DEVICE

FIELD OF THE INVENTION

The present invention relates to a system and method for providing augmented breathing. More specifically, the invention provides an automated IOT (Cellular/wifi/bluetooth) and AI (machine learning) enabled non-invasive respiratory support device providing high flow rate oxygen therapy for treating and supporting patients with respiratory disease while sensing vitals of a patient.

BACKGROUND OF THE INVENTION

Respiratory support and ventilation therapies provide mechanical ventilation to the patients who require augmented breathing, and do so mechanically. Mechanical ventilation (MV) therapies require the patient to be inserted with a tracheal tube, or a sealing face or nasal mask or sealing nasal cannula. While helpful in supporting the breathing of a patient, it interfaces with mechanical ventilation, as it may be obtrusive and/or invasive to the user. Further, MV does not facilitate mobility therefore the patient needs to be sedentary and cannot perform activities that require mobility. Non-invasive ventilation exists as an alternative, which ventilates a patient with a face or nasal mask rather than requiring intubation, which can be an advantage in many situations.

There are various forms of oxygen therapy available which is judiciously administered to patients depending upon the severity of the respiratory disease. The most common form of oxygen therapy includes administering supplemental oxygen to the patient with a small bore nasal canula, using a metering device known as an oxygen conserver that releases the oxygen in boluses during a patient's inspiratory phase. Some oxygen therapy systems deliver mixtures of air and therapeutic gas. Such therapies are not considered as ventilation therapy or respiratory support, because it does not mechanically help in the work of breathing.

Recently, a variant of oxygen therapy has been in much use due to the recent COVID 19 pandemic, known as high flow oxygen therapy (HFOT). The primary strategy for COVID- 19 patients is supportive care, including oxygen therapy for hypoxemic patients, in which high-flow nasal cannula (HFNC) has been reported to be effective in improving oxygenation. Among patients with acute hypoxemic respiratory failure, HFNC was proven to avoid intubation compared to conventional oxygen devices. A high-flow nasal cannula (HFNC) is commonly used in the management of hypoxic respiratory failure, and is associated with more ventilator-free days and lower mortality compared with standard oxygen therapy or non-invasive ventilation.

High flow oxygen therapy allows administration of high flow gas that exceeds the patient's peak inspiratory flow, above 30 L/min in adults, heated to 37 °C and with a humidity of 100%. Although HFNC is not a mechanical ventilation system, but is more of a respiratory support system.

The mechanisms of action of the HFNC are multiple, highlighting its ability to increase alveolar recruitment, improving the ventilatory pattern, generating a positive expiratory pressure (PEEP) and producing dead-space CO2 washout. By providing the gas breathed at 37 °C and 100% humidity, the HFNC is better tolerated and more comfortable for the patient.

According to a study published in Heart and Lung Journal VOLUME 49, ISSUE 5, P444-445, SEPTEMBER 01, 2020, the COVID patients exhibiting acute respiratory distress syndrome (ARDS) were tested for efficacy of HFNC. Out of 8 patients who maintained Oxygen saturation (Sp02) at 84%-92%; two patients immediately received HFNC treatment, while the remaining six patients switched to HFNC treatment due to deterioration of respiratory function after 4.50±3.08 days of general oxygen therapy. Blood-gas analysis before receipt of HFNC treatment showed that the mean oxygenation index (partial pressure of oxygen/fraction of inspired oxygen, P/F) of the eight patients was 259.88±58.15 mmHg; six patients had developed ARDS, with a mean pneumonia severity index of 3.62±1.19. Findings suggest that HFNC is a suitable choice for treatment of patients with severe or critical COVID-19 symptoms.

HFNC can provide a specific positive end-expiratory pressure, which has a robust effect on mild to moderate type I respiratory failure and it can also provide adequately warmed and humidified gas through the nasal pharynx which reduces the metabolic work associated with gas conditioning. Moreover, HFNC can reduce the intubation rate and improve clinical prognosis in patients with acute respiratory failure.

