Title of Invention: i loT-Based Breath Analyzer

Technical Field

The present invention generally uses an Internet of Things (loT) based breath sampling device. More particularly, the present invention relates to the apparatus of an loT-based breath sampling device for acquiring breath samples from the user, sensing breath analysis parameters like acetone level, humidity etc., using a plurality of sensors present in breath and transferring the readings of the breath analysis parameters on a remote server or any processing device using loT wirelessly.

Background Art

In medical science, Invasive and non-invasive methods are used to identify and diagnose any disease. These two methods include medical equipment or tool for getting an accurate sample of medical data to be analyzed for diagnosis. An invasive method is painful for patients; however, the low risk of infection and painless patient monitoring is possible with non-invasive sampling techniques. Quick analysis and diagnosis are possible with real-time data monitoring. However, the existing non-invasive methods like X-ray, ECG, and MRI require heavy instruments, qualified professionals for operation and costly procedures typically only available in multi-speciality hospitals. This invention discloses the apparatus and method of the breath analysis device, one of the non-invasive methods.

One of the earliest methods used to diagnose diseases and monitor people's health is breath analysis. Breath can be sampled from patients non-obtrusively and in almost limitless amounts. Ammonia, acetone, isoprene, nitric oxide, hydrogen sulfide, methane, ethane and pentane are some of the most important biomarkers of diseases in the human body. The existing spectrometry-based breath analysis method, like gas chromatography, requires a skilled operator, which is bulky and expensive. The alternative method is E-nose, which is less expensive and more portable but limits its disease detection performance since its sensor selection has to match the broad application. The above-listed drawbacks have led to research on alternative sensing methods. This invention uses chemical sensors susceptible to compounds in human breath and signs of specific diseases. The developed system is non-invasive, ubiquitous, painless, portable, compact, low cost and user-friendly. Summary of Invention

The present invention generally uses an Internet of Things (loT) based breath sampling device. More particularly, the present invention relates to the apparatus of an loT-based breath sampling device for acquiring breath samples from the user, sensing breath analysis parameters like acetone level, humidity etc., using a plurality of sensors present in breath and transferring the readings of the breath analysis parameters on a remote server or any processing device using loT wirelessly.

The present invention seeks to overcome some problems with known breath samplers by providing a sampler adapted for effectively capturing pathogens and other biomarkers from a gas of breath through which a patient can breathe normally during a sampling procedure. Therefore, aspects of the present invention are directed to a breath sampler configured to deliver a breath sample to detect present gases, which may indicate the presence of any disease or early diagnosis of the particular disease.

The main components in this device are a mouthpiece (100), a non-return valve (101), folded plates (102), a threaded connector (106), an air valve (107), an inflatable air sac (108), a sensor module (109), indicators (110), exhaust valve (111), inflatable air sac (209) enclosed in the folded plates (102).

The exhaled breath is collected through the mouthpiece (100). Next, that sample was collected into the silicon bag (209); the working is similar to the Ambu bag. The inflatable air sac (104) is covered with folded plate (102). The inlet non-return valve (101) is between the mouthpiece and bag, and the outlet valve (107) is controlled. When the bag (104) is filled with the breath, the outlet valve is open, and after pressing the hand, the compressor air is passed to the sensor module (109).

Object:

An object of the present invention is to,

1. Collect breath samples for the clinical purpose

2. Sense gases present in the breath samples

3. Reusable and non-infectious device arrangements to collect breath samples from various patients

4. Transfer collected breath sample readings in turns of gas composition values wirelessly using loT

5. Device to collect breath samples in a clinically proven way to analyze breath and disease prediction and early diagnosis. To further clarify the advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention is described and explained in detail in the accompanying drawings.

Technical Problem

In the non-invasive breath analysis, MS-based techniques have certain limitations, such as instrument size, cost, trained personnel and time-consuming data collection and analysis. These limitations make the implementation of this method difficult for routine clinical applications.

Another approach is that the E-nose is a low-cost, simple-to-use device with a small size for portability. The designing and configuring of an E-nose for different diseases requires a well- defined dataset. E-noses are available with certain detection limits and specificity. Some of the devices require selection for detecting specific volatile organic compounds. These devices cannot e used to screen multiple ailments unless embedded with more pattern analysis techniques for disease-specific patterns.

