WO2021210015A1

WO2021210015A1 - A standalone, portable, singleuse and wireless ventilator system and a method for operating thereof

Info

Publication number: WO2021210015A1
Application number: PCT/IN2021/050362
Authority: WO
Inventors: Soundarapandian Santhanakrishnan; Sarathkumar LOGANATHAN; Vinothkumar PARAMASIVAM; Arunn Narasimhan; Rebecca PUNITHAVALLI BONIFACE; Vinoth Kumar Krishnamoorthy
Original assignee: Indian Institute of Technology Madras
Current assignee: Indian Institute of Technology Madras
Priority date: 2020-04-15
Filing date: 2021-04-12
Publication date: 2021-10-21
Anticipated expiration: 2022-10-15

Abstract

A ventilator system having portable ventilation unit wirelessly controlled by a controller is disclosed. The ventilating unit comprises compressor (2) and an oxygen cylinder (1) individually connected with a mixing chamber (3) through a connector (9). The controller (10) determines ventilation parameters (110) required for patient based on prestored patient data (108). The controller (10) further determines compressed air amount and oxygen amount required for the patient based on the ventilation parameters (110). Further, the controller (10) regulates compressor valve and oxygen cylinder valve to enable the compressor (2) and the oxygen cylinder (1) to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber (3) for mixing. Based on the mixing, the controller (10) further regulates the mixing chamber valve to deliver required ventilation amount to the patient.

Description

A STANDALONE, PORTABLE, SINGLEUSE AND WIRELESS VENTILATOR SYSTEM AND A METHOD FOR OPERATING THEREOF

CROSS - REFERENCE TO RELATED PATENT APPLICATION

The embodiments herein claim the priority of Indian patent application 202041016194 filed on April 15, 2020 and the contents of which are included entirely as reference herein.

TECHNICAL FIELD

The present disclosure relates in general to a ventilation system, and more particularly to a standalone portable single-use wireless ventilator.

BACKGROUND

World has witnessed a pandemic type of situation many times. For example, the recent and ongoing pandemic of Coronavirus disease - COVID-19 has already infected more than a million people all over the world, with a significant number under strict quarantine, as nations have gone on lockdown to check the spread of the infection. In such pandemic situations, especially of lung-related infections, quarantined patients require intense medical care and treatment. Artificial respiratory support systems are imperative when the patient is critically ill. Hospitals and medical institutions usually have a limited number of artificial breathing support systems (respiratory systems), which are insufficient to meet the exacerbated demands of a pandemic.

Respiratory systems currently in use are manually operated, require complex infrastructure requirements like centralised 02 supply for the full functionality which makes them difficult to handle. Transport ventilators are temporarily used and are not fully functional. Since current ventilators are being used for multiple patients by multiple doctors, there is huge difficulty to limit the spreading of the disease among patients and the health care employees. There is void for a standalone ventilation system that can be used at any makeshift hospitals and it can be operated wirelessly by eliminating hazard to health care employees.

The respiratory systems that are currently employed must either be discarded or subjected to rigorous sterilization according to medical device regulations, before being used on the next patient. However, if the sterilization is not done properly, it may lead to dangerous situation of passing of the virus to another person. Several medical device manufacturers produce and distribute respiratory systems to health care organizations, but these systems are not individualized and are often expensive. Indigenously manufactured individualized respiratory systems can potentially save more human lives than currently possible. Such systems will also be of use in possible future pandemics. Hence, there is an immediate need of an inexpensive, standalone, single-use, wireless ventilator system for indigenous use.

SUMMARY

In one non-limiting embodiment of the present disclosure, a ventilator system is disclosed. The ventilator system comprises a portable ventilation unit which further comprises a compressor and an oxygen cylinder individually connected with a mixing chamber through a connector. The compressor comprises a compressor valve, the oxygen cylinder comprises oxygen cylinder valve, and the mixing chamber comprises mixing chamber valve. The ventilator system further comprises a controller for wirelessly controlling the portable ventilation unit, wherein the controller comprises a processor and a memory storing patient data. Further, the processor is configured to determine ventilation parameters required for a patient based on the patient data for ensuring personalized usage of the ventilating unit to the patient. The processor is further configured to determine compressed air amount and oxygen amount required for the patient based on the ventilation parameters. Further, the processor is configured to regulate the compressor valve and the oxygen cylinder valve to enable the compressor and the oxygen cylinder to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber for being mixed. The processor is further configured to regulate mixing chamber valve to deliver required ventilation amount to the patient based on the mixing.

