Smart Management of Medical Devices

Abstract

The medical device (100) includes an airway adapter (212, 312) configured to be connected to a patient's airway, a first sensor (104, 202, 302) configured to detect a first parameter (e.g., air flow rate, air pressure, O2 level, CO2 level, or humidity level) of a space fluidly connected to the airway adapter, a second sensor (104, 204, 304) configured to detect a second parameter (e.g., O2 level or air pressure) of the space, a display (216, 316), and a processor (510), wherein the processor is configured to: determine a relationship between the first parameter and the second parameter; identify a leak between the airway adapter and the patient's airway based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations; generate an alert indicative of the leak; and cause the display to output the alert. The medical device may include, for example, a bag valve mask (BVM), and the airway adapter may include, for example, a mask, a supraglottic airway device, or an endotracheal tube.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 63 / 476,253, entitled "Smart Management of Medical Devices," filed December 20, 2022, which is incorporated herein by reference in its entirety. [Background technology]

[0002] Medical devices, such as bag valve mask (BVM) devices, can be used to facilitate patient monitoring, facilitate patient treatment, or both. Healthcare professionals can use BVM devices in emergency situations where a patient has stopped breathing. BVM devices can be used to provide positive pressure ventilation to a patient. Healthcare professionals place the BVM device mask over the patient's face and deflate the BVM device bag, forcing oxygenated air into the patient's airway. BVM devices are frequently used outside of hospitals, in emergency rooms, or in intensive care settings where mechanical ventilation is not available. [Brief explanation of the drawings]

[0003] [Figure 1] 1 shows a diagram of an example of a medical device interconnected with a monitoring device and including one or more sensors.

[0004] [Figure 2] 1 shows a diagram of an example medical device including an air flow sensor and an air pressure sensor.

[0005] [Figure 3] 1 illustrates an example diagram of a medical device that includes one or more modular sensors.

[0006] [Figure 4] 1 shows a diagram of an example of a medical device that includes an air flow sensor, a CO2 sensor, and an air pressure sensor.

[0007] [Figure 5] 1 shows an example of a medical device and a modular sensor, and a schematic diagram of an example of an electrical circuit for the modular sensor.

[0008] [Figures 6A-6B] 1 shows a diagram of an example of a medical device being operated to provide ventilation.

[0009] [Figure 7] 1 illustrates an example of an environment in which a patient is treated in a critical care setting using a medical device that includes at least one sensor.

[0010] [Figure 8] 1 illustrates an example of signal flow for communication exchange between medical devices, monitoring devices, and treatment devices.

[0011] [Figure 9] 1 illustrates an example environment of a medical device equipped with one or more sensors and interconnected with a monitoring device and a relay device.

[0012] [Figure 10] 1 illustrates an example process for managing a medical device that includes an air flow sensor and an air pressure sensor.

[0013] [Figure 11] 1 illustrates an example process for managing a medical device that includes one or more modular sensors.

[0014] [Figure 12] 1 illustrates an example process for managing a medical device that includes an air flow sensor, a CO2 sensor, and an air pressure sensor. DETAILED DESCRIPTION OF THE INVENTION

[0015] In some environments, a bag valve mask (BVM) device may include sensors used to monitor a patient's condition. The patient's condition can be monitored based on various types of physiological parameters detected by various types of sensors. Various implementations described herein relate to techniques for identifying leaks using sensors in a bag valve mask (BVM) device. For example, the BVM device detects a physiological parameter and, in response to the physiological parameter, determines whether a leak exists between the medical device and the patient's face. In a specific example, the BVM device includes a sensor for detecting the flow rate of air within its cavity. In this or another example, the BVM device determines whether a leak exists between the medical device and the patient's face in response to the detected flow rate.

[0016] However, certain environments may be cluttered, noisy, and / or have poor visibility. Therefore, it is important that medical devices (e.g., BVM devices) used to facilitate patient monitoring and / or administer medical procedures have components that enable effective use of the medical device in a variety of environmental conditions, patient conditions, and / or caregiver conditions. Furthermore, in high-stress clinical and / or outdoor environments, users may encounter difficulties in maintaining and / or reliably maintaining a seal between the medical device and the patient's face. Furthermore, users may encounter difficulties in accurately measuring airflow rates at the medical device. Therefore, in some environments, it is desirable for a medical device to be able to measure various types of medical device data that enable operation of the medical device with minimal or no hindrance, difficulty, and / or uncertainty.

[0017] According to various implementations of the present disclosure, a medical device (e.g., a BVM device) measures medical device data. The medical device data may include airflow and air pressure data measured by sensors, physiological parameter data measured by modular sensors, and / or aggregate data measured by multiple sensors. One or more portions of the medical device data may be communicated to an external device and / or used to output video or audio instruction data. The medical device may include a user interface (UI) for outputting data and a transceiver for exchanging communications with another device.

[0018] The medical device includes sensors used to detect physiological parameters, such as air flow rate (i.e., "airflow") and pressure (e.g., air pressure). The physiological parameters include artifacts that indicate that the medical device is administering therapy (e.g., assisted ventilation) to the patient. The physiological parameters are detected in a space fluidly connected to the patient's airway. The therapy may include, for example, ventilation administered by a user deflating a bag on the medical device. The medical device measures ventilation volume by analyzing the airflow during ventilation. The medical device determines the ratio of air pressure to ventilation volume associated with ventilation. The medical device includes additional sensors for detecting additional physiological parameters, such as CO2 levels, O2 levels, humidity, temperature, and mask-to-face contact levels. The medical device determines whether a discrepancy exists between the ratio of air pressure to ventilation volume associated with ventilation and, in response to the discrepancy and / or the additional physiological parameters, determines whether a leak exists based on the discrepancy. The medical device outputs an alert in response to the leak being identified. Thus, implementations of the present disclosure allow the medical device to identify such discrepancies and accurately determine whether a seal is being maintained between the medical device and the patient.

[0019] As previously described in this disclosure, the sensors may be utilized to detect physiological parameters, but are not limited to such implementations. In various examples, any physiological parameter may be communicated from a sensor and / or from one or more devices comprising the sensors, which are communicatively connected to the medical device implementations described herein.

[0020] According to these or other implementations of the present disclosure, a medical device (e.g., a BVM device) includes a modular sensor utilized to detect a physiological parameter. The modular sensor connected to the medical device provides a temporary or permanent connection between the medical device bag and the medical device mask. The modular sensor detects the physiological parameter in a space within the medical device that is fluidly connected to a patient's airway. In some examples, the modular sensor is connected to the medical device along with another modular sensor utilized to detect another physiological parameter in the space. The physiological parameter, along with the other physiological parameter, is utilized to determine whether a leak is present. The medical device outputs an alert in response to the leak being identified. Thus, implementations of the present disclosure enable a medical device including a modular sensor to accurately determine whether a seal is maintained between the medical device and a patient.

[0021] According to these or other implementations of the present disclosure, a medical device (e.g., a BVM device) includes a sensor, a user interface (UI) (e.g., a display, an indicator, a speaker, a tactile feedback device, or a combination thereof), and a transceiver. The sensor is utilized to detect a physiological parameter. The UI and the transceiver are controlled based on the detected physiological parameter. The medical device includes a processor for determining metrics including an airflow-to-air pressure ratio. The physiological parameters include airflow, CO2 level, and air pressure. The processor measures other metrics including a ventilation-to-air pressure ratio, a difference between inspired and expired volumes, a difference between patient and provider respiratory rates, leak size, and end-tidal carbon dioxide partial pressure. The medical device determines whether a leak exists in a volume of the medical device fluidly connected to the patient's airway in response to the physiological parameter, another physiological parameter, the metrics, and / or another metric. Additionally or alternatively, the medical device determines instructional data, visual output data, and / or audio output data, and / or exchanges communications. Thus, implementation of the present disclosure enables a medical device that detects the above and / or other physiological parameters and / or determines the above and / or other indicators to accurately determine whether a seal is maintained between the medical device and the patient.

[0022] Implementations of the present disclosure relate to improvements in the field of medical devices, such as BVM devices. The implementations described herein can detect physiological parameters and determine indicators in a simplified and automated manner without requiring complex configuration, assembly, and interconnection of multiple devices. In some cases, the medical devices of the present disclosure can be used in medical settings, particularly in emergency situations where a rapid and accurate response to complex and / or unexpected patient conditions is required, due to the ability to detect various types of physiological parameters using various types of sensors that are customized and included in the medical device.

[0023] Various examples are described below with reference to the accompanying drawings.

[0024] FIG. 1 illustrates an example of a medical device 100 interconnected with a monitoring device 102 and including one or more sensors 104. In some cases, the medical device 100 is a ventilation device. For example, the medical device 100 includes a bag-valve-mask (BVM) device including a bag, a valve, and a mask. In this or another example, the mask includes at least one of a cover, a cushion (e.g., an inflatable air cushion), an air bladder, a pillow, a mat, etc., around an end of the mask that includes an opening. In this or another example, the bag may include an air bladder.

[0025] In various implementations, the medical device 100 includes a processor, which performs operations used, for example, to control and / or operate the medical device 100.

[0026] The mask forms a seal between the medical device 100 and the patient's face, creating a space fluidly connected to the patient's airway. The medical device 100 contains this space, which extends from the environment to the patient. The bag is deflated by the user, allowing air to ventilate through the medical device 100.

[0027] In some cases, the sensor 104 detects at least one physiological parameter. Examples of the sensor 104 include, for example, an air flow sensor, an air pressure sensor, a CO2 sensor, an O2 sensor, a humidity sensor, a temperature sensor, etc. Examples of the physiological parameter include, for example, air flow, air pressure, CO2 level, O2 level, humidity, temperature, etc.

[0028] In some examples, the medical device 100 detects a physiological parameter and / or measures at least one indicator to determine whether a leak exists in a space in the medical device fluidly connected to the patient's airway. The medical device 100 detects the flow rate and air pressure in this space. The medical device 100 determines ventilation by analyzing the airflow during ventilation, which involves bag deflation and release. As used herein, the term "tidal volume" and equivalent terms refer to the volume of air entering the patient's airway, the volume of air flowing through the ventilation device (e.g., BVM device), the volume of air exiting the ventilation device, or any combination thereof. The medical device 100 examines the ratio of ventilation volume to pressure multiple times during ventilation to determine discrepancies between these ratios.

[0029] As previously described in this disclosure, various types of physiological parameters are detected by the sensor 104, but are not limited to such embodiments. In some examples, the various types of physiological parameters include at least one of the patient's electrocardiogram (ECG), the patient's temperature, the patient's blood pressure, the patient's blood oxygenation (e.g., regional blood oxygenation (rSO), arterial blood oxygen saturation, plethysmographic blood oxygenation (SpO), etc.), the patient's heart rate, the patient's pulse rate, and one or more airway parameters. As used herein, the term "airway parameter" and terms synonymous therewith may refer to an indicator related to and / or indicative of air present in and / or flowing through the patient's lungs, trachea, pharynx, or oral cavity. Examples of airway parameters that may be included in the physiological parameters include parameters that indicate characteristics of the patient's airway, characteristics of the patient's breathing, or characteristics of the ventilation the patient is receiving, such as airway pressure (e.g., positive end-expiratory pressure (PEEP), plateau pressure, peak inspiratory pressure (PIP), etc.), airway flow, airway volume (e.g., inspired volume, expired volume, tidal volume, or minute ventilation), respiratory rate / ventilation rate, inspiratory and / or expiratory time, CO2 partial pressure, end-tidal CO2, O2 partial pressure, end-tidal O2, etc.

[0030] In various examples, the medical device 100 communicates with an oximeter device (not shown), such as a pulse oximeter, configured to detect the patient's SpO2. For example, the medical device 100 receives data from the pulse oximeter indicative of the patient's blood oxygenation. The medical device 100 may verify whether ventilation is accurate and sufficient and / or whether a leak exists in the seal between the medical device 100 and the patient's face based on the blood oxygenation. For example, the medical device 100 may determine whether assisted ventilation administered to the patient is sufficient by analyzing the patient's airway parameters, and further verify the sufficiency of the assisted ventilation by determining whether the patient's blood oxygenation is sufficient (e.g., by determining whether the blood oxygenation is above a threshold). In some cases, the medical device 100 infers or confirms the presence of a leak based, at least in part, on the patient's blood oxygenation being below a threshold. In such cases or in other cases, it may be determined whether oxygenated air is being delivered to the patient (e.g., whether the air being delivered contains more than a threshold percentage, level and / or amount of oxygenated air) by reference to blood oxygenation, and / or whether the patient's chest rises above a threshold level during inspiration (which may indicate the presence or absence of a leak).

[0031] As previously described in this disclosure, various types of physiological parameters may be utilized to determine whether a leak exists, but the disclosure is not limited to such aspects. In various cases, for purposes of performing any of the techniques described herein, any of the physiological parameters, such as parameters obtained from at least one pressure sensor in a mask cover (e.g., a bladder), at least one capacitance sensor inside or on the mask, at least one resistance sensor inside or on the mask, at least one pressure sensor inside or on the mask, a chest compression depth sensor, etc., may be used individually or in combination to determine whether a leak exists. In these or other cases, for purposes of performing any of the techniques described herein, any of the physiological parameters, such as parameters obtained from at least one pressure sensor, at least one capacitance sensor, at least one resistance sensor, at least one pressure sensor, a chest compression depth sensor, etc., may be used individually or in combination to determine whether a leak exists, instead of or in addition to physiological parameters obtained from another sensor, such as sensor 104.

[0032] As previously described in this disclosure, the medical device 100 may include a BVM device, but is not limited to such an embodiment. In some examples, the medical device 100 includes a gas source, components configured to transfer gas to and from the patient's airway, and an airway adapter configured to connect a ventilator to the patient's airway. For example, the gas source may include an O tank or other container for O-containing gas to be administered to the patient. In some cases, the components configured to transfer gas to and from the patient's airway include a manual device such as a BVM device (e.g., a bag valve device, e.g., a bag that a rescuer manually squeezes to propel gas into the patient's airway and then manually releases to encourage exhalation from the patient), or an automatic device such as a ventilator. In various cases, the medical device 100 includes at least one conduit (e.g., a tube, pipe, etc.) fluidly connected to the patient's airway through which air enters, flows through, and exits the patient's airway. In some cases, medical device 100 includes a BVM that includes multiple valves, such as a valve configured to prevent exhaled air from flowing into the bag, thereby preventing exhaled CO2 from being re-breathed. In various examples, the supraglottic airway device includes a bag attached to a tube that fits into the patient's glottic opening without being inserted past the vocal cords, or that otherwise delivers air to the patient's glottic opening. In various examples, medical device 100 includes a valve that selectively vents a fluid circuit connecting the interior of medical device 100 with the patient's airway and to the external environment.

[0033] In various cases, the medical device 100 includes an airway adapter (also called an "airway interface"). In some implementations, the airway adapter includes a mask that is placed on the patient's face (e.g., over the patient's mouth and nose), an endotracheal tube that is placed in the patient's trachea, or a supraglottic airway that is placed in the patient's pharynx.

[0034] In some examples, the sensor 104 of the medical device 100 comprises at least one modular sensor. Examples of modular sensors include removable sensors, separable sensors, temporarily connectable sensors, etc. For example, the modular sensor comprises at least one screw, at least one rivet, at least one clasp, at least one tongue, at least one fastener, at least one hook, at least one buckle, at least one pin, at least one screw, etc. In such examples or other examples, the modular sensor is adaptable and / or adjustable to allow connection of the modular sensor to the medical device 100 by press-fitting and / or compression-fitting the modular sensor to the medical device 100. The medical device 100 determines whether a leak exists in the volume of the medical device in response to the physiological parameter detected by the modular sensor.

[0035] In some examples, the physiological parameters detected by the medical device 100 include flow rate, CO2 level, and air pressure. The medical device 100 measures at least one indicator in response to the flow rate, CO2 level, and air pressure. Examples of the indicator include the ratio of ventilation volume to air pressure, the difference between inspired and expired volumes, the difference between the patient's respiratory rate and the provider's respiratory rate, the magnitude of the leak, and the end-tidal carbon dioxide partial pressure. As used herein, the term "inspired volume" and equivalent terms may refer to the volume of air entering the patient's airway and / or the volume of air exiting the ventilator. As used herein, the term "expired volume" and equivalent terms may refer to the volume of air exhaled from the patient's airway and / or the volume of air entering the ventilator from the patient's airway. The medical device 100 determines whether a leak exists between the face and the mask based on the flow rate, CO2 level, air pressure, and the indicator. The medical device 100 transmits a signal indicative of the leak via the transceiver and outputs an alert indicative of the leak via the display.

[0036] In various implementations, a leak is detected by analyzing at least one physiological parameter of the patient. For example, a leak is detected based on any of the physiological parameters being outside a predetermined physiological parameter range. In some examples, the predetermined physiological parameter range is determined based on patient data such as the patient's age, weight, height, etc., or any combination thereof. The patient data is received from the monitoring device 102 and / or via user input.

[0037] In some examples, a physiological parameter (e.g., a first parameter) of a space within a bag valve mask fluidly connected to a patient's airway and positioned on the patient's face is detected. In various examples, a physiological parameter (e.g., a second parameter) of the space within the bag valve mask is detected. For example, a relationship between the first parameter and the second parameter is determined. In some implementations, a change in the relationship between the first parameter and the second parameter over multiple ventilations administered to the patient through the bag valve mask is determined. Based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations, for example, a leak between the bag valve mask and the patient's face is identified. In some cases, an alert indicating the leak is output.

[0038] In some examples, the first physiological parameter includes an airflow rate and the second physiological parameter includes an air pressure level or an O2 level. A mismatch may be identified, for example, based on an initial similar relationship and then changing over multiple ventilations such that the relationship is no longer similar.

[0039] In some examples, the first physiological parameter includes a CO2 level and the second physiological parameter includes an O2 level. A mismatch may be identified, for example, based on an initial inverse relationship and then further identified based on the relationship changing over multiple ventilations such that it is no longer inversely related.

[0040] In some examples, the first physiological parameter includes a CO2 level and the second physiological parameter includes humidity or temperature. A mismatch may be identified, for example, based on an initial inverse relationship that has changed over multiple ventilations and is no longer inversely related.

[0041] In some cases, determining whether a leak exists is based solely on air pressure. For example, a leak can be detected by determining that the air pressure in the medical device 100 is below a predetermined threshold. If a leak is present, the air pressure may decrease, for example, due to oxygenated air being released into the atmosphere during the inhalation phase or air entering the medical device 100 from the atmosphere during the exhalation phase. In some implementations, a leak is detected based on changes in the air pressure waveform over time. For example, if the medical device 100 is properly sealed to the patient's face, the air pressure during the inhalation phase may increase over time due to increasing pressure from the patient's lungs as they fill with air. Thus, a leak can be detected if the rate of change of air pressure over time during the inhalation phase is below a threshold.

[0042] In some cases, a determination of whether a leak exists is made based on the ratio between the flow rate and the air pressure (e.g., the ratio of the flow rate to the air pressure). In various cases, a determination of whether a leak exists is made based on the ratio between the ventilation rate and the air pressure (e.g., the ratio of the ventilation rate to the air pressure). For example, when the medical device 100 is sealed to the patient's face, the flow rate may be expected to be positively correlated with the rate of change of the air pressure over time. That is, when the medical device 100 is properly sealed to the patient's face, it is expected that the pressure from the patient's lungs will increase as the amount of air in the lungs increases. In contrast, when a leak exists between the medical device 100 and the patient's face, the pressure observed at the medical device 100 will not change even if the amount of air entering and / or exiting the medical device 100 changes. In some examples, a leak is detected by comparing the ratio of the flow rate to the derivative of the air pressure over time to a threshold value and / or by comparing the ratio of the integral of the flow rate over time to the air pressure to a threshold value.

[0043] In some cases, the determination of whether a leak exists is based on a combination of at least one of air pressure, a ratio of flow to air pressure, and a ratio of ventilation to air pressure, and the ventilation rate. In some cases, the determination of whether a leak exists is based on humidity or temperature within a space fluidly connected to the patient's airway. For example, humidity or temperature within the patient's airway is used to determine whether a leak exists. In various cases, the determination of whether a leak exists is based on an inspiratory rate (e.g., respiratory rate) minus an expiratory rate (e.g., ventilation rate).

