Multi-purpose diagnostic and drug delivery method and system

Abstract

A multi-purpose diagnostic and drug delivery system comprises a vessel 20 for holding an active pharmaceutical ingredient, an actuator seat 24, an actuator nozzle 26, a mouthpiece, at least one sensor

Description

TITLE OF THE INVENTION MULTI-PURPOSE DIAGNOSTIC AND DRUG DELIVERY METHOD AND SYSTEM FIELD OF THE INVENTION [1] The subject matter of the present invention generally relates to inhaler systems. Particularly and not exclusively, the subject matter of the present invention is related to a reusable and multi-purpose inhaler system that can be used to deliver a dose of an inhalable active ingredient and can also be extended to diagnose multi indications of diseases. Further, the multi-purpose diagnostic and drug delivery method and system allows the replacement of the vessel comprising a fluid(s), along with the actuator seat, filter, mouthpiece, dose counter, or a combination(s) thereof, of a system. BACKGROUND OF THE INVENTION [2] An inhaler is a medical device used for delivering medicinal and non-medicinal fluids via an orifice like mouth, nose, or both, which provides the ability for targeted medical treatment to a specific region of the body, as well as a reduction in the side effects of oral medications. Inhalers are commonly used to treat numerous medical conditions, for example, Asthma and Chronic Obstructive Pulmonary Disease (COPD), or intranasal drug delivery for patients. [3] The conventional type of inhaler includes metered-dose inhaler, dry powder inhaler systems, soft mist inhalers (breath-actuated inhaler), and nebulizers. Each device has advantages and disadvantages and can be selected based on individual specific user needs, as well as age, pathological conditions, coordination, and lung function. Currently, “inhalers” are mostly utilized for single use and typically have a maximum dose count of 200. An example of an exception to this is Boehringer Ingelheim’s Respimat, (US7727984B2) breath-actuated inhaler may be reused with X number of cartridges for Y number period before being disposed of. There are “smart inhalers” which typically consist of “sensors”, examples of these are Propeller Health (US9550031B2) which can also be attached to the Respimat® (Propeller™ Sensor Model II) or Cohero Health (US11173259B2 ), sensors which wrap around the actuator. Another example is Teva Pharmaceutical DigiHaler (US6026809A) which is a single-use dry powder inhaler system (DPI), with a maximum dose count of 120md, with disposable electronics and battery(s). Typically, these devices last from 1-18 months before being disposed of. [4] Some of the existing Purcell inhaler(s) or inhaler systems are: Purcell Smart Inhaler™ (GB2594048B) is a baseline version with base colors and materials that is compatible with one medication having a fixed sprayer head, further comprises one or more microphones and inertial measuring units; [5] Purcell Smart Inhaler Pro will come in premium colors / materials selection can allow for interchangeable medications by having removable sprayer head, having one or more microphones, camera sensor and having canister fluid(s) alignment - “Volt coil”; [6] Purcell Smart Inhaler Pro+™ is an extended version of Purcell Smart Inhaler Pro™ and further has limited editions colors and materials additional camera(s), MEMS LiDar and Adjustable air flow; [7] Purcell Cap Pro™ comprises inhaler mouthpiece cap, MEMS Hardware to include, Spectrograph, ultrafine particle sensor and this can be bought separately as an “upgrade” for Purcell Smart Inhaler Pro and / or Purcell Smart inhaler Pro+; [8] Purcell Bio Pro™ is a compact and portable respiratory device (combinational features of Inhaler Pro+ and Cap Pro), that anyone can use at home to analyze, diagnose, and monitor disease(s) of, but not limited to, the nostril(s), mouth, throat, and lungs, or other parts of these cavities, it may / may not deliver medications into or via them to a body or body part; [9] Purcell Bio Pro+™ is a compact and portable, respiratory medical device (extension of Bio Pro with Oscillometry), that anyone can use at home to diagnose and analyze disease(s) of the mouth, throat, and lungs;

[10] Purcell Therapy Pro™ is a Freemium and Gamified product that facilitates Telemedicine, provides Electronic Health Record (EHR), Personal Health Record (PHR), Electronic prescription service and AI / ML predictions modules;

[11] Purcell Therapy Pro+™ is a premium application that can offer everything the Therapy Pro has to offer with built-in Generative AI UX / UI experience;

[12] Purcell Medical™ is the App store that is available for “other” regulator-approved SaMD (AI / ML etc) which could be prescribed by their doctor to be used with Purcell® device range ; and prominently is a Purcell Clinical Development Environment™ (CDE) that enables researchers and developers of Class 1, 2, and 3 life style and medical devices, AI / ML / DNN, SaMD, to build and test in an environment with high quality datasets and within compliance and regulatory frameworks of the FDA, MHRA EMA, TGA, etc etc, simply a clinical research and development tool that streamlines device description, information for use, and clinical testing requirements, competitor searching, it will seamlessly integrate with proprietary AI SaMD neural network to enable faster development and approval innovations.

