HK40002966B - Systems and methods for pulmonary health management - Google Patents

Description

Systems and methods for lung health management

Cross-reference related applications

This application claims the benefit under 35 U.S.C. §119 of U.S. Provisional Patent Application No. 62/331,328, filed May 3, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; U.S. Provisional Patent Application No. 62/332,352, filed May 5, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; U.S. Provisional Patent Application No. 62/334,076, filed May 10, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; and U.S. Provisional Patent Application No. 62/335,077, filed June 24, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”. and U.S. Provisional Patent Application No. 62/354,437, filed on September 23, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; U.S. Provisional Patent Application No. 62/399,091, filed on September 23, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; U.S. Provisional Patent Application No. 62/416,026, filed on November 1, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; U.S. Provisional Patent Application No. 62/422,932, filed on November 16, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; and U.S. Provisional Patent Application No. 62/439,691, filed on December 1, 2016, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”. and U.S. Provisional Patent Application No. 62/428,696, filed on January 20, 2017, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; U.S. Provisional Patent Application No. 62/448,796, filed on January 20, 2017, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”; and U.S. Provisional Patent Application No. 62/471,929, filed on March 15, 2017, entitled “DISPOSABLE PULMONARY DRUG DELIVERY APPARATUS AND METHODS OF USE”. The contents of each application are incorporated herein by reference in their entirety.

Technical Field

Aspects of the present disclosure relate to pulmonary health management of one or more patients, and more particularly to generating pulmonary health management analyses using one or more inhalation devices configured to monitor pulmonary conditions and deliver medications through the lungs to treat various pulmonary and/or non-pulmonary conditions.

Background Art

Aerosol generating devices are commonly used to treat various respiratory diseases. For example, inhalation is used to deliver aerosolized drugs to treat asthma, chronic obstructive pulmonary disease (COPD) and site-specific disorders with reduced systemic adverse reactions. The main challenge is to provide devices that can deliver accurate, consistent and verifiable doses with droplet sizes suitable for successful delivery to the target lung passages. Effective delivery of drugs to the deep lung regions of the lungs via the alveoli has always been problematic due to their limited vital capacity and constricted respiratory passages, especially for children and the elderly and patients in diseased states. The effects of constricted lung passages limit the depth of inspiration and synchronization of the administered dose with the patient's respiratory cycle, including inspiration and expiration.

Conventional equipment usually or can not provide high enough momentum to realize dosage ejection from equipment, perhaps low enough to stop dosage from being deposited on throat back.More particularly, many conventional inhaler systems (such as metered dose inhaler (MDI) and pressurized metered dose inhaler (p-MDI) or pneumatic and ultrasonic drive equipment) generally produce the droplet with high speed and large-scale droplet size, include the large droplet of high momentum and kinetic energy.Droplet and aerosol with such high momentum can not arrive distal lung or lower lung passage, but are deposited in oral cavity and throat.Therefore, need bigger total drug dosage to realize the deposition of expectation in target zone.These large doses have increased the possibility of undesirable side effect.

Due to its high jet velocity and rapid expansion of the propellant carrying the drug, the aerosol plume produced by conventional aerosol delivery systems causes localized cooling and subsequent condensation, deposition, and crystallization of the drug on the injector surface, creating additional challenges. This blockage of the injection orifice by deposited drug residues inhibits effective delivery of the dose. This phenomenon of surface condensation and drug deposition is also a challenge for conventional nebulizers.

Furthermore, many patients fail to use their inhalers correctly, exacerbating the challenges healthcare providers face in treating various conditions. Delivering and inhaling the correct dose at the prescribed time is crucial for treatment. However, conventional devices cannot verify the delivery and quality of the dose, making it difficult for providers to interpret current treatment results and modify prescribed treatments if they are not achieving therapeutic results. Similarly, providers must rely on patient symptom descriptions combined with clinical testing. However, this often fails to provide a comprehensive picture of the status and effectiveness of a specific medication in treating lung conditions.

It is with these observations and others in mind that various aspects of the present invention were conceived and developed.

Summary of the Invention

The implementations described and claimed herein solve the aforementioned problems by providing systems and methods for lung health management. In one implementation, lung health management information is received from one or more inhalation devices over a network. Each of the one or more inhalation devices has one or more pressure sensors that measure the flow rate of airflow through a tube of the inhalation device. Environmental data is received for one or more geographic locations where the one or more inhalation devices are deployed. The environmental data is captured using one or more environmental sensors, and the environmental data corresponds to ambient air conditions in each of the one or more geographic locations. Using at least one computing unit, the lung health management information is associated with the environmental data based on at least one management parameter; and using the at least one computing unit, an aerial analysis is generated from the associated data.

Other implementations are also described and described herein. In addition, although multiple implementations are disclosed, it will become clear to those skilled in the art from the detailed description below that other implementations of the currently disclosed technology are also available, and this detailed description illustrates and describes an illustrative implementation of the currently disclosed technology. As will be appreciated, the currently disclosed technology can be modified in various aspects without departing from the spirit and scope of the currently disclosed technology. Accordingly, the accompanying drawings and detailed description should be considered to be illustrative rather than restrictive in nature.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 illustrates an example inhalation device used by a patient for lung health management.

2 is a functional block diagram of example components of an inhalation device, including a medication cartridge.

FIG3 illustrates example operations for delivering medication to a patient using an inhalation device.

4 illustrates a lung health management system including an air analyzer that may be run on a computer server, computing device, or other network device for lung health management using one or more inhalation devices.

5 is an example air analysis user interface for managing the lung health of one or more patients or geographic regions.

FIG6 illustrates example operations for lung health management.

FIG7 is a functional block diagram of an electronic device including an operating unit arranged to perform lung health management operations.

FIG. 8 is an example computing system in which the various systems and methods of the disclosed technology may be implemented.

9A-9C illustrate front perspective, rear perspective, and rear views, respectively, of an example inhalation device.

FIG10 is a cross-sectional view of the inhalation device taken along the line shown in FIG9C .

Figure 11 shows an exploded view of the inhalation device.

FIG. 12A illustrates a bottom perspective view of an example medicine cartridge.

12B is an exploded view of the injector assembly of the cartridge.

FIG. 12C illustrates a cross-sectional view of the cartridge with a detailed view of the injector O-ring.

13 shows a detailed view of an example orifice plate having jet orifices having multiple diameters configured to generate droplets of multiple sizes to target different regions of the lung airways.

14A-14B each illustrate an example inhalation device configured to sense airflow by detecting a pressure differential across a flow restriction, wherein FIG. 14A illustrates the restriction being inside an aerosol delivery tube and FIG. 14B illustrates the restriction being an air inlet screen.

15A-15C illustrate various examples of pressure sensor assemblies.

16A is a circuit diagram of an example power on/off circuit for an example inhalation device.

16B is a circuit diagram of an example power connector circuit for an example inhalation device.

16C is a circuit diagram of an example volt-power regulation circuit for an example inhalation device.

16D is a circuit diagram of an example controller circuit for an example inhalation device.

16E is a circuit diagram of an example controller programming connector circuit for an example inhalation device.

16F is a circuit diagram of an example piezoelectric connector circuit for an example inhalation device.

16G is a circuit diagram of an example user switch with a debounce circuit for an example inhalation device.

16H is a circuit diagram of an example piezoelectric driver circuit for an example inhalation device.

161 is a circuit diagram of an example pressure sensor circuit for an example inhalation device.

16J is a circuit diagram of an example light emitting diode indicator circuit for an example inhalation device.

16K is a circuit diagram of an example buzzer driver circuit for an example inhalation device.

DETAILED DESCRIPTION

Aspects of the present disclosure generally relate to systems and methods for monitoring lung health using one or more inhalation devices. In one aspect, each air inhalation device includes one or more sensors configured to capture lung health data for a patient. Using this data, an air analysis can be generated that relates to individualized patient health, the general health of people living in a specific geographic location, the air quality of a specific geographic area, operating parameters of the inhalation device, and the like. For example, the air analysis can be output for display on a user device (such as a patient user device, a healthcare provider user device, and/or an administrator user device).

In general, inhalation devices provide delivery of a fluid in the form of an aerosol comprising one or more medicaments to the patient's lungs for local pulmonary and/or systemic delivery of (one or more) medicaments. Inhalation devices are configured to provide aerosol droplet sizes within the human respirable range so that effective, repeatable dose delivery is achieved. The human respirable range includes droplets with an aerodynamic diameter less than 5 microns, which are transported almost entirely by the motion of airflow and entrained air rather than by their own momentum. More particularly, in order to optimally deposit in the alveolar airways, the human respirable range includes droplets with an aerodynamic diameter within the range of 1 to 5 μm, wherein particles below 4 μm reach the alveolar region of the lungs. Larger droplets (i.e., greater than 5 μm) often deposit on the tongue or impact the throat and coat the bronchial passages. Smaller particles (less than 1 μm in diameter) that penetrate deeper into the lungs tend to be exhaled. Thus, inhaler devices as herein described deliver particles of a suitable size range, avoid surface fluid deposition and pore clogging, and provide verifiable doses simultaneously. As such, feedback is provided to patients and healthcare providers regarding the correct and consistent use of the inhaler device.

In addition, inhaler devices can monitor a patient's breathing pattern to diagnose a condition and/or manage treatment. For example, a decrease in peak flow is a useful indicator of an increased probability of an asthma attack, and measurement of lung output (i.e., FEV1) can be useful in determining the effectiveness of a particular drug therapy for treating a lung condition.