[0044] In various instances, a lack of a complete seal between the mask and face is indicated by an inhalation rate that is less than the exhalation rate. For example, a leak is indicated by a difference between the respiratory rate and the exhalation rate that is less than a threshold difference. A leak prevents air from entering the patient's lungs during exhalation, reducing the amount of air flowing into the mask and out of the patient's lungs during inhalation, for example.

[0045] In some examples, the leak determination is based on the compression level of the bag of the medical device being equal to or greater than a threshold compression level and the air pressure level being below a predetermined air pressure level. In some examples, the leak determination is based on a physiological characteristic when the compression level of the air bag of the medical device is equal to or greater than a threshold compression level, the physiological characteristic indicating a humidity level being below a predetermined humidity level.

[0046] In some examples, determining whether a leak exists includes determining the results of a mask seal assessment algorithm. The index including the result of the mask seal assessment algorithm is a value corresponding to the likelihood that a leak exists and that the leak will affect the patient's health status. The mask seal assessment algorithm includes performing an analytical hierarchy process. A first tier of the mask seal assessment algorithm includes, for example, calculating an index including a ratio of ventilation to pressure based on the current breath; and calculating an index including a ratio of ventilation to pressure based on each of at least one previous breath. For example, determining an index including an average value of the ventilation to pressure ratio. For example, calculating the average value of the ventilation to pressure ratio includes determining an average value of the ventilation to pressure ratio (e.g., the ratio of ventilation to pressure) based on the current breath and each previous breath.

[0047] As used herein, the term "breath" and cognate terms may refer to exhalation, which includes air flowing into a patient's lungs. As used herein, the term "volume" and cognate terms may refer to the amount of air entering a patient's lungs during breathing. As used herein, the term "pressure" and cognate terms may refer to the pressure level within a patient's lungs during breathing.

[0048] If the average ventilation-to-pressure ratio is determined to be below a threshold (e.g., a first threshold for the average ventilation-to-pressure ratio), a relatively low amount of air may be indicated, for example, due to some air leaking from the mask where the patient's face is separated from the mask. If the average ventilation-to-pressure ratio is determined to be above a threshold (e.g., a second threshold for the average ventilation-to-pressure ratio), a relatively low air pressure may be indicated, for example, due to some air leaking from the mask where the patient's face is separated from the mask. If the average ventilation-to-pressure ratio is determined to be between the first threshold for the average ventilation-to-pressure ratio and the second threshold for the average ventilation-to-pressure ratio, a no leakage between the mask and the patient's face may be indicated, for example.

[0049] In some instances, the change in the similar relationship between ventilation and air pressure indicates that the air pressure utilized by the lungs during inspiration and the ventilation volume during inspiration are consistent with the expected changes in air pressure and ventilation. For example, the presence of a leak may be identified based on inversely proportional changes in ventilation or air pressure between multiple ventilations. In various instances, a leak is identified by determining an inverse relationship between changes in ventilation and changes in air pressure based on increases in air pressure and decreases in ventilation.

[0050] The second tier of the mask seal assessment algorithm may include, for example, calculating an index including the difference between the inhaled and exhaled volumes (e.g., the difference between the inhaled and exhaled volumes). For example, if the difference between the inhaled and exhaled volumes is greater than a threshold difference between the inhaled and exhaled volumes (e.g., a first threshold difference between the inhaled and exhaled volumes), a leak may be present and the leak may be relatively large. For example, if the difference between the inhaled and exhaled volumes is less than a threshold difference between the inhaled and exhaled volumes (e.g., a second threshold difference between the inhaled and exhaled volumes), a leak may be present and the leak may be relatively small.

[0051] The third tier of the mask seal assessment algorithm involves calculating metrics, including, for example, capnography (e.g., EtCO2) (or "end-tidal carbon dioxide partial pressure"), to determine whether to issue an alert indicating a leak. Capnography may be calculated, for example, based on a difference between inspired and expired volumes being less than a second threshold value for the difference between inspired and expired volumes. For example, a relatively small capnography waveform (e.g., 10 millimeters of mercury (mmHg) or 5 mmHg) may indicate a relatively large impact of the leak on the patient's health. For example, a relatively large capnography waveform (e.g., 35 mmHg, 40 mmHg, 45 mmHg, etc.) may indicate a relatively small impact of the leak on the patient's health.

[0052] In some examples, the ratio of ventilation to air pressure is determined based on the current breath. In various examples, the ratio of ventilation to air pressure is determined based on each of at least one previous breath. For example, a larger ratio of ventilation to air pressure between successive breaths may indicate an increase in ventilation, a decrease in air pressure, or a combination thereof. An increase in ventilation, a decrease in air pressure, or a combination thereof may indicate, for example, a decreasing rate of leak and / or an improvement in leak. For example, a smaller ratio of ventilation to air pressure between successive breaths may indicate a decrease in ventilation, an increase in air pressure, or a combination thereof. A decrease in ventilation, an increase in air pressure, or a combination thereof may indicate, for example, a decreasing rate of leak and / or an improvement in leak.

[0053] For example, the ventilation-to-air pressure ratio of the current breath may be compared to the ventilation-to-air pressure ratio of a previous breath to determine whether the seal between the medical device 100 and the patient's face is trending worse or better. For example, a trend toward an improving seal may indicate that the user is addressing the leak and / or that the source of the leak is becoming less of a problem. A trend toward a worsening seal may indicate that the source of the leak is still present, e.g., a trend toward a worsening seal may indicate that the source of the leak may be becoming more of a problem.

[0054] In some examples, the medical device 100 may measure the patient's pulmonary compliance. Pulmonary compliance is, for example, the change in the volume of air within the lungs relative to a change in airway pressure. In some implementations, the medical device 100 includes a flow sensor configured to detect the flow of air into and / or out of the airways. For example, an in-line bidirectional flow sensor may be physically connected to an airway adapter and / or tubing in a fluid circuit within the medical device 100. The medical device 100 may be configured to calculate the volume of air entering or leaving the patient's lungs by integrating measurements of flow over time. In some examples, the medical device 100 further includes a pressure sensor configured to detect the pressure of air in the patient's lungs by detecting pressure within the fluid circuit of the medical device 100. In various implementations, the medical device 100 estimates the patient's pulmonary compliance by dividing the change in air volume by the change in air pressure. In various cases, the medical device 100 is configured to output an indication of pulmonary compliance or analyze the patient's condition based on pulmonary compliance.

[0055] For example, an alert may be output to warn the user to check for leaks, e.g., based on a lack of a good seal or a worsening seal trend after multiple ventilations (e.g., two ventilations, four ventilations, etc.). For example, an alert may not be output and / or the alert may be terminated if an alert was previously output, based on a lack of a good seal trend after multiple ventilations (e.g., two ventilations, four ventilations, etc.). In some cases, the number of ventilations utilized for outputting an alert or not outputting an alert may be relatively low if the rate of occurrence indicating a leak trend is greater than a leak rate threshold, or relatively high if the rate of occurrence indicating a leak trend is less than a leak rate threshold.

[0056] In some cases, medical device 100 used in a field such as an ambulance traveling over uneven terrain or windy roads, or in a noisy or chaotic environment where the user or medical device 100 may be bumped, roughly handled, or struck by objects may become askew or cause portions of the mask of medical device 100 to separate from the patient's face. By using at least one metric including, for example, the results of a mask seal assessment algorithm, ventilation-to-pressure ratio, inspiratory-to-expiratory volume difference, capnography, etc., a user may be able to accurately determine whether a leak exists even under adverse conditions during use in an ambulance or a chaotic field.

[0057] In various cases, the medical device 100 includes one or more additional sensors and / or is connected to one or more additional sensors via a wireless or wired connection. Examples of additional sensors include, for example, at least one pressure sensor in a mask cover (e.g., a bladder), at least one capacitance sensor inside or on the mask, at least one resistance sensor inside or on the mask, at least one pressure sensor inside or on the mask, a chest compression depth sensor, etc. These additional sensors may be located, for example, in the rim portion of the mask. For example, the rim portion of the mask, which may include the outermost portion of the mask, may include a material that is the same as or different from the at least one additional material of the mask. In such or other examples, the material of the rim portion may be the same type as or different from the at least one additional material of the mask. In various cases, the material of the rim portion may be softer, more flexible, harder, more rigid, etc. than the material of the other portions of the mask. In various cases, the rim portion of the mask is flexible and configured to achieve a fluid seal on the patient's face. The other sensors described above detect, for example, at least one electrical parameter. The capacitance sensor detects, for example, an electrical parameter including at least one capacitance (e.g., a capacitance level above a threshold capacitance level) or at least one change in capacitance based on an object contacting the capacitance sensor. The resistance sensor detects, for example, an electrical parameter including at least one resistance (e.g., an electrical resistance level below a threshold resistance level) or at least one change in resistance based on an object contacting the resistance sensor. Either of these parameters is detected during inhalation or exhalation of air.

[0058] In some cases, the medical device 100 and the monitoring device are connected to a relay device 106. The medical device 100 exchanges communications with the monitoring device 102 via a wireless connection 108 and / or a wired connection 110. The medical device 100 and / or the monitoring device exchanges communications with the relay device 106 via a wireless connection and / or a wired connection. The wireless connection and / or the wired connection through which the medical device 100 and / or the monitoring device exchange communications with the relay device 106 may be implemented in a manner similar to the wireless connection 108 and / or the wired connection 110. For example, the wired connection through which the medical device 100 and / or the monitoring device exchange communications with the relay device 106 may include the wired connection 110, and / or the wireless connection through which the medical device 100 and / or the monitoring device exchange communications with the relay device 106 may include the wireless connection 108.

[0059] In various cases, the medical device 100 includes a user interface (UI) that outputs physiological parameters. As used herein, the terms "user interface" and "UI," as well as equivalent terms, may refer to at least one hardware element configured to interact with a user by outputting and / or receiving signals to and from the user. The UI of the medical device 100 visually and / or audibly outputs the physiological parameters. For example, the UI of the medical device 100 includes a display, indicators, speakers, tactile feedback devices, or combinations thereof that communicate the physiological parameters. In some examples, the display of the medical device 100 outputs an airflow waveform showing airflow data over time and an air pressure waveform showing air pressure data over time.

[0060] In various examples, the medical device 100 presents, via a display, a numerical value and / or some type of visual representation of any physiological parameter in a manner similar to a waveform. In these or other examples, the medical device 100 audibly outputs, via a UI, a numerical value and / or some type of representation of any physiological parameter in a manner similar to a waveform. In various cases, the medical device 100 outputs, in any manner and / or visually and / or audibly, any number of physiological parameters or combinations thereof. In various cases, the medical device 100 visually, audibly, or otherwise outputs a numerical value and / or representation of any value calculated utilizing any number of physiological parameters discussed in this disclosure.

[0061] In various cases, the monitoring device 102 includes a UI (e.g., a display, an indicator, a speaker, a tactile feedback device, or a combination thereof) that outputs the physiological parameters. The UI of the monitoring device 102 outputs the physiological parameters visually and / or audibly. For example, the UI of the monitoring device 102 includes a display, a speaker, or a tactile feedback device that communicates the physiological parameters. In some examples, the display of the monitoring device 102 outputs an airflow waveform that shows airflow data over time and an air pressure waveform that shows air pressure data over time. The UI of the monitoring device 102 is controlled in exactly the same way as the medical device 100 and / or operates in the same manner as the medical device 100. For example, the airflow waveform and / or air pressure waveform output by the monitoring device 102 are the same as the airflow waveform and / or air pressure waveform output by the medical device 100.

[0062] To exchange data, the medical device 100, the monitoring device 102, and / or the relay device 106 are established and / or configured to communicate via at least one communication channel. As used herein, the term "communication channel" and its equivalents may refer to a medium for transmitting information from a first endpoint (e.g., a transmitter) to one or more second endpoints (e.g., receivers). Examples of communication channels include wired connections (also referred to as "wired interfaces") such as Ethernet, USB, HDMI, or fiber optic paths via physical wires and / or cables, and wireless connections (also referred to as "air interfaces") such as Institute of Electronics and Electrical Engineers (IEEE) (e.g., Wi-Fi, Bluetooth, etc.) and 3rd Generation Partnership Program (3GPP) connections (e.g., Long Term Evolution (LTE) and New Radio (NR)). As used herein, the term "endpoint" and its equivalents may refer to something configured to transmit and / or receive data. Examples of endpoints include user equipment (UE) (e.g., mobile phones, tablet computers, etc.), computers, base stations, access points (APs), servers, compute nodes, medical devices, and Internet of Things (IoT) devices.

[0063] In some implementations, a communication channel between the medical device 100, the monitoring device 102, and / or the relay device 106 is established when the medical device 100, the monitoring device 102, and / or the relay device 106 are paired. As used herein, the term "paired" and equivalent terms may refer to the state of two or more devices having a common link key that allows each device to cryptographically authenticate data received from another device.

[0064] In certain cases, data transmitted between the medical device 100, the monitoring device 102, and / or the relay device 106 may include encrypted data. This data is encrypted (e.g., converted from an unencoded format to another format (e.g., an encoded format)) and transmitted by either the medical device 100, the monitoring device 102, and / or the relay device 106. The encrypted data is received and decoded (e.g., converted from an encoded format to another format (e.g., an unencoded format)) by either the medical device 100, the monitoring device 102, and / or the relay device 106.

[0065] As previously described in this disclosure, the medical device 100, the monitoring device 102, and / or the relay device 106 are configured to establish and / or communicate, but are not limited to such aspects. In various cases, the medical device 100, the monitoring device 102, the relay device 106, other devices (e.g., oximetry sensors), and any combination thereof, directly or indirectly (e.g., via direct exchange and / or direct path) communicates (e.g., sends and / or receives) any data of any kind with the medical device 100, the monitoring device 102, the relay device 106, other devices, and any combination thereof.

[0066] As previously described in this disclosure, various types of data may be presented by the UI and / or transmitted by the transceiver of the medical device 100, but are not limited to such aspects. In some cases, data similar to the data presented by the UI and / or output in some manner may be transmitted by the transceiver in a manner similar to the UI used and / or used to manage data transmission from the transmitter, in order to implement the medical device 100 to perform any of the techniques discussed herein. In some cases, data similar to the data transmitted by the transceiver and / or output in some manner may be presented by the UI and / or used to manage data presentation by the UI in a manner similar to the transceiver used.

[0067] As previously described in this disclosure, various types of input data (e.g., user input data) may be received by the UI of medical device 100 and / or by the transceiver (e.g., received as user input via communications from a remote device operated by the user), but are not limited to such aspects. In some cases, for purposes of implementing medical device 100 to perform any of the techniques discussed herein, input data received by the UI and / or data similar to the input data received in some manner may be received by the transceiver in a manner similar to the UI and / or used to manage the receipt of the input data from a transmitter. In some cases, input data received by the transceiver and / or data similar to the input data received in some manner may be presented by the UI and / or used to manage the receipt of the input data by the UI in a manner similar to the transceiver.

[0068] As previously described in this disclosure, various thresholds may be utilized in various methods associated with the operation of the medical device 100, but such implementations are not limited to these. In some cases, the medical device 100 is configured to compare one or more values ​​described herein (e.g., values ​​of one or more ventilation parameters, blood oxygenation, or other parameters) to a collective threshold. For example, the medical device 100 is configured to determine whether an example parameter exceeds a first threshold and / or whether the example parameter is below a second threshold. If the medical device 100 determines that the parameter exceeds the first threshold or that the parameter is below the second threshold, the medical device 100 may, depending on the condition, output an alert or perform one or more additional functions described herein. In some implementations, the first threshold is greater than the second threshold. In some cases, the second threshold is greater than the first threshold.

[0069] 2 shows a diagram of an example medical device 200 that includes an air flow sensor 202 and an air pressure sensor 204. In some examples, the medical device 200 is the medical device 100 described above with reference to FIG.

[0070] In various implementations, the medical device 200 includes a processor, which performs operations used, for example, to control and / or operate the medical device 200.

[0071] In various examples, the medical device 200 includes a bag 206, an inlet valve 208, an exhalation valve 210, and a mask 212. The air flow sensor 202 and the air pressure sensor 204 are disposed, for example, in line with the bag 206 and the mask 212 of the medical device 200. In some cases, the mask 212 is configured to contact the patient's face. In some examples, the medical device 200 includes a tube 214 through which air flows during ventilation.

[0072] In some instances, the inlet valve 208 allows air to enter from the environment when fresh gas flow is inadequate. The exhalation valve 210 forces air into the patient's lungs, for example, in response to the mask 212 being placed on the patient's face and the bag 206 being squeezed. In various instances, the exhalation valve 210 allows air to leave the patient's lungs in response to the mask 212 being placed on the patient's face and the bag 206 being inflated (e.g., self-inflated).

[0073] In various cases, the medical device 200 includes at least one other sensor, such as a CO2 sensor, an O2 sensor, a humidity sensor, a temperature sensor, etc. The other sensor may be, for example, in line with the bag, mask, and valve of the medical device 200.

[0074] In some examples, the bag 206 is fluidly connected to the mask 212. The bag 206 and mask 212 enclose a space that is fluidly connected to the patient's airway. At a first time, ventilation occurs when the bag 206 is deflated and released (e.g., a first ventilation). In various examples, at a second time, ventilation occurs when the bag 206 is deflated and released (e.g., a second ventilation).

[0075] In some cases, the medical device 200 detects at least one physiological parameter and / or measures at least one indicator to determine whether a leak exists in a space of the medical device fluidly connected to the patient's airway. Examples of physiological parameters include, for example, air flow, air pressure, CO2 level (e.g., at least one of CO2 partial pressure, EtCO2 partial pressure, etc.), O2 level (e.g., O2 partial pressure), humidity, temperature, etc.

[0076] In various cases, the medical device 200 measures ventilation by analyzing the airflow during ventilation when a bag is deflated and released. As used herein, the term "ventilation" and terms synonymous therewith may refer to the operation of a ventilator and methods based on the operation of a ventilator, including a ventilation cycle in which a bag is successively deflated and released to allow air to flow into and out of a patient's lungs. A ventilation cycle includes, for example, the expiration and inspiration of air based on the deflation and release of a bag. Additionally or alternatively, as used herein, the term "ventilation" and terms synonymous therewith may refer to the operation of a ventilator and methods based on the operation of a ventilator, including the deflation of a bag to allow air to flow into and out of a patient's lungs. Additionally or alternatively, as used herein, the term "ventilation" and terms synonymous therewith may refer to the operation of a ventilator and methods based on the operation of a ventilator, including the deflation of a bag to allow air to flow into and out of a patient's lungs.

[0077] In various examples, the medical device 200 measures ventilation (e.g., a first ventilation) by analyzing airflow during a first ventilation, and measures ventilation (e.g., a second ventilation) by analyzing airflow during a second ventilation. In some examples, the medical device 200 determines a ratio of a first ventilation to air pressure (e.g., a first ratio) during the first ventilation and determines another ratio of a second ventilation to air pressure (e.g., a second ratio) during the second ventilation. The medical device 200 determines, for example, a discrepancy between the first ratio and the second ratio; and determines that a leak exists between the mask 212 and the patient's face in response to determining that there is a discrepancy between the first ratio and the second ratio.

[0078] In various cases, the medical device 200 includes a user interface (UI) (e.g., a display, an indicator, a speaker, a tactile feedback device, or a combination thereof) that is controlled based on the physiological parameter. For example, the UI includes a display 216 and an indicator 218.

[0079] In some examples, the medical device 200 causes an alert to be output on the display 216 indicating that a leak exists between the mask and the patient's face. The alert may be output temporarily, for example, for a predetermined period of time, or in some implementations, until the leak is stopped.

[0080] In some examples, the medical device 200 causes physiological parameter data indicative of the physiological parameter to be output to the display 216. For example, the physiological parameter data is output as at least one of text, graphical elements, geometric shapes, etc.

[0081] In some examples, the medical device 200 activates (e.g., illuminates) an indicator 218 to indicate the presence of a leak. The indicator 218 may be activated, for example, as a light, periodic light (e.g., flashing), or pattern light (e.g., light timed to a pattern indicating a dialogue word, or a pattern indicating the notes or beats of a song or the rhythm of a song), or as a color (e.g., red), depending on a threshold time (e.g., a first threshold time) to indicate the leak. For example, the indicator 218 may be activated as a light, periodic light (e.g., flashing), or color (e.g., green), depending on a threshold time (e.g., a second threshold time), to indicate that the leak is terminating (e.g., the leak has slowed or the leak has completely ceased). The type of light indicating the leak (e.g., the first light type) may be different from the type of light indicating that the leak is terminating (e.g., the second light type). In some cases, the type of light indicating a leak includes the indicator 218 being activated with a red periodic light until a first threshold time is reached or exceeded, and the type of light indicating a leak is closing includes the indicator 218 being activated with a green light until a second threshold time is reached or exceeded. For example, the indicator 218 is activated indefinitely (e.g., for a trigger-based time) and remains activated for a predetermined time (e.g., 10 seconds, 30 seconds, 1 minute, etc.) until the leak is closed.

