Method and system for collecting spirometry data

Abstract

Spirometers useful for assessing pulmonary lung function are disclosed herein. The disclosed systems, computer readable media, and methods can be directed to applications in a variety of settings by healthcare professionals, clinical trial specialists, and individual users.

Description

[0001] This application is a divisional application of Chinese patent application No. 201780032572.X, entitled "Method and System for Collecting Data of Vital Capacity Measurement" (the corresponding PCT application was filed on March 24, 2017, with application number PCT / US2017 / 024007).

[0002] Cross-references

[0003] This application claims priority to U.S. Provisional Application No. 62 / 313,016, filed on March 24, 2016, which is incorporated herein by reference in its entirety. Background Technology

[0004] Spirometry provides information about lung function, respiration, blood oxygenation, and even cardiac function. Spirometry readings are available to humans. Individuals can use spirometers to monitor their personal health, healthcare professionals can use spirometers to diagnose conditions or assess patient condition status, and clinical trial professionals can use spirometers to evaluate the efficacy of specific drugs or monitor the occurrence of specific conditions in subjects within specific demographic, genetic, or other medically relevant categories. This article presents improved methods and systems for obtaining spirometry data. Summary of the Invention

[0005] This document provides a system for assessing lung function, comprising: (a) a wireless detection unit that may include a tubular channel, the tubular channel including a first opening and a second opening, the first opening being opposite to the second opening; and (b) a base station configured to communicate with the detection unit, wherein the base station may include an integrated biometric sensor, wherein the integrated biometric sensor may be a fingerprint sensor, and wherein the base station may further include an environmental sensor and a docking cradle sized and adapted to store the detection unit. In some embodiments, the detection unit may further include a power source. In some embodiments, the power source may be a battery. In some embodiments, the battery may be a lithium-ion battery pack. In some embodiments, the detection unit may further include a charging receiver coil. In some embodiments, the charging receiver coil may be a wireless charging receiver coil. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the system may further include a mouthpiece. In some embodiments, the mouthpiece may include a tubular elongated body, which may include a first end and a second end, the first end being opposite to the second end, the first end including an opening and configured to allow a subject to exhale into the mouthpiece. In some embodiments, the second end may be disposed within the tubular channel of the detection unit. In some embodiments, the mouthpiece may include a sensor. In some embodiments, the sensor may be an ethanol sensor. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a pneumotachtube. In some embodiments, the pneumotachtube may be a Lilly-type pneumotachtube. In some embodiments, the detection unit or the base station may further include one or more indicator elements. In some embodiments, the one or more indicator elements may include one or more sound sources. In some embodiments, the one or more indicator elements may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or user. In some embodiments, the one or more light-emitting diodes may guide the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes may guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds.In some embodiments, the detection unit can transmit data to the base station via a network. In some embodiments, the detection unit can transmit data to the base station via Bluetooth. In some embodiments, the network can be a wireless network. In some embodiments, the base station can communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or short-range wireless communication. In some embodiments, the base station can communicate with two or more detection units. In some embodiments, the detection unit and the base station can be separated by a certain distance. In some embodiments, the base station may further include a visual display. In some embodiments, the visual display can display lung capacity measurement data in real time. In some embodiments, the visual display can include animated icons indicating the validity of the data in real time. In some embodiments, the visual display can display user icons or subject icons providing feedback on successfully collecting the data through the detection unit. In some embodiments, the base station may further include a power source. In some embodiments, the power source can be a battery. In some embodiments, the battery can be a lithium-ion battery pack. In some embodiments, the base station may further include a charging transmitter coil. In some embodiments, the charging transmitter coil can be a wireless charging transmitter coil. In some embodiments, the environmental sensor may be a humidity sensor.

[0006] This document also discloses a system for assessing lung function, comprising: (a) a wireless detection unit that may include a tubular channel, the tubular channel including a first opening and a second opening, the first opening being opposite to the second opening, the detection unit further including a charging receiver coil; and (b) a base station configured to communicate with the detection unit, wherein the base station may include a touchable visual display and a docking bracket, wherein the docking bracket may include a charging transmitter coil and is sized and adapted to store the detection unit and wirelessly charge the detection unit. In some embodiments, the detection unit may further include a power source. In some embodiments, the power source may be a battery. In some embodiments, the battery may be a lithium-ion battery pack. In some embodiments, the charging receiver coil may be a wireless charging receiver coil. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the system may further include a mouthpiece. In some embodiments, the mouthpiece may include a tubular elongated body, which may include a first end and a second end, the first end being opposite to the second end. The first end may include an opening and be configured to allow a subject to exhale into the mouthpiece. In some embodiments, the second end may be disposed within a tubular channel of the detection unit. In some embodiments, the mouthpiece may include a sensor. In some embodiments, the sensor may be an ethanol sensor. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit or the base station may further include one or more indicator elements. In some embodiments, the one or more indicator elements may include one or more sound sources. In some embodiments, the one or more indicator elements may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or user. In some embodiments, the one or more LEDs may guide the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes can guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the detection unit can transmit data to the base station via a network. In some embodiments, the detection unit can transmit data to the base station via a Bluetooth connection.In some embodiments, the network may be a wireless network. In some embodiments, the base station may communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or short-range wireless communication. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the touch visual display may display lung capacity measurement data in real time. In some embodiments, the touch visual display may include animated icons indicating the validity of the data in real time. In some embodiments, the touch visual display may display user icons or subject icons providing feedback on successfully collecting the data through the detection unit. In some embodiments, the base station may further include a power source. In some embodiments, the power source may be a battery. In some embodiments, the battery may be a lithium-ion battery pack. In some embodiments, the charging transmitter coil may be a wireless charging transmitter coil. In some embodiments, the base station may further include a biometric sensor. In some embodiments, the biometric sensor may be a fingerprint sensor.

[0007] This document also discloses a system for assessing lung function, comprising: (a) a wireless detection unit that may include a power supply and a charging receiver coil, the detection unit comprising a tubular channel having a first opening and a second opening, the first opening being opposite to the second opening; and (b) a base station configured to communicate with the detection unit via Bluetooth, wherein the base station may include an environmental sensor and an integrated biometric sensor, wherein the integrated biometric sensor may be a fingerprint sensor, wherein the fingerprint sensor may be located between a docking bracket and a touch visual display, wherein the docking bracket may include a charging transmitter coil and may be sized and adapted to store the detection unit and wirelessly charge the detection unit. In some embodiments, the charging receiver coil may be a wireless charging receiver coil. In some embodiments, the detection unit may further include a gyroscope or an accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the system may further include a mouthpiece. In some embodiments, the mouthpiece may include a tubular elongated body, which may include a first end and a second end, the first end being opposite to the second end, the first end including an opening and configured to allow a subject to exhale into the mouthpiece. In some embodiments, the second end may be disposed within a tubular channel of the detection unit. In some embodiments, the mouthpiece may include a sensor. In some embodiments, the sensor may be an ethanol sensor. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit or the base station may further include one or more indicator elements. In some embodiments, the one or more indicator elements may include one or more sound sources. In some embodiments, the one or more indicator elements may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide a subject or user. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes can guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the detection unit can transmit data to the base station via a network. In some embodiments, the network can be a wireless network.In some embodiments, the base station may communicate with the detection unit using ZigBee, infrared transmission, or short-range wireless communication. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the touch visual display may display lung capacity measurement data in real time. In some embodiments, the touch visual display may include animated icons indicating the validity of the data in real time. In some embodiments, the touch visual display may display user icons or subject icons providing feedback on successfully collecting the data through the detection unit. In some embodiments, the base station may further include a power source. In some embodiments, the power source may be a battery. In some embodiments, the battery may be a lithium-ion battery pack. In some embodiments, the charging transmitter coil may be a wireless charging transmitter coil. In some embodiments, the environmental sensor may be a humidity sensor.

[0008] This document also provides a method for performing a lung function test, the method comprising: a. providing a subject with a detection unit that may include a mouthpiece and a sensor; b. identifying a user of an application using biometric data; c. receiving spirometry data transmitted from the detection unit at a base station; and d. monitoring the base station to determine test error. In some embodiments, the test error is caused by variations in the subject's attempts. In some embodiments, the method may further comprise generating spirometry data from a breath sample provided by the subject, wherein the spirometry data may be generated from the breath sample via the sensor. In some embodiments, the method may further comprise transmitting the spirometry data from the detection unit via a network. In some embodiments, the method may further comprise transmitting the spirometry data from the detection unit via a Bluetooth connection. In some embodiments, the base station may receive remote commands and configurations from a cloud. In some embodiments, the sensor may include a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the breathing flow tube may be a Lilly-type breathing flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or user using the detection unit. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicator element may include one or more sound sources. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the base station may include sensors including integrated biometric sensors. In some embodiments, the biometric sensor may be a fingerprint reader. In some embodiments, the biometric sensor may collect biometric data. In some embodiments, the biometric data may control access to an application. In some embodiments, the application may provide access to stored spirometry data. In some embodiments, the application may provide access to operate the detection unit. In some embodiments, the application may identify an individual authorized to use the base station.In some embodiments, the individual may be a clinician. In some embodiments, the base station may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or the user. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicator element may include one or more sound sources. In some embodiments, the detection unit may be charged on the base station. In some embodiments, the detection unit may be wirelessly charged. In some embodiments, the network is a wireless network. In some embodiments, the base station may communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communications. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the base station may further transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the lung capacity measurement data may be transmitted to one or more servers, databases, storage units including network-attached storage units, containers, or any combination thereof. In some embodiments, the base station may further transmit data via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the base station may further transmit data via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the base station may further include a visual display. In some embodiments, the visual display may show real-time lung capacity measurement data. In some embodiments, the visual display may show a user icon or subject icon providing feedback on successful data collection by the detection unit.

[0009] This document also provides a method for collecting spirometry data, the method comprising: a. collecting biometric data from a user at a base station from an integrated biometric sensor; b. providing a subject with a detection unit that may include a mouthpiece and a sensor; c. receiving spirometry data transmitted from the detection unit; d. correlating the biometric data collected from the base station with the spirometry data collected from the detection unit; and e. processing the collected spirometry data at the base station. In some embodiments, the method may further comprise generating spirometry data from a breath sample provided by the subject, wherein the spirometry data may be generated from the breath sample via the sensor. In some embodiments, the method may further comprise transmitting the spirometry data from the detection unit via a network. In some embodiments, the method may further comprise transmitting the spirometry data from the detection unit via a Bluetooth connection. In some embodiments, the base station may receive remote commands and configurations from a cloud. In some embodiments, the sensor may include a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or user using the detection unit. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or the user. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale.In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may be charged at the base station. In some embodiments, the detection unit may be wirelessly charged. In some embodiments, the network is a wireless network. In some embodiments, the base station may communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communications. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the base station may further transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the spirometry data may be transmitted to one or more servers, databases, storage units including network-attached storage units, containers, or any combination thereof. In some embodiments, the base station may further transmit data via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the base station may further transmit data via a wireless connection.

[0010] In some embodiments, the wireless connection may be Wi-Fi, 3G, 4G LTE, or Bluetooth. In some embodiments, the base station may further include a visual display. In some embodiments, the visual display displays real-time lung capacity measurement data. In some embodiments, the visual display may display a user icon or subject icon providing feedback on the successful collection of data through the detection unit.

[0011] This document also provides a method for improving the quality of spirometry data, the method comprising: a. collecting biometric data from a user at a base station from an integrated biometric sensor; b. providing a subject with a detection unit that may include a mouthpiece and a sensor; c. receiving spirometry data transmitted from the detection unit, wherein the base station may be configured to graphically display the spirometry data and indicate test errors; and d. processing the received spirometry data at the base station. In some embodiments, the test errors may stem from variability in the subject's attempts. In some embodiments, the user and the subject may be the same individual. In some embodiments, the user and the subject may not be the same individual. In some embodiments, the method may further comprise generating spirometry data from a breath sample provided by the subject, wherein the spirometry data may be generated from the breath sample via the sensor. In some embodiments, the method may further comprise transmitting the spirometry data from the detection unit via a network. In some embodiments, the method may further comprise transmitting the spirometry data from the detection unit via a Bluetooth connection. In some embodiments, the base station may receive remote commands and configurations from the cloud. In some embodiments, the sensor may include a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a breathing flow tube. In some embodiments, the breathing flow tube may be a Lilly-type breathing flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or user using the detection unit. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicator element may include one or more sound sources. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or the user.In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may be charged on the base station. In some embodiments, the detection unit may be wirelessly charged. In some embodiments, the network may be a wireless network. In some embodiments, the base station may communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communication. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the base station may further transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the lung capacity measurement data may be transmitted to one or more servers, databases, storage units including network-attached storage units, containers, or any combination thereof. In some embodiments, the base station may further transmit data via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the base station may further transmit data via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the base station may further include a visual display. In some embodiments, the visual display may display real-time lung capacity measurement data. In some embodiments, the visual display may display a user icon or subject icon providing feedback on successful data collection through the detection unit.

[0012] This document also provides a method for manufacturing a system for collecting spirometry test results from subjects, the method comprising: a. constructing a detection unit that may include a sensor and a mouthpiece, wherein the detection unit may be configured to reduce test errors caused by variations in the subjects' attempts; b. configuring wireless communication between the detection unit and a base station, wherein the base station may include a visual display of the spirometry data collected by the detection unit; and c. installing an application for processing or transmitting the collected spirometry data on the base station. In some embodiments, the base station may receive remote commands and configurations from a cloud. In some embodiments, the sensor may include a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide the subject or user using the detection unit. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more LEDs. In some embodiments, the one or more LEDs may guide the subject or the user. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may be charged on the base station. In some embodiments, the detection unit may be wirelessly charged.In some embodiments, the base station may communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communications. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the base station may further transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the lung capacity measurement data may be transmitted to one or more servers, databases, storage units including network-attached storage units, containers, or any combination thereof. In some embodiments, the base station may further transmit data via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the base station may further transmit data via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection.

[0013] This document also provides a method for manufacturing a system to reduce subject error in lung capacity measurement data from subjects, the method comprising: a. constructing a system that may include a detection unit and a base station; b. integrating a biometric sensor into the base station; and c. configuring the base station to have one or more mechanisms for receiving lung capacity measurement data from the detection unit. In some embodiments, the base station may receive remote commands and configurations from a cloud. In some embodiments, the lung capacity measurement data may be transmitted from the detection unit via a network. In some embodiments, the method may further include transmitting the lung capacity measurement data from the detection unit via a Bluetooth connection. In some embodiments, the detection unit may include a sensor and a mouthpiece. In some embodiments, the sensor may include a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes. In some embodiments, the one or more light-emitting diodes may guide the subject or user using the detection unit. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer may detect axial changes, including orientation, rotation, and vibration. In some embodiments, the biometric sensor may be a fingerprint reader. In some embodiments, the biometric sensor may collect biometric data. In some embodiments, the biometric data may control access to an application. In some embodiments, the application may provide access to stored spirometry data. In some embodiments, the application may provide access to operate the detection unit. In some embodiments, the application may identify an individual authorized to use the base station. In some embodiments, the individual may be a clinician. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs).In some embodiments, the one or more light-emitting diodes may guide the subject or the user. In some embodiments, the method may further include guiding the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the detection unit may be charged on the base station. In some embodiments, the detection unit may be wirelessly charged. In some embodiments, the network may be a wireless network. In some embodiments, the base station may communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communication. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the base station may further transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the pulmonary capacity measurement data may be transmitted to one or more servers, databases, storage units including network-attached storage units, containers, or any combination thereof. In some embodiments, the base station may further transmit data via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the base station may further transmit data via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the base station may further include a visual display. In some embodiments, the visual display may display real-time pulmonary capacity measurement data. In some embodiments, the visual display may display a user icon or subject icon that provides successful feedback on the data collected by the detection unit.

[0014] This document also provides a system for testing lung function, which may include: a. a wireless detection unit that may include a sensor and a mouthpiece; b. a base station configurable to communicate with the detection unit, wherein the base station may include an integrated biometric sensor; and c. a docking holder configurable to charge and store the detection unit. In some embodiments, the base station may receive remote commands and configurations from a cloud. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs may guide a subject or user using the detection unit. In some embodiments, guiding the subject may include instructing the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicator element may include one or more sound sources. In some embodiments, the base station may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes. In some embodiments, the one or more light-emitting diodes can guide a subject or user. In some embodiments, guiding the subject may include informing the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicator element may include one or more sound sources. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer can detect axial changes, including orientation, rotation, and vibration. In some embodiments, the biometric sensor may include a fingerprint reader. In some embodiments, the detection unit can be wirelessly charged. In some embodiments, the detection unit transmits data to the base station via a network. In some embodiments, the detection unit transmits data to the base station via a Bluetooth connection. In some embodiments, the network may be a wireless network.In some embodiments, the base station may communicate with the detection unit via Bluetooth, ZigBee, infrared transmission, or short-range wireless communication. In some embodiments, the base station may communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the base station may further include a visual display. In some embodiments, the visual display may display real-time lung capacity measurement data. In some embodiments, the visual display may include animated icons indicating the validity of the data in real time. In some embodiments, the visual display may display user icons or subject icons that provide feedback on successfully passing the data collected by the detection unit.

[0015] This document also provides a non-transitory computer-readable medium suitable for use in electronic devices, the medium containing instructions that, when executed by the electronic device, cause the electronic device to: a. provide a subject with a detection unit that may include a mouthpiece and a sensor; b. control access to an application using biometric data; c. receive data transmitted from the detection unit at a base station; and d. transmit data from the base station to an external server or database. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the base station to transmit data via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the base station to transmit data via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the base station to receive remote commands and configurations from the cloud. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the generation of data from a breath sample provided by a subject, wherein the data may be generated by the breath sample via the sensor. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the detection unit to transmit the data via a Bluetooth connection. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the detection unit to transmit the data via a network. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a respiratory flow tube. In some embodiments, the respiratory flow tube may be a Lilly-type respiratory flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the one or more LEDs to guide the subject or user using the detection unit. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, may cause the detection unit to instruct the subject to inhale, hold their breath in their lungs, or exhale.In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the detection unit to instruct the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs). In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the one or more LEDs to guide the subject or the user. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to instruct the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs). In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the gyroscope or accelerometer to detect axial changes, including orientation, rotation, and vibration. In some embodiments, the biometric sensor is a fingerprint reader. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the biometric sensor to collect the biometric data. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the biometric data to control access to an application. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the electronic device to associate the biometric data with the lung capacity measurement data. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to provide access to the lung capacity measurement data stored on the base station. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to provide access to operate the detection unit.In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to identify an individual authorized to use the base station. In some embodiments, the individual may be a clinician. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the detection unit to charge on the base station. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the detection unit to perform wireless charging. In some embodiments, the network may be a wireless network. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communications. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to the database or server via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to the database or server via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the base station may further include a visual display. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the visual display to display lung capacity measurement data in real time. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the visual display to display animated icons indicating the validity of the data in real time. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to show a user icon or subject icon that can provide feedback on the successful collection of the spirometry data by the detection unit.

