Highly oxygenated advanced closed system incentive spirometer

Abstract

A highly oxygenated advanced closed system incentive spirometer (HOAC-IS) that allows a high concentration oxygen supply during incentive spirometry procedures without allowing atmospheric air and providing oxygen, both oral and nose inhalation during spirometry exercise, at various times of inspiratory period from single oxygen flow meter. It can be performed on patients dependent on low flow oxygen therapy. This device uses maximum dependent oxygen therapy up to a simple oxygen face mask, partially rebreather oxygen mask, and tracheostomy T- piece. This spirometry is non-electrical. This helps provide incentive spirometry benefits without interruption of low flow oxygen therapy. It can even reduce the rate of ICU psychosis and device using negligence by keeping a voice reminder alarm clock in the incentive spirometer. This incentive spirometer component can be converted for use in multiple ways: as a normal open system incentive spirometer, an oxygen facemask, an NRBM and nebulization mask with oxygen supply.

Description

[0001] HIGHLY OXYGENATED ADVANCED CLOSED SYSTEM INCENTIVE SPIROMETER

[0002] FIELD OF INVENTION:

[0003] This invention relates to the field of biomedical engineering.

[0004] More particularly, this invention relates to a highly oxygenated advanced closed system incentive spirometer (HOAC-IS) that provides a relatively higher concentration of oxygen during incentive spirometer exercise to patients even with relatively low-flow oxygen therapy like a face mask oxygenation.

[0005] BACKGROUND, PRIOR ART, AND PROBLEM TO BE SOLVED:

[0006] In its current state of prior arts, the incentive spirometer consists of a plastic bell jar with a float inside the bell that rises due to air being inhaled through a tube attached to the jar. The patient attempts to reach different volumes represented on the bell jar by inhaling through the tube. Float is used inside a measuring device that moves slowly to make a visual impression and to read its measurements on the scale on the bell jar.). The sole purpose of this prior art is to bring air into a patient's lungs and to increase lung functions through exercise.

[0007] However, during the recent COVID- 19 pandemic, a gross limitation was evident - that, it can only be used with very low or no oxygen requirement patients as it requires interruption of oxygen therapy during the incentive spirometry exercise.

[0008] Nowadays, available incentive spirometer in the medical field (open system) atmospheric air are possible to enter into a spirometer chamber and reach to patients’ mouth or tracheostomy during incentive spirometer exercise. All this incentive spirometry device cannot be possible for use for oxygen-dependent patients; because, it would require disconnection of oxygen therapy and possibility of oxygen desaturation in the body.

[0009] Further, the presently available incentive spirometers are not useful for providing oxygen through oral and nose inhalation during spirometry exercise at various times of the inspiratory period. The atmospheric air enters the spirometer chamber, which works as an open-system incentive spirometer. It is followed by exhalation by nasal route, and the gas is released into atmosphere. Patients requiring high oxygen supply due to their lung pathology cannot do incentive spirometry as they may get hypoxic during the interruption of oxygen therapy, so here incentive spirometry cannot be used for relatively higher oxygen-dependent patients.

[0010] So here, disclosure is made regarding a highly oxygenated advanced closed system incentive spirometer (HOAC-IS) that aspires to address this problem by allowing a higher concentration oxygen supply during the incentive spirometry process without allowing atmospheric air and providing oxygen both oral and nose / tracheostomy inhalation during spirometry exercise at various time of inspiratory period from single oxygen flow meter (possibility of oxygen supply to patients and spirometer chamber both from single oxygen flow meter / oxygen cylinder). Thus, it can be performed by sick patients dependent on relatively higher oxygenation, like CO VID- 19. Further, it can be used in tracheotomized patients requiring or not requiring oxygen supplements and all other patients where the usual incentive spirometer can be used.

[0011] OBJECTS OF THE INVENTION:

[0012] A principal objective of the invention is the design and working of a closed-system incentive spirometer created without atmospheric air interruption that provides higher concentration humidified oxygenation during spirometer exercise for patients who cannot tolerate even a short- duration interruption of supplemental oxygen, and providing oxygen both oral and nose / tracheostomy inhalation during spirometry exercise at various time of inspiratory period from single oxygen flow meter.

[0013] Another objective of the invention is that the incentive spirometry will also benefit for caring patients like COVID-19 and AIRBORNE respiratory disease where aerosols should not be directly released to the atmosphere.

[0014] Another objective of the invention is to make a low-cost lung recruitment respiratory kit (NRBM, oxygen and nebulization mask and incentive spirometer all together) to early weaning of oxygen therapy by the way of allowing incentive spirometer and nebulization therapy for low flow oxygen depends patients. A further objective of the invention is that it provides benefits to heart, lungs, abdominal pre- and post-operative surgical patients and all other patients without interrupting the low flow oxygen therapy

[0015] A further objective of the invention is to prevent or slow down the progression of the disease from mild to moderate stage or from moderate to severe stage of disease of covid 19 and another disease by providing incentive spirometer’s benefits.

[0016] A further objective of the invention is to prevent dryness of the respiratory system during incentive spirometry exercise by providing the humidified oxygen with closed system of ventilation.

[0017] A further objective of the invention is to reduce the rate of ICU psychosis and negligence by providing a voiced reminder alarm clock in the spirometer (periodical alarm, date and time).

[0018] SUMMARY OF THE INVENTION:

[0019] The therapy that pulmonary specialists provide depends on the use of incentive spirometry. This procedure requires the patient to breathe in (or out) forcefully from a spirometer so that any mucus and secretions can be coughed out quickly and effectively. Recruitment of alveoli takes place and leads to better oxygenation and removal of carbon dioxide from the body. By using an incentive spirometer, it can improve overall lung function, by increasing the amount of oxygen breathed into the lung, ultimately increasing the oxygen that ends up in the body. Incentive spirometry also helps in the reduction of respiratory infections like pleural effusion and collapsed lung (pneumothorax=air in thoracic cavity) and alveoli (atelectasis). The patients with spirometry exercise improving lung function, reducing mucus build-up, strengthening of lung during extended rest, lowering chance of developing infection and etc.

[0020] The incentive spirometers which are used nowadays can only be used with very low or no oxygen requirement patients due to interruption of oxygen therapy during the spirometry exercise. The present incentive spirometers during the usage gets the atmospheric air entered into spirometer chamber so it starts working as an open system spirometer. The patients requiring high oxygen supply due to their lung pathology cannot do incentive spirometry as they may get hypoxic during the interruption of oxygen therapy so here incentive spirometry benefits can’t possible to give who really need for it (oxygen depends patients). This invention’s highly oxygenated advanced closed system incentive spirometer (HOAC-IS) aspires to address this problem by allowing high concentration oxygen supply during the spirometry procedure without allowing atmospheric air (closed system incentive spirometer). Thus, it can be performed by sick patients who are depend on low flow oxygen covid-19 and tracheotomy patients (up to simple o2 face mask, partially re breather oxygen mask and tracheostomy t piece max 10 liters per minute of oxygen flow depend and their respiratory rate and pattern).