[0082] In some examples, the medical device 200 activates a speaker in response to a threshold time (e.g., a first threshold time) to output a sound (e.g., a horn, chime, bell, etc.) at a volume (e.g., a first volume) to indicate the presence of a leak. For example, the medical device 200 activates a speaker in response to a threshold time (e.g., a second threshold time) to output a sound (e.g., a horn, chime, bell, etc.) at a volume (e.g., a second volume) to indicate that the leak is terminating (e.g., the leak has slowed or has completely terminated). In some cases, the first threshold time is different from the second threshold time. In some cases, the type of first sound is different from the type of second sound. In some cases, the first volume is different from the second volume. The sound output to indicate the presence or cessation of at least one leak can be constant, periodic, or in accordance with a pattern (e.g., a sound timed to a pattern indicating words in a dialogue, or a pattern indicating musical notes or beats or rhythms of a song). For example, a type of sound to indicate a leak can include a horn that is constant and is output for an indefinite period (e.g., for a trigger-based period) until the leak is cessation, and a type of sound to be output when the leak is cessation can include a bell that is output periodically for a predetermined period (e.g., 10 seconds, 30 seconds, 1 minute, etc.).

[0083] In some examples, the medical device 200 outputs audio including dialogue from a speaker. The type of dialogue output based on the presence of a leak (e.g., a first type of dialogue) is different from the type of dialogue output based on, for example, the leak being terminated (e.g., the leak has slowed or the leak has completely terminated) (e.g., a second type of dialogue). In some cases, the type of dialogue output based on the presence of a leak includes a notice or instruction informing the user of the presence of the leak, and the type of dialogue output based on the leak being terminated includes a notice or instruction informing the user that the leak has been terminated.

[0084] In some examples, the medical device 200 provides tactile feedback (e.g., vibration, movement, etc.) from a tactile feedback device. For example, the medical device 200 may activate the tactile feedback device in response to a threshold time (e.g., a first threshold time) to move the tactile feedback device with a certain magnitude of movement (e.g., a first magnitude of movement) to indicate the presence of a leak. For example, the medical device 200 may activate the tactile feedback device in response to a threshold time (e.g., a second threshold time) to move the tactile feedback device with a certain magnitude of movement (e.g., a second magnitude of movement) to indicate that the leak is terminating (e.g., the leak has slowed down, the leak has completely ceased, etc.). The tactile feedback device indicating the presence or cessation of at least one leak can be controlled to move steadily, periodically, or in a pattern (e.g., movement timed to a pattern indicating a dialogue word, or a pattern indicating the notes or beats of a song or the rhythm of a song). For example, the type of movement indicating a leak may be at least one of relatively fast and relatively large movement occurring for an unlimited period of time (e.g., over a trigger-based period) until the leak has ceased, and the type of movement at the time the leak has ceased may be relatively slow and / or relatively small movement occurring periodically over a predetermined period of time (e.g., 10 seconds, 30 seconds, 1 minute, etc.).

[0085] In various examples, the UI includes a display 216 that outputs the alert visually or audibly as an increasing alert characterized by a first alert level at an earlier time being lower than a second alert level at a subsequent time. In various examples, the UI identifies an alert override selection received via user input to the UI. The alert is, for example, muted or turned off based on the alert override selection.

[0086] In various examples, the medical device 200 includes at least one sensor. An example of the sensor is at least one electrode 220. The electrode 220 is disposed, for example, on the edge or rim of the mask and configured to detect an electrical signal. The medical device 200 detects the separation of the edge of the mask from the patient's face, for example, by analyzing the electrical signal. An example of the sensor included in the medical device 200 is at least one sensor provided inside the mask 212 in addition to or instead of the electrode 220 to detect pressure based on the application of the mask to the patient's face. For example, the sensor inside the mask 212 may be included in a cover, cushion (e.g., an inflatable air cushion), air bladder, pillow, mat, etc. of the mask 212. Additionally or alternatively, an example of the sensor is at least one sensor provided between the mask 212 and a portion of the medical device 200 to detect pressure based on the application of the mask to the patient's face. For example, a sensor between the mask 212 and a portion of the medical device 200 may be located between the mask and the neck of the medical device 200 .

[0087] In some cases, the medical device 200 includes an accelerometer configured to detect movement of the patient's chest. The medical device 200 detects separation of the mask from the patient's face, for example, by analyzing the movement of the patient's chest taking into account airflow or air pressure. In various cases, in response to detecting separation of the edge of the mask from the patient's face, the medical device 200 changes at least one of a UI feature (e.g., a first UI feature) or an intensity (e.g., a first intensity) of an alert (e.g., a first alert) to another UI feature (e.g., a second UI feature) or another intensity (e.g., a second intensity). For example, the medical device 200 increases the first intensity to a second intensity. The medical device 200 outputs an alert (e.g., a second alert) from a UI (e.g., a display, an indicator, a speaker, a haptic feedback device, or a combination thereof) to indicate that the mask is separated from the patient's face.

[0088] In various cases, the medical device 200 determines that the leak exceeds a severity threshold by analyzing the physiological parameters. For example, in response to determining that the leak exceeds the severity threshold, the medical device 200 changes at least one of a UI characteristic or the intensity of the first alert. For example, the medical device 200 causes a display to output a second alert indicating that the leak exceeds the severity threshold.

[0089] In various examples, changes to UI features based on the leak exceeding a severity threshold may include changing at least one of the following: the color of the indicator illumination or display output, the display format of the display 216 output (e.g., wording, graphical elements, geometric shapes, etc.), the brightness level of the indicator 218 illumination, the volume of the speaker output, the size of the wording, graphical elements, geometric shapes, etc. output by the display 216, the brightness level of the indicator 218, the brightness level of the wording, graphical elements, geometric shapes, etc. output by the display 216, the magnitude of the haptic feedback device movement, the type of sound output by the speaker (e.g., a steady sound, a patterned sound, etc.), the type of illumination of the indicator 218 (e.g., a steady light, a flashing light, etc.), the type of movement of the haptic feedback device (e.g., a steady motion, a patterned motion, etc.), the type of wording, graphical elements, geometric shapes, etc. output by the display 216 (e.g., a steady light, a flashing light, etc.), other UI features, and any combination thereof. In some cases, the level of the UI feature indicating a first alert is changed to a more aggressive level indicating a second alert.

[0090] In various cases, the medical device 200 determines that the leak has fallen below the severity threshold by analyzing physiological parameters at another time point (e.g., a second time after the first time point) based on determining that the leak exceeds the severity threshold at one time point (e.g., a first time point). In response to determining that the leak has fallen below the severity threshold, the medical device 200, for example, changes at least one of the UI features or the intensity of the second alert. For example, the medical device 200 causes a third alert to be output on the display (e.g., the intensity of the second alert is changed to a third intensity for the third alert). In some cases, the level of the UI feature indicating the second alert is changed to an even stronger level indicating the third alert. For example, the UI feature of the third alert can be controlled to be at the same level as the UI feature of the first alert.

[0091] In some examples, the medical device 200 measures the percentage of leaking air based on a physiological parameter, such as comparing the ventilation to a predetermined expected ventilation, the airflow to a predetermined expected airflow, or the air pressure to a predetermined air pressure. The medical device 200 determines an index including the percentage of airflow based on the comparison based on a table identifying the percentage of airflow corresponding to at least one of the ventilation, the airflow, and the air pressure.

[0092] In various cases, an additional notification, distinct from the leak closing notification or leak closing notification, is output to notify the user that the leak is slowing down, such as an intermediate notification that notifies the user that the leak is slowing down and the percentage of air that is escaping.

[0093] In some implementations, the medical device 200 identifies sensor status data associated with the air flow sensor 202 and / or the air pressure sensor 204. The sensor status data may include, for example, a sensor identifier, a sensor name, an identification number (or "ID number"), a sensor type, sensor calibration information, sensor compatibility information, a sensor lifespan, a sensor version number, and the like, or a combination thereof.

[0094] In various examples, the sensor status data is stored on the medical device 300. Additionally or alternatively, the sensor status data is transmitted to the monitoring device 102 and / or the relay device 106. In some examples, at least some of the data included in the sensor status data is presented on the display 316, the display of the monitoring device 102, and / or the display of the relay device 106.

[0095] 3 shows a diagram of an example of a medical device including one or more modular sensors. In some examples, the medical device 300 is the medical device 100 described above with reference to FIG. 1. In some implementations, the medical device 300 is the medical device 200 described above with reference to FIG. 2, but does not include at least one of the air flow sensor 202 and the air pressure sensor 204.

[0096] In various implementations, the medical device 300 includes a processor, which performs operations used, for example, to control and / or operate the medical device 300.

[0097] In various examples, the medical device 300 includes a bag 306, an inlet valve 308, an exhalation valve 310, a mask 312, a tube 314, a display 316, and an indicator 318. In some implementations, the bag 306, the inlet valve 308, the exhalation valve 310, the mask 312, the tube 314, the display 316, and the indicator 318 are the bag 206, the inlet valve 208, the exhalation valve 210, the mask 212, the tube 214, the display 216, and the indicator 218 described above with reference to FIG.

[0098] In various cases, the medical device 300 includes at least one connector to which at least one modular sensor is connected. For example, the modular sensor includes a modular sensor 302 electrically connected to the medical device 300 and at least one modular sensor 304 connected to the medical device 300. In some examples, at least one of the modular sensors 302 or 304 can be implemented in a manner similar to the air flow sensor 202, the air pressure sensor 204, or other sensors (e.g., CO2 sensor, O2 sensor, humidity sensor, temperature sensor, etc.), except that the modular sensor 302 or 304 is modular rather than a fixed sensor. In some examples, at least one of the modular sensors 304 can be implemented in a manner similar to the modular sensor 302.

[0099] In some examples, the modular sensor 302 is removably connected to the medical device 300. For example, a removably connected modular sensor 302 is detachably connected, temporarily connected, or otherwise connected to the medical device 300. In some implementations, the modular sensor 302 is physically and / or electrically connected to the medical device 300.

[0100] The connector may include, for example, at least one screw, at least one rivet, at least one clasp, at least one tongue, at least one fastener, at least one hook, at least one buckle, at least one pin, at least one screw, etc., or any combination thereof. The modular sensor 302 may include, for example, at least one screw, at least one rivet, at least one clasp, at least one tongue, at least one fastener, at least one hook, at least one buckle, at least one pin, at least one screw, etc., or any combination thereof. In various implementations, the connector and the modular sensor 302 may include a screw, rivet, clasp, tongue, fastener, hook, buckle, pin, screw, etc. to connect the modular sensor 302 to the connector, thereby connecting the modular sensor 302 to the medical device 300.

[0101] In some examples, the modular sensor 302 is connected to the medical device 300 without utilizing a connector, for example, if the medical device 300 does not include a connector for the modular sensor. In various examples, the modular sensor 302 is connected to at least one portion of the medical device 300, including a tube, a sleeve, a cover, a shell, the mask 312, the bag 306, any other portion of the medical device 300, or any combination thereof. The modular sensor 302 is connected to the medical device 300 based on, for example, a screw, a rivet, a clasp, a tongue, a fastener, a hook, a buckle, a pin, a screw, or the like, connected to at least one portion of the medical device 300.

[0102] In various implementations, for example, the modular sensor 302 is molded to fit snugly around at least one portion of the medical device 300, e.g., if the modular sensor 302 does not include screws, rivets, clasps, tongues, fasteners, hooks, buckles, pins, screws, etc. For example, the modular sensor 302 includes a flexible, bendable, elastic, adhesive, etc. material for connecting the modular sensor 302 to the medical device 300. Additionally or alternatively, the modular sensor 302 includes at least one flexible, bendable, elastic, adhesive, etc. connector for connecting the modular sensor 302 to the medical device 300, e.g., connector. For example, in instances where at least one of the modular sensors 302 or the connectors of the modular sensor 302 are adhesive, at least a portion of the modular sensor 302 or at least a portion of the connector is covered or coated with adhesive.

[0103] In some examples, the medical device 300 includes at least one of a slot, compartment, hole, inlet, receptacle, etc. that is used to connect the modular sensor 302 to the medical device 300. The modular sensor 302 is, for example, rigidly or loosely attached to the slot, compartment, hole, inlet, receptacle, etc., or combinations thereof.

[0104] In some examples, the modular sensor 302 is connected to at least one other modular sensor (e.g., modular sensor 304). For example, the modular sensor 302 is connected to another modular sensor via a screw, rivet, clasp, tongue, fastener, hook, buckle, pin, screw, or the like, or a combination thereof, to a screw, rivet, clasp, tongue, fastener, hook, buckle, pin, screw, or the like, or a combination thereof, of the other modular sensor. In some cases, the modular sensor 302 is connected to another modular sensor but is not directly connected to the medical device 300. In various cases, the modular sensor 302 is connected to the medical device 300 by being connected to another modular sensor.

[0105] In some examples, modular sensor 302 and another modular sensor are connected to each other to form a modular sensor assembly, which is removably connected to medical device 300, for example.

[0106] In various implementations, the modular sensor 302 is connected to, inserted into, or integrated with a case, cover, bracket, shell, etc., or combination thereof. For example, the case, cover, bracket, shell, etc., or combination thereof of the modular sensor 302 is removably connected to the medical device 300. In some examples, the modular sensor assembly is connected to, inserted into, or integrated with a case, cover, bracket, shell, etc., or combination thereof. For example, the case, cover, bracket, shell, etc., or combination thereof of the modular sensor assembly is removably connected to the medical device 300. In some cases, the modular sensor 302 and / or the modular sensor assembly is removably connected or rigidly connected to at least one fixed sensor (e.g., sensor 104) and / or medical device 200.

[0107] In some examples, the modular sensor 302 is electrically connected to the medical device 300 by direct or indirect contact. The electrical connection may be, for example, a wired or wireless connection. In various examples, direct contact includes physically connecting an electrical connector of the modular sensor 302 to an electrical connector of the medical device 300. In some implementations, the modular sensor 302 includes a transceiver.

[0108] In some implementations, the modular sensor 302 and the medical device exchange communications based on the electrical connector of the modular sensor 302 being conductive, capacitive, inductive, or a combination thereof. In some implementations, for example, in instances where the modular sensor 302 does not include an electrical connector physically connected to the electrical connector of the medical device 300, communications between the modular sensor 302 and the medical device 300 are induced and / or exchanged, for example, magnetically, capacitively, inductively, or a combination thereof. Physiological parameters detected by the modular sensor 302 are determined and / or transmitted to the medical device 300, for example.

[0109] In some examples, the modular sensor 302 is electrically connected to at least one of the monitoring device 102 or the relay device 106 via at least one of a wired connection and a wireless connection. In some examples, the wired connection and / or wireless connection utilized to exchange communications between the modular sensor 302 and the monitoring device 102 and / or the relay device 106 is implemented in a manner similar to the wired connection 110 and / or the wireless connection 108. For example, the wired connection utilized by the medical device 100 and / or the monitoring device to exchange communications with the modular sensor 302 includes the wired connection 110, and / or the wireless connection utilized by the medical device 100 and / or the monitoring device to exchange communications with the modular sensor 302 includes the wireless connection 108.

[0110] In some implementations, the medical device 300 determines that the modular sensor 302 has been connected to the medical device 300. The medical device 300 determines modular sensor status data associated with the modular sensor 302, for example, based on the modular sensor 302 being connected to the medical device 300. The modular sensor status data may include, for example, a sensor identifier, a sensor name, an identification number (or "ID number"), a sensor type, sensor calibration information, sensor compatibility information, a sensor lifespan, a sensor version number, etc., or any combination thereof. In various examples, the modular sensor status data includes a flag set based on the modular sensor 302 being connected to the medical device 300.

[0111] In various cases, the medical device 300 determines that a modular sensor assembly has been connected to the medical device 300. The medical device 300 determines, for example, modular sensor status data associated with at least one modular sensor (e.g., modular sensor 302) included in the modular sensor assembly.

[0112] In various examples, the modular sensor status data is stored on the medical device 300. Additionally or alternatively, the modular sensor status data is transmitted to the monitoring device 102 and / or the relay device 106. In some examples, at least some of the status data included in the modular sensor status data is presented on the display 316, a display of the monitoring device 102, and / or a display of the relay device 106. For example, a physiological parameter detected by the modular sensor 302 is transmitted to the monitoring device 102 and / or the relay device 106.

[0113] In various examples, the modular sensor 302 and / or modular sensor assembly is activated by the medical device 300, the monitoring device 102, and / or the relay device 106. In some examples, the modular sensor 302 and / or modular sensor assembly is deactivated by the medical device 300, the monitoring device 102, and / or the relay device 106. This activation and / or deactivation is performed, for example, to conserve power from a power supply of the medical device 300. The activation and / or deactivation is automatically controlled, for example, by the medical device 300, the monitoring device 102, and / or the relay device 106. The activation and / or deactivation is automatically controlled, for example, based on the modular sensor 302 and / or modular sensor assembly being connected and / or disconnected to the medical device 300. For example, the medical device 300 may send a signal (e.g., a status signal) to the monitoring device 102, activate an indicator on the medical device 300, and / or output status information via a display on the medical device 300 based on the modular sensor 302 being connected to or disconnected from the medical device 300. The signal may indicate, for example, that the modular sensor 302 has been connected to or disconnected from the medical device 300.

[0114] In some implementations, for example, activation and / or deactivation of the modular sensors is manually controlled by the medical device 300, the monitoring device 102, and / or the relay device 106 based on an activation or deactivation selection received via user input to the medical device 300, the monitoring device 102, and / or the relay device 106. This activation or deactivation selection is received, for example, via user input to at least one UI of the medical device 300, the monitoring device 102, and / or the relay device 106. The UI of the medical device 300, the monitoring device 102, and / or the relay device 106 includes a display, for example, a touchscreen. In some examples, the UI of the medical device 300, the monitoring device 102, and / or the relay device 106 includes at least one keypad, at least one mouse, at least one scroll wheel, at least one button, at least one toggle stick, at least one joystick, at least one touchpad, etc., or any combination thereof.

[0115] In some examples, the modular sensor 302 includes a display, a power storage device (e.g., a battery), and circuitry. In some implementations, the display of the modular sensor 302 is the display 506, described below with reference to FIG.

[0116] In various examples, the circuitry is included on a printed circuit board (PCB). The PCB includes, for example, at least one of a processor, a memory device, a voltage regulator, a transceiver, etc., or any combination thereof, connected to or integrated within the circuitry. In some examples, the PCB includes a bus and / or a microcontroller in addition to or instead of the circuitry and processor. The charger includes, for example, a wireless charger including an induction coil for wireless power reception, an induction coil for wireless power transmission, or a combination thereof. In some examples, the PCB includes a charging connector and a data connector.

[0117] In various implementations, the PCB is connected to the physiological parameter sensor via a connector. In some examples, the PCB is optically connected to the physiological parameter sensor. The type of physiological parameter sensor corresponds to, for example, the type of modular sensor 302. For example, the type of physiological parameter detected by the physiological parameter sensor corresponds to the type of physiological parameter sensor.

[0118] 4 shows a diagram of an example of a medical device including an air flow sensor, a CO2 sensor, and an air pressure sensor. In some examples, medical device 400 is medical device 100, medical device 200, or medical device 300 described above with reference to FIGS. 1-3.

[0119] In various implementations, the medical device 400 includes a processor, which performs operations used, for example, to control and / or operate the medical device 400.

[0120] In various examples, the medical device 400 includes a bag 406, an inlet valve 408, an exhalation valve 410, a mask 412, a tube 414, a display 416, and an indicator 418. In some implementations, the bag 406, the inlet valve 408, the exhalation valve 410, the mask 412, the tube 414, the display 416, the indicator 418, and the electrode 420 are the bag 306, the inlet valve 308, the exhalation valve 310, the mask 312, the tube 314, the display 316, the indicator 318, and the electrode 320 described above with reference to Figure 3. In some implementations, the bag 406, the inlet valve 408, the exhalation valve 410, the mask 412, the tube 414, the display 416, the indicator 418, and the electrode 420 are the bag 206, the inlet valve 208, the exhalation valve 210, the mask 212, the tube 214, the display 216, the indicator 218, and the electrode 220 described above with reference to Figure 2.

