DESC:4. DESCRIPTION

Technical Field of the Invention

The present invention relates generally to respiratory systems and more particularly to an apparatus for enhanced ventilation of a patient.

Background of the Invention

As cities and hospitals across the globe are overrun with coronavirus patients, the acute shortage of medical equipment has been the biggest problem. So acute is the problem of shortage of equipment that doctors in Italy have to pray to god in deciding who lives and who dies. As more and more people are getting admitted in hospitals across India, the fear now is that the requirement of critical care equipment such as ventilators, sanitizers, masks, and scrub suits should not lead to a similar predicament. This acute shortage tends to impede India’s fight against Covid-19.

At the heart of the demand is the urgent need for ventilators. Covid-19 can lead to severe lower respiratory tract infection, which means patients often need ventilator support. But what is the status of ventilators in India? According to Johns Hopkins University, the demand for ventilator demand can be as high as 1 million in the country. Current availability in India is estimated to between 30,000 and 50,000 ventilators.

Brief Summary of the Invention

According to an aspect of the present invention, apparatus for respiratory support for a patient's breath, wherein the apparatus comprises a respiratory unit and compressor and oxygen cylinder.

In accordance with the aspect of the present invention, the apparatus respiratory unit comprises a control unit and a Control and Monitory Display.

In accordance with the aspect of the present invention, a control unit houses valves and electronic circuitry to regulate the flow of oxygen or air to the patient. And The control unit includes an inlet, an outlet, pressure valves to control airflow, and a mixing chamber;

In accordance with the aspect of the present invention, wherein the control unit has various controls, indicators, Inlets and outlets, power supply, ON\OFF switches, adjustable knobs and different indicators of the Respiratory unit.

In accordance with the aspect of the present invention, wherein the Control and Monitory Display has a touch screen functionality. And allow the physician to set ventilation mode as required.

In accordance with the aspect of the present invention, wherein the Control and Monitory Display have different alarms for safety.

In accordance with the aspect of the present invention, the unit is portable and can be set up either on a trolley for easy movement or can be operated from the carrying case.

In particular, all combinations of claimed subject matter appearing at the end of this disclosure are contemplated as being part of the inventive subject matter disclosed herein. It should also be appreciated that terminology explicitly employed herein that also may appear in any disclosure incorporated by reference should be accorded a meaning most consistent with the particular concepts disclosed herein.

Brief Description of the Drawings
Although the characteristic features of this invention will be particularly pointed out in the claims, the invention itself and manner in which it may be made and used may be better understood after a review of the following description, taken in connection with the accompanying drawings wherein like numeral annotations are provided throughout.

Fig. 1a is a line diagram of the apparatus, according to an exemplary embodiment of the present invention;

Fig. 1b is a line diagram of the respiratory unit of the apparatus, according to an exemplary embodiment of the present invention;

Fig. 1c is a front view of the apparatus, according to an exemplary embodiment of the present invention;

Fig. 1d is a front view of the apparatus with parts labelling, according to an exemplary embodiment of the present invention;

Fig. 1e is a rare view of the apparatus with parts labelling, according to an exemplary embodiment of the present invention;

Fig. 1f is a compressor unit of the apparatus, according to an exemplary embodiment of the present invention;

Fig. 2a to 2j is a different set of the application and apparatus extensions of the apparatus, according to an exemplary embodiment of the present invention;

Detailed Description of the Invention

Referring to Figs. 1a-1f, an apparatus for respiratory support for a patient is disclosed in accordance with an exemplary embodiment of the present invention. In accordance with the exemplary embodiment, the apparatus comprise of a respiratory unit, a compressor (6) and a oxygen cylinder (not shown).

In accordance with the exemplary embodiment of the present invention, a respiratory unit further comprises of a control unit (2) and control monitory display (4).

In accordance with the exemplary embodiment of the present invention, the control unit is further comprising of electronic circuitry to regulate the flow of oxygen or air to the patient and valves.