Solution to Problem

This invention uses chemical sensors susceptible to compounds in human breath and signs of specific diseases. These sensors are compact, have a comprehensive dynamic range, are inexpensive, simple to implement automatic measurement, and are mainly used online and in continuous detection. The developed system is non-invasive, ubiquitous, painless, portable, compact, low cost and user-friendly.

Advantageous Effects of Invention

This solution gives a non-invasive, painless, portable, compact, low-cost, and user-friendly system. This solution gives a low risk of infection, and painless patient monitoring is possible with non-invasive sampling techniques. Quick analysis and diagnosis are possible with realtime data monitoring. Skilled professionals do not require to operate the device.

Brief Description of Drawings

These and other features, aspects, and advantages of the present invention will become better understood when the following detailed description is read concerning the accompanying drawings in which like characters represent like parts throughout the drawings, wherein: Figure 1 shows a 2D diagram of the detailed process of breath collection. First, breath is collected through a mouthpiece (100), stored in an inflatable air sac (104), then the air valve (107) opens, and that breath is transferred into another air sac (108), which is mounted into the plurality of sensors called sensor module. Then, the Battery and data acquisition unit starts (112), sensor array senses the gas and acquires data. The acquired data is sent to the server with the wi-fi, Zigbee, or BlueToothTM type of wireless transmission module, which is part of the data acquisition module (112) to the remote server or any processing device.

Figure 2 shows an isometric view of the complete assembly of the device. Medical-grade plastic materials are used for the mouthpiece (201), non-return valve (202), threaded connector (204), and ball valve (205) and (208). For the hand compressor (203) and (206), acrylic plastic and polythene are used. FR4 epoxy laminate material was used for the sensor module (207). For the air sac (209), medical-grade silicon material is used.

The materials used for any component described in the embodiment are not limited and can be changed as per the requirement and application.

Figure 3 shows an isometric view of the mouthpiece (301), one-way valve (302), hand compressor (303), threaded connector (304) and ball valve (305); those are the main components of the device.

Figure 4 shows the front view and top view of the device with the dimension. The size of the mouthpiece (a) is 25 mm-30 mm, the one-way valve (b) 40 mm to 49 mm, the disposal buffer part size (c) is 160-175 mm, the size of the ball valve (e) and (h) is 25-30 mm, the threaded connector size (d) is 60-70 mm, and the size of the sensor module is (g) 45-50 mm.

Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help to improve understanding of aspects of the present invention. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

Description of Embodiments

For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiment illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.

It will be understood by those skilled in the art that the foregoing general description and the following detailed description are exemplary and explanatory of the invention and are not intended to be restrictive thereof.

Reference throughout this specification to "an aspect", "another aspect", or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase "in an embodiment", "in another embodiment," and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.

The terms "comprises", "comprising", or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises... a" does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub- systems or additional elements or additional structures or additional components.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The system, methods, and examples provided herein are illustrative only and not intended to be limiting.

Embodiments of the present invention will be described below in detail with reference to the accompanying drawings.

The present invention generally uses an Internet of Things (loT) based breath sampling device. More particularly, the present invention relates to the apparatus of an loT-based breath sampling device for acquiring breath samples from the user, sensing breath analysis parameters like acetone level, humidity etc., using the plurality of sensors present in breath and transferring the readings of the breath analysis parameters on a remote server or any processing device using loT wirelessly. The present invention seeks to overcome some problems with known breath samplers by providing a sampler adapted for effectively capturing pathogens and other biomarkers from a gas of breath through which a patient can breathe normally during a sampling procedure. Therefore, aspects of the present invention are directed to a breath sampler configured to deliver a breath sample to detect present gases, which may indicate the presence of any disease or early diagnosis of the particular disease. The part from the mouthpiece (100) to the threaded connector (106) is disposable (i.e., inflatable air sac(104) of breath buffer (105)), as depicted in Figure 1. Therefore, it benefits the diagnosis of viral and bacterial infectious diseases. When the breath is exhaled, it goes to the disposable breath buffer(105). The air valve (107) is opened when the sac is full of air. Using a Hand Compressor (103), sampled breath is pushed into the sensor module (109). The structure of this module is similar to the disposable breath buffer only difference is that one part of the sac (108) is connected to the folded plates (114). The second part is connected to the sensor module (109). The nonreturn valve (101) is present in this sac (104).