Many of the example implementations described herein refer to pulmonary conditions. However, those skilled in the art will recognize that the technology of this disclosure is applicable to non-pulmonary conditions that can be diagnosed and/or treated via analysis and delivery of drugs through the lungs. Additionally, the various inhalation devices described herein are merely exemplary. Other health monitoring devices can be used to generate air analysis.

1 , an example inhalation device 100 is shown for use with a patient 104 for lung health management. In one implementation, the inhalation device 100 includes a cartridge 102, which may be disposable or reusable, for ejecting a dose of medication for delivery to the lungs of the patient 104 during an inhalation cycle. As described herein, the inhalation device 100 may also capture lung health data of the patient 104 for use in diagnosing the patient's condition and/or generating an air analysis.

In one implementation, the inhalation device 100 is configured to be used for electronically activated breath actuation. The inhalation device 100 comprises a pressure sensor assembly that automatically detects a trigger point during the inhalation cycle of the patient 104 to activate and trigger the ejection and delivery of the medicine. For example, the pressure sensor assembly can be programmed to trigger a two-second ejection when airflow is 10 standard liters per minute (SLM). The trigger point during the inhalation cycle can provide the optimal point for activating and triggering the ejection and delivery of the medicine during the inhalation cycle of the patient 104. Because breath actuation does not require patient-device coordination, the breath actuation trigger mechanism of the inhalation device 100 for delivering an aerosol dose has ensured the optimal delivery of the medicine.

As shown in FIG1 , the inhalation device 100 generates entrained air (e.g., 5 μm in diameter and smaller) from the droplets ejected from the cartridge 102 due to the combined momentum transfer from the droplets to the surrounding air and the large specific surface area of the droplet particles. FIG1 illustrates an inertial filter mechanism provided by the inhalation device 100 for filtering and excluding larger droplets (e.g., greater than 5 μm in diameter) from the aerosol plume by virtue of their higher inertial forces and momentum. In one implementation, as the droplets emerge from the cartridge 102 and are swept by the airflow 106 through the laminar flow element prior to being inhaled into the lung airways of the patient 104, the droplets undergo an approximately ninety-degree change in ejection direction from the first region 108 to the second region 110.

In the event that droplet particles having an aerodynamic diameter greater than 5 microns are generated by the drug cartridge 102, the inhalation device 100 excludes them from the airflow 106 by using their increased inertial mass to deposit them onto the airway tubes. Alternatively, if all ejected particles are targeted for delivery as a dose, the velocity of the airflow 106 can be increased so that larger droplet particles can be carried into the lung airways of the patient 104. This feature of the inhalation device 100 further increases the respirable dose, thereby providing improved targeted delivery of medication either deep into the lower alveolar airways or to the upper respiratory regions of the patient 104.

The inhalation device 100 can also verify the dose by verifying the presence of a plume of drug droplets. In one implementation, the inhalation device 100 verifies the plume by measuring optical absorption or scattering of the droplets between the medicine box 102 and the patient 104. The optical measurements are performed using a sunlight-blind ultraviolet light source and detector. In another implementation, the inhalation device 100 verifies the plume by measuring the temperature of the airflow carrying the plume.

As further described herein, in an implementation, suction device 100 uses air flow sensor assembly to generate the diagnosis for lung disease state monitoring, and described air flow sensor assembly has the sensitivity of increase, no drift, low hysteresis and the sensor output that is independent of air density and temperature under low pressure differential.More particularly, suction device 100 can capture one or more diagnostic indices of the pulmonary function of patient 104, include but not limited to peak inspiratory flow rate, inhaled volume, nitric oxide concentration, lung output etc.Suction device 100 can capture diagnostic indices by using preset flow resistance element, adjustable flow resistance element etc. to measure the pressure drop between the airway of suction device 100 and the surrounding atmosphere.Diagnostic indices can be stored in the suction device 100 and/or be sent to user device for generating air analysis.

Generally speaking, inhalation device 100 includes a cartridge 102 for delivering a safe, suitable, and repeatable dose for pulmonary use to a patient 104. Cartridge 102 delivers a predetermined volume of fluid in the form of aerosol droplets having the property of delivering a sufficient and repeatable high percentage of deposition into the alveolar airways of patient 104 upon administration.

As described in more detail herein, in one implementation, the cartridge 102 includes a reservoir for receiving a volume of fluid and an ejector assembly having a piezoelectric actuator plate and an aperture plate (screen) configured to eject a stream of aerosol droplets having an average ejected droplet diameter of less than 5 microns. The aerosol droplets are small, have low inertial forces and low momentum, and are transported to the lungs almost entirely by the motion of the airflow (entrained air) and reach the lower alveolar airways of the subject during use.

In other words, suction device 100 is delivered to the lung of patient 104 with aerosol, is used to deliver small molecules, macromolecule and biopharmaceutical, is used for local lung or systemic drug delivery.In an implementation, suction device 100 provides the aerosol droplet size in the human breathable range (for example, less than 5 microns), makes to realize effective, repeatable dosage delivery.In addition, suction device 100 generates aerosol in the mode of in-situ temperature or the power that does not generate the rising that may make activating agent denaturation or decomposition.As such, suction device 100 can be used for delivering biological preparation and other macromolecule that may otherwise be easy to denaturation and degraded in traditional inhaler and nebulizer.

In one implementation, the medicine cartridge 102 includes an ejector assembly configured to eject an aerosol stream of droplets. The ejector assembly includes an orifice plate coupled to a piezoelectric actuator. In some implementations, the orifice plate can be coupled to an actuator plate, which is coupled to the piezoelectric actuator. The orifice plate includes a plurality of openings formed through its thickness, and the piezoelectric actuator oscillates the orifice plate at a frequency and voltage that generates a directional aerosol stream of droplets that pass through the smaller openings of the orifice plate and enter the lungs when the patient 104 inhales, causing the fluid to contact one surface of the orifice plate. In other implementations where the orifice plate is coupled to the actuator plate, the actuator plate is oscillated by the piezoelectric oscillator at a frequency and voltage that generates a directional aerosol stream or plume of aerosol droplets.

The medicine cartridge 102 can be replaced or disposed of daily, weekly, or monthly, as appropriate for the prescribed treatment. Due to its short lifespan, the disposable nature of the medicine cartridge 102 can be minimized and prevent the accumulation of surface deposits or microbial contamination on the orifice plate. Alternatively, the medicine cartridge 102 can be reusable for delivering multiple medications or flavorings for multiple medicaments. Thus, the inhalation device 100 can deliver multiple medications prescribed to a patient using the same device. The medicine cartridge 102 can include dual cartridge modules with similar orifice plates designed to deliver doses of inhaled medication targeted to similar regions of the pulmonary airways and with droplets having a similar aerodynamic size distribution. Alternatively, the use of multiple medications or multiple medicaments may require drug delivery to different regions of the pulmonary airways. In these cases, each dual cartridge module of the medicine cartridge 102 can include orifice plates with different spray hole designs and different inlet and outlet hole sizes to provide delivery of different droplet sizes to different regions of the pulmonary airways of the patient 104.

In one implementation, the medicine box 102 delivers multiple medications or flavorings for multiple-flavored medications, wherein the spray orifice plate of each medication-containing medicine box unit is designed with spray orifices of different sizes. This design provides a system and method for producing different droplet sizes using a single orifice plate. This design can target different areas of the lung airways and thereby promote compliance with medication regimens in children and adults by providing flavored medications that improve the taste of medications in the mouth and throat. In certain aspects, this system and method of designing an orifice plate with different spray orifices can improve the taste or feel of a nicotine delivery device by delivering droplets large enough to deposit on the tongue and throat and delivering droplets to the deep alveolar airways.

The ejector assembly of medicine box 102 can be horizontally oriented and positioned so that the fluid or medicine contained therein is in constant contact with the inlet surface of orifice plate. The horizontally oriented ejector assembly allows and provides uniform fluid distribution and uniform coating of fluid onto the orifice plate. In some implementations, the horizontally positioned ejector assembly provides an orifice plate with uniform fluid/medicine coating, which also has the benefit of providing a uniform load across the orifice plate. This design provides a more efficient and stable orifice plate oscillation, and can provide a more efficient fluid injection and minimize the possibility of chaotic film oscillation. In some aspects, chaotic oscillation may cause the delivery of inappropriate doses and minimize or completely stop injection or cause fluid and/or medicine to be deposited on the orifice plate surface and cause hole clogging. Reducing or eliminating chaotic oscillation provides a more efficient and stable orifice plate oscillation and a more efficient and stable drug delivery.

In one implementation, after a dose is ejected from the piezoelectric ejector of the ejection assembly, the inhalation device 100 monitors and detects the amount of fluid ejected and the amount of drug remaining in the drug cartridge 102. For example, as described by the Sauerbrey equation, a frequency shift in the resonant frequency oscillation of the orifice plate is associated with a change in mass loading. In certain implementations, detecting a change in the resonant frequency of the orifice plate's oscillation can provide dose verification because the change in the resonant frequency of the orifice plate's oscillation is associated with a change in mass or loading on the piezoelectric actuator.

Suction device 100 can comprise surface tension plate, such as porous grid or porous plate.Surface tension plate can comprise the set of vertex, edge and the hole of definition shape, wherein shape can be but not limited to square, triangle, polygon or the grid form of any shape, it is placed on the orifice plate back on the fluid inlet surface side and is constructed to keep constant fluid loading.The space of the opening on the surface tension plate and the surface tension plate can be optimized and specified by the surface tension force of fluid with respect to the distance and the arrangement of the orifice plate surface.In some aspects, the existence of the surface tension plate that is placed on the orifice plate back also causes more stable and controlled vibration and the actuation of orifice plate, and minimizes the chaotic vibration of fluid and/or medicine and to the deposition on the orifice plate surface.