In another embodiment of the present disclosure, a method of operating a ventilation system is disclosed. The method comprises providing a portable ventilation unit comprising a compressor and an oxygen cylinder individually connected with a mixing chamber through a connector. The compressor comprises a compressor valve, the oxygen cylinder comprises oxygen cylinder valve, and the mixing chamber comprises mixing chamber valve. The method further comprises providing a controller for wirelessly controlling the portable ventilation unit, wherein the controller comprises a processor and a memory storing patient data. The method further comprises determining, by the processor, ventilation parameters required for a patient based on the patient data for ensuring personalized usage of the ventilating unit to the patient. Further, the method comprises determining, by the processor, compressed air amount and oxygen amount required for the patient based on the ventilation parameters. The method further comprises regulating, by the processor, the compressor valve and the oxygen cylinder valve to enable the compressor and the oxygen cylinder to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber for being mixed. The method further comprises regulating, by the processor, mixing chamber valve to deliver required ventilation amount to the patient based on the mixing.

The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

The accompanying drawings, which are incorporated in and constitute a part of this disclosure, illustrate exemplary embodiments and, together with the description, serve to explain the disclosed principles. In the figures, the left-most digit(s) of a reference number identifies the figure in which the reference number first appears. The same numbers are used throughout the figures to reference like features and components. Some embodiments of system and/or methods in accordance with embodiments of the present subject matter are now described, by way of example only, and with reference to the accompanying figures, in which:

FIG. 1 shows a block diagram of standalone portable single -use wireless ventilator system, in accordance with some embodiments of the present disclosure;

FIG. 2 shows a schematic of mixing chamber of the ventilator system, in accordance with some embodiments of the present disclosure; FIG. 3A and 3B show a parts and functional arrangement of the mixing chamber, in accordance with some embodiments of the present disclosure;

FIG. 4 illustrates a flowchart illustrating a method of operating the ventilator system, in accordance with some embodiments of the present disclosure; and

FIG. 5 shows an example of key values and Spirogram Analysis graph, in accordance with an embodiment of present disclosure.

It should be appreciated by those skilled in the art that any block diagrams herein represent conceptual views of illustrative systems embodying the principles of the present subject matter. Similarly, it will be appreciated that any flow charts, flow diagrams, and the like represent various processes which may be substantially represented in computer readable medium and executed by a computer or processor, whether or not such computer or processor is explicitly shown.

DETAILED DESCRIPTION

In the present document, the word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any embodiment or implementation of the present subject matter described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other embodiments.

While the disclosure is susceptible to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the drawings and will be described in detail below. It should be understood, however that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the disclosure is to cover all modifications, equivalents, and alternative falling within the spirit and the scope of the disclosure.

The terms “comprises”, “comprising”, “includes”, or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a setup, device, apparatus, system or method that comprises a list of components or steps does not include only those components or steps but may include other components or steps not expressly listed or inherent to such setup or device or apparatus or system or method. In other words, one or more elements in a system or apparatus or device proceeded by “comprises... a” does not, without more constraints, preclude the existence of other elements or additional elements in the system or method.

In the following detailed description of the embodiments of the disclosure, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments in which the disclosure may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the disclosure, and it is to be understood that other embodiments may be utilized and that changes may be made without departing from the scope of the present disclosure. The following description is, therefore, not to be taken in a limiting sense.

FIG. 1 shows a block diagram of standalone portable single-use wireless ventilator system, in accordance with some embodiments of the present disclosure.

The ventilator system comprises portable ventilation unit comprising an oxygen cylinder 1, a compressor 2, a mixing chamber 3, patient side 4, motor control drive 5, control valve 6 (i.e., mixing chamber valve associated with the mixing chamber), flow control 7, pressure control 8, connector 9, and Y tube 11. The system further comprises a wireless remote control 10 (i.e., controller) for remotely/wirelessly controlling the portable ventilation unit.