[0021] According to this invention, there is provided a highly oxygenated advanced closed system incentive spirometer comprising: a spirometer chamber consisting, essentially, of: o a chamber air inlet tube with an oxygen adapter configured to allow inflow of closed system of humidified oxygen air into said spirometer chamber; o a chamber air outlet tube configured to allow outflow of oxygenated air out of said spirometer chamber; o an exhalation one-way valve connected to a mouthpiece; o an inhalation one-way valve connected to a mouthpiece; o a viral filter in line with said exhalation one-way valve and said inhalation oneway valve; o an ETCO2 port located above said filter to sample the expired air to assess the appropriate ETCO2 during use of said spirometer; a detachable mask with several ports, said mask connected to said spirometer chamber by means of said a chamber air outlet tube, said mask consisting, essentially, of: o two inspiratory one-way valve openings, connected with a spirometer mouthpiece attached to said mask, being oxygen inlet openings connected to a reservoir bag; o four expiratory one-way valve openings, connected with a spirometer mouthpiece attached to said mask said openings being outlets ensuring passage of air only during expiration and ensuring blockage of air during inspiration,

[0022] ■ with two openings adapting both its adaptors, respectively, • to a straight flexible tube with a one-way valve outlet, and

[0023] • to a “U” shaped flexible tube (30) with a one-way valve outlet from the reservoir bag, o a simple opening at said spirometer mouthpiece, located directly opposite a user’s mouth wearing said mask, for input and output with an in-and-out moving adapter; o a multifunctional port, in line with said in-and-out moving adapter, located directly opposite a user’s mouth wearing said mask, said multifunctional port configured to adapt and connect said mask and said in-and-out-moving adaptor during incentive spirometer exercise for low flow oxygen delivering through said mask; a non-collapsible oxygen reservoir bag (NCORB), connected to said mask and to said spirometer chamber, said non-collapsible oxygen reservoir bag (NCORB), consisting, essentially, of: o an oxygen tube inlet, inside said bag,

[0024] ■ with its outer end connected with an oxygen flowmeter;

[0025] ■ with its outer end, also connected to a flexible tube having a one-way valve outlet; o an “U” shaped flexible tube, inside said bag,

[0026] ■ with its outer end connected with a one-way valve outlet

[0027] ■ with its outer end connected with an oxygen outlet opening connected to said spirometer chamber through a pressure-releasing and chamberemptying one-way valve; and o one-way valves connecting said bag with said mask with a spirometer mouthpiece through the multifunctional port.

[0028] In at least an embodiment, said spirometer comprises: a bi-directional microfilter double one-way valve connecting said spirometer mouthpiece to said chamber air outlet tube of said spirometer chamber such that said in-and-out moving adapter connects said mask with said bi-directional microfilter double one-way valve. In at least an embodiment, a lower part of said mask being connected to a non-collapsible oxygen reservoir bag through two one-valve tubular inspiratory opening for oxygen supply; and a middle part of said mask being connected with a spirometry mouthpiece through said multifunctional port, said mask being fully sealed onto a face of a user with an adjustable upper strap and an adjustable lower strap.

[0029] In at least an embodiment, said two inspiratory one-way valve openings being in a lower side of said mask and being connected with non-collapsible tubes in said reservoir bag.

[0030] In at least an embodiment, said four expiratory one-way valve openings being near both side of nose and mouth of a wearer of said mask, said multifunctional port being in a centre of said mask directly opposite patient’s mouth for spirometer mouthpiece attachment, and said one-way valve being present at an exit point of said expiratory opening in said mask such that it allows passage of air only during expiration and closes during inspiration.

[0031] In at least an embodiment, said multifunctional port having an adapter configured to adaptively attach: spirometer mouthpiece during spirometery exercises; oxygen adapter during face mask usage; and nebulization chamber during nebulizer mask with or without oxygen;

[0032] Non-Collapsible Oxygen Reservoir bag during NRBM usage.

[0033] In at least an embodiment, said spirometer comprises: a bi-directional microfilter double one-way valve connecting said spirometer mouthpiece to said chamber air outlet tube of said spirometer chamber such that said in-and-out moving adapter connects said mask with said bi-directional microfilter double one-way valve; said bi-directional microfilter double one-way valve having two numbers of one-way valves, with a first one-way valve being inside the tube and allowing air flow from chamber to a user’s mouth / tracheostomy tube and a second one-way valve being connected with atmospheric opening when a user is exhaling air flow to go outside from the user’s mouth or from the user’s tracheostomy tube; and connection between tube and mask junction being adjustable by a moving adaptor.

[0034] In at least an embodiment, said bag comprising having two flexible tubes and one straight tube having oxygen inlet for collecting humidified oxygen from an oxygen flow meter in a central oxygen port or from an oxygen cylinder and a downward side opening delivering oxygen to reservoir bag for quick filling and another upward opening having one valve attached to said mask, said tube being directly connected to an oxygen flowmeter via an oxygen tube, such that inside of this tube always has high pressure.

[0035] BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

[0036] The invention will now be described in relation to the accompanying drawings, in which:

[0037] Figure - 1 shows the Highly Oxygenated Advanced Closed System Incentive Spirometer (HOAC- IS) for oxygen mask dependent patients (Model A) Line Diagram;

[0038] Figure - 2 illustrates the Highly Oxygenated Advanced Closed System Incentive Spirometer (HOAC-IS) for oxygen mask dependent patients (Model A);

[0039] Figure - 3 shows the Highly Oxygenated Advanced Closed System Incentive Spirometer (HOAC- IS) For Tracheostomy T-piece oxygen dependent Patients. (MODEL-B) Line Diagram;

[0040] Figure - 4 illustrates the Highly Oxygenated Advanced Closed System Incentive Spirometer (HOAC-IS) For Tracheostomy T-piece oxygen dependent Patients. (MODEL-B).

[0041] Figure - 5 shows the Incentive Spirometer chamber Parts and its detachable devices;

[0042] Figure - 6 shows the non-collapsible oxygen reservoir bag (NCORB) and its oxygen tubes;

[0043] Figure - 7 shows the Oxygen-delivering mask and its Advanced Features with Bi-directional Micro filter Doubled One-way Value Unite; Figure - 8 shows the HOAC-IS (Model A) Closed system incentive spirometry during inhalation and exhalation air flow Diagram for low flow oxygen mask depends patients (possibility of oxygen supply to patients and spirometer chamber both from single oxygen flow meter / oxygen cylinder) (Red arrow -Inhalation AIR FLOW (02), blue arrow- Exhalation AIR FLOW (C02));

[0044] Figure - 9 shows the HOAC-IS (Model B) Closed system inhalation and exhalation air flow Diagram (on Tracheostomy T-piece Patients) (Red arrow -Inhalation AIR FLOW (02), blue arrow- Exhalation AIR ELOW (C02);