In accordance with the exemplary embodiment of the present invention, the valves are further divided into inspiratory and expiratory valves.

In accordance with the exemplary embodiment of the present invention, the inspiratory section comprises a pressure regulator, a flow sensor, a flow control valve, a safety valve, oxygen sensor and a bacterial filter.

In accordance with the aspect of the present invention, the expiratory section comprises a pressure regulator, a flow sensor, a flow control valve, a safety valve, and a bacterial filter a plurality of oxygen and carbon dioxide sensors. both the inspiratory section and the expiratory section contents to a mixing chamber then to an oxygen sensor.

In accordance with the aspect of the present invention, the external section comprises oxygen and air blender for defining the oxygen percentage in the air. The external section comprises a gas pump operatively connected to an oxygen-bearing gas source, a control unit for activating the gas pump, sensors controlled by the control unit for detecting spontaneous respiration of the patient, and a catheter adapted to be inserted into the respiratory system of the patient fluidly connected to the oxygen-bearing gas delivery device.

In accordance with the aspect of the present invention, the electronic circuitry system has a microcontroller and a power regulatory unit.

In accordance with the aspect of the present invention, the oxygen and air blender of the external section have adaptations to connect to a hospital’s air and oxygen supply line and/or a supplementary oxygen cylinder and a medical grade compressor for the supply of oxygen and the required dry air.

In accordance with the aspect of the present invention, the control monitory display has a touch screen facility and is optimised to allows the physician to set the parameters and modes of ventilation.

In accordance with the aspect of the present invention, the apparatus has various controls, indicators, inlets and outlets of the respiratory unit are shown in fig 1b to fig 1e.

In accordance with the exemplary embodiment of the present invention,
Control and Monitoring Display (8): allows the physician to set the parameters and modes of ventilation.
Status LED (10): shows the power ON status of the ventilator. If this LED is on then the physician can connect the patient circuit.
Run LED (12): indicates that patient circuit is connected and ventilation is going on.
Inspiration LED (14): indicates that inspiration action is going on in the ventilator.
Expiration LED (16): indicates that expiration action is going on in the ventilator.
Adjust Knob (18): knob is used to adjust the parameters on the Control and Monitoring display. Pressing this knob sets the parameter.
Inspiration & Expiration Port (20): This is where the patient circuit is connected.
Exhaust Air (22): Here the exhaled air is let out.
Nebulizer Port (26): This port is used to connect the external nebulizer in case if the patient needs it.
Ventilator Power Button with Flip Switch (28): Opening the flip switch exposes the Power button. Pressing this button switches on the ventilator. This button should be used to switch off the ventilator using a long press. A minimum of the 1-minute interval should be there between one ON/OFF cycle.
Monitor Power & Data Port (30): These ports are used to supply power and Data to the Control and Monitoring Display.
Mains ON/OFF and inlet plug (34): A mains plug is available where the power input cable should be connected. Mains ON/OFF switch provides AC power to the ventilator. In case the ventilator is not switched ON the power is provided to recharge the battery.
Oxygen Inlet (38): Oxygen inlet tube from hospital lines is to be connected here. In case the ventilator is to be used outside a hospital, connect the Oxygen cylinder tube here.
Breathing Air Inlet (40): Breathing Air inlet tube from hospital lines is to be connected here. In case the ventilator is to be used outside a hospital, connect the compressor outlet tube here.
Exhaust Fan (42): This fan regulates the heat inside the ventilator.
External Port (44): For upgrades and future uses.

In accordance with the aspect of the present invention, the starting and stopping procedures of the apparatus. the pipes of the air compressor should be connected; one from the compressor outlet to the water trap, the second from the water trap to the ventilator air inlet on the backside. The power cable should also be connected with mains.