[0121] In various examples, the medical device 400 includes an air flow sensor 402 and an air pressure sensor 404. In some implementations, the air flow sensor 402 and the air pressure sensor 404 are the air flow sensor 202 and the air pressure sensor 204 described above with reference to Figure 2. In some various examples, the medical device 400 includes a CO2 sensor 422.

[0122] In some examples, the air flow sensor 402 is connected between the mask 412 and the bag 406. The air flow sensor 402 detects, for example, the flow rate of air flowing between the mask 412 and the bag 406. In some examples, the air pressure sensor 404 is connected between the mask 412 and the bag 406. The air pressure sensor 404 detects, for example, the air pressure. In some examples, the CO2 sensor 422 is connected between the mask 412 and the bag 406. The CO2 sensor 422 detects, for example, the CO2 level (e.g., at least one of CO2 partial pressure, EtCO2 partial pressure, etc.) of air within a space within the medical device 400. The space within the medical device 400 includes, for example, a space fluidly connected to the patient's airway.

[0123] In some cases, the medical device 400 includes at least one sensor, such as an O2 sensor, a humidity sensor, a temperature sensor, etc. In some implementations, the sensor is the sensor 104. In various implementations, the sensor detects physiological parameters including O2 levels (e.g., O2 partial pressure), humidity, temperature, etc.

[0124] In various implementations, the air flow sensor 402, the air pressure sensor 404, and the CO2 sensor 422 may be coupled to each other in any order, and in some examples, the air flow sensor 402, the air pressure sensor 404, and / or the CO2 sensor 422 are integrated into a single sensor.

[0125] In some examples, the medical device 400 determines that a leak exists between the face and the mask based on the flow rate, CO2 level, and pressure. In response to determining that a leak exists between the face and the mask, the processor may, for example, cause the transceiver 424 to transmit a signal indicative of the leak and / or output an alert indicative of the leak on a display.

[0126] In some implementations, the medical device 400 determines whether a leak exists based on an indicator including end-expiratory ventilation, mean ventilation, or a combination thereof. The end-expiratory ventilation, mean ventilation, or a combination thereof may be determined, for example, based on flow rate. In various examples, the medical device 400 determines end-expiratory ventilation, mean ventilation, or a combination thereof based on flow rate determined and integrated over time. The flow rate may be integrated over time, for example, to calculate ventilation. For example, a ventilation including a current volume of air (in milliliters (mL)) being delivered to the patient by the medical device 400 may be determined. For example, a ventilation including a current volume of air (in mL) being inhaled by the patient may be determined. For example, a ventilation including a current volume of air (in mL) being exhaled by the patient may be determined. In some examples, the end-expiratory ventilation may be determined (e.g., obtained) based on the end of ventilation or the end of breathing by the patient (e.g., the end of ventilation or the end of breathing based on air being exhaled). In some cases, the end-expiratory ventilation may be determined based on the end of ventilation or the end of breathing. The end-tidal ventilation is determined, for example, based on the ventilation volume, in a ventilation cycle that includes ventilation administered to the patient.

[0127] In some examples, the average ventilation is determined using at least one indicator including the end-expiratory ventilation. For example, the end-expiratory ventilation determined in a ventilation cycle is held until the next ventilation cycle. In various cases, any number of end-expiratory ventilations may be determined and held. For example, the average ventilation is determined based on the end-expiratory ventilation determined in a ventilation cycle.

[0128] In various cases, a face-to-mask leak is identified based on end-tidal ventilation, mean ventilation, or a combination thereof, for example, a face-to-mask leak is identified based on mean ventilation being below a mean ventilation threshold.

[0129] In some implementations, the medical device 400 determines that a leak exists in a space fluidly connected to the patient's airway based on an indicator including a ventilation-flow graph. In various examples, the ventilation-flow graph is determined based on at least one ventilation. The ventilation may include, for example, a ventilation based on an inspiratory cycle including the patient's inspiration (e.g., air flowing through the space in a first direction, e.g., air flowing from the medical device 400 into the patient's airway), a ventilation based on an expiratory cycle including the patient's expiration (e.g., air flowing through the space in a second direction different from the first direction, e.g., air flowing from the patient's airway into the medical device 400), or any combination thereof. The ventilation-flow graph may be determined based, for example, on a comparison of the ventilation during an inspiratory cycle with the ventilation during an expiratory cycle.

[0130] In various examples, the presence of a leak is identified based on a ventilation-flow graph, the ventilation-flow graph including a ventilation determined based on an inspiratory cycle and a ventilation determined based on an expiratory cycle. In some examples, the presence of a leak is identified based on a difference between the ventilation determined based on an inspiratory cycle and a ventilation determined based on an expiratory cycle being below a threshold difference. In various examples, the presence of a leak is identified based on a difference between a ventilation determined based on an inspiratory cycle (e.g., a first ventilation) and another ventilation determined based on another inspiratory cycle (e.g., a second ventilation) being above a threshold difference. In various examples, the presence of a leak is identified based on a difference between a ventilation determined based on an expiratory cycle (e.g., a third ventilation) and another ventilation determined based on another expiratory cycle (e.g., a fourth ventilation) being above a threshold difference.

[0131] In various examples, the presence of a leak is identified based on a ventilation-flow graph, including a local real-time ventilation-flow graph. The local real-time ventilation-flow graph is dynamically (e.g., in real time) determined by the medical device 400, for example, at a location near the patient's airway, and dynamically (e.g., in real time) presented by the display 416. With respect to the meaning of the local real-time ventilation-flow graph, the term "local" refers to a ventilation-flow graph presented by the medical device 400, for example, a ventilation-flow graph presented by the display 416. The local real-time ventilation-flow graph presented in real time by the display 416 includes, for example, a local real-time ventilation-flow graph presented during operation of the medical device 400. The display 416 has a resolution equal to or greater than a resolution threshold, for example, to present a ventilation-flow graph that is easily viewable by a caregiver.

[0132] In various examples, the presence of a leak is determined based on indicators including the patient's breath detection and breathing rate. The patient's breath detection and breathing rate are determined, for example, based on CO2 levels (e.g., at least one of CO2 partial pressure and EtCO2 partial pressure). In some examples, the patient's breath detection and breathing rate are determined based on the start of inspiration. In some examples, the patient's breath detection and breathing rate are determined based on the end of inspiration. The patient's breath detection and breathing rate are determined based on flow data including, for example, a flow rate detected at the start of inspiration and a flow rate detected at the end of inspiration. The patient's breath detection and breathing rate include, for example, a patient's breath detection and breathing rate determined based on the start and end of expiration. The flow data include, for example, a flow rate detected at the start of expiration and a flow rate detected at the end of inspiration.

[0133] In some cases, the flow data is used to measure, for example, breath duration. Breath duration may include, for example, the duration of an inspiratory cycle between the start and end of inspiration, the duration between the end of inspiration and the start of expiration, the duration of an expiratory cycle between the start and end of expiration, the duration between the end of expiration and the start of inspiration, or any combination thereof. For example, the breath rate may be calculated based on the reciprocal of the average duration of the most recent number of inspiratory and expiratory cycles (e.g., the most recent eight inspiratory and expiratory cycles). For example, the presence of a leak may be identified based on the breath rate being below a breath rate threshold (e.g., a first breath rate threshold) or above another breath rate threshold (e.g., a second breath rate threshold).

[0134] In various examples, the presence of a leak is determined based on an index including compression feedback via a ventilation index. The compression feedback via the ventilation index is determined based on, for example, an O2 level. The compression feedback via the ventilation index is determined based on, for example, noise in a capnogram. The capnogram is determined based on, for example, a detected CO2 level and includes at least one phase and at least one angle. The phases include, for example, an inspiratory phase and an expiratory phase. The angles include, for example, an alpha angle and a beta angle. The compression level within a predetermined time period is determined based on, for example, noise in the capnogram. The compression feedback is determined using only ventilation parameters based on the determined compression level. The presence of a leak is determined based on compression feedback including, for example, a compression level below a compression level threshold.

[0135] In various examples, the presence of a leak is identified based on an index including an adaptive inspiratory-expiratory ratio. The adaptive inspiratory-expiratory ratio is identified based on, for example, oxygenation feedback. For example, oxygenation feedback is identified, and the oxygenation feedback includes an oxygenation feedback parameter indicating how effective breathing is. The oxygenation feedback includes, for example, inspired O2 and exhaled CO2. For example, gas concentrations are measured based on inspired O2 and exhaled CO2. In some examples, the presence of a leak is identified based on a difference between the concentration of inspired O2, including inspired O2, and the concentration of exhaled CO2, including exhaled CO2, exceeding a threshold difference. For example, a concentration of inspired O2 that is too high compared to the concentration of exhaled CO2 indicates a potential problem with the patient's airway due to a leak. A potential problem with the patient's airway may indicate, for example, that alveolar diffusion is not occurring properly.

[0136] In various examples, the presence of a leak is identified based on an indicator including a distinction between respiration and ventilation. The distinction between respiration and ventilation may be based, for example, on exhalation. The distinction between respiration and ventilation may be based, for example, on a difference between the humidity of exhalation and the humidity of inspiration. In various cases, the presence of a leak is identified based on the difference between the humidity of exhalation and the humidity of inspiration being below a threshold difference. In some examples, the patient's respiration and ventilation are identified based on the difference between the humidity of exhalation and the humidity of inspiration. In some cases, for example, a user may return the patient to spontaneous breathing based on the difference between the humidity of exhalation and the humidity of inspiration being above a threshold difference.

[0137] For example, if the humidity of the exhaled air is higher than the humidity of the inhaled air, ventilation may be stopped to allow the patient to continue breathing normally, which may indicate that the patient does not need the medical device 400. The difference between the humidity of the inhaled air and the humidity of the exhaled air may exceed a threshold difference, indicating that the patient does not need the medical device 400.

[0138] In various examples, the presence of a leak is identified based on indicators including obstruction due to accumulated airway secretions. Obstruction due to accumulated airway secretions may be identified based on detected humidity, including, for example, humidity levels. The obstruction may include the space of the medical device 400 fluidly connected to the patient's airway, and the obstruction may be determined based on, for example, humidity. Obstruction due to accumulated airway secretions may occur, for example, based on an increase in the amount of airway secretions during long-term ventilation administered by the medical device 400. The obstruction due to accumulated airway secretions may cause problems depending on the hose material, including, for example, the material of the tube 414. Obstruction due to accumulated airway secretions may be determined based, for example, on humidity exceeding a humidity threshold. In various implementations, if an obstruction is identified in the airway, an alert based on obstruction due to accumulated airway secretions, or a combination thereof, is output. The alert may enable the user to, for example, clear the obstruction to relieve the obstructed airway, thereby continuing to maintain an adequate airway for the patient.

[0139] In some examples, any one or any combination of the indicators may be measured, for example, based on any one or any combination of the indicators, it may be determined that a leak exists in the airway of the medical device 400.

[0140] In various implementations, the coaching data identified based on any one or any combination of the indicators is determined, and the coaching data includes ventilation coaching data. The coaching data includes, for example, target tidal volume range data, which includes a target tidal volume range. The coaching data includes, for example, a graph, which may include a bar graph, a line graph, or a combination thereof. The graph may include, for example, a target tidal volume range, a current air volume integrated from flow data, or any combination thereof. In some implementations, the graph includes multiple bar graphs presented on the display 416 to provide feedback. The feedback may include, for example, instantaneous feedback or real-time feedback. In some cases, the feedback may include the volume of air detected by the medical device 400 and delivered to the patient. In some implementations, the graph includes a highlighted portion corresponding to a target volume range. For example, the highlighted portion clearly indicates the target volume range to the user, allowing the user to determine when to stop compressing the bag 406.

[0141] In some examples, the instructional data is presented on the display 416 or on a display of a sensor, including any of the air flow sensor 402, air pressure sensor 404, CO2 sensor 422, or a combination thereof.

[0142] In some cases, the medical device 400 outputs guidance data, such as audio guidance data or visual guidance data, in response to data determined by the medical device 400, the monitoring device 102, the relay device 106, or any combination thereof, including, for example, medical device data, monitoring device data, therapy device data, physiological parameter data, sensor status data, feedback data, or any combination thereof. In some examples, the guidance data is used to provide instructions to a caregiver, including a caregiver using the medical device 400 in an ambulance traveling on uneven terrain or windy roads. In some examples, the guidance data is used to provide instructions to a caregiver using the medical device 400 in the field, such as in a noisy or chaotic environment where the user may not be able to easily identify the treatment to provide to the patient. In these or other examples, the guidance data is used to provide instructions to a caregiver (e.g., a caregiver using the medical device 400 in an ambulance or in the field) in situations where the data determined and / or output by the medical device 400 cannot be easily received and / or processed by the caregiver, thereby enabling the caregiver to identify the treatment to provide to the patient. In various cases, the caregiver is a vocational caregiver, a caregiver with limited medical training, a caregiver with no medical training, or some other type of caregiver.

[0143] In some examples, the instructional data includes various types of instructional data configured, tailored, formatted, or any combination thereof, according to various levels of medical skill of caregivers. For example, the instructional data is output in a default mode selected by a user, a manufacturer, a distributor, a caregiver, or any combination thereof. The default mode may be identified and / or set to, for example, an unskilled caregiver level for cases where the medical device 400 is likely to be used by an unskilled person. The default mode may be set to, for example, an experienced caregiver level for cases where the medical device 400 is likely to be used by an experienced caregiver. The default mode may be set to various other levels for cases where the medical device 400 is likely to be used by various people with various levels of skill. Identifying these possibilities may include, for example, determining whether these possibilities meet or exceed a probability threshold.

[0144] In various implementations, the type of instructional data may be modified by a caregiver from the default level to another level before the instructional data is output, after a portion of the instructional data is output, or any combination thereof. The type of instructional data may be selected, for example, based on a selection of instructional data levels received via user input to the medical device 400. The various portions of the instructional data may include various levels of detail, including, for example, relatively comprehensive data for a less skilled caregiver level, detailed data, in-depth data, simplified data, etc., or any combination thereof. The various portions of the instructional data may include, for example, relatively abbreviated data for a more skilled caregiver level, specific data, complex data, etc., or any combination thereof. Any combination of various levels of detail may be used as the default or modified level of instructional data. The various levels of detail may be selected based on various instructional data detail selections received via user input to the medical device.

[0145] In some cases, different levels of detail may be selected for different types of medical procedures of the medical device 400. For example, different types of unskilled caregiver-level instructional data may be provided for medical procedures that may be familiar to caregivers, including unskilled caregivers, skilled caregivers, or a combination thereof. In some cases, different types of skilled caregiver-level instructional data may be provided for medical procedures that may not be familiar to caregivers, including unskilled caregivers, skilled caregivers, or a combination thereof. For example, for relatively specialized, rare, and infrequently used medical procedures of the medical device 400, the instructional data may be relatively comprehensive, detailed, thorough, concise, exhaustive, or any combination thereof. For example, for relatively common, known, and frequently occurring medical procedures of the medical device 400, the instructional data may be relatively abbreviated, specific, complex, or any combination thereof.

[0146] In some implementations, the instructional data includes instructions regarding the operation of the medical device 400. For example, a portion of the instructional data includes instructions indicating deflation of the bag 406, release of the bag 406, deflation level (e.g., current deflation, next deflation, number of next deflations, sequence of deflations), release level (e.g., current release, next release, number of next releases, sequence of releases), etc., or any combination thereof.

[0147] In various examples, the instructional data includes instructions for an operation involving any component of the medical device 400, such as the air flow sensor 402, the air pressure sensor 404, another sensor, the bag 406, the inlet valve 408, the exhalation valve 410, another valve, the mask 412, the tubing 414, the display 416, the indicator 418, the electrodes 420, the CO2 sensor, the transceiver 424, or the like, or any combination thereof. For example, the instructional data includes instructions for installing, removing, adjusting, inspecting, replacing, or the like, or any combination thereof, of any component of the medical device 400. In some examples, the instructional data includes instructions for operating the display 416 to provide user input utilized to perform some operation of the medical device 400.

[0148] In some examples, the instructional data includes instructions on how to repair or mitigate a leak between the mask 412 and the patient, if a leak exists. The instructional data may, for example, instruct the caregiver to verify that a portion of the mask is in the leaking area or that a portion of the mask may be in the leaking area. The instructional data may instruct the caregiver how to stop the leak, in some cases, for example, by repositioning the medical device 400 (e.g., the mask 412) or any combination thereof. The instructional data may instruct the caregiver how to stop the leak, for example, by removing an object between the mask 412 and the patient's face, such as an attachment of the medical device, an attachment of the patient, an attachment of the caregiver, a foreign object, a liquid, or the like, or any combination thereof.

[0149] The instructional data may include, for example, instructions to verify the integrity of the medical device 400, instructions on how to repair and / or replace components of the medical device 400, or any combination thereof. The instructional data may, for example, instruct a caregiver on how to stop a leak, in some cases by replacing or repairing a component such as the mask 412. In some examples, the instructional data may instruct a caregiver to update software on an electrical component of the medical device 400, or to disable a component, such as a malfunctioning component, e.g., a component with out-of-date software, or any combination thereof.

[0150] In various examples, the instructional data is output in an interactive format, such as by outputting a portion of the instructional data followed by a subsequent portion of the instructional data based on user input including a response to a query output via the portion of the instructional data. The interactive format may be used, for example, for the medical device 400 to output a portion of the instructional data from a larger set of available instructions by identifying an instruction or set of instructions. The identified instructions may be identified, for example, based on user input.

[0151] In some implementations, the coaching data includes instructions for operating other devices utilized in connection with the operation of the medical device 400. For example, the coaching data includes instructions for operating the monitoring device 102, the relay device 106, other devices, or any combination thereof. The coaching data includes, for example, instructions for obtaining data utilized by the medical device 400 to request and / or identify other data, such as medical device data, monitoring device data, therapy device data, physiological parameter data, sensor status data, feedback data, or any combination thereof.

[0152] In various examples, the instructional data, the level of detail of the instructional data, the type of instructional data, etc., or any combination thereof, is identified by the medical device 400, the monitoring device 102, the relay device 106, or any combination thereof. In some implementations, the user input utilized to identify and / or modify the instructional data is received by the medical device 400, the monitoring device 102, the relay device 106, or any combination thereof in various circumstances and then utilized in a manner similar to user input received by the medical device 400, as described above.

[0153] In some implementations, the instructional data is determined and / or output by the medical device 400, the monitoring device 102, the relay device 106, or any combination thereof, in a manner similar to the data determined and / or output by the medical device 400, the monitoring device 102, the relay device 106, or any combination thereof, as described throughout this disclosure. For example, the instructional data is output by the above devices or any combination thereof as audio data, image data, or any combination thereof.

[0154] In various implementations, the feedback data is received by the medical device 100, the monitoring device 102, the relay device 106, or any combination thereof. The feedback data includes data based on user input received by the medical device 100, the monitoring device 102, the relay device 106, or any combination thereof. The feedback data includes operating instructions, suggestions, treatment response information, treatment, device and / or sensor status information, etc., or any combination thereof.

[0155] In various implementations, the medical device 400 includes a power source. The medical device 400 includes, for example, a charging connector for receiving and transmitting power, a wireless charging device, or a combination thereof. The wireless charging device includes, for example, an induction coil for receiving wireless power, an induction coil for transmitting wireless power, or a combination thereof. The medical device 400 includes, for example, a wireless charging device but does not include a charging connector. For example, by not including a charging connector, the medical device 400 has a relatively higher international protection ("IPX") waterproof rating than a medical device 400 with a charging connector when the number of open connections of the medical device 400 is below a threshold number based on the medical device 400. The higher the waterproof rating, the less likely it is that the presence of, for example, blood or other bodily fluids will cause a medical problem, an operational problem with the medical device 400, or a combination thereof.

[0156] In various implementations, the medical device 400 exchanges communications via the transceiver 424 based on received signal strength indicator (RSSI)-based asset management. This communications may include, for example, data and physiological parameters determined by the medical device 400, the monitoring device 102, the relay device 106, or any combination thereof. This communications may include, for example, medical device data, physiological parameter data, sensor status data, coaching data, feedback data, or any combination thereof.