[0045] Figure - 10 shows the Oxygen-delivering mask and its advanced features for supporting normal nose and mouth inhalation and exhalation air flow during the incentive spirometry exercise (concept diagram for without disconnecting oxygen therapy can possible to do the incentive spirometry) (Red arrow -Inhalation AIR FLOW (02), blue arrow- Exhalation AIR FLOW (CO2)); Figure - 11 shows the non-collapsible oxygen reservoir bag (NCORB) and its oxygen tubes providing oxygen delivery for patient’s normal respiration and to the closed system spirometry chamber oxygen delivery with very low pressure (intervening pressure realising one valve in site) concept design. (Red colour arrow -Inhalation AIR FLOW (02));

[0046] Figure - 12 shows the Advanced Open System Incentive Spirometer (Model C);

[0047] Figure - 13 shows the Advanced Open System Incentive Spirometer (Model C) For both non oxygen dependent tracheostomy and normal breather (oxygen diluted with atmospheric air inhalation and exhalation air flow diagram) (Red arrow -Inhalation AIR FLOW (02), blue arrow- Exhalation AIR FLOW (C02), Green Arrow- Atmospheric AIR FLOW);

[0048] Figure - 14 shows the Incentive spirometer mask and bag can be used as a non -rebreathing mask (NRBM);

[0049] Figure - 15 shows the Incentive spirometer mask can be used as a simply oxygen face mask; and Figure - 16 shows the Incentive spirometer mask can be used as a nebulization mask with oxygen support (Red arrow -Inhalation AIR FLOW (02), blue arrow- Exhalation AIR FLOW (C02), Green Arrow- Atmospheric AIR FLOW).

[0050] DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

[0051] Before explaining at least one embodiment of the invention in detail, it is to be understood that the present invention is not limited in its application to the details outlined in the following description or exemplified by the examples. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for description and should not be regarded as limiting.

[0052] 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 the invention belongs. Besides, the descriptions, materials, methods, and examples are illustrative only and not intended to be limiting. Methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention.

[0053] According to this invention, there is provided a highly oxygenated advanced closed (HOAC) system incentive spirometer.

[0054] Here the HO AC-incentive volumetric spirometer is a totally closed system incentive spirometer without atmospheric air interruption for providing high concentration oxygenation during spirometer exercise for the patients depended on low flow oxygen therapy.

[0055] The present invention is about a highly oxygenated advanced closed system incentive spirometer (HOAC-IS) that allows high concentration oxygen supply during the spirometry procedure without allowing atmospheric air (closed system incentive spirometer). Thus, it can be performed by sick patients who are depend on low flow oxygen covid-19, tracheotomy and all other patients. This device should use maximum dependent oxygen therapy up to simple 02 face mask (20), partially rebreather oxygen mask (max 10 liters per minute of o2) and tracheostomy t piece (max 5 L / mts of 02 - And their respiratory rate and pattern to be consider). (Fig. 1, 2, 3, and 4)

[0056] This spirometry is a non-electrical apparatus that can be used by a single patient at a time and it has separate electrical appliances like a voiced remainder alarm clock (16), finger pulse oximetry (17), and digital thermometer. (Fig. 5)

[0057] It helps to provide incentive spirometry benefits to heart, lungs, abdominal pre and postoperative surgical patients and all other patients without interruption of their low flow oxygen therapy. It can even reduce the rate of ICU psychosis In this closed system spirometer, during spirometry, deep inhalation by the patients from the mouthpiece (14) or tracheostomy tube takes place via a simple opening from the spirometry chamber inhalation tube. Here, the tube near patient ends the atmosphere one-way valve opening immediate will close and inside the one-way valve will open and get full of highly concentrated oxygen from the non-closable oxygen reservoir bag via spirometer chamber. During the exhalation from mouthpiece (14) / tracheostomy tube and nose, the tube near patient’s end of the atmosphere one-way valve opening immediate will open and inside the one-way valve will close (bi-directional microfiltered doubled one-way valve unite (8)). So, the exhaled air will reach to the atmosphere. For the nose inhalation and exhalation of the normal respiration the NCORB attached spirometer mask will help for both. So here during the incentive spirometer exercise ‘no’ atmosphere air involvement occurs in the inspiration phase of deep inhalation or respiration from the mouth, trachea and nose. So, this incentive spirometer exercise considers as a closed system spirometry. (Fig. 7, 8, 9, and 10)

[0058] Closed system inhalation air flow on oxygen mask dependent patients (model-A) (Fig. 8)

[0059] Patients’ deep inhalation from mouthpiece (14) — Oxygen flow from 02 flow meter— 02 inlet (23) NCRB -straight tube delivers to 02 reservoir bag — oxygen enter to “U” shaped tube (30) by patient negative pressure inhalation via mouth piece — NCRB outlet tube — spirometer tube air inlet — inside chamber -spirometer chamber inhalation tube — one-way valve open -viral filter (11) - mouthpiece (14) - highly concentrated oxygen received to patient inhalation phases of incentive spirometry exercise. (No atmosphere air entry) (Red arrow -Inhalation AIR FLOW (02) in Fig.

[0060] 8)

[0061] Closed system exhalation air flow on oxygen mask dependent patients (model-A);

[0062] (Fig. 8and, 10)

[0063] Patients’ exhalation into mouthpiece (14) - viral filter (11) — atmospheric one-way valve open — inspiratory one-way valve close — exhale air reach to atmospheric AND nose / mouth breath inside oxygen mask (20) —four one-way valves (24) open in mask and air exit to atmospheric, (blue arrow- Exhalation AIR FLOW (CO2) in Fig. 8. The HOAC incentive spirometer is made of 3 major parts of components comprising the spirometer chamber and its detachable devices (Fig. 5), a mask (20) along with its advanced features (Fig. 7) and a non-collapsible oxygen reservoir bag (NCORB) and its tubes. (Fig. 6)

[0064] A) Incentive Spirometer chamber and its detachable devices (Fig. 5)

[0065] Transplant spirometer barrel (1),

[0066] Color coding label in barrel (2),

[0067] Measuring scale in barrel (3),

[0068] Rising Piston (4),

[0069] Pointer (5),

[0070] Chamber Air inlet tube with 02 adapter (6)

[0071] Chamber Air outlet tube (7)

[0072] BI-DIRECTIONAL MICROFILTERIC DOUBLED ONE-WAY VALVE UNITE (8)

[0073] Exhalation one-way valve (9)

[0074] Inhalation one-way valve (10)

[0075] Viral filter (11)

[0076] ETCO2 port (12)

[0077] Emergency red button (13)

[0078] Inhalation mouthpiece (14)

[0079] Hand holder (15)

[0080] Voice reminder alarm clock (16)

[0081] Detachable finger pulse oximeter (17)

[0082] Stress-reducing soft smiley ball (18)

[0083] Digital thermometer (19)

[0084] B) Oxygen-delivering mask and its advanced features (Fig.7)

[0085] Transparent Plastic mask (20)

[0086] Multifunctional port (21)

[0087] In and out moving adapter (22)

[0088] Two numbers of Oxygen inlet opening from the bag (23)

[0089] Four numbers of expiratory air one way-valve outlet (24)

[0090] Metallic arch for nose clip (25) Upper elastic band (26)

[0091] Lower elastic band (27)

[0092] C) Non-collapsible oxygen reservoir bag (NCORB) and its oxygen tubes (Fig. 6)

[0093] Oxygen tube inlet from oxygen flowmeter (28)

[0094] Straight flexible plastic tube with one-way valve outlet (29)

[0095] “U” shaped flexible plastic tube with one-way valve outlet (30)

[0096] Oxygen outlet opening for spirometer chamber (31)

[0097] Transparent oxygen reservoir plastic bag (32) pressure -releasing and chamber-emptying one-way valve (33)

[0098] The spirometer chamber is made of transparent plastic material. It has a detachable finger pulse oximeter (17), a digital thermometer, a voiced reminder alarm clock (16), and a softball (18). The incentive spirometry design has a special, detachable pulse oximeter (17) on the left side which shows real-time spo2 during spirometry which helps to recognize the condition of the patient itself and at the same time, desaturation and tachycardia can be identified by the patient or health workers to immediately stop using the device. During patient shifting and home setup also, this device can be used.

