DESC:FORM 2
THE PATENT ACT 1970
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule 13)

1. TITLE OF THE INVENTION:
A BREATHING APPARATUS
2. APPLICANT

Name: Mediklik Webhealth Pvt Ltd
Nationality: An Indian Company
Address: 401, Crystal Arcade, Avanti Bai Chowk, Raipur (CG), India

3. PREAMBLE TO THE DESCRIPTION:
PROVISIONAL
The following specification describes the invention. COMPLETE
The following specification particularly describes the invention and the manner in which it is to be performed.

A BREATHING APPARATUS
FIELD OF THE INVENTION:
The present invention relates to medical devices, and more particularly, the present invention relates to a breathing apparatus integrated with inspiratory and expiratory assemblies for a respirator.
BACKGROUND OF THE INVENTION
A mechanical ventilator is a medical device utilized to assist or replace natural breathing during surgery or in a critical illness, to improve respiratory function, to reduce respiratory energy consumption, and to save heart reserve. The respirator controls the delivery of respiratory gas to a user such as a patient to supplement the patients breathing efforts or to cause the inflation and deflation of a non-breathing patient's lung.
Breathing takes place in two phases, first is an inspiratory phase, in which a patient inhales the gas and the second is the expiratory phase in which the patient exhales the gases. The respirator manoeuvers the entire operation during these two phases by two different ports to accurately control the breathing. One is an inspiratory port to provide the gas flow during the inspiratory phase to the patient, and the second is an expiratory port from which the patient’s breathe returns towards the respirator during the exhalation cycle.
The inlet blocks are a common component of ventilators generally located close to the patient’s inspiratory end. The inlet blocks have a pressure relief valve assembly for protection from excessive pressure in the pneumatic system and are used directly as an inspiratory inlet for the patients. One side of the inlet block is connected to the pneumatic flow control of the system, and the other side is treated as the respirator’s output port and is connected to any breathing circuit, a humidifier, a bacteria filter, and the like.
The safety valve in the inlet block is a switch valve between atmospheric air and the respirator’s pneumatic flow output of the machine. In a normal scenario or standby, the safety valve is in the open state, and as soon as the ventilation begins, the valve is activated and remains closed to ensure the pneumatic flow output of the respirator is connected with the machine outlet.
In the event of power failure, standby, or spontaneous breathing by the patient, the safety valve is deactivated and comes in a natural state, i.e., open state, and connects the second airway to the patient inlet. This allows the patient to inhale atmospheric gases in the event of power failure or spontaneous breathing awareness, mainly to prevent suffocation during any adverse event or human-machine confrontations.
The safety valve itself acts as a pressure relief valve to limit the pneumatic pressure of the machine and opens during the inspiratory cycle to release excessive pressure other than the threshold set by an operator.
In order to accurately control the delivery of respiratory gas, the pressure in the patient circuit is controlled so that the gas is released during an exhalation phase and, typically but not always, the flow is completely blocked during an inhalation phase. For that, the exhalation (PEEP) valve is moved between open and closed positions according to the phase of the breathing cycle.
During the inspiration phase, the exhalation valve is closed to allow delivery of the compressed gas from the ventilator to the patient. During the exhalation phase, the exhalation (PEEP) valve opens to allow the patient to exhale to the atmosphere.
The Variable Orifice Differential Flow Sensing Technique is used for monitoring the pressure and flow of exhaled gases. To do so, a flapper orifice plate is introduced between two pressure measuring points inside the expiratory port itself. The flapper orifice plate serves as a variable orifice that increases in size with larger flows. The sample pressures are collected from both sides of the orifice, and the flow and pressure are calculated for the exhaled breath.
The gas flowing through the entire assembly consists of the air exhaled by the patient. Whether the gas flows at the expiratory side during exhalation or releases excess pressure during the inspiratory cycle, this ensures the need for cleaning and disinfection of the cassette before being used again.
In existing respirators, sterilization and maintenance is complex and the cost is high, the drawbacks of the existing system are as listed below;
• Most of the existing respirators have monolithic inspiratory ports and only the expiratory port is detachable assembly, which makes the regular disinfection of the inspiratory assembly impossible. To prevent cross-contamination in these machines, appropriate consumable filters are used, which increases the running cost for the machine.
• The existing respirators either do not have detachable inspiratory assemblies and even if they have the expiratory and inspiratory assemblies, they are separate units, which increases the difficulty in handling, hassle in disinfecting, and complexity in procedure to attach/detach the units without causing leakage.
• The proper sterilization of such parts is very crucial which gets in contact with the patient’s breathing. If the parts are not sterilized properly, it may cause infection or cross-contamination. Although the most common, least expensive, and most effective way of sterilization is high-temperature sterilization or autoclave in which the parts are to be exposed to 135°C for at least 15 minutes. However, the existing respirators recommend various cleaning and disinfection methods like ETO, plasma sterilization, chemical sterilization, and sometimes autoclave, depending upon the robustness and criticality of the parts used, some of the respirators even have different recommendations for different parts. Even with the autoclave sterilization in the existing respirators, there is no way to identify if the units are properly disinfected or not. These ambiguous practices sometimes lead to cross-contamination and sometimes resulting in disaster.