In one implementation, the ejector assembly of the cartridge 102 can be oriented vertically so that placement of the surface tension plate behind the vertically oriented ejector assembly on the fluid side of the orifice plate provides constant and uniform fluid loading. This arrangement provides uniform fluid coating on the orifice plate and also has the advantage of providing uniform loading across the orifice plate. In certain implementations, this arrangement also provides more efficient and stable orifice plate oscillation, which can result in more efficient fluid ejection and aerosol formation and minimize the possibility of chaotic film oscillation.

The suction device 100 can be posture insensitive. More particularly, placing a surface tension plate behind and beside the orifice plate provides constant and uniform fluid load on the orifice plate, and does not rely on the overall orientation of the suction device 100 about fluid loading or placing fluid or availability behind the orifice plate before actuation and injection. This can also provide more efficient and stable orifice plate oscillation, which can cause more efficient fluid injection and minimize the possibility of chaotic membrane oscillation.

Inhalation apparatus 100 can be made insensitive to the pressure differential that may occur when patient 104 is traveling in an airplane or in the weather-related variation of atmospheric pressure from sea level to seabed height and high altitude. In some aspects, the application and use of the super-hydrophobic ventilation valve adjacent to the placement of the drug reservoir in medicine box 102 provide and prevent water and medicine from invading or crossing the exchange of valve, and avoid leaking from reservoir. In some implementations, the super-hydrophobic air exchange valve allows air to pass through valve and freely enter and exit reservoir, stops moisture or fluid by the air exchange valve simultaneously. This high efficiency particulate air filter also normalizes the pressure differential between environment and the reservoir, and wherein the highly filtered air removes all particles and pathogens (comprising viral pathogens, bacterium and spore), because inhalation apparatus 100 stands the variation of atmospheric pressure and experiences pressure differential thus. The ability that is provided for the active and dynamic mechanism of efficient air filtration also provides and prevents drug leakage, because by allowing the free exchange of air, the pressure in the reservoir of medicine box 102 keeps and balances its environment.

The inhalation device 100 is insensitive to changes in ambient air pressure caused by changes in weather or altitude. This allows the inhalation device 100 to be used without the possibility of fluid leakage when it is transferred to different altitudes. The inhalation device 100 can also reduce fluid and drug deposition on the surface of the orifice plate and prevent clogging of the orifice, which can prevent improper delivery of a dose or render the inhalation device 100 inoperable.

Suction device 100 delivers a certain volume of fluid and moves in the entrained air as aerosol plume or tiny liquid mist, has laminar flow when it enters the pulmonary airway of patient 104.A source of the entrained air with laminar flow is provided by laminar flow element, wherein a plurality of parallel tubes have hexagonal or other cross sections, and are placed on the air inlet end of the aerosol delivery tube of suction device 100, as described herein.Laminar flow element generates laminar airflow 106 by air stream is divided into many parallel flow channels, and described flow channel has enough small diameter to generate laminar airflow 106 but can not be too small to produce significant pressure difference between the inlet side of laminar flow element and the outlet side of laminar flow element.Owing to only have small stream to pass through each laminar flow element passage, therefore the Reynolds number of the stream by each passage is enough little to maintain laminar flow 106. In certain implementations, air drawn into the inhalation device 100 has laminar flow characteristics as it is drawn through the laminar flow element and sweeps across the face of the orifice plate, entraining and carrying the ejected particles further downstream into the airway of the patient 104 .

The inhalation device 100 can include a mini-fan or centrifugal blower located on the air inlet side of the laminar flow element. The mini-fan can provide additional airflow and pressure for the airflow output. If the patient 104 has low lung output, this additional airflow ensures that the droplets containing the drug are pushed through the inhalation device 100 and into the patient's 104 airway. In certain implementations, this additional airflow source ensures that the ejector face of the medicine cartridge 102 sweeps the aerosol droplets and also diffuses the droplet plume into the airflow, which creates greater separation between the droplets. The airflow provided by the mini-fan can also act as a carrier gas, thereby ensuring significant dilution, which reduces the possibility of rapid dosing and rapid drug uptake. For some drugs, this rapid drug absorption may cause undesirable side effects. In addition, a capsule that can be squeezed manually or by electromechanical components can be used to generate high air pressure during drug administration to improve lung drug deposition in patients 104 who have low lung output or are experiencing deterioration. A manual button on the inhalation device 100 can be used to trigger the injection of drug during "rescue" mode.

In one embodiment, the inhalation device 100 provides a high modulus polymer orifice plate whose periodic oscillations generate acoustic waves emitted from the nozzle plate surface when accelerating and decelerating during the aerosol spray cycle. The surface acoustic waves generate pressure waves or compression waves, which further enhance the generation and propagation of droplets in the entrained air. The high modulus polymer orifice plate with multiple openings ejects liquid as droplets through the inlet and outlet holes contained in the accelerating orifice plate. In some embodiments, when the oscillating high modulus orifice plate is at its maximum displacement, the velocity at the orifice plate membrane surface is zero, while its acceleration has a negative maximum value in the range of 0.1-50 km/s ² , 5-50 km/s ² , but not limited to 5-25 km/s ^2. The directional aerosol droplet stream directed through the openings in the thickness of the orifice plate surface emerges from the openings with a maximum inertial force that is sufficient to carry the aerosol downstream, away from the orifice plate.

The inhalation device 100 can also employ a laser Doppler vibrometer (LDV) system and method to characterize the electromechanical system and piezoelectric actuator, measuring the instantaneous phase, displacement, velocity, and acceleration of the oscillating membrane. In certain aspects, LDV can provide a three-dimensional representation of the phase relationship between displacement, velocity, and acceleration to identify resonances and eigenmodes of the electromechanical system, including the piezoelectric actuator, enabling efficient optimization of piezoelectric materials, piezoelectric geometry, and ejector system design for optimal aerosol droplet generation and atomization characteristics. Such analytical parameters can be simultaneously detected, captured, and stored for subsequent analysis by the inhalation device 100 and/or an air analyzer.

When the fluid emerges from the outlet orifice of the oscillating nozzle plate, the inhalation device 100 can deliver electrostatically charged drug aerosol particles generated during ejection and droplet formation. In one implementation, the surface of the outlet chamber or tube through which the aerosol plume passes is coated with a surfactant to reduce the charge. The electrostatic coating can increase the fine particle dose delivered to the lung airways and reduce the deposition of drug particles onto the inner surface of the device tube of the inhalation device 100. Alternatively, the outlet tube or the entire body of the inhalation device 100 can be made of a charge dissipating polymer, which further reduces the accumulation of static charge in the outlet chamber.

In one implementation, the inhalation device 100 includes a spray verification system for detecting the pressure differential between the interior and exterior areas of the ejector tube to verify aerosol spray and drug delivery. The signal provided by the pressure sensor of the spray verification system provides a trigger to activate the spray at the peak or during the inspiratory cycle of the patient 104 and ensure optimal deposition of the aerosol spray and drug delivery to the lung airways.

The spray verification system of the inhalation device 100 can include an infrared light emitting diode (LED) having a wavelength of, for example, approximately 850 nm, and an infrared photodetector. In one implementation, the spray verification system can use a solar-blind photodetector and a UV-C LED having a peak emission wavelength below approximately 280 nm for measuring and sensing in either transmission or backscatter mode to detect the presence and amount of sprayed medication.

The spray verification system of the inhalation device 100 operates in fluorescent mode, wherein the air stream is exposed to an energy source, such as ultraviolet light, and a substance in the air stream that fluoresces, emitting photons of a specific wavelength. This mode can be used to detect and measure a variety of airborne substances and provides spray verification with maximum detection, ensuring the elimination of incorrect or erroneous spray detection. The solar-blind detector provides greater flexibility in the use and operation of the inhalation device 100 outdoors and in bright sunlight without interference.

In another implementation, the inhalation device 100 uses an audio signal for spray verification when a dose is dispensed by breath actuation and/or when a stream of aerosol droplets is detected. Adding a sound chip to the electronics of the inhalation device 100 via a speaker provides immediate feedback to the patient 104 when a dose is successfully delivered. By providing real-time feedback, the audio signal can maximize patient compliance by providing assurance that a dose was successfully delivered.

Alternatively or additionally, the inhalation device 100 can measure and quantify the amount of drug ejected during spraying and aerosolization. The absorbance of the aerosolized drug dose can be provided by measuring the absorbance of light. A drug solution can be pre-calibrated using a known concentration to provide a drug absorbance value at a specified wavelength. The inhalation device 100 verifies that the drug is aerosolized and sprayed, and provides the amount and quantity of the drug in the aerosol stream ejected and the amount of drug remaining in the reservoir of the drug cartridge 102.

For diagnosis of lung conditions and/or air analysis, the inhalation device 100 can sense and detect disease biomarkers in exhaled breath. Human breath contains many volatile organic compounds (VOCs), accurate detection of which can generally provide basic information about the early diagnosis of human or animal diseases. For example, nitric oxide can be used to evaluate or sense asthma diagnosis; acetone, ammonia, _H2S and toluene can be used to evaluate diabetes, renal dysfunction, bad breath and lung cancer, respectively. The diagnosis of these diseases can be achieved by including miniaturized MEMS-based current sensors. For example, in the device's mouthpiece or droplet outlet, a MEMS sensor can be used to analyze the concentration of nitric oxide in the exhaled breath for ASTMA monitoring and diagnosis. In addition, changes in the concentration of exhaled VOCs can be used as biomarkers for specific diseases and can be used to distinguish healthy patients from sick patients.