[0099] The device has incorporated a digital thermometer (19), which can be used before incentive spirometry when required. Many oxygen-dependent patients with lung infection diseases and symptoms of fever is a commonly occurring symptom in which the use of high-grade fever spirometry is not recommended. So, the digital thermometer (19) will help to detect fever before use to avoid any errors of use of the spirometry.

[0100] It has a voiced reminder alarm clock (16), that can be used in three ways:

[0101] Firstly, to check on the spirometry inspiratory holding seconds;

[0102] Secondly, to set a reminder for the next session to use spirometry - this can be set by patients or health care workers which prevents the chances of the negligence of using this device;

[0103] Thirdly, voice-induced announcement of the shown date, time, and day will help keep the patient oriented and reduce the chance of ICU-induced delirium. A soft stress reducing ball (18), is present that helps to decrease or reduce the level of tension or stress and maintain the mood of the patient, especially during pandemic covid-19 disease or when the patient is alone either at home or ICU setup. It is helpful for decreases blood pressure and increasing blood circulation and it makes the collateral blood circulation better in the hand when the doctors are in need to remove the artery for heart and other vascular surgery .it can help to reduce oedema in the hands also.

[0104] The measuring barrel (3), is larger in size (real 500ml or 1000 ml / 1 liter) and thus makes accurate readings of inhaled volume by the patients (closed system with NCORB) and normal incentive spirometry reading during open system without NCORB (volume reading up to 2000ml)

[0105] The pointer (5) on the measuring barrel (1) can be adjusted based on the patient's lung condition. This device includes different color coding’s (2) based on volume. The very low volume (0 to 200ml) is black code in closed and open (200 to 400ml). The low volume (200 to 400ml) is red code in closed and open (400 to 800ml) the average volume (400 to 800ml) is yellow code in closed and open (800 to 1600ml) and the good volume (800 to 1000ml) is green code in closed &open (1600 to 2000ml). It indirectly shows the patient's LUNG condition during spirometry exercise (1, 2, 3, 4, 5).

[0106] The setting of the spirometer is based on the patient’s weight and lung condition. For example, HOAC-IS closed system spirometer, that is setup for lung disease (5 to 8 ml / kg x 2 / his (inspiratory holding seconds) in Covid- 19, tracheostomy and other diseases. Open system spirometer has a goal setup for (7 to 10 ml / kg x 3 / IHS in heart, abdomen and other pre and post operative surgery patients).

[0107] Here, the inhalation spirometer volume needs to be set. Example for closed system spirometer (with NCORB): if the patient weight is 50kg than it would be 5x50x2=500ml which has to be held for some seconds at initial days. Next day 0.5ml / kg / inspiration x2 has to be increased up to 1000ml per inspiration once reaching the maximum limit of 1000ml the time (in seconds) will be increased The HOAC-IS mask (Fig. 7, 10) is similar to a normal NRB mask structure made by transparent rubber mixed with flexible plastic material manufactured according to the size of the patient’s face- small, medium, and large size. It has a flexible metal arch-support at the nose bridge area outside of the mask for the support and well sealing and adjustments of mask. The lower part of the mask is connected to a non-collapsible oxygen reservoir bag through two one-way valves tubular inspiratory opening for oxygen supply and the middle part of the mask is connected with a spirometry mouthpiece (14) through the multifunctional port (21), mask is fully sealed to the face of the patient with the help of adjustable upper and lower straps (2 in number).

[0108] The mask (Fig. 7, 10) has 7 ports in it (2 inspiratory one-way valve openings, 4 expiratory oneway valve openings, 1 simple opening both ins + exp and multifunctional purpose in nature), each having its own distinguished function and a different diameter size. It has two (2) inspiratory ports one valve opening in the lower side of the mask and is connected with non-collapsible tubes in the oxygen reservoir bag, four (4) one-way valve expiratory ports in near both side of the nose and mouth. One (1) simple opening or multifunctional port (21) in the center of mask direct opposite of patient mouth for spirometer mouthpiece (14) attachment, here the mask attached with spirometer mouth piece tubular structure possible to adjustment in and outward in case of any emergency during patients coughing or seizing. This multifunctional port (21) is used for attaching with the nebulizer chamber for nebulization or oxygen adapter (6) for act as a simple oxygen mask when we are disconnecting the incentive spirometer. (Fig. 15, 16)

[0109] Oxygen-delivering mask with advanced features, including a Multifunctional port (21)

[0110] It is in the center of the oxygen mask, directly opposite the patient's mouth. This port adapts and connects the mouthpiece and in-and-out-moving adaptor during incentive spirometer exercise. It can also adapt the nebulization chamber (which acts as a nebulization mask) and oxygen adaptor (which acts as an oxygen mask) during conventional approaches.

[0111] In and out moving adapter (22)

[0112] Five rounded diameter plastic wrings are attached with inter-connecting transparent single-layer rubber / plastic material. One side end of the wring is connected with an oxygen mask and mouthpiece, and the other side of the plastic wring is attached with BI-DIRECTIONAL MICROFILTERIC DOUBLED ONE-WAY VALVE UNITE with the help of an emergency red button. The primary function of the in-and-out moving adaptor is that if patients are coughing or seizing during spirometer exercise, this adaptor facilitates the removal and movement of the patient's mouth. This way, it will prevent accidents during the spirometer exercise.

[0113] The expiratory opening has four (4) one way valve opening present in mask near both side of nose and mouth. One (1) simple opening or multifunctional port (21) in center of mask direct opposite of patient mouth for spirometer mouthpiece attachment 1 simple opening work both inspiratory + expiratory state. 4 opening are designed for only expiration, the one-way valve is present at the exit point of the expiratory opening in the mask, which allows passage of air only during expiration and closes during inspiration. (Fig. 7, 10)

[0114] Two numbers of Oxygen inlet openings from the bag (23),

[0115] This opening is situated on the lower side of the oxygen mask, with two openings adapting both adaptors of a Straight flexible plastic tube with a one-way valve outlet (29) and a “U” shaped flexible plastic tube with a one-way valve outlet (30) from the reservoir bag.