[0016] This document also provides a non-transitory computer-readable medium suitable for use in electronic devices, the medium containing instructions that, when executed by the electronic device, cause the electronic device to: a. collect biometric data from a user at a base station that may include an integrated biometric sensor; b. receive data transmitted by a detection unit, wherein the detection unit may include a mouthpiece and a sensor; c. associate the biometric data collected from the base station with the data collected from the detection unit; and d. process the collected data at the base station. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the generation of the data from a breath sample provided by a subject, wherein the data may be generated by the breath sample via the sensor. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the detection unit to transmit the data via a Bluetooth connection. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the detection unit to transmit the data over a network. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a breathing flow tube. In some embodiments, the breathing flow tube may be a Lilly-type breathing flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, can cause the one or more LEDs to guide the subject or user using the detection unit. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, can cause the detection unit to instruct the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, can cause the detection unit to guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs).In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the one or more light-emitting diodes to guide the subject or the user. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to instruct the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more light-emitting diodes. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the gyroscope or accelerometer to detect axial changes, including orientation, rotation, and vibration. In some embodiments, the biometric sensor may be a fingerprint reader. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the biometric sensor to collect the biometric data. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the biometric data to control access to an application. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the electronic device to associate the biometric data with the lung capacity measurement data. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to provide access to lung capacity measurement data stored on the base station. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to provide access to operate the detection unit. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to identify an individual authorized to use the base station. In some embodiments, the individual may be a clinician. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the detection unit to charge on the base station. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the detection unit to perform wireless charging. In some embodiments, the network may be a wireless network.In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communications. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the base station may further include a visual display. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to display lung capacity measurement data in real time. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to display animated icons indicating the validity of the data in real time. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to display a user icon or subject icon that provides feedback on the successful collection of lung capacity measurement data through the detection unit.

[0017] This document also provides a non-transitory computer-readable medium suitable for use in electronic devices, the medium containing instructions that, when executed by the electronic device, cause the electronic device to: a. collect biometric data from a user at a base station that may include an integrated biometric sensor; b. receive data transmitted from a detection unit that may include a mouthpiece and a sensor, wherein the detection unit may include a mouthpiece and a sensor, and the base station may be configured to indicate whether the biometric data is valid; and c. process the received data at the base station. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the generation of the data from a breath sample provided by a subject, wherein the data may be generated by the breath sample via the sensor. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the detection unit to transmit the data via a Bluetooth connection. In some embodiments, the computer-readable medium may further contain instructions that, when executed by the electronic device, cause the detection unit to transmit the data via a network. In some embodiments, the sensor may be a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a breathing flow tube. In some embodiments, the breathing flow tube may be a Lilly-type breathing flow tube. In some embodiments, the detection unit may further include one or more indicator elements. In some embodiments, the indicator element may include one or more light-emitting diodes (LEDs). In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, can cause the one or more LEDs to guide the subject or user using the detection unit. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, can cause the detection unit to instruct the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, can cause the detection unit to guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more sound sources. In some embodiments, the base station may further include one or more indicating elements. In some embodiments, the indicating element may include one or more light-emitting diodes (LEDs).In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the one or more light-emitting diodes to guide the subject or the user. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to instruct the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the indicating element may include one or more light-emitting diodes. In some embodiments, the detection unit may further include a gyroscope or accelerometer. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the gyroscope or accelerometer to detect axial changes, including orientation, rotation, and vibration. In some embodiments, the biometric sensor may be a fingerprint reader. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the biometric sensor to collect the biometric data. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the biometric data to control access to an application. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the electronic device to associate the biometric data with the lung capacity measurement data. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to provide access to the lung capacity measurement data stored on the base station. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to provide access to operate the detection unit. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the application to identify an individual authorized to use the base station. In some embodiments, the individual may be a clinician. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the detection unit to charge on the base station. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the detection unit to perform wireless charging. In some embodiments, the network may be a wireless network.In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to communicate with the detection unit using Bluetooth, ZigBee, infrared transmission, or other short-range wireless communications. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to communicate with two or more detection units. In some embodiments, the detection unit and the base station may be separated by a certain distance. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server. In some embodiments, the database or server may be a cloud-based database or server. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server via a wired connection. In some embodiments, the wired connection may be a USB or Ethernet connection. In some embodiments, the computer-readable medium may further include instructions, when executed by the electronic device, to cause the base station to transmit data to a database or server via a wireless connection. In some embodiments, the wireless connection may be a Wi-Fi, 3G, 4G LTE, or Bluetooth connection. In some embodiments, the base station may further include a visual display. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to display lung capacity measurement data in real time. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to display animated icons indicating the validity of the data in real time. In some embodiments, the computer-readable medium may further include instructions that, when executed by the electronic device, cause the visual display to display a user icon or subject icon that provides feedback on the successful collection of lung capacity measurement data through the detection unit.

[0018] This document provides a system for assessing lung function, comprising a wireless detection unit including a tubular channel having a first opening and a second opening, the first opening being opposite to the second opening; a mouthpiece including a tubular elongated body having a first end and a second end, the first end being opposite to the second end, the first end having an opening and configured to allow a subject to exhale into the mouthpiece, and the second end being disposed within the tubular channel of the detection unit; and a base station configured to communicate with the detection unit, wherein the base station includes an integrated biometric sensor, wherein the integrated biometric sensor is a fingerprint sensor, and wherein the base station further includes an environmental sensor and a docking holder sized and adapted to store the detection unit. In some embodiments, the detection unit further includes a power source. In some embodiments, the power source is a battery. In some embodiments, the battery is a lithium-ion battery pack. In some embodiments, the detection unit further includes a charging receiver coil. In some embodiments, the charging receiver coil is a wireless charging receiver coil. In some embodiments, the detection unit further includes a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer detects axial changes, including orientation, rotation, and vibration. In some embodiments, the mouthpiece includes a sensor. In some embodiments, the sensor is an ethanol sensor. In some embodiments, the sensor is a flow sensor. In some embodiments, the flow sensor is pre-calibrated. In some embodiments, the flow sensor is a disposable flow sensor. In some embodiments, the flow sensor is a breathing flow tube. In some embodiments, the breathing flow tube is a Lilly-type breathing flow tube. In some embodiments, the detection unit or the base station further includes one or more indicating elements. In some embodiments, the one or more indicating elements include one or more sound sources. In some embodiments, the one or more indicating elements include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs guide the subject or user. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more light-emitting diodes guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the detection unit transmits data to the base station via a network. In some embodiments, the detection unit transmits data to the base station via a Bluetooth connection. In some embodiments, the network is a wireless network.In some embodiments, the base station communicates with the detection unit using Bluetooth, ZigBee, infrared transmission, or short-range wireless communication. In some embodiments, the base station communicates with two or more detection units. In some embodiments, the detection units and the base station are separated by a distance. In some embodiments, the base station further includes a visual display. In some embodiments, the visual display displays lung capacity measurement data in real time. In some embodiments, the visual display includes animated icons indicating the validity of the data in real time. In some embodiments, the visual display displays user icons or subject icons providing feedback on successfully collecting data through the detection unit. In some embodiments, the base station further includes a power source. In some embodiments, the power source is a battery. In some embodiments, the battery is a lithium-ion battery pack. In some embodiments, the base station further includes a charging transmitter coil. In some embodiments, the charging transmitter coil is a wireless charging transmitter coil. In some embodiments, the environmental sensor is a humidity sensor.

[0019] This document provides a system for assessing lung function, comprising: a wireless detection unit including a tubular channel having a first opening and a second opening, the first opening being opposite to the second opening, the detection unit further including a charging receiver coil; a mouthpiece including an elongated tubular body having a first end and a second end, the first end being opposite to the second end, the first end having an opening and configured to allow a subject to exhale into the mouthpiece, and the second end being disposed within the tubular channel of the detection unit; and a base station configured to communicate with the detection unit, wherein the base station includes a touch visual display and a docking bracket, wherein the docking bracket includes a charging transmitter coil and is sized and adapted to store the detection unit and wirelessly charge the detection unit. In some embodiments, the detection unit further includes a power source. In some embodiments, the power source is a battery. In some embodiments, the battery is a lithium-ion battery pack. In some embodiments, the charging receiver coil is a wireless charging receiver coil. In some embodiments, the detection unit further includes a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer detects axial changes, the axial changes including orientation, rotation, and vibration. In some embodiments, the mouthpiece includes a sensor. In some embodiments, the sensor is an ethanol sensor. In some embodiments, the sensor is a flow sensor. In some embodiments, the flow sensor is pre-calibrated. In some embodiments, the flow sensor is a disposable flow sensor. In some embodiments, the flow sensor is a breathing flow tube. In some embodiments, the breathing flow tube is a Lilly-type breathing flow tube. In some embodiments, the detection unit or the base station further includes one or more indicating elements. In some embodiments, the one or more indicating elements include one or more sound sources. In some embodiments, the one or more indicating elements include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs guide the subject or user. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the detection unit transmits data to the base station via a network. In some embodiments, the detection unit transmits data to the base station via a Bluetooth connection. In some embodiments, the network is a wireless network. In some embodiments, the base station communicates with the detection unit using Bluetooth, ZigBee, infrared transmission, or short-range wireless communication.In some embodiments, the base station communicates with two or more detection units. In some embodiments, the detection units and the base station are separated by a distance. In some embodiments, the touch visual display shows lung capacity measurement data in real time. In some embodiments, the touch visual display includes animated icons indicating the validity of the data in real time. In some embodiments, the touch visual display displays a user icon or subject icon providing feedback on successfully collecting the data through the detection units. In some embodiments, the base station further includes a power source. In some embodiments, the power source is a battery. In some embodiments, the battery is a lithium-ion battery pack. In some embodiments, the charging transmitter coil is a wireless charging transmitter coil. In some embodiments, the base station further includes a biometric sensor. In some embodiments, the biometric sensor is a fingerprint sensor.

[0020] This document provides a system for assessing lung function, comprising: a wireless detection unit including a power supply and a charging receiver coil, the detection unit including a tubular channel having a first opening and a second opening, the first opening being opposite to the second opening; a mouthpiece including an elongated tubular body having a first end and a second end, the first end being opposite to the second end, the first end having an opening and configured to allow a subject to exhale into the mouthpiece, and the second end being disposed within the tubular channel of the detection unit; and a base station configured to communicate with the detection unit via Bluetooth, wherein the base station includes an environmental sensor and an integrated biometric sensor, wherein the integrated biometric sensor is a fingerprint sensor, wherein the fingerprint sensor is located between a docking bracket and a touch visual display, wherein the docking bracket includes a charging transmitter coil and is sized and adapted to store the detection unit and wirelessly charge the detection unit. In some embodiments, the charging receiver coil is a wireless charging receiver coil. In some embodiments, the detection unit further includes a gyroscope or accelerometer. In some embodiments, the gyroscope or accelerometer detects axial changes, including orientation, rotation, and vibration. In some embodiments, the mouthpiece includes a sensor. In some embodiments, the sensor is an ethanol sensor. In some embodiments, the sensor is a flow sensor. In some embodiments, the flow sensor is pre-calibrated. In some embodiments, the flow sensor is a disposable flow sensor. In some embodiments, the flow sensor is a breathing flow tube. In some embodiments, the breathing flow tube is a Lilly-type breathing flow tube. In some embodiments, the detection unit or the base station further includes one or more indicating elements. In some embodiments, the one or more indicating elements include one or more sound sources. In some embodiments, the one or more indicating elements include one or more light-emitting diodes (LEDs). In some embodiments, the one or more LEDs guide the subject or user. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale. In some embodiments, the one or more LEDs guide the subject to inhale, hold their breath in their lungs, or exhale for at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 seconds. In some embodiments, the detection unit transmits data to a base station via a network. In some embodiments, the network is a wireless network. In some embodiments, the base station communicates with the detection unit using ZigBee, infrared transmission, or short-range wireless communication. In some embodiments, the base station communicates with two or more detection units.In some embodiments, the detection unit and the base station are separated by a certain distance. In some embodiments, the touch visual display shows lung capacity measurement data in real time. In some embodiments, the touch visual display includes animated icons indicating the validity of the data in real time. In some embodiments, the touch visual display displays a user icon or subject icon providing feedback on successfully collecting the data through the detection unit. In some embodiments, the base station further includes a power source. In some embodiments, the power source is a battery. In some embodiments, the battery is a lithium-ion battery pack. In some embodiments, the charging transmitter coil is a wireless charging transmitter coil. In some embodiments, the environmental sensor is a humidity sensor.

[0021] Incorporation

[0022] All publications, patents and patent applications mentioned in this specification are incorporated herein by reference to the extent that each individual publication, patent or patent application is specifically and individually cited and incorporated herein by reference. Attached Figure Description

[0023] The novel features of the exemplary embodiments are particularly set forth in the appended claims. A better understanding of the features and advantages will be obtained by referring to the following detailed description of illustrative embodiments utilizing the principles of the exemplary embodiments, along with the accompanying drawings, in which:

[0024] Figure 1 The illustration shows a base station that includes a fingerprint sensor, a docking bracket, and a visual display.

[0025] Figure 2 The illustration shows a front view of a base station that includes a fingerprint sensor, a docking bracket, and a visual display.

[0026] Figure 3 The diagram shows a rear view of the base station.

[0027] Figure 4 The diagram shows a left view of the base station.

[0028] Figure 5 The diagram shows a right view of the base station.

[0029] Figure 6 The illustration shows a top view of a base station that includes a fingerprint sensor, a docking bracket, and a visual display.

[0030] Figure 7 The diagram shows a bottom view of the base station.

[0031] Figure 8 The illustration shows a front side view of the detection unit.

[0032] Figure 9 The diagram shows a front view of the detection unit.

[0033] Figure 10 The diagram shows a rear view of the detection unit.

[0034] Figure 11 The diagram shows a left view of the detection unit.

[0035] Figure 12 The diagram shows a right view of the detection unit.

[0036] Figure 13 The diagram shows a top view of the detection unit.

[0037] Figure 14 The diagram shows a bottom view of the detection unit.

[0038] Figure 15 The illustration shows a base station comprising a fingerprint sensor and a detection unit inserted into a docking bracket. The detection unit has a blowhole.

[0039] Figure 16 The illustration shows a front view of a base station including a fingerprint sensor and a detection unit inserted into a docking bracket. The detection unit has a blowhole.

[0040] Figure 17 The illustration shows a rear view of a base station with a detection unit inserted into a docking bracket. The detection unit has a blowhole.

[0041] Figure 18 The illustration shows a left view of a base station with a detection unit inserted into a docking bracket. The detection unit has a nozzle.

[0042] Figure 19 The illustration shows a right view of a base station with a detection unit inserted into a docking bracket. The detection unit has a nozzle.

[0043] Figure 20 The illustration shows a top view of a base station including a fingerprint sensor and a detection unit inserted into a docking bracket. The detection unit has a blowhole.

[0044] Figure 21 The illustration shows a bottom view of a base station with a detection unit inserted into a docking bracket. The detection unit has a blowhole.

[0045] Figure 22 The diagram illustrates the user activation workflow.

[0046] Figure 23 The diagram shows an exploded view of the detection unit. This detection unit includes a charging receiver coil and a power supply.

[0047] Figure 24The diagram shows an exploded view of the base station. The base station includes a power supply, a charging transmitter coil, a fingerprint sensor, and a visual display.

[0048] Figure 25 The diagram illustrates the graphical user interface (GUI). Figure 25 A shows some of the available options on the main screen. Figure 25 B depicts an example of a graphical display that can be used for spirometry data.

[0049] Figure 26 The illustration shows a longitudinal view of the mouthpiece.

[0050] Figure 27 The illustration shows a longitudinal view of the mouthpiece.

[0051] Figure 28 The illustration shows a longitudinal view of the mouthpiece.

[0052] Figure 29 The illustration shows a longitudinal view of the mouthpiece.

[0053] Figure 30 The diagram shows a cross-sectional view of the nozzle.

[0054] Figure 31 The diagram shows a cross-sectional view of the nozzle.

[0055] Figure 32 The diagram illustrates the workflow for user and subject activation. Detailed Implementation

[0056] Several aspects are described below with reference to illustrative examples. It should be understood that many specific details, relationships, and methods are elaborated to provide a complete understanding of the features described herein. However, those skilled in the art will readily recognize that the features described herein can be practiced without one or more specific details or using other methods. The features described herein are not limited to the order of actions or events shown, as some actions may occur in a different order and / or simultaneously with other actions or events. Furthermore, not all actions or events shown are required to implement methods consistent with the features described herein.

[0057] The terminology used herein is for the purpose of describing a particular situation only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “the” used herein may also include the plural forms. Furthermore, when the terms “comprising,” “including,” “having,” “containing,” “having,” or variations thereof are used in the specific description and / or claims, these terms are intended to indicate inclusion, similar to the term “comprising.”

[0058] The terms “about” or “approximately” can refer to a range of + / - 10% of a given value.

[0059] As used herein, the term "user" can refer to an individual undergoing a test. The term "subject" as used herein can refer to an individual undergoing a spirometry test. In some cases, a "user" or "subject" can be a patient. In some cases, the terms "subject," "user," and "patient" can refer to the same individual. In further embodiments, the terms "subject," "user," and "patient" can refer to different individuals. In some embodiments, the subject, user, or patient can be in the same room. In some cases, the subject, user, or patient can be in different rooms, cities, or countries. In some cases, the user, subject, or patient can be a mammal. In some cases, the subject, user, or patient can be a human aged 0 to 135 years. In some cases, the subject, user, or patient can be male. In some cases, the subject, user, or patient can be female. In some cases, the subject, user, or patient can be an individual capable of understanding instructions. In some cases, the subject, user, or patient can be a literate individual.