• To measure the flow of the exhaled gases, samples are needed to be drawn from the patient’s exhaled breath, and to ensure accuracy, the sample collection module needs to be placed in the main airway of the patient’s breath. At the same time, it increases the chances of cross-contamination if the flow sensor is not sterilized or not replaced.
• To overcome this problem in the existing respirators, the measurement of the flow of exhaled gases is done either via disposable sensors or via expensive reusable sensors with limited life. The running cost of the respirator is very high in both cases.
• In the existing respirators the patient’s exhaled gases are relived in the atmosphere after passing through a disposable bacteria filter. The changing of the bacteria filter every time is expensive and increases the running cost of the respirator. And if the filter is not applied, the gases released in the surrounding atmosphere may be very harmful to other patients and for doctors as well.
Accordingly, there exists a need for a breathing apparatus with integrated inspiratory and expiratory assemblies, which is detachable, autoclavable, and with inbuilt indicator for proper sterilization.
Object of the invention
An object of the present invention is to provide inspiratory and expiratory assemblies integrated with a detachable structure of a breathing cassette assembly.
Another object of the present invention is to integrate an easily detachable structure for sterilization in a breathing cassette assembly.
Yet, another object of the present invention is to provide an integrated autoclavable unit for respirator capable of sterilizing at high temperature, easy to use, remove and handle.
Yet, another object of the present invention is to ensure the safety of the patients and other people surrounding them, like other patient’s, Doctors, Nurses etc.
Yet, another object of the present invention is to integrate various parts in the detachable structure to enable the breathing cassette assembly to perform multiple functions including pressure monitoring at expiratory and inspiratory on both sides, flow measurement of exhaled gases, data logging for effective sterilization, communication port for data logger, sterilization of exhaled gases before releasing to the atmosphere, and accommodating membranes for PEEP valve and safety valve.
Yet, another object of the present invention is to provide a mounting assembly for the breathing cassette to enable multiple functionalities like providing mounting support for the PEEP valve, the safety valve, the UVC sterilization assembly, and the communication unit.
Yet, another object of the present invention is to ensure the proper sterilization of the parts of the breathing cassette assembly.
Yet, another object of the present invention is to reduce the complexity and running cost of the breathing cassette assembly.
Yet another object of the present invention is to enhance patient safety and ensure precise gas delivery.
SUMMARY OF THE INVENTION
The present invention discloses a breathing apparatus comprising a mounting assembly fitted on a respiratory machine, and an autoclavable breathing cassette assembly detachably secured in the mounting assembly.
The mounting assembly includes, an air disinfector unit secured in an exhaled breath collecting chamber close to the exhaled air outlet, a safety valve secured on a mounting box, and a positive end-expiratory pressure (PEEP) valve secured on the mounting box. The air disinfector unit includes a plurality of UV LED lights and at least two guide fins, wherein the plurality of UV LED lights are configured for disinfecting exhaled breaths from the patient before getting released into the atmosphere, and at least two guide fins are configured for restricting the light from coming out of the exhaled air outlet to increase the exposure of the UV LED light inside the chamber. The safety valve is configured with ON/OFF functionality for connecting an airway channel to the atmosphere allowing atmospheric breathing for the patient. The PEEP valve is configured to maintain a minimum pressure at the end of the exhalation cycle and close the airway channel between the atmosphere and the patient’s exhaled breath, after releasing the exhaled air into the atmosphere.
The breathing cassette assembly comprises an air outlet assembly and an exhaled air outlet fitted on the mounting box, an inspiratory assembly, an expiratory assembly, and a data logger assembly. The air outlet assembly includes a plurality of channels for an expiratory air outlet, an inspiratory air outlet/ patient inlet, and a non-return valve. The exhaled air outlet includes an air channel for releasing exhaled breaths from a patient to the atmosphere. The inspiratory assembly includes, an air sample collection line setup with the PEEP valve, wherein the air sample collection line is configured for monitoring the inspiratory pressure; a non-return valve configured for ensuring the unidirectional flow of the gas from the respiratory machine to the inlet via a first airway, a safety valve actuating assembly configured for controlling the ON/OFF functionality of the safety valve and connecting the inlet to the atmosphere via a second airway upon excitation; and an inspiratory air release pocket connecting the atmospheric air channel to the second airway and a pressure monitoring channel. The inspiratory assembly is configured to allow a unidirectional gas flow towards the inlet, monitor the precise value of inspiratory pressure and ensures air flow from the atmosphere to the inlet in case of failure in the respiratory machine. The expiratory assembly comprises a flow monitoring module having a metal flapper and at least two sampling channels secured in exhalation channel, for connecting a differential pressure sensor to measure the flow of air therethrough; a PEEP valve actuating assembly configured to receive a push from the PEEP valve (17) on a membrane therein and disconnect the expiratory airway from the atmosphere to ensure a minimum pressure in the airway suitable for patient’s lung at the end of each of the breath cycles, and an expiratory air release pocket coupled to the air disinfector unit wherein the expiratory air release pocket allows the exhaled air to be passed through the disinfector unit before released into the atmosphere through the non-return valve. The data logger assembly comprises a temperature data logger secured on a data logger circuit board, the temperature data logger configured to monitor the temperature and timing during autoclaving process; and a transmission unit embedded on the data logger circuit board, and is configured to establish communication between the temperature data logger and the respiratory machine. The data logger assembly is configured for monitoring the sterilization cycle of the breathing cassette assembly, comparing with a preset value of temperature and timing, recording temperature values during the sterilization cycle to ensure disinfection process before connecting to the respiratory machine after every use.