Similarly, the regulator should be fixed with the oxygen cylinder with the tool provided. The oxygen pipe from the regulator should be connected to the ventilator.
On the compressor, the water trap and water collector should be connected/placed. Ensure all the power cables and data cables are appropriately connected on the ventilator

Steps for starting the Ventilator:
• Switch ON the Mains power supply
• Switch on the Air Compressor
• Ensure the reading on the compressor and the regulator read 4 bars.
• Switch on the mains power on the ventilator.
• Flip open the red switch on the ventilator and press the red button once. Clos the flip switch.
• Press the ON/OFF button on the display unit, wait for the application software to start up. Once the above steps are done connect the patient circuit.
• Perform the pre-use and diagnostic checks
• Set the upper and lower alarm limits.
• Select ventilation mode (with requisite settings) and start ventilation

Steps for stopping the Ventilator:
• Ensure patient circuit is disconnected.
• Switch OFF the air compressor
• Close the regulator valve in the cylinder
• Flip open the red switch on the ventilator and give a long press to the red button (5 seconds), the display unit and ventilator shut down.

In accordance with the aspect of the present invention, the control and Monitoring Display allows the physician to set the ventilation mode as required by the patient and continuous monitoring of the setting is possible.

As shown in the (fig 2a) is a default screen (1) indicates the various modes, indicates the parameters set, (3) indicates the sensed parameters and (4) indicates additional sensed/calculated parameters.

The ventilator can be operated two major modes viz. invasive and non invasive modes of ventilation. In the invasive mode, the various sub-modes like Continuous Mandatory Ventilation (CMV), Assist Controlled Mandatory Ventilation (A/CMV), Synchronous Intermediate Mandatory Ventilation (SIMV), and Pressure Regulated Volume Control (PRVC). In the non-invasive mode, the various sub-modes are Pressure Support Ventilation (PSV) and Continuous Positive Airway Pressure (CPAP).

Mode Setting Screen Once the patient circuit is connected, the mode of ventilation can be set up by the physician in the mode setting screen.

The selected mode gets displayed in green as shown in the left hand side of the screen. After selecting the mode, the physician can set up various parameters like Respiratory Rate (RR), Tidal volume, I:E ratio etc. depending on the mode selected.

The supply status (mains/battery) is depicted pictorially. The current status of the battery is also displayed. Each mode has a different set of parameters which can be set and the screen automatically changes when the mode is selected. The steps for setting different modes is given as under

The CMV Mode (fig 2b) - In Continuous Mandatory Ventilation (CMV) – (volume based) mode breaths are delivered based on set variables. It is an invasive mode of ventilation. In the volume mode, a mixture of oxygen in the desired percentage along with the air is sent to the patient at a pre-set volume.

In accordance with the exemplary embodiment of the present invention, Continuous Mandatory Ventilation (CMV) (fig 2b) – (pressure based) mode breaths are delivered based on set variables. Here oxygen air mixture is delivered to the patient at the constant set pressure. The volume delivered depends on the pressure.

Here other parameters like the respiratory rate (No of respiratory cycles per minute), IE Ratio (Duration of Inspiration w.r.t expiration, e.g. If the respiratory rate is 12, one breath cycle is of 5 seconds. So, if IE ratio is set at 1:4, Inspiration will be approx. 1 second and expiration for approx. 4 seconds), PEEP (Positive end expiratory pressure), and plateau can be set (Plateau is set as a percentage of the inspiratory time).

Steps to set the CMV mode (fig 2b) -
Step 1: Tap on the Mode setting button in the top menu
Step 2: Select Invasive mode by tapping on the radio button next to ‘invasive mode’
Step 3: Select the CMV mode
Step 4: Select Volume or Pressure mode by tapping on the respective mode button.
Step 5: Set the values in the various parameter as per the requirement of the patient.
For example: In case Tidal volume is to be changed, select tidal volume, Increase/decrease the Tidal volume by dragging the slider or by rotating the adjustment knob on the respiratory unit front panel.
Step 6: Tap on the accept button on the screen or press adjusts knob to accept.
Step 7: Tap on the Start button on the bottom right corner on the screen to start ventilation.
In this mode, Sigh can be set. Sigh is generally given twice after every 100 breaths or after every 7 minutes, whichever is earlier. Here 1.5 times the normal volume of air and oxygen mixture is given to the patient. In Case sigh is to be applied click on the check box next to sigh.