Inhalation device 100 may include one or more visual, audio and/or tactile indicators to provide instructions or feedback to patient 104. Alternatively or additionally, an indicator may be provided via a user device communicating with inhalation device 100, as described herein. For example, inhalation device 100 may indicate to the patient to initialize inhalation device 100 by taking a set number (e.g., five) of slow, deep breaths. This provides information for determining a trigger point during inhalation to generate a breath-actuated drug jet by a piezoelectrically driven ejector, to maximize the inhalation of prescription drugs by patient 104. It also provides a baseline for diagnosing the change in lung disease. For example, the minimum pressure reached during inspiration corresponds directly to peak inspiratory flow. The reduction of peak flow during inspiration can predict asthma exacerbation. When peak flow measured values are combined with the measured value of exhaled nitric oxide, the predictive power of the on-board diagnosis configured in inhalation device 100 and/or air analyzer becomes more powerful.

In one implementation, the inhalation device 100 captures measurements related to lung output (FEV1) by measuring the maximum flow achieved during maximum exhalation. The air analyzer described herein uses indicators to provide prompts to the patient 104 to guide the patient 104 through the breathing exercises required to perform measurements related to lung output.

In addition, the suction device 100 can comprise differential (Δ P) sensor, to allow measurement of the required inspiratory pressure for realizing predetermined flow. This measurement can allow the device to approximate the variation of dynamic airway resistance by comparing the pressure required for producing air flow measured during initialization. Although not the measurement of absolute airway resistance, this measurement of the pressure change measured on airway side under a given flow during inspiration measures the variation of the lung health of the patient 104 suffering from asthma or COPD. This can be referred to as the relative variation of dynamic airway resistance (RCDAR) in this article, and it is expressed as the percentage change of the pressure measured under 50% air flow measured at baseline. For example, the reading of 10%RCDAR is 10% reduction of the pressure required for 50% of the maximum flow measured at baseline. In addition, the suction device 100 can be used for confirming the speed of the plume of injection before inhalation, and can serve as the confirmation that the flow sensor of confirmation suction device 100 is correctly calibrated and operates.

The ΔP sensor measures airflow by measuring the pressure drop between the interior of the inhalation device 100 and the surrounding atmosphere. The flow rate is calculated based on the measured pressure drop between the ΔP sensor ports; one ΔP sensor port is located upstream of the device's aerosol delivery tube, near the air inlet, near the laminar flow element, while the second ΔP sensor port measures the ambient pressure outside the inhalation device 100, as described in more detail herein. This measurement is also used to trigger the start and end of the droplet ejection cycle in order to coordinate the optimal point in the inhalation cycle with the ejection of the aerosol plume. The pressure measurement subsystem also distinguishes between inhalation and exhalation, so that droplet particles are inhaled and dispensed only during the inhalation cycle.

In one implementation, the optical aerosol sensor of the inhalation device 100 measures and detects the presence of droplets by detecting the light emitted from an LED source placed across the diameter of the inhalation tube by a photodetector and detecting the light scattered or absorbed by the droplets. The light source is a narrow viewing angle (e.g., less than 8 degrees) LED or a laser diode. In addition, for example, multiple light sources and multiple detectors placed along the outlet of the inhalation device 100 or in front of the ejector plate of the medicine box 102 can determine the shape of the aerosol plume, including cross-section and length, for estimating the mass injected.

For example, where the inhalation device 100 includes a flow tube having an average diameter of 20 mm, a four-second inhalation of air from 100 ml to 500 ml will have an average velocity of 8 to 40 cm/s. Where the optical sensor is located 20 mm downstream of the ejector assembly of the cartridge 102, the leading edge of the aerosol particle will reach the optical detector 50 to 250 milliseconds after ejection.

Typical photodetectors that can be used in the inhalation device 100 can have a response time of less than 1 millisecond, allowing accurate resolution of entrained droplet velocity. A second LED/photodetector system can be added and used to provide finer aerosol velocity resolution. In one implementation, the inhalation device 100 measures and detects the arrival of the aerosol plume at two downstream points a few centimeters apart. In this case, the LED light sources used for each system are pulsed, and synchronous detection is used to synchronize each detector with its associated light source.

To continue the detailed description of the specific implementation 200 of the inhalation device 100, reference is made to Figure 2. The various components of the inhalation device 200 coordinate all operational functions, as well as archive and communicate captured air lung health management data, including spray verification data, diagnostic indicators and device operating parameters, for generating an air analysis. In addition, the identification or dose size parameters of the medicine box 202 can also be stored in the memory of the inhalation device 200 and/or the medicine box 202. For onboard data storage, the controller 222 can include a low-power microprocessor with several kilobytes of data memory, several channels of 10 to 12 bit analog-to-digital conversion, and several digital outputs. However, other controllers are contemplated.

The inhalation device 200 may include a pressure sensor 206, a plume sensor 208, a tile sensor 210, a plume illuminator 212, a switch 214, an annunciator 216, a display 218, a wired or wireless link 220 to one or more user devices, a cartridge controller 224, and a power source 226. The cartridge controller 224 may control the operation of the cartridge 202 and/or capture information from the cartridge 202, including the cartridge tag 228, the ejector assembly 230, and the cartridge sensor 232. It will be appreciated that more or fewer of these components may be included in the inhalation device 200.

In one implementation, the controller 222: activates when the power button is pressed; monitors the pressure sensor 206; waits for a dispense command or an inhalation profile of rapidly decreasing pressure; activates the cartridge controller 224 (such as a piezoelectric driver with a predetermined frequency and voltage); monitors the cartridge controller 224 to assess the dispense condition; monitors the flow rate and plume using the pressure sensor 206 and plume sensor 208, respectively, to dispense at the trigger point; and illuminates the annunciator 216 (such as, for example, an LED) on or off as appropriate to signal a valid or invalid dispense or provide other user feedback.

Controller 222 can have internal clock, to wake up and send signal when arranging the next dosage of patient 104.This event can be notified by signaler 216 (such as flashing LED or piezoelectric buzzer).Alternatively, can output alarm to user device 204 via link 220.Controller 222 is configured to operate when communicating with user device 204 or not communicating with user device 204, and stores the time and success of each distribution accordingly.Can also store the distribution curve of suction flow and plume for 5 to 10 seconds around distribution, it has the resolution of 0.1 to 0.01 second.In addition, if suction device 200 has tilt sensor 210 (such as attitude or piezoelectric grid sensor), can also store or process that data in real time so, to indicate good or possible good distribution.Controller 222 can also use display 218 and/or user device 204 to track and display the quantity of dosage and the remaining dose that stays in medicine box 202.

Power supply 226 can comprise one or more power sources, is configured to store and provide electric power (such as solar power, battery power or DC or AC electric power) to the parts of suction device 200.In an implementation, power supply 226 comprises a non-rechargeable battery system, such as lithium polymer.On suction device 200, can have connector to charge this battery, or have other charging method, include but not limited to solar cell, inductive link or even mechanical motion.Controller 222 can be configured to deactivate under very low power consumption level, and still monitors input button and responds by entering fully awake state and presses.

In one implementation, in order to ensure and maximize patient compliance and ensure the correct use of the aerosol delivery device, the inhalation device 200 and/or the user device 204 can convey various information to the patient 104. Examples of such information that promote compliance with the prescribed aerosol therapy include, but are not limited to: device ON, good/bad dispensing, the number of remaining doses, the time for another dose, and an explanation of an error condition of the inhalation device 200 (such as incorrect delivery orientation, or no plume visible). Some of this information can be communicated with two to three light sources of the annunciator 216: one for signaling the unit to turn on, and another for signaling successful or unsuccessful dispensing. Two or three color (red-green-yellow) LEDs can be used for more user-friendly information communication. Error codes based on the flashing of either one or two LEDs are possible. Similarly, a four-digit LCD display can be used to display the number of remaining doses or an error code. An explanation of the error code or more detailed information can be transmitted via the user device 204. One or two user input buttons turn on (wake up) the inhalation device 200 and can initiate dispensing or request an error code or provide remaining dose information.

Link 220 can facilitate archiving, analysis, and training of the patient 104, and can transmit usage and lung/airway diagnosis to a health provider via the user device 204. The user device 204 can also be a resource for understanding proper usage. The user device 204 can also transmit password-protected information from the health provider (such as a corrected dose amount or frequency based on the respiratory flow rate measured by the device) back to the inhalation device 200, with or without actual dispensing. In one implementation, the user device 204 can initiate a reorder when the remaining dose is below a preset limit.

Link 220 can also be used in a clinical facility or pharmacy to set basic parameters or retrieve archived information from the inhalation device 200. This information includes, but is not limited to, the following settings that can be transferred to the device: dispense duration, ejector frequency, number of breaths per dose, inhalation flow to trigger dispense, desired dosing interval (e.g., twice daily or once every 12 hours), maximum number of good doses allowed in a period of time (e.g., two hours), maximum number of bad doses allowed in a period of time, number of doses dispensed before an almost empty signal is given, parameters describing a good dose (inhalation volume after dispense, plume opacity), date/time, expiration date or interval for the medication, a password for use with the vendor's office or pharmacy office to change settings, and/or other information describing good or bad dose limits.

In one implementation, the piezoelectric injector frequency and voltage of the injector assembly 230 can be preset during factory filling of the drug cartridge 202. Such values can be modified using the user device 204 via the link 220. Similarly, the fill or expiration date, the type of medication, or even a security code to prevent misuse can be carried by the drug cartridge label 228. Examples of information that can be stored and/or transmitted via the drug cartridge label 228 can include, but are not limited to: dose volume and dosing interval (number of times per day); acceptable inhalation flow rates or characteristics; and/or the option to allow repeat dosing if an undesirable dose is sensed.