[13] A conventional inhaler as disclosed in EP1244486A2 is equipped with a refill unit and a means for counting the number of different refill units engaged with the inhaler. This inhaler is disabled after a predetermined number of refill units have been replaced. Also, inhalers as disclosed in US5544647A and JPH09508845A have an improved electronic counting means to indicate the doses remaining in the aerosol vessel component of the inhaler system assembly. Further, the inhaler disclosed in SI23597A2 has a single capsule chamber, located in the middle of the central longitudinal axis of the inhaler and the used capsule must be removed from this single chamber and a new capsule inserted during each use.

[14] The prior patent applications like WO2020047102A1 (Cohero Health Inc (US)), US2022273235A1 (Reciprocal Lab Corp (US)), WO2022200434A1 (Respiratory Analytics (GB)), US2016144141A1 (Cogmta Lab LLC (US)) and US2017100550A1 (Koninklijke Philips NV (NL)), disclose systems and method of analyzing the inhaler techniques using sound and image sensors. Further, patent application US2008308095A1 discloses the method of emulsifying the medical fluid through the atomization technique.

[15] Some conventional inhalers may replace the refilling unit, comprising a fluid(s) of powdered medication but they still need to adjust the dynamics of the driving means like the actuator that allows the free flow of the medicine. There is a need for an inhaler drug delivery system that can be reused by replacing the vessel with any part of the inhaler that allows the actuation of the medicine through inhalation. SUMMARY OF THE INVENTION

[16] One or more implementations of the present specification provide a multi-purpose diagnostic and drug delivery system. To achieve the objective(s) above, one or more implementations of the present specification provide the following technical solution(s):

[17] In one aspect of one or more implementations of the present specification is to provide an effective, and multi-purpose diagnostic and drug delivery method and system that replaces the vessel or the container comprising the medicine and the actuator that allows the actuation of the medicine's) through the mouthpiece of an inhaler system.

[18] In another aspect, the inhaler systems have an actuator that houses an actuator seat, that releases medical fluid or powder and drives that medicine through a mouthpiece of the inhaler system. A vessel, blister pack, capsule, or pill comprising medicine in powdered form or liquid form is inserted into the actuator sea for actuation.

[19] In another aspect, when an inhaler system is activated mechanically, digitally, or by pressing a vessel, which pierces a dry powder pack or crushes a capsule that contains the active pharmaceutical ingredient(s) and the released medicine is driven through a mouthpiece through inhalation.

[20] In another aspect of pressure-metered dose inhaler systems, the vessel is pre-filled with an active pharmaceutical ingredient, like a solution or suspension, which is commonly referred to as a fluid(s). The fluid(s) is typically designed in conjunction with the actuator seat geometries. The sizes and shapes, the geometries of the actuator seat, the properties of the fluid(s) like the ratios of, and the size of, particle(s), the solvent(s), excipient(s), refrigerant(s), and the pressure in the vessel impact or influence the efficacy and performance of the active pharmaceutical ingredient(s).

[21] In another aspect, the vessel is attached to a valve and a stem which has internal &external diameters and length(s) that can impact or influence the efficacy and performance of the active pharmaceutical ingredient(s). The actuator seat houses a stem block (for a stem), a sump, an orifice, and an actuator nozzle, and the geometries of these components are designed to enhance the efficacy and the performance of the active pharmaceutical ingredient(s) which can be tested using Aerodynamic particle size distribution tests like Next generation impaction (NGI), computational fluid dynamics, like the plume geometry and Jet length. The actuator seat receives a stem into the stem block, which is attached to a stem valve, which is attached to a vessel that holds fluid(s) which can be a suspension, solution, or powder.