[0116] Four numbers of expiratory air one-way valve outlets (24),

[0117] The expiratory opening has four- way valve openings in the mask near both the nose and mouth. Four openings are designed for only expiration, and the one-way valve is present at the exit point of the expiratory opening in the mask. This valve allows the passage of air only during expiration and closes during inspiration. Due to this valvular structure attached to the outer portion of the mask, the center of the portion has a bulge shape holding the single-layer rubber material and the rubber layer-covered expiratory holes in the mask.

[0118] Oxygen tube inlet from oxygen flowmeter (28),

[0119] This plastic-made small tubular structure is attached in the middle of the straight tube's external portion of the adaptor. This tubular external-dimeter structure adapts the oxygen tube from the flow meter. The multi-functional port (part 21) in HO AC- IS mask adapter has the possibility to attach spirometer mouthpiece (14) during spirometer (while doing spirometer this opening will act as both inspiratory and expiratory opening for mouth or tracheostomy tube breath), possibility to attach oxygen adapter (6) during face mask usage, possible to attached nebulization chamber during nebulizer mask with or without oxygen and NCOR bag.

[0120] Near the multifunctional port (21) outside the mask comprising patient mouth piece (14) that is a connected with Bidirectional micro filter doubled one way valve unit (8) it has an emergency red button (13), viral filter (11), and two numbers of one-way valve, a first valve is inside the tube (10) and it allow the air flow from chamber to patient mouth and a second valve (9) one is connected with atmospheric opening when patient is exhaling the air flow go outside from the patient’s mouth or tracheostomy tube. The connection between tube and mask junction can possible to adjustable (moving adaptor (22)) in and out of spirometry mouth piece to prevent accidental oral injuries by patient’s cough. (Fig. 7)

[0121] Viral filter (11) helps to filter and prevent micros to spread from patient to the atmosphere and any dust particle to spread from the spirometer chamber to patients. Emergency red button (13) helps to detach spirometry mouth or t- piece tuber structure whenever any emergency like a failure of oxygen delivery in the closed system or respiratory difficulty during the exercise, especially for tracheostomy patients. The detaches will occur immediately after pressing the red button (13) in the place before the viral filter (11) so after detaching the tube it makes a simple opening and fully contacts with the atmosphere so there’s no residence for respiration and easy breathing is possible. The ETCO2 port (12) is present above the filter to sample the expired air to assess the appropriate etco2 during the exercise. (Fig. 7)

[0122] The mask facilitates easy breathing in both inspiratory and expiratory phases time of device usage. In the inspiratory phase, a mask will facilitate the inhaling of the highly concentrated oxygen from both the mouth (for mouth inhalation, oxygen will enter from the NCORB via the spirometry chamber and mouthpiece) and nose (for nose inhalation, oxygen will directly enter into the mask from reservoir bag (32) through one-way valve inlet (33). During the expiration phase of respiration 4, one-way exits (24) in the mask will help exhale air from the nose and 1 a -one-way exit in the mouthpiece will help exhale air from the mouth. (Fig. 7, 10)

[0123] Straight flexible plastic tube with one-way valve outlet (29)

[0124] This straight plastic tube has a way valve-like part (9) that allows the air to flow from the bag to the oxygen mask; inside the reservoir bag, the plastic tube is flexible; outside of the tube has hard, non-flexible plastic in nature, so this structured to prevent the collapse the neck of the bag and facilitating for continues airflow supply to oxygen mask and reservoir bag. This tube structure helps to receive the oxygen flow from the flow meter through the oxygen tube inlet, and after receiving the high-flow oxygen, it is divided into the upper and lower parts of the tube. The upper part, the way valve, will open the patient's nose / mouth inhalation in the oxygen mask and close during expiration. Flow will be delivered to the lower part and fill the reservoir bag this time.

[0125] Transparent oxygen reservoir plastic bag (32)

[0126] The non -collapsible oxygen reservoir bag (NCORB) is made of transparent plastic polythene material like an oxygen bag of the non-rebreather mask. Still, this NCOR bag structure has two attached flexible tubular (29 & 30) structures with unique functions & air pressure comprising one straight tube (29) having to intervene two inlets for collecting humidified oxygen from the oxygen flow meter in the central oxygen port or oxygen cylinder and the downward side opening will deliver oxygen to reservoir bag for quick filling and another upward opening it has one value. It’s attached to the mask, so when patients need inhalation from the nose, the value will open & quickly pressurized oxygen will be delivered to the mask for respiration. This tube is directly connected to the oxygen flowmeter via an oxygen tube, so the inside of this tube always has high pressure.

[0127] “U” shaped flexible plastic tube with one-way valve outlet (30)

[0128] Another tubular (30) structure has an intervening one-way value opening for delivering oxygen to the spirometer chamber. This tube’s lower end dropped downward into the reservoir bag, and its tip is 'u' in shape; bending with the opening is opposite to gravity force, so in this tube, oxygen flow pressure is very low when the patient deep inhaling from the mouthpiece or tube during the spirometry exercise one way vale opening in the inspiratory tube will open. Two atmospheres opening one valve (33, 9) will close, and this closed tubular structure will create negative pressure in the spirometer chamber. Patient is supposed to create negative pressure - because of the U- shaped tube - Inventors have reduced pressure because of this modification. Hence, the tubular opening oxygenated air flow reaches the patient's mouth or trachea through the spirometer chamber. The airflow movement will raise the piston (4) in the spirometer of the measuring chamber. The tube has minimal airflow pressure the rest of the time due to the ‘U’ tube opening in the opposite direction to the gravitational force and the upward end opening to a one-way value. It's connected with a mask when pressure coverage is in the bag or when this tube releases pressure into the mask. The presence of two tubular structures will prevent the collapsing of the neck of the bag and will facilitate good oxygen air filling in the NCORB. (Fig. 6 and 11)

[0129] Oxygen outlet opening for spirometer chamber (31)

[0130] This outlet opening is situated in the upper part of the U structure tube but below the one-way valve adaptor in the tube. This opening is attached to a flexible oxygen transferring tube for oxygen delivery from the reservoir bag to the spirometer chamber during the patient's mouthpiece or tracheostomy inhalation.

[0131] Pressure realizing and chamber emptying one-way valve (33)

[0132] Near the atmospheric end of the spirometer chamber, there is a flexible, non-collapsible plastic tube connecting the spirometer chamber and NCORB. This spirometer end has a one-way valve (33) like part (9), a valve opening towards the atmosphere to release the airflow and emptying the spirometer chamber after a deep inhalation relies such that the spirometer chamber piston will come down to zero level. The valve will be closed during the patient's spirometry inhalation phase.

[0133] The non-collapsible oxygen reservoir bag (NCORB) is made of transparent plastic polythene material like an oxygen bag of the non-rebreather mask. Still, this NCOR bag structure has two attached flexible tubulars (29 and 30) structures with unique functions and air pressure comprising one straight tube (29) having to intervene two inlets for collecting humidified oxygen from the oxygen flow meter in the central oxygen port or oxygen cylinder and the downward side opening will deliver oxygen to reservoir bag for quick filling and another upward opening it has one valve. It’s attached to the mask, so when patients need inhalation from the nose, the valve will open and quickly pressurized oxygen will be delivered to the mask for respiration. This tube is directly connected to the oxygen flowmeter (28) via an oxygen tube, so the inside of this tube always has high pressure.