When breath enters the sensor module (109), the battery and data acquisition (112) of the sensor module gets start. The sensor array (109) senses the gas and acquires readings of various gases present in sampled breath with quantity. That acquired data is sent to the server. The acquired data is sent to the remote server with the wi-fi, Zigbee, or BlueToothTM type of wireless transmission module, which is part of the data acquisition module (112) to the remote server or any processing device. The mouthpiece (100) and disposable breath buffer (105) are removed from the threaded connector (106) when the transmission is complete, and all data is received at the server. Next, the exhaust valve (111) is turned ON, and the hand compressor (113) is pressed to remove the sampled breath from the sac of the sensor module (109). When the sampled breath is completely removed from the sac of the sensor module (109), indicator (110) indicates that the device is ready to collect another breath sample.

Figure 1 shows a 2D diagram of the detailed process of breath collection. First, breath is collected through a mouthpiece (100), stored in an inflatable air sac (104), then the air valve (107) opens, and that sampled breath is transferred into another air sac (108), which is mounted into the sensor module(109). Then, the Battery and data acquisition unit starts (112), sensor array senses the gas and acquires various gas readings present in sampled breath. These gas readings are sent to the remote server through a wireless transmission module, part of the data acquisition unit (112).

Figure 2 shows an isometric view of the complete assembly of the device. Medical-grade plastic materials are used for the mouthpiece (201), non-return valve (202), threaded connector (204), and ball valve (205) and (208). For the hand compressor (203) and (206), acrylic plastic and polythene are used. FR4 epoxy laminate material was used for the sensor module (207). For the air sac (209), medical-grade silicon material is used. The materials used for any component described in the embodiment are not limited and can be changed as per the requirement and application.

Figure 3 shows an isometric view of the mouthpiece (301), one-way valve (302), hand compressor (303), threaded connector (304) and ball valve (305); those are the main components of the device.

Figure 4 shows the front view and top view of the device with the dimension. The size of the mouthpiece is 25 mm-30mm; the one-way valve is 40 mm to 49 mm; the disposal buffer part size is 160-175 mm; the size of the ball valve is 25-30 mm, the threaded connector size is 60-70 mm, and the size of the sensor module is 45-50 mm.

Our invention particularly discloses the novel and economical way of clinically collecting breath samples, wherein the mouthpiece (100) and breath buffer (105) are detachable, and an inflatable air sac (104) is disposable, which in turn makes breath sampling device reusable to collect multiple breath samples; the indicator on the sampler indicates nonexistence of previous breath samples; the wireless transmission module gives ease to transfer sampled readings in real-time to server for analysis and disease diagnosis, particularly it makes breath sampler portable; the array of sensors helps to detect various gases present in the breath sample to detect different types of diseases.

Benefits, other advantages, and solutions to problems have been described above concerning specific embodiments. However, the benefits, advantages, solutions to problems, and any component(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential feature or component of any or all the claims.

Examples

[1] Example 1

Example 1 describes an event where tedlar bags are the most commonly used collection container polymer bag in breath research. These bags are utilized because they are affordable and reusable. The volume collected during bag sampling should be as large as is practical to minimize contact with the polymer surface. Therefore, these bag samples are a collection of several breaths. Furthermore, storage time should be kept to a minimum to prevent compound deterioration. The interaction of breath elements with the polymer film, which results in contamination through emission, losses due to diffusion, and adsorption, is the primary cause of the problems associated with using bags. Nevertheless, they have been employed to collect entire air samples, late expiratory breath, and end-tidal breath in various research.

[2] Example 2

Example 2 describes an event where a hard plastic sampling and a cardboard mouthpiece for the Bio-Voc replace the Tedlar bag. The sample tube has no flow valves and is open on both ends. A plunger moves air from the sampler onto a sorbent tube once a breath has been exhaled. The Bio-Voc is a well-liked option for breath analysis because of its portability and ease of usage. However, the bio-voc's modest sample volume places restrictions on it. The breath sampling process was repeated several times by the Bio-Voc to increase the sample volume.

Industrial Applicability

The process of breath analysis is non-invasive, gives a low risk of infection, and is painless patient monitoring. Pathological laboratories and hospitals can use this invention. This invention is a portable, compact, low cost and user-friendly system. It also gives a quick analysis and diagnosis of real-time data monitoring. It is used for early disease diagnosis. Skilled professionals do not require to operate the device. This invention can also be used for in-house disease identification at an early stage. This invention will benefit medical colleges, universities, and hospitals, especially in rural areas where pathological laboratories are unavailable, and the pathological laboratories.