Three additional components can be a part of the suction device 200, such as grid monitoring, direction monitoring (for example, via tilt sensor 210) and reservoir fluid measurement components. Grid monitoring allows to immediately determine whether the piezoelectric grid is vibrating correctly by sensing vibration of a small piece of piezoelectric material that is mechanically coupled to the grid. An analog-digital input of controller 222 can be used to amplify, rectify and measure the electrical output from the small piezoelectric. This can supplement or replace the grid monitoring completed by electronic driver impedance measurement. Towards monitoring, determine that the suction device 200 is correctly oriented so that the back side of the fluid wetting grid in the reservoir is to generate good droplets. This same posture measurement sensor can also be used to verify the remaining fluid amount (therefore, dosage) in the reservoir. This is achieved by slowly tilting the suction device 200 until the fluid is sensed by a capacitance sensor on a wire, the reservoir housing or an optical sensor of the fluid. The tilt is noted at the moment when the fluid sensor indicates a transition from not sensing the fluid to sensing the fluid. A simple algorithm (or look-up table) in the controller 222 provides the remaining fluid amount as a function of the tilt angle. This function can be used to more accurately assess the number of doses remaining in the cartridge 202 and is particularly important when a pharmacy is blindly filling a reservoir and needs to confirm the remaining available doses.

As described herein, suction device 200 generates droplets and controls the operation and monitoring of suction flow and plume, to verify the effective delivery of medicine. The following is how the patient 104 operates the example of suction device 200 with different user modes. Under the manual distribution mode, the patient 104 opens and presses the distribution button, and the suction device 200 sends the signal of the plume seen at the correct inhalation window place, and the patient 104 closes the suction device 200 or it automatically deactivates. Under the distribution mode of stream triggering, the patient 104 activates the equipment and breathes in. The suction device 200 triggers administration at the trigger point corresponding to the specific inhalation flow rate provided by the provider. The suction device 200 sends a good distribution signal and cuts off the power. Under the triggered distribution mode of training, the patient 104 opens the suction device 200 and breathes several times to carry out the complete breathing cycle of inhalation and exhalation. The suction device 200 records and distributes dosage at the trigger point, which is detected automatically by the pressure sensor 206. The suction device 200 sends the signal of good distribution and deactivates. In training or diagnostic mode, the patient 104 turns on the inhalation device 200, and the inhalation device 200 or user device 204 prompts the patient 104 through the breathing cycle. Diagnostic indicators and other lung health data are captured using the inhalation device 200 and then archived on the controller 222 and/or transmitted to the air analyzer via the link 220 and/or the user device 204. The inhalation device 200 is deactivated.

In an implementation of the normal automatic mode of the suction device 200, prompting patient 104 to deliver dosage. Suction device 200 and/or user device 204 indicate patient 104 to breathe one or more cycles and press the distribution button. Suction device 200 detects inhalation and ejects plume into airflow. If pressure sensor 206 illustrates correct breathing and distribution timing, annunciator 216 provides feedback so, such as light flashing green. If the dosage is not good, the red light or yellow light of annunciator 216 flashes so. If the yellow light of annunciator 216 flashes, prompting patient 104 to carry out another distribution so, and send the signal of correct or incorrect distribution. After no activity for 30 seconds, controller 222 closes suction device 200. If there are multiple bad distributions, error code is generated so by controller 222 and for example, user device 204 is used to transmit error code to patient 104. Annunciator 216 can comprise visual, audio and/or tactile signal of prompting next administration. Can show counter by display 218, it comprises remaining number of administrations.

As described herein, the user device 204 and/or the inhalation device 200 can provide feedback to the patient 104 and/or transmit information to the provider. The feedback can include information about any errors, including possible remedies and error codes, which can include, but are not limited to, no cartridge, wrong cartridge, no plume seen, dose exceeded based on count, insufficient inhalation, low battery, ejector vibration issue, dose request not compatible with prescription, or collecting diagnostic information, etc.

Turning to FIG3 , operations 300 for delivering a drug to a patient using an inhalation device are shown. In one implementation, operation 302 activates the inhalation device, and operation 304 detects an inhalation by a user. Operation 306 generates a dose inhaled by the user, the dose corresponding to the detected inhalation. Operation 308 detects the quality of the dose, and operation 310 deactivates the inhalation device.

Fig. 4 is an example lung health management system 400, which is included in an air analyzer 402 running on a computer server, a computing device or other network device for lung health management. In one implementation, a user (such as a patient 104) accesses and interacts with the air analyzer 402 and/or one or more inhalation devices 100 via a network 406 (e.g., the Internet). In another implementation, a user device 204 operates the air analyzer 402 locally, and the inhalation device 100 is connected to the user device 204 using a wired or wireless connection. Other users can be one or more parties that sell, operate, manage and/or otherwise monitor the inhalation device 100, including doctors, health clinics, health laboratories, etc.

The network 404 is used by one or more computing or data storage devices (e.g., one or more databases 406) to implement the lung health management system 400. A user can access and interact with the air analyzer 402 using a user device that is communicatively connected to the network 404. The user device 204 is generally any form of computing device capable of interacting with the network 404, such as a desktop computer, workstation, terminal, laptop computer, mobile device, smartphone, tablet computer, multimedia console, etc. Depending on the user, the user device 204 can be a patient user device, a provider user device, etc.

The server 408 can host the lung health management system 400. The server 408 can also host a website or application, such as an air analyzer 402 that a user accesses to access the system 400. The server 408 can be a single server, multiple servers (each such server being a physical server or a virtual machine), or a collection of physical servers and virtual machines. In another implementation, a cloud hosts one or more components of the system 400. One or more inhalation devices 100 connected to the network 404, user devices 204 used by users, the server 408, and other resources (such as one or more databases 406) can access one or more other servers to access one or more websites, applications, web service interfaces, etc. for lung health management. The server 408 can also host a search engine used by the system 100 to access and modify information for lung health management.

The inhalation device 100 communicates with the air analyzer 402 executed by the user device 204 via a wireless connection (such as Bluetooth), over a network 404, or via a wired connection (such as a USB connection). The inhalation device 100 can communicate in a similar manner with other computing devices (such as smart watches, smart phones, tablets, computers, music players, Bluetooth-enabled devices, etc.).

In one implementation, the inhalation device includes one or more sensors for capturing lung health data (including diagnostic indicators, operating parameters of the inhalation device 100, spray verification data, etc.). The sensors may include, but are not limited to, one or more pressure sensors, plume sensors, tilt sensors, humidity sensors, temperature sensors, particle sensors, heart rate sensors, carbon dioxide sensors, oxide sensors, ozone sensors, nitric oxide sensors, microphones, imaging sensors, etc. Such data may be stored in a storage medium of the inhalation device 100 and/or transmitted to the air analyzer 402 via the user device 204. For example, the data captured by the sensors may be retrieved and stored on the consumer device 204 and/or uploaded to a secure cloud database 406 via the network 404.

Once the air analyzer 402 acquires the data, it can be used in a variety of ways by the patient 104, providers, and other approved parties. As explained herein, the inhalation device 100 generates a large amount of sensor data, which the air analyzer 402 can correlate to generate associations and understand patterns and trends to improve healthcare, save lives, and reduce costs. Furthermore, the air analysis generated by the air analyzer 402 can provide clinical decision support, disease state health, and healthcare management in real time while the patient 104 is receiving treatment.

Air analyzer 402 generates air analysis, and this air analysis includes the date/time and inhalation flow rate of each distribution, and this not only provides key personal information for provider, but also provides valuable data for supporting the collective analysis of patient 104 and other lung diseases (such as asthma and COPD).The air analysis generated by air analyzer 402 can remind or warn individual and a group of users about dangerous or challenging health deterioration or environmental conditions.The air analysis for specific patient can comprise the use pattern of for example inhalation device 100, the comparison of the inhalation flow rate of patient 104, frequency of use, medicine and administration information.Other diagnostic indexes can be recorded and stored in database 406, such as airway resistance, inspiratory volume, inspiratory vital capacity and corresponding diagnosis, peak inspiratory flow (PIF) and 50% maximum inspiratory flow (MIF is 50%).

The air analyzer 402 can generate an air analysis by comparing the lung health management data with previously stored data to determine when the use of the inhalation device 100 changes or the lung function of the patient 104 changes, and can also predict acute exacerbations of COPD. The lung health management information from multiple patients can be anonymized by the air analyzer 402 to determine general usage patterns, inhaled volume and life cycle status, date/time and regional location of each use, general user classification data (such as disease type and severity, age, (one or more) medication types, and general patient medical history). The operating parameters for each inhalation device 100 can also be captured and processed by the air analyzer 402 for air analysis generation for troubleshooting, improvement, etc.

Air analysis can be used to predict and determine the locations and times of day that pose the greatest threat to patients with similar conditions. For example, if asthma patients in a particular area report a decrease in inspiratory lung capacity or increased use of the inhalation device 100, possibly due to unknown environmental conditions (such as pollen or other allergens), warnings can be provided to other people in that area with asthma or other lung conditions via the user device 204 and/or the inhalation device 100, advising them to stay indoors. Such a system can also take into account and incorporate regional or local environmental monitoring by governments or third parties.

5 , an example air analysis user interface 500 is shown. The air analysis user interface 500 is generated by the air analyzer 402 and displays air analysis, including but not limited to air quality 502, disease information 504, healthcare information 506, device information 508, alerts/trends 510, and other analysis 512. The navigation tabs 502-512 are exemplary only and not limiting.