In accordance with the exemplary embodiment of the present invention, Assist Controlled Mandatory Ventilation (A/CMV) (fig 2c) mode is similar to CMV mode with the addition of a trigger. This mode allows the patient to breathe and the triggered breaths are converted into full breath. The trigger pressure is set by the physician depending on the state of the patient. In case the patient tries to breathe spontaneously and the pressure is below the set trigger a full breath is provided by the ventilator.

Steps to Set the A/CMV Mode (fig 2c)
Step 1: Tap on the Mode setting button in the top menu
Step 2: Select Invasive mode by tapping on the radio button next to ‘invasive mode’
Step 3: Select the A/CMV mode
Step 4: Select Volume or Pressure mode by tapping on the respective mode button.
Step 5: Set the values in the various parameter as per the requirement of the patient.
For example: In case Tidal volume is to be changed, select tidal volume, Increase/decrease the Tidal volume by dragging the slider or by rotating the adjustment knob on the respiratory unit front panel.
Step 6: Set the Trigger pressure which is below the peep level (units cmH2O)
For Example: if PEEP is 3 and Trigger is 2, That means if the pressure becomes less than 1 during the patient spontaneous breath, it will take as patient trigger breath and deliver a full breath.
Step 7: Tap on the accept button on the screen or press adjusts knob to accept.
Step 9: Tap on the Start button on the bottom right corner on the screen to start ventilation.
In this mode, Sigh can be set. Sigh is generally given twice after every 100 breaths or after every 7 minutes, whichever is earlier. Here 1.5 times the normal volume of air and oxygen mixture is given to the patient. In Case sigh is to be applied click on the check box next to sigh.

In accordance with the exemplary embodiment of the present invention, SIMV (Synchronous Intermediate Mandatory Ventilation) (fig 2d) is a combination mode where the patient receives mandatory breaths synchronized with his breathing efforts and according to the selected SIMV mode. This mode is put in when the patient has somewhat recovered. The patient can breathe spontaneously with Pressure Support in between the mandatory breaths. In SIMV mode, the first triggered breath will be mandatory. The ventilator allows the patient to take spontaneous breaths, these breaths are supported with set pressure support. In the last 10% of the breath cycle time (Synchronization window), If the patient triggers a breath, it gets converted into a mandatory breath.

SIMV supports the following modes, depending on the modes installed:
SIMV (Volume Control) + Pressure Support
SIMV (Pressure Control) + Pressure Support

The mandatory breath is defined by the following basic settings:
Tidal Volume (depending on configuration), FiO2, I:E ratio/Inspiration time (depending on configuration), Respiratory rate, PEEP, Trigger pressure, Plateau Pressure support.

The Breath cycle time is the length of the mandatory breath (Inspiration + expiration) in seconds.

For example: For a respiratory rate of 12, the breath cycle time is of 5 seconds with an I:E ratio of 1:4 means that the inspiration will take 1 second and the expiration 4 seconds.

Steps to Set the SIMV Mode (fig 2d):
Step 1: Tap on the Mode setting button in the top menu
Step 2: Select Invasive mode by tapping on the radio button next to ‘invasive mode’
Step 3: Select the SIMV mode
Step 4: Select Volume or Pressure mode by tapping on the button
Step 5: Set the values in various parameters as per the requirement of the patient.
For example, in case Tidal volume is to be changed select tidal volume. Increase/decrease the Tidal volume by dragging the slider or by rotating the knob on the respiratory unit.