Citation List

[2] The citation List follows:

Patent Literature

PTL 1 discloses a breath analyzer, for instance, for measuring alcohol in breath, comprises a housing, a cavity defining a flow path in direct communication with the exterior of the housing at two ends, the internal surface of which includes at least one window transmissive to radiation and at least one mirror portion reflective to radiation; a radiation source that emits radiation into the cavity via the window; and a radiation sensor that detects the radiation after it has been reflected from the reflective portion back through the window. The cavity may be provided with two or more reflective portions and with a separate radiation entry and exit window, wherein the device of our invention makes use of chemical sensors and analyze the gases present in exhaled breath and transfers the sampled values of sensors through the internet on the remote server or to the processing device for further analysis. Our invention is not limited to detecting only alcohol presence, but different combinations of gases exhaled through human breath and transferring the sampled data to the processing and storage device using loT.

PTL 2 discloses an analyzer for collecting and analyzing a breath condensate. The analyzer comprises a housing, the housing having a cooling means and, further, retaining a cartridge device comprising a condensation zone to condense exhaled breath from a subject; the cooling means being in a cooling relationship with the condensation zone, the device including one or more further discrete regions for detection of analyte and measurement of analyte, the cartridge device further comprising a fluid path connecting the condensation zone to the or each discrete region, the housing including a mouthpiece having an entry port to enable a user to breathe into the mouthpiece, the mouthpiece comprising one or more fluid passages to direct breath entering the mouthpiece into the condensation zone; wherein in our invention we sample breath in gas form and detect the presence of various gases. The condensation process of the said invention is different from our disclosed invention.

PTL 3 discloses the invention of a breath analyzer device and a related method. The invention mainly discloses a tamper-evident breath analyzer. The breath is sampled and sensed through sensors, and simultaneously an image of the subject is taken to determine whether any tampering is done during breath sampling, wherein the disclosed invention does not talk about sampling the gases of exhaled breath and transferring it wirelessly using loT. The arrangement and apparatus of our invention are different.

PTL 4 discloses a breath analyzer device to detect the presence of alcohol in the test subject's breath, indicating the test subject has a raised blood-alcohol level and thus impaired judgment and reaction times. The invention proposes a type of no-contact breath analyzer device that addresses the issue of ambient air dilution of the breath sample by measuring the concentration of a tracer substance such as carbon dioxide within the sample to estimate the degree of dilution and thereby allow the estimation of the true breath concentration of alcohol; wherein in our invention we sample breath in gas form and detect the presence of various gases. Our invention is not limited to detecting only alcohol presence, but different combinations of gases exhaled through human breath and transferring the sampled data to the processing and storage device using loT.

Thus, the existing system and apparatus have their limitations and rigid structure. Herewith, we are disclosing the apparatus of loT based breath sampling device for acquiring breath samples from the user, sensing gases in them using sensors and transferring the readings of the gas samples on a remote server or any processing device using loT wirelessly.

PTL 1: Patent GB2468522A

PTL 2: Patent US2020033323A1 PTL 3: Patent EP3106872A1

PTL 4: Patent US2016146780A1

Non-Patent Literature

[3] NPL 1 refers to the development of a compact, loT- enabled electronic nose for breath analysis. Authors report on the in-house developed electronic nose for use with breath analysis. For breath, a sample collection mouthpiece is used, which is disposable. In our invention, the mouthpiece is disposable, and the breath buffer part is removable, reusable and disposable. Therefore, it benefits the diagnosis of viral and bacterial infectious diseases.

[4] NPL 2 relates to the detection of levels of blood sugar using simple loT-based breath analysis. The authors present a method of detection of blood sugar levels using loT- based breath analysis. The hardware used is Arduino UNO, ESP 8266, TGS 822, DHT11, buttons, mouthpiece, LCD, potentiometer, breadboard and Jumper wires. But authors do not disclose a constructional feature or method of acquiring breath samples using a device that is in our invention.

[5] NPL 1: Akira Tiele et al. "Development of a Compact, loT-Enabled Electronic Nose for

Breath Analysis", MDPI, Electronics 2020, 9(1), 84; https://doi.Org/10.3390/electronics9010084.

[6] NPL 2: Dr. Khalid Nazim Abdul Sattar, Dr. Mohammad Mahmood Otoom, Dr. Mutasim Al Sadig, Dr.Nandini . N., "Detection of Levels of Blood Sugar Using Simple loT-Based Breath Analysis", IJCSNS International Journal of Computer Science and Network Security, VOL.20 No.8, August 2020J