Air quality 502 may include air analysis for a specific geographic location(s) based on lung health management information, and environmental data captured using one or more environmental sensors deployed in the ambient atmosphere of the geographic location(s). Air quality 502 may include an air quality interface 514 that provides air quality monitoring and air pollution for a geographic location(s), such as Beijing, China. The air quality interface 514 may include the relevance and impact of various air pollution conditions and pollutants on respiratory diseases. For example, in addition to weather conditions such as temperature, dew, pressure, humidity, and wind speed, air quality factors such as PM2.5, PM10, O ₃ , NO ₂ , SO ₂ , and CO are used as inputs captured by environmental sensors to monitor or predict the occurrence of respiratory problems or generate warnings recommending staying indoors.

Disease information 504 can include diagnostic indicators captured by the inhalation device 100, which are associated with one or more patients to diagnose lung conditions. An overview of disease conditions can be provided for (one or more) specific geographic locations to identify any environmental or other causes, as well as to monitor the overall disease state of the group. Healthcare information 506 can be used by individual patients or groups of patients to track treatment, diagnosis, disease state, etc. Device information 508 can include information about the operation of the inhalation device 100 for troubleshooting, improvement, quality control, etc. Various alarms and/or trends corresponding to the various tags 502-508 and 512 can be included in the alarm/trend 210 for the management of one or more patients, groups, and/or inhalation devices 100.

For example, real-time reporting of the occurrence of acute exacerbations of COPD correlated with recorded environmental conditions can lead to precise warning levels and provide a better understanding of patient recovery and outcomes and potential discovery of trends and patterns in the impact of environmental irritants, combined with prescribed medication effects and dosage levels. The use of air analysis and real-time sensing and reporting can quickly identify improved dosing regimens or drug combinations, or provide a method for quickly identifying problematic or potentially tampered drug batches. Air analysis is valuable for medical and pharmaceutical research, clinical decision-making, and disease surveillance, which can improve healthcare, save lives, and reduce costs.

As described above, the inhalation device 100 collects and distributes information other than inhaler usage and inhalation parameters. Additional user data may include the amount of various gases in the inhaled air temperature, humidity, ozone and nitrogen dioxide levels, the amount of various gases in the patient's 104 exhaled breath, and even the level of particulate matter in the inhaled air. By communicating to the air analyzer 402, warnings can be issued to individual users or groups of users based on real-time environmental and lung health management information.

Air analyzer 402 provides personalized healthcare by providing a means to compare and optimize the effectiveness of individual therapies with the results of larger populations. Air analyzer 402 discovers relationships between prescribed treatments, air pollutants, or other environmental conditions. This information can be used to improve healthcare or predict impending user deterioration. The combination of individual measurements and real-time support from air analyzer 402 improves the quality of healthcare delivery while reducing costs and providing insights for making more informed healthcare decisions.

When applied to personalized healthcare, the air analysis generated by the air analyzer 402 alerts the patient 104 based on their own usage patterns of the inhalation device 100 when visiting different environments. For example, a patient who occasionally visits a friend's home where formaldehyde or other harmful vapors are emitted by carpet or building materials may discover its effects later in the day and cause a change in their usage and dosage pattern of the inhalation device 100. The air analyzer 402 detects this pattern change and notifies the patient 104 of the development of a new trend of a more frequent dosing regimen after spending time in a specific location and alerts the user to the newly discovered correlation.

Air analyzer 402 can apply air analysis to inhalation device 100 to sense and detect disease biomarkers in exhaled breath. Human breath contains many volatile organic compounds (VOCs), and accurate detection of these compounds can provide essential information for the early diagnosis of human or animal diseases. For example, nitric oxide can be used to assess or sense asthma diagnosis; acetone, ammonia, _H2S , and toluene can be used to assess diabetes, renal dysfunction, bad breath, and lung cancer, respectively.

Relative measurements of lung function taken during medication administration or at another time can provide valuable information to the user or physician. Combined with air analyzer 402, this can be used to teach the user when or how to administer a dose of medication, with the help of a healthcare provider. Lung function measurements can be used to teach the user when to take action and provide relevant lung function information. This education can be accomplished via air analyzer 402, which shows the user the extent to which lung function has declined in various situations.

A useful diagnostic indicator for obstructive airway disease is called FEV1, which is the forced expiratory volume of air in 1 second. Ideally, lung function measurements would be made independent of the user's breathing muscle strength, but current medical diagnostic equipment eliminates the variable factor of respiratory muscle strength by using a chamber surrounding the user, which changes the pressure around the user to assess the airway and alveolar restriction to breathing. Typically, FEV1 is expressed as the amount of air exhaled in one second through forced exhalation after a full inhalation. This number is expressed as a percentage of vital capacity.

The availability of the FEV1 value measured multiple times every day over many days can provide doctors with valuable diagnostic indicators for air analysis. In restrictive lung diseases (such as pulmonary fibrosis), vital capacity drops to below normal levels, but the expiratory rate is normal. In obstructive lung diseases (such as asthma, emphysema, bronchitis), vital capacity is normal because lung tissue is not damaged and its compliance is constant. In asthma, the small airways (bronchioles) contract, increasing the resistance to airflow. Although vital capacity is normal, the increase in airway resistance makes exhalation more difficult and requires longer time. Obstructive diseases are diagnosed by tests measuring forced expiratory rate (such as FEV1 and FEV25-75), and the significant reduction of these values shows obstructive lung disease.

The pulmonary diagnostic system provided by the air analyzer 402 can be implemented by the user using the inhalation device 100 by measuring the flow rate over multiple breaths with the same sensor, which is used to time the optimal period during inspiration. Diagnostic indicators can be derived by comparing each test to a baseline pattern or number performed under the supervision of the patient's 104 physician. Comparison can be made to the peak measured flow over a portion of the inhalation cycle or only during each inhalation or exhalation.

To measure FEV1, the user is first asked to perform several forced exhalations after a full inhalation, while the inhalation device 100 measures and records the flow rate. The FEV1 is then calculated by integrating the flow rate over the entire exhalation and over a one-second interval. These results are stored and later or immediately transmitted to the air analyzer 402. If the calculated FEV1 is below a preset limit, the device provides feedback that the airway obstruction is greater than a preset value. The preset value can be determined by a medical professional and provided via the air analyzer 402.

The diagnostic indicators listed above are not a complete list of all possible diagnoses. For example, alveolar restriction can be inferred from the relative difference between inspiratory and expiratory flow rates, where a decrease in inspiratory rate relative to expiratory rate indicates greater restriction in expanding alveoli. Integrating the flow rate over the entire inspiratory and/or expiratory portion of one or more respiratory cycles estimates the total amount of air inhaled. As with FEV1, this value may be measured and recorded multiple times daily.

In addition to peak and one-second flow, the inhalation device 100 can also perform methods to assess airway resistance and even lung compliance. For example, the effect of airway resistance is modeled using the air analyzer 402 by the following equation: F = (P1-P2)/R, where the airflow F (commonly referred to as dV/dt) is equal to the pressure in the mouth P1 minus the alveolar pressure P2 divided by the airflow resistance R. P2 is difficult to measure directly because it is the pressure in the alveolar bags of the lungs. However, by measuring the flow rate at two different values of P1 (oral pressure) for a relatively constant alveolar pressure, the airway resistance R can be calculated as follows:

For the oral pressure P1a, the flow rate Fa = (P2-P1)/R

For oral pressure P1b, flow rate Fb = (P2-P1b)/R

The flow and pressure under these conditions can be used to directly calculate the airway resistance value using the following formula:

R＝(P1b–P1a)/(Fa-Fb)

It is important to note that this assumes a relatively rapid transition between the two oral pressures, as airway resistance and alveolar pressure change significantly during the respiratory cycle as lung and airway geometry changes. With a rapid transition in pressure, the assumption of nearly constant alveolar pressure between the two pressures is correct. There is a limit to how quickly the pressure can change, as the compliance of the air and flow resistance effectively eliminates much of the variation, as the low-pass filter minimizes high-frequency signals.

Suction device 100 can generate two different oral pressures required for above-mentioned formula by various means, such as the pressure source of rapid change (as cylinder and piston, or even long-distance audio speaker).These modes and means all need a large amount of volume, weight and power.Similarly, direct or centrifugal fan can be used.But the inertial force that generates in these devices can make it difficult to measure the rapid change of pressure that occurs in single breath.

In one implementation, air analyzer 402 uses a variable resistance valve between mouth and atmosphere to realize the small and rapid pressure change that causes during the respiratory cycle. As a non-limiting example, a flapper valve can be used to open and close a part of the airflow path that enters the inhaler from the atmosphere. This value can be made up of a rotating disk, wherein half of the disk is open and half is almost blocked, so that when it rotates it fully opens or partially closes the air inlet of the inhaler. Utilize a small, relatively low-power 60 to 600rpm micro gear motor, this disk can be rotated at a frequency of 1 to 10Hz with ease. When the disk was in the open position C where the flow resistance was Rc, the flow rate in the inlet was: Fc=Pc/Rc.

Here, Pc is the pressure in the mouth measured relative to atmosphere. When the disc is in the restricted flow condition D, the flow rate into the mouth is Fd = Pd / Rd. Substituting these flow and pressure conditions into the above equation yields the airway resistance,

R=(P1c-P1d)/(P1c/Rc–P1d/Rd).

For the case where the inhaler flow restriction increases from condition C to D by a factor of K = Rd/Rc, the equation for airway resistance simplifies to:

R = (P1c - P1d) / (P1c/Rc - P1d/KRc) or

R＝(1/Rc)*(P1c-P1d)/(P1c–P1d/K).

Thus, by rapidly changing the flow resistance in the inhalation device 100 , the airway flow resistance can be directly estimated by the air analyzer 402 .

