ARI Smart Inhaler with Integrated Spacer

Abstract

Disclosed is an ARI smart inhaler with an integrated spacer. The smart inhaler is an Internet of Things (IoT) inhaler that measures lung conditions, including partial pressure, nitric oxide, oxygen, peak flow, and forced expiratory volume, and delivers medication. The data is collected and transmitted to a mobile app and web portal so that patients and healthcare providers can track and view respiratory conditions in real time. Other embodiments include software and a cloud network with algorithms that can predict and alert stakeholders before any trends or problems materialize. The smart inhaler also utilizes blockchain technology to keep stakeholders informed of treatment and health status in real time. An object of the present invention is to help patients maintain their medication plans and quickly inform healthcare professionals of their respiratory conditions.

Description

Detailed Description of the Invention

[0001] [Cross - Reference to Related Applications This application includes and claims priority to the subject matter disclosed in a provisional application entitled "ARI Smart Respiratory Inhaler with Integrated Spacer" assigned application number 633,490,97, filed on June 5, 2022, and made by the present inventor. Further, it should be noted that the present inventor has also filed similar utility models and design patents in Taiwan in June 2022. These applications claim the priority of TW1781673B and TWD218780S, both filed in Taiwan and reported under 35 U.S.C. § 119 or 365.

[0002] [Field of the Invention The present invention generally relates to the Internet of Things (IoT). More specifically, the present invention relates to a smart inhaler device.

[0003] [Background Internet of Things (IoT) devices first emerged in the early 1980s when students at Carnegie Mellon University modified a soda vending machine. This machine was considered the first internet-connected device cable to report its inventory and notify customers when freshly refilled beverages would be chilled. The term IoT was most likely coined by Procter & Gamble, who used radio frequency identification tags as part of an IoT system. Others define IoT simply as a point in time where more "things or objects" than people are connected (or will be connected in the future) to the internet. Today, IoT is dramatically changing how businesses operate and how society functions in general. The entire IoT communication is beginning to accelerate with the deployment of 5G networks in urban areas, and the data generated from connected devices is helping businesses run more efficiently and enabling them to make real-time decisions by gaining insights into business processes. While IoT is gaining popularity in many industries, only a handful of IoT devices are being utilized in inhalation devices. U.S. Patent US20020032387A1 discloses a combination of a spirometer and oximeter with IoT capabilities. It communicates wirelessly with others but does not incorporate an inhaler. U.S. Patent US5522380A discloses a dosage medication adapter with a built-in spirometer, but it does not have IoT communication. U.S. Patent US8333190B2 discloses an IoT nebulizer with a flow meter, but it does not incorporate a spirometer. U.S. Patent US20170000382A1 discloses an IoT inhaler that tracks usage, but it does not utilize blockchain technology. What is needed is an IoT-based smart inhaler that can deliver inhaled medication, track usage, communicate with stakeholders, and securely predict trends and treatment problems. For example, tracking respiratory illnesses in the elderly could be particularly useful. People who do not take their medication regularly may experience various problems. Firstly, they may not get the full therapeutic effect of the prescribed medication.This can lead to a deterioration of existing health conditions or even new health problems. Secondly, not taking medication regularly can lead to troublesome problems such as hospitalization, prolonged illness, and increased medical costs. When older adults do not take their doses, it can become difficult for healthcare professionals to effectively manage their condition and maintain their health. Thirdly, failure to adhere to medication schedules is often a sign of other health problems such as memory loss or depression, which may require additional treatment or support. Therefore, it is essential for older adults to take their medications regularly and follow the prescribed schedule. Smart inhalers can play a vital role in helping older adults manage their medications effectively, which can help improve their health outcomes and overall quality of life.