The apparatus ensures a unidirectional flow of air from the respiratory machine to the patient via the inspiratory assembly and restricts contamination of the air in the breathing cassette assembly by passing the exhaled air towards the atmosphere after disinfection via the expiratory assembly and allowing sterilization of the breathing cassette assembly and the components therein, that is in direct contact with the patient's breath to make the breathing cassette assembly autoclavable.
BRIEF DESCRIPTION OF DRAWINGS
The objects and advantages of the present invention will become apparent when the disclosure is read in conjunction with the following figures, wherein
Figure 1 shows an exploded view of a breathing cassette assembly, in a breathing apparatus, in accordance with an embodiment of the present invention;
Figures 1a and 1b respectively illustrate a left-side view and a right-side view of the breathing cassette assembly in the breathing apparatus, in accordance with an embodiment of the present invention;
Figure 2a illustrates a perspective view of the detachable breathing cassette assembly in a breathing apparatus, in accordance with an embodiment of the present invention;
Figure 2b illustrates an exploded view of the detachable breathing cassette assembly in a breathing apparatus, in accordance with an embodiment of the present invention;
Figure 3a,3b&3c respectively illustrate left side view, a front view and a right side view of the mounting assembly of the breathing apparatus, in accordance with an embodiment of the present invention; and
Figure 3d illustrates an exploded view of the mounting assembly in a breathing apparatus, in accordance with an embodiment of the present invention.
DETAIL DESCRIPTION OF THE INVENTION
The foregoing objects of the present invention are accomplished and the problems and shortcomings associated with the prior art, techniques, and approaches are overcome by the present invention as described below in the preferred embodiment.
The present invention provides a breathing apparatus integrated with inspiratory and expiratory assemblies for a respirator. The apparatus comprises a breathing cassette assembly removably mounted in a mounting assembly allowing a patient to avail the support of the respirator in a hygienic and safer way.
The present invention is illustrated with reference to the accompanying drawings, throughout which reference numbers indicate corresponding parts in the various figures. These reference numbers are shown in bracket in the following description and in the table below.
Table:
Ref No: Component Ref No: Component
100 Breathing cassette assembly 24 Pressure monitoring channel

101 Detachable breathing cassette 25 Inspiratory port
102 Mounting assembly 30 Expiratory assembly
1 Non-return valve assembly 31 Flow monitoring module
4 Metal flapper 32 PEEP valve actuating assembly
5 Two sampling channels 33 Expiratory air release pocket
10 Mounting box 34 Expiratory Port
11 Exhaled air outlet 35 Silicon Cover (membrane)
12 UVC disinfector unit 40 Data logger assembly
13 Spring ejection assembly 41 Temperature data logger
14 Quick-release assembly 42 Transmission unit
15 Communication unit 43 Power supply
16 Safety valve 50 Base plate
17 Positive end-expiratory pressure (PEEP) valve 61 Front Plate
18 Ejection shafts
62 Inspiratory cover plate
19 Base plate 63 Expiratory cover plate
20 Inspiratory assembly 64 Sliding cover
21 Non-return valve 71 Mass Flow Sensor
22 Safety valve actuating assembly 72 Mounting Cover
23 Inspiratory air release pocket
Referring to figures from 1 to 3, a breathing apparatus (100) (hereinafter referred as “the apparatus (100)”) is shown in accordance with the invention. The apparatus (100) comprising a breathing cassette assembly (101) detachably secured in a mounting assembly (102) for connecting a respiratory machine to a patient inlet.
The breathing cassette assembly (101) comprises an air outlet assembly, an exhaled air outlet (11), an inspiratory assembly (20), an expiratory assembly (30), a data logger assembly (40), and a base plate (50). The base plate (50) allows a mesh for the air release channel. The breathing cassette assembly (101) ensures easy sterilization of all the components therein, that are in contact with patient’s breath directly. After detaching, the detachable breathing cassette assembly (101) is capable of being sterilized via a commonly available technique such as a high-temperature sterilization.
The mounting assembly (102) comprises a mounting box (10), a UVC disinfector unit (12), a quick-release assembly (14), a power supply unit, a communication unit (15), a safety valve (16), and a positive end-expiratory pressure (PEEP) valve (17). The mounting assembly (102) provides support to all the valves present in the breathing cassette assembly (101), and allows the valves to function as designed.