[0157] For example, the medical device 400 exchanges communications via the transceiver 424 based on signal strength. In some examples, based on the signal strength for communications between the medical device 400 and the monitoring device 102, between the medical device 400 and the relay device 106, or any combination thereof, falling below a signal strength threshold, the medical device 400 transmits a notification signal to the monitoring device 102, the relay device 106, or any combination thereof. The notification signal may be used, for example, to indicate that a ventilation coaching instruction is delayed. In some cases, the notification signal may be utilized to cause a message to appear on the display of the monitoring device 102, the relay device 106, or any combination thereof, informing the user that operation of the medical device 100 is delayed.

[0158] FIG. 5 shows an example diagram of a medical device 500 and a modular sensor 502, along with a schematic diagram of an example electrical circuit 508 of the modular sensor 502. In some examples, the medical device 500 includes a mask 504. In some implementations, the medical device 500 is the medical device 100, the medical device 200, the medical device 300, or the medical device 400 described above with reference to FIGS. 1-4. In some examples, the mask 504 is the mask 212, the mask 312, or the mask 412 described above with reference to FIGS. 2-4. In some implementations, the sensor 502 is any of the sensors of the medical device 100, or the sensors 302 or 304 described above with reference to FIGS. 1 or 3. In some implementations, the modular sensor 502 is implemented similarly to the sensor 202 or the sensor 204, or the sensor 402, the sensor 404, or the sensor 422 described above with reference to FIGS. 2 or 4, except that the modular sensor 502 is modular.

[0159] In some cases, the modular sensor 502 includes a user interface (UI) (e.g., a display, an indicator, a speaker, a tactile feedback device, or a combination thereof). For example, the UI includes the display 506.

[0160] In some examples, the modular sensor 502 includes at least one of an electrical circuit 508, at least one electrical component, or a combination thereof, such as a processor 510, a power supply 512, a charger 514, at least one display driver 516, an SD card 518, a debug interface 520, a sensor interface 522, a wireless device 524, at least one connector 526, at least one physiological parameter sensor 528, at least one other component of any type, or any combination thereof.

[0161] The power source 512 is, for example, a battery. In some examples, the electrical circuit 508 is included on a printed circuit board (PCB). In some cases, the PCB includes the processor 510, at least one other processor, at least one microprocessor, or any combination thereof. In some examples, the electrical circuit 508 includes the processor 510 integrated within a microprocessor. In some examples, the PCB includes a bus connected to at least one other component of the PCB. The charger 514 includes, for example, a wireless charger including an induction coil for wireless power reception, an induction coil for wireless power transmission, or a combination thereof. In some examples, the modular sensor 502 includes at least one connector. Examples of connectors include at least one charging connector, at least one data connector, or a combination thereof. The modular sensor 502 includes, for example, a PCB, which includes at least one of the above components, at least one of the above connectors, or any combination thereof.

[0162] As previously described in this disclosure, power source 512 may be charged wirelessly, but is not limited to such an embodiment. In various cases, power source 512 may be charged via a wireless connection, a wired connection via any number of wires and / or cables connected to any number of external power sources, or any combination thereof.

[0163] In various implementations, the electrical circuitry 508 includes or is connected to a physiological parameter sensor 528 via a sensor interface 522. The at least one type of physiological parameter sensor 528 corresponds, for example, to at least one sensor type of the modular sensor 502. For example, a physiological parameter sensor corresponding to the sensor type detects a corresponding type of physiological parameter.

[0164] In some examples, the sensor interface 522 optically couples the physiological parameter sensor 528 to at least one other component. In various examples, the sensor interface 522 couples the physiological parameter sensor 528 to at least one other component via the electrical circuitry 508. In various examples, the physiological parameter sensor 528 is coupled to at least one other component via conductors and at least one connector. The conductors, connectors, or a combination thereof may be utilized to couple the physiological parameter sensor 528 to at least one component of the electrical circuitry 508, for example, in addition to or as an alternative to an optical interface.

[0165] 6A and 6B show diagrams of an example medical device 600 being operated to perform ventilation. In some implementations, the medical device 600 is the medical device 100, medical device 200, medical device 300, medical device 400, or medical device 500 described above with reference to FIGS. 1-5. The medical device 600 includes, for example, a bag 602. In some implementations, the bag 602 is the bag 206, bag 306, bag 406, or bag of the medical device 100, or the bag of the medical device 500 described above with reference to FIGS. 1-5. The medical device 600 includes, for example, a mask 604. In some implementations, the bag 602 is the mask, mask 212, mask 312, mask 412, or mask 504 of the medical device 100 described above with reference to FIGS. 1-5. The medical device 600 includes, for example, at least one sensor 606. In some implementations, any of the sensors 606 is any of the sensors of the medical device 300 described above with reference to Figures 1-5, sensor 202 or sensor 204, any of the sensors of the medical device 300, any of sensor 402, sensor 404 and sensor 422, or modular sensor 502.

[0166] 6A, bag 602 is deflated. Deflation of bag 602, for example, causes air flow 610 to flow within bag 602. Air flow 610 may be, for example, inspiration as part of an inspiration cycle.

[0167] 6B, bag 602 is deflated. Deflation of bag 612, for example, causes air flow 612 to form within bag 602. Air flow 612 may be, for example, exhaled air as part of an exhalation cycle.

[0168] 7 illustrates an example environment in which a patient 706 is treated at a critical care site 700 using a medical device 702 including at least one sensor 704. In some implementations, the medical device 702 is medical device 100, medical device 200, medical device 300, medical device 400, medical device 500, or medical device 600 described above with reference to FIGS. 1-6. In some implementations, any of the sensors 704 is any of the sensors of medical device 100, any of sensors 202 and 204, any of sensors 302 and 304, any of sensors 402, 404 and 422, any of sensors 528, or any of sensors 606 described above with reference to FIGS.

[0169] In various examples, the medical device 702 includes a user interface (UI) (e.g., a display, an indicator, a speaker, a tactile feedback device, or a combination thereof). The UI includes, for example, an indicator 708.

[0170] In some examples, the environment 700 includes a monitoring device 710, a treatment device 712, or a combination thereof, operated by a rescuer 714. The treatment device 712 includes, for example, at least one sensor 716. In some examples, the medical device 702 exchanges communications with the monitoring device 710, the treatment device 712, or a combination thereof, via a wireless connection 718, a wired connection, or a combination thereof.

[0171] For example, the monitoring device 710 may include a monitor-defibrillator, a medical imaging device, an ultrasound monitor, a stand-alone ECG monitor, or another type of patient monitoring device. The monitoring device 710 may include and / or be communicatively coupled to a sensor 716. The sensor 716 may be configured to detect at least one physiological parameter of the patient 706. Examples of physiological parameters may include, for example, an ECG, impedance, force applied to the patient 706, blood pressure, airway parameters (e.g., partial carbon dioxide pressure, partial oxygen pressure, capnography, end-tidal gas parameters, flow rate, etc.), blood oxygenation (e.g., pulse oximetry values, regional oximetry values, etc.), electroencephalogram (EEG), body temperature, heart sounds, blood flow, physiological geometries (e.g., vascular geometry, inner ear geometry, etc.), heart rate, pulse rate, etc. For example, the sensor may include at least one of an electrode, a detection circuit, a defibrillator pad, a force sensor, a blood pressure cuff, an ultrasound-based blood pressure sensor, an invasive blood pressure sensor (e.g., an intra-arterial blood pressure sensor) (e.g., a blood pressure sensor having a cannula inserted into the patient's body), a gas sensor (e.g., a carbon dioxide sensor and / or an oxygen sensor), a flow meter, a pulse oximetry sensor, a local oximetry sensor, a thermometer, a microphone, an ultrasound transducer, a medical imaging device, and the like (e.g., an ultrasound imaging device).

[0172] In various cases, the monitoring device 710 outputs the physiological parameter to the rescuer 714. For example, the monitoring device 710 includes a display, a speaker, or a tactile feedback device that communicates the physiological parameter to the rescuer 714.

[0173] In some examples, the therapy device 712 administers therapy to the patient 706. For example, the therapy device 712 may include a monitor-equipped defibrillator, an automated external defibrillator (AED), a mechanical chest compression device, a smart bag-valve mask, a ventilator, a heart-lung machine, an intravenous fluid (IV) pump, etc. Examples of therapy include defibrillation, pacing, electrical cardioversion, administering chest compressions, administering oxygen to the patient's 706 airway, introducing air into the patient's airway, administering fluids to the patient 706, extracorporeal membrane oxygenation (ECMO), administering medication to the patient 706, etc. In some implementations, the monitoring device 710 is further configured to administer therapy to the patient 706. Additionally, in some cases, the therapy device 712 is configured to sense one or more physiological parameters of the patient 706.

[0174] In some examples, the medical device 702 determines whether a leak exists between the face of the patient 706 and the mask of the medical device 702 based on the physiological parameters detected by the sensor 704. In various examples, the medical device 702, the monitoring device 710, the therapy device 712, or a combination thereof, exchanges communications including and / or presenting data determined by the medical device 702, the monitoring device 710, the therapy device 712, or a combination thereof. The presented data may include, for example, medical device data, monitoring device data, therapy device data, physiological parameter data, sensor status data, coaching data, feedback data, or any combination thereof.

[0175] In some examples, the monitoring device 710, the treatment device 712, or any combination thereof, determines whether a leak exists and operates in a manner similar to the medical device 702. For example, the monitoring device 710, the treatment device 712, or any combination thereof, outputs an alert indicating that a leak exists.

[0176] 8 illustrates an example of a signal flow 800 for communication exchanges between a medical device 702, a monitoring device 710, and a therapy device 712. In some examples, pairing communications 802 are exchanged between the monitoring device 710 and the therapy device 712 to pair the monitoring device 710 and the therapy device 712.

[0177] In some examples, the pairing communications 802 include at least one pairing request sent from the monitoring device 710 to the therapy device 712 or at least one pairing request sent from the therapy device 712 to the monitoring device 710. In some examples, the pairing communications 802 include at least one pairing response sent from the therapy device 712 and received by the monitoring device 710 or at least one pairing response sent from the monitoring device 710 and received by the therapy device 712.

[0178] In various examples, the medical device 702 sends a pairing request 804 to the monitoring device 710. In various examples, the medical device 702 receives a pairing response 806 from the monitoring device 710. For example, at least one pairing request, including the pairing request 804, and at least one pairing response, including the pairing response 806, are used to pair the medical device 702 with the monitoring device 710, the therapy device 712, or any combination thereof.

[0179] In some examples, the medical device 702 exchanges communications with the monitoring device 710. In various examples, this communication includes a report communication 810. For example, the exchange of communications may be performed by the medical device 702, the monitoring device 710, the therapy device 712, or a combination thereof. For example, the exchange of communications may include the medical device 702 transmitting at least one report 808 to the monitoring device 710. For example, the report 808 includes data determined by the medical device 702. The transmitted data may include, for example, medical device data, physiological parameter data detected by the sensor 704, sensor status data associated with the sensor 704, feedback data, or any combination thereof.

[0180] In various examples, the communication exchange may include, for example, the medical device 702 receiving an instruction 812 from the monitoring device 710. The instruction 812 may include, for example, data determined by the monitoring device 710. The received data may include, for example, physiological parameter data detected by the sensor 716, sensor status data associated with the sensor 716, feedback data, or any combination thereof.

[0181] FIG. 9 illustrates an example environment 900 of a medical device 902 including one or more sensors 904 and interconnected to a monitoring device 906 and a relay device 908. In some implementations, the medical device 902 is medical device 100, medical device 200, medical device 300, medical device 400, medical device 500, medical device 600, or medical device 702 described above with reference to FIGS. 1-7. In some implementations, the relay device 908 is relay device 106. In some implementations, the monitoring device 906 is monitoring device 710. In some implementations, any of the sensors 904 is any of the sensors of medical device 100 described above with reference to FIGS. 1-7, any of sensors 202 and 204, any of sensors 302 and 304, any of sensors 402, 404, and 422, any of sensors 528, any of sensors 606, or any of sensors 704.

[0182] For example, medical device 902 exchanges communications with monitoring device 906 via wireless connection 910 and with relay device 908 via wireless connection 912. Monitoring device 906 exchanges communications with relay device 908 via wireless connection 914. In some implementations, wireless connection 910 is wireless connection 108 or wireless connection 718. In some implementations, wireless connection 912 is a wireless connection between medical device 100 and relay device 106. In some implementations, wireless connection 914 is a wireless connection between monitoring device 102 and relay device 106.

[0183] In various examples, the monitoring device 906 includes a display 916 that presents sensor data 918, at least one pairing element 920, or a combination thereof. In some implementations, the display 916 is the display of the monitoring device 102. For example, the display 916 displays data including data as discussed throughout this disclosure, such as medical device data, physiological parameter data, sensor status data, coaching data, feedback data, or any combination thereof.

[0184] In some implementations, medical device 902 includes a display that presents the same or different information as the information presented by display 916. In some examples, the information presented by the display of medical device 902 is in the same format or a different format than the information presented by display 916 and / or has at least one characteristic that is the same as or different from corresponding at least one characteristic of display 916. In various implementations, sensor data 918 includes physiological parameter data determined based on at least one detected physiological parameter, such as those described above with reference to FIGS.

[0185] The sensor status data 918 includes, for example, data indicative of physiological parameters. In some implementations, the sensor status data 918 can be any of the data, such as graphs, described throughout this disclosure.

[0186] In some examples, the pairing element 920 includes a pairing element that is activated based on the medical device 902 being paired with the monitoring device 906. In some examples, at least one other pairing element included in the pairing element 920 operates based on pairing with at least one other medical device (e.g., at least one other BVM device). The pairing is performed, for example, by a pairing request 804 and a pairing response 806.

[0187] For example, any pairing element 920 may be activated based on the medical device 902 being paired with the monitoring device 906. For example, activation of the pairing element 920 based on activation (e.g., a first pairing activation) may include illuminating the pairing element 920 and the illuminated pairing indicator 922 having at least one characteristic (e.g., color, flashing level, shading level, etc.) based on the pairing. For example, the pairing element 920 may be deactivated based on the medical device 902 not being paired with the monitoring device 906. In some examples, the pairing element 920 may be activated based on an activation (e.g., a second pairing activation) that includes illuminating the pairing element 920 and the illuminated pairing element 920 having at least one characteristic (e.g., color, flashing level, etc.) that is different from at least one corresponding characteristic of the first pairing activation.

[0188] In various implementations, either the pairing element 920, various portions of the display 916, or a combination thereof, includes sensor status data. In some implementations, this sensor status data is modular sensor status data, such as described above with reference to FIG. 3. In some examples, the display 916 is a touchscreen that receives user inputs utilized to control the UI, as described throughout this disclosure.

[0189] In some examples, the medical device includes a pairing indicator 922. The pairing indicator 922 is activated, for example, based on the medical device 902 being paired with the monitoring device 906. For example, activating the pairing indicator 922 based on an activation (e.g., a first pairing activation) includes illuminating the pairing indicator 922, and the illuminated pairing indicator 922 having at least one characteristic (e.g., color, flashing level, etc.) based on the pairing. The pairing indicator 922 is deactivated, for example, based on the medical device 902 not being paired with the monitoring device 906. In some examples, the pairing indicator 922 is activated based on an activation (e.g., a second pairing activation) including illuminating the pairing indicator 922, and the illuminated pairing indicator 922 having at least one characteristic (e.g., color, flashing level, etc.) that is different from the at least one corresponding characteristic of the first pairing activation.

[0190] In some examples, the monitoring device 906 includes a button 924 and a light 926. The button 924, the light 926, or a combination thereof, may comprise part of a user interface (UI) of the monitoring device 906, for example, the UI of the monitoring device 102. In some examples, the button 924 is used to change the sensor data 918 being presented by the medical device 902 to different sensor data or to change one or more other characteristics of the data being presented by the display 916. For example, when a user activates the button 924, the button 924 receives an input signal from the user. Activation of the button 924 may include, for example, pressing, rotating, toggling, etc., or any combination thereof. The light 926 may indicate, for example, a channel and / or link key associated with wireless communication with the medical device 902.

[0191] 10 illustrates an example process 1000 for managing a medical device that includes an air flow sensor and an air pressure sensor. In some implementations, the medical device is medical device 100, medical device 200, medical device 300, medical device 400, medical device 500, medical device 600, medical device 702, medical device 702, or medical device 902 described above with reference to FIGS. 1-7 and 9.

[0192] At 1002, the medical device detects a first parameter of a bag valve mask chamber. In some examples, the bag valve mask chamber is fluidly connected to a patient's airway. For example, the bag valve mask is placed on the patient's face. For example, the first parameter may include air flow, air pressure, CO2 level, O2 level, humidity, temperature, etc.

[0193] At 1004, the medical device detects a second parameter of the bag valve mask space, for example, the second parameter may include flow rate, air pressure, CO2 level, O2 level, humidity, temperature, etc.

[0194] At 1006, the medical device determines a relationship between the first parameter and the second parameter. For example, the relationship includes a ratio of the first parameter to the second parameter. In some examples, the relationship includes a relationship between a change in the first parameter over multiple ventilations and a change in the second parameter over multiple ventilations.

[0195] At 1008, the medical device determines that the relationship has changed after multiple ventilations, for example, multiple ventilations delivered to the patient through a bag valve mask.

[0196] At 1010, the medical device identifies a leak between the bag valve mask and the patient's face, for example, based on determining that the relationship has changed over multiple breaths.

[0197] At 1012, the medical device outputs an alert indicating the leak. For example, the alert is output based on the leak being identified. In some examples, a signal is sent to an external device based on the alert or the leak.

[0198] 11 illustrates an example process 1100 for managing a medical device that includes one or more modular sensors. In some implementations, the medical device is medical device 100, medical device 200, medical device 300, medical device 400, medical device 500, medical device 600, medical device 702, medical device 702, or medical device 902 described above with reference to FIGS. 1-7 and 9.

[0199] At 1102, the medical device detects that a modular sensor has been connected to the medical device.

[0200] At 1104, the medical device identifies a physiological parameter of the patient detected by the modular sensor. In some examples, the physiological parameter is detected in response to connecting the modular sensor to the medical device. In some examples, detecting connecting the modular sensor to the medical device includes detecting connecting the modular sensor to a bag or mask of a smart bag-valve-mask system. In various examples, the physiological parameter includes air flow, air pressure, CO2 level, O2 level, humidity, temperature, etc.

[0201] At 1106, the medical device detects the presence of a leak between the medical device and the patient. The leak is detected, for example, by analyzing a physiological parameter. In some examples, a type of sensor is identified in response to connecting a second modular sensor to the medical device. The type of the second modular sensor is identified. In various examples, a second alert is output to a display indicating that the second physiological parameter is outside of a predetermined parameter range.

[0202] At 1108, the medical device causes the transceiver to transmit an alert signal. In some examples, the alert signal indicates the presence of a leak between the medical device and the patient. In some examples, the alert signal alerts the user to check for a leak, for example, based on the seal not trending good or the seal trending worsening, for example, by going through multiple ventilations (e.g., two ventilations, four ventilations, etc.).

[0203] 12 illustrates an example process 1200 for managing a medical device that includes an air flow sensor, a CO2 sensor, and an air pressure sensor. In some implementations, the medical device is medical device 100, medical device 200, medical device 300, medical device 400, medical device 500, medical device 600, medical device 702, medical device 702, or medical device 902 described above with reference to FIGS. 1-7 and 9.

[0204] At 1202, the medical device detects a physiological parameter with a sensor. In various examples, the physiological parameter includes flow rate, air pressure, CO2 level, O2 level, humidity, temperature, etc.

[0205] At 1204, the medical device determines that the physiological parameter is below a physiological parameter threshold. In some examples, the medical device determines that the mask is away from the patient's face by determining, based on the physiological parameter detected during the current ventilation, that the current physiological parameter has decreased compared to a previous physiological parameter detected during a previous ventilation.

[0206] At 1206, the medical device determines that the mask is off the patient's face. In some examples, the mask being off the patient's face is determined based on the physiological parameter being below a physiological parameter threshold.