[22] In another aspect of the present invention, the actuator seat can be inserted and removed by having it either attached to the stem or vessel, or both. The actuator seat can also be inserted or removed individually without disturbing the stem and vessel of the inhaler. This aspect of insertion and removal of the actuator seat with or without the stem or vessel, or both does facilitate the reuse of the inhaler. Generally, the actuator seat is attached to the actuator and the dose counter is attached to the actuator stem and the vessel, which can be inserted / removed from the inhaler together. The combination of the geometries of the actuator, actuator seat, mouthpiece, and fluid(s) determine the performance and efficacy.

[23] In another aspect, the inhaler system is equipped with a mechanism that enables the removal of an “actuator seat” whether it be in contact with a channel with an opening at one, or multiple ends, a vessel, a stem, a mouthpiece, a mouthpiece cap, a filter, an adjustable filter, a dose counter(s), electronic component(s), a housing, or other “components” and or, combinations of any part of the systems.

[24] After the use of the inhaler system, the actuator seat geometry tolerance is impacted by the pressure applied on the vessel and / or the release of fluid(s) through the actuator seat. The shape of the actuator seat may be distorted through use and may impact the performance of the fluid(s), through use, the fluid(s) attach to the fluid pathway and impact the efficacy of the device. This makes the entire inhaler system unit disposable after repeated use. Further, the actuator seat can be easily replaced with or without replacing the vessel or, any other combination of inhaler parts, to facilitate the reuse of the inhaler system.

[25] In another aspect, the vessel of the inhaler system can be constructed using an insulating material such that the consistency of the fluid(s) is controlled in extreme environmental conditions.

[26] In another aspect, to alleviate the emulsification issue an electrical charge can be passed through the fluid(s) to suspend / align the particles for optimisation of particle distribution and thus allow free flow of the fluid(s) through the actuator seat and to a specific region(s) of the body.

[27] Other objects, aspects, features, and goals of the present invention will be better understood from the following detailed description. The following description is illustrative and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the following detailed description. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[28] The accompanying drawings illustrate the best mode for carrying out the invention as presently contemplated and set forth hereinafter. The present invention may be more clearly understood from a consideration of the following detailed description of the preferred embodiments taken in conjunction with the accompanying drawings wherein the like reference letters and numerals indicate the corresponding parts in various figures in the accompanying drawings, and in which:

[29] Figure 1 illustrates the schematic view of the multi-purpose diagnostic and drug delivery method and system .

[30] Figure 2 illustrates the vessel of the multi-purpose diagnostic and drug delivery method and system .

[31] Figure 3 illustrates the cross-sectional view of the multi-purpose diagnostic and drug delivery method and system .

[32] Figure 4 illustrates the connectivity of the multi-purpose diagnostic and drug delivery method and system with loT devices. DETAILED DESCRIPTION OF THE PREFERRED AND ILLUSTRATED EMBODIMENTS OF THE PRESENT INVENTION

[33] Example implementations are described in detail here, and examples of the example implementations are presented in the accompanying drawings. When the following description relates to the accompanying drawings, unless specified otherwise, the same numbers in different accompanying drawings represent the same or similar elements. The implementations described in the following example implementations do not represent all implementations that are consistent with one or more implementations of the present specification. On the contrary, the implementations are only examples of apparatuses and methods that are described in the appended claims in detail and consistent with some aspects of one or more implementations of the present specification.

[34] It is worthwhile to further note that the term “include”, “contain”, or any other variant is intended to cover a non-exclusive inclusion, so that a process, a method, merchandise, or a device that includes a list of elements not only includes those elements but also includes other elements which are not expressly listed, or further includes elements inherent to such process, method, merchandise, or device. An element preceded by “includes a . . .” does not, without more constraints, preclude the existence of additional identical elements in the process, method, merchandise, or device that includes the element.

[35] The terms used in one or more implementations of the present specification are merely used to describe specific implementations and are not intended to limit one or more of the implementations of the present specification. The terms “a”, “said”, and “the” of singular forms used in the present specification and the appended claims are also intended to include plural forms unless otherwise specified in the context. It should also be understood that the term “and / or” used in the present specification indicates and includes any or all possible combinations of one or more associated listed items.

