments of the present invention have been described and explained herein, a person of ordinary skill in the art will readily imagine various other means and / or structures for carrying out the functions described herein and / or for obtaining the results and / or one or more advantages, and each of such variations and / or modifications will be considered to fall within the scope of the embodiments of the present invention described herein. More generally, a person skilled in the art will readily realize that all parameters, dimensions, materials and configurations described herein are intended to be illustrative, and that the actual parameters, dimensions, materials and / or configurations will depend on the specific application in which the teachings of the present invention are used. A person skilled in the art will be able to recognize or confirm many embodiments equivalent to the specific embodiments of the present invention described herein by mere conventional experimentation. It should be understood that the embodiments described herein are presented merely as examples, and that embodiments of the present invention may be carried out within the scope of the appended claims and their equivalents, in addition to those specifically described and claimed herein. The embodiments of the present invention in this disclosure cover the individual features, systems, parts, materials, kits and / or methods 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 present invention in this disclosure, provided that such features, systems, components, materials, kits, and / or methods are not mutually inconsistent.

[0123]

[0147] Where the above-described methods and steps represent an event occurring in a certain order, a person of ordinary skill in the art who is interested in the present disclosure will recognize that the order of some steps may be changed, and such changes will be modifications of the present invention. Also, some of the steps may be performed simultaneously in parallel processing whenever possible, or sequentially as described above. Although embodiments are specifically shown and described, it will be understood that various modifications of form and detail are possible.

[0124]

[0148] For example, various embodiments are described as having specific features and / or combinations of components, but other embodiments are possible having any combination or subcombination of any features and / or components of any of the embodiments described herein. For example, some embodiments are described as having a dosage measurement system similar to a pen cap, but the dosage measurement system may be integrated with a drug delivery device. In some embodiments, vibration and / or ultrasound are used instead of electromagnetic radiation to generate a signal signature. The specific configuration of various components may also be modified. For example, the size and specific shape of various components may differ from those of the illustrated embodiments, but still provide the functionality described herein.

[0125]

[0149] The embodiments described above can be implemented by any of many methods. 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 set of processors, whether provided within a single computer or distributed between multiple computers.

[0126]

[0150] Furthermore, it should be noted that computers can be embodied in any of many forms, such as rack-mount computers, desktop computers, laptop computers, or tablet computers. It may be embedded in devices that are not generally considered computers but have sufficient processing power, including personal digital assistants (PDAs), smartphones, or any other suitable portable or fixed electronic devices.

[0127]

[0151] Furthermore, a computer may have one or more input and output devices. These devices may, among other things, be used 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 speech recognition or in other audible formats.

[0128]

[0152] Such computers may be interconnected by one or more networks of any suitable form, including local area networks or wide area networks such as enterprise networks, and intelligent networks (INs) or the Internet. Such networks may be based on any suitable technology, may 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 various operating systems or platforms. Such software may also be written using any of a number of suitable programming languages ​​and / or programming or scripting tools, and may be compiled as executable machine code or intermediate code that runs on a framework or virtual machine.

[0130]

[0154] Furthermore, various concepts of the present invention may be embodied in one or more methods, and one example is provided. The actions performed as part of the method may be ordered in any suitable manner. Thus, embodiments may be constructed in which the actions are performed in a different order than those described, which may include performing several actions simultaneously, even if they are shown as sequential actions in the exemplary embodiments.

[0131]

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

[0132]

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

[0133]

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

[0134]

[0158] When used in the specification and claims of this application, the phrase "and / or" should be understood to mean "one or both" of the elements thus combined, that is, elements that exist together in some cases and separately in other cases. Multiple elements listed with "and / or" should similarly be interpreted as "one or more" of the elements thus combined. Whether or not elements other than those specifically identified by the "and / or" clause are related to those specifically identified... Nevertheless, they may exist at will. Therefore, as a non-restrictive example, when "A and / or B" is used in combination with open-form expressions such as "comprising," it may refer to A only (with the optional inclusion of elements other than B) in one embodiment; B only (with the optional inclusion of elements other than A) in another embodiment; and both A and B (with the optional inclusion of other elements) in yet another embodiment.

[0135]

[0159] Where 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 dividing items in a list, “or” or “and / or” should be interpreted as inclusive, that is, including at least one of a number of elements or a list of elements, but also including two or more, and optionally including items that are not further listed. Only terms that are explicitly indicated as not being such, such as “one of” or “only one of” or, when used in the claims, “consisting of,” refer to including only one element from a number of elements or a list of elements. In general, where used herein, the term “or” should be interpreted only as an exclusive choice (i.e., “one or the other, but not both”) when preceded by terms of exclusivity such as “either one,” “one of,” “only one of,” or “only one of.” Where used in the claims, “essentially consisting of” should have its usual meaning as used in the field of patent law.