Step 6: Set the Trigger pressure which is below the peep level (units cmH2O)
For Example: if PEEP is 3 and Trigger is 2, That means if the pressure becomes less than 1 during the patient spontaneous breath, it will take as patient trigger breath and deliver pressure support as per set parameter of pressure support. Here the pressure support is an extra parameter which is Pressure support on the patient breath.
Step 7: Tap on the accept button on the screen or press adjusts knob to accept.
Step 8: Tap on the Start button on the bottom right corner on the screen to start ventilation.

In accordance with the exemplary embodiment of the present invention, Pressure Regulated Volume Control (fig 2e) Mode is an invasive ventilation mode. Here, the patient is provided with a target Tidal Volume (2) to be delivered with pressure control and within the pre-set pressure limit (1).

Here parameters like pressure, oxygen percentage, RR, IE ratio, PEEP and Plateau time can be varied.

In order to change the values of the parameters, tap the parameter and increase/decrease the values using the slider or physical knob. Click on accept after the desired values are set. Click on start to start the ventilation.

Steps to Set the CMV Mode (fig 2e):
Step 1: Tap on the Mode setting button in the top menu
Step 2: Select Invasive mode by tapping on the radio button next to ‘invasive mode’ Step 3: Select the CMV mode
Step 4: Select Tidal Volume and Pressure Limit by tapping on the respective parameters. Tidal volume is target delivered volume and pressure limit is pressure will not go beyond the limit. This is pressure regulated and volume control ventilation mode. Mode operates in pressure control and delivers set volume.
Step 5: Set the values in the various parameter as per the requirement of the patient.

For example: In case Tidal volume is to be changed, select tidal volume, Increase/decrease the Tidal volume by dragging the slider or by rotating the adjustment knob on the respiratory unit front panel.
Step 6: Tap on the accept button on the screen or press adjusts knob to accept.
Step 7: Tap on the Start button on the bottom right corner on the screen to start ventilation.

The PSV or Pressure support ventilation is a non-invasive mode of ventilation. It is a spontaneous mode with each breath is supported with pressure support and PEEP at desired FiO2.

In accordance with the exemplary embodiment of the present invention, A continuous PEEP (Positive End Expiratory Pressure) (fig 2f) is provided to prevent end-expiratory alveolar collapse.
Please note NIV mask should be used in this mode.

Steps to Set the PSV Mode (fig 2f):
Step 1: Tap on the Mode setting button in the top menu
Step 2: Select Non Invasive mode by tapping on the radio button next to ‘Non Invasive mode’
Step 3: Select the PSV mode
Step 4: Set the values in various parameters as per the requirement of the patient.
Here pressure support will be provided by the ventilator when the patient takes spontaneous breaths. The apparatus generates high priority alarm if patient not taken/triggered spontaneous breaths more than or equal to RR min parameter set value,
Step 5: Tap on the accept button after changing parameters
Step 6: Tap on the Start button on the bottom right corner to start ventilation.

In accordance with the exemplary embodiment of the present invention, The CPAP (fig 2g) ventilation is a non-invasive mode of ventilation. It is open PEEP or continuously delivery of air oxygen mixture to the patient. It is used for spontaneously breathing patients. This mode also requires an NIV mask for ventilation.

In order to change the values of the parameters, tap the parameter and increase/decrease the values using the slider or physical knob. Click on accept after the desired values are set. Click on start to start the ventilation.

Steps to Set the CPAP mode (fig 2g)
Step 1: Tap on the Mode setting button in the top menu
Step 2: Select Non Invasive mode by tapping on the radio button next to ‘Non Invasive mode’
Step 3: Select the CPAP mode
Step 4: Set the values in various parameters as per the requirement of the patient.
Here continuous positive airway pressure will be provided by the ventilator when the patient takes spontaneous breaths.
Step 5: Tap on the accept button after changing parameters
Step 6: Tap on the Start button on the bottom right corner to start ventilation.