[36] The present specification is related to a multi-purpose diagnostic and drug delivery method and system that replaces the vessel comprising the medicine and the actuator that allows the actuation of the medicinal and noon medicinal fluid. The present multi-purpose diagnostic and drug delivery method and system (Fig 1- 3) comprises a vessel 20 containing fluid(s); a housing unit 10 to hold the vessel wherein, distal end is extended into an orifice to accommodate a mouthpiece 30; a stem 22 included in the vessel 20 and extending outwards from distal end of the vessel 20; an actuator seat 24 to house in the stem 22 of the vessel 20; an actuator nozzle 26 extending from actuator seat 24 to allow flow of fluid(s)(s) through the mouthpiece 30; an Al-trained acoustic sound sensor(s) (11 a, 11b, 11c) ; an activation node to activate the actuator nozzle 26 when optimum inhaling technique is detected; an optical sensor(s) (12a, 12b); a biosensor(s) (13a, 13b); spectrometer 14 to identify the fluid(s) to identify organic compounds, and / or in the vessel; an ultrafine particle sensor 15 to determine the environmental factors of pollen and / or particle size and ratios of the dispensed fluid(s) from the actuator nozzle; a pressure sensor 16 to determine the pressure of flow of fluid through the actuator nozzle 26; a counter component to track number of dosages of the fluid(s); a measuring component to track the quantity of the fluid(s) in the vessel; an adjustable flow regulator 17 to determine the effectiveness of a dosing; a LiDar component 18; adjustable air vents 19; a diagnostic module 41; a data storing module; a communicating module 42 to notify the user regarding the functioning of the device; a power supply unit 43 and a display component 40 located on the housing unit 10, wherein the diagnostic module comprises a computer program application operable, when run on a user device(s), to allow the user device(s) to receive inhaler data from the data storing module through the communication module of the multi-purpose multi-indication and drug delivery system.

[37] The multi-purpose multi-indication and drug delivery system, has an actuator that houses an actuator seat 24, which releases medical fluid or powder and drives the fluid(s) through the mouthpiece 30 of the multi-purpose diagnostic and drug delivery method and system. A vessel 20, blister pack, capsule, or pill comprising medicine in powdered form or liquid form is inserted into the actuator seat 24 for actuation. In one of the embodiments, when the multi-purpose inhaler system is activated mechanically, digitally, or by pressing a vessel, which pierces a dry powder pack or crushes a capsule that contains the active pharmaceutical ingredient(s), and the releases medicine is driven through the mouthpiece 30 through inhalation.

[38] In one of the embodiments, vessel 20 is filled with an active pharmaceutical ingredient (pressure meter-dose), like a solution or suspension, which is commonly referred to as a fluid(s). The fluid(s) is typically designed in conjunction with the actuator seat geometries. The sizes and shapes, the geometries of the actuator seat, the properties of the fluid(s) like the ratios of, and the size of, particle(s), the solvent(s), excipient(s), refrigerant(s), and the pressure in the vessel impact or influence the efficacy and performance of an active pharmaceutical ingredient(s).

[39] The vessel 20 of the present multi-purpose, reusable inhaler system 100 is attached to a valve and a stem 22 that has internal &external diameters and length(s) that can impact or influence the efficacy and performance of the active pharmaceutical ingredient(s). The actuator seat 24 houses a stem block (for a stem), a sump, an orifice, and an actuator nozzle 26, and the geometries of these components are designed to enhance the efficacy and the performance of the active pharmaceutical ingredient(s) that is tested for with Aerodynamic particle size distribution tests like Next generation impaction (NGI), computational fluid dynamics and other software modelling tools. The actuator seat 24 receives a stem 22 into the stem block, which is attached to a stem valve, which is attached to a vessel 20 that holds fluid(s) which can be a suspension, solution, or powder.

[40] In one of the embodiments, to alleviate the emulsification issue an electrical charge can be passed through the fluid(s) to suspend / align the particles for better particle distribution, thus allowing free flow of the fluid(s) through the actuator seat and to a specific region(s) of the body, targets different particle(s) or fluid(s) in a vessel(s) to reach a desired outcome(s); increases drug deposition and increases the life cycle of a fluid(s) and the dose form. It can take a few seconds to emulsify a formulation whether it be a suspension, solution, or fluid formulation which are typically referred to as “fluids”, and in practical terms, the patient does not shake the inhaler for 20 seconds before use (find Scientific studies) and when done IFU is not followed to the manufacturers' specification, it negatively impacts the performance and efficacy of the “fluid(s)” and / or the deposition within a cavity (lungs). An electric charge may be activated by the user by interacting with the device in several ways like shaking the inhaler; user-specific movements / actions “prompts” or any forced prompts. The charge may be varied depending on a vessel(s) and / or a fluid(s). A way of charging is achieved through a battery stored in the device.