The controller 10 may further comprise a processor 102, Input/ Output (I/O) interface 104, and a memory 106 for storing patient data 108 and ventilation parameters 110. The processor 402 may include specialized processing units such as integrated system (bus) controllers, memory management control units, floating point units, graphics processing units, digital signal processing units. The I/O interface 104 may include a variety of software and hardware interfaces, for example, a web interface, a graphical user interface, input device, output device and the like. The I/O interface 104 may allow the patient and health workers to interact with the ventilation unit. The memory 106 is communicatively coupled to the processor 102. Further, the memory 106 stores patient data 108 and ventilation parameters 110. According to an embodiment, the memory 106 may further comprises set of instructions which may be processed by the processor 102 for performing various operations for controlling the ventilation unit. Now, once the treatment will start, the patient data 108 stored in the memory 106 may be accessed by the processor 102 for determining the ventilation parameters 110 required for the patient. This ensures individualization of ventilator care for best possible care of the patient. It may be understood that the ventilation parameters 110 may vary from one patient to another based on the patient data 108. According to embodiments of present disclosure, the ventilation parameters depend on the type of disease process and other factors. These parameters may be broadly divided into two modes i.e., volume mode and pressure mode. The volume mode may comprise continuous mandatory ventilation (CMV or CV), assisted mandatory ventilation (AMV or AV), intermittent mandatory ventilation (IMV) and SIMV. Similarly, the pressure mode may comprise pressure controlled ventilation (PCV) or pressure support ventilation (PSV), continuous positive airway pressure (CPAP), positive end- expiratory pressure (PEEP), and bilevel positive airway pressure (BiPAP). According to an embodiment of present disclosure, the initial ventilation parameters may comprise following values shown in below table:

Further, the patient’s lung capacity may depend upon the pulmonary function tests done on the patient. Patient’s disease process may be based on saturation and ABG (arterial blood Gases). Further, the controller 10 may also consider additional patient data which may include for example, previous lung surgery, respiratory diseases like (asthma, COPD), renal diseases, neuromuscular diseases, chemotherapy drugs for malignancy, and allergy to drugs.

From the above table, it may be observed that how the ventilation parameters 110 are determined based on different conditions of the patient. Further, an example of Spirogram Analysis graph is shown in figure 5 for better understanding. Figure 5 has been explained here below in detail: - Tidal volume (TV):

Volume of air inspired during quiet breathing = 0.5 liters Inspiratory reserve volume (IRV):

Forced inhalation = 3.0 liters

Maximal (peak) inspiration = 6.0 liters lung volume - Expiratory reserve volume (ERV): The volume of forceful exhalation = L0 liter

Maximal expiration = 1.5 liters lung volume

Residual volume (RV): The volume of air still in the lungs after maximal expiration Lung capacity = sum of two or more lung volumes

Vital capacity (VC): The difference between maximal inspiration and maximal expiration.

VC = TV + IRV + ERV

Total lung capacity (TLC): the total volume of air that the lungs can hold.

TLC = VC + RV

Inspiratory capacity (IC): the maximum volume of air that the lungs can inspire.

IC = IRV +TV

Functional residual capacity (FRC): the volume that remains in the lungs after a single quiet breath.

FRC = ERV + RV

Upon determining the ventilation parameters 110, the controller 10 understands the profile of the patient and his/her requirement. This information further helps the controller for wirelessly controlling the operations of the ventilating unit.

In next step, the processor 102 now determines compressed air amount and oxygen amount required for the patient based on the ventilation parameters 110. That is, the appropriate quantity of compressed air and oxygen required for mixing into the mixing chamber 3 is determined by the controller 10. This data helps the processor 102 to regulate the compressor valve and the oxygen cylinder valve to enable the compressor 2 and the oxygen cylinder 1 to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber 3 for mixing. That is, the processor remotely controls the opening and closing of the control valves (like volume control valve, flow control valve, and pressure control valve) of compressor 2 and oxygen cylinder 1.

According to an embodiment, the compressor 2 may have a following technical specification which may include, for example, Power supply: 240 VAC + 10%, Frequency: 50-60 Hz, Capacity of tank: 2 litre, Peak flow: 3 litre/sec at 1-3 bar, Air filtration: 5pm, and Noise level: < 50 dB. Similarly, the oxygen cylinder 1 may be of 20 litre, 10 litre, and 5 litre capacities which can be used according to the needs of the patient. It may be understood to a skilled person that the compressor 2 and the oxygen cylinder 1 are not limited with the abovementioned technical specification and it may vary according to various embodiments of the present disclosure.

Further, the remotely operated mixing chamber 3 plays a vital role in the ventilating unit. As can be seen from the figure 2 that compressed air amount and oxygen amount enters, in a wirelessly regulated control, into the through inlet 2 and inlet 1 of the mixing chamber 3. It can be observed from figure 2 that a timing valve (4 in Fig. 2) is operated based on the compressed air amount and oxygen amount required for the patient. The operation of the timing valve may be controlled by the controller 10. This allows several configurations such as fully closed, inlet ports open, outlet port open, etc., thereby precisely regulating the flow rates of compressed air, oxygen, and mixed air into the mixing chamber 3.