[0207] At 1208, the medical device outputs an alert indicating that the mask is away from the patient's face. In various examples, the alert is output visually or audibly as an increasing alert characterized by a first alert level at an earlier time being lower than a second alert level at a subsequent time. In various examples, a user interface (UI) identifies an alert override selection received via user input to the UI. The alert is, for example, turned off or muted based on the alert override selection. Example terms 1. A medical device comprising: an airway adapter configured to connect to an airway of a patient; a first sensor configured to detect a first parameter of a space fluidly connected to the airway adapter; a second sensor configured to detect a second parameter of the space; and The display and Processor and Including, the processor: determining a relationship between the first parameter and the second parameter; identifying a leak between the airway adapter and the patient's airway based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations; generating an alert indicating the leak; outputting the alert on the display; The medical device is configured to: 2. The medical device of paragraph 1, wherein the airway adapter comprises a mask, a supraglottic airway device, or an endotracheal tube. 3. The medical device according to paragraph 1 or 2, wherein the medical device comprises a bag valve mask. 4. The first parameter includes an air flow rate; the processor: determining a first ventilation rate by integrating over time an airflow rate of air flowing through the space in a first direction; A second ventilation rate is calculated by integrating the air flow rate of air flowing through the space in a second direction different from the first direction over time. It is further structured as follows: and identifying the leak includes determining that a first ventilation rate is different from a second ventilation rate. Item 4. The medical device according to any one of Items 1 to 3. 5. The medical device of paragraph 4, wherein the medical device comprises a ventilator. 6. The medical device according to any one of paragraphs 1 to 5, further comprising a gas source fluidly connected to the space, the gas source configured to deliver air through the space. 7. The medical device of paragraph 6, wherein the gas source comprises a bag, a ventilator, or a gas tank. 8. The first parameter includes air pressure; 8. The medical device of any one of claims 1 to 7, wherein the processor is further configured to generate an alert indicating that the air pressure is below a predetermined air pressure level when the compression level of the airbag of the medical device becomes equal to or greater than a compression level threshold. 9. The first parameter includes a humidity level; 9. The medical device of any one of claims 1 to 8, wherein the processor is further configured to identify a physiological characteristic indicating that the humidity level is below a predetermined humidity level when the compression level of the airbag of the medical device is equal to or greater than a threshold compression level. 10. Further comprising a third sensor connected to the rim portion of the airway adapter; the third sensor is configured to detect a first value at a first time point and a second value at a second time point; the first value comprises a first electrical resistance or capacitance; the second value comprises a second electrical resistance or capacitance; the first time point is when air enters the space, the second point in time is when air leaves the space; the processor: determining that a difference between the first value and the second value is greater than or equal to a threshold difference; generating a third alert in response to determining that the difference between the first value and the second value is greater than or equal to the threshold difference; Item 10. The medical device according to any one of items 1 to 9, further configured as follows: 11. The first parameter includes an air flow rate; the second parameter includes an O2 level; the processor is further configured to determine that a relationship between the first parameter and the second parameter at the first time point is a similar relationship; Determining that the relationship between the first parameter and the second parameter has changed over the multiple ventilations includes determining that the relationship between the first parameter and the second parameter at the second time point is no longer a similar relationship. Item 11. The medical device according to any one of items 1 to 10. 12. The first parameter includes a CO2 level; the second parameter includes an O2 level; the processor is further configured to determine that a relationship between the first parameter and the second parameter at the first time point is an inverse relationship; Determining that the relationship between the first parameter and the second parameter has changed over the multiple ventilations includes determining that the relationship between the first parameter and the second parameter at the second time point is no longer inversely correlated. Item 12. The medical device according to any one of items 1 to 11. 13. The first parameter includes an air flow rate; the second parameter includes an O2 level; the processor is configured to cause the display to output numerical values ​​indicative of the airflow rate, O2 level, and air pressure within the space. Item 13. The medical device according to any one of items 1 to 12. 14. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space; and a second sensor configured to detect a pressure in the space; and a display configured to visually output an airflow waveform indicative of air flow over time and an air pressure waveform indicative of air pressure over time; Processor and Including, At a first time, a first ventilation occurs when the bag is deflated and released, and at a second time, a second ventilation occurs when the bag is deflated and released; the processor: measuring a first ventilation by analyzing airflow during the first ventilation; measuring a second ventilation volume by analyzing the airflow during the second ventilation; identifying a first ratio of a first ventilation volume to air pressure during a first ventilation; identifying a second ratio of second ventilation volume to air pressure during the second ventilation; determining a discrepancy between the first ratio and the second ratio; determining that a leak exists between the mask and the patient's face in response to determining that there is a discrepancy between the first ratio and the second ratio; outputting an alert on the display indicating that a leak exists between the mask and the patient's face; The smart bag valve mask device is configured to: 15. The alert is a first alert; the smart bag-valve-mask device further includes a third sensor configured to detect a physiological parameter of the space, including CO2 partial pressure, temperature, or humidity; the display is further configured to output a physiological parameter waveform indicative of the physiological parameter over time; the processor: determining that the leak exceeds a severity threshold by analyzing the physiological parameter; in response to determining that the leak exceeds a severity threshold; Increase the intensity of the first alert, or causing the display to output a second alert indicating that the leak exceeds a severity threshold. Item 15. The smart bag valve mask device according to item 14, further configured as follows: 16. The alert is a first alert; the smart bag valve mask device further includes an electrode disposed on an edge of the mask, the electrode configured to detect an electrical signal; the processor: detecting a separation between an edge of the mask and the patient's face by analyzing the electrical signal; in response to detecting a separation between an edge of the mask and the patient's face; Increase the intensity of the first alert, or outputting a second alert on the display indicating that the mask is away from the patient's face; Item 16. The smart bag valve mask device according to item 14 or 15, further configured as follows: 17. The alert is a first alert; the smart bag valve mask device further comprising an accelerometer configured to detect chest movement of the patient; the processor: detecting a separation between the mask and the patient's face by analyzing chest movement of the patient taking into account the air flow or the air pressure; in response to detecting a separation between the mask and the patient's face; Increase the intensity of the first alert, or outputting a second alert on the display indicating that the mask is away from the patient's face; 17. The smart bag valve mask device according to any one of items 14 to 16, further configured as follows: 18. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space; and a second sensor configured to detect a pressure in the space; and a third sensor configured to detect a CO2 level; and Processor and Including, the processor: determining, in response to detecting the air flow, the pressure, and the CO2 level, that a leak exists between the mask and the patient's face; outputting an alert on a display indicating that a leak exists between the mask and the patient's face; The smart bag valve mask device is configured to: 19. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space; and a second sensor configured to detect a pressure in the space; and A transceiver; Processor and Including, At a first time, a first ventilation occurs when the bag is deflated and released, and at a second time, a second ventilation occurs when the bag is deflated and released; the processor: measuring a first ventilation by analyzing airflow during the first ventilation; measuring a second ventilation volume by analyzing the airflow during the second ventilation; identifying a first ratio of a first ventilation volume to air pressure during a first ventilation; identifying a second ratio of second ventilation volume to air pressure during the second ventilation; determining a discrepancy between the first ratio and the second ratio; determining that a leak exists between the mask and the patient's face in response to determining that there is a discrepancy between the first ratio and the second ratio; causing the transceiver to transmit an alert indicating the presence of a leak between the mask and the patient's face. The smart bag valve mask device is configured to: 20. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space, the first sensor being utilized over time to determine an air volume; a display configured to visually output an airflow value indicating the air flow and an air volume value indicating the air volume; Processor and Including, ventilation occurs when the bag is deflated and released; the processor: measuring the amount of inhalation by analyzing the amount of air when the bag is deflated; measuring exhaled volume by analyzing the volume of air when the bag is released; identifying a discrepancy between the inhaled volume and the exhaled volume; determining that a leak exists between the mask and the patient's face in response to identifying a discrepancy between the inhaled volume and the exhaled volume; outputting an alert on the display indicating that a leak exists between the mask and the patient's face; The smart bag valve mask device is configured to: 21. Detecting a first parameter of a space within a bag valve mask fluidly connected to a patient's airway and positioned on the patient's face; detecting a second parameter of the space; identifying a relationship between the first parameter and the second parameter; determining that the relationship has changed over multiple ventilations administered to the patient through the bag-valve-mask; identifying a leak between the bag valve mask and the patient's face based on determining that the relationship has changed over multiple ventilations; and outputting an alert indicating the leak based on the identification of the leak. A method comprising: 22. The first parameter includes an air flow rate; The method comprises: integrating the airflow rate over time; and determining the result of the airflow integrated over time as ventilation. further comprising wherein identifying the leak comprises identifying the leak based on the ventilation rate. Item 22. The method according to item 21. 23. The method of claim 21 or 22, wherein the first parameter comprises an air flow rate, the second parameter comprises an air pressure level, and the relationship comprises a similarity relationship. 24. The method of any one of items 21 to 23, wherein the first parameter comprises an air pressure level, the second parameter comprises a CO2 level, the CO2 level comprises a CO2 partial pressure or EtCO2, and the relationship comprises a similarity relationship. 25. The first parameter includes a CO2 level; the relationship includes a first relationship; the alerts include a first alert identifying a first time point; The method comprises: identifying a third parameter comprising an O2 level of air in the airway; identifying a second relationship between said CO2 level and said O2 level; determining that the second relationship has changed over multiple ventilations; identifying a leak between the bag valve mask and the patient's face at a second time based on determining that the second relationship has changed over multiple ventilations; and outputting an alert indicating the second leak based on identifying the second leak at the second time point. 25. The method according to any one of items 21 to 24, further comprising: 26. The first parameter includes a CO2 level; the CO2 level comprises a partial pressure of CO2; the relationship includes a first relationship; the alerts include a first alert; The method comprises: identifying a third parameter; identifying a second relationship between a third parameter including a humidity level or a temperature level of air in the airway and the CO2 level; determining that the second relationship has changed over multiple ventilations; identifying the CO2 level as being outside a predetermined range of CO2 levels based on determining that the relationship has changed over multiple ventilations; and outputting an alert indicating a leak based on determining that the CO2 level is outside a predetermined CO2 level range. Item 26. The method according to any one of items 21 to 25, further comprising: 27. The step of outputting the alert on the display comprises: Item 27. The method of any one of items 21 to 26, further comprising outputting the alert visually or audibly on the display as an increasing alert, characterized in that a first alert level at an initial time point is lower than a second alert level at a subsequent time point. 28. The alert includes a first alert; The method comprises: determining an electrical resistance level via first and second electrodes attached to a rim portion of the bag valve mask; and causing a second alert on the display of the bag valve mask to prompt the user to check for leaks. further comprising Item 28. The method according to any one of Items 21 to 27, wherein the second alert specifies that the electrical resistance level is equal to or less than a threshold electrical resistance level. 29. The alert includes a first alert; The method comprises: determining an electrical resistance level via a first sensor and a second sensor attached to a rim portion of the bag valve mask; and causing a second alert on the display of the bag valve mask to prompt the user to check for leaks. further comprising Item 29. The method according to any one of Items 21 to 28, wherein the second alert specifies that the electrical resistance level is equal to or less than a threshold electrical resistance level. 30. The alert includes a first alert; The method comprises: determining a capacitance level via a capacitance sensor attached to a rim portion of the bag valve mask; and causing a second alert on the display of the bag valve mask to prompt the user to check for leaks. further comprising Item 30. The method according to any one of items 21 to 29, wherein the second alert specifies that the capacitance level is equal to or less than a threshold capacitance level. 31. The method according to any one of items 21 to 30, further comprising the step of audibly or visually outputting instructions for guiding the operation steps of the bag valve mask. 32. Determining blood oxygenation; and comparing said blood oxygenation to a threshold value; further comprising Item 32. The method according to any one of items 21 to 31, wherein the step of identifying the leak is further based on a comparison of the blood oxygenation with the threshold value. 33. The method of claim 32, wherein determining the blood oxygenation comprises receiving an indication of the blood oxygenation from an oximetry device. 34. A first parameter includes an amount of air flowing from the bag valve mask into the airway; the second parameter includes an air pressure in the bag valve mask; Item 34. The method according to any one of Items 21 to 33, further comprising measuring lung compliance based on the change in air volume and the change in air pressure. 35. A medical device comprising: a first sensor configured to detect a first parameter of a space within a bag valve mask fluidly connected to the patient's airway; a second sensor configured to detect a second parameter of the space; and The display and Processor and Including, the processor: determining a relationship between the first parameter and the second parameter; identifying a leak between the bag-valve-mask and the patient's face based on determining that the relationship has changed over multiple ventilations; generating an alert indicating the leak; outputting the alert on the display; The medical device is configured to: 36. The first parameter includes an air flow rate; the processor: integrating the air flow rate over time; The result of the airflow integrated over time is identified as ventilation. It is further structured as follows: Item 36. The medical device of item 35, wherein identifying the leak includes identifying the leak based on the ventilation volume. 37. The first parameter includes air pressure; the processor: a compression level of an airbag of the medical device is equal to or greater than a threshold compression level; and Air pressure level drops below the specified level 37. The medical device of claim 35 or 36, wherein the medical device is configured to generate an alert in response to simultaneously determining: 38. The first parameter includes a humidity level; 38. The medical device of any one of clauses 35 to 37, wherein the processor is further configured to identify a physiological characteristic indicative of the humidity level being below a predetermined humidity level when the compression level of an airbag of the medical device is equal to or greater than a threshold compression level. 39. Rim part and a sensor attached to the rim portion; further comprising the sensor determines an electrical resistance or capacitance; the processor is further configured to generate a third alert indicating that a difference between a first sensor value of the sensor and a second sensor value of the sensor is equal to or greater than a threshold difference; a first sensor value identifying an electrical resistance or capacitance of air in the space at a first point in time entering the medical device; Item 39. The medical device according to any one of items 35 to 38, wherein a second sensor value identifies an electrical resistance or capacitance at a second point in time when air leaves the medical device and enters the space. 40. The first parameter includes an air flow rate; the second parameter includes an O2 level; the processor: determining that a relationship between the first parameter and the second parameter is a similarity relationship; Identifying a leak based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations and is no longer similar. 40. The medical device according to any one of items 35 to 39, further configured as follows: 41. The first parameter includes a CO2 level; the CO2 level comprises a CO2 partial pressure; the second parameter includes an O2 level; the processor: determining that the relationship between the first parameter and the second parameter is an inverse correlation; Identifying a leak based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations and is no longer an inverse relationship. Item 41. The medical device according to any one of items 35 to 40, further configured as follows. 42. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, A sensor connector; a modular sensor configured to detect a physiological parameter of the patient, the modular sensor being connected to the mask, the bag, or the sensor connector; a display configured to visually output a waveform indicative of the physiological parameter over time; Processor and Including, the processor: Responsive to the modular sensor being connected to the mask, the bag, or the sensor connector, identifying a sensor type; In response to identifying a sensor type, causing the modular sensor to sense the physiological parameter; Detecting a leak between the mask and the patient's face by analyzing the physiological parameter; outputting an alert on the display indicating that there is a leak between the mask and the patient's face; The smart bag valve mask device is configured to: 43. The modular sensor is connected to the sensor connector; the smart bag valve mask further comprising a transceiver; the processor: transmitting a status signal from the transceiver indicating that the modular sensor is connected to the sensor connector; causing the transceiver to transmit an alert signal in response to the physiological parameter indicating a leak between the mask and the patient's face. Item 43. The smart bag valve mask device of item 42, further configured as follows: 44. The modular sensor includes a first modular sensor; the sensor connector includes a first sensor connector; the sensor types include a first type of sensor; the smart bag valve mask further includes a second modular sensor, a second sensor connector, and a transceiver; the processor: identifying a second type of sensor in response to a second modular sensor being connected to the mask, the bag, or the sensor connector; In response to identifying the second type of sensor, identifying a second physiological parameter sensed by the second modular sensor; transmitting a status signal including a first type of sensor and a second type of sensor from the transceiver; Item 44. The smart bag valve mask device of item 42 or 43, further configured as follows: 45. Detecting that the modular sensor is connected to the medical device; identifying a physiological parameter of the patient sensed by the modular sensor in response to connecting the modular sensor to the medical device; detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter; and causing a transceiver to transmit an alert signal indicating the presence of a leak between the medical device and the patient. A method comprising: 46. ​​The medical device includes a smart bag valve mask device; 46. ​​The method of claim 45, wherein the step of detecting that the modular sensor has been connected to the medical device includes the step of detecting that the modular sensor has been connected to the bag or mask of the smart bag valve mask device. 47. The modular sensor includes a first modular sensor; the alert signal includes a first alert signal; the leak includes a first leak; The method comprises: identifying a type of sensor in response to connecting a second modular sensor to the medical device; detecting a second physiological parameter in response to identifying the sensor type; and causing the transceiver to transmit a second alert signal indicating that a second physiological parameter is outside of a predetermined parameter range. 47. The method of claim 45 or 46, further comprising: 48. The modular sensor includes a first modular sensor; the alert signal includes a first alert signal; the leak includes a first leak; The method comprises: identifying a type of sensor in response to connecting a second modular sensor to the medical device; and causing the display to output a second alert indicating that the second physiological parameter is outside of a predetermined parameter range. Item 48. The method according to any one of items 45 to 47, further comprising: 49. outputting an identifier indicative of said physiological parameter on a display; determining that the modular sensor has been disconnected from the medical device; and ceasing output of the identifier from the display in response to the modular sensor being disconnected from the medical device. Item 49. The method according to any one of items 45 to 48, further comprising: 50. causing the display to output a first notification that the modular sensor is connected to the medical device; determining that the modular sensor has been disconnected from the medical device; and causing the display to output a second notification that the modular sensor has been disconnected from the medical device. Item 50. The method according to any one of items 45 to 49, further comprising: 51. The medical device is a smart bag valve mask device; detecting the physiological parameter detecting the physiological parameter in response to connecting the modular sensor to a bag or mask of the medical device; determining that the modular sensor has been disconnected from the bag or the mask; and causing the transceiver to transmit an alert signal in response to the modular sensor being disconnected from the bag or the mask. 51. The method according to any one of items 45 to 50, further comprising: 52. The modular sensor includes a first modular sensor; the physiological parameters include a first physiological parameter; the step of detecting that the modular sensors have been connected to the medical device further includes the step of activating a first modular sensor to detect a first physiological parameter in response to the first modular sensor being connected to the medical device; the step of detecting a first physiological parameter further comprises detecting the first physiological parameter in response to the modular sensor being activated; The method comprises: activating a second modular sensor to sense a second physiological parameter in response to the second modular sensor being connected to the medical device; and deactivating the first modular sensor in response to the second modular sensor being activated; 52. The method according to any one of items 45 to 51, further comprising: 53. The method of any one of clauses 45 to 52, wherein the physiological parameter comprises an airflow level, air pressure, CO2 level, O2 level, humidity level, temperature level, electrical resistance level, capacitance level, bag compression level, or another type of physiological parameter. 54. The step of detecting the modular sensor comprises: identifying a type of sensor in response to connecting the modular sensor to the medical device; and activating the modular sensor to sense the physiological parameter in response to the sensor type. Item 54. The method according to any one of items 45 to 53, further comprising: 55. A medical device comprising: a modular sensor configured to determine a physiological parameter associated with the patient; Transceiver and Processor and Including, the processor: Detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter; outputting an alert signal from the transceiver indicating the presence of a leak between the medical device and the patient; The medical device is configured to: 56. The modular sensor is a first modular sensor; the physiological parameter is different from a second physiological parameter sensed by a second modular sensor; 56. The medical device of claim 55, wherein outputting the alert signal from the transceiver further comprises outputting an alert signal from the transceiver indicating that a second physiological parameter is outside a range of predetermined parameters. 57. The physiological parameter is a first physiological parameter including airflow, air pressure level, CO2 level, O2 level, humidity level, temperature level, electrical resistance level, capacitance level, bag compression level, or other type of physiological parameter; the second physiological parameter comprises an air flow, an air pressure level, a CO2 level, an O2 level, a humidity level, a temperature level, an electrical resistance level, a capacitance level, a bag compression level, or any other type of physiological parameter; a first type of parameter among the first physiological parameters is different from a second type of parameter among the second physiological parameters; 57. The medical device of claim 55 or 56, wherein the processor is configured to detect the presence of a leak between the medical device and the patient by further analyzing a second physiological parameter. 58. The physiological parameter is a first physiological parameter; the processor: outputting a first identifier indicative of the first physiological parameter on a display; causing the display to output a second identifier indicative of a second physiological parameter. 58. The medical device according to any one of items 55 to 57, further configured as follows. 59. The processor: Identifying that the modular sensor has been disconnected from the medical device; outputting a status signal from the transceiver indicating that the modular sensor has been disconnected from the medical device; 59. The medical device according to any one of items 55 to 58, further configured as follows. 60. The modular sensor is a first modular sensor; the processor: Identifying that a second modular sensor is connected to the medical device; causing the transceiver to output a status signal indicating that a second modular sensor has been connected to the medical device; 60. The medical device according to any one of items 55 to 59, further configured as follows. 61. The processor: Identifying that the modular sensor has been disconnected from the medical device; outputting a notification on the display that the modular sensor has been disconnected from the medical device; Item 61. The medical device according to any one of Items 55 to 60, further configured as follows. 62. The medical device according to any one of paragraphs 55 to 61, further comprising a power supply and a power cable used to charge the power supply. 63. The medical device of any one of clauses 55 to 62, further comprising a tactile device, wherein the processor is further configured to cause the tactile device to provide tactile feedback in response to detecting the presence of the leak. 64. The processor: Identifying a chest compression depth parameter received via the transceiver; Detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter and the chest compression depth parameter. Item 64. The medical device according to any one of Items 55 to 63, further configured as follows. 65. A medical device comprising: a modular sensor including a first sensor configured to determine a first physiological parameter associated with a patient and a second sensor configured to determine a second physiological parameter associated with the patient; A transceiver; Processor and Including, the processor: Detecting the presence of a leak between the medical device and the patient by analyzing a first physiological parameter or a second physiological parameter; outputting an alert signal from the transceiver indicating the presence of a leak between the medical device and the patient; The medical device is configured to: 66. A medical device comprising: a modular sensor configured to determine a physiological parameter associated with the patient; a transceiver configured to transmit and receive data; Processor and Including, the processor: causing the transceiver to receive patient data; Detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter in response to receiving the patient data; outputting an alert signal from the transceiver indicating the presence of a leak between the medical device and the patient; The medical device is configured to: 67. An apparatus comprising: a mask configured to contact the patient's face; A bag and a flow sensor connected between the mask and the bag and configured to detect the flow rate of air flowing between the mask and the bag; a CO2 sensor connected between the mask and the bag and configured to detect the CO2 level in the air; an air pressure sensor connected between the mask and the bag and configured to detect the pressure of the air; A transceiver; The display and Processor and Including, the processor: determining that a leak exists between the face and the mask based on the flow rate, the CO2 level, and the pressure; In response to determining that a leak exists between the face and the mask, causing the transceiver to transmit a signal indicative of the leak; outputting an alert indicating the leak on the display; The apparatus is configured to: 68. The device described in clause 67, wherein the processor is configured to determine that a leak exists between the face and the mask based on the flow rate, the CO2 level and the pressure by determining that the flow rate, the CO2 level or the pressure is below a predetermined parameter level. 69. The device described in clause 67 or 68, wherein the processor is configured to determine that a leak exists between the face and the mask based on the flow rate, the CO2 level and the pressure detected during current ventilation by determining that the flow rate, the CO2 level or the pressure detected during current ventilation is reduced compared to a previous flow rate, a previous CO2 level or a previous pressure detected during a previous ventilation. 70. The processor: determining that the leak has been eliminated based on the flow rate, the CO2 level, and the pressure; and ceasing output of the alert from the display in response to determining that the leak has disappeared. Item 69. The device according to any one of Items 67 to 69, further configured as follows: 71. The processor: receiving, in a receiving coil, an electromagnetic induction signal from an external device that induces a current in the receiving coil; storing the energy generated by said current in a capacitor or battery; supplying the energy to the flow sensor, the CO2 sensor, or the air pressure sensor; Item 71. The device according to any one of Items 67 to 70, further configured as follows: 72. Detecting a physiological parameter with a sensor; determining that the physiological parameter is below a physiological parameter threshold; determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold; and outputting an alert indicating that the mask is away from the patient's face. A method comprising: 73. The physiological parameter thresholds include a first physiological parameter threshold; determining that the physiological parameter is below a physiological parameter threshold further comprises determining that the physiological parameter is below a first physiological parameter threshold and above a second physiological parameter threshold; determining that the mask is away from the patient's face further comprises determining that the mask is away from the patient's face based on the physiological parameters being below a first physiological parameter threshold and above a second physiological parameter threshold; Item 73. The method according to item 72. 74. The physiological parameter includes the flow rate of air flowing between the mask and the bag, the CO2 level of the air, or the pressure of the air; The step of outputting the alert comprises: determining whether the physiological parameter is below a first threshold or above a second threshold; and causing the external device to wirelessly transmit an alert signal from the transceiver. 74. The method of claim 72 or 73, comprising: 75. The step of outputting the alert comprises: determining whether the physiological parameter is below a first threshold or above a second threshold; and outputting an alert via a wired interface; Item 75. The method according to any one of items 72 to 74, comprising: 76. The step of outputting the alert includes a step of outputting an acoustic signal including the alert from a speaker. Item 76. The method according to any one of items 72 to 75, comprising: 77. The physiological parameter is flow rate, CO2 level, or pressure; 77. The method of any one of clauses 72 to 76, wherein determining that the mask is away from the patient's face based on the physiological parameter being below a threshold value for the physiological parameter includes determining that the flow rate, the CO2 level, or the pressure has decreased compared to a previous flow rate, a previous CO2 level, or a previous pressure detected during a previous ventilation. 78. The physiological parameter is flow rate; the method further comprising detecting a CO2 level with a second sensor; determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold includes determining that the flow rate is reduced compared to a previous flow rate detected during a previous ventilation; 78. The method of any one of paragraphs 72 to 77, wherein the step of determining that the mask is away from the patient's face is further based on a decrease in the CO2 level compared to a previous CO2 level detected during a previous ventilation. 79. The physiological parameter is a humidity level; 79. The method of any one of clauses 72 to 78, wherein determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold comprises determining that the humidity level has decreased compared to a previous humidity level detected during a previous ventilation. 80. The physiological parameter is a temperature level; 80. The method of any one of clauses 72 to 79, wherein determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold comprises determining that the temperature level has decreased compared to a previous temperature level detected during a previous ventilation. 81. Determining that there is no leakage between the mask and the patient's face based on the physiological parameter; and ceasing the output of the alert from the display in response to determining that the leak has disappeared. Item 81. The method according to any one of items 72 to 80, further comprising: 82. receiving, at a receiving coil, an electromagnetic induction signal from an external device that induces a current in the receiving coil; storing the energy generated by the current in a capacitor or battery; and providing the energy to a sensor configured to detect the physiological parameter; Item 82. The method according to any one of items 72 to 81, further comprising: 83. A medical device comprising: A flow sensor; CO2 sensor and An air pressure sensor; A transceiver; The display and Processor and Including, the processor: determining that a leak exists between the face and the mask based on the flow rate detected by the flow sensor, the CO2 level detected by the CO2 sensor, or the air pressure detected by the air pressure sensor; In response to determining that a leak exists between the face and the mask, transmitting a signal indicative of the leak from the transceiver; outputting an alert indicating the leak on the display; The medical device is configured to: 84. The medical device of clause 83, wherein the processor is configured to determine that a leak exists between the face and the mask based on the flow rate, the CO2 level, and the air pressure by determining that the flow rate, the CO2 level, or the air pressure is below a predetermined parameter level. 85. The medical device of clause 83 or 84, wherein the processor is configured to determine that a leak exists between the face and the mask based on the flow rate, the CO2 level and the air pressure detected during current ventilation by determining that the flow rate, the CO2 level or the air pressure detected during current ventilation is reduced compared to a previous flow rate, a previous CO2 level or a previous air pressure detected during a previous ventilation. 86. The processor: determining that the leak has been eliminated based on the flow rate, the CO2 level, and the air pressure; and ceasing output of the alert from the display in response to determining that the leak has disappeared. Item 86. The medical device according to any one of Items 83 to 85, further configured as follows. 87. The processor: receiving, in a receiving coil, an electromagnetic induction signal from an external device that induces a current in the receiving coil; storing the energy generated by said current in a capacitor or battery; supplying the energy to the flow sensor, the CO2 sensor, or the air pressure sensor; Item 87. The medical device according to any one of Items 83 to 86, further configured as follows. 88. A medical device described in any one of clauses 83 to 87, wherein the processor is configured to determine that the mask is away from the patient's face based on the flow rate, CO2 level and air pressure detected during current ventilation by determining that the flow rate, CO2 level or air pressure detected during current ventilation is lower than a previous flow rate, CO2 level or air pressure detected during a previous ventilation.