[41] In one of the embodiments, the multi-purpose diagnostic and drug delivery method and system , the actuator seat can be inserted and removed by having it either attached to the stem or vessel, or both. The actuator seat can also be inserted or removed individually without disturbing the stem and vessel of the inhaler system. This aspect of insertion and removal of the actuator seat with or without the stem or vessel, or both does facilitate the reuse of the inhaler system. Generally, the actuator seat is attached to the actuator and the dose counter is attached to the actuator stem and the vessel, which can be inserted / removed from the inhaler system together. The combination of the geometries of the actuator, actuator seat, mouthpiece, and fluid(s) determine the performance and efficacy.

[42] Further, the inhaler system is equipped with a mechanism that enables the removal of an “actuator seat” whether it be in contact with a channel with an opening at one, or both ends, a vessel, a stem, a mouthpiece, a mouthpiece cap, a filter, an adjustable filter, a dose counter(s), electronic component(s), a housing, using a tool(s), or other “components” and or, combinations thereof. The replaceable / removable parts enable the cleaning and / or reuse of the device, to maintain the performance and efficacy of the device or a formulation in any combination. After the use of the inhaler system, the actuator seat geometry tolerance is impacted by the pressure applied on the vessel to facilitate the release of fluid(s) through the actuator seat. The shape of the actuator seat may be distorted through use and may impact the performance of the fluid(s). This makes the entire inhaler system unit disposable after repeated use.

[43] In accordance with the present invention, the actuator seat can be easily replaced with or without replacing the vessel or, any other combination of parts, to facilitate the reuse of the inhaler system. The mouthpiece is replaceable by a rig to facilitate clinical fluid(s) development. The multi-purpose diagnostic and drug delivery method and system allows fluid(s) development by determining the device dynamics wherein the device dynamics include the geometries of the vessel, the stem, the actuator seat, and the actuator nozzle, the flow rate of the fluid(s) through the stem, the actuator seat, the actuator nozzle, and the rig; the inhalation speed and inhalation volume.

[44] The actuator nozzle is removable or replaceable, wherein the actuator nozzle is attached to the stem, and being removable means any pMDI medication can be inserted into the device without having to manufacture the entire actuator again, thereby reducing the plastics manufacturing. The estimated life cycle assessment of the present inhaler systems is +5 years, which will reduce manufacturing costs, pollution, and waste materials, replacing the actuator seat "sprayer nozzle" after a specificied quantity of doses effectively resets the acatutator seat geometries and enables optimal efficacy of a fluid(s) being delivered, allows the user to resue the device and enables interoperability with other fluid(s) vessels for precision medicine applications, for example adjusting the fluid(s) being dispended via the device.

[45] In one of the embodiments, the multi-purpose diagnostic and drug delivery method and system comprises an Al-trained acoustic sound sensor(s)(s) that can determine the lung(s) orchestra, “personal lung print” (PLP) or “personal lung profile” or “lung print” and to diagnose, treat, and / or monitor the patient remotely (Oscillometry), and such data is communicated to loT device(s) through communication module(s) and the data acquired can be used for biomechanic mathematical modeling, for example, to analyze disease change, and determine progression alerts, optimize medication / patient selection or fluid(s) delivery. Further, the Al-trained acoustic sound sensor(s)s can acquire data on inhaler technique and can determine parameters like length of inhalation, respiratory rate, Peak Inspiratory Flow, Peak Expiratory Flow, Wheeze detection, volume, and pressure of inhalation, wherein any respiratory parameters can determine the patient's inhalation technique and provide real-time feedback to improve the inhaler technique, or improve lung health, which is crucial for effective and increased drug deposition, which can be achieved through the correct dosage form that hits the desired area(s) which will increase disease control. The Al-trained acoustic sound sensor(s)(s) establishes the difference between spraying and inhalation sound. Additional benefits include increased patient awareness of how / why to use the device properly which reduces misuse of medication(s) and unnecessary "extra" prescriptions being prescribed. Further, the loT devices can enable ‘Inhalation, lung, and / or patient profiling’, to create individual profiles for users to help providers tailor treatment. The change in the acoustic profile during inhalation can also reflect the presence of disease and disease change, and patients will be alerted to these disease "trigger" changes and informed about the predictions of the occurrence of attacks.