Further, the safety valve (16) is fitted on the mounting assembly (102) with the help of suitable fitting means. In an exemplary embodiment of the invention, the safety valve (16) is an electromagnetic linear valve fitted on the mounting assembly (102) with the help of suitable fitting means. The safety valve (16) is a stationary part with ON/OFF functionality for atmospheric breathing for the patient. The safety valve (16) comprises a shaft and a pull tubular solenoid with a spring assembly. The shaft is provided on the top thereof, and the spring assembly is provided at the bottom. The safety valve (16) is configured to connect the atmospheric airway channel to the atmosphere for inhalation purpose in case of an adverse event or failure of the components.
Further, the PEEP valve (17) is a voice coil valve mounted on the mounting assembly (101). The PEEP valve (17) functions by moving a shaft between the voice coils in a linear direction. During operation, upon excitation, the shaft presses a silicon membrane placed on the expiratory side of the breathing cassette (102) and keeps the airway channel between the atmosphere and the patient’s exhaled breath closed when the exhaled air is released into the atmosphere. The PEEP valve (17) is provided with a base for mounting on the mounting assembly (102). In one of the exemplary embodiment of the invention, the PEEP valve (17) is provided with a metal base for mounting on the mounting assembly (102) by using fixing means preferably by using screws. In one of the exemplary embodiment of the invention, the PEEP valve (17) is positioned in the center of the mounting assembly (102). The base plate (19) is kept to support the placement of the PEEP valve (17) sturdy in position. Further, the PEEP valve (17) maintains a minimum pressure at the end of the exhalation cycle and closes the first atmospheric channel accordingly.
Further, the inspiratory assembly (20) comprises the first airway allowing air passage from the respiratory machine to the inlet, a second airway allowing the air passage from the atmosphere to the inlet, a sample collection line, a non-return valve (21), a safety valve actuating assembly (22), an inspiratory air release pocket (23), and a pressure monitoring channel (24). The sample collection line is configured to collect the sample for pressure at the nearest end to the patient to monitor the precise value of inspiratory pressure. The inspiratory assembly (20) is directly connected with an inlet for a patient and the breathing cassette (101). The inspiratory assembly (20) provides precise and unidirectional gas flow delivery during normal active ventilation. Additionally, the inspiratory assembly (20) ensures the airway channel connected to the patient is a unidirectional flow channel. This allows the channel to collect the sample for pressure at the nearest end to the patient to monitor the precise value of inspiratory pressure and ensures that the patient can breathe from the atmosphere in adverse situations by eliminating the chances of being suffocated.
In one of the exemplary embodiment of the invention, the non-return valve (21) is a detachable silicon flap assembly. The non-return valve (21) ensures the flow of the gases from the respiratory machine to the patient via an inspiratory channel, where the gas flow is unidirectional, thus, air flow from the patient to the breathing cassette via the inspiratory channel is not possible. This restricts contamination of the air therein and the components that are in direct contact with the patient's breath can be removed and sterilized.The safety valve actuating assembly (22) has at least two circular ducts, a silicon membrane, and a metal insert. The first duct is a smaller duct and is connected to the first airway channel. The second duct is a duct with a bigger diameter and placed over the smaller duct. The bigger duct is connected to the air release pocket which is directly connected to the atmosphere. In an embodiment, the silicon membrane is a removable flap. The silicon membrane with the metal insert is placed on the bigger duct in such a way that on pressing the silicon membrane, the smaller duct is blocked and disconnected from the bigger duct. When there is no pressure applied on the silicon membrane, due to a positive pressure inside the small duct, the silicon membrane is open and both ducts are interconnected. Thus the second airway is connected to the atmosphere and allows the patient to take breaths from the atmosphere, avoiding any chances of suffocation. The force implied to the silicon membrane to keep the ducts disconnected is achieved via the safety valve (16). The shaft of the safety valve (16) keeps a positive pressure on the silicon membrane on excitation. In the absence of excitation, the shaft comes back to its original position and both the ducts get connected.
Further, the safety valve (16) is configured for triggering the safety valve actuating assembly (22). In the embodiment, the shaft in the safety valve (16) moves up and down direction, to actuate the silicon membrane in the safety valve actuating assembly (22). The shaft goes up and presses the silicon membrane of the safety valve actuating assembly (22) upon excitation, and disconnects the first airway from the first atmospheric channel. Whereas, under excitation, the safety valve (16) remains in the down position due to the spring force. Therefore, the silicon membrane of the safety valve actuating assembly (22) is not pressed and hence the first airway stays connected with the first atmospheric channel. This way, the safety valve (16) does not touch the patient's breath or the airway directly but controls the ON/OFF functionality of the airway channel to the atmosphere.
Further, in one of the exemplary embodiments of the invention, the safety valve actuating assembly (22) is a combination of an electromagnetic valve, a spring, and a shaft. The safety valve actuating assembly (22) is configured to operate in two positions, such as ON and OFF with an initial and stable state of OFF position such that when experienced with spring force and no electric excitation, the safety valve (16) stays in a neutral or OFF state, but changes the state to ON when provided with an electric current to the electromagnetic valve sufficient to surpass the spring force. During the ON state, the safety valve (16) keeps the inspiratory channel disconnected from the atmospheric channel. So in any adverse situation even if the respiratory machine is switched OFF, the safety valve (16) goes into a neutral state and connects the patient’s airway to the atmosphere avoiding suffocation.