In this case, the oxygen flow rate is increased beyond standard LTOT, for example, above 10 LPM or 15 LPM. The effects of such high flow therapies are reported as therapeutic and embraced by some clinicians while questioned by others because it involves unknown factors and arbitrary administration techniques. In this method high pressured air is administered, the idea is to overcome the positive air pressures generated in the patients' airways and lungs due the lung damage and facilitate oxygenation. The features that affect the efficacy of the LTOT include cannula size, nare size, flow rate, and patients breathing rate. However, these variables are enough to keep many physicians from utilizing HFT as such systems required continuous monitoring and trained professionals for operating and maintenance.

These HFNC is especially useful where access to infrastructure or ICU care is limited or transport of clinically critical patients to an advanced facility is desired. , it is concluded that there is prominent need of developing an IOT enabled, economical and robust system for high flow rate oxygen therapy which can be used by mass with minimal training and user friendly interface. There is a technological gap wherein there are several drawbacks to the current state of the art HFNC devices, which includes: Optimizing selection between the flow and fraction of inspired oxygen (Fi02):the device has the capacity of pumping 16-90 L/min, therefore it is very essential to optimize the alveolar recruitment, the dead- space CO2 washout automatically to facilitate recovery; how to interpret the partial pressure of oxygen/fraction of inspired oxygen (Pa02/Fi02) assessment: the state of the art devices provide no information about the real PEEP that the HFNC can generate; and most of the devices do not show appropriate plug-in time, i.e. device reaches the programmed temperature and degree of humidification.

Air sterilization and filtration: as most of these devices are used when the patient is immune-compromised, filtration and sterilization of external air is essential.

The Pa02/Fi02 ratio is frequently used to determine the severity of lung injury in mechanically ventilated patients. The nonlinear relation between Pa02/Fi02 and Fi02 underlines the limitations describing the intensity of hypoxemia using Pa02/Fi02 and is thus of major importance for the clinician.

Some adverse effects have been cited that occur when we use HFNC and its limitations. However, there are numerous aspects that we should consider when prescribing this treatment and that are not documented in the literature to date.

OBJECT(S) OF THE INVENTION

Accordingly, to overcome the drawbacks of the prior art, the main object of the present invention is to provide an IOT and AI enabled high flow rate oxygen device that optimizes selection between the flow and Fi02, interpret the Pa02/Fi02 assessment via the sensors and the IOT enabled modules, show appropriate plug-in time, provide air sterilization and also filters the air. Yet another object of the present invention is to provide a system and method for respiratory user interface incorporating high flow rate oxygen therapy along with IOT connectivity for monitoring respiratory ratein a real-time dynamic working condition.

Yet another object of the present invention is to provide a system and method for providing a respiratory user interface incorporating high flow rate oxygen therapy and disinfection of the inhaled air.

Yet another object of the present invention is to provide a system for respiratory user interface incorporating high flow rate oxygen therapy that is easily portable, light weight and economical.

Yet another object of the present invention is to provide a system that will automatically increase or decrease or maintain a specific flow rate and Fi02 based on the respiratory rate, blood pressure and oxygen saturation of the patient.

Yet another object of the present invention is to provide a system which is automated and self-regulated for high flow nasal oxygen therapy.

SUMMARY OF THE INVENTION

In carrying out the above objects of the present invention, in one embodiment of present invention provides an IOT and AI enabled high flow rate oxygen therapy system for treating mild, moderate and severe grade of respiratory diseases. The system comprises of a housing that incorporates a front section and a back section fastened together. The front section has provisions for a touch display unit and plurality of buttons to operate the high flow rate oxygen therapy system. Further, the front section has provisions for connecting ports to connect different online sensors such as, but not limited to like SpC>2 sensor, heart rate sensor, breathe rate sensor, etc. The front section also has a removable cover that in-house a humidification chamber for performing disinfection of incoming oxygen-air mixture. The back section holds an air filter to bring in atmospheric air into the system and a connector for oxygen gas supply with is also provided with gauge and a regulator. An oxygen concentration sensor is also provided in the oxygen gas supply line to measure real-time concentration of supplied oxygen. Further, the system incorporates a high RPM motor connected to an air mixer unit consists on a housing having an impeller. Through air mixer unit, a suitable mixture of air-oxygen gas is supplied to the heating and humidification chamber and an air flow sensor is provided to calculate the flow rate to the IOT module that includes computing hardware for receiving one or more sensor signals from the one or more sensors. Further, an AI module is provided that incorporates reinforced neural network comprises of multiple processors to perform several computation and run artificial intelligence algorithm based on the patient’s oxygen saturation, blood pressure, respiratory rate, etc. The temperature controlled and humidified air-oxygen gas mixture from system is then delivered to a patient through a connecting tube.