[46] In one of the embodiments, the acoustic sensor(s) can acquire sound data from the flow of fluid, or dosage waveform(s); can identify any medication inserted into, and dose count(s), and alert the patient (in software or ) when a new medication is inserted, and send prompts to confirm "medication" has been changed, if it’s the same vessel, and to alert the patient to stop swapping medications into / out of the system; can send alerts for the patient to track which medication(s) they are being used and if someone else has used the inhaler system. Further, the acoustic sensor(s) can determine the change in the acoustic profile(s) of a medication by monitoring the parameters like length of dosage through valve opening time(s), and the sounds(s) of a plume(s), and / or jet length; if sensitive enough we should be able to detect the heart rate “pulse” by comparing the readings from one microphone input to another.

[47] The optical sensor(s) will analyze the inhaler technique and how to correct it, and based on object detection, the inhaler system can confirm the correct inhaler system angle to any part of an orifice, like the mouth or throat. Further, the optical sensors can acquire the image(s) data of the orifice like mouth, throat, and / or gums, and the image(s), and / or video(s) data is further analyzed by applying Computer vision to detect EKG, BPM, Sp02, tidal breathing, internal / external temperature, time of dosage, dose count, lung disease identification(s) / change(s), and / or for example other disease(s) like inflammation(s), virus(s) or cancer(s) of a cavity. Further, the data from the optical sensors is communicated to loT device(s) to determine the angle of a body, cavity, head, mouth, throat to an inhaler; flow rate(s), or impact(s) on the flow rate(s) of the mouth and throat fluid pathway (Computational modeling) based on the size / shape of the mouthpiece and the proper angle alignment achieved through and from this data the inhaler system can analyze as how this inhaler system angle impacts drug deposition. For example, the data from the optical sensors are used to perform mapping of the geometries of a cavity(s) and calculate the impacts of a fluid(s) dispersion, deposition, and the fluid(s) pathway(s), or combinations thereof.

[48] The optical sensors also work in combination with other sensors like inertial measuring units to indicate a delivery position; and also in combination with a microphone or other sensors. There are multiple optical sensors located at various angles within the circuitry housed in the housing unit of the present multi-purpose diagnostic and drug delivery method and system s. The camera(s) will analyze visible and / or non-visible light frequencies. One or more cameras can acquire Thermal images of a cavity for various applications like determining the temperature analytics of fluid(s); fluid(s) pathway(s); cavity(s) or any combination of them. The optical sensors in combination with other sensors can identify a medication being dispersed by analyzing a plume or fluid(s) in a fluid(s) pathway(s) and send Notification(s) of changes(s) of a fluid(s) plume(s); changes(s) to a fluid(s) quantity(s); changes(s) to a fluid(s) quality(s) and changes(s) to a fluid(s) end of life. Further, a LiDAR ( Light detection and ranging) component can perform Laser imaging of the orifices like mouth, throat, and / or gums.

[49] The biosensors equipped near the mouthpiece of the inhaler system can detect the Saliva -“Sputum” sample(s) from the orifice, which can be further utilized in Genome “nomic” testing. The data collected can then be used to provide personalized health advice and recommendations. This data can also be used to monitor changes, create tailored treatment plans and interventions. Additionally, this data can help to detect health risks and conditions earlier. This system also provides improved patient outcomes through more precise delivery of medication. Additionally, this system can help reduce healthcare costs by providing more efficient monitoring of medication effectiveness.

[50] In one of the embodiments, the multi-purpose diagnostic and drug delivery method and system s comprise Inertial measuring Units to determine the angle of an inhaler; the angle of the patient's head with the inhaler; correct / incorrect angle(s); works in combination with one or more sensors like works with the camera(s), and / or LiDar, to alert the user of incorrect / correct inhaler angle; works with the laser sensor to alert the user of incorrect / correct inhaler angle.