Further, in one of the exemplary embodiments of the invention, the safety valve (16) is also configured for releasing the airway pressure to atmosphere in case of the pressure exceeds a threshold set by the user based on a feedback data from a pressure monitoring unit.
Further, the inspiratory air release pocket (23) is an airway to connect the second airway to the inspiratory assembly (20). The air release pocket (23) ensures that the second airway is well connected with the outside environment and that there is no blockage or resistance in the channel.
Further, the pressure monitoring channel (24) is a small sampling line taken out from the inspiratory assembly (20) to monitor the pressure from the nearest possible point to the patient. The pressure monitoring channel (24) is connected to a pressure sensor for getting the exact data. A rinse flow is ensured in the sampling line so that the sensor does not come in contact with the patient’s breath.
Further, the expiratory assembly (30) is a venturi-shaped assembly configured for maintaining a precise level of the patient end-expiratory pressure at a stable level and monitors the gas flow. The expiratory assembly (30) comprises a second atmospheric channel, an exhalation channel, a flow monitoring module (31), a PEEP valve actuating assembly (32), and an expiratory air release pocket (33). The expiratory assembly (30) is mounted on the mounting assembly (102) by means of a base plate (7). The flow monitoring module (31) includes at least one metal flapper (4) and at least two sampling channels (5) respectively disposed of in the exhalation channel. The two sampling channel inlets respectively disposed on both sides of the metal flapper (4). In an exemplary embodiment, the flapper (4) can be also made with thin plastic film. The two sampling channels (5) include a first sampling channel and a second sampling channel. In the embodiment, the sampling channels (5) are pressure sampling channels configured for taking pressure samples of the gases pass before and beyond the metal flapper (4). The metal flapper (4) is used to separate the first sampling channel and the second sampling channel in the expiratory assembly (30) as per the flow measurement principle for the gases. The metal flapper (4) is made of a material with high-temperature sustainability that makes the component free from damage during the high-temperature sterilization procedures. The two sampling channels (5) are then connected to a differential pressure sensor to measure the flow of the gases in the expiratory assembly (30). The metal flapper (4) and the sampling channels (5) are configured before the PEEP valve actuating assembly (32). This placement minimizes the effect of the PEEP valve actuating assembly (32) on flow values, thereby improving the flow monitoring accuracy.
Further, the PEEP valve actuating assembly (32) ensures precise positive pressure and maintains a minimum pressure at the end of the exhalation cycle and closes the atmospheric channel accordingly. The PEEP valve actuating assembly (32) has at least two tubes a first tube and a second tube and a silicon membrane with a metal insert. The first tube is smaller than the second tube and is connected to the sample collection side of the expiratory assembly which is connected to the expiratory side of the circuit. The second tube with a bigger diameter is placed over the first tube. The second tube is connected to an air disinfection unit which releases the gases into the atmosphere after disinfection. The silicon membrane with a metal insert is placed on the second tube in such a way that on pressing the membrane, the first tube is blocked and disconnected from the second tube. During the inhalation cycle, the pressure is built in the patient’s lungs and the first airway, and during the exhalation cycle the inspiratory valve is closed and the PEEP valve (17) is opened, so gases flow from the patient’s lung and the first airway towards the expiratory assembly (30). At the moment pressure reaches the set value of PEEP, the PEEP valve (17) again pushes the silicon membrane of the PEEP valve actuating assembly (32) and disconnects the expiratory airway from the atmosphere, hence a minimum pressure is ensured in the airway and patient’s lung at the end of the breath cycle.
Further, in one of the exemplary embodiments of the invention, the PEEP valve actuating assembly (31) and the safety valve actuating assembly (22) are electromagnetic components coupled to a controller that is communicatively coupled to the data logger assembly (40). The controller is configured with an application for receiving threshold values set by the user and the monitoring modules connected thereto. The controller is further configured for triggering the PEEP valve actuating assembly (31) and the safety valve actuating assembly (22) based on values set by the user or data obtained from the monitoring modules such as the pressure monitoring unit.
In one of the exemplary embodiment of the present invention, the inspiratory valve is an internal component of the respiratory machine that is responsible to control flow, Pressure, and volume in the inspiratory channel. The inspiratory channel acts as a medium and provides a base to accommodate the safety valve (16), and the non-return valve (21). Thus the inspiratory valve is configured to control the flow/pressure/volume of the gas delivered to the patient via the inspiratory channel of the breathing cassette.
The gases that expired through the expiration assembly (30) go into the expiratory air release pocket (33). The expiratory air release pocket (33) is connected to the UVC disinfector unit (12). Thus, the exhaled air first passes through the UVC disinfector unit (12) and then is released into the atmosphere through a non-return valve assembly (1).