[0134] Another tubular (30) structure has an intervening one-way valve opening for delivering oxygen to the spirometer chamber. This tube’s lower end dropped downward into the reservoir bag, and its tip is 'u' in shape; bending with the opening is opposite to gravity force, so in this tube, oxygen flow pressure is very low when patient deep inhaling from the mouthpiece or tube during the spirometry exercise one way vale opening in the inspiratory tube will open and two atmospheres opening one valve will close and this closed tubular structure will create negative pressure in spirometer chamber so u tubular opening oxygenated air flow come and reach to patient mouth or trachea through the spirometer chamber, the air flow movement will raise the piston (4) in the spirometer of the measuring chamber. The rest of the time u tube has a minimal air flow pressure due to the opening of ‘u’ tube in the opposite direction to the gravitational force and the upward end opening to one way valve and it is connected with a mask when pressure coverage is in the bag or this tube pressure will be released into the mask. The presence of two tubular structures will prevent the collapsing of the neck of bag and will facilitate good oxygen air filling in the NCORB. (Fig. 6, 11)

[0135] Near the atmospheric end of the spirometer chamber, there is a flexible non-collapsible plastic tube (31) for connecting the spirometer chamber and NCORB. This spirometer end has a one-way valve (33) opening towards the atmosphere for the release of the airflow and for emptying the spirometer chamber after a deep inhalation relies such that the spirometer chamber piston (4) will come down to zero level. The valve will be closed during patient spirometry inhalation phase.

[0136] HO AC incentive spirometry can act as a normal open system incentive spirometer (model” C” (Fig. 12, 13) when the non-collapsible oxygen reservoir bag (NCORB) is detached along with the mask. The spirometer chamber at the atmospheric end tube has a small adapter for the oxygen inlet to give oxygen when needed. With the open system spirometry, it will help, but atmospheric air also can enter into spirometer chamber so here patient will get oxygen mixed atmosphere air during the spirometer exercise. (Red arrow - Inhalation AIR FLOW (02), blue arrow - Exhalation AIR FLOW (CO2), Green Arrow - Atmospheric AIR FLOW) (Fig. 13) Chamber Air inlet tube with 02 adapter (6),

[0137] This air inlet with an 02 adaptor (6) is attached to a shaped plastic alloy wheel-like structure. The center portion has an inner tubular opening for adapting the oxygen tube from the flowmeter (28) (open system spirometer), and the outer portion of the rounder diameter has an intervening few openings, allowing the atmospheric air to enter the chamber. This tube's outer diameter can adapt the pressure-realizing valve adaptor in the oxygen-delivering tube from the reservoir bag (closed system spirometer); the primary function of this part is to allow the airflow from the oxygen reservoir and atmosphere. This outer portion opening helps to empty air into the atmosphere from the chamber when the patient stops inhaling or stops creating negative pressure in the chamber through the mouthpiece inhalation.

[0138] The incentive spirometer can be used in multiple ways with different approaches including the closed system incentive spirometry approach and the open system incentive spirometer approach. HOAC-closed system incentive spirometer approach means, during spirometer exercise, atmospheric air can’t get involve in inspiratory phases of respiration from the nose, mouth and trachea. So, without atmospheric air interruption HOAC closed system can possibly provide the high concentration oxygenation for the patients who are dependent on low flow oxygen therapy. The closed system incentive spirometer makes it possible to provide more than 95-% fio2(fraction of inspired oxygen) in inspiratory reserve volume (IRV) during incentive spirometry exercise through mouth or tracheostomy tube inhalation. (Model A and B)

[0139] This closed system incentive spirometry providing more than 95% fio2 in normal vt (tidal volume) during the spirometry exercise through nose inhalation via NRB oxygen mask and its directly getting concentrated oxygen from non-closable oxygen reservoir bag. So, this HOA closed system spirometry, without interrupting the oxygen therapy incentive spirometry, benefits to provide low flow oxygen to the dependent patients of covid- 19, and other pre- and post-oxygen therapy patients on nasal prongs, face mask, partially rebreather mask and tracheal piece(t-piece) o2 therapy devices. The HOA closed system incentive spirometer structure will help to provide inspiratory oxygen for both nose inhalation and mouth or tracheostomy tube inhalation from the single oxygen flowmeter (28) in centralized oxygen port or single oxygen cylinder during incentive spirometry exercise.

[0140] Closed system inhalation air flow on oxygen mask dependent patients (model-A) (Fig. 8)

[0141] Patients’ deep inhalation from mouthpiece ==Oxygen flow from o2 flow meter— o2 inlet NCRB -straight tube delivers to 02 reservoir bag — oxygen enter to “U” shaped tube (30) by patient negative pressure inhalation via mouth piece — NCRB outlet tube (7) — spirometer tube air inlet — inside chamber -spirometer chamber inhalation tube — one-way valve open -viral filter (11) - mouthpiece -highly concentrated oxygen received to patient inhalation phases of incentive spirometry exercise. (No atmosphere air entry) (Red arrow -Inhalation AIR FLOW (02) in Fig.

[0142] 8)

[0143] Closed system exhalation air flow on oxygen mask dependent patients (model-A) (Fig. 8, 10) Patients’ exhalation into mouthpiece - viral filter (11) — atmospheric one-way valve open — inspiratory one-way valve close — exhale air reach to atmospheric AND nose / mouth breath inside oxygen mask —four one-way valves open in mask and air exit to atmospheric, (blue arrow- Exhalation AIR FLOW (CO2) in Fig. 8)

[0144] Closed system inhalation airflow (model-B For tracheostomy T-piece oxygen dependent patients) (Fig. 9)

[0145] Patients’ deep inhalation from tracheostomy t-tube pi ==Oxygen flow from o2 flow meter— o2 inlet NCRB -straight tube delivers to o2reservoir bag — oxygen enters to “U” shaped tube (30) by patient negative pressure inhalation via mouthpiece — NCRB outlet tube — spirometer tube air inlet — inside the chamber -spirometer chamber inhalation tube — one-way valve open -viral filter (11) - t- piece -highly concentrated oxygen received to patient inhalation phases of incentive spirometry exercise (No atmosphere air entry). (Red arrow -Inhalation AIR FLOW (02) in Fig.

[0146] 9) Closed system exhalation airflow (model-b for tracheostomy T-piece oxygen dependent patients) (Fig. 9)

[0147] Patients exhale air from tracheostomy t piece to spirometer inhalation tube opening - viral filter (11) — atmospheric one-way valve open — inspiratory one-way valve close — exhale air reach to atmospheric, (blue arrow- Exhalation AIR FLOW (CO2) in Fig. 9)

[0148] As seen in Fig, 8, the chamber air outlet tube (7) is a plastic flexible tubular structure with both sides having a non-flexible plan diameter portion connecting the spirometer chamber opening and bi-direction doubled one-way valve unit. This tube's primary function is to deliver airflow from the spirometer opening end to the doubled one-way valve unit during the patient, creating negative pressure in the chamber through the mouthpiece inhalation.