The mixing chamber 3 may also include virus filtration, filters with pore sizes of 40pm, 20pm, 5pm, and 1pm which are used at various levels before entering into patient’s side. According to other embodiments, the volume capacity of the mixer chamber 3 may vary from 200 ml to 1000 ml. Further, the flow controller and regulator are provided with embedded electrical circuit for remote control and regulation, so that the operator may be insulated from the patient. The various parts and functional arrangement of the mixing chamber are shown in figure 3A and 3B. The technical specification of the mixing chamber 3 may include a cylinder of capacity of 200 ml - 1000 ml, in which, enclosure of cylinder is provided with two inlets and one with opening for connecting the shaft embedded valve. The mixing chamber 3 may further include timing valve with shaft, outer enclosure of mixing chamber, stepper motor, power supply (240 VAC + 10%, 50/60 Hz), programming circuit board, and a display.

Once the mixing is precisely done into the mixing chamber 3, in next step, the processor may regulate the mixing chamber valve to deliver required ventilation amount to the patient. According to embodiments of present disclosure, the controller 10 continuously monitors supply of the ventilation amount to the patient relative to predefined range indicating sufficient amount of ventilation required for the patient. In case a deviation is detected during the monitoring, the controller 10 is further configured to regulate the operations of at least one of the compressor valve, the oxygen cylinder valve, and the mixing chamber valve to keep the supply of the ventilation amount according to the patient’s requirement.

Thus, the disclosed ventilation system provides various advantages over the conventional ventilation system. For example, one of main advantage is that it can be handled wirelessly for providing contactless operation of the ventilator as well as treatment of the patient. Another advantage is that it is an individualized ventilator which further helps in preventing spreading of communicable infections such as COVID-19 to healthcare workers and other patients. Further, the disclosed ventilator system may not only be used during a pandemic like COVID-19 but also while treating prevailing killer respiratory diseases like TB at the primary level.

FIG. 4 illustrates a flowchart illustrating a method of operating the ventilator system, in accordance with some embodiments of the present disclosure.

As illustrated in figure 3, the method 400 includes one or more blocks illustrating a method for operating the ventilator system. The method 400 may be described in the general context of computer executable instructions. Generally, computer executable instructions can include routines, programs, objects, components, data structures, procedures, modules, and functions, which perform specific functions or implement specific abstract data types.

The order in which the method 400 is described is not intended to be construed as a limitation, and any number of the described method blocks can be combined in any order to implement the method. Additionally, individual blocks may be deleted from the methods without departing from the spirit and scope of the subject matter described herein. Furthermore, the method can be implemented in any suitable hardware, software, firmware, or combination thereof.

At block 402, a portable ventilation unit is provided which comprises a compressor 2 and an oxygen cylinder 1 individually connected with a mixing chamber 3 through a connector. The compressor 2 comprises a compressor valve, the oxygen cylinder 1 comprises oxygen cylinder valve, and the mixing chamber 3 comprises mixing chamber valve.

At block 404, a controller 10 is provided for wirelessly controlling the portable ventilation unit. The controller 10 comprises a processor 102 and a memory 106 storing patient data 108. The patient data 106 comprises at least one of patient’s age, patent’s lung capacity data, patient’s disease process, and patient immunity data

At block 406, the processor 102 determines ventilation parameters 110 required for a patient based on the patient data 108 for ensuring personalized usage of the ventilating unit to the patient. The ventilation parameters 110 comprise at least one of tidal volume (TV), partial pressure of oxygen (Pa02), and peak inspiratory pressure.

At block 408, the processor 102 determines compressed air amount and oxygen amount required for the patient based on the ventilation parameters 110.

At block 410, the processor 102 regulates the compressor valve and the oxygen cylinder valve to enable the compressor 2 and the oxygen cylinder 1 to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber 3 for mixing.

At block 412, the processor 102 regulates the mixing chamber valve to deliver required ventilation amount to the patient based on the mixing.

The terms "an embodiment", "embodiment", "embodiments", "the embodiment", "the embodiments", "one or more embodiments", "some embodiments", and "one embodiment" mean "one or more (but not all) embodiments of the invention(s)" unless expressly specified otherwise.

The terms "including", "comprising", “having” and variations thereof mean "including but not limited to", unless expressly specified otherwise. The enumerated listing of items does not imply that any or all of the items are mutually exclusive, unless expressly specified otherwise.

The terms "a", "an" and "the" mean "one or more", unless expressly specified otherwise.

A description of an embodiment with several components in communication with each other does not imply that all such components are required. On the contrary, a variety of optional components are described to illustrate the wide variety of possible embodiments of the invention.