[0004] [Summary of the Invention] The devices disclosed and described herein offer solutions to the shortcomings of prior art through the disclosure of an IoT-based smart inhaler. The purpose of the device is to deliver respiratory medications to a patient's lungs. The device includes an inhaler with a disposable conventional pressurized vapor canister and an adapter for receiving a powder cartridge, and is used in a typical manner (the patient inserts it into their mouth and presses a button to release the vaporized medication into their lungs). For the purposes of this disclosure, a conventional inhaler is defined as a medical device that delivers medication directly to the lungs in the form of a mist or spray. Inhalers are commonly used to treat respiratory diseases such as asthma, chronic obstructive pulmonary disease, and bronchitis. They typically consist of a small medication canister and a mouthpiece, and function by delivering a measured dose of medication when the user inhales through the mouthpiece. Inhalers are designed to be portable and easy to use and are often used for the routine management of respiratory disease symptoms. In this disclosure, IoT refers to a network of physical objects and devices that incorporate sensors, software, and connectivity, enabling the collection and exchange of data over the Internet. Another objective of the present invention is to minimize drug deposition in the inhaler and maximize delivery to the deep lungs with a novel integrated spacer having a convergent / branching nozzle. This unique chamber spacer relies on air intake to mix the distributed drug with air as the user inhales through the convergent / branching airflow path. The resulting mixture of drug molecules is slowed down for easier inhalation, and harmful carrier molecules are then evaporated so as not to be inhaled by the user or deposited in the mouth and throat.

[0005] Another object of the present invention is to provide an embedded sensing technique for measuring lung function and parameters, including, but not limited to, partial pressure oxygen, nitric oxide, peak flow, and forced expiratory volume. Such data can present an overall state of the patient's overall lung health. Such data can be extremely useful when monitoring patients with complex respiratory diseases such as COVID-19 or pneumonia. The device also has an embedded exhaled body temperature sensor, which allows the system to track changes in inflammation that correlate with lung diseases such as asthma or COPD. For the purposes of this disclosure, embedded sensing is considered a “microsensor,” which is defined in the purposes of this disclosure as a tiny electronic device designed to sense and measure the physical or chemical properties of the surrounding environment, such as temperature, pressure, humidity, light, and gas concentration. They typically consist of a sensing element and electronic circuitry that converts the sensed information into an electrical signal, which can be analyzed or transmitted to another device. Microsensors are typically manufactured using micro-electromechanical systems technology, which enables the production of small, lightweight, and low-power sensors that can be integrated into a variety of applications, including biomedical devices, environmental monitoring systems, and industrial control systems.

[0006] Another objective of the present invention is to collect all device data and transmit it wirelessly via Bluetooth to a mobile device app, and then to a web portal, enabling patients and their healthcare providers to track and view their respiratory health status in real time. This functionality can help vulnerable patients, such as the elderly, who may not always be able to track their condition or report it to a doctor. In this disclosure, wireless is defined as the transmission of data or information between two or more devices without the use of physical cables or wires. Instead, wireless communication uses electromagnetic waves, such as radio waves, to transmit information from one device to another. Examples of wireless communication technologies include Wi-Fi, Bluetooth, cellular networks, and satellite communications.

[0007] Another object of the present invention is to include software and a cloud network equipped with algorithms that can predict any trend or problem before it manifests itself and warn stakeholders. Such algorithms may include artificial intelligence routines for predictive analytics. Data from the system is fed to algorithms in the cloud network, which analyze it and compare it with a database and conditions, enabling predictions about any trend. For example, an asthma patient has been reported to have episodes of hypoxia and low forced expiratory volume and not feel well. The algorithm can predict the problem and notify the patient to seek medical attention in the near future. In this disclosure, a cloud network is defined as a type of computer network that provides services and resources over the Internet using cloud computing technology. In a cloud network, data and applications are hosted on servers located in remote data centers, and users access them over the Internet. Cloud networks typically provide on-demand access to scalable computing resources, such as processing power, storage, and network bandwidth, which can be dynamically adjusted to meet changing user needs. Cloud networks are frequently used by enterprises and organizations to reduce the cost of their IT infrastructure, improve its scalability and flexibility, and enhance its data security and disaster recovery capabilities.