[0060] In some cases, the user may be an individual trained to operate the spirometer. The user may be an individual with medical technical knowledge. In some cases, the user may be an individual capable of installing the software, preparing and / or maintaining the spirometer. In some cases, the user may be an individual capable of using the spirometer to perform measurements. In some cases, the user may be a healthcare provider. In some cases, the healthcare provider may be a professional in a clinic or hospital, such as a doctor, nurse, or technician. In some cases, the user may be a non-healthcare provider, such as an information technology specialist.

[0061] Overview

[0062] This document provides a method for conducting lung function tests. In some embodiments, the method may include providing a subject with a detection unit that may include a mouthpiece and sensors, using biometric data to identify the user of the application, receiving spirometric data transmitted from the detection unit at a base station, and monitoring the base station to determine test error.

[0063] This article also provides a method for collecting lung function data. The method may include collecting biometric data from a user at a base station, providing the subject with a detection unit that may include a mouthpiece and sensors, receiving vital capacity measurement data transmitted from the detection unit, correlating the biometric data collected from the base station with the vital capacity measurement data collected from the detection unit, and processing the collected data at the base station.

[0064] This article also provides a method for improving the quality of spirometry data. The method may include collecting biometric data from a user at a base station; providing a subject with a detection unit that may include a mouthpiece and a sensor to receive spirometry data transmitted from the detection unit, wherein the base station may be configured to graphically display the spirometry data and indicate test errors; and processing the received spirometry data at the base station.

[0065] This document also provides a method for monitoring lung function data. The method may include generating spirometry data by providing a breath sample to a detection unit that may include a mouthpiece and a sensor, wherein the detection unit may be configured to operate without calibration, and includes transmitting the spirometry data from the detection unit to a remote base station in real time.

[0066] This document also provides a method for manufacturing a system for collecting spirometry test results. The method may include constructing a detection unit that may include a sensor and a mouthpiece, wherein the detection unit may be configured to reduce test errors caused by variations in user effort, including configuring wireless communication between the detection unit and a base station, wherein the base station may include a visual display of the spirometry data collected by the detection unit, and including an application mounted on the base station for processing or transmitting the collected spirometry data.

[0067] This document also provides a method for manufacturing a system to reduce user error in spirometry data. The method may include constructing a system that may include a detection unit and a base station, integrating a biometric sensor into the base station, and configuring the base station to have one or more mechanisms for receiving spirometry data from the detection unit.

[0068] This article also provides a system for testing lung function. The system may include a wireless detection unit that may contain sensors and a mouthpiece, a base station that can be configured to communicate with the detection unit, wherein the base station may contain integrated biometric sensors, and a docking bracket that may contain a charging and storage device configured to charge and store data for the detection unit.

[0069] This document also provides a non-transitory computer-readable medium suitable for use in electronic devices. This medium may contain instructions that, when executed by the electronic device, cause the electronic device to: use biometric data to control access to an application, receive spirometry data transmitted from a detection unit at a base station, and transmit the spirometry data from the base station to an external server or database.

[0070] This document also provides a non-transitory computer-readable medium suitable for use in electronic devices. The medium may contain instructions that, when executed by the electronic device, cause the electronic device to: collect biometric data from a user at a base station; receive lung capacity measurement data transmitted from a detection unit, wherein the detection unit may include a mouthpiece and a sensor; correlate the biometric data collected from the base station with the lung capacity measurement data collected from the detection unit; and process the collected data at the base station.

[0071] This document also provides a non-transitory computer-readable medium suitable for use in an electronic device, the medium containing instructions that, when executed by the electronic device, cause the electronic device to: collect biometric data from a user at a base station; receive lung capacity measurement data transmitted from a detection unit that may include a mouthpiece and a sensor, wherein the detection unit may include a mouthpiece and a sensor, and the base station may be configured to indicate whether the biometric data is valid; and process the received lung capacity measurement data at the base station.

[0072] In some embodiments, this document provides a spirometer. In some embodiments, the spirometer may include a base station and a detection unit. In some embodiments, the detection unit may include a mouthpiece. In some embodiments, the detection unit may include a flow sensor. In some embodiments, the flow sensor may be pre-calibrated. In some embodiments, the flow sensor may be disposable. In some embodiments, the flow sensor may be a respiratory rate sensor. In some embodiments, the detection unit may include one or more indicating elements. In some embodiments, the indicating element may be a light-emitting diode (LED). In some embodiments, the detection unit may be remotely configured. In some embodiments, the detection unit may be configured via a cloud. In some embodiments, the detection unit may transmit spirometry data to a database or server. In some embodiments, the database or server may be a cloud server or database. In some embodiments, the detection unit may transmit data wirelessly. In some embodiments, the base station and the detection unit may communicate wirelessly. In some embodiments, the detection unit may transmit data to the base station via a Bluetooth connection. In some embodiments, the base station may include a docking bracket. In some embodiments, the docking bracket may be configured to charge the detection unit. In some embodiments, the docking bracket may wirelessly charge the detection unit. In some embodiments, the base station may include a visual display. In some embodiments, the visual display can display lung capacity measurement data in real time. In some embodiments, the base station can include one or more indicating elements. In some embodiments, the indicating element can be a light-emitting diode (LED). In some embodiments, the base station can transmit lung capacity measurement data to a database or server. In some embodiments, the database or server can be a cloud server or a database. In some embodiments, the base station can transmit data wirelessly. In some embodiments, the base station can be remotely configured. In some embodiments, the base station can be configured via the cloud. In some embodiments, the base station can include an integrated biometric sensor (e.g., a fingerprint sensor). In another embodiment, the integrated biometric sensor can be located on a detection unit.

[0073] As used herein, the term "cloud" can refer to cloud computing. Cloud computing can be internet-based computing that provides shared processing resources and data to computers and other devices as needed. In some cases, cloud computing may require sharing resources (e.g., data) over a network. In some implementations, the spirometer can be configured remotely. In some implementations, the spirometer can be configured via the cloud. In some cases, data can be uploaded from the spirometer to a cloud-based server or database. In some cases, data can be retrieved from a cloud-based server or database to the spirometer.

[0074] In some implementations, the spirometer may utilize Bluetooth connectivity. As used herein, the term "Bluetooth" may refer to a global wireless communication standard that connects devices over a distance. Bluetooth devices can use radio waves instead of wires or cables to connect to another device. In some cases, the device may contain a microcomputer chip with a Bluetooth radio and software that allows it to connect. In some cases, two Bluetooth devices may be paired for communication. Communication between Bluetooth devices can occur within a short-range, self-organizing network known as a piconet. A piconet can be a network of devices connected using Bluetooth technology. In some cases, the network may encompass two to eight or more connected devices. When the network is established, one device may act as the master device, while other devices may act as slave devices. Piconet formation can be dynamic and automatic as Bluetooth devices enter and leave the wireless short range. In some implementations, the Bluetooth core specification may be the Bluetooth Basic Rate / Enhanced Data Rate (BR / EDR) core specification. In some implementations, the Bluetooth core specification may be the Bluetooth core specification with Low Energy capability. In some implementations, the Bluetooth core specification may be the Bluetooth Smart core specification.

[0075] In other embodiments, the spirometer and / or its base station described herein can enter a standby or idle mode for a configurable duration when not in use. In other cases, the software installed on the spirometer described herein can be updated wirelessly.

[0076] system

[0077] The spirometer described herein may include a detection unit and an integrated biometric sensor (e.g., a fingerprint sensor). The spirometer may include other components. For example, the spirometer may include a mouthpiece, which may be connected to the detection unit. The detection unit may contain one or more sensors, such as a flow sensor or an ambient air sensor. The spirometer may include one or more indicating elements, such as light-emitting diodes (LEDs). The spirometer may include a visual display, power supply, accelerometer, gyroscope, integrated environmental sensor, pre-calibrated respiratory rate, multi-language support, USB and / or Bluetooth connectivity to external devices (e.g., printers, SpO2), and / or may be app- and tablet-enabled. In some cases, the spirometer may be rechargeable. The spirometer may be configured for data storage. The spirometer described herein may be a compact, portable spirometer and may include intelligent features (e.g., seamless zero flow, automatic detection of start / end of test), multi-mode data transfer capabilities (e.g., Wi-Fi, 3G, Ethernet, USB, HL7, GDT), and may be cloud-enabled. In some cases, users can choose a preferred communication type. The spirometer described herein can be used online or offline. The spirometer described herein may include a wireless handle with wireless charging and LED, auditory or haptic feedback.

[0078] The spirometer described herein may include a touchscreen display. In some cases, the touchscreen display may be an 8-inch capacitive high-resolution display. In some embodiments, the touchscreen includes a color screen. In some cases, the touchscreen may have a resolution of at least or about 800x600. In some cases, the touchscreen may allow multi-touch gestures. The touchscreen may allow calibration and / or correction for differences in finger size. Furthermore, the touchscreen may allow use while wearing gloves (e.g., latex surgical gloves). In some cases, the power button may be integrated into the touchscreen. In some cases, the power button may be separate from the touchscreen.

[0079] The spirometer may include integrated firmware. In some cases, the firmware can be updated by connecting to an external device, as described herein. The spirometer is capable of backing up and / or restoring data. In some cases, data can be backed up to the external device described herein. In some cases, data can be restored from the external device described herein. In some cases, the external device may be a USB device. In some cases, the external device may be a cloud storage server. The spirometer can perform partial or full backups according to user instructions.

[0080] In some embodiments, one or more or all components of the spirometer are non-removable. In some embodiments, one or more components of the spirometer are detachable. For example, the detection unit is removable from another component of the spirometer, such as a base station. For example, the detection unit can be connected to another part of the spirometer, such as a base station, via, for example, a docking bracket, and the detection unit can be detached from the docking bracket. The spirometer may include sensors, such as distance sensors for sensing the detachable components. An integrated biometric sensor (e.g., a fingerprint sensor) may be located in the base station. In another embodiment, an integrated biometric sensor (e.g., a fingerprint sensor) may be located on the detection unit.

[0081] like Figures 15-21 As shown, the spirometer provided herein may include a base station (105) and a detection unit (130) having a mouthpiece (135). The base station may include a visual display (110), a biometric sensor (e.g., a fingerprint sensor) (125), and a docking bracket (120).

[0082] The system described herein can include a high-quality respiratory rate. The system described herein can have a flow rate range of 0.1 to approximately ±16 L / s. The system described herein can have a flow rate accuracy of approximately 0.1 to 14 L / s: + / -5% / 0.2 L / s. The system described herein can have a flow rate resolution of approximately 5 mL / s. The system described herein can have a resistance of approximately 0.05 kPa / (L / s) at 10 L / s. The system described herein can have digitally integrated volumetric measurement. The system described herein can have a volumetric range of approximately 0.1 to 8 L. The system described herein can have a volumetric accuracy of approximately 0.5 to 8 L: + / -3% / 0.05 L. The system described herein can have a volumetric resolution of approximately 1 mL. The system described herein can have a backlit, high-resolution graphic LCD touchscreen display. The visual display disclosed herein can be 16.2 cm x 12.2 cm, color, touchscreen, 1024 x 800 pixels. The system described in this article can have a power input of 100-240VAC, 50 / 60Hz, 1.5A. The system described in this article can have a power output of approximately 5V, 6A.

[0083] docking bracket

[0084] In some embodiments, the detection unit (130) described herein may be stored in the docking bracket (120). In some cases, such as Figure 1 and Figure 2As shown, the docking bracket (120) can be installed in the base station (105). In other cases, the docking bracket (120) can be removed from the base station (105). In some embodiments, the docking bracket may have a separate plug or power supply. In some embodiments, the docking bracket may share the power supply of the base station. In some embodiments, the detection unit can be charged via the docking bracket. For example, in some embodiments, if the subject is at a remote location, the detection unit (130) and a separate docking bracket unit can be provided to the subject for charging the detection unit in the absence of a base station. In some embodiments, if the base station is inaccessible, the detection unit (130) and a separate docking bracket unit can be provided to the subject for charging the detection unit in the absence of a base station. In some cases, the docking bracket, whether connected to a base station or as a separate unit, can be equipped with a distance sensor to detect the presence of the detection unit associated with the docking bracket. The docking bracket can be configured to inductively charge the detection unit. Inductive charging between the detection unit and the docking bracket can be performed under the Qi standard. In some cases, the docking bracket can be configured to improve charging efficiency by including additional components; for example, one or more additional magnets can be used to provide tactile feedback between the detection unit and the base station. The detection unit may include one or more charging plates. In some embodiments, the charging plate may include a coil array. In some embodiments, the coil array allows the detection unit to be charged regardless of its positioning in the docking bracket on the charging plate. Figure 24 As shown, the docking bracket of the base station may include a charging transmitter coil (10502). In a further embodiment, the detection unit may include a limited communication protocol other than power transmission. In some embodiments, the limited communication protocol and power transmission may enable the detection unit to provide control feedback to the base station or docking bracket. In some embodiments, the control feedback may include the detection unit's charging status, charge percentage, battery life, and operational status (e.g., ready for use).

[0085] In some embodiments, when the detection unit (130) is docked in the docking bracket, the docking bracket (120) can automatically pair (identify) the detection unit (130). In some embodiments, when the detection unit (130) approaches the docking bracket (120), the docking bracket (120) can pair (identify) the detection unit (130). In some cases, the detection unit (130) may approach the docking bracket (120) when the distance between the detection unit (130) and the docking bracket (120) is at least, at most, or about 1 cm, 10 cm, 15 cm, 30 cm, 50 cm, 75 cm, 100 cm, 150 cm, 200 cm, 300 cm, 400 cm, 500 cm, 600 cm, 700 cm, 800 cm, 900 cm, 1000 cm, 1500 cm, 2000 cm, 2500 cm, 3000 cm, 4000 cm, 5000 cm, 10 m, 25 m, 50 m, 75 m, or 100 m. In some embodiments, the detection unit (130) and the docking bracket (120) may be paired (identified) by incorporating a distance sensor.

[0086] The docking bracket may have a flat, circular, or curved surface. When the detection unit is placed on / in the docking bracket, the bracket can be shaped to secure the detection unit. The docking bracket may include a housing forming a receiving groove to receive the detection unit. The size and shape of the receiving groove can be adjusted to receive the detection unit therein. The docking bracket may have a mechanism for accommodating the detection unit in a suitable position on / in the docking bracket.

[0087] Distance sensor

[0088] In some embodiments, the spirometer provided herein may include one or more detachable components. A first component may include a proximity sensor capable of detecting a second component. The second component is capable of emitting a signal detectable by the proximity sensor. In some cases, the proximity sensor on the first component can detect the signal emitted from the second component. In some cases, the proximity sensor on the first component can detect the signal emitted from the second component when the first and second components are within a certain distance. For example, a docking bracket (120) or base station (105) may include a proximity sensor for detecting, for example, a detachable detection unit (130), and a detachable detection unit (130) capable of emitting a signal detectable by the proximity sensor located on the docking bracket or base station. In some cases, the docking bracket (120) or base station (105) can emit a signal detectable by the proximity sensor of the detection unit (130).

[0089] In some embodiments, the distance sensor in the first component can communicate with a second component, such as a docking bracket (120) or a base station, for example, via an electrical connection, such as a wireless or wired connection. In some embodiments, electrical signals can be transmitted via a USB connection. In some embodiments, electrical signals can be transmitted via a fiber optic connection. In some embodiments, electrical signals can be transmitted via an Ethernet cable. In some embodiments, wireless signals can be transmitted via 3G data signals. In other embodiments, wireless signals can be transmitted via a Bluetooth connection. In some embodiments, wireless signals can be transmitted via a Wi-Fi connection. In other embodiments, wireless signals can be transmitted via an infrared data association link. When wirelessly connected, the spirometer can provide an indication of signal strength. In some cases, the spirometer can provide feedback regarding the connection. For example, the spirometer can provide an indication of a disconnected connection, or the success or failure of data transmission through the connection.

[0090] In some embodiments, a distance sensor in the first component can detect signals emitted from a second component, such as a detection unit (130). In some embodiments, the distance sensor can detect the detection unit (130) when it is docked in the docking bracket (120). In some embodiments, the distance sensor can detect the detection unit (130) when it approaches the docking bracket.

[0091] In some embodiments, when the first component and the second component are at a distance of about 1 cm to about 5,000 cm, about 1 cm to about 4,000 cm, about 1 cm to about 3,000 cm, about 1 cm to about 2,000 cm, about 1 cm to about 1,000 cm, about 1 cm to about 500 cm, about 1 cm to about 250 cm, about 1 cm to about 200 cm, about 1 cm to about 150 cm, about 1 cm to about 100 cm, about 1 cm to about 50 cm, about 1 cm to about 25 cm, about 1 cm to about 20 cm, about 1 cm to about 15 cm, about 1 cm to about 10 cm, or about 1 cm to about 5 cm, a distance sensor on the first component, such as the docking bracket (120) or the base station (105), can detect the signal emitted from the second component, such as the detection unit (130). In some embodiments, the distance between the first component and the second component is at least, at most, or about 1 cm, at least, at most, or about 2 cm, at least, at most, or about 5 cm, at least, at most, or about 10 cm, at least, at most, or about 15 cm, at least, at most, or about 20 cm, at least, at most, or about 25 cm, at least, at most, or about 50 cm, at least, at most, or about 75 cm, at least, at most, or about 100 cm, at least, at most, or about 150 cm, at least, at most, or about 200 cm, at least, at most, or about 250 cm, at least, at most, or about 300 cm, at least, at most, or about 350 cm, at least, at most, or about 400 cm, at least, at most, or about 450 cm, at least, at most, or about 500 cm, at least about 600 cm, at least about 700 cm, at least about 800 cm, at least about 900 cm, at least, at most, or about 1,000 cm. When the distance is at least, at most, or about 1,100, at least, at most, or about 1,200 cm, at least, at most, or about 1,300 cm, at least, at most, or about 1,400 cm, at least, at most, or about 1,500 cm, at least, at most, or about 1,750 cm, at least, at most, or about 2,000 cm, at least, at most, or about 2,250 cm, at least, at most, or about 2,500 cm, at least, at most, or about 2,750 cm, at least, at most, or about 3,000 cm, at least, at most, or about 5 m, at least, at most, or about 10 m, at least, at most, or about 25 m, at least, at most, or about 50 m, at least, at most, or about 75 m, or at least, at most, or about 100 m, a distance sensor in the first component, such as the docking bracket (120) or the base station (105), can detect a signal emitted from the second component, such as the detection unit (130).