[0136]

[0160] When used in the specification and claims of this application, the phrase “at least one” in relation to 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 element specifically listed in the list of elements, nor excluding any combination of elements in the list of elements. This definition also makes it possible that elements other than those specifically identified in the list of elements referred to by the phrase “at least one” may exist at will, regardless of whether they are related to those specifically identified elements or not. Therefore, as a non-restrictive example, "at least one of A and B" (or similarly, "at least one of A or B," or similarly, "at least one of A and / or B") may refer, in one embodiment, to include at least one, optionally two or more A's, and no B (and optionally an element other than B); in another embodiment, to include at least one, optionally two or more B's, and no A (and optionally an element other than A); and in yet another embodiment, to include at least one, optionally two or more A's, and at least one, optionally two or more B's (and optionally an other element).

[0137]

[0161] In the claims and in the above-mentioned specification, all transitional phrases such as “comprising,” “including,” “carrying,” “having,” “containing,” “involving,” “holding,” and “composed of” should be understood as open forms, meaning “includes but not limited to.” Only the transitional phrases “consisting of” and “consisting essentially of” are defined in the United States Patent and Trademark Office (USPTO) Patent Examination Manual. As shown in Section 2111.03 of the Patent Office Manual of Patent Examining Procedures, each shall be a closed or semi-closed transitional clause.

Claims

1. A device for measuring the volume of liquid in a container, Multiple light sources are arranged and configured to emit electromagnetic radiation toward the container, A plurality of sensors that can be optically coupled to the plurality of light sources, and each sensor is configured to detect the electromagnetic radiation emitted by at least a portion of the plurality of light sources, A temperature sensor configured to measure at least one temperature related to the liquid in the container, The system comprises at least one processor configured to receive data representing the portion of electromagnetic radiation detected from each of the plurality of sensors, and at least one temperature measured from the temperature sensor. The aforementioned at least one processor is The received data is converted into a signal signature containing multiple values ​​representing the electromagnetic radiation detected by each of the multiple sensors. The signal signature is corrected based on the measured at least one temperature, the calibration temperature, and one or more of the background light, where the measured at least one temperature, the calibration temperature, and one or more of the background light are used to determine one or more adjustments to the signal signature for the plurality of values. The corrected signal signature is compared with a plurality of reference signatures to determine the liquid volume in the container. A device capable of operating in such a manner.

2. The apparatus according to claim 1, wherein the temperature sensor is installed in close proximity to one of the plurality of light sources.

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

4. The apparatus of claim 1, wherein the at least one processor is further operable to determine at least one of the following based on temperature events related to the received data: a level of efficacy, a level of safety, a subject's comfort level, and an expiration date related to the liquid.

5. The apparatus of claim 4, further comprising at least one communication interface configured to transmit to a user information relating to at least one of the following: the level of efficacy, the level of safety, the level of comfort of the subject, and the expiration date of the liquid.

6. Further comprising a blood glucose meter configured to measure the blood glucose of a subject, The aforementioned at least one processor further, Receive blood glucose measurement, The blood glucose measurement is normalized based on temperature events related to the blood glucose measurement. The apparatus according to claim 1, configured as follows.

7. The at least one processor is further configured to receive data from the plurality of sensors representing the background light detected by the plurality of sensors when the plurality of light sources are in a dark state, The apparatus according to claim 1, wherein the signal signature is corrected based on the measured at least one temperature and the background light.

8. The at least one processor is capable of converting the data representing the background light into a background signature, The correction of the signal signature includes comparing the signal signature with the background signature. The apparatus of claim 1, wherein the one or more adjustments for the plurality of values ​​of the signal signature include removing the background signature from the signal signature.

9. A method performed by a liquid measurement system for estimating the volume of liquid in a drug container, Multiple light sources emit electromagnetic radiation toward the drug container, The electromagnetic radiation emitted after passing through the drug container is detected by multiple sensors, The temperature of at least one of the liquids in the drug container is measured by a temperature sensor, At least one processor of the liquid measurement system converts the data from the plurality of sensors into a signal signature that includes a plurality of values ​​representing the electromagnetic radiation detected by each of the plurality of sensors, The at least one processor corrects the signal signature based on the measured at least one temperature, the calibration temperature, and one or more of the background light, wherein the correction of the signal signature includes using the measured at least one temperature, the calibration temperature, and one or more of the background light to determine one or more adjustments for the plurality of values ​​of the signal signature. The at least one processor determines the volume of the liquid in the drug container by comparing the corrected signal signature with a plurality of reference signatures, Methods that include...

10. The method according to claim 9, wherein the temperature sensor is installed in close proximity to one of the plurality of light sources.

11. The method of claim 9, wherein the temperature event is at least one of the relationship and difference between the at least one measured temperature and the at least one temperature indicator.

12. The method of claim 9, further comprising storing the measured at least one temperature by the at least one processor.

13. The method of claim 9, further comprising using the at least one processor to determine at least one of the levels of efficacy, safety, comfort level of the subject, and expiration date associated with the liquid, based on temperature events related to data from the plurality of sensors.

14. The method of claim 13, further comprising transmitting to a user information relating to at least one of the following: the level of efficacy, the level of safety, the comfort level of the subject, and the expiration date, relating to the liquid, via at least one communication interface.

15. The method of claim 9, further comprising normalizing a subject's blood glucose measurement received from a blood glucose meter based on a temperature event related to the blood glucose measurement by at least one processor.

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