[0008] In this disclosure, artificial intelligence is defined as a field of computer science that includes the development of intelligent machines capable of performing tasks that typically require human intelligence, such as vision, speech recognition, decision-making, and language translation. AI technology uses algorithms and mathematical models to analyze large amounts of data, learn from patterns and trends, and improve their performance over time. Examples of AI applications include chatbots, autonomous vehicles, image and speech recognition systems, recommendation engines, and fraud detection systems. AI is considered a rapidly growing, transformative technology with the potential to have a significant impact on a wide range of industries and domains.

[0009] Another objective of the present invention is to leverage the security of blockchain technology to provide a historical database and, based on smart contracts, to continuously notify multiple parties in real time of the activity, sensors, treatments, and patient health status of all smart ventilators via a distributed ledger. In this disclosure, blockchain is defined as a decentralized digital ledger technology that enables multiple parties to store, share, and verify data in a secure and transparent manner. In a blockchain system, data is stored in blocks linked to each other in a chronological and immutable chain, with cryptographic techniques used to ensure the integrity and authenticity of the data. Each block contains a unique digital signature called a hash, which is generated based on the data in the block and the hash of the previous block in the chain. This makes it virtually impossible to modify or tamper with data stored on the blockchain without detection.

[0010] It is briefly stated that a person skilled in the art will recognize various means for carrying out these intended features of the present invention. Therefore, it should be understood that other methods, applications, and systems suited to the task may be configured to perform these features and are therefore considered and expected to fall within the scope and intent of the present invention. With respect to the above description, before detailing at least one preferred embodiment of the present invention disclosed herein, it should be understood that the present invention is not limited in its application to the configuration details and arrangement of components shown in the following description or in the following drawings. Other embodiments of the present invention as described herein are possible and can be carried out in various ways that are obvious to a person skilled in the art. Furthermore, it should be understood that the expressions and terms used herein are for illustrative purposes only and should not be considered limiting.

[0011] Accordingly, those skilled in the art will understand that the underlying concepts of this disclosure can be readily used as a basis for designing other structures, methods, and systems to perform some of the purposes of the devices of this disclosure. Therefore, it is important that the claims are deemed to include such equivalent structures and methodologies, without departing from the spirit and scope of the invention. When used in the claims to describe various aspects and embodiments of the invention, “comprising” means including, but not limited to, what follows the word “comprising.” Thus, the use of the term “comprising” indicates that the enumerated elements are necessary or essential, while other elements are optional, may or may not be present. “Consisting of” means including, and being limited to, everything that follows the phrase “consisting of.” Thus, the phrase “consisting of” indicates that the listed elements are necessary or essential, and other elements may or may not be present.

[0012] "Consisting essentially of" means that it includes any elements listed after it, and that other elements are limited to those that do not interfere with or contribute to the activity or action specified in the disclosure of the listed elements. Therefore, the phrase "consisting essentially of" indicates that the listed elements are necessary or essential, while other elements are optional and may or may not be present, depending on whether they affect the activity or action of the listed elements. The objectives, features, and advantages of the present invention, as well as its advantages over the prior art as will become apparent from the following description, are achieved by the improvements described herein and in the following detailed description. This fully discloses the present invention, but should not be construed as imposing any limitations thereto.

[0013] The accompanying drawings, incorporated herein and constituting part of the specification, illustrate some, but not exclusive, examples of embodiments and / or features.

[0014] [Brief explanation of the drawing] Figure 1 shows a perspective view of the top surface of the smart inhaler.

[0015] Figure 2 shows an exploded view of the smart inhaler.

[0016] Figure 3 shows a typical diagram of the functions of a smart inhaler.

[0017] Figure 4 shows a typical diagram of a blockchain.

[0018] Figure 5 shows a typical diagram of the smart inhaler method.

[0019] [Detailed explanation of the drawing] Other aspects of the present invention will be more readily apparent when considered in conjunction with the accompanying drawings and the following detailed description. None of these should be considered limiting.