[0092] In some embodiments, detection of a transmitted signal by a distance sensor may cause activation of an indicator. In some cases, insufficient detection of a transmitted signal by the distance sensor may cause activation of the indicator. In some embodiments, the distance sensor may communicate with an indicator, such as a sound source, a tactile source, or a visual source (e.g., an LED), via, for example, an electrical connection, a wired or wireless connection, indicating when the distance sensor has detected or not detected a transmitted signal. A sound source may be, for example, a speaker. A sound source may be a device that generates sound. In some embodiments, a sound source may be one or more speakers. For example, in an exemplary embodiment, a sound source may be a sound whose volume and / or frequency varies according to signal strength. In some embodiments, a sound source may provide a sound output of about 90 dB to about 100 dB. In other embodiments, the sound output may be between at least 0 dB and 140 dB. In some cases, the volume level of the sound source may be adjustable. A tactile source may be, for example, a rotary motor. In some embodiments, a tactile source may be a vibrating motor. In some embodiments, a tactile source may generate high-frequency, low-amplitude vibrations. In some embodiments, the tactile source may vibrate in a constant and continuous mode, or the vibration may be discontinuous, such as intermittent periodic or cyclical vibration and no vibration. For example, in an exemplary embodiment, the tactile source may be a vibration whose frequency changes according to signal strength. The visual source may be, for example, light, an LED, etc. In some embodiments, the visual source may be light, multiple light sources, instruments, displays, etc. For example, in an exemplary embodiment, the visual source may be light whose frequency and / or pulse rate and / or intensity changes according to signal strength.

[0093] Any combination of the above embodiments can also be used to provide, for example, indication of the proximity of a detachable component of the detection unit (130) to the docking bracket (120). For example, the docking bracket (120) may include both a vibration motor and a sound source. In some embodiments, the detection unit (130) may include both a vibration motor and a sound source.

[0094] power supply

[0095] In some embodiments, the detection unit (130) is rechargeable. In some cases, the detection unit can be charged via an external power source. In some cases, the external power source is rechargeable or replaceable. In some cases, the detection unit may include an internal power source. In some cases, the internal power source is rechargeable or replaceable. In some cases, the detection unit (130) can be charged when docked onto the docking bracket (120). In some embodiments, charging can be performed by inductive charging. In some cases, the detection unit (130) may include one or more induction coils to allow charging. In some cases, the docking bracket (120) may include one or more induction coils to allow charging. In some embodiments, the detection unit (130) and the docking bracket (120) may each independently include one or more induction coils to allow effective charging when the detection unit (130) contacts the docking bracket (120). In some embodiments, the docking bracket (120) and the detection unit (130) may include one or more magnets. In some embodiments, the docking bracket (120) and the detection unit (130) may include one or more magnets to ensure proper orientation and contact, thereby allowing for better inductive charging. In some embodiments, inductive charging between the detection unit (130) and the docking bracket (120) can be performed via the Qi standard. In other embodiments, inductive charging between the detection unit (130) and the docking bracket (120) can be performed via the Power Matters Alliance (PMA) standard. In some embodiments, such as Figure 23 As shown, the detection unit may include a charging receiver coil, while the base station may include a charging transmitter coil.

[0096] In some embodiments, the detection unit can be charged via resonant inductive charging. In some embodiments, resonant inductive charging can be performed when one or more induction coils are tuned to resonate at the same frequency, thereby allowing charging when the detection unit (130) and the docking bracket (120) are close together. In some embodiments, the detection unit (130) can be charged when it is in direct contact with the docking bracket (120). In some embodiments, the detection unit (130) can be charged when it is at least 0.001 cm, at least 0.002 cm, at least 0.01 cm, at least 0.03 cm, at least 0.05 cm, at least 0.1 cm, at least 0.2 cm, at least 0.3 cm, at least 0.4 cm, at least 0.5 cm, at least 0.6 cm, at least 0.7 cm, at least 0.8 cm, at least 0.9 cm, at least 1 cm, at least 2 cm, at least 3 cm, at least 5 cm, or at least 10 cm away from the docking bracket (120). In some embodiments, when the detection unit (130) is at least, at most, or 1, 2, 5, 10, 15, 25, 50, 100, 500, 1000, 1500, 2000, 2500, 3000, 3500, 4000, 5000, or 10000 cm away from the docking bracket (120), the detection unit (130) can be charged by resonant inductive charging. In some embodiments, when the detection unit (130) is about 1 cm to about 5,000 cm, about 1 cm to about 4,000 cm, about 1 cm to about 3,000 cm, about 1 cm to about 2,000 cm, about 1 cm to about 1,000 cm, about 1 cm to about 500 cm, about 1 cm to about 250 cm, about 1 cm to about 200 cm, about 1 cm to about 150 cm, about 1 cm to about 100 cm, about 1 cm to about 50 cm, about 1 cm to about 25 cm, about 1 cm to about 20 cm, about 1 cm to about 15 cm, about 1 cm to about 10 cm, or about 1 cm to about 5 cm, the detection unit (130) can be charged by resonant inductive charging.

[0097] In some embodiments, the detection unit (130) can be wirelessly recharged via wireless charging. In such embodiments, the detection unit (130) may include a receiver capable of receiving radio signals from a radio transmitter on the docking bracket (120). In some embodiments, the detection unit (130) may include a radio transmitter. In some embodiments, the docking bracket (120) may include a receiver capable of receiving radio signals. In some embodiments, the detection unit (130) can be charged when it is close to the docking bracket (120). In some embodiments, the detection unit (130) can be charged when it is in direct contact with the docking bracket (120). In some embodiments, when the detection unit (130) is at least, at most, or about 1 cm, at least, at most, or about 2 cm, at least, at most, or about 5 cm, at least, at most, or about 10 cm, at least, at most, or about 15 cm, at least, at most, or about 20 cm, at least, at most, or about 25 cm, at least, at most, or about 50 cm, at least, at most, or about 75 cm, at least, at most, or about 100 cm, at least, at most, or about 150 cm, at least, at most, or about 200 cm, at least, at most, or about 250 cm, at least, at most, or about 300 cm, at least, at most, or about 350 cm, at least, at most, or about 400 cm, at least, at most, or about 450 cm, at least, at most, or about 500 cm, at least, At distances of up to or about 600 cm, at least, up to or about 700 cm, at least, up to or about 800 cm, at least, up to or about 900 cm, at least, up to or about 1,000 cm, at least, up to or about 1,100 cm, at least, up to or about 1,200 cm, at least, up to or about 1,300 cm, at least, up to or about 1,400 cm, at least, up to or about 1,500 cm, at least, up to or about 1,750 cm, at least, up to or about 2,000 cm, at least, up to or about 2,250 cm, at least, up to or about 2,500 cm, at least, up to or about 2,750 cm, at least, up to or about 3,000 cm, the detection unit (130) can be charged by wireless charging.In some embodiments, the detection unit (130) can be charged by wireless charging when the detection unit (130) is about 1 cm to about 5,000 cm, about 1 cm to about 4,000 cm, about 1 cm to about 3,000 cm, about 1 cm to about 2,000 cm, about 1 cm to about 1,000 cm, about 1 cm to about 500 cm, about 1 cm to about 250 cm, about 1 cm to about 200 cm, about 1 cm to about 150 cm, about 1 cm to about 100 cm, about 1 cm to about 50 cm, about 1 cm to about 25 cm, about 1 cm to about 20 cm, about 1 cm to about 15 cm, about 1 cm to about 10 cm, or about 1 cm to about 5 cm away from the docking bracket (120).

[0098] In other embodiments, the detection unit (130) may include a radio receiver capable of charging the detection unit using 3G, 4G LTE, or Wi-Fi signals. In such embodiments, radio charging efficiency can be improved by proximity to a wireless router. In some embodiments, charging can be performed via background backscattering. In some embodiments, the docking bracket (120) may include a wireless router. In some embodiments, the wireless router may be detachable from the docking bracket (120).

[0099] Detection unit

[0100] Figures 5-14 The detection unit (130) is shown. The detection unit (130) included herein is adaptable to the mouthpiece (135). Figures 15-21 Implementations of a detection unit (130) and a mouthpiece (135) are shown. As illustrated in these figures, the mouthpiece (135) may be disposed within the detection unit. In some implementations, the mouthpiece (135) may be removable and / or disposable. In some implementations, the mouthpiece (135) and the sensor may be a single unit. In some implementations, the mouthpiece (135) and the sensor may be separate units. In some implementations, the sensor and the mouthpiece (135) may be a single disposable unit. In some implementations, the detector unit (130) may enter an energy-saving mode when not in use. In some implementations, the detection unit (130) may be wireless or wired. In some implementations, the detection unit (130) described herein may be used to measure spirometry data at one or more time points. For example, spirometry data may be measured before and / or after a subject receives treatment to determine the effectiveness of the treatment. In some implementations, spirometry data may be measured at multiple time points to monitor a subject's disease or condition. Figure 23The detection unit (130) disclosed herein may include a power source (13001). In some cases, the power source may be a lithium-ion battery. The detection unit (130) may include a tubular channel (130c) having a first opening (130a) and a second opening (130b), the first opening (130a) being on the opposite side of the second opening (130b).

[0101] Figure 23 A detection unit (130) is described. The detection unit (130) can be assembled and includes a left cover (13004) and a right cover (13005). When assembled, the right bracket (13006), the left bracket (13007), and the PT tube seal (13008) can form a tubular channel (130c). The detection unit (130) may include a power source (13001). The power source may be a lithium-ion battery pack having a capacity of 3.7V / 640mAh. The detection unit (130) may include a charging receiver coil (13002). The charging receiver coil (13002) may be a wireless power charging receiver coil for a 34x26.5mm device. The charging receiver coil (13002) can be used to wirelessly charge the power source (13001) of the detection unit (130) in close proximity to the charging transmitter coil (10502). The detection unit (130) may include a power button (13009) that can be used to power on or off the detection unit (130). The detection unit (130) may include a printed circuit board assembly (13003) that can connect electronic components of the detection unit (130). The detection unit (130) may further include at least one indicator element (140).

[0102] mouthpiece

[0103] In some embodiments, the mouthpiece (135) may be a cylindrical body having an outer surface and an inner surface. The cylindrical body may have a first end (135a) through which an individual or animal can inhale or exhale. In some embodiments, the cylindrical body may have a second end (135b) rotated 180 degrees from the face of the first end (135a). In some embodiments, the second end (135b) may be inserted into an interface included in the detection unit (130). In some embodiments, the mouthpiece (135) may be adapted to have a contour resembling a human mouth. In some embodiments, the first end (135a) may be adapted to have a contour resembling a human mouth. In some embodiments, the first end (135a) may have a contour ergonomically adapted to the user's mouth. In some embodiments, the mouthpiece (135) may have a contour for a more effective seal against the user's mouth. In some embodiments, the first end (135a) may have a contour for a more effective seal against the user's mouth. In some implementations, the first end (135a) may have sufficient structural strength to prevent collapse during use.

[0104] In some cases, the nozzle (135) may comprise a plastic material, such as polyethylene, polypropylene, nylon, polyvinyl chloride, or other plastics known in the art. In some embodiments, the nozzle (135) may comprise cardboard or fiberboard. In some embodiments, the nozzle (135) may comprise a malleable material. The malleable material can be deformed by pressure to provide a more suitable shape. In some embodiments, the nozzle (135) may comprise a composite material.

[0105] In some embodiments, the blowhole (135) may be a removable and disposable single unit. In some embodiments, the disposable blowhole (135) may be at least partially biodegradable, for example, capable of decomposing the component or material into environmentally acceptable components, such as carbon dioxide, water, methane, etc., through natural biological processes such as microbial activity, for example, assuming exposure to typical landfill conditions for no more than five years, no more than three years, or no more than one year. In some embodiments, the blowhole (135) may be at least 5%, at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% biodegradable.

[0106] In some embodiments, the mouthpiece (135) may be robust when in use, but may be folded into a flat shape for storage before use and for setting. This feature allows for efficient storage and setting of the mouthpiece (135).

[0107] In some embodiments, the detection unit (130) may include a filter. In some embodiments, the detection unit (130) may include an in-line filter located between the nozzle (135) and the flow sensor. In some embodiments, an in-line filter may be used to prevent contamination of the spirometer between uses. In some embodiments, the in-line filter may be removable and disposable. For example, as described in US 5,601,458, in some embodiments, the in-line filter may be a bag-shaped or sock-shaped filter with a mesh or sieve support mechanism. In some embodiments, the in-line filter may contain any material commonly used by those skilled in the art. In some embodiments, the in-line filter may contain an electrostatic material. In some embodiments, the in-line filter may contain woven, non-woven, or synthetic materials.

[0108] In some implementations, such as Figures 26-31The mouthpiece (135) shown may comprise a tubular elongated body. In some cases, the tubular elongated body may comprise a first end (135a) and a second end (135b). In some cases, the first end (135a) may be opposite to the second end (135b). In some embodiments, the first end (135a) may include an opening and may be configured to allow a subject to blow air into the mouthpiece. In some cases, the second end (135b) may be disposed within a tubular channel (130c) of the detection unit (130).

[0109] Flow sensor

[0110] In some embodiments, the detection unit (130) or nozzle (135) may include one or more flow sensors. In some cases, the flow sensor described herein may include a respiratory rate sensor disposed within a tube to form a respiratory rate meter. In some embodiments, the respiratory rate sensor may be a wireless respiratory rate sensor. In some embodiments, the respiratory rate meter may measure airflow as a pressure difference across a small tube with fixed resistance. In some embodiments, the respiratory rate sensor and tube may form a specific type of respiratory rate meter. In some embodiments, the tube of the respiratory rate meter may be configured to optimize laminar flow over a wide range of flow rates or velocities. In some embodiments, the tube or respiratory rate meter may include a horn-shaped configuration. In some embodiments, the flow sensor may include a Lilly-type respiratory rate meter. In some embodiments, a Lilly-type respiratory rate meter may be configured such that the detection element may be a light curtain or mesh inserted into the tube, wherein the tube has the maximum surface area of ​​the detection element perpendicular to the airflow orientation. In some embodiments, the flow sensor may include a Fleisch-type respiratory rate meter. In some embodiments, a Fleisch-type respiratory rate meter may be configured such that the flow resistance may originate from an array of capillary tubes arranged parallel to the airflow direction. In other embodiments, the flow sensor may include a turbine flow meter, wherein airflow through the pipe causes the blades to rotate, allowing the airflow rate to be calculated in proportion to the number of revolutions per unit time. Further embodiments may rely on a hot-wire anemometer to sense the airflow. The hot-wire anemometer may comprise a thin platinum wire heated to a constant temperature and disposed within the pipe. The opening as air passes through the pipe cools the platinum wire, allowing the airflow to be calculated using the value of the additional electrical energy required to maintain the temperature of the platinum wire. In some embodiments, the flow sensor may include an ultrasonic sensor. In such a configuration, the detection unit may comprise two ultrasonic transducers facing each other. In some embodiments, one ultrasonic transducer may function as a transmitter, and the second ultrasonic transducer as a receiver to convert sound-mediated signals. In some embodiments, the ultrasonic sensor may include a piezoelectric element for amplifying the signal.

[0111] The respiratory rate sensor can be unique to the subject or patient. In some implementations, the respiratory rate sensor can be removed and / or replaced after use by the subject or patient.

[0112] In some embodiments, the flow sensor may include a fiber optic flow meter. In such embodiments, airflow can be calculated by utilizing fiber vibrations caused by vortex shedding, which can induce phase modulation of an internal optical carrier. In such embodiments, the flow velocity can then be calculated based on the fiber's vibration frequency. A velocity sensor can then be used to convert the vibration oscillations into an electrical signal, which can then be used to determine the flow velocity. In some embodiments, vortex shedding is facilitated by incorporating a shedder. In such embodiments, the pressure and velocity fields near the shedder can oscillate at the vortex shedding frequency. A velocity sensor or pressure sensor, such as a pitot tube, can then be used to convert the oscillating field into an electrical signal, current, or voltage to calculate the vortex shedding frequency. In some embodiments, the aforementioned ultrasonic sensor can be used to independently detect vortex shedding and process the resulting vibration frequency into an airflow velocity.

[0113] In some embodiments, the flow sensor may be a pressure sensor. In some embodiments, the pressure sensor may be a pitot tube. The pitot tube may be oriented within the detection unit (130) such that an opening in the front of the pitot tube is positioned in the airflow to measure stagnation pressure, while an opening in the side of the pitot tube can be used to measure static pressure. The difference between the stagnation pressure and the static pressure allows the user to calculate the airflow velocity.

[0114] In some embodiments, the vital capacity measurement data may include information about airflow and / or flow velocity. The above embodiments may be combined to provide multiple flow sensors within the detection unit (130). For example, a pitot tube may be combined with a vortex shedding sensor that may include a shedding element, for example, to calculate pressure differentials and vortex shedding frequencies, for example, to independently calculate the airflow velocity through each sensor. In some embodiments, multiple sensors may be distributed throughout the detection unit (130) or the nozzle (135) to calculate variations in airflow velocity through different areas of the detection unit. In some embodiments, the detection unit (130) or the nozzle (135) may include at least one, at least two, at least three, at least four, or at least five flow velocity sensors. In some embodiments, the flow velocity sensors may be located on the same surface of the detection unit (130) or the nozzle (135). In some embodiments, the flow velocity sensors may be located on different surfaces of the detection unit (130) or the nozzle (135). In other embodiments, the flow rate sensor may be located on the opposite surface of the detection unit (130) or the nozzle (135).

[0115] In some embodiments, the flow sensor may be a disposable flow sensor. In some embodiments, the flow sensor may be a single-use flow sensor. In some embodiments, the flow sensor may be a flow sensor used by a single subject. In some embodiments, the flow sensor may be replaceable after each use. In some embodiments, the flow sensor may be replaceable after each use by a subject.