In another embodiment of present invention, the humidification chamber provided has its own temperature controlling system heating system that sets and adjusts air/oxygen mixture temperature at different temperatures.

In another embodiment of present invention, the humidification chamber provided has a removable pump to auto fill saline water in humidifier along with provisions like a float or level sensor which turn ON/OFF the removable suction pump as per the required level of water.

In another embodiment of present invention, the provided humidification chamber can automatically maintain the temperature and humidification of the air/oxygen mixture administered to the patient and is also equipped with an overheating prevention system, in order not to compromise patient treatment or damage equipment or its performance.

In another embodiment of the present invention, the system provides distinct advantage as the deviceis automated, that provides non-invasive ventilation while sensing multiple vitals of a patient. The vital data received from the patient would be fed to the neural network algorithm of the main controlling processor and this data is then processed and classified into specific data categories. The data can be classified into various categories and the patient would be matched to a specific disease category. This will help the machine to learn the patient’s vital data such as blood pressure, respiratory rate, oxygen saturation, temperature, pulse rate etc, and measure the responses over time and adjust the oxygen flow rates, Fi02, air temperature and humidity specific to the patient in a way that would help the patient recover early.

In another embodiment of the present invention, the system provides distinct advantage as the device provides high flow rate oxygen device that is optimized for making selection between the air and oxygen flow and Fi02, interpret the Pa02/Fi02 assessment via IOT and AI enabled modules, show appropriate plug-in time and provide air sterilization and filtration of the air.

In another embodiment of the present invention, the system provides a module containing pulse oximeter, temperature sensor, inertial motion sensor, blood pressure module, electro-cardio gram (ECG) sensor, wifi and bluetooth modules.

In another embodiment of the present invention, the system will be provided with multiple buttons for different functions such as, but not limited to ON/OFF, adjustment of Fi02, flow rates, temperature, connecting to wifi, bluetooth, connect to phone app, etc.

BRIEF DESCRIPTION OF THE DRAWING

The object of the invention may be understood in more details and more particularly description of the invention briefly summarized above by reference to certain embodiments thereof which are illustrated in the appended drawings, which drawings form a part of this specification. It is to be noted, however, that the appended drawings illustrate preferred embodiments of the invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective equivalent embodiments.

Fig. 1 illustrates a schematic view of respiratory user interface incorporating high flow rate oxygen therapy system according to the embodiments of the present invention;

Fig. 2 is a block diagram showing an example of the components of high flow rate oxygen therapy system according to the embodiments of the present invention;

Fig. 3a shows perspective view of the high flow rate oxygen therapy system according to the embodiments of the present invention;

Fig. 3b shows another perspective view of the high flow rate oxygen therapy system according to the embodiments of the present invention;

Fig. 4 shows exploded perspective view of the high flow rate oxygen therapy system according to the embodiments of the present invention;

Fig. 5 shows sectional view of the high flow rate oxygen therapy system according to the embodiments of the present invention; and

Fig. 6 shows a flow chart describing working of the high flow rate oxygen therapy system according to the embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will now be described more fully hereinafter with reference to the accompanying drawings in which a preferred embodiment of the invention is shown. This invention may, however, be embodied in many different forms and should not be construed as being limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough, and will fully convey the scope of the invention to those skilled in the art. The term “user” or “patient” refers hereinafter to any person operating the high flow rate oxygen therapy system.

The present invention provides system and method for respiratory user interface incorporating high flow rate oxygen therapy for non-invasively treating various grades of respiratory disease. Further, the system incorporates IOT connectivity for monitoring of multiple vitals of a patient such as, but not limited to respiratory rate, pulse rate, blood pressure, ECG, oxygen saturation, temperature, partial pressure of oxygen/fraction of inspired oxygen (PaCVFiCE), SpC> ₂ , etc. in a real-time dynamic working environment. Further, an AI module is provided that incorporates reinforced neural network comprises of multiple processors to perform several computation and run artificial intelligence algorithm based on the patient’s oxygen saturation, blood pressure, respiratory rate, etc.