[0020] In this specification, directional prefixes and other such terms, such as top, up, down, down, front, back, top, upper side, bottom, lower side, left, right, refer to the device as it is oriented and as it appears in the drawings, and are used for convenience only. They are not intended to be limiting or to suggest that the device must be used or positioned in any particular orientation. The prior art components of the present invention are well known in the prior art and are not discussed in detail in this disclosure. One such component is a smart inhaler.

[0021] Figure 1 shows a perspective view of a preferred embodiment of a smart inhaler having a triangular shape and communicating with a mobile software application 3 (app) on a desktop computer 9 operated by a mobile phone 2 and a healthcare provider 3A. The app resides in a non-transient computer-readable medium containing computer-readable instructions. Figure 2 shows an exploded view of a smart inhaler 1 having components including, but not limited to, outer casings 1 and 5, a mouthpiece 10, a built-in battery 11 (such as lithium-ion), a vapor accelerator 12 with an attachment for receiving the nozzle of a conventional drug canister 8 inside, an integrated spacer 4 for receiving and securing the body of the drug canister 8, and a square liner 7 configured to receive a microcontroller 6 inside. The integrated spacer 4 is a convergent / branching nozzle that results in enhanced drug delivery and flow, specifically, it increases the mixing of propellant and inhaled air while avoiding drug deposition in the inner portion of the device. The integrated spacer 4 prevents drug deposition in the pharynx while maintaining performance in the breathable fraction. Furthermore, the integrated spacer 4 prevents drug deposition in the pharynx, thereby allowing the drug to reach deep into the lungs. The smart inhaler also has a removable drug canister 8, which is held in place within the outer casing 5 by a guide 9. All of the aforementioned components (except the microcontroller 6 and drug canister 8) are made of a rigid, lightweight material such as plastic. The microcontroller 6 has built-in memory with dedicated firmware that controls multiple built-in sensors that detect parameters including, but not limited to, lung function, partial pressure oxygen, nitric oxide, exhaled body temperature, peak flow, and forced exhalation volume, temperature, drug residue flow rate, and temperature. The microcontroller 6 also has a built-in wireless communication module (such as Bluetooth) for data transmission.

[0022] Figure 3 shows a typical diagram of the cloud-based network, where users have the ability to select software subscription levels, pair and configure new and existing smart inhalers, and monitor data and readings on computing devices including, but not limited to, desktop computers, laptops, tablets, and mobile phones. Smart inhalers have the ability to pair with other wireless devices, collect and receive patient data, and transmit data wirelessly, but are not limited to these functions. Users and smart inhalers are connected via the cloud-based network, and operations include management routines (patient profiles, demographic information, and subscription management), a web portal for stakeholders and users to log into and view smart inhaler sensor data in real time, initialization (pairing new inhalers, threshold setting, and calibration), artificial intelligence algorithms for trend detection and state prediction, collection of encrypted data for all stakeholders stored on a blockchain under a distributed ledger, and automatic notification to stakeholders (via text message, SMS, email, etc.) when any sensor threshold is exceeded or an abnormal trend is detected. Figure 4 shows a typical diagram of blockchain software, whose main function is to build irreplaceable patient records that enable patients to be compensated for the use of their data and to adhere to treatment plans with recognition of initial transactions (such as sensor readings). The diagram shows a blockchain with registered origin blocks after being approved by network nodes consisting of, but not limited to, administrators, patients, doctors, and insurance agents. As a patient continues transactions, including registration and device pairing, each transaction is encrypted and added to the previous block to form a hash blockchain, and each transaction has a timestamp and metadata, which are broadcast as recorded transactions to the authorized parties and are available on the cloud-based network. By design, the blockchain is resistant to data modification.When used as a distributed ledger, a blockchain is typically managed by a peer-to-peer network and collectively follows protocols for inter-node communication and confirmation of new blocks. Once recorded, the data in any given block cannot be retrospectively altered without altering all subsequent blocks, and it requires consensus of the network's majority. Combined with smart contracts, such a blockchain can be viewed as a decentralized notarization service that enables transparency, allowing a person with pre-configured privileges to see what lies within the data element records, constructed using cryptographic hashes and timestamped. Smart contracts are dynamic, live contracts that cannot be altered once created, but can perform specific actions when certain conditions are met (such as automatically sharing records with pre-approved parties using digital signatures). The diagram also illustrates an embodiment of the notification process when patients, administrators, doctors, and agents are notified of the patient's smart inhaler data on a cloud interface website, as well as on smartphones and desktop computers.