The data logger assembly (40) logs the data of the sterilization cycles and confirms if the proper sterilization is done for the detachable breathing cassette (101). The data logger assembly (40) comprises a temperature data logger (41), a transmission unit (42), and a battery (43). In one of the exemplary embodiment of the invention, the data logger assembly (40) is encapsulated by a suitable material that prevents the data logger assembly (40) from getting damaged during the high-temperature sterilization process. Further, the data logger assembly (40) records the data of the high-temperature sterilization cycle to ensure that the breathing cassette (101) is disinfected properly before connecting to the respiratory machine after every use. The data logger assembly (40) also allows the users to access all the temperature and sterilization logs after connecting the assembly (100) to the respiratory machine. In case the breathing cassette assembly (100) is not sterilized to a recommended temperature or for a suitable time period, the user gets a warning to sterilize on connecting back the breathing cassette assembly (100) to the respiratory machine.
The temperature data logger (41) is configured on a data logger circuit board and is used to log the temperature and timing above a preset value of temperature. In an embodiment, the transmission unit (42) is a spring contact or a wireless transmission module. Further, the transmission unit (42) is embedded on the data logger circuit board to transmit the data back to the respirator machine, once the detachable breathing cassette (101) is inserted therein. Additionally, the transmission unit (42) is placed between the inspiratory assembly (20) and the expiratory assembly (30) on the mounting assembly (102). The transmission unit (42) consists of a plurality of contact points to establish the connection between the mounting assembly (102) and the detachable breathing cassette (101), while the detachable breathing cassette (101) is inserted therein. The transmission unit (42) accommodates communication between the data logger (40) on the breathing cassette assembly (100) and the main respiratory machine. The transmission unit (42) transmits all data along with the unique ID of the breathing cassette assembly (100) back to the respirator machine to keep a log of the patient data to avoid any cross-contamination.
The power supply (43) is connected to the the data logger circuit board and is secured within the data logger assembly (40). In the embodiment, the power supply comprises a plurality of batteries with a printed circuit board capable of sustaining high-temperature sterilization cycles. The battery (43) provides power to the breathing cassette assembly (100) when it is disconnected from the respirator machine.
The mounting box (10) is configured with a positioning port for the exhaled air outlet (11) at the left side of the center therein, a port for the transmission unit (42) at the right of the center therein, a port for the inspiratory assembly (20) and the pressure monitoring channel (24) at the bottom side therein, a port for the expiratory assembly (30) and the PEEP valve (17) at the top side therein, a port for the safety valve (16) at bottom side external wall thereof, and a port for the quick release button assembly (14) at the right side external wall thereof.
The exhaled air outlet (11) is an outer end of the mounting assembly (102). In an exemplary embodiment of the invention, the exhaled air outlet (11) is made of autoclavable and biocompatible metal. Further, the exhaled air outlet (11) accommodates an air channel for exhaled breaths from the expiratory assembly (30) to the outside of the breathing cassette assembly (100). The air channel ensures that the machine does not get contaminated and the patient’s exhaled breath is released properly after the disinfection process. Additionally, the exhaled air outlet (11) helps in maintaining a contamination-free environment inside ICU. The exhaled air outlet (11) is operably coupled to the non-return valve assembly (1), formed by a simple silicon flap assembly. Further, the non-return valve assembly (1) ensures that the air channel has a unidirectional flow of gases, i.e., from inside to outside. The air outlet assembly includes the channels for the expiratory air outlet, the inspiratory air outlet, the non-return valve assembly (1), and the transmission unit (42).
The UVC disinfector unit (12) disinfects the exhaled air before releasing it into the atmosphere. The UVC disinfector unit (12) comprises a plurality of UV LED lights for disinfecting the gases coming from the expiratory assembly (30), and at least two guide fins to increase the exposure of the gas to LED lights and restrict the light from coming out of the exhaled air outlet (11). The UVC LED lights are placed on a gas chamber in such a way that while the exhaled air passes therethrough, it gets disinfected due to the property of UVC lights before releasing the exhaled air into the air. Further, the UVC disinfector unit (12) is built in such a way that air passing therethrough is circulated due to the guide fins, which increases the exposure time and kills the microorganisms more effectively. The gas flow is then passed through an air channel where the no-return valve (21) is placed using a silicon flap, and at last, the gas is passed to the atmosphere.
The quick-release assembly (14) comprises a snap-fit mechanism allowing press fitting and releasing of the breathing cassette assembly (101) by means of a press button from the mounting assembly (102).
In one of the exemplary embodiment of the invention, the quick-release assembly (14) comprises a spring ejection assembly (13), at least two shafts, a connecting pin, and a button. The spring ejection assembly (13) comprises of at least four springs mounted on four corners of the quick-release assembly (14) on respective screws. The at least two shafts (18) are given inside the mounting assembly, one at top side and one at the bottom side. The at least four springs enable the user to release the breathing cassette assembly (101) by pressing the button. When the button is pressed, the force exerted by each of the at least four springs moves the respective shaft in contact, outwards, to eject the breathing cassette assembly (101) from the mounting assembly (101) for the disengagement.