[0116] Ambient air sensor

[0117] The detection unit (130) and / or base station (105) may include one or more ambient air sensors. In some embodiments, an ambient air sensor or an ambient sensor (10503) may be used to sense ambient air characteristics, such as temperature, humidity, or atmospheric pressure. In some embodiments, the ambient air sensor may be a temperature sensor, a humidity sensor (10503), a pressure sensor, or a combination thereof. The humidity sensor (10503) is used to measure the ambient air humidity level and / or to estimate the air humidity level at the detection unit (130) or base station (105). The ambient air pressure at the detection unit (130) or base station (105) may also be measured. In some embodiments, multiple ambient air sensors may be distributed throughout the detection unit (130) or base station (105) to calculate changes in ambient air characteristics across different areas of the detection unit (130) or base station (105). In some embodiments, the detection unit or base station (105) may include at least one, at least two, at least three, at least four, or at least five ambient air sensors. In some embodiments, the ambient air sensor may be located on the same surface of the detection unit (130) or the base station (105). In some embodiments, the ambient air sensor is located on different surfaces of the detection unit (130) or the base station (105). In some embodiments, the ambient air sensor is located on opposite surfaces of the detection unit (130) or the base station (105). In some embodiments, the ambient air sensor can be used to measure ambient air characteristics at one or more time points. Figure 24 As shown, the environmental sensor (10503) may be located in the base station.

[0118] Air volumetric flow rate can be affected by the amount of ambient humidity, temperature, and / or pressure. The devices provided herein may include temperature, humidity, and / or pressure sensors. By recording ambient air conditions before an individual uses the spirometer, these conditions can be controlled and kept as consistent as possible. In some embodiments, errors, such as all errors that may be associated with changes in ambient air characteristics, can be controlled using the methods, devices, and computer-readable media provided herein. In some embodiments, a temperature sensor can be used to report the ambient temperature in the room, which can then be regulated using a thermostat. In other embodiments, a humidity sensor can be used to report the ambient humidity in the room, which can then be regulated using a humidifier. In some embodiments, the spirometer described herein can compensate for and / or adjust spirometry data based on changes in environmental characteristics such as humidity, pressure, temperature, or combinations thereof. Ambient air sensors can be integrated into the spirometer or connected to it as peripheral devices.

[0119] Breath analyzer

[0120] The detection unit (130) or nozzle (135) may further include additional sensors for additional applications. In some embodiments, the detection unit (130) or nozzle (135) may include a fuel cell sensor for detecting ethanol in a breath sample. In some embodiments, the breath sample may be introduced into a fuel cell that may include a double platinum electrode. Ethanol may be oxidized by the fuel cell, thereby generating an electric current. The magnitude of the current may be proportional to the amount of ethanol in the breath sample, and the difference in current may be used to calculate an individual's blood-ethanol content. In some embodiments, the device provided herein may include one or more sensors to measure one or more gases. In some embodiments, the device provided herein may include a carbon dioxide (CO2) sensor and / or a carbon monoxide (CO) sensor.

[0121] Indicator element

[0122] In some embodiments, the detection unit (130) and the base station (105) may include one or more indicating elements. The indicating element (140) may include any mechanical, acoustic, or light-emitting component, including a vibrator, one or more speakers, a light bulb, a light-emitting diode (LED), or an icon display. Figure 8 , Figure 9 , Figure 11 and Figure 12As shown, one or more indicator elements (140) can be directly integrated into the detection unit (130). In some embodiments, the indicator elements (140) can be configured to allow a subject, medical professional, or user to monitor the indicator during testing. The indicator elements (140) integrated into the base station (105) can be configured to provide feedback to the subject and / or medical professional and / or user. One or more indicator elements (140) can be used to guide the subject during testing. In some embodiments, one or more indicator elements (140) can be independently activated or initiated by the detection unit (130). In some embodiments, one or more indicator elements (140) can be initiated by the user at the base station (105). The indicator elements (140) can have one or more colors, and the colors can be any frequency within the electromagnetic spectrum, including standard colors in the visible light spectrum from 380 nm to 700 nm. Different colors, frequencies, or intensities of flashes or flash patterns can be used to communicate with the subject or user of the device. For example, in some embodiments, indicator elements (140) of different colors can be used to prompt the subject or user through various actions. For example, a green LED can be used to prompt a subject to begin blowing, while a red LED can be used to prompt a subject to stop blowing. In a further embodiment, the indicator element (140) can prompt a subject to perform any single or combined action, including inhaling, exhaling, and holding air in the lungs. In some embodiments, multiple indicator elements (140) may be present, for example, an array of indicator elements (140) may be illuminated sequentially to inform a subject, for example, in some cases tracking a subject's blowing and notifying the subject when blowing is complete. In other cases, indicator elements (140) of different colors may be used, for example, a blue LED may be used to inform a subject or user that the detection unit (130) needs to be tilted or repositioned before the test can be performed. In some embodiments, a green LED may be used to indicate to a subject or user that the detection unit (130) component is ready for use. In a further embodiment, the indicator element (140) may respond to patient performance during a pulmonary function test; for example, when a subject inhales a sufficient volume, the indicator may flash, produce sound, and / or vibrate for a predetermined period of time to "guide" the subject through the test. In other embodiments, a green LED may be used, for example, to prompt a subject to maintain air inhalation. The subject can then be instructed to continue inhaling air until the green LED turns off, or another LED, such as the red LED, turns on.

[0123] In other embodiments, combinations of indicator elements (140) may be used in series. In some embodiments, a green LED and an audible beep may be used to instruct the patient to begin blowing, while a red LED and an audible buzz may be used to instruct the patient to stop blowing. In some embodiments, a series of LEDs may be arranged such that each LED lights up sequentially, for example, until all are lit, to provide the subject with instructions to begin and stop blowing into the detection unit. In some embodiments, one or more speakers may be used to play motivating cues, such as songs, while the subject is blowing. This feature may be used in conjunction with LED lights to help teach the subject to blow for longer. In some embodiments, the auditory signal may be a pre-recorded voice instructing the subject to begin and stop blowing. This signal may also be accompanied by additional indicator elements (140) such as flashing LEDs, additional speakers, or icons.

[0124] In some embodiments, one or more indicator elements (140) may be located on the base station (105). In some embodiments, one or more indicator elements (140) may be located on the detection unit (130). In other embodiments, one or more indicator elements (140) may be located on both the base station (105) and the detection unit (130). In some embodiments, both the base station (105) and the detection unit (130) may include the same indicator element (140). In some embodiments, both the detection unit (130) and the base station (105) may include LEDs. In some embodiments, both the base station (105) and the detection unit (130) may include different indicator elements (140). In some embodiments, LEDs may be located on the detection unit (130), while a speaker may be located on the base station (105). In some embodiments, an action icon may be present on the base station (105), while LEDs may be arranged on the detection unit (130). In some embodiments, the detection unit (130) may include at least one, at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine, or at least ten indicating elements (140). In some embodiments, the base station (105) may include at least one, at least two, at least three, at least four, at least five, at least six, at least seven, at least eight, at least nine, or at least ten indicating elements (140).

[0125] base station

[0126] The base station (105) may be configured to have a visual display (110). The visual display (110) may be part of an integrated base station or may be a separate component. The visual display (110) may be, for example, an organic LED, a liquid crystal display (LCD), a plasma, or a cathode ray tube. In some embodiments, the visual display (110) may include a touchscreen. In some embodiments, the touchscreen may allow an operator, user, and / or subject to interact directly with the visual display (110). In some embodiments, the touchscreen may allow an operator, user, and / or subject to manipulate or derive a subject's pulmonary embolism, compare the pulmonary embolism with one or more previous pulmonary embolisms, or annotate using the touchscreen interface. The visual display may have a diameter of at least, at most, or about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 inches. In some embodiments, the resolution of the visual display (110) may be at least 100, 150, 200, 250, 300, 350, 400, 450, 500, 550, 600, 650, 700, 800, 1000, 1200, 2000, 3000, or at least 5000 pixels per inch. In some embodiments, the operator, user, and subject may be the same person. In some embodiments, the operator, user, and subject may be different individuals.

[0127] In some embodiments, the spirometer disclosed herein may include a backlight power supply to provide sufficient power to the visual display. In some embodiments, the backlight may illuminate the visual display when the spirometer is in use. In some embodiments, the backlight may be turned off at least 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, or 300 seconds after the spirometer has been used. In some embodiments, the backlight may be turned off at least 1, 2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 25, 30, or 60 minutes after the spirometer has been used.

[0128] like Figure 25As shown in A-25B, spirometry readings and / or spirometry data may be presented on a visual display (110). In some embodiments, spirometry readings may be presented on the visual display (110) in real time. The visual display (110) may provide feedback to the user or subject. In some embodiments, the user may monitor one or more of icons, indicators, or other display tools that may inform the user of the validity of the test. In some embodiments, the count of the number of times the subject inhales the required volume of air into the lungs may be visually displayed. In some embodiments, a spirometry curve may be visible on the visual display (110) while the subject is performing the procedure. In some embodiments, the measurement curve and / or results may be printable.

[0129] like Figure 24 The base station (105) disclosed herein may include a power source (10501). In some cases, the power source may be a lithium-ion battery. In other embodiments, the base station (105) disclosed herein may include a charging transmitter coil. When the detection unit (130) is adjacent to the base station (105) containing the charging transmitter coil (10502), the charging transmitter coil (10502) may charge the detection unit (130) containing the charging receiver coil (13002).

[0130] Figure 24A base station (105) is shown. The base station (105) may include a visual display (110). The visual display (110) may include a touchscreen having a front glass (1101) and a display panel (10512). The base station (105) may include a fingerprint sensor (125). The base station may include a top cover (10515) and a bottom cover (10509). The base station may include a power button (10504) for powering on and off the base station (105). The power button (10504) may have a power button light guide (10505) that illuminates the area surrounding the power button (10504). The power button (10504) can be connected to a power source using a power cable (10508). The base station (105) may include a 3G antenna (10506). The 3G antenna (10506) may have a 3G antenna mast (10507). The base station (105) may include an environmental sensor (10503). The environmental sensor (10503) may be a humidity sensor that can be connected to a humidity sensor cable (10510). The base station (105) may further include a speaker (10511) that can provide instructions or feedback to a user or subject. The base station (105) may further include a power supply (10501), which may be a lithium-ion battery. The power supply may be encapsulated in battery compartment A (10513) and battery compartment B (10514). The base station (105) may include a charging transmitter coil (10502). When the charging transmitter coil (10502) is in close proximity to the charging receiver coil (13002), the charging transmitter coil (10502) can charge the power supply (13001) of the detection unit (130).

[0131] In some cases, the detection unit (130) and / or base station (105) may have one or more indicator elements (140), icons, or other mechanisms that provide feedback to inform the user or subject of various test errors. Test errors may include one or more of the following: submaximal inhalation, excessive extrapolation volume, submaximal impact, cough within the first second, premature termination, variable subject attempts, cessation of airflow from glottal closure or breath-holding, partially blocked mouthpiece, leakage, extra breath, positive zero flow error, negative zero flow error, or a combination thereof. In some embodiments, test errors may be displayed on a visual display (110).

[0132] In some implementations, several processing steps can be completed before the results are obtained and / or displayed, once the raw spirometry data has been transmitted to the base station. These steps may include sensor zero-flow correction (zero-flow drift correction), temperature correction, and quality assessment. In some implementations, zero-flow correction may include compensating for variations in the zero-flow sensor signal level. For example, drift can be corrected by changing the average value of the added signal in the direction opposite to the drift of the zero-flow sensor signal level.

[0133] In some implementations, the detection unit (130) and / or base station (105) may be integrated for use with any wireless or mobile technology platform, including smartphones, tablets, applications, or for use with third-party devices.

[0134] In some embodiments, the base station (105) may include an application that processes and transmits spirometry data. In some embodiments, the spirometry data may include all data related to the data obtained through the detection unit (130). In some embodiments, the application may be installed on the base station (105) prior to use. In some embodiments, the application may be pre-installed on the base station (105). In some embodiments, the application may be used to manipulate patient data using a touchscreen interface. In some embodiments, the application may display the pulmonary function variables described herein. In some embodiments, the application may export patient data to a cloud-based storage service.

[0135] Biometric sensors

[0136] The spirometer described herein may include at least one biometric sensor. The biometric sensor may be used by a user to verify the functionality of the spirometer and / or may be used to identify an individual before, during, or after the use of the detection unit (130) and / or the base station (105).

[0137] In some embodiments, the biometric sensor may be a fingerprint sensor (125). Any type of fingerprint sensor (125) known in the art can be used. In some embodiments, the fingerprint sensor (125) may be a capacitive sensor. A capacitive sensor may use an array of capacitor plates to image a fingerprint. When a subject's or user's fingerprint is swiped across or placed on or over the fingerprint sensor, the sensor can measure the capacitive coupling of the skin at the fingertip. Because the ridges of the fingertip are closer to the detector when swiped, the ridges can have a higher capacitance relative to the valleys of the fingertip. In some embodiments, the capacitive sensor may apply a small voltage to the finger to amplify the signal and thus provide a more accurate capacitive image of the fingertip.

[0138] In some embodiments, the fingerprint sensor (125) may be an optical sensor. In such embodiments, the detector can convert energy in light incident on the detector into electrical charge. In some embodiments, the detector may be a photodiode array detector. In other embodiments, the detector may be a phototransistor detector. In some embodiments, the sensor may include an LED to illuminate the finger and thus provide a more accurate optical image of the fingertip. In some embodiments, the optical sensor may be a charge-coupled device-based optical imager. In other embodiments, the optical sensor may be a complementary metal-oxide-semiconductor (CMOS)-based optical imager. In some embodiments, the fingerprint sensor (125) may be a thermal sensor. In some embodiments, an individual's finger may be placed on a sensor, which may include a thermoelectric material. The thermoelectric material may then measure the contact temperature of the finger. Ridges of the finger that are in contact with the thermoelectric material may be imaged, while valleys that are not in contact with the thermoelectric material in some cases may not be imaged. The temperature difference between the ridges and valleys of the fingertip can be used to form a thermal image of the fingertip.

[0139] In some embodiments, the fingerprint sensor (125) may be a pressure sensor. In such embodiments, fingerprints can be imaged by physical contact between an individual's fingertip and a thin film therein, in which a physical imprint of the fingertip can be recorded. In some embodiments, the pressure sensor may be a conductive film detector. In some embodiments, the sensor may comprise a double layer of electrodes on a flexible film. In some embodiments, the pressure sensor may be a microelectromechanical device (MEMS). In some embodiments, the sensor may comprise a tiny silicon switch on a silicon wafer, such that when a fingerprint ridge touches the switch, the switch closes and the ridge is electronically detected.

[0140] In some embodiments, the fingerprint sensor (125) can be a radio frequency (RF) sensor. A low-frequency RF signal can be applied to an individual's fingertip. The signal can then be read by a detector array, where each pixel operates like a tiny antenna. This detector array can then be used to provide an image of the fingertip contour pixel by pixel. In some embodiments, the fingerprint sensor (125) can be an ultrasonic sensor. In some embodiments, the sensor uses sound waves to penetrate the surface layer of the skin, which can provide a 3D image of an individual's fingerprint from the inside out. In some embodiments, the ultrasonic sensor can comprise steel, sapphire, glass, or plastic. In some embodiments, any of the above-described fingerprint sensors (125) can be used as a static fingerprint sensor (125). In some embodiments, the individual's finger can be placed still on a surface before image acquisition. In other embodiments, any of the above-described fingerprint sensors (125) can be used as a brush fingerprint reader, where the individual's finger can be dragged across the sensor, and the complete image can be assembled by pressing together partial images of the finger.

[0141] In some embodiments, the biometric sensor may be a retinal scanner. In some embodiments, the biometric sensor may be a facial recognition scanner. In some embodiments, the retinal scanner may include a small camera for capturing images of an individual's retina. In some embodiments, the retinal scanner may include an infrared light source for illuminating the retina. In some embodiments, the individual can position his or her eye near the lens of the retinal sensor before use. In some embodiments, infrared light can illuminate the individual's retina, and the camera can subsequently scan the individual's retina. The sensor can capture and analyze vascular patterns on a thin layer of nerves at the back of the eyeball that processes light. This vascular pattern is unique to the individual to allow for accurate identification of the individual.

[0142] In some implementations, an individual may be registered during the initial scan. In some implementations, a first biometric sensor may be used to acquire the individual's biometric information during registration. In some implementations, the biometric information acquired during registration may be stored on a base station (105) or a server. In other implementations, the biometric information may be stored in a cloud-based storage system. After registration, the biometric information may be compared with the biometric data captured during registration, which can be used to accurately identify the individual. As used herein, the term "registration" may mean the collection and storage of an individual's biometric data for future authentication. During registration, multiple scans of the individual's retina may be collected from various angles. In some implementations, the images may then be stored in a computer storage system contained in the base station (105). In other implementations, the images may be stored in a cloud-based storage system. After registration, subsequent retinal scans may be compared with the scans captured during registration, which can be used to accurately identify the individual.

[0143] In some embodiments, the biometric sensor may be a voice recognition scanner. The voice recognition scanner may include a microphone capable of recording and analyzing an individual's speech. In some embodiments, the base station (105) may include a microphone to record and translate an individual's speech. In other embodiments, the detection unit (130) may include a microphone to record and translate an individual's speech. A digital profile of an individual's speech can be recorded by the individual speaking. The spoken words can then be converted into segments consisting of several dominant frequencies, which can be used to construct a digital profile of the individual's speech. In some embodiments, the individual may be instructed to recite the alphabet. In other embodiments, the individual may be instructed to recite a series of numbers. In other embodiments, the individual may be instructed to recite a predetermined series of words. In other embodiments, a unique password may be given to the individual to recite, which can be used to definitively identify the individual in a subsequent authentication session.