[51] In one of the embodiments, the inhaler system comprises a Ultra Fine Particle Sensor (UFPS) to determine the ambient environment in a housing unit, and orifices like mouth, throat, or nose; to measure the concentration of particles of inhaled fluid(s), and exhaled fluid(s). Further, the inhaler system in communication with the loT devices acquires some regional parameters like location data and Air quality index in such location and accordingly determines the frequency of dosage, medication, and treatment planning (example: "take your inhaler system with you, and dose at X time, etc") and enable dosage tracking. Factors like Pollution, pollen, heat, and cold are disease triggers, therefore knowing the AQI of location, and how they impact the disease (and biomarkers) allows the patient to avoid situations that "trigger" disease, and or, alert them to "triggers" they may, or may not, have been aware of. Further, the location data can allow the inhaler system to analyze the personalized risk assessments, levels, and insights and may be extended to provide suggestions on Lifestyle adjustments of indoor and outdoor activities, which may, or may not, be performed in-combination with any other sensor(s), or software(s).

[52] The present multi-purpose diagnostic and drug delivery method and system comprises a spectrometer that determines the ambient environment within the housing unit, and orifices like mouth, throat, or nose; to measure electromagnetic radiation of inhaled fluid(s), and exhaled fluid(s). The spectrometer measures the radiation of VOCs and VOC biomarkers, which are used to determine the presence, severity, and / or changes of any disease. In one of the embodiments, dosage tracking is achieved through data parameters based on time, date, location data, and frequency of drug inhaling, wherein dosage tracking keeps track of where, when, and how many dose(s) are to be taken and provides “triggers” based on location AQI data, provide alerts to misuse and automates electronic prescription repeats and ordering. Through the results of dosage tracking the loT devices can further extend to determine insights into how each medication form (a reliever VS preventer medication) impacts health metric(s) and therefore "disease control", to further empower the understanding of which medication should be used when, and why, while reducing, or stopping, over reliance, or misuse of medications, giving them better disease control and confidence in the medications by generating automated reports to disease management plan, reducing manually recording all the information. The inhaler system monitors, analyses, scores and reports the data collected within the system(s).

[53] In one of the embodiments, a diagnostic module 41 of the inhaler system comprises a computer program application operable, when run on a user device (loT device), allows the user device to receive inhaler data, and the inhaler system dynamics data from the data storing module through the communication module 42 of the multi-purpose diagnostic and drug delivery method and system . The diagnostic module 41 acquires the data from all the acoustic sound sensors, optical sensors, biosensors, spectrometer, pressure sensor(s), metering component, measuring component, adjustable flow regulator, LiDar component and each dataset from each sensor is stored in the data storing module, wherein when the user device (loT device) requests data from the inhaler system, the communication module 43 sends the stored data to the user device through a Bluetooth network, wherein the stored data can be classified as inhaler data and inhaler system dynamics data. The software API that runs on the user device will implement artificial intelligence, machine learning, computer vision, deep neural networks convolutional neural networks, and digital twins (deep learning) on such inhaler and inhaler system dynamics data to analyze and determine the condition of the user (diagnosis), and such data can be viewed as a statistical report by all stakeholders, for example, patient, caregivers, clinician, healthcare provider, pharmaceutical companies, researchers the analyzed data is available. Integrations with ML / AI / DNN, Digital Twin’s, Deep Learning, or quantum computing tools may, or may not be autonomous. The analyzed data can further be classified as a health status record that indicates the occurrence of disease(s), or progression of a disease(s), and some predictive analysis that can depict the chances of disease(s) forming, occurrence of the next attack(s), and such health status record can be viewed by any stakeholder; and instruction dataset(s) to optimize the working of the inhaler system wherein such instruction dataset(s) can be sent as ‘triggers’ to the user device or the inhaler system such that the user can rectify the issue and ‘triggers’ can be in form of the dosage instructions which can be further communicated to the diagnostic module 41 of the inhaler system wherein the diagnostic module allows the display o such triggers on the display screen 40 of the inhaler system. The diagnostic module 41 can also send an alert to the user device if the severity of the symptoms increases. The user can then take appropriate action. For example, the triggers can also be used to remind the user to take preventive measures such as wearing protective clothing or avoiding certain activities.

[54] In one of the embodiments, (Fig 4) the multi-purpose inhaler system can also be a diagnostic device wherein the data acquired from all the sensors are communicated to an loT device through a Bluetooth module, wherein such loT device should have a software API with integration and interoperability for other AI or SaMD which could be downloaded with, or in addition to, the existing AI or SaMD, to analyze, diagnose, treat, monitor and / or to optimize medication selection, quantity, and drug delivery options. The rich data quality from the inhaler system will be accessible to researchers, academia, pharmaceutical companies, and industry for further research. The software API is a gamified application that helps with patient adherence, treatment(s) effectiveness, and increased patient outcomes.