Referring to Fig. 1, illustrates a schematic view of respiratory user interface incorporating high flow rate oxygen therapy system according to the embodiments of the present invention. The automated IOT enabled high flow rate oxygen therapy system 100 is configured with an external oxygen supply 200 such as, medical oxygen tank, medical oxygen supply from the wall outlet or the medical gas pipeline in a hospital. The external oxygen supply 200 is an optional embodiment and the whole setup can be run with it or without it, customizable as per availability. In an embodiment, external oxygen supply 200 is often used to assist and supplement patients who have respiratory impairments that respond to supplemental oxygen for recovery or healing. The high flow rate oxygen therapy system 100 further has provision to provide natural air 300 which is sucked into the system through air pump incorporated into the system. The air/oxygen mixture from the system 100 will be transferred to a patient 400 using a nasal cannula 600 positioned at the nostrils of the patient. The nasal cannula 600 consists of a lightweight tube 500 which on one end splits into two prongs which are placed in the nostrils and from which a mixture of air and oxygen flows. The other end of the tube is connected to the high flow rate oxygen therapy system 100.

Further, the system 100 is provided with a detachable module 900 containing pulse oximeter, temperature sensor, inertial motion sensor, blood pressure sensing module, electro cardio gram (ECG) sensor, cellular, wifi and bluetooth modules. This said module 900 is connected via a long cable to the system 100.

The system 100 typically provides an air/oxygen mixture at flow rates of 0 to 120 liters/minute (L/min) at temperature between 31-39° C. At this configuration, it is possible to provide a patient with F1O2 (percent oxygen in the inhaled 02/air mixture) of about 30-100% oxygen. Further, the system 100 has additional advantages as follows: wash out carbondioxide (CO2) retained in lungs; wash out nasopharyngeal carbondioxide (CO2); maintain mucociliary function; decreases anatomical dead space; provide positive airway pressure thus increases air-way calibers; increases end-expiratory transpulmonary pressure; anddecreases hydrostatic capillary-alveolar gradient.

Referring to Fig. 2 is a block diagram showing an example of the components of high flow rate oxygen therapy system according to the embodiments of the present invention. The high flow rate oxygen therapy system can be coupled with plurality of attachments such as, but not limited to a heated humidifier unit, a flow sensor, a temperature sensor, IMU-Respiratory sensor, oxygen saturation sensor, blood pressure sensor, electro cardio gram (ECG) sensor, etc. All the attachments used are such that it can be easily be communicated with an IOT module of the high flow rate oxygen therapy system which have all the computing hardware such as microprocessor with their respective memory devices. The IOT module allows the recorded data to exchange over any other computing device such as, but not limited to laptop, tablet, mobile phone, etc. through its inbuilt Cellular/Wi-Fi/Bluetooth communication channels. Further, an AI module is provided that incorporates reinforced neural network comprises of multiple processors to perform several computation and run artificial intelligence algorithm based on the patient’s oxygen saturation, blood pressure, respiratory rate, etc.A graphical user interface is provided with high flow rate oxygen therapy system in the form of touch-screen module which allows the remote operations associated with the high flow rate oxygen therapy system.

Referring to Fig. 3a shows perspective view of the high flow rate oxygen therapy system 100 according to the embodiments of the present invention. The high flow rate oxygen therapy system 100 comprises of a front section 102 and a back section 104 fastened together. The front section 102 has provisions for a touch display unit 106 and plurality of buttons 108 to operate the high flow rate oxygen therapy system lOO.The touch display unit 106 is any standard LED display and shows different operations and configuration related to the system 100.

The front section has provisions for connecting ports 110 to connect different online sensors such as, but not limited to like SpCE sensor, blood pressure sensor, electro cardio gram (ECG) sensor, heart rate sensor, respiratory rate sensor, etc. The front section 102 also has a removable cover 112 that in-house a humidification chamber 114 for performing disinfection of incoming oxygen-air mixture.

The back section 104 holds an air filter 116 to bring in atmospheric air into the system 100. Further, a motorized valve connector 118 with gauge 120 and a regulator 122 is provided for oxygen gas supply.