[0023] Figure 5 shows a typical diagram of a smart inhaler method, including, but not limited to, the following steps: the user loading a conventional medication cartridge inside the device; wirelessly pairing the smart inhaler(s) with an app and / or web portal; activating settings (sensor type, sensor thresholds, dose schedule, and alarm settings); delivering medication to the user; the sensor detecting parameters; and distributing sensor data to a cloud network.

[0024] In consideration of the disclosures provided herein, mobile applications are created by the art known to those skilled in the art, using hardware, languages, and development environments known in the art. Those skilled in the art will recognize that mobile applications are written in several languages, including, but not limited to, C, C++, C#, Objective-C, Java®, Javascript, Pascal, Object Pascal, Python®, Ruby, VB.NET, WML, and XHTML / HTML with or without CSS, or a combination thereof. The software also supports multiple operating systems, including, but not limited to, Windows®, Apple®, and Android®, and multiple hardware platforms, including, but not limited to, personal desktops, laptops, tablets, and smartphones. Suitable mobile application development environments are available from several sources. Commercial development environments include, but not limited to, AirplaySDK, alcheMo, Appcelerator®, Celsius, Bedrock, Flash Lite, .NET Compact Framework, Rhomobile, and WorkLight Mobile Platform. As a non-exclusive example, other development environments, including Lazarus, MobiFlex, MoSync, and Phonegap, are available at no cost. Additionally, mobile device manufacturers distribute software developer kits, including, as a non-exclusive example, the iPhone and iPad (iOS) SDK, Android® SDK, BlackBerry® SDK, BREW SDK, Palm® OS SDK, Symbian SDK, webOS SDK, and Windows® Mobile SDK.

[0019] A person skilled in the art will recognize, as a non-limiting example, several commercial forums available for the distribution of mobile applications, including Apple® App Store, Google® Play, Chrome Web Store, BlackBerry® App World, App Store for Palm devices, App Catalog for WebOS, Windows® Marketplace for mobile devices, Ovi Store for Nokia® devices, Samsung® Apps, and Nintendo® DSi Store.

[0025] In some embodiments, a computer program includes a standalone application, which is a program that runs as an independent computer process, not an add-on to an existing process, such as a plug-in. Those skilled in the art will recognize that standalone applications are often compiled. A compiler is a computer program(s) that translates source code written in a programming language into binary object code, such as assembly language or machine code. Suitable compiled programming languages, in non-limiting examples, include C, C++, Objective-C, COBOL, Delphi, Eiffel, Java®, Lisp, Python®, Visual Basic, and VB .NET, or combinations thereof. Compilation is often performed at least partially to create an executable program. In some embodiments, a computer program includes one or more executable compiled applications. In some embodiments, a computer program includes a web browser plugin (e.g., an extension). In computing, a plugin is one or more software components that add specific functionality to a larger software application. Software application makers support plugins, enabling third-party developers to easily add new functionality by creating features that extend the application, thereby reducing the size of the application. When supported, plugins allow for the customization of the functionality of software applications. For example, plugins are commonly used in web browsers to play videos, generate interactivity, scan for viruses, and display specific file types.