When a single device or article is described herein, it will be readily apparent that more than one device/article (whether or not they cooperate) may be used in place of a single device/article. Similarly, where more than one device or article is described herein (whether or not they cooperate), it will be readily apparent that a single device/article may be used in place of the more than one device or article or a different number of devices/articles may be used instead of the shown number of devices or programs. The functionality and/or the features of a device may be alternatively embodied by one or more other devices which are not explicitly described as having such functionality/features. Thus, other embodiments of the invention need not include the device itself.

Finally, the language used in the specification has been principally selected for readability and instructional purposes, and it may not have been selected to delineate or circumscribe the inventive subject matter. It is therefore intended that the scope of the invention be limited not by this detailed description, but rather by any claims that issue on an application based here on. Accordingly, the embodiments of the present invention are intended to be illustrative, but not limiting, of the scope of the invention, which is set forth in the following claims.

While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope and spirit being indicated by the following claims.

Claims

CLAIMS:

1. A ventilator system comprises: a portable ventilation unit comprising a compressor (2) and an oxygen cylinder (1) individually connected with a mixing chamber (3) through a connector (9), wherein the compressor (2) comprises a compressor valve, the oxygen cylinder (1) comprises oxygen cylinder valve, and the mixing chamber (3) comprises mixing chamber valve, and a controller (10) for wirelessly controlling the portable ventilation unit, wherein the controller (10) comprises a processor (102) and a memory (106) storing patient data (108), and wherein the processor (102) is further configured to: determine ventilation parameters (110) required for a patient based on the patient data (108) for ensuring personalized usage of the ventilating unit to the patient; determine compressed air amount and oxygen amount required for the patient based on the ventilation parameters (110); regulate the compressor valve and the oxygen cylinder valve to enable the compressor (2) and the oxygen cylinder (1) to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber (3) for being mixed; and regulate the mixing chamber valve to deliver required ventilation amount to the patient based on the mixing.

2. The ventilator system as claimed in claim 1, wherein the patient data (108) comprises at least one of patient’s age, patent’s lung capacity data, patient’s disease process, and patient immunity data.

3. The ventilator system as claimed in claim 1, wherein the ventilation parameters (110) comprises at least one of tidal volume (TV), partial pressure of oxygen (Pa02), and peak inspiratory pressure.

4. The ventilator system as claimed in claim 1, wherein the controller (10) is further configured to: continuously monitor supply of the ventilation amount to the patient relative to predefined range indicating sufficient amount of ventilation required for the patient; and regulate the operations of at least one of the compressor valve, the oxygen cylinder valve, and the mixing chamber valve when a deviation is detected during the monitoring.

5. The ventilator system as claimed in claim 1, wherein the compressor valve, the oxygen cylinder valve, and the mixing chamber valve comprises at least one of volume control valve, flow control valve, and pressure control valve.

6. A method of operating a ventilation system, the method comprising: providing a portable ventilation unit comprising a compressor (2) and an oxygen cylinder (1) individually connected with a mixing chamber (3) through a connector (9), wherein the compressor (2) comprises a compressor valve, the oxygen cylinder (1) comprises oxygen cylinder valve, and the mixing chamber (3) comprises mixing chamber valve, and providing a controller (10) for wirelessly controlling the portable ventilation unit, wherein the controller (10) comprises a processor (102) and a memory (106) storing patient data (108), and wherein the method further comprising: determining, by the processor (102), ventilation parameters (110) required for a patient based (108) on the patient data for ensuring personalized usage of the ventilating unit to the patient; determining, by the processor (102), compressed air amount and oxygen amount required for the patient based on the ventilation parameters (110); regulating, by the processor (102), the compressor valve and the oxygen cylinder valve to enable the compressor (2) and the oxygen cylinder (1) to deliver the compressed air amount and the oxygen amount required for the patient into the mixing chamber (3) for being mixed; and regulating, by the processor (102), the mixing chamber valve to deliver required ventilation amount to the patient based on the mixing.

7. The method as claimed in claim 6, wherein the patient data (108) comprises at least one of patient’s age, patent’s lung capacity data, patient’s disease process, and patient immunity data.

8. The method as claimed in claim 6, wherein the ventilation parameters (110) comprises at least one of tidal volume (TV), partial pressure of oxygen (Pa02), and peak inspiratory pressure.

9. The method as claimed in claim 6, is further comprising: continuously monitoring, by the processor (102), supply of the ventilation amount to the patient relative to predefined range indicating sufficient amount of ventilation required for the patient; and regulating, by the processor (102), the operations of at least one of the compressor valve, the oxygen cylinder valve, and the mixing chamber valve when a deviation is detected during the monitoring.

10. The method as claimed in claim 6, wherein the compressor valve, the oxygen cylinder valve, and the mixing chamber valve comprises at least one of volume control valve, flow control valve, and pressure control valve.