[55] In one of the embodiments, the multi-purpose inhaler system can be integrated with the wearables to acquire the health data collected by such wearables, and the data from the inhaler system and other wearables is analyzed together to determine more accurate insights on the progression of the existing disease and can further provide more accurate predictions on the occurrence of next attack to the stakeholders such that precautions can be taken ahead of time. The application will utilize inhaler data, loT, wearables data, and biomarkers, and process such data using machine learning, and artificial intelligence and can also be processed in a deep neural network or digital twins, for analyses and to provide clinical, or non-clinical based digital therapeutic and therapeutic interventions, and ecosystem insights like understanding in-vivo pharmacodynamics and pharmacokinetics, develop and / or test formulations in-silica for instance with digital twins or within preclinical or clinical trials, or provide precision medicine adjustments to the users. The software application can be centralized and / or decentralized, for example cloud-based, on a personal device, or server-based. The performance and effectiveness of the inhaler, diagnosis, and treatment of a patient are enhanced with the present multi-purpose inhaler systems.

[56] In an exemplary embodiment, the present multi-purpose inhaler system is integrated with a MEMS (Microelectromechanical System) wearable that will monitor health metrics, for example; EKG, BPM, SpO2, Variable heart rate, and respiratory rate etc. The inhaler system collects the inhaler data like inhaler technique, volume, and pressure of inhalation, dosage, biomechanics and the “orchestra” of the lungs, images from the optical sensor, spectrography data. Biosensors data, UFPS data, wherein the inhaler system will identify biomarkers separately or in combination with any “other” sensor and / or system data. The Inhaler data along 'with the wearable data, is analyzed by applying AI / ML algorithms in simple, multimodal, or complex models and may be linked to a Deep neural network (DNN) and / or, maybe in combination with a Convolutional Neural network (CNN) to analyze, for example, the padent(s) behavior (s), pathology(s), epidemiology(s), and the pharmacdogy(s) effectiveness to provide diagnosis, to provide an effective treatment plan, monitoring the progress of the disease, and predict the patient)s) behavior and their disease(s) and can further provide suggestions to the patient or other stakeholders about the information. A “user” may be any number of stakeholders) accessing the data, for example, a healthcare professional, pharmaceutical company, researcher, patient, parent, or caregiver. Under the application of the present inhaler system, the data access levels could be based on a patient's performance, if the data is paid / unpaid, or a user's role in a company, which will allow different ways for the data visualization to occur from one user profile to another, or from one use case to another. For example: For example - the healthcare professional can ask a personalized query to the application like “Maw me the patient QALY’s based on current adherence and medication usage?”; “Project the patient DALF’s”; “Show me 200patients from diversified backgrounds with “specified’' input / parameters and analyze “dijfeivnces / similarities”; the user can ask a personalized query to the application like “Mrow me the impact my preventer / reliever medication has on my biomarkers”; “flaw does this compare to other people with the same condition and dosage in my area?”; “What can I do to Improve my Qualify of life (QOL)?”; or “too much information” please simplify &show me what is stopping me from (1) adhering, (2) maintaining disease control”; “Show me how many days my biomarkers have been positive. “

[57] In another exemplary embodiment, the application platform on the smart devices will have generative, conversational, responsive, chat, and adaptive AI UX / UI aspects, wherein the application adopts to the smart device and / or adapts to a user depending on any number of inputs, for example: age, medication, disease, device(s), location, time, health data, exercise data, or any other data around offline / online “profiles” “habits” “interests” or user inputs, so it can iterate and design(s) a UX / UI interface according to the “user” to keep them engaged and to grow with the user over time and provide a personalized response(s) and language(s) with data visualization, for example, based on the users need(s), skill level, role in the treatment of the patient, the analysis of the data, the present application for the multi-purpose inhaler system can implement contact and contactless gestures of eye / hand / voice / haptic feedback and commands to simplify the navigation of the UX / UI of the application. UX / UI Generate an interface with wording, colors, and UI "skins" that a user may be familiar with seeing, and based on their "profiles", or generated by Purcell. For example, a UX / UI for children which is based on "Zelda®" "Mario®" "Uego®". If the users' online activity changes so do the UI "skins" that the program generates, there would be "basic" UI, "unlockable" UI, gamified through adherence, and other gamification factors, and / or the user could purchase "special" UI "skins", while the UX would be simplified to match their age.

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