The air analyzer 402 can generate additional air analysis regarding lung compliance and can assess the position of airway resistance by performing the above-described dual pressure test with different cycle times. In this case, instead of cycling between two different pressures, the flow resistance in the inhalation device 100 varies as a sinusoidal curve to approximate the assumption of linear signal processing.

In cases where the patient has significant airway resistance and cannot tolerate the additional airflow resistance from the inhalation device, a small fan can be used to create additional pressure on the atmospheric side of the variable resistance valve. The additional pressure can be generated by stacking the fans so that the total pressure is the sum of the pressure gains in each fan.

The air analyzer 402 measures the airway resistance of the patient 104 for patient diagnosis by comparing the current airway resistance of the patient 104 with previous data generated by the inhalation device 100. The comparative data can also be used to assess the effectiveness of inhaled drug droplets to improve restricted airways. The inhalation device and/or air analyzer 402 can also track changing pressure sources or flow restrictions, monitoring internal pressure before and after administration of various medications.

Due to the ability of the inhalation device 100 and/or the user device 204 to store, process, and transmit data, the inhalation device 100 may include additional sensors related to diagnosis or warnings. For example, an NO2 sensor may be added to the device to provide additional diagnostics of airway conditions and airflow resistance, and to help the user and their physician understand how the patient 104 is responding to asthma.

FIG6 illustrates example operations 600 for lung health management of one or more patients. In one implementation, operation 602 receives lung health data from one or more inhalation devices via a network. Operation 604 correlates the lung health data with environmental data using at least one management parameter. Operation 606 generates an air analysis from the correlated data, and operation 608 outputs the air filtration analysis.

Turn to Fig. 7, show the electronic device 700 that comprises operating unit 702-710, operating unit 702-710 is arranged to perform the various operations of the disclosed technology.The operating unit 702-710 of equipment 700 is realized by hardware or the combination of hardware and software, to realize the principle of present disclosure.It will be appreciated by those skilled in the art that the operating unit 702-710 described in Fig. 7 can be combined or separated into sub-blocks, to realize the principle of present disclosure.Therefore, the description herein supports any possible combination or separation or further definition of operating unit 702-710.

In one implementation, the electronic device 1700 includes a display unit 702 that displays information, such as a graphical user interface, and a processing unit 704 in communication with the display unit 1702 and an input unit 706 that receives data from one or more input devices or systems, such as the air analyzer 402, the inhalation device 100, etc. Various operations described herein can be implemented by the processing unit 704 using data received by the input unit 706 to output information for display using the display unit 702.

Additionally, in one implementation, the electronic device 700 includes a correlation unit 708 and an air analysis generation unit 710. The correlation unit 708 correlates the lung health information with the environmental information, and the air analysis generation unit 710 generates an air analysis using the correlated information.

In another implementation, the electronic device 700 includes units that implement the operations described with respect to Figure 6. For example, operation 602 may be implemented by the input unit 706, operation 604 may be implemented by the correlation unit 1108, operation 606 may be implemented by the fairness analysis generation unit 710, and operation 608 may be implemented by the output unit 702.

8 , a detailed description of an example computing system 800 having one or more computing units that can implement the various systems and methods discussed herein is provided. The computing system 800 can be applicable to the air analyzer 402, the controller 222, the server 408, the inhalation device 100, and other computing or network devices. It will be appreciated that the specific implementation of these devices can have different possible specific computing architectures, not all of which are specifically discussed herein, but which will be understood by those of ordinary skill in the art.

Computer system 800 can be a computing system that can execute computer program product to perform computer process.Data and program file can be input to computer system 800, and computer system 800 reads file and executes program wherein.Some elements of computer system 800 are shown in Figure 8, comprise one or more hardware processors 802, one or more data storage devices 804, one or more memory devices 808 and/or one or more ports 1808-1810.In addition, other elements that those skilled in the art will recognize can be included in computing system 800, but do not clearly describe or further discuss at this in Figure 8.The various elements of computer system 800 can communicate with each other by one or more communication buses, point-to-point communication path or other communication means that are not clearly drawn in Figure 8.

The processor 802 may include, for example, a central processing unit (CPU), a microprocessor, a microcontroller, a digital signal processor (DSP), and/or one or more internal cache levels. There may be one or more processors 802, such that the processor 1202 includes a single central processing unit or multiple processing units capable of executing instructions and performing operations in parallel with each other, which are collectively referred to as a parallel processing environment.

The computer system 800 may be a conventional computer, a distributed computer, or any other type of computer, such as one or more external computers available via a cloud computing architecture. The presently described techniques are optionally implemented in software stored on (one or more) data storage devices 804, stored on (one or more) memory devices 806, and/or transmitted via one or more ports 808-810, thereby transforming the computer system 800 in FIG8 into a dedicated machine for implementing the operations described herein. Examples of computer system 800 include personal computers, terminals, workstations, mobile phones, tablet computers, laptop computers, personal computers, multimedia consoles, game consoles, set-top boxes, and the like.

The one or more data storage devices 804 may include any non-volatile data storage device capable of storing data generated or used within the computing system 800, such as computer executable instructions for executing computer processes, which may include instructions for both application programs and the operating system (OS) that manages the various components of the computing system 800. The data storage device 804 may include, but is not limited to, a magnetic disk drive, an optical disk drive, a solid-state drive (SSD), a flash drive, and the like. The data storage device 1804 may include removable data storage media, non-removable data storage media, and/or external storage devices available via a wired or wireless network architecture with such a computer program product, wherein the computer program product includes one or more database management products, web server products, application server products, and/or other additional software components. Examples of removable data storage media include compact disk read-only memory (CD-ROM), digital versatile disk read-only memory (DVD-ROM), magneto-optical disks, flash drives, and the like. Examples of non-removable data storage media include internal magnetic hard drives, SSDs, and the like. The one or more memory devices 806 may include volatile memory (eg, dynamic random access memory (DRAM), static random access memory (SRAM), etc.) and/or non-volatile memory (eg, read-only memory (ROM), flash memory, etc.).

A computer program product containing mechanisms for implementing the systems and methods according to the presently described technology may reside in the data storage device 804 and/or the memory device 806, which may be referred to as a machine-readable medium. It should be appreciated that a machine-readable medium may include any tangible, non-transitory medium capable of storing or encoding instructions to perform any one or more operations of the present disclosure for execution by a machine, or capable of storing or encoding data structures and/or modules used by or associated with such instructions. A machine-readable medium may include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store one or more executable instructions or data structures.

In some implementations, the computer system 800 includes one or more ports, such as input/output (I/O) port 1808 and a communication port 810 for communicating with other computing, network, or vehicle devices. It should be appreciated that the ports 808-810 may be combined or separated, and that more or fewer ports may be included in the computer system 800.

I/O port 808 may connect to an I/O device or other device through which information is input to or output from computing system 800. Such I/O devices may include, but are not limited to, one or more input devices, output devices, and/or environmental transducer devices.

In one implementation, an input device converts human-generated signals (such as human speech, physical movement, physical touch, or pressure) into electrical signals that are input to the computing system 800 as input data via the I/O port 808. Similarly, an output device can convert electrical signals received from the computing system 800 via the I/O port 808 into signals that can be sensed by a human as output (such as sound, light, and/or touch). The input device can be an alphanumeric input device, including alphanumeric and other keys for transmitting information and/or command selections to the processor 802 via the I/O port 808. The input device can be another type of user input device, including but not limited to: a direction and selection control device such as a mouse, trackball, cursor direction keys, a joystick, and/or a wheel; one or more sensors such as a camera, microphone, position sensor, orientation sensor, gravity sensor, inertial sensor, and/or accelerometer; and/or a touch-sensitive display screen ("touch screen"). The output device can include but is not limited to a display, a touch screen, a speaker, a tactile and/or haptic output device, and/or the like. In some implementations, the input device and the output device can be the same device, for example, in the case of a touch screen.

The environmental transducer device converts one form of energy or signal into another form for input to or output from the computing system 800 via the I/O port 808. For example, an electrical signal generated within the computing system 800 can be converted into another type of signal, and/or vice versa. In one implementation, the environmental transducer device senses characteristics or aspects of the environment, such as light, sound, temperature, pressure, magnetic field, electric field, chemical properties, physical motion, orientation, acceleration, gravity, etc., local to or remote from the computing device 800. In addition, the environmental transducer device can generate a signal to exert some effect on the environment, such as the physical movement of an object (e.g., a mechanical actuator), the heating or cooling of a substance, the addition of a chemical substance, etc., local to or remote from the exemplary computing device 800.

In one implementation, the communication port 810 is connected to a network, and the computer system 800 can receive network data useful in executing the methods and systems set forth herein and sending information and network configuration changes determined therefrom through the port. In other words, the communication port 810 connects the computer system 800 to one or more communication interface devices, which are configured to send and/or receive information between the computing system 800 and other devices via one or more wired or wireless communication networks or connections. Examples of such networks or connections include, but are not limited to, universal serial bus (USB), Ethernet, Wi-Fi, near field communication (NFC), long term evolution (LTE), etc. One or more such communication interface devices can be utilized via the communication port 1210 to communicate with one or more other machines directly via a point-to-point communication path, via a wide area network (WAN) (e.g., the Internet), via a local area network (LAN), via a cellular (e.g., third generation (3G) or fourth generation (4G)) network, or via another communication means. In addition, the communication port 810 can communicate with an antenna or other link for transmitting and/or receiving electromagnetic signals.

In an example implementation, lung health management data, air analysis, and software and other modules and services may be implemented by instructions stored on data storage device 804 and/or memory device 806 and executed by processor 802. Computer system 800 may be integrated with or otherwise form part of inhalation device 100.