[0144] In some embodiments, one or more biometric sensors described herein may be integrated into a base station (105). These biometric sensors may be electronically connected to a visual display (110). In this configuration, the biometric sensors may send electrical signals to the visual display (110) after being occupied by an individual. In some embodiments, the electrical signals may cause a visual image to appear on the visual display (110). For example, when a retinal scan matches a retinal scan registered in a database, the retinal scanner may send an electronic signal to the visual display (110), and the visual display (110) may subsequently display an image of the individual as additional identity verification. In other embodiments, the biometric sensors may be electronically connected to one or more indicating elements (140). For example, when a collected fingerprint image matches an image of an individual in a database, a fingerprint sensor (125) may send an electronic signal to a sound source, and the sound source may subsequently emit a sound indicating a successful match. In some embodiments, the base station (105) may contain at least one, at least two, at least three, at least four, or at least five biometric sensors. In some embodiments, at least one biometric sensor may be located between the visual display (110) and the docking bracket (120). In other embodiments, at least one biometric sensor may be located below the docking bracket (120). In some embodiments, at least one biometric sensor may be located above or below the visual display (110). In other embodiments, at least one biometric sensor may be located on the side or back of the base station (105).

[0145] In some embodiments, one or more biometric sensors may be integrated into the detection unit (130). In other embodiments, the biometric sensors may be electronically connected to one or more indicating elements (140) on the detection unit (130). For example, a fingerprint sensor (125) may send an electrical signal to a vibrating element indicating successful capture of a fingerprint image, which may cause the vibrating element to vibrate. In some embodiments, the detection unit (130) may include at least one, at least two, at least three, at least four, or at least five biometric sensors. In some embodiments, at least one biometric sensor may be disposed along the outer cylindrical wall of the detection unit (130). For example, a fingerprint sensor (125) may be disposed along the cylindrical wall such that when the detection unit (130) is gripped by an individual, the fingerprint sensor (125) engages with the individual's finger. In another embodiment, the biometric sensor may be attached to the top of the detection unit (130) and oriented in the direction of the nozzle (135). In some implementations, the orientation of the biometric sensor can allow biometric information to be collected while the patient is blowing air into the mouthpiece (135) of the detection unit (130).

[0146] In some implementations, both the detection unit (130) and the base station (105) may include one or more integrated biometric sensors. For example, the detection unit (130) may include a fingerprint scanner along the cylindrical wall, while the base station (105) may include a voice recognition sensor. For example, both the detection unit (130) and the base station (105) may include a fingerprint scanner. This example allows a patient to perform biometric authentication while holding the detection unit (130), while allowing a doctor or medical professional to perform biometric authentication separately to enter the base station (105).

[0147] In some embodiments, at least one biometric sensor may be separate from the base station (105) or the detection unit (130). In such embodiments, the biometric sensor may be modularly connected to the base station (105) or the detection unit (130). In some embodiments, at least one biometric sensor may be connected to the base station (105) via a Universal Serial Bus (USB) connection. In other embodiments, at least one biometric sensor may be connected to the base station (105) via a coaxial cable connection. In other embodiments, at least one biometric sensor may be connected to the base station (105) via an Ethernet cable such as a Cat5 or Cat6 cable. In other embodiments, at least one biometric sensor may be connected to the base station (105) via an optical fiber cable. In some embodiments, at least one biometric sensor may be wirelessly connected to the base station (105) via a Wi-Fi connection. In other embodiments, at least one biometric sensor may be connected to the base station (105) via a mobile data signal such as a 3G or 4G LTE data signal. In other embodiments, at least one biometric sensor may be connected to the base station (105) via a Bluetooth signal. In some embodiments, at least one biometric sensor may be connected to the detection unit (130) via a Universal Serial Bus (USB) connection. In other embodiments, at least one biometric sensor may be connected to the detection unit (130) via a coaxial cable. In other embodiments, at least one biometric sensor may be connected to the detection unit (130) via an Ethernet cable such as a Cat5 or Cat6 cable. In other embodiments, at least one biometric sensor may be connected to the detection unit (130) via an optical fiber cable. In some embodiments, at least one biometric sensor may be wirelessly connected to the detection unit (130) via a Wi-Fi connection. In other embodiments, at least one biometric sensor may be connected to the detection unit (130) via a mobile data signal such as a 3G or 4G LTE data signal. In other embodiments, at least one biometric sensor may be connected to the detection unit (130) via a Bluetooth signal.

[0148] Biometric-controlled access

[0149] In some embodiments, individual biometric authentication may be necessary for the operation of certain functions of the spirometer provided herein. In some embodiments, patient authentication may be necessary for the spirometer to function. For example, a patient may undergo fingerprint scanning on the detection unit (130) before blowing air into the nozzle (135) to calculate the patient's airflow. In another instance, a patient may undergo fingerprint scanning on the base station (105) and voice recognition scanning on the detection unit (130) before blowing air into the nozzle (135) to calculate the patient's airflow. In some embodiments, the user may be a healthcare provider. The healthcare provider may perform biometric authentication before the patient uses the spirometer. In some embodiments, both the healthcare provider and the patient may perform biometric authentication before the patient uses the spirometer. In some embodiments, law enforcement officers may biometrically authenticate another individual before they use the spirometer. In some embodiments, both law enforcement officers and the second individual may perform biometric authentication before the second individual uses the spirometer.

[0150] In some implementations, access to certain components of the spirometer described herein can be biometrically restricted to certain individuals. The spirometer provided herein can be configured to allow certain individuals specific rights based on their use of the spirometer. For example, a patient may only have the ability to activate and use the spirometer after biometric authentication, while a healthcare provider may have additional capabilities after biometric authentication, such as the ability to review patient information and transfer patient data. Furthermore, a patient may only have the ability to view and manage his or her own patient records after biometric authentication, while a healthcare provider may have the ability to review all patient records collected by the spirometer. In some implementations, biometric authentication can be used to access a local or cloud-based database server. This integration can eliminate the need for separate database authentication, thereby providing a user-friendly interface.

[0151] Figure 22 and Figure 32 An exemplary workflow for biometric authentication is described. Figure 22A single-user experiment is illustrated, in which the user and the subject can be the same individual. The user can perform biometric authentication by swiping their fingerprint on a fingerprint sensor (125) located on a base station (105). After authentication, the user can exhale through a first end of a mouthpiece connected to a detection unit (130) into a mouthpiece (135) wirelessly connected to the base station (105) until indicated by an indicator light to stop exhaling. A spirograph can be displayed on a touchscreen visual display (110) on the base station (105). Upon verification, the user can either locally output the data to local storage, such as a hard drive, or output the data to a cloud-based storage server.

[0152] Figure 32 A single-user, single-subject experiment is illustrated, where the user and subject can be different individuals. The user can perform biometric authentication by swiping their fingerprint on a fingerprint sensor (125) located on a base station (105). After this user authentication, the subject can authenticate using the fingerprint sensor (125) located on a detection unit (130). The subject can exhale into a mouthpiece (135) connected to the detection unit (130) (wirelessly connected to the base station (105)) until an audible audible prompt indicates that exhalation should cease. A lung capacity graph can be displayed on a touchscreen visual display (110) on the base station (105). Upon verification, the user can locally output the data to local storage, such as a hard drive; or the data can be output to a cloud-based storage server. As described above, Figure 32 The described workflow can provide enhanced security by restricting access to certain functionalities for users and by verifying the identity of subjects prior to the experiment.

[0153] Biometric authentication, as described herein, can be used to protect patient data collected via the spirometers described herein. In some cases, the collection, backup, and / or protection of patient data can be performed in accordance with HIPAA regulations. In some cases, the collection, backup, and / or protection of patient data can be performed in accordance with FDA regulations.

[0154] Data storage

[0155] Data collected from individuals using or having used spirometers can be stored using a variety of different media. In some embodiments, an integrated hard disk drive (HDD) can be used to store the data. In some embodiments, the HDD can be electrically connected to the base station (105). In some specific embodiments, the HDD can be a solid-state drive (SSD). In some embodiments, the HDD can be a SATA hard disk drive (SATA). In some embodiments, the hard disk drive can be an eSATA hard disk drive (eSATA). In some embodiments, the HDD can be removed from the base station (105).

[0156] In some embodiments, an external hard drive can be used to store data. In some embodiments, the external hard drive can be connected to the base station (105). In some embodiments, the external hard drive can be connected via a USB connection. In some embodiments, the USB connection can be a USB 2.0 connection. In some embodiments, the USB connection can be a USB 3.0 connection. In some embodiments, the external hard drive can be a solid-state hard drive. In some embodiments, the base station can include an SD card slot. In some embodiments, data can be stored on an SD card.

[0157] In some embodiments, the removable storage medium can be used to store data. In some embodiments, the removable storage medium can be a USB flash drive, for example, wherein the USB flash drive can be electrically connected to the base station (105) via a USB interface. In some embodiments, the removable storage medium can be a Memory Stick. In such embodiments, the Memory Stick can be electrically connected to the base station (105) via a Memory Stick adapter. In some embodiments, the removable storage medium can be an optical disc (CD). In some specific embodiments, the CD can be a DVD or Blu-ray disc, for example, a CD burner can be electrically connected to the base station (105) via a USB interface.

[0158] In some implementations, data may be stored wirelessly. In some implementations, data may be stored on a wireless hard drive. In some implementations, data may be stored on network-attached storage (NAS). In some implementations, cloud-based storage devices may be used to store data. In some implementations, biometric data may be transferred to one or more servers, databases, storage units including network-attached storage units, containers, or any combination thereof.

[0159] Multiple detection units

[0160] In some embodiments, the base station (105) can communicate with one or more detection units (130) simultaneously. In some embodiments, the base station (105) can communicate with at least one, at least two, at least three, at least four, or at least five detection units (130). In some embodiments, each detection unit can include multiple different biometric sensors, such as those described above. In some embodiments, each detection unit can include multiple airflow sensors, such as those described above. In some embodiments, the detection unit (130) can be electronically connected to the base station (105) via a USB connection. In some embodiments, the detection unit (130) can be electronically connected to the base station (105) using a coaxial cable. In some embodiments, the detection unit (130) can be connected to the base station (105) using an optical fiber. In some embodiments, the detection unit (130) can be connected to the base station (105) via a wireless connection. In some embodiments, the wireless connection can be a mobile data signal. In some specific embodiments, the mobile data signal can be a 3G or 4G LTE signal. In some embodiments, the wireless connection can be a Wi-Fi connection. In some embodiments, the wireless connection can be a Bluetooth connection.

[0161] In some embodiments, multiple detection units can be paired with a base station before use. In some embodiments, pairing can be performed by docking the detection units (130) to docking brackets (120) on the base station (105). In some embodiments, the base station (105) may include multiple docking brackets (120) to dock multiple detection units (130). In some embodiments, the base station (105) may include at least one, at least two, at least three, at least four, or at least five docking brackets (120).

[0162] In some implementations, physical contact between the detection unit (130) and any surface of the base station (105) can be used to pair the detection unit (130) to the base station (105) using a distance sensor as described above. In some implementations, the detection unit (130) is at least, at most, or about 1 cm, at least, at most, or about 2 cm, at least, at most, or about 5 cm, at least, at most, or about 10 cm, at least, at most, or about 15 cm, at least, at most, or about 20 cm, at least, at most, or about 25 cm, at least, at most, or about 50 cm, at least, at most, or about 75 cm, at least, at most, or about 100 cm, at least, at most, or about 150 cm, at least, at most, or about 200 cm, at least, at most, or about 250 cm, at least, at most, or about 300 cm, at least, at most, or about 350 cm, at least, at most, or about 400 cm, at least, at most, or about 450 cm, at least, at most, or about 500 cm, at least, at most, or about 600 cm, at least, at most, or about 700 cm from the base station (105). When the distance is at least, at most, or about 800cm, at least, at most, or about 900cm, at least, at most, or about 1,000cm, at least, at most, or about 1,100cm, at least, at most, or about 1,200cm, at least, at most, or about 1,300cm, at least, at most, or about 1,400cm, at least, at most, or about 1,500cm, at least, at most, or about 1,750cm, at least, at most, or about 2,000cm, at least, at most, or about 2,250cm, at least, at most, or about 2,500cm, at least, at most, or about 2,750cm, at least, at most, or about 3,000cm, at least, at most, or about 5m, at least, at most, or about 10m, at least, at most, or about 50m, or at least, at most, or about 100m, the detection unit (130) may be paired with the base station (105). In some implementations, the detection unit (130) can be paired with the base station (105) when the distance between the detection unit (130) and the base station (105) is 0 to about 100m, 0 to about 50m, 0 to about 25m, 0 to about 10m, about 1cm to about 5,000cm, about 1cm to about 4,000cm, about 1cm to about 3,000cm, about 1cm to about 2,000cm, about 1cm to about 1,000cm, about 1cm to about 500cm, about 1cm to about 250cm, about 1cm to about 200cm, about 1cm to about 150cm, about 1cm to about 100cm, about 1cm to about 50cm, about 1cm to about 25cm, about 1cm to about 20cm, about 1cm to about 15cm, about 1cm to about 10cm, or about 1cm to about 5cm.

[0163] In some embodiments, pairing of the detection unit (130) with the base station (105) can generate a visible indication on the detection unit (130) or the base station (105) using an indicator element (140) such as the LED described above. In some embodiments, pairing of the detection unit (130) with the base station (105) can generate an audio indication on the detection unit (130) or the base station (105) using an indicator element (140) such as the sound source described above.

[0164] power supply

[0165] In some embodiments, the base station (105) may include a power supply unit. The power supply unit may be capable of converting AC current into low-voltage regulated DC power for the internal components of the base station (105). In some embodiments, the power supply may be a general-purpose power supply (e.g., 110V 50 / 60Hz). In some embodiments, the power supply unit may be an original IBM power supply unit. In other embodiments, the power supply unit may be an ATX standard power supply unit. In some embodiments, the ATX standard power supply unit may be an ATX12V standard power supply unit.

[0166] In some embodiments, the detection unit (130) may include at least one battery. In some embodiments, the base station (105) may include at least one battery. In some embodiments, both the base station (105) and the detection unit (130) may include at least one battery. In some embodiments, the battery may be a cylindrical battery. In some embodiments, the cylindrical battery may be an AAA battery. In some embodiments, the cylindrical battery may be an AA battery. In some embodiments, the cylindrical battery may be a C battery. In some embodiments, the cylindrical battery may be a D battery. In some embodiments, the battery may be a non-cylindrical battery. In some embodiments, the non-cylindrical battery may be a 4.5-volt battery. In some embodiments, the non-cylindrical battery may be a 9-volt battery. In some embodiments, the non-cylindrical battery may be a 6-volt handlight battery. In some embodiments, the non-cylindrical battery may be a button cell battery. In some embodiments, the button cell battery may be a CR927 battery. In some embodiments, the button cell battery may be a CR1216 battery. In some embodiments, the button cell battery may be a CR1220 battery. In some embodiments, the button cell battery may be a CR1225 battery. In some embodiments, the button cell battery may be a CR1616 battery. In some embodiments, the button cell battery may be a CR1620 battery. In some embodiments, the button cell battery may be a CR2016 battery. In some embodiments, the button cell battery may be a CR2025 battery. In some embodiments, the button cell battery may be a CR2032 battery. In some embodiments, the button cell battery may be a CR2450 battery. In some embodiments, the button cell battery may be a CR2477 battery. In some embodiments, the button cell battery may be a CR927 battery.

[0167] In some embodiments, the battery may be a rechargeable battery. In some embodiments, the battery may be a non-rechargeable battery. In some embodiments, the battery may be an alkaline battery. In some embodiments, the battery may be a nickel-cadmium battery. In some embodiments, the battery may be a nickel-metal hydride battery. In some embodiments, the battery may be a carbon-zinc battery. In some embodiments, the battery may be a lithium-ion battery. In some embodiments, the battery may be a zinc-air battery.

[0168] If applicable, the spirometer may include an indication or marker of the remaining power in the power source. For example, a spirometer containing a rechargeable battery may include an indication of the remaining power and / or state of charge when in a charging configuration.

[0169] accelerometer

[0170] In some implementations, the base station (105) may include an accelerometer. In some specific implementations, the accelerometer may be included on the visual display (110). This configuration may allow an individual to interact with the visual display (110) in landscape or portrait mode depending on the orientation of the visual device.

[0171] In some embodiments, the detection unit (130) may include an accelerometer. In some embodiments, the detection unit (130) may include a gyroscope. In some embodiments, the detection unit (130) may include both a gyroscope and an accelerometer. In each configuration, the orientation of the detection unit (130) can be determined. The combination of an accelerometer and a gyroscope can provide a more precise measurement of the orientation of the detection unit (130) in three-dimensional space. For example, the combination of an accelerometer and a gyroscope can provide an indication of when the detection unit (130) is in the appropriate orientation relative to the base station (105) to provide effective wireless charging. This can be electronically coupled to an indicating element (140) as described above to provide a visible, audible, or mechanical indication of the appropriate orientation of the detection unit (130) relative to the base station (105).

[0172] Peripheral equipment

[0173] The spirometer provided herein can be configured to connect to one or more peripheral devices. Peripheral devices may be, for example, monitors, printers, computers, tablets, smartphones, other spirometers, fax machines, etc. Peripheral devices can be connected to the spirometer provided herein via any of the connection methods described herein. In some embodiments, the spirometer provided herein can be coupled to one or more peripheral devices. In some embodiments, peripheral devices may include health (e.g., medical) sensors / devices and / or environmental sensors / devices. For example, health sensors may include blood pressure monitors, pulse oximeters, scales, thermometers, blood glucose meters, pulse oximeters, and other similar devices and / or sensors. Environmental sensors / devices may include smoke detectors, CO detectors, and temperature sensors. In some embodiments, peripheral devices may include video capture devices, motion direction / motion trackers, accelerometers, gyroscopes, attitude sensors, GPS, temperature monitors, blood pressure monitors, biometric security devices, electrocardiogram (EKG / ECG) sensors, or electroencephalogram (EEG) sensors. In some aspects, the ECG may be a 12-lead ECG.

[0174] Language support

[0175] The spirometer provided herein can provide audible or visible information in one or more languages, such as English, Spanish, French, Chinese, Dutch, etc. In some embodiments, the spirometer provided herein can support multiple languages, including but not limited to German, English, French, Italian, Spanish, Polish, Portuguese, Swedish, Norwegian, Danish, Finnish, Lithuanian, Latvian, Estonian, Dutch, Greek, Catalan, Basque, Czech, Slovak, Arabic, Japanese, Chinese, Russian, Serbian, Croatian, Icelandic, Swahili, Bantu, Hindi, and other world languages.