Referring to Fig. 3b shows another perspective view of the high flow rate oxygen therapy system 100 according to the embodiments of the present invention. At the bottom section of the back section 104, an outlet 124 is provided that transfers highly disinfected and right metered air/oxygen mixture to a patient using a nasal cannuala fixed at the nostrils of the patient. Further, a port 126 to insert power a cord is provided along with a LAN port 128 to connect the system 100 to the internet. Referring to Fig. 4 shows exploded perspective view of the high flow rate oxygen therapy system 100 according to the embodiments of the present invention. In current embodiment the removable cover 112 is removed from the cavity provided in the front section 102 to expose the in-built humidification chamber 114 with its heating system 132 that sets and adjust air/oxygen mixture temperature at different temperatures. The humidification chamber 114 comprises of a container unit 130 having atleast one inlet 134 and outlet 136 connections and has a removable pumpl38 to auto fill saline water in humidification chamber 114. Once temperature is set by the user, the humidification chamber 114 automatically maintains the temperatures of the air/oxygen mixture administered to the patient and also equipped with an overheating prevention system, in order not to compromise patient treatment or damage equipment or its performance. The humidification chamber 114 has provisions like a float or level sensor which turn ON/OFF the removable suction pump 138 as per the required level of water.

Referring to Fig. 5 shows sectional view of the high flow rate oxygen therapy system 100 according to the embodiments of the present invention. Through the cut- out section of the high flow rate oxygen therapy system 100, inner instruments and connections are exposed. An oxygen concentration sensor 140 is provided on oxygen gas supply line 142 to measure real-time concentration of supplied oxygen. Further, the system 100 incorporates an air mixer unit 144 consists on a housing having an impeller into it connected with a high RPM motor. Through air mixer unit 144 a suitable mixture of air-oxygen is supplied into the humidification chamber 114 and a flow sensor 146 is provided at the outlet connection 124 to measure and forward the flow rate to the central processing unit 148.

The central processing unit 148 includes an IOT module incorporating computing hardware for receiving one or more sensor signals from the one or more sensors. Further, an AI module is provided that incorporates reinforced neural network comprises of multiple processors to perform several computation and run artificial intelligence algorithm based on the patient’s oxygen saturation, blood pressure, respiratory rate, etc. The computing hardware further includes a wireless network interface such as, but not limited to WIFI, bluetooth, radiofrequency or implemented as a cellular modem, for example complying with contemporary, GSM and/or 3G communication standards and includes one or more physical memory devices, each of which can be a type of random access memory (RAM), such as dynamic RAM (DRAM) or static RAM (SRAM), read-only memory (ROM), which may be programmable, such as flash memory, or any combination thereof. The computing hardware is programmed to send information corresponding to the one or more sensor signals in a constant manner. The computing hardware is further configured to perform real-time or intermittent monitoring data processed through multiple monitoring sensors in the cloud connected systems which can be further sent remotely to user assistance or care taker on their smart devices such as, but not limited to mobiles, laptop, computer, etc.

Referring to Fig. 6 shows a flow chart describing working of the high flow rate oxygen therapy system according to the embodiments of the present invention. First, a medical oxygen supply will be attached to the high flow rate oxygen therapy system and its concentration will be checked. If oxygen concentration is above or below a certain percentage then its flow will be adjusted before it will be sent to the air mixer unit. Simultaneously, patient vitals are monitored by plurality of sensor provided with the high flow rate oxygen therapy system and their data is forwarded to AI module for computing. Through air mixing unit, the air-oxygen mixture will be send to the humidification chamber which automatically maintains the temperatures of the air- oxygen mixture administered to the patient. Before administering the air-oxygen mixture to the patient, its flow rate will be calculated by a flow sensor provided at the outlet. To form an automated operation cycle, patient vitals will be monitored continually and the computing hardware of AI module will automatically control the flow rate employing reinforced neural network / artificial intelligence algorithm based on the patient’s oxygen saturation, blood pressure, respiratory rate, etc.

While certain exemplary embodiments have been described and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative of, and not restrictive on, the broad invention, and that this invention not be limited to the specific constructions and arrangements shown and described, since various other changes, combinations, omissions, modifications and substitutions, in addition to those set forth in the above paragraphs, are possible. Those skilled in the art will appreciate that various adaptations and modifications of the just described embodiments can be configured without departing from the scope and spirit of the invention.