8 is merely one possible example of a computer system that may be employed or configured in accordance with aspects of the present disclosure. It should be appreciated that other non-transitory tangible computer-readable storage media storing computer-executable instructions for implementing the presently disclosed technology on a computing system may be utilized.

9A-16K provide specific examples of various aspects of the inhalation device 100. The description of these aspects is intended to be illustrative only and not limiting.

9A-9C , in one implementation, the inhalation device 100 includes a handle 900 , a housing 902 enclosing a mouthpiece 904 , a cartridge mount 906 for receiving a disposable or reusable cartridge 908 , a laminar flow element 910 , and an opening 912 defined by the mouthpiece 904 .

Figure 10 and 11 illustrate respectively the cross section and the exploded view of the suction device 100 shown in Fig. 9 A-9C.In an implementation, suction device 100 comprises pressure sensor assembly 914, pressure sensor electronic board 916, steam trap 918, piezoelectric actuator 920, orifice plate 922, light source electronic board 924, one or more light sources 926 (for example, LED), aerosol tube 928, power supply 930, power contacts 932, pressure sensor O-ring 934, power supply mounting base 936, detachable handle cover 938, controller 940, manual distribution button 942, loud speaker 946, audio chip 948 and user equipment link 950 that are communicated with mouthpiece 904.These parts can be used for carrying out one or more operations discussed herein.

12A-12C , the drug cartridge 908 may include a guide 954 and a drug cartridge label 952. The injector assembly of the drug cartridge 908 may include a surface tension plate 956, an actuator 920, an injector O-ring 960, and an orifice plate 922 that may have a droplet formation opening 958. As shown in FIG13 , the droplet formation opening 958 may be of various sizes (e.g., 962 and 964) to generate different droplet sizes for targeting specific areas of the lung airways.

Figures 14A-15C illustrate various configurations of the pressure sensor assembly 914. In one implementation shown in Figure 14A, the pressure sensor assembly 914 includes a first pressure sensor 1000 and a second pressure sensor 1002 to sense airflow by detecting the pressure differential across an airflow restriction within the airflow tube 928. Figure 14B shows the pressure sensor assembly 914 with one pressure sensor 1002, where the restriction is a laminar flow screen 910, and the pressure is sensed as the difference between the pressure inside the tube 928 and the pressure outside the tube 928. The first and second pressure sensors 1000 and 1002 can be used for nebulization verification by detecting the pressure differential between the interior and exterior areas of the aerosol tube 928 as airflow moves from the inlet 1004 to the outlet 1006. The sensor assembly 914 can also coordinate with the patient's 104 breathing cycle to identify a trigger point to activate nebulization at the peak of the inhalation cycle.

FIG14A shows a pressure sensor assembly 914 having a pressure sensor 1000 for sensing the pressure within the tube 928 and a second sensor 1002 for sensing the atmospheric pressure outside the tube. This configuration allows for very low internal resistance to airflow. The very low internal resistance of the droplet delivery device has significant benefits. Since the device 100 is breath-activated to spray and deliver medication in the form of an aerosol, the very low internal resistance to airflow provides the patient with the opportunity for deep inhalation, thereby allowing aerosol particles to penetrate deep into the lung airways. The breath-activated trigger mechanism for delivering an aerosol dose also ensures optimal delivery of the medication.

15A-15C show an example of a ΔP sensor assembly 1100 of sensor electronics 916 and pressure sensor assembly 914 having a printed circuit board (PCB) 1102, a pressure sensor controller 1104, a sensor die 1108, a ball top 1106, and a hole 110. Assembly 1100 may also include a motherboard 1112 and an O-ring 1114. This example includes a single-port design and its assembly to a device board (15A), with the sensor having a pneumatic connection through a hole in the PCB and mounted on a main PCB or daughterboard, as shown in the schemes of (15B) or (15C).

The ΔP sensor specification (not limited by the example) can be as follows:

Pressure range: +/-500Pa; ΔP measurement relative to the surrounding environment;

Sensor assembly 914 can outperform conventional piezoresistive film sensors in terms of sensitivity at low differential pressures, offset drift, and hysteresis. These performance parameters allow for increased resolution and more accurate measurements at low pressures. These performance parameters are particularly important for children and elderly patients with low lung output.

In one implementation, the signal generated by the pressure sensor provides a trigger for activating the spray at the peak of or during the inspiratory (inhalation) cycle of patient 104 and ensures optimal deposition of the aerosol spray and medication into the lung airways, as described herein.

In addition, an image capture device including a camera, scanner, or other sensor (e.g., without limitation, a charge-coupled device (CCD)) may be provided to detect and measure the ejected aerosol plume. These detectors, LEDs, ΔP transducers, and CCD devices all provide control signals to controller 940 for monitoring, sensing, measuring, and controlling the ejection of fluid and reporting patient compliance, treatment time, dosage, and patient usage history, which may be transmitted to user device 204 via link 950.

16A-16K , various exemplary circuit diagrams 1200-1220 are provided, which are exemplary only and not intended to be limiting. The circuit diagrams include a power on/off circuit 1200, a power connector circuit 1202, a voltage regulation circuit 1204, a controller circuit 1206, a controller programming connector circuit 1208, a piezoelectric connector circuit 1210, a user switch with a debounce circuit 1212, a piezoelectric driver circuit 1214, a pressure sensor circuit 1216, an LED indicator circuit 1218, and a buzzer driver circuit 1220. Variations on these circuits, as well as additions, deletions, or other modifications to the circuits, are contemplated.

In the present disclosure, the disclosed methods can be implemented as a device-readable instruction set or software. In addition, it should be understood that the specific hierarchy or levels of steps in the disclosed methods are examples of exemplary methods. Based on design preferences, it should be understood that the specific order or hierarchy of steps in the method can be rearranged while remaining within the disclosed subject matter. The accompanying method claims present elements of the various steps in an exemplary order and are not necessarily meant to be limited to the specific order or hierarchy presented.

The described disclosure may be provided as a computer program product or software, which may include a non-transitory machine-readable medium having instructions stored thereon, which may be used to program a computer system (or other electronic device) to perform a process according to the present disclosure. A machine-readable medium includes any mechanism for storing information in a form (e.g., software, processing application) readable by a machine (e.g., a computer). A machine-readable medium may include, but is not limited to, magnetic storage media, optical storage media; magneto-optical storage media, read-only memory (ROM); random access memory (RAM); erasable programmable memory (e.g., EPROM and EEPROM); flash memory; or other types of media suitable for storing electronic instructions.

Although the present disclosure has been described with reference to various implementations, it should be understood that these implementations are exemplary and the scope of the present disclosure is not limited thereto. Many variations, modifications, additions, and improvements are possible. More generally, embodiments according to the present disclosure have been described in the context of specific implementations. In various embodiments of the present disclosure, functions may be separated or combined in blocks in different ways, or described using different terms. These and other variations, modifications, additions, and improvements may fall within the scope of the present disclosure as defined in the following claims.

Claims (7)

1. A system for monitoring the lung health of a patient, the system comprising: One or more electronic inhalation devices for coordinating the capture of lung health management data, each of the electronic inhalation devices being configured to: The peak inspiratory flow rate achieved by the patient during inspiration is measured and stored in memory, the peak inspiratory flow rate measurement being generated based on the minimum pressure of the airflow during inspiration; The patient's lung output is measured and stored in a memory, the lung output being determined by measuring the maximum flow rate achieved during expiration; and Detects and stores in memory the date/time of use, regional location, dose volume, and dosing interval; An air analyzer, communicatively coupled to the electronic inhalation device, and including at least one computing unit configured to: A lung health profile for the patient is generated, at least in part, based on the peak inspiratory flow measurement and the lung output received from the electronic inhalation device; and Determine whether the lung health profile indicates any detected location and time of day that predicts an undesirable lung health outcome, and if so, generate an alert; The lung health profile is based on one or more of the following: the patient's mode of using the electronic inhalation device, the patient's inspiratory flow rate, the frequency of the patient's use of the electronic inhalation device, the medication administered to the patient by the electronic inhalation device, dosage information, patient airway resistance, patient inspiratory volume, patient inspiratory vital capacity, patient peak inspiratory flow rate, and 50% of the patient's maximum inspiratory flow rate; and User equipment, communicatively coupled to the air analyzer and including a display configured to show the output of the lung health profile and any alarms for the predicted location or time of day of any unwanted lung health results received from the air analyzer. 2. The system of claim 1, wherein the electronic inhalation device further comprises one or more sensors for detecting biomarkers of patient health in the exhaled airflow, and the at least one computing unit of the air analyzer is further configured to generate the lung health profile based on the concentration value of the biomarker of subject health in the exhaled airflow, wherein the biomarker of patient health is selected from nitric oxide, acetone, ammonia, _H2S , or toluene. 3. The system of claim 1, wherein the at least one computing unit of the air analyzer is further configured to track changes in the patient's lung health profile over time. 4. The system of claim 1, wherein the lung health profile includes at least one of a diagnosis of a lung condition or a treatment for a lung condition. 5. The system of claim 1, wherein the electronic inhalation device further comprises one or more environmental sensors configured to measure environmental data associated with one or more environmental conditions from one or more geographical locations where the inhalation device is located; and The at least one computing unit of the air analyzer is further configured to correlate the lung health profile with the environmental data. 6. The system of claim 1, wherein the one or more airflow sensors of the electronic inhalation device include a first sensor disposed upstream of the airflow in the inhalation tube during use and a second sensor disposed outside the airflow in the inhalation tube during use, the first sensor measuring internal pressure and the second sensor measuring external pressure during use, the airflow rate being measured based on the pressure difference between the internal pressure and the external pressure. 7. The system of claim 6, wherein the air velocity is measured based on the pressure drop between the airflow and the surrounding atmosphere.