In accordance with the exemplary embodiment of the present invention, Paediatric Mode (fig 2h) In case the ventilator is to be connected to a patient up to 12 years of age then the paediatric mode should be selected. In order to operate the ventilator in paediatric mode tap on the check box “paediatric mode”. All the modes like CMV, A/CMV, SIMV, PRVC, PSV, CPAP etc. can be set in the paediatric mode. The range of the parameters is restricted in the paediatric mode. The display on the bottom left corner also starts to show paediatric mode. A sample screen is shown as under:

Once all the parameters are set the Start button must be pressed. On pressing the start button the following can be seen:
1. The start button automatically changes to stop
2. The ventilation timer starts to be operational.
3. The dot next to the timer changes from red to green
4. The ‘set’ parameters are shown at the bottom of the screen
5. Live data of various parameters can be seen on the right side of the screen.

In case the parameters are to be changed after ventilation has started then tap on the parameter to be changed in the mode setting screen, the parameter gets highlighted and then change it using the knob at the bottom right corner. As soon as a parameter is changed the Accept button gets highlighted. Click on the “Accept” button to set the changed parameter.

In accordance with the exemplary embodiment of the present invention, 100% O2 (fig 2i) In case this option is selected then 100 % is provided to the patient for 3 minutes.

In accordance with the exemplary embodiment of the present invention, Nebulizer On (fig 2j): In case this option is selected then the connected nebulizer will be on for a period 5 minutes.

The procedure to connect the nebulizer is given in the following pictures
Connect the nebulizer cable to the Respiratory Unit.
Connect the nebulizer to the inspiratory circuit using a T Junction.
Pour the required drug into the nebulizer unit by unscrewing the nebulizer cover. Put the cover back after the drug is poured.
Start nebulization.

The following are the different alarms available in the apparatus:
Sl No. Alarm Cause of Alarm Resolution
1. Power Failure - No Input Supply
- AC Power switch turned OFF on the Respiratory Unit Check power supply and connections.
Ensure the power switch is ON.
2. Patient Disconnected - The patient circuit could have been disconnected or loosely connected Check patient circuit
3. Gas Supply Failure - No input gas from a compressor or central supply Check the central supply line in the case connected to hospital line
Ensure the compressor is ON in case connected to the compressor
4. High PIP - There could be blockage/kink/obstruction in the patient tubes Clear the blockage/kink/obstruction in the patient tube.
Check patient’s airway for any blockage
Check if the patient is biting the endotracheal tube
5. Low PIP - There could be leakage or the patient tube could be loosely connected. Check for leaks at connectors, water traps, endotracheal tube cuff.
6. Apnea - The patient is not taking breaths as per physician’s setting
- If the patient is not taking breaths continuously for 20 seconds Check for spontaneously breathing of the patient.
Go for mandatory breath modes.
7. High Respiratory rate - If the patient is breathing more than the high value of RR alarm setting. - Call physician
8. Low Respiratory rate - If the patient is breathing less than the low value of RR alarm setting. - Call physician
9. High PEEP - Caused if there is air trapped in the lungs
- Exhale time setting is insufficient. - Check whether PEEP value is set too high and there is insufficient exhale time.
10. Low PEEP - Caused if there is a leakage in the exhale valve - Check if exhale valve is fitted properly
11. High Tidal Volume - Fault in inspiratory valves/flow sensors
- If the physician set values are higher than the alarm setting. - Check Alarm limit settings.
- Call for Technical Assistance if the alarm is not resolved.
12. Low Tidal Volume - There could be leakages in the patient circuit or endotracheal tube cuff or expiratory valve
- If the physician set values are lower than the alarm setting. Check for patient tube or expiratory valve leaks or ET tube cuff leakage.
Reconfirm alarm limit settings
13. Low Minute Volume - There could be leakages in the patient circuit or endotracheal tube cuff or expiratory valve
- If the physician set values are lower than the alarm setting. Check for patient tube or expiratory valve leaks or ET tube cuff leakage.
Reconfirm alarm limit settings
14. High Minute Volume - If the set values are not correct
- The patient is taking high spontaneous breaths. Call physician.
Reconfirm alarm limit settings or provide suitable treatment to the patient.
15. Low FiO2 - Oxygen supply is low from hospital lines or gas cylinder
- There could be a settings issue
- There could be a problem in the oxygen cell - Check oxygen supply
16. High FiO2 - There could be a settings issue
- Air supply could be low Check air supply
17. Regulation Pressure Limited Pressure limit parameter value in the PRVC mode is not sufficient to deliver target volume Increase the pressure limit or reduce target tidal volume as per the physician’s suggestion
18. Ventilator Inoperative Valves or sensors may not be functional Call Technical support
19. Ventilator Not Connected message The Respiratory unit may not be switched on. Switch ON the respiratory unit.
20. Low Battery The battery power is <=20% Connect the respiratory unit to the mains.
21. Continuous High Pressure If there any air traps Check and clear air traps.
22. Exhale Valve Failure If the exhale valve is not fitted properly Fit the exhale valve properly
23. High Temperature Cooling Fan may not be working Call Technician
24. RR minimum limit In the spontaneous breaths of the patient in PSV mode in less than RR min parameter value this alarm is a trigger Change the mode as the patient is not able to breathe.