[0208] conclusion The features of the present disclosure expressed in the foregoing detailed description, the following claims, or the accompanying drawings as particular forms or means for performing a disclosed function, or methods or processes for suitably achieving the results of the present disclosure, may be used separately or in combination to realize implementations of the present disclosure in various forms.

[0209] As will be understood by those skilled in the art, each implementation disclosed herein comprises, consists essentially of, or consists of the specific components, steps, or parts described. Accordingly, the terms "comprise" or "comprising" should be interpreted to mean "comprise, consist essentially of, or consist of." The transitional phrase "comprises" means the inclusion of, but is not limited to, unrecited components, steps, materials, or parts, however large the amount. The transitional phrase "consisting of" excludes all unrecited components, steps, materials, or parts. The transitional phrase "consisting essentially of" limits the scope of implementations of the present disclosure to the recited components, steps, materials, or parts, as well as components, steps, materials, or parts that do not materially affect the implementation of the present disclosure. Unless otherwise noted, the term "based on" is used interchangeably herein with the term "based at least in part on."

[0210] Unless otherwise indicated, all numerical values ​​expressing quantities, properties, conditions, and the like in the specification and claims are to be construed in all instances as modified by the term "about." Accordingly, unless otherwise indicated, the numerical parameters set forth in the specification and appended claims are approximations that may vary depending upon the desired properties sought to be obtained by the present disclosure. Without intending to limit the scope of the doctrine of equivalents to the scope of the claims, each numerical parameter should, at the very least, be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. More specifically, the term "about," when used in conjunction with a stated value or range, has the meaning reasonably interpreted by one of ordinary skill in the art, i.e., within ±20% of the stated value; ±19% of the stated value; ±18% of the stated value; ±17% of the stated value; ±16% of the stated value; ±15% of the stated value; ±14% of the stated value; ±13% of the stated value; ±12% of the stated value; ±11% of the stated value; ±10% of the stated value; ±9% of the stated value; ±8% of the stated value; ±7% of the stated value; ±6% of the stated value; ±5% of the stated value; ±4% of the stated value; ±3% of the stated value; ±2% of the stated value; or ±1% of the stated value.

[0211] Although the numerical ranges and parameters setting forth the broad scope of the present disclosure are approximations and approximate ranges, the numerical values ​​set forth in the specific examples are reported as precisely as possible, however, all numerical values ​​inherently contain certain errors necessarily resulting from the standard deviation found in their respective testing measurements.

[0212] When used in describing implementations of the present disclosure (particularly in the claims that follow), the terms "a," "an," "the," and similar designators are intended to encompass both the singular and the plural unless otherwise indicated or the context clearly dictates otherwise. Numerical ranges recited herein are intended as a shorthand way of referring individually to each numerical value within the range. Unless otherwise indicated, each numerical value is described herein as if it were individually described herein. Any method described herein can be performed in any suitable order unless otherwise indicated or the context clearly dictates otherwise. The use of any examples or illustrative language (e.g., "etc.") provided herein is intended only to further describe implementations of the present disclosure and does not limit the scope of the disclosure. No term used herein should be construed as indicating any non-claimed element essential to the practice of implementations of the present disclosure.

[0213] Groupings of alternative elements or implementations disclosed herein should not be construed as limitations on the invention. Members of each group may be described herein or in the claims individually, or in combination with other members of the group or other elements described herein. It is anticipated that one or more members of a group may be added to another group, or one or more members may be deleted from a group, for reasons of convenience and / or patentability. In making such additions or deletions, the specification includes groups that are constructed to satisfy the recitation of all Markush groups set forth in the appended claims.

[0214] Specific implementations are described herein, including the best mode known to the inventors for carrying out implementations of the present disclosure. Of course, those skilled in the art will readily recognize, upon review of the foregoing detailed description, that the implementations described herein can be modified in various ways. The inventors anticipate that such modifications will be readily apparent to those skilled in the art, and intend that implementations of the present disclosure may be practiced in ways other than those specifically described herein. Accordingly, the scope of the present disclosure includes all modifications of the inventive subject matter recited in the appended claims and all equivalents of the inventive subject matter to the extent permitted by applicable law. Furthermore, any combination of the above-described elements, in any and all variations thereof, is included in implementations of the present disclosure, unless expressly stated otherwise or the context clearly dictates otherwise.

Claims

1. A medical device comprising: an airway adapter configured to connect to an airway of a patient; a first sensor configured to sense a first parameter of a space fluidly connected to the airway adapter; a second sensor configured to detect a second parameter of the space; The display and Processor and Including, the processor: determining a relationship between the first parameter and the second parameter; identifying a leak between the airway adapter and the patient's airway based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations; generating an alert indicative of the leak; outputting the alert on the display; The medical device is configured to:

2. 10. The medical device of claim 1, wherein the airway adapter comprises a mask, a supraglottic airway, or an endotracheal tube.

3. The medical device of claim 1 , wherein the medical device comprises a bag valve mask.

4. the first parameter comprises an air flow rate; the processor: determining a first ventilation rate by integrating over time an airflow rate of air flowing through the space in a first direction; A second ventilation volume is calculated by integrating the air flow rate of the air flowing through the space in a second direction different from the first direction over time. It is further structured as follows: and identifying the leak includes determining that a first ventilation rate is different from a second ventilation rate. The medical device of claim 1 .

5. The medical device of claim 4 , wherein the medical device comprises a ventilator.

6. The medical device of claim 1 , further comprising a gas source fluidly connected to the space, the gas source configured to force air through the space.

7. The medical device of claim 6 , wherein the gas source comprises a bag, a ventilator, or a gas tank.

8. the first parameter includes air pressure; 10. The medical device of claim 1, wherein the processor is further configured to generate an alert indicating that the air pressure is below a predetermined air pressure level when a compression level of an airbag of the medical device is equal to or exceeds a threshold compression level.

9. the first parameter comprises a humidity level; 10. The medical device of claim 1, wherein the processor is further configured to identify a physiological characteristic indicative of the humidity level being below a predetermined humidity level when a compression level of an airbag of the medical device is equal to or exceeds a threshold compression level.

10. a third sensor connected to a rim portion of the airway adapter; the third sensor is configured to detect a first value at a first time point and a second value at a second time point; the first value comprises a first electrical resistance or capacitance; the second value comprises a second electrical resistance or capacitance; the first time point is when air enters the space, the second point in time is when air leaves the space; the processor: determining that a difference between the first value and the second value is greater than or equal to a threshold difference; generating a third alert in response to determining that the difference between the first value and the second value is greater than or equal to the threshold difference; The medical device of claim 1 , further configured to:

11. the first parameter comprises an air flow rate; The second parameter is O 2 Including levels, the processor is further configured to determine that a relationship between the first parameter and the second parameter at the first time point is a similar relationship; Determining that the relationship between the first parameter and the second parameter has changed over the multiple ventilations includes determining that the relationship between the first parameter and the second parameter at the second time point is no longer a similar relationship. The medical device of claim 1 .

12. The first parameter is CO 2 Including levels, The second parameter is O 2 Including levels, the processor is further configured to determine that a relationship between the first parameter and the second parameter at the first time point is an inverse relationship; determining that the relationship between the first parameter and the second parameter has changed over the multiple ventilations includes determining that the relationship between the first parameter and the second parameter at the second time point is no longer inversely correlated; The medical device of claim 1 .

13. the first parameter comprises an air flow rate; The second parameter is O 2 Including levels, The processor determines the airflow rate in the space, O 2 configured to output a numerical value indicating the level and air pressure to the display; The medical device of claim 1 .

14. 1. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space; and a second sensor configured to detect a pressure in the space; and a display configured to visually output an airflow waveform indicative of air flow over time and an air pressure waveform indicative of air pressure over time; Processor and Including, At a first time, a first ventilation occurs when the bag is deflated and released, and at a second time, a second ventilation occurs when the bag is deflated and released; the processor: measuring a first ventilation by analyzing airflow during the first ventilation; measuring a second ventilation by analyzing the airflow during the second ventilation; identifying a first ratio of a first ventilation volume to an air pressure during a first ventilation; identifying a second ratio of a second ventilation volume to air pressure during the second ventilation; determining a discrepancy between the first ratio and the second ratio; determining that a leak exists between the mask and the patient's face in response to determining that there is a discrepancy between the first ratio and the second ratio; outputting an alert on the display indicating that a leak exists between the mask and the patient's face; The smart bag valve mask device is configured to:

15. the alert is a first alert, The smart bag valve mask device 2 further comprising a third sensor configured to detect a physiological parameter of the space, including partial pressure, temperature, or humidity; the display is further configured to output a physiological parameter waveform indicative of the physiological parameter over time; the processor: determining that the leak exceeds a severity threshold by analyzing the physiological parameter; in response to determining that the leak exceeds a severity threshold; Increase the intensity of the first alert, or causing the display to output a second alert indicating that the leak exceeds a severity threshold.

15. The smart bag valve mask device of claim 14, further configured to:

16. the alert is a first alert, the smart bag valve mask device further includes an electrode disposed on an edge of the mask, the electrode configured to detect an electrical signal; the processor: detecting a separation between an edge of the mask and the patient's face by analyzing the electrical signal; in response to detecting a separation between an edge of the mask and the patient's face; Increase the intensity of the first alert, or outputting a second alert on the display indicating that the mask is away from the patient's face; 15. The smart bag valve mask device of claim 14, further configured to:

17. the alert is a first alert, the smart bag valve mask device further comprising an accelerometer configured to detect chest movement of the patient; the processor: detecting a separation between the mask and the patient's face by analyzing chest movement of the patient taking into account the air flow or the air pressure; in response to detecting a separation between the mask and the patient's face; Increase the intensity of the first alert, or outputting a second alert on the display indicating that the mask is away from the patient's face; 15. The smart bag valve mask device of claim 14, further configured to:

18. 1. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space; and a second sensor configured to detect a pressure in the space; and CO 2 a third sensor configured to detect the level; Processor and Including, the processor: the air flow, the pressure, and the CO 2 determining, in response to detecting the level, that a leak exists between the mask and the patient's face; outputting an alert on a display indicating that a leak exists between the mask and the patient's face; The smart bag valve mask device is configured to:

19. 1. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space; and a second sensor configured to detect a pressure in the space; and A transceiver; Processor and Including, At a first time, a first ventilation occurs when the bag is deflated and released, and at a second time, a second ventilation occurs when the bag is deflated and released; the processor: measuring a first ventilation by analyzing airflow during the first ventilation; measuring a second ventilation by analyzing the airflow during the second ventilation; identifying a first ratio of a first ventilation volume to an air pressure during a first ventilation; identifying a second ratio of a second ventilation volume to air pressure during the second ventilation; determining a discrepancy between the first ratio and the second ratio; determining that a leak exists between the mask and the patient's face in response to determining that there is a discrepancy between the first ratio and the second ratio; causing the transceiver to transmit an alert indicating the presence of a leak between the mask and the patient's face. The smart bag valve mask device is configured to:

20. 1. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, a first sensor configured to detect airflow within the space, the first sensor being utilized over time to determine an air volume; a display configured to visually output an airflow value indicating the air flow and an air volume value indicating the air volume; Processor and Including, Ventilation occurs when the bag is deflated and released; the processor: measuring the amount of inhalation by analyzing the amount of air when the bag is deflated; measuring exhaled volume by analyzing the volume of air when the bag is released; identifying a discrepancy between the inhaled volume and the exhaled volume; determining that a leak exists between the mask and the patient's face in response to identifying a discrepancy between the inhaled volume and the exhaled volume; outputting an alert on the display indicating that a leak exists between the mask and the patient's face; The smart bag valve mask device is configured to:

21. detecting a first parameter of a space within a bag valve mask fluidly connected to a patient's airway and positioned on the patient's face; detecting a second parameter of the space; identifying a relationship between the first parameter and the second parameter; determining that the relationship has changed over multiple ventilations administered to the patient through the bag-valve-mask; identifying a leak between the bag valve mask and the patient's face based on determining that the relationship has changed over multiple ventilations; and outputting an alert indicating the leak based on the identification of the leak. A method comprising:

22. the first parameter comprises an air flow rate; The method comprises: integrating the airflow rate over time; and determining the result of the airflow integrated over time as ventilation. further comprising wherein identifying the leak comprises identifying the leak based on the ventilation rate.