[0149] BI-DIRECTIONAL MICROFILTERIC DOUBLED ONE-WAY VALVE UNITE (8)

[0150] This unit is a tuber structure made of plastic materials. One end of the unit is connected with an in-and-out moving adaptor (22) in the oxygen mask. Another end of the unit is connected with a flexible inhalation tube from a spirometer outlet (here has an Inhalation one-way valve (10), an alloy wheel rounded shape plastic window situated in vertical placement the unites (8) the center of portion has a bulge shape holding for the single layer rubber equipment and the rubber layer covered whole diameter of the tube so this one-way valve structure allows air flow movement from the spirometer outlet tube to patients side by nature of rubber materiel and flexible movement towards creation of negative pressure by the patients inhalation. It restricts the airflow movements towards the spirometer chamber side due to the presence of plastic alloy wheels in the structured window (10)

[0151] Exhalation one-way valve (9) looks like an inhalation one-way valve (10). Still, it is situated above the united inner to the outer motion of function for realizing the exhalation airflow to the atmosphere during the patient exhalation phase by the patient's mouth / tracheostomy exhalation air flow positive pressure. The valve will be close during patient inhalation (9).

[0152] The unit (8) has a vertical place of the Viral filter (11) between the two bigger diameter meters of the tube in the unit. Still, it's smaller than the viral filter diameter, so this structure prevents the displacement of the viral filter during the two directional airflow movements by the inhalation and exhalation phases through the patient’s mouth and tracheostomy. The primary function of this filter is to prevent dust and microorganisms from the atmospheric or flowmeter (28) air to the patient’s respiratory tract and, at the same time, bioaerosol from the patient’s tracheostomy or mouth to the atmosphere.

[0153] EtCO2 port (12),

[0154] The port is incorporated after the viral filter. This unit (8) has a small plastic tubular structure closed by a plastic cap; this tubular structure adapts the EtCO2 sensor attachment if needed to take air samples for appropriate EtCO2 assessment of low-flow oxygen, depending on the patient.

[0155] Inhalation mouthpiece (14): made of strong plastic materials, it has a rounder, two-sided flat surface with an opening for patient mouth inhalation and another end connected with an in-and-out-moving adaptor (22) in the oxygen mask.

[0156] In open system spirometer while doing the spirometer exercise atmospheric air can entered in to the spirometer charmer with or without oxygenate air dilution. In this spirometer, approaches need to disconnect the HOAC spirometer mask and non-collapsible oxygen reservoir bag. So, if we need to provide some amount of oxygen during spirometer deep inhalation, there is a need to attach the oxygen tube directly to the spirometer atmospheric end 02 adapter. Patient will deep inhale from spirometer mouth piece or tracheotomy tube, the atmosphere air will go with oxygen dilution. (Fig. 12, 13) (Red arrow - Inhalation AIR FLOW (02), blue arrow- Exhalation AIR FLOW (CO2), Green Arrow-Atmospheric AIR FLOW)

[0157] The highly oxygenated advanced closed system incentive spirometer can be utilized in three ways comprising the 1) high oxygen concentration delivering model (more than 95% fio2), 2) low oxygen concentration delivering model (open system spirometry-up to 60 % fio2) (Model C) and room air delivering model for pre and post non-oxygen dependent, non-pathological lung patients (open system spirometry). High oxygen concentration delivering model(closed) can deliver high concentration oxygen for who are all the patients their depending oxygen therapy 5 to 10 liters per minute via simple oxygen facemask, partially re breather o2 mask and tracheostomy t -piece before doing this closed system spirometer the actually getting oxygen flow from the oxygen flowmeter in 02 cylinder or central oxygen port. The flow rate must be increased by 4 liters of the actual flow rate of patients depends. For e.g., 5 to 10 liters / minutes of oxygen going on via simply 02 facemask mean during spirometry exercise flow rate should be set 9 to 14 liters per minute, because during closed system spirometer there’s ‘no ‘atmosphere air flow during the inhalation phase of respiration through deep inhalation from mouth and nose .so, here other than oxygen there’s no any other gas mixture like nitrogen, CO2 and other gases .here only the inspiratory tidal volume or inspiratory reserve volume patient will be getting inside the spirometer mask and mouth piece. Increasing the level of oxygen will help to maintain the respiratory minute volume(mv) and facilitate easy breathing during exercise. The components for this model comprise the HO AC spirometer with NCORB and HO AC mask. For the tracheostomy patient HO AC mask and mouth piece should be removed. (MODEL A and B) (Fig. 11, 10, 9, 8).

[0158] The low oxygen concentration delivering model (open) only works for the patients undergoing oxygen therapy with 1 to 4 liter per minute of oxygen flow via nasal prongs and T-piece. While doing the spirometer exercise atmospheric air with oxygen dilution can possibly enter into the spirometer chamber. This model also can be used for non-oxygen dependent patients but SP02 level between 95 to 99%, the SP02 is an acceptable range even though need some support during spirometry excises due to their lung pathological condition. The components for this model comprise the HO AC spirometer with direct oxygen supply to chamber. For tracheostomy patient mouth piece needs to be removed.

[0159] The room air delivering model(open) for pre- and post-non-oxygen dependent, non-pathological lung patients, are for the patients in the condition inhaling the room air without pathological lung condition like heart, abdominal and other surgical pre- and post-patients. Especially in pre-op period while doing the spirometer exercise, the atmospheric air can possibly to enter in spirometer chamber. The components for this model comprise the HOAC spirometer with mouth piece without oxygen supply so, patients will get only atmospheric air. (Fig. 12, 13).

[0160] Table -1 shows the importance and difference between HOAC-IS (closed and open system) and normal incentive spirometry

[0161] Further the utilization and working of a closed system spirometer comprise connected oxygen tube from the oxygen cylinder or central oxygen flow meter to HOAC-IS non-collapsible oxygen reservoir bag oxygen inlet (23).

[0162] Set the oxygen flow based on patients depending on the oxygen level before doing this closed system spirometer the actually getting oxygen flow from the flowmeter of oxygen cylinder or central oxygen port. Flow rate must to be increased 4 liters of actual flow rate of patients depends. For e.g., 5 tolO liters / minutes of oxygen going on via simply 02 facemask mean during spirometry exercise flow rate should be set 9 to 14 liters per minute

[0163] Attach the HO AC mask to the patient and secure it with upper elastic band (26) and lower (27) elastic band. Ascertain good sealing around nose and mouth of the patient. Rest of the steps are usually the same as normal incentive spirometry. The spo2 and heart rate should be monitored during the procedure. Use adjustable part and emergency red button in case of any emergency and cough reflex. The connection between tube and mask junction can adjustable in and out of spirometry mouth piece to prevent accidental oral injuries by patient’s cough.