[0176] Equipment settings

[0177] The spirometer described herein can be configured with minimal user setup requirements. In some cases, the spirometer can be configured to allow a "quick start" mode, enabling spirometry capture without requiring patient demographic information. In some cases, the spirometer can be configured with user-modifiable default settings. In some cases, the spirometer may prompt the user for parameters such as language, date, time, date / time format, time zone, daylight saving time, location information, and user information. In some cases, the spirometer may include a calendar function to track patient visits, whether scheduled or unscheduled. The spirometer may prompt the user for input and / or control of environmental conditions. In some cases, the spirometer may prompt the user to perform calibration. In some cases, the spirometer may perform calibration automatically.

[0178] Depending on the input settings, a spirometer can be configured to operate within a specific workflow by modifying the operating protocol. The spirometer can select appropriate reference values ​​based on the input settings. The spirometer can be configured to allow for multiple patient studies. In some cases, the spirometer can calculate criteria for inclusion, randomization, withdrawal, and notification in clinical trials tailored to a specific workflow. In some cases, different parts of a clinical trial (e.g., screening, treatment, follow-up) can be separate workflows.

[0179] The device or system described herein can be configured for operation by a right-handed or left-handed individual. In some cases, the user can adjust the brightness or volume of the visual display. In some cases, device settings can be reset to factory defaults.

[0180] Equipment and systems

[0181] The equipment and systems described herein can be used for spirometry or spirometry testing, or pulmonary function testing. The equipment or systems described herein may have a mass of less than 1000g, less than 900g, less than 800g, less than 700g, less than 600g, less than 500g, or less than 400g.

[0182] Lung capacity testing quantifies the quality of a subject's breathing. The process of breathing, also known as respiration, can be divided into two phases—inspiration and exhalation. Inspiration can involve drawing air into the lungs. Exhalation can involve expelling air from the lungs. During testing using the apparatus or system described herein, the subject can exhale into a mouthpiece (135), inhale through a mouthpiece, or breathe through a mouthpiece, and a flow sensor, as described herein, can measure volume and / or flow rate during inspiration, exhalation, or both. Data from lung capacity testing, also known as lung capacity data, can be used to assess pre-disease states, describe risk facts, and evaluate lung growth. Lung capacity data can also be used in clinical trials or for healthcare purposes by providing information, for example, that can be used to diagnose conditions, monitor or assess the prognosis of a subject or patient, quantify the severity of airway disease, or evaluate the effectiveness of treatment. Lung capacity data can also be used to monitor, screen, or investigate workers exposed to respiratory hazards.

[0183] In some cases, spirometry data can be collected by a single organization from multiple users, such as in clinical trials, hospitals, healthcare facilities, and from other organizations performing healthcare-related services. Clinical trial organizations include, for example, pharmaceutical companies, contract research organizations, and biotechnology companies, and these organizations can conduct global clinical trials in the field of respiratory therapy. The healthcare market, including research institutes and healthcare organizations such as hospitals and clinics, can collect spirometry data from diverse user groups around the world. The spirometers described herein can also be used for private purposes, such as by patients with chronic conditions or those chronically exposed to reagents or chemicals that can cause chronic conditions.

[0184] In some cases, lung capacity testing can be performed on test subjects or patients by clinical trial professionals or healthcare professionals.

[0185] The spirometer described herein can be a device or system used to perform pulmonary function tests or collect spirometry data. Spirometry can be used to diagnose many diseases, including asthma, bronchitis, pulmonary fibrosis, cystic fibrosis, chronic obstructive pulmonary disease (COPD), and emphysema. In some embodiments, individual spirometry measurements can be compared to standards. In some cases, these standards can be calculated based on an individual's age, height, and sex, as the diagnostic threshold for obstructive pulmonary disease varies according to body size and demographic subgroups. In some cases, spirometry data can be viewed in the form of a graph called a spirometry chart. In some embodiments, at least three spirometry charts can be generated to diagnose a specific obstructive disease. In some embodiments, spirometry charts can include volume-time spirometry charts. The basic volume-time curve may contain points corresponding to FEV1 and FVC. In some embodiments, spirometry charts can include flow-volume spirometry charts: the expiratory flow-volume curve can show the instantaneous airflow as a function of expiratory volume. This curve may also contain points corresponding to PEF and FVC. To generate a spirometry chart, the patient may exhale into the mouthpiece (135) for a period of time. In some embodiments, the patient or subject may exhale into the mouthpiece (135) for at least approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 20, 30, 40, 50, 60, 100 seconds or approximately 300 seconds. In some embodiments, the patient or subject may exhale into the mouthpiece (135) for at least 6 seconds and stop when the volume no longer changes for 1 second. Forced vital capacity (FVC), which may be the total volume of air exhaled during maximal expiratory effort, and forced expiratory volume in one second (FEV1), which may be the volume of air exhaled in the first second at maximal inhalation, can both be subsequently calculated from the spirometry chart. If both FVC and FEV1 values ​​are decreased, but the FEV1 / FVC ratio is normal, restrictive respiratory organ damage such as asthma, bronchitis, or emphysema may be present.

[0186] Table 1-1. Results of Lung Diseases and Vital Capacity Measurement

[0187]

[0188]

[0189] In some cases, the spirometers described herein can be used to diagnose, manage, or assess damage from lung conditions or diseases. The spirometers provided herein can be used to monitor disease progression and / or the effectiveness of specific treatments. The spirometers provided herein can be used to identify the cause of shortness of breath; for example, in some cases, spirometers can be used in patients with dyspnea symptoms to differentiate between respiratory and cardiac conditions. In some cases, spirometers can be used to differentiate obstructive lung diseases such as asthma, bronchiectasis, bronchitis, or chronic obstructive pulmonary disease (COPD) from restrictive lung diseases. Spirometers can also be used to assess the risk of injury or exposure to contaminants or chemicals; for example, it can be used to assess the risk of barotrauma during scuba diving or to assess the potential risk or impact of exposure to agents associated with occupational asthma. Spirometers can be further used to assess preoperative risks before anesthesia or surgery, to measure the effectiveness of treatment for lung-related conditions, and even to diagnose vocal cord dysfunction.

[0190] Reduce error

[0191] This document describes a spirometer that incorporates one or more mechanisms for overcoming sources of error. Overcoming sources of error can be a requirement for use in therapeutic or clinical trials. Spirometry data can be caused, for example, by systematic errors that may not be reduced when taking the average of observations or tests, thus posing a problem for clinical trial applications. Systematic errors in spirometry testing can include errors due to instrument malfunction, observation errors, operator errors, and environmental errors. Observation errors may be caused by errors that occur during measurement or data recording, which can lead to a difference between the measured value and the true value. Operator errors can be caused by errors produced by the user or individual performing the spirometry test, or by the subject or participant performing the test; for example, invalid spirometry readings can result from improperly performed tests if the subject does not perform the test correctly and / or if the user or test administrator does not inform the subject that they have not performed the test correctly. The spirometer described herein can employ a training or proficiency mode to allow users to train and / or demonstrate proficiency in operating the spirometer before use, thereby reducing operator error. Environmental variables, including temperature, humidity, and air turbidity, can also affect the quality and / or variability of spirometry test results.

[0192] A spirometer may include one or more mechanisms for reducing systematic errors. These mechanisms may include biometric sensors for identifying the user, test administrator, or subject. The biometric sensor may be, for example, a fingerprint sensor (125). Biometric sensors, such as fingerprint sensors (125), allow for convenient error identification and correction; for example, spirometry data collected by a specific test administrator or user can be analyzed relative to the remainder of the collected data to determine whether the test administrator or user properly performed the spirometry test. In some embodiments, the error-reducing mechanisms may also include improved sensors, such as sensors that detect the subject's position during the test to determine if the subject is leaning forward, which could lead to lung collapse and incorrect readings. Additional sensors may be included to detect environmental factors such as temperature, humidity, and air turbidity. In some embodiments, the test can be performed and displayed in real time on a screen that can be monitored by the user or test administrator. In some cases, the system or device may be configured to be calibration-free to avoid errors caused by user or subject mistakes. The system or device may include components that enhance the quality of user training by incorporating accelerometers, gyroscopes, or other sensors capable of detecting movement, orientation, or change in the position of the mouthpiece (135) or detection unit (130). Data transmission can be made directly from the detector unit to a dedicated base station (105) or system, wherein the data transmission can be processed without additional error-prone transmission steps. The device or system may be configured to facilitate easy interaction with the user interface, which can reduce operator error. The device or system may be configured to include a base station (105) and a wireless detection unit (130) to reduce testing errors caused by subjects restricted by vocal cords or confined to a restricted position during lung capacity testing. To identify sources of error, the base station (105) may be configured to analyze data or take the average of data by given variables, such as date, user / test administrator, environmental conditions, or other potential variables.

[0193] The devices or systems described herein integrate error reduction components into an easy-to-use platform for analyzing clinical trial or healthcare data. The user interface can be easy to use, allowing users, clinicians, or clinical trial professionals to perform rigorous error analysis using variables. In some implementations, error analysis can be performed manually by individuals such as clinicians or clinical trial professionals. In further implementations, the system can include user-friendly or automated mechanisms for error analysis or cross-correlation analysis of results, for example, under different environmental conditions or from specific users. The system or device can be configured to automatically perform error analysis or cross-correlation analysis between different variables or across different tests, for example, by calculating a statistical distribution from results of all users and comparing it with the distribution of results collected from specific users or test administrators. Devices or systems that integrate inputs of multiple variables, such as user identity, environmental conditions, and test validity, can facilitate more efficient methods and mechanisms for improving error identification and reproducibility in clinical trials, across different demographics, and across different climatic conditions. Improved devices and systems used with integrated testing and user quality mechanisms can improve the diagnostic quality of results by reducing the impact of noise and allowing comparisons between cleaner and more standardized datasets; a set of improvements may be crucial for health-based research struggling with the reproducibility dilemma of results.

[0194] In the event of errors caused by malfunctions of the spirometer described herein, the spirometer may have a function that allows technical support personnel to adjust the workflow status.

[0195] Types of tests

[0196] Different types of spirometers can be used individually or in combination, depending on the type of test being performed. As described above, the devices and systems provided herein allow for the integration of multiple detection units (130) with a single base station (105), which can allow for the use of multiple spirometers. In some embodiments, the spirometer can be a respiratory rate meter for measuring the rate at which gas passes through a fine sieve. In other embodiments, the spirometer can be a whole-body plethysmometer, in which the subject can be enclosed in a small space during measurement. In other embodiments, the spirometer can be fully electronic and does not require a fine sieve to detect pressure differences. The spirometer can be a stimulation spirometer for training or improving lung function. In other embodiments, the spirometer can be a peak flow meter for measuring a subject's expiratory capacity. In other embodiments, the spirometer can be a windmill type that utilizes a turntable to measure lung function. The spirometer can be a tilt-compensated spirometer that assesses and / or compensates for the subject's position during spirometry measurements. The spirometer can include a fuel cell sensor capable of measuring the amount of ethanol in a breath sample, which can be used to calculate an individual's blood ethanol content. In some cases, the spirometer described in this article can measure and generate a baseline for users with or without a disease or condition.

[0197] Lung function variables

[0198] The spirometer described herein can be operated according to the guidelines of the American Thoracic Society (ATS) and / or the European Respiratory Society (ERS). The spirometer provided herein can measure multiple lung function variables, including a non-limiting list of lung function variables disclosed herein. The spirometer can measure forced vital capacity (FVC), which measures the amount of air a subject can forcefully exhale after inhaling as deeply as possible. The spirometer can also measure forced expiratory volume (FEV), which is a measure of the amount of air a subject forcefully exhales in a single breath. The amount of air exhaled by a subject can be measured in 1 second (FEV1), 2 seconds (FEV2), or 3 seconds (FEV3). In some embodiments, the amount of air exhaled by a subject for at least 1 second, at least 2 seconds, at least 3 seconds, at least 4 seconds, or at least 5 seconds may be measured, depending on the spirometer test being performed. FEV1 / FVC can also be measured using the spirometer. A spirometer can be equipped to measure the airflow of exhaled breaths, utilizing 25% to 75% of the forced expiratory flow rate. The spirometer can measure peak expiratory flow rate (PEF), a measure of how much air a subject can exhale with maximum effort. PEF can be measured simultaneously with forced vital capacity (FVC). Maximum spontaneous ventilation (MVV) can also be measured by the spirometer, a measure of the maximum amount of air a subject can inhale and exhale in one minute. In some embodiments, MVV can be measured for at least 15 seconds, at least 30 seconds, at least 45 seconds, at least 1 minute, at least 2 minutes, at least 3 minutes, at least 4 minutes, or at least 5 minutes, depending on the spirometer test being performed. The spirometer can also measure slow vital capacity (SVC), a measure of the amount of air a subject can slowly exhale after inhaling as deeply as possible. The spirometer can measure total lung capacity (TLC), a measure of the amount of air in a subject's lungs after inhaling as deeply as possible. TLC can be the sum of VC and RV. In an additional embodiment, the spirometer can measure functional residual capacity (FRC), which can be a measure of the amount of air in the subject's lungs at the end of a normal exhalation. The spirometer can be further configured to measure residual volume (RV), which can be a measure of the amount of air in the subject's lungs after a complete exhalation; this test can be performed by inhaling helium or nitrogen and observing how much is exhaled. The spirometer can be configured to further measure expiratory reserve capacity (ERV), which can be a measure of the difference between the amount of air in the subject's lungs after a normal exhalation (FRC) and the amount after a forced exhalation (RV). Inspiratory volume (IVC) can also be measured, providing an input of the change in lung volume between maximal exhalation to residual volume and complete inspiration to total lung capacity.Slow vital capacity (SVC) can be measured by the amount of air a subject can exhale after taking the deepest possible breath.

[0199] In some respects, the systems disclosed herein can be used to determine, or help determine, one or more lung function measures. Total lung capacity (TLC) can be the volume of the lungs at maximum inflation, i.e., the sum of VC and RV. Tidal volume (TV) can be the amount of air entering or leaving the lungs during quiet breathing. TV can indicate the division of the lungs. In some cases, when tidal volume is measured as part of gas exchange calculations, the symbols TV or V may be used. T Residual volume (RV) can be the amount of air remaining in the lungs after maximal exhalation. Expiratory reserve (ERV) capacity can be the maximum amount of air that can be exhaled from the end of exhalation. Inspiratory reserve (IRV) capacity can be the maximum volume that can be inhaled from the end-inspiratory level. Inspiratory capacity (IC) can be the sum of IRV and TV. Inspiratory vital capacity (IVC) can be the maximum amount of air inhaled from the point of maximal exhalation. Vital capacity (VC) can be the amount of air exhaled after the deepest inspiration. Functional residual capacity (FRC) can be the volume of the lungs at the end of exhalation. Residual volume can be expressed as a percentage of total lung capacity (RV / TLC%). Forced expiratory flow rate (FEF) x This can be correlated with certain parts of the FVC curve, where the x modifier can indicate the amount of FVC already exhaled. FEF max It can be the maximum instantaneous flow rate reached during the FVC operation.

[0200] In some embodiments, vital capacity measurement data can be plotted as a spirometry chart. In some embodiments, a spirometry chart can be depicted as a volume-time plot. In other embodiments, a spirometry chart can be depicted as an airflow-volume plot. In some embodiments, a spirometry chart can be used to obtain numerical data on the mechanical properties of the lungs. In some embodiments, airflow parameters can be obtained from a spirometry chart. In some embodiments, airflow parameters can be an individual's FEV1, FEV2, or FEV3. In other embodiments, exhaled lung volume parameters can be obtained from a spirometry chart. In some embodiments, exhaled lung volume parameters can be an individual's FVC or SVC. In some embodiments, these obtained values ​​can be corrected for changes in ambient temperature or humidity between subsequent measurements.

[0201] The spirometry chart can be displayed visually on a visual monitor. In some cases, the spirometry chart can be displayed after the completion of a spirometry test. In some cases, the spirometry chart can be displayed in real time while the subject is performing the spirometry test. The spirometry chart can be transmitted to the storage device described herein and / or printed using a printer that communicates with the spirometer. In some embodiments, cross-device data transmission can be secure. In some embodiments, the transmitted data can be encrypted. In some cases, data can be transmitted and / or printed individually. In some cases, data can be transmitted and / or printed in batches. In some cases, data can be sent from the spirometer via email. The spirometer can convert the data into computer-readable formats such as png, pdf, jpeg, etc. The spirometer can capture, save, and / or print screenshots.

[0202] The spirometer can support action sequences or workflow branches. Furthermore, the spirometer can compile a list of all patients whose data has been collected. The spirometer can switch between collected patient data. In some cases, the spirometer can employ a waiting room function to switch between patients active in the access workflow. The spirometer can also allow disabling patient data from active workflows.

[0203] A spirometry chart can display the medications and / or dosages already administered to a patient. Once the spirometry procedure is complete, the spirometer can display reversible changes from before to after the dose. In some cases, reversible changes can be measured as a percentage. In some cases, reversible changes can be measured as absolute values. In some cases, the spirometer can display predicted values ​​for airflow parameters. In some cases, the spirometer can display a percentage deviation from the predicted values. The spirometer can allow authors to select predicted values ​​for specific patients. The spirometer may display errors, such as non-compliance with ATS or ERS guidelines.

[0204] Once the spirometry operation is complete, the user can process the spirometry data. In some cases, the user can select or deselect specific spirometry charts. In some cases, the user can add or delete data. In some cases, the user can add annotations or provide comments. In some cases, the user can modify patient demographics, such as the patient's date of birth, age, medication dosage, location information, etc. In some cases, the spirometer can recalculate airflow parameters based on any changes in the patient's demographics. Based on the user's processing, the spirometer can generate customized reports. In some cases, the report may have a header section, a body section displaying specific data defined in the report, a footer section, or a combination thereof.

[0205] In some cases, users can configure the format or the cells in which patient data is displayed. In other cases, patient data can be filterable.

[0206] Pre-calibration

[0207] In some implementations, spirometer calibration may be required at regular time intervals, and this calibration can be performed by personnel specifically trained for such calibration. Calibration may require shipping the spirometer unit to a third-party calibrator or manufacturer for routine calibration, which can result in instrument downtime and increased costs. This document provides pre-calibrated sensors that can be shipped in a calibrated state and therefore do not require initial calibration. Because routine use of the sensors may necessitate recalibration, replacing the sensors with new pre-calibrated sensors eliminates the need for routine calibration.