In accordance with the exemplary embodiment of the present invention, Cleaning and sanitizing procedure in general, always clean all outer surfaces of the ventilator with surgical spirit or any non-detergent based disinfecting liquid after every use.

In accordance with the exemplary embodiment of the present invention, all menu driven system provides customizable information at the point of care or to wherever the clinicians/physician desire, though Android and iOS Apps. The mobile apps for Android and iOS enable the clinicians to monitor parameters remotely.

In accordance with the exemplary embodiment of the present invention, the apparatus can be operated in a non-hospital environment and will enable the experts to guide the ventilator parameter locally. In situations where Air and Oxygen lines are not available, this option will help in ventilating the patients with compressor and oxygen cylinder provision, the apparatus can record patient data and has an option for printing reports, the apparatus can operate in a failsafe manner under the guidance of the physician.
,CLAIMS:5. CLAIMS
I/We Claim
1. An apparatus for respiratory support (100), wherein the apparatus (100) comprises of:
a respiratory unit at an elevated position on a stand comprising of a control unit (2), and a control and monitor display (4);
a portable air compressor (6) placed over a platform beneath the respirator unit;
an oxygen cylinder (62), a resuscitator (not shown), accessories for operation, a battery system, and pipes for connecting inlet and outlets of the said control unit to carry air, oxygen at inlet and mixed air with oxygen at outlet;
the said apparatus is provided with trolley wheels with locking mechanism;
the respiratory unit comprises a control unit (2), a control and monitory display (4);
the said control unit (2) an inlet, an outlet, pressure valves to control airflow, and a mixing chamber (38);
the said control unit (2) comprises of micro-flow pressure sensors (50), electronic circuitry (34) to regulate the flow of oxygen or air and a software component configured to provide control of the said apparatus and monitoring of the patient’s vitals;
the control and monitoring display (4) allow the clinician to set a ventilation mode as required;
the said mixing chamber comprises an inspiratory channel (12) and expiratory channel (60);
the said control unit comprises an inspiratory channel that includes air and oxygen lines with air inlet port (22) and oxygen inlet ports (20);
the said airline comprises of a pressure regulator (30), a flow meter (32), a proportional flow control valve (36);
the said oxygen line comprises of a pressure regulator (40), a flow meter (42), a proportional flow control valve (46);
the said air and oxygen lines meets at a mixer chamber (38) in which the oxygen and air mixes to further proceed to an inspiratory inlet port (12);
the mixed air in the said mixer chamber (38) is monitored by an oxygen sensor for desired percentage of oxygen to be delivered that is preset/selected by the clinician;
a pressure sensor (50) is provided after the said oxygen sensor to recheck the pressure of the mixed air that will be delivered to the said inspiratory port (12);
Characterized in that
the said flow meter (42) after the said pressure regulator (40) in both air and oxygen lines inputs value to a controller board (44) for feedback,
the said mixer chamber (38) comprising of electronic valve control system (not shown) will not allow any leakages of inlet air, oxygen and mixed air;
the said apparatus stores parameters like pressure, respiratory rate, tidal volume, peak flow rate, PEEP, pressure support, inspiratory pause, Inspiratory: Expiratory (I:E) Ratio, Trigger pressure sensitivity, and FiO2;
the said apparatus monitors Peak Pressure and Tidal volume, Spontaneous Volume, I:E ratio, PEEP, Static compliance and resistance, FiO2 Percentage;
the said micro-flow pressure sensors and related software component ensures, patient behavior-based ventilator operations; and
the said apparatus is configured to provide atmospheric air, pure oxygen or a combination of oxygen and atmospheric air depending on the patients breathing patterns.