[0164] After the procedure is completed, the straps should be loosened, oxygen flow should be reduced and then the spirometer can disconnect completely from the patient.

[0165] Highly oxygenated advanced closed system incentive spirometer can be used with multiple approaches consisting of HOAC-IS mask and non-closable oxygen reservoir bag where it can be used as a non-rebreather mask (NRBM) (Fig. 14) by detaching the spirometer with mouth piece and closing the spirometer mouth piece opening site of mask and close the u tubular opening site for spirometer chamber. Now it’s ready to act as an NRBM (Fig. 14). in case the facemask patients need to change more supportive oxygen administering approach like NRBM. This HOAC-IS NRBM has facility to give nebulizer chamber adapted in spirometer adapter opening incase need to give nebulization with oxygen therapy this mask will work.

[0166] The second approach is a simple oxygen mask, detach the spirometer with mouth piece and NCORB. The spirometer mouth piece opening site of a mask attached the oxygen tube adapter (6). Now, its acts as a standard simple oxygen face mask. (Fig. 15)

[0167] The other approach is using it as a nebulizer mask with or without oxygenation. Here HO AC -is mask can be used as a nebulization mask with or without oxygen therapy. Detach the spirometer and NCORB. Close and attach a particular opening in the mask. (Fig. 16)

[0168] While there has been illustrated and described embodiments of the present invention, those of ordinary skill in the art, to be understood that various changes may be made to these embodiments without departing from the principles and spirit of the present invention, modifications, substitutions and modifications, the scope of the invention being indicated by the appended claims and their equivalents.

Claims

CLAIMS,1. A highly oxygenated advanced closed system incentive spirometer comprising: a spirometer chamber (1, 2, 3, 4, 5) consisting, essentially, of: o a chamber air inlet tube with an oxygen adapter (6) configured to allow inflow of closed system of humidified oxygen air into said spirometer chamber (1, 2, 3, 4, 5); o a chamber air outlet tube (7) configured to allow outflow of oxygenated air out of said spirometer chamber (1, 2, 3, 4, 5); o an exhalation one-way valve (9) connected to a mouthpiece (14); o an inhalation one-way valve (10) connected to a mouthpiece (14); o a viral filter (11) in line with said exhalation one-way valve (9) and said inhalation one-way valve (10); o an ETCO2 port (12) located above said filter (12) to sample the expired air to assess the appropriate ETCO2 during use of said spirometer; a detachable mask (20) with several ports, said mask (20) connected to said spirometer chamber (1, 2, 3, 4, 5) by means of said a chamber air outlet tube (7), said mask (20) consisting, essentially, of: o two inspiratory one-way valve openings, connected with a spirometer mouthpiece (14) attached to said mask (20), being oxygen inlet openings (23) connected to a reservoir bag (32); o four expiratory one-way valve openings (24), connected with a spirometer mouthpiece (14) attached to said mask (20, said openings (24) being outlets ensuring passage of air only during expiration and ensuring blockage of air during inspiration,■ with two openings adapting both its adaptors, respectively,• to a straight flexible tube with a one-way valve outlet (29), and• to a “U” shaped flexible tube (30) with a one-way valve outlet (30) from the reservoir bag (32)o a simple opening at said spirometer mouthpiece (14), located directly opposite a user’s mouth wearing said mask (20), for input and output with an in-and-out moving adapter (22); o a multifunctional port (21), in line with said in-and-out moving adapter (22), located directly opposite a user’s mouth wearing said mask (20), said multifunctional port (21) configured to adapt and connect said mask (20) and said in-and-out-moving adaptor (22) during incentive spirometer exercise for low flow oxygen delivering through said mask (20); a non-collapsible oxygen reservoir bag (NCORB) (32), connected to said mask (20) and to said spirometer chamber (1, 2, 3, 4, 5), said non-collapsible oxygen reservoir bag (NCORB) (32), consisting, essentially, of: o an oxygen tube inlet (28), inside said bag (32),■ with its outer end connected with an oxygen flowmeter;■ with its outer end, also connected to a flexible tube having a one-way valve outlet (29); o an “U” shaped flexible tube (30), inside said bag (32),■ with its outer end connected with a one-way valve outlet (30)■ with its outer end connected with an oxygen outlet opening (31) connected to said spirometer chamber through a pres sure -releasing and chamber-emptying one-way valve (33); and o one-way valves connecting said bag (32) with said mask (20) with a spirometer mouthpiece (14) through the multifunctional port (21).

2. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, said spirometer comprises: a bi-directional microfilter double one-way valve (8) connecting said spirometer mouthpiece (14) to said chamber air outlet tube (7) of said spirometer chamber (1, 2, 3, 4, 5) such that said in-and-out moving adapter (22) connects said mask (20) with said bi-directional microfilter double one-way valve (8).

3. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, a lower part of said mask (20) being connected to a non-collapsible oxygen reservoir bag through two one-valve tubular inspiratory opening for oxygen supply; and a middle part of said mask (20) being connected with a spirometry mouthpiece through said multifunctional port, said mask (20) being fully sealed onto a face of a user with an adjustable upper strap and an adjustable lower strap.

4. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, said two inspiratory one-way valve openings being in a lower side of said mask and being connected with non-collapsible tubes in said reservoir bag.

5. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, said four expiratory one-way valve openings being near both side of nose and mouth of a wearer of said mask, said multifunctional port being in a centre of said mask directly opposite patient’s mouth for spirometer mouthpiece attachment, and said one-way valve being present at an exit point of said expiratory opening in said mask such that it allows passage of air only during expiration and closes during inspiration.

6. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, said multifunctional port having an adapter configured to adaptively attach: spirometer mouthpiece during spirometery exercises; oxygen adapter during face mask usage; and nebulization chamber during nebulizer mask with or without oxygen;Non Collapsible Oxygen Reservoir bag during NRBM usage.

7. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, said spirometer comprises:a bi-directional microfilter double one-way valve (8) connecting said spirometer mouthpiece (14) to said chamber air outlet tube (7) of said spirometer chamber (1, 2, 3, 4, 5) such that said in-and-out moving adapter (22) connects said mask (20) with said bi-directional microfilter double one-way valve (8); said bi-directional microfilter double one-way valve (8) having two numbers of oneway valves, with a first one-way valve being inside the tube (10) and allowing air flow from chamber to a user’s mouth / tracheostomy tube and a second one-way valve (9) being connected with atmospheric opening when a user is exhaling air flow to go outside from the user’s mouth or from the user’s tracheostomy tube; and connection between tube and mask junction being adjustable by a moving adaptor (22).

8. The highly oxygenated advanced closed system incentive spirometer as claimed in claim 1 wherein, said bag (32) comprising having two flexible tubes (29, 30) and one straight tube (29) having oxygen inlet (28) for collecting humidified oxygen from an oxygen flow meter in a central oxygen port or from an oxygen cylinder and a downward side opening delivering oxygen to reservoir bag (32) for quick filling and another upward opening having one valve attached to said mask (20), said tube (29) being directly connected to an oxygen flowmeter via an oxygen tube, such that inside of this tube always has high pressure.

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