Advantages of the invention
1. The data logger assembly (40) is integrated with the breathing cassette (101) to ensure proper sterilization of those components which came in contact with the patient’s breath. This prevents any possibility of cross-contamination.
2. The valve assembly ensures the safety of the patients by allowing them to breathe from the atmosphere directly during any adverse event and eliminating suffocation.
3. In the apparatus (100), the components which come in contact with the patient 's breath including the safety valve are removable and autoclavable. The electromagnetic valve and the shaft are configured in isolation from the patient’s breath.
4. The autoclavable non-return valve (21) in the apparatus (100) is designed such that the inspiratory assembly ensures that none of the patient’s breath gets in touch with any sensor or parts inside the ventilator, it eliminates the chances of contamination of any internal components of the ventilator.
5. The quick-release assembly (14) ensures that the removal of the entire breathing cassette (101) from the mounting assembly (102) is easy and hassle-free, by operating the button. Hence, there are no complicated procedures to mount or dismount the breathing cassette (101), and it also ensures that when the breathing cassette (101) is placed back it is sitting properly and there are no leakages.
6. In the apparatus (100), the integrated flow measurement unit can sustain high-temperature sterilization. There is no need for separate tubing or connections, which improves efficiency, ensures hassle-free operations, and reduces the running cost.
7. According to the flow direction of the exhaled gas, the flow collection line is placed in front of the PEEP valve (17), so that the influence of the control PEEP valve (17) on the flow collection module is negligible, thereby improving the flow test accuracy and stability of the PEEP valve control.
8. The integrated UVC disinfection chamber ensures that any gases exhaled by the patient are disinfected before it is released into the atmosphere. This ensures the safety of others nearby and doctors around with reduced cross-contamination.
9. The mounting assembly (102) provides support to all the valves present in the breathing cassette assembly (101), and allows the valves to function properly and precisely without any displacement or vibrations even when the respiratory machine is moving.
The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, and to thereby enable others skilled in the art to best utilize the present invention and various embodiments with various modifications as are suited to the particular use contemplated. It is understood that various omissions and substitutions of equivalents are contemplated as circumstances may suggest or render expedient, but such omissions and substitutions are intended to cover the application or implementation without departing from the scope of the claims of the present invention.
,CLAIMS:We claim:
1. A breathing apparatus (100) comprising,
a mounting assembly (102) fitted on a respiratory machine, the mounting assembly (102) includes,
an air disinfector unit (12) secured in an exhaled breath collecting chamber closer to the exhaled air outlet (11), the air disinfector unit (12) includes a plurality of UV LED lights and at least two guide fins, wherein the plurality of UV LED lights are configured for disinfecting exhaled breaths from the patient before getting released into the atmosphere, and at least two guide fins are configured for restricting the light from coming out of the exhaled air outlet (11) to increase the exposure of the UV LED light inside the chamber,
safety valve (16) secured on the mounting box, the safety valve (16) is configured with ON/OFF functionality for connecting an airway channel to the atmosphere allowing atmospheric breathing for the patient; and
a positive end-expiratory pressure (PEEP) valve (17) secured on the mounting box, the PEEP valve (17) is configured to maintain a minimum pressure at the end of the exhalation cycle and close the airway channel between the atmosphere and the patient’s exhaled breath, after releasing the exhaled air into the atmosphere; and
a breathing cassette assembly (101) detachably secured in the mounting assembly (102), the breathing cassette assembly (101) capable of being autoclavable having,
an air outlet assembly mounted on a mounting box (10), the air outlet assembly includes a plurality of channels for an expiratory air outlet, an inspiratory air outlet/inlet, and a non-return valve assembly (1),
an exhaled air outlet (11) mounted on the mounting box (10), the exhaled air outlet (11) includes an air channel for releasing exhaled breaths from a patient to the atmosphere,
an inspiratory assembly (20), the inspiratory assembly (20) includes,
an air sample collection line setup with the PEEP valve (17), wherein the air sample collection line is configured for monitoring the inspiratory pressure,
a non-return valve (21), the non-return valve (21) is configured for ensuring the unidirectional flow of the gas from the respiratory machine to the patient inlet via a first airway,
a safety valve actuating assembly (22), the safety valve actuating assembly (22) is configured for controlling the ON/OFF functionality of the safety valve (16) and connecting the inlet to the atmosphere via a second airway upon excitation, and
an inspiratory air release pocket (23) connecting the atmospheric air channel to the second airway and a pressure monitoring channel (24),
wherein the inspiratory assembly (20) is configured to allow a unidirectional gas flow towards the inlet, monitor the precise value of inspiratory pressure and ensures air flow from the atmosphere to the inlet in case of failure in the respiratory machine;
an expiratory assembly (30), the expiratory assembly having,
a flow monitoring module (31), the flow monitoring module (31) having a metal flapper (4) and at least two sampling channels (5) secured in exhalation channel, for connecting a differential pressure sensor to measure the flow of air therethrough;
a PEEP valve actuating assembly (32), wherein the PEEP valve actuating assembly (32) is configured to receive a push from the PEEP valve (17) on a membrane therein and disconnect the expiratory airway from the atmosphere to ensure a minimum pressure in the airway suitable for patient’s lung at the end of each of the breath cycles, and
an expiratory air release pocket (33) coupled to the air disinfector unit (12), the expiratory air release pocket (33) allows the exhaled air to be passed through the disinfector unit (12) and then is released into the atmosphere through the non-return valve assembly (1), and
a data logger assembly (40), the data logger assembly (40) having,
a temperature data logger (41) secured on a data logger circuit board, the temperature data logger (41) is configured monitor the temperature and timing during autoclaving process, and
a transmission unit (42) embedded on the data logger circuit board, and is configured to establish communication between the temperature data logger (41) and the respiratory machine,
wherein the data logger assembly (40) is configured for monitoring the sterilization cycle of the breathing cassette assembly (101), comparing with a preset value of temperature and timing, recording temperature values during the sterilization cycle to ensure disinfection process before connecting to the respiratory machine after every use;
wherein the apparatus ensures a unidirectional flow of air from the respiratory machine to the patient via the inspiratory assembly and restricts contamination of the air in the breathing cassette assembly by passing the exhaled air towards the atmosphere after disinfection via the expiratory assembly and allowing sterilization of the breathing cassette assembly and the components therein, that is in direct contact with the patient's breath to make the breathing cassette assembly autoclavable.