[0026] In some embodiments, the platforms, systems, media, and methods disclosed herein include software, servers, and / or database modules, or uses thereof. In consideration of the presented disclosure, a software module is created by the art known to those skilled in the art, using machines, software, and languages ​​known in the art. The software modules disclosed herein are implemented in numerous ways. In various embodiments, a software module includes files, sections of code, programming objects, programming structures, or a combination thereof. In even more various embodiments, a software module includes multiple files, multiple sections of code, multiple programming objects, multiple programming structures, or a combination thereof. In various embodiments, one or more software modules include, as non-limiting examples, web applications, mobile applications, and standalone applications. In some embodiments, a software module is a single computer program or application. In other embodiments, a software module is more than one computer program or application. In some embodiments, a software module is hosted on a single machine. In other embodiments, a software module is hosted on more than one machine. In further embodiments, a software module is hosted on a cloud computing platform. In some embodiments, the software module is hosted on one or more machines in one location. In other embodiments, the software module is hosted on one or more machines in one or more locations.

[0027] The device is shown in its simplest form, but it is further noted and anticipated that the various components and aspects of the device may be of different shapes or may be slightly modified when forming the present invention herein. Accordingly, those skilled in the art will understand that the descriptions and depictions set forth in this disclosure are merely intended to depict examples of preferred manners within the overall scope and intent of the present invention and should not be considered limiting in any way. Although the basic features and all of the features of the present invention have been shown and described herein, reference to its specific embodiments, modifications, various changes and permutations are contemplated in the foregoing disclosure, and in some instances, some features of the present invention may be used without corresponding use of other features without departing from the scope of the described invention.

Brief Description of the Drawings

[0028] [Figure 1] Shows a perspective view of the top surface of the smart inhaler. [Figure 2] Shows an exploded view of the smart inhaler. [Figure 3] Shows a representative diagram of the functions of the smart inhaler. [Figure 4] Shows a representative diagram of the blockchain. [Figure 5] Shows a representative diagram of the method of the smart inhaler.

Claims

1. A system for delivering medication and tracking the respiratory health of patients, the following parts, namely a) An inhaler for delivering respiratory drugs, b) A microcontroller for managing the sensors, c) A web portal for accessing the cloud network, d) The system comprising a mobile software application.

2. A system for delivering the drug according to claim 1 and tracking the respiratory health of a patient, wherein the inhaler has a guided outer casing.

3. A system for delivering a drug according to claim 1 and tracking the respiratory health of a patient, wherein the inhaler has a vapor accelerator for receiving the nozzle of a drug canister.

4. A system for delivering the drug described in claim 1 and tracking the respiratory health of a patient, wherein the inhaler has a mouthpiece.

5. The inhaler comprises a liner, and the system is for delivering the drug described in claim 1 and tracking the respiratory health of a patient.

6. The system for delivering a drug and tracking the respiratory health of a patient, wherein the inhaler has an integrated spacer that facilitates drug delivery.

7. A system for delivering a drug according to claim 6 and tracking the respiratory health of a patient, wherein the integrated spacer has a convergence-diffusion nozzle for the purpose of slowing down drug molecules.

8. A system for delivering a drug according to claim 1 and tracking the respiratory health of a patient, wherein the mobile software application is a non-temporary computer-readable medium containing computer-readable instructions.

9. A system for delivering the drug described in claim 1 and tracking the respiratory health of a patient, wherein the inhaler also includes a built-in battery.

10. A system for delivering a drug and tracking the respiratory health of a patient, according to claim 1, wherein the microcontroller has a wireless transmitter for managing sensors, built-in memory, and firmware.

11. A system for delivering the drug according to claim 1 and tracking the respiratory health of a patient, wherein the sensors include one that measures temperature, partial pressure, nitric oxide, oxygen, peak flow, and forced exhalation volume.

12. A system for delivering the drug described in claim 1 and tracking the respiratory health of a patient, wherein the software application tracks the respiratory status in real time.

13. A system for delivering a drug and tracking the respiratory health of a patient, according to claim 1, wherein the web portal for accessing the cloud network also has functions including management routines, a web portal with login for stakeholders, an artificial intelligence algorithm for initialization, trend detection and state prediction, and collection of encrypted data stored on a blockchain, and automatic notification to stakeholders.

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