2. The apparatus according to claim 1, wherein the compressor (6) and an oxygen cylinder are provided as optional accessories to be used in places where hospital lines are not available.

3. The apparatus according to claim 1, wherein the apparatus is portable and is easy to set up either on a trolley for easy movement or can be operated from the carrying case.

4. The apparatus according to claim 1, wherein the procedure to switch ON the respiratory support comprises steps of:
switch on the mains power supply;
switch on the air compressor;
ensure the reading on the compressor and the regulator read 4 bars;
switch on the mains power on the ventilator;
flip opens the red switch on the ventilator and press the red button once;
close the flip switch;
press the ON/OFF button on the display unit, wait for the application software to start up;
perform the pre-use and diagnostic checks;
set the upper and lower alarm limits; and
select ventilation mode (with requisite settings) and start ventilation.

5. The apparatus according to claim 1, wherein the procedure to switch OFF the respiratory support comprises steps of:
ensure patient circuit is disconnected;
switch OFF the air compressor;
close the regulator valve in the cylinder; and
flip opens the red switch on the ventilator and give a long press to the red button (5 seconds), the display unit and ventilator shuts down.

6. The apparatus according to claim 1, wherein the apparatus is portable to use in different purposes of ventilation like Continuous Mandatory Ventilation (CMV), Assist Controlled Mandatory Ventilation (A/CMV), Synchronous Intermediate Mandatory Ventilation (SIMV), Pressure Regulated Volume Control (PRVC), Pressure Support Ventilation (PSV) and Continuous Positive Airway Pressure (CPAP) can be set up by the clinician in the mode setting screen.

7. The apparatus according to claim 1, wherein the control unit (2) has a facility to connect an external ultrasonic nebulizer, wherein the procedure to connecting the nebulizer includes steps of:
connecting the nebulizer cable to the respiratory unit;
connecting the nebulizer to the inspiratory circuit using at junction; and
the required drug into the nebulizer unit by unscrewing the nebulizer cover.

8. The apparatus according to claim 1, wherein the control unit (2) has a provision to connect a humidifier, wherein the humidifier comprises of a:
humidifier chamber, de-ionized water, and a limb from the humidifier;
the procedure to connecting the humidifier includes steps of:
sliding the humidifier in slot provided, and adding de-ionized water up to a lever indicated on the chamber;
connecting a small limb from the humidifier to inspiratory port and other end is connected to the inspiratory port; and
the inspiratory circuit of the patient should be connected to the other outlet of the humidifier chamber.

9. The apparatus according to claim 1, the apparatus has alarm limits, to allow ranges of the lower and upper limits for alarms like pressure, volume, FiO2 and minute volume for alarms to be set, and has a feature to pre-set parameters.

10. The apparatus according to claim 1, the apparatus needs to be pre-use check and cleaning and sanitizing precautions.

6. DATE AND SIGNATURE

Dated this 24th day of December 2021
Signature

(Mr Srinivas Maddipati)
Authorized Signatory at IP Cell
For., Zen medical technologies private limited