2. The apparatus (100) as claimed in claim 1, wherein the safety valve (16) is an electromagnetic valve having a shaft and a pull tubular solenoid with a spring member.
3. The apparatus (100) as claimed in claim 1, wherein the pressure monitoring channel (24) is configured for monitoring the precise value of inspiratory pressure.
4. The apparatus (100) as claimed in claim 1, wherein the sample collection line is configured to collect a sample at the nearest end of the patient inlet for monitoring precise value of inspiratory pressure.
5. The apparatus (100) as claimed in claim 1, wherein the PEEP valve actuating assembly (32) includes a first tube placed below a second tube and a silicon membrane with a metal insert placed on the second tube in such a way that on pressing the silicon membrane, the first tube is blocked and disconnected from the second tube that is connected to the air disinfection unit and releases the gases into the atmosphere after disinfection.
6. The apparatus (100) as claimed in claim 1, wherein the PEEP valve actuating assembly (31) and the safety valve actuating assembly (22) are electromagnetic components triggered by a controller based on the data set by the user and data obtained from the monitoring modules such as a pressure monitoring unit.
7. The apparatus (100) as claimed in claim 1, wherein the positive end-expiratory pressure (PEEP) valve (17) is a voice coil valve operated by moving a shaft between the voice coils in a linear direction in response to the instructions from the controller.
8. The apparatus (100) as claimed in claim 1, wherein the non-return valve (21) is a detachable silicon flap assembly.
9. The apparatus (100) as claimed in claim 1, wherein the non-return valve (21) is configured for ensuring a unidirectional flow of gases, from the respiratory machine to the inlet via an inspiratory channel.
10. The apparatus (100) as claimed in claim 1, wherein the safety valve actuating assembly (22) having, a first duct, a second duct, and a silicon membrane with a metal insert, wherein the first duct is connected to the first airway channel, the second duct with bigger diameter is placed over the first duct, and the silicon membrane with the metal insert is placed on the second duct in such a way that upon pressing the silicon membrane, the first duct is blocked and disconnected from the second duct and upon no pressure applied on the silicon membrane, due to a positive pressure inside the small duct, the silicon membrane stays in an open position and both ducts are interconnected, such that the second airway gets connected to the atmosphere.
11. The apparatus (100) as claimed in claim 1, wherein the exhaled air outlet (11) is made of autoclavable and biocompatible metal.
12. The apparatus (100) as claimed in claim 1, wherein the data logger assembly (40) is configured for keeping a record of the autoclaving process allowing users to access data on temperature and timing after connecting the breathing cassette assembly (101) to the respiratory machine.
13. The apparatus (100) as claimed in claim 1, wherein the data logger assembly (40) is configured for producing warning signals in case of the breathing cassette assembly (101) is not sterilized at a preset temperature for preset time period, before connecting back to the breathing cassette assembly (101) to the respiratory machine.
14. The apparatus (100) as claimed in claim 1, wherein the expiratory assembly (30) is mounted on the mounting assembly (102) by means of a base plate (7).
15. The apparatus (100) as claimed in claim 1, wherein the data logger assembly (40) comprises a power supply unit therein, containing a plurality of batteries with a printed circuit board capable of sustaining autoclaving process.
16. The apparatus (100) as claimed in claim 1, wherein the breathing cassette assembly (101) is secured on the mounting assembly (102) by means of a quick-release assembly (14).
17. The apparatus (100) as claimed in claim 1, wherein the a quick-release assembly (14) comprises a mechanical snap-fit shaft mechanism allowing press fitting and releasing of the breathing cassette assembly (101) by means of a press button from the mounting assembly (102).
Dated this on 19th day of September, 2022

Ragitha. K
(Agent for Applicant)
IN-PA/2832