[0208] In some embodiments, the pre-calibrated breathing flow tube may rely on JAEGER technology. In some aspects, the pre-calibrated sensor may rely on JAEGER technology. In some embodiments, the breathing flow tube may be attached to the mouthpiece. In some embodiments, the mouthpiece may include the breathing flow tube.

[0209] In some embodiments, the air flow sensor and / or ethanol sensor in the detection unit (130) described herein can be standardized to a set standard. In such embodiments, each sensor can be pre-calibrated before initial use by an individual. Multiple pre-calibrated sensors can replace sensors requiring recalibration, thereby eliminating the need for routine calibration. In some embodiments, individual sensors can be calibrated specifically for an individual; for example, sensors can be swapped between individuals, giving each individual its own set of sensors. Before subsequent use by the same individual, sensors previously calibrated for that individual can be transferred to the detection unit (130), thus eliminating the need for recalibration for that individual.

[0210] Linking biometric data with vital capacity measurement data

[0211] In some implementations, individuals may perform biometric authentication before operating the spirometer provided herein. In some implementations, biometric authentication can be used to create a biometric profile for the individual. In such implementations, the individual's biometric data (e.g., fingerprints, retinal scans, etc.) can be associated with the individual's spirometry data after operating the spirometer. A subsequent biometric authentication session can then be used to establish a profile of the individual's spirometry data, which can be easily accessed by, for example, a healthcare provider or law enforcement agent. The process can allow for continuous monitoring of an individual's spirometry data over time on the same instrument, which can be used to assess the effectiveness of a given treatment or the progression of obstructive pulmonary disease.

[0212] Although the invention has been described with reference to preferred embodiments, it should be readily understood that various changes and / or modifications can be made to the invention without departing from its spirit.

[0213] In some embodiments, the spirometer disclosed herein may have one or more of the technical features disclosed in Table 2-2.

[0214]

[0215] IV. Examples

[0216] Example 1 – Fingerprint Biometric Registration

[0217] Before the initial use of the spirometer, fingerprint biometric data can be collected from the patient. The patient can swipe their fingertip across or place it over or on the optical fingerprint sensor at the base station. After swiping, an audible beep indicates successful fingerprint capture. This process can be repeated 3 to 5 times to generate accurate fingerprint registration data, which can be stored on a cloud-based server for future biometric authentication.

[0218] Example 2 – Registration of Retinal Biometrics

[0219] Before the initial use of a spirometer, retinal biometric data can be collected from the patient. The patient or healthcare professional holds the detection unit, which may contain a retinal sensor, so that infrared light is focused onto the patient's eye. The patient or healthcare professional holds the detection unit in the appropriate position centered on the eye until an audible beep indicates that an image of the patient's retina has been successfully captured. This process can be repeated 3 to 5 times to produce accurate retinal registration data, which can be stored on a cloud-based server for future biometric authentication.

[0220] Example 3 – Voice Recognition Biometric Registration

[0221] Before the initial use of a spirometer, voice recognition biometric data can be collected from the patient. The patient is given a unique phrase, which they recite aloud to a microphone attached to a base station. An audible prompt indicates successful voice capture. This process can be repeated 3 to 5 times to generate accurate voice recognition registration data, which can be stored on a cloud-based server for future biometric authentication.

[0222] Example 4 – Activation of the Spirometer Base Station

[0223] Before a patient uses the device, a doctor or healthcare professional can swipe or place their finger on a thermal or optical fingerprint scanner. Successful biometric authentication allows the spirometer base station to be activated before the patient uses it. Consecutive unsuccessful biometric authentication attempts can lock the spirometer base station, in which case alternative forms of authentication can be used to unlock it.

[0224] Example 5 – Activation of the Spirometer Detection Unit

[0225] Before a patient uses the device, the spirometer detection unit wirelessly connects to a spirometer base station. The base station is activated by the patient's biometric authentication. The patient holds the detection unit so that their finger comes into contact with an optical fingerprint scanner positioned along the outer cylindrical surface of the unit. Successful authentication results in an audible beep from a speaker on the unit, followed by an image of the patient appearing on a visual display, allowing a healthcare provider to perform additional physical examinations to ensure proper authentication. Unsuccessful authentication results in a beep from the speaker, indicating that authentication needs to be attempted again.

[0226] Example 6 – Collection of Expiratory Data

[0227] After biometric authentication activates the spirometer unit, a green LED on the unit prompts the patient to place the mouthpiece of the unit in their mouth and exhale into the unit. All air flows through the unit, where the exhaled air comes into contact with an ultrasonic flow sensor within the unit. After 5 seconds of exhalation, a red LED illuminates instead of the green LED, prompting the patient to stop exhaling. The flow rate can then be plotted as a function of time to construct a spirometry chart, which can subsequently appear on a visual display.

[0228] Example 7 – Collection of Inspiratory Data

[0229] After biometric authentication activates the spirometer unit, a green LED on the unit prompts the patient to place the mouthpiece of the unit in their mouth and exhale into the unit. All air flows through the unit, where the inhaled air comes into contact with the ultrasonic flow sensor and pitot tube within the unit. After 5 seconds of exhalation, a red LED illuminates instead of the green LED, prompting the patient to stop inhaling. The flow rate can then be plotted as a function of time to construct a spirometry chart, which can subsequently appear on a visual display.

[0230] Example 8 – Processing of Patient Lung Capacity Measurement Data

[0231] After collecting spirometry data from a patient, healthcare providers can review the data by interacting directly with a touchscreen visual display on the base station. They can annotate the current spirometry data appropriately, compare it to previously collected data from the same individual, and output the patient data to a cloud-based storage service that links the patient data to biometric data collected from that patient during enrollment.

[0232] Example 9 – Detection of Blood Ethanol Content (BAC) in Lung Capacity

[0233] Prior to use, law enforcement officers can activate the spirometer's base station via biometrics. The detection unit, which wirelessly connects to the base station, is then given to the individual to measure their blood alcohol content (BAC). The individual exhales into the detection unit's nozzle, where all exhaled air comes into contact with a dual platinum fuel cell within the unit. The oxidation of ethanol (if present) in the exhaled air generates an electric current. This current can then be converted into a blood alcohol content, which can be wirelessly transmitted to the base station and displayed on its visual display. The BAC data can be output and saved to a cloud-based server, or stored on an integrated hard drive contained within the base station for later retrieval.

[0234] Example 10 – Error Reduction

[0235] Before being used in a clinical trial environment, various parameters can be controlled to reduce errors to an appropriate level. Temperature and / or humidity and / or air pressure can be recorded using an ambient temperature sensor on the spirometer's detection unit before collecting spirometry data. A thermostat and / or humidifier can be used to maintain consistent levels throughout the clinical trial.

[0236] Each patient participating in the clinical trial can use a separate, pre-calibrated airflow sensor. A suitable sensor can be installed in the detection unit before using the spirometer. At least two forms of biometric authentication are used, including retinal scanning and fingerprint scanning, which can be used to actively identify patients and eliminate the possibility of misidentification. During spirometry data collection, the proper orientation of the detection unit can be monitored using gyroscopes and accelerometers on the unit. Sphygmometry data can be wirelessly transmitted in real time to a base station where it can be displayed on a visual monitor. If erroneous readings or instrument malfunctions occur before data is output to a cloud-based server, the healthcare provider can approve or disapprove the spirometry. The airflow sensor can be removed and stored for later use on the same patient, minimizing the impact of sensor variability.

[0237] Example 11 – Monitoring the progression of restrictive respirator injury

[0238] Spirometry can be used to examine patients suspected of having restrictive respirator impairment such as asthma or emphysema. After biometric authentication, the patient exhales into the mouthpiece for at least 6 seconds when prompted by a green LED, and stops when there is no change in volume for 1 second when prompted by a red LED. Forced vital capacity (FVC) is the total volume of air exhaled during maximal expiratory effort, while forced expiratory volume in one second (FEV1) is the volume of air exhaled in the first second at maximal inhalation; both can be calculated based on spirometry. If both FVC and FEV1 values ​​are decreased, but the FEV1 / FVC ratio is normal, restrictive respirator impairment such as asthma, bronchitis, or emphysema may be present. The patient can then be monitored over time, and healthcare providers can compare consecutive spirometry results to monitor the progression of restrictive respirator impairment through decreases in FVC and FEV1 values, or to monitor the effectiveness of treatment through increases in FVC and FEV1 values.

[0239] While exemplary embodiments have been shown and described herein, it will be apparent to those skilled in the art that such embodiments have been demonstrated by way of example only. Many variations, modifications, and substitutions will occur to those skilled in the art. It should be understood that various alternatives to the embodiments described herein may be employed. The scope of this disclosure is intended to be defined by the following claims, and is intended to cover methods and structures within the scope of these claims and their equivalents.

Claims

1. A system for assessing lung function, the system comprising: (a) A mouthpiece having a cylindrical body and a plurality of flow sensors, each flow sensor being disposed at a different location on the cylindrical body having a first end and a second end, wherein the first end is on the opposite side of the second end, at least the first end being configured to interact with a human mouth, wherein the flow sensors are capable of generating lung function data from a respiratory sample provided by a subject. (b) A wireless detection unit having an interface for receiving at least the second end of the mouthpiece, wherein the mouthpiece is removable from the wireless detection unit; (c) A base station configured to communicate with the wireless detection unit; (d) A first biometric sensor and a second biometric sensor, wherein the first biometric sensor is located on the base station and configured to collect biometric data of a user, and the second biometric sensor is located on the wireless detection unit and configured to collect biometric data of a subject, wherein the user and the subject are not the same person; and (e) A non-transitory computer-readable medium, including instructions, The nozzle is attached to multiple flow sensors. When executed by the system, the instructions cause: i) The base station receives lung function data. ii) The system authenticates the user based on the user's biometric data. iii) The system allows for the use of the user's biometric data to authenticate different users and determine different rights. iv) The biometric data of the user collected by the first biometric sensor controls access to an application, wherein the application provides access to operate the wireless detection unit, and v) The system authenticates the subject based on the subject's biometric data. The system is configured to perform cross-correlation analysis, which cross-correlates the lung function data generated by the subject with stored lung function data. The system is configured to select stored lung function data based on the identification information of one or more subjects, or based on multiple variables, including the identification information of one or more subjects and at least one of the following: the identity of the authenticated user, one or more environmental conditions measured when the breath sample was provided, and the validity of the lung function data. The system is configured to standardize the lung function data of the subjects based on cross-correlation analysis, and the standardized lung function data is used to assess the lung function of the subjects.

2. The system according to claim 1, wherein the flow sensor is a breathing flow tube.

3. The system of claim 1, wherein the computer-readable medium includes instructions, when executed by the system, causing the base station to receive the lung function data transmitted from the wireless detection unit.

4. The system of claim 1, wherein the computer-readable medium includes instructions that, when executed by the system, cause the system to authenticate the user based on the user's fingerprint.

5. The system of claim 1, wherein the wireless detection unit further comprises one or more indicating elements, the one or more indicating elements comprising one or more light-emitting diodes (LEDs).

6. The system of claim 1, wherein the base station further includes a visual display.

7. The system of claim 6, wherein the visual display includes animated icons that indicate the validity of the lung function data in real time.

8. The system according to claim 1, wherein the wireless detection unit includes the nozzle.

9. The system of claim 1, wherein the base station further comprises one or more indicating elements, the one or more indicating elements comprising one or more speakers.

10. The system of claim 1, wherein the base station further includes a touch screen display.

11. The system according to claim 1, wherein the base station further includes a docking bracket, the docking bracket including a charging transmitter coil.

12. A system for assessing lung function, the system comprising: (a) A mouthpiece having a cylindrical body and a plurality of flow sensors, each flow sensor being disposed at a different location on the cylindrical body having a first end and a second end, wherein the first end is opposite to the second end, at least the first end being configured to interact with a human mouth, wherein the flow sensors are capable of generating lung function data from a respiratory sample provided by a subject. (b) A wireless detection unit having an interface for receiving at least the second end of the mouthpiece, wherein the mouthpiece is removable from the wireless detection unit, wherein the wireless detection unit further includes a charging receiver coil. (c) A base station configured to communicate with the wireless detection unit, wherein the base station includes a touch visual display and a docking bracket, wherein the docking bracket includes a charging transmitter coil, and the docking bracket is sized and adapted to store the wireless detection unit and wirelessly charge the wireless detection unit. (d) A first biometric sensor and a second biometric sensor, wherein the first biometric sensor is located on the base station and configured to collect biometric data of a user, and the second biometric sensor is located on the wireless detection unit and configured to collect biometric data of a subject, wherein the user and the subject are not the same person; and (e) A non-transitory computer-readable medium, including instructions, The nozzle is attached to multiple flow sensors. When executed by the system, the instructions cause: i) The base station receives lung function data. ii) The system authenticates the user based on the user's biometric data. iii) The system allows for the use of the user's biometric data to authenticate different users and determine different rights. iv) The biometric data of the user collected by the first biometric sensor controls access to an application, wherein the application provides access to operate the wireless detection unit, and v) The system authenticates the subject based on the subject's biometric data. The system is configured to perform cross-correlation analysis, which cross-correlates the lung function data generated by the subject with stored lung function data. The system is configured to select stored lung function data based on the identification information of one or more subjects, or based on multiple variables, including the identification information of one or more subjects and at least one of the following: the identity of the authenticated user, one or more environmental conditions measured when the breath sample was provided, and the validity of the lung function data. The system is configured to standardize the lung function data of the subjects based on cross-correlation analysis, and the standardized lung function data is used to assess the lung function of the subjects.

13. The system of claim 12, wherein the flow sensor is a breathing flow tube.

14. The system of claim 12, wherein the wireless detection unit further comprises a gyroscope or an accelerometer.

15. The system of claim 12, wherein the nozzle further comprises an ethanol sensor.

16. The system of claim 12, wherein the flow sensor is pre-calibrated.

17. The system of claim 12, wherein the flow sensor is a disposable flow sensor.

18. The system of claim 13, wherein the breathing flow tube is a lilly-type breathing flow tube.

19. The system of claim 12, wherein the wireless detection unit transmits data to the base station via a network.

20. The system of claim 19, wherein the wireless detection unit transmits data to the base station via Bluetooth connection.

21. The system of claim 19, wherein the network is a wireless network.

22. The system of claim 21, wherein the base station employs short-range wireless communication.

23. The system according to claim 21, wherein the base station communicates with the wireless detection unit via Bluetooth, ZigBee, or infrared transmission.

24. The system of claim 12, wherein the touch visual display displays lung function data in real time.

25. The system of claim 24, wherein the touch visual display includes animated icons that indicate the validity of the lung function data in real time.

26. The system of claim 12, wherein the first biometric sensor is a fingerprint sensor.

27. A system for assessing lung function, the system comprising: (a) A mouthpiece having a cylindrical body and a plurality of flow sensors, each flow sensor being disposed at a different location on the cylindrical body having a first end and a second end, wherein the first end is opposite to the second end, at least the first end being configured to interact with a human mouth, wherein each flow sensor is capable of generating lung function data from a respiratory sample provided by a subject. (b) A wireless detection unit having an interface for receiving at least the second end of the mouthpiece, wherein the mouthpiece is removable from the wireless detection unit, wherein the wireless detection unit further includes a power supply and charging receiver coil. (c) A base station configured to communicate with the wireless detection unit via short-range wireless communication, wherein the base station includes a docking bracket and a touch visual display, wherein the docking bracket includes a charging transmitter coil, and the docking bracket is sized and adapted to allow the wireless detection unit to store the detection unit and wirelessly charge the wireless detection unit. (d) A first biometric sensor and a second biometric sensor, wherein the first biometric sensor is located on the base station and configured to collect biometric data of a user, and the second biometric sensor is located on the wireless detection unit and configured to collect biometric data of a subject, wherein the user and the subject are not the same person; and (e) A non-transitory computer-readable medium, including instructions, The nozzle is attached to multiple flow sensors. When executed by the system, the instructions cause: i) The base station receives lung function data. ii) The system authenticates the user based on the user's biometric data. iii) The system allows for the use of the user's biometric data to authenticate different users and determine different rights. iv) The biometric data of the user collected by the first biometric sensor controls access to an application, wherein the application provides access to operate the wireless detection unit, and v) The system authenticates the subject based on the subject's biometric data. The system is configured to perform cross-correlation analysis, which cross-correlates the lung function data generated by the subject with stored lung function data. The system is configured to select stored lung function data based on the identification information of one or more subjects, or based on multiple variables, including the identification information of one or more subjects and at least one of the following: the identity of the authenticated user, one or more environmental conditions measured when the breath sample was provided, and the validity of the lung function data. The system is configured to standardize the lung function data of the subjects based on cross-correlation analysis, and the standardized lung function data is used to assess the lung function of the subjects.

28. The system of claim 27, wherein the flow sensor is a breathing flow tube.

29. The system of claim 27, wherein the charging receiver coil is a wireless charging receiver coil.

30. The system of claim 27, wherein the wireless detection unit further comprises a gyroscope or an accelerometer.

31. The system of claim 27, wherein the nozzle further comprises an ethanol sensor.

32. The system of claim 27, wherein the flow sensor is pre-calibrated.

33. The system of claim 27, wherein the flow sensor is a disposable flow sensor.

34. The system of claim 28, wherein the breathing flow tube is a lilly-type breathing flow tube.

35. The system of claim 27, wherein the wireless detection unit transmits data to the base station via a network.

36. The system of claim 35, wherein the network is a wireless network.

37. The system of claim 36, wherein the base station communicates with the detection unit using ZigBee and infrared transmission.

38. The system of claim 36, wherein the base station communicates with two or more wireless detection units.

39. The system of claim 36, wherein the wireless detection unit and the base station are separated by a certain distance.

40. The system of claim 27, wherein the touch visual display displays lung function data in real time.

41. The system of claim 40, wherein the touch visual display includes animated icons that indicate the validity of the lung function data in real time.

42. The system of claim 40, wherein the touch visual display displays a user icon or subject icon that provides feedback on the successful collection of the data by the wireless detection unit.

43. The system of claim 27, wherein the base station further comprises a power supply.

44. The system of claim 27, wherein the charging transmitter coil is a wireless charging transmitter coil.

45. The system of claim 27, wherein the base station includes an environmental sensor, the environmental sensor being a humidity sensor, the humidity sensor being used to measure the environmental conditions of the one or more environmental conditions.

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