22. The method of claim 21.

23. 22. The method of claim 21, wherein the first parameter comprises an air flow rate and the second parameter comprises an air pressure level, and the relationship comprises a similarity relationship.

24. The first parameter includes the air pressure level and the second parameter includes the CO 2 The CO 2 The level is CO 2 Partial pressure or EtCO 2 and the relationship comprises a similarity relationship.

25. The first parameter is CO 2 Including levels, the relationships include a first relationship; the alerts include a first alert identifying a first time point; The method comprises: O of air in the airways 2 identifying a third parameter comprising a level; The CO 2 Level and 2 identifying a second relationship between the levels; determining that the second relationship has changed over multiple ventilations; identifying a leak between the bag valve mask and the patient's face at a second time based on determining that the second relationship has changed over multiple ventilations; and outputting an alert indicating the second leak based on identifying the second leak at the second time point; 22. The method of claim 21 further comprising:

26. The first parameter is CO 2 Including levels, The CO 2 Level is CO 2 including the partial pressure of the relationships include a first relationship; the alerts include a first alert; The method comprises: identifying a third parameter; a third parameter including a humidity level or a temperature level of the air in the airway; and 2 identifying a second relationship between the levels; determining that the second relationship has changed over multiple ventilations; Based on determining that the relationship has changed over multiple ventilations, 2 CO levels are specified 2 identifying the level as being outside the range; and The CO 2 CO levels are specified 2 and outputting an alert indicating a leak based on the identified out-of-range level.

22. The method of claim 21 further comprising:

27. outputting the alert on the display, 22. The method of claim 21, further comprising causing the display to visually or audibly output the alert as an increasing alert, characterized by a first alert level at an earlier time being lower than a second alert level at a subsequent time.

28. the alerts include a first alert; The method comprises: determining an electrical resistance level via first and second electrodes attached to the rim of the bag valve mask; and causing a second alert on the display of the bag valve mask to prompt the user to check for leaks. further comprising 22. The method of claim 21, wherein the second alert identifies the electrical resistance level being at or below a threshold electrical resistance level.

29. the alerts include a first alert; The method comprises: determining an electrical resistance level via a first sensor and a second sensor attached to a rim portion of the bag valve mask; and causing a second alert on the display of the bag valve mask to prompt the user to check for leaks. further comprising 22. The method of claim 21, wherein the second alert identifies the electrical resistance level being at or below a threshold electrical resistance level.

30. the alerts include a first alert; The method comprises: determining a capacitance level via a capacitance sensor attached to a rim portion of the bag valve mask; and causing a second alert on the display of the bag valve mask to prompt the user to check for leaks. further comprising 22. The method of claim 21, wherein the second alert identifies the capacitance level being at or below a threshold capacitance level.

31. 22. The method of claim 21, further comprising the step of audibly or visually outputting instructions to guide the operation of the bag valve mask.

32. Determining blood oxygenation; and comparing said blood oxygenation to a threshold value; further comprising 22. The method of claim 21, wherein identifying the leak is further based on comparing the blood oxygenation to the threshold value.

33. 33. The method of claim 32, wherein determining the blood oxygenation comprises receiving an indication of blood oxygenation from an oximetry device.

34. a first parameter comprising an amount of air flowing from the bag valve mask into the airway; a second parameter including an air pressure within the bag valve mask; 22. The method of claim 21, further comprising measuring lung compliance based on the change in air volume and the change in air pressure.

35. A medical device comprising: a first sensor configured to sense a first parameter of a space within a bag valve mask fluidly connected to a patient's airway; a second sensor configured to detect a second parameter of the space; The display and Processor and Including, the processor: determining a relationship between the first parameter and the second parameter; identifying a leak between the bag-valve-mask and the patient's face based on determining that the relationship has changed over multiple ventilations; generating an alert indicative of the leak; outputting the alert on the display; The medical device is configured to:

36. the first parameter comprises an air flow rate; the processor: integrating the air flow rate over time; The result of the airflow integrated over time is identified as ventilation. It is further structured as follows:

36. The medical device of claim 35, wherein identifying the leak comprises identifying the leak based on the ventilation rate.

37. the first parameter includes air pressure; the processor: a compression level of an airbag of the medical device is equal to or greater than a threshold compression level; and Air pressure level drops below the specified level 36. The medical device of claim 35, configured to generate an alert in response to simultaneously determining:

38. the first parameter comprises a humidity level; 36. The medical device of claim 35, wherein the processor is further configured to identify a physiological characteristic indicative of the humidity level being below a predetermined humidity level when a compression level of an airbag of the medical device is equal to or exceeds a threshold compression level.

39. A rim portion and a sensor attached to the rim portion; further comprising the sensor determines an electrical resistance or capacitance; the processor is further configured to generate a third alert indicating that a difference between a first sensor value of the sensor and a second sensor value of the sensor is equal to or greater than a threshold difference; a first sensor value identifying an electrical resistance or capacitance of air in the space at a first time entering the medical device; 36. The medical device of claim 35, wherein a second sensor value identifies an electrical resistance or capacitance at a second time when air exits the medical device into the space.

40. the first parameter comprises an air flow rate; The second parameter is O 2 Including levels, the processor: determining that a relationship between the first parameter and the second parameter is a similarity relationship; Identifying a leak based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations and is no longer similar.

36. The medical device of claim 35, further configured to:

41. The first parameter is CO 2 Including levels, The CO 2 Level is CO 2 Including partial pressures, The second parameter is O 2 Including levels, the processor: determining that the relationship between the first parameter and the second parameter is an inverse correlation; Identifying a leak based on determining that the relationship between the first parameter and the second parameter has changed over multiple ventilations and is no longer an inverse relationship.

36. The medical device of claim 35, further configured to:

42. 1. A smart bag valve mask device, comprising: a mask configured to contact the patient's face; a bag fluidly connected to the mask; Including, the mask and the bag enclose a space fluidly connected to the patient's airway; moreover, A sensor connector; a modular sensor configured to detect a physiological parameter of the patient, the modular sensor being connected to the mask, the bag, or the sensor connector; a display configured to visually output a waveform indicative of the physiological parameter over time; Processor and Including, the processor: Responsive to the modular sensor being connected to the mask, the bag, or the sensor connector, identifying a sensor type; In response to identifying a sensor type, causing the modular sensor to sense the physiological parameter; Detecting a leak between the mask and the patient's face by analyzing the physiological parameter; outputting an alert on the display indicating that there is a leak between the mask and the patient's face; The smart bag valve mask device is configured to:

43. the modular sensor is connected to the sensor connector; the smart bag valve mask further comprising a transceiver; the processor: transmitting a status signal from the transceiver indicating that the modular sensor is connected to the sensor connector; causing the transceiver to transmit an alert signal in response to the physiological parameter indicating a leak between the mask and the patient's face.

43. The smart bag valve mask device of claim 42, further configured to:

44. the modular sensor includes a first modular sensor; the sensor connector includes a first sensor connector; the sensor types include a first type of sensor; the smart bag valve mask further includes a second modular sensor, a second sensor connector, and a transceiver; the processor: identifying a second type of sensor in response to a second modular sensor being connected to the mask, the bag, or the sensor connector; In response to identifying the second type of sensor, identifying a second physiological parameter sensed by the second modular sensor; transmitting a status signal including a first type of sensor and a second type of sensor from the transceiver; 43. The smart bag valve mask device of claim 42, further configured to:

45. detecting that the modular sensor has been connected to a medical device; identifying a physiological parameter of the patient sensed by the modular sensor in response to connecting the modular sensor to the medical device; detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter; and causing a transceiver to transmit an alert signal indicating the presence of a leak between the medical device and the patient. A method comprising:

46. the medical device comprises a smart bag valve mask device; 46. ​​The method of claim 45, wherein detecting that the modular sensor is connected to the medical device comprises detecting that the modular sensor is connected to a bag or mask of the smart bag-valve-mask system.

47. the modular sensor includes a first modular sensor; the alert signal comprises a first alert signal; the leak includes a first leak; The method comprises: identifying a type of sensor in response to connecting a second modular sensor to the medical device; detecting a second physiological parameter in response to identifying the sensor type; and causing the transceiver to transmit a second alert signal indicating that a second physiological parameter is outside of a predetermined parameter range.

46. ​​The method of claim 45, further comprising:

48. the modular sensor includes a first modular sensor; the alert signal comprises a first alert signal; the leak includes a first leak; The method comprises: identifying a type of sensor in response to connecting a second modular sensor to the medical device; and causing a second alert to be output on the display indicating that the second physiological parameter is outside of a predetermined parameter range.

46. ​​The method of claim 45, further comprising:

49. outputting an identifier indicative of the physiological parameter on a display; determining that the modular sensor has been disconnected from the medical device; and ceasing output of the identifier from the display in response to the modular sensor being disconnected from the medical device.

46. ​​The method of claim 45, further comprising:

50. causing the display to output a first notification that the modular sensor has been connected to the medical device; determining that the modular sensor has been disconnected from the medical device; and causing the display to output a second notification that the modular sensor has been disconnected from the medical device.

46. ​​The method of claim 45, further comprising:

51. the medical device is a smart bag valve mask device; detecting the physiological parameter detecting the physiological parameter in response to the modular sensor being connected to a bag or mask of the medical device; determining that the modular sensor has been disconnected from the bag or the mask; and causing the transceiver to transmit an alert signal in response to the modular sensor being disconnected from the bag or the mask.

46. ​​The method of claim 45, further comprising:

52. the modular sensor includes a first modular sensor; the physiological parameters include a first physiological parameter; the step of detecting that the modular sensors have been connected to the medical device further includes the step of activating a first modular sensor to detect a first physiological parameter in response to the first modular sensor being connected to the medical device; the step of detecting a first physiological parameter further comprises detecting the first physiological parameter in response to the modular sensor being activated; The method comprises: activating a second modular sensor to sense a second physiological parameter in response to the second modular sensor being connected to the medical device; and deactivating the first modular sensor in response to the second modular sensor being activated; 46. ​​The method of claim 45, further comprising:

53. The physiological parameters include airflow level, air pressure, CO 2 Level, O 2 46. ​​The method of claim 45, wherein the physiological parameter comprises a level, a humidity level, a temperature level, an electrical resistance level, a capacitance level, a bag compression level, or another type of physiological parameter.

54. detecting the modular sensor, identifying a type of sensor in response to connecting the modular sensor to the medical device; and activating the modular sensor to sense the physiological parameter in response to the sensor type.

46. ​​The method of claim 45, further comprising:

55. A medical device comprising: a modular sensor configured to determine a physiological parameter associated with the patient; Transceiver and Processor and Including, the processor: Detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter; outputting an alert signal from the transceiver indicating the presence of a leak between the medical device and the patient; The medical device is configured to:

56. the modular sensor is a first modular sensor; the physiological parameter is different from a second physiological parameter sensed by a second modular sensor; 56. The medical device of claim 55, wherein outputting the alert signal from the transceiver further comprises causing the transceiver to output an alert signal indicating that a second physiological parameter is outside of a range of predetermined parameters.

57. The physiological parameters include airflow, air pressure level, CO 2 Level, O 2 a first physiological parameter including a level, a humidity level, a temperature level, an electrical resistance level, a capacitance level, a bag compression level, or any other type of physiological parameter; The second physiological parameter is airflow, air pressure level, CO 2 Level, O 2 level, humidity level, temperature level, electrical resistance level, capacitance level, bag compression level, or other types of physiological parameters, a first type of parameter of the first physiological parameters is different from a second type of parameter of the second physiological parameters; 56. The medical device of claim 55, wherein the processor is configured to detect the presence of a leak between the medical device and the patient by further analyzing a second physiological parameter.

58. the physiological parameter is a first physiological parameter; the processor: outputting a first identifier indicative of the first physiological parameter to a display; causing the display to output a second identifier indicative of a second physiological parameter; 56. The medical device of claim 55, further configured to:

59. the processor: Identifying that the modular sensor has been disconnected from the medical device; outputting a status signal from the transceiver indicating that the modular sensor has been disconnected from the medical device; 56. The medical device of claim 55, further configured to:

60. the modular sensor is a first modular sensor; the processor: Identifying that a second modular sensor is connected to the medical device; causing the transceiver to output a status signal indicating that a second modular sensor has been connected to the medical device; 56. The medical device of claim 55, further configured to:

61. the processor: Identifying that the modular sensor has been disconnected from the medical device; outputting a notification on the display that the modular sensor has been disconnected from the medical device; 56. The medical device of claim 55, further configured to:

62. 56. The medical device of claim 55, further comprising a power source and a power cable utilized to charge the power source.

63. 56. The medical device of claim 55, further comprising a tactile device, wherein the processor is further configured to cause the tactile device to provide tactile feedback in response to detecting the presence of the leak.

64. the processor: Identifying a chest compression depth parameter received via the transceiver; Detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter and the chest compression depth parameter.

56. The medical device of claim 55, further configured to:

65. A medical device comprising: a modular sensor including a first sensor configured to determine a first physiological parameter associated with a patient and a second sensor configured to determine a second physiological parameter associated with the patient; A transceiver; Processor and Including, the processor: Detecting the presence of a leak between the medical device and the patient by analyzing a first physiological parameter or a second physiological parameter; outputting an alert signal from the transceiver indicating the presence of a leak between the medical device and the patient; The medical device is configured to:

66. A medical device comprising: a modular sensor configured to determine a physiological parameter associated with the patient; a transceiver configured to transmit and receive data; Processor and Including, the processor: causing the transceiver to receive patient data; Detecting the presence of a leak between the medical device and the patient by analyzing the physiological parameter in response to receiving the patient data; outputting an alert signal from the transceiver indicating the presence of a leak between the medical device and the patient; The medical device is configured to:

67. 1. An apparatus comprising: a mask configured to contact the patient's face; A bag and a flow sensor connected between the mask and the bag and configured to detect the flow rate of air flowing between the mask and the bag; A connection is made between the mask and the bag, and the CO 2 configured to detect levels of CO 2 A sensor, an air pressure sensor connected between the mask and the bag and configured to detect the pressure of the air; A transceiver; The display and Processor and Including, the processor: the flow rate, the CO 2 determining that a leak exists between the face and the mask based on the level and the pressure; In response to determining that a leak exists between the face and the mask, causing the transceiver to transmit a signal indicative of the leak; outputting an alert indicating the leak on the display; The apparatus is configured to:

68. The processor determines the flow rate, the CO 2 determining that the flow rate, the CO level, or the pressure is below a predetermined parameter level; 2 68. The device of claim 67, configured to determine the presence of a leak between the face and the mask based on a level and the pressure.

69. The processor detects the flow rate, the CO 2 Level or pressure detected during previous ventilation, past flow, past CO 2 the flow rate, the CO2 pressure, or the CO2 pressure detected during the current ventilation by determining whether the flow rate, CO2 pressure, or the CO2 pressure has decreased compared to a previous ventilation level. 2 68. The device of claim 67, configured to determine the presence of a leak between the face and the mask based on a level and the pressure.

70. the processor: the flow rate, the CO 2 determining that the leak has ceased based on the level and the pressure; and ceasing output of the alert from the display in response to determining that the leak has disappeared.

68. The apparatus of claim 67, further configured to:

71. the processor: receiving, at the receiving coil, an electromagnetic induction signal from an external device that induces a current in the receiving coil; storing the energy generated by said current in a capacitor or battery; the flow rate sensor, 2 supplying the energy to the sensor or the air pressure sensor 68. The apparatus of claim 67, further configured to:

72. detecting a physiological parameter with a sensor; determining that the physiological parameter is below a physiological parameter threshold; determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold; and outputting an alert indicating that the mask is away from the patient's face. A method comprising:

73. the physiological parameter thresholds include a first physiological parameter threshold; determining that the physiological parameter is below a physiological parameter threshold further comprises determining that the physiological parameter is below a first physiological parameter threshold and above a second physiological parameter threshold; determining that the mask is away from the patient's face further comprises determining that the mask is away from the patient's face based on the physiological parameters being below a first physiological parameter threshold and above a second physiological parameter threshold; 73. The method of claim 72.

74. The physiological parameters include the flow rate of air flowing between the mask and the bag, the CO 2 the level, or the pressure of the air, The step of outputting the alert comprises: determining whether the physiological parameter is below a first threshold or above a second threshold; and causing the external device to wirelessly transmit an alert signal from the transceiver.

73. The method of claim 72, comprising:

75. The step of outputting the alert comprises: determining whether the physiological parameter is below a first threshold or above a second threshold; and outputting an alert via a wired interface; 73. The method of claim 72, comprising:

76. the step of outputting the alert includes outputting an acoustic signal including the alert from a speaker.

73. The method of claim 72, comprising:

77. The physiological parameters include flow rate, CO 2 level or pressure, The step of determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold includes: 2 Level or pressure detected during previous ventilation, past flow, past CO 2 73. The method of claim 72, including determining that the pressure has decreased compared to a level or past pressure.

78. the physiological parameter is flow rate; The method further comprises measuring CO 2 detecting the level of determining that the mask is away from the patient's face based on the physiological parameter being below a physiological parameter threshold includes determining that the flow rate is reduced compared to a previous flow rate detected during a previous ventilation; The step of determining that the mask is away from the patient's face may include determining whether or not the mask is away from the patient's face based on past CO detected during a past ventilation. 2 CO levels compared to 2 73. The method of claim 72, further performed based on a decreased level.

79. the physiological parameter is humidity level; 73. The method of claim 72, wherein determining that the mask is off the patient's face based on the physiological parameter being below a physiological parameter threshold comprises determining that the humidity level has decreased compared to a previous humidity level detected during a previous ventilation.

80. the physiological parameter is a temperature level; 73. The method of claim 72, wherein determining that the mask is off the patient's face based on the physiological parameter being below a physiological parameter threshold comprises determining that the temperature level has decreased compared to a previous temperature level detected during a previous ventilation.

81. determining, based on the physiological parameter, that there is no leakage between the mask and the patient's face; and ceasing the output of the alert from the display in response to determining that the leak has disappeared.

73. The method of claim 72, further comprising:

82. receiving, at the receiving coil, an electromagnetic induction signal from an external device that induces a current in the receiving coil; storing the energy generated by the current in a capacitor or battery; and providing the energy to a sensor configured to detect the physiological parameter; 73. The method of claim 72, further comprising:

83. A medical device comprising: A flow sensor; CO 2 A sensor, An air pressure sensor; A transceiver; The display and Processor and Including, the processor: the flow rate detected by the flow sensor, 2 CO detected by the sensor 2 determining that a leak exists between the face and the mask based on the level or the air pressure detected by the air pressure sensor; In response to determining that a leak exists between the face and the mask, transmitting a signal indicative of the leak from the transceiver; outputting an alert indicating the leak on the display; The medical device is configured to:

84. The processor determines the flow rate, the CO 2 determining that the flow rate, the CO2 level, or the air pressure is below a predetermined parameter level; 2 84. The medical device of claim 83, configured to determine the presence of a leak between the face and the mask based on a level and the air pressure.

85. The processor detects the flow rate, the CO 2 level or pressure, past flow rate, past CO detected during past ventilation 2 the flow rate, the CO2 detected during the current ventilation, by determining whether the flow rate, the CO2 level, or the CO2 level has decreased compared to a previous ventilation. 2 84. The medical device of claim 83, configured to determine the presence of a leak between the face and the mask based on a level and the air pressure.

86. the processor: the flow rate, the CO 2 determining that the leak has ceased based on the level and the air pressure; and ceasing output of the alert from the display in response to determining that the leak has disappeared.

84. The medical device of claim 83, further configured as follows:

87. the processor: receiving, at the receiving coil, an electromagnetic induction signal from an external device that induces a current in the receiving coil; storing the energy generated by said current in a capacitor or battery; the flow rate sensor, 2 supplying the energy to the sensor or the air pressure sensor 84. The medical device of claim 83, further configured as follows:

88. The processor detects the flow rate, the CO 2 level or pressure, past flow rate, past CO detected during past ventilation 2 the flow rate, the CO2 detected during the current ventilation, by determining whether the flow rate, the CO2 level, or the CO2 level has decreased compared to a previous ventilation. 2 84. The medical device of claim 83, configured to determine when the mask is away from the patient's face based on the